Microsoft · 2017. 2. 7. · UNITED STA1ES PA1ENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF...

UNITED STA1ES PA1ENT AND TRADEMARK OFFICE

UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS

P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov

APPLICATION NO. ISSUE DATE PATENT NO. ATTORNEY DOCKET NO. CONFIRMATION NO.

13/397,398 03/01/2016 9272280 10114-003US1 1282

96039 7590 02/10/2016

Meunier Carlin & Curfman LLC 999 Peachtree Street NE Suite 1300 Atlanta, GA 30309

ISSUE NOTIFICATION

The projected patent number and issue date are specified above.

Determination of Patent Term Adjustment under 35 U.S.C. 154 (b) (application filed on or after May 29, 2000)

The Patent Term Adjustment is 0 day(s). Any patent to issue from the above-identified application will include an indication of the adjustment on the front page.

If a Continued Prosecution Application (CPA) was filed in the above-identified application, the filing date that determines Patent Term Adjustment is the filing date of the most recent CPA.

Applicant will be able to obtain more detailed information by accessing the Patent Application Information Retrieval (PAIR) WEB site (http://pair.uspto.gov).

Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the Office of Patent Legal Administration at (571)-272-7702. Questions relating to issue and publication fee payments should be directed to the Application Assistance Unit (AAU) of the Office of Data Management (ODM) at (571)-272-4200.

APPLICANT(s) (Please see PAIR WEB site http://pair.uspto.gov for additional applicants):

Francesco Viola, Charlottesville, VA; William F. Walker, Charlottesville, VA; Gregory V. Browne, Victoria, CANADA; Robert S. Magyar, Victoria, CANADA; Name Hansen, Victoria, CANADA; Christopher G. Denny, Victoria, CANADA, Deceased; Karen Platt, Victoria, BC, CANADA, Legal Representative;

The United States represents the largest, most dynamic marketplace in the world and is an unparalleled location for business investment, innovation, and commercialization of new technologies. The USA offers tremendous resources and advantages for those who invest and manufacture goods here. Through SelectUSA, our nation works to encourage and facilitate business investment. To learn more about why the USA is the best country in the world to develop technology, manufacture products, and grow your business, visit SelectUSA.gov.

IR103 (Rev. 10/09) IL Exhibit 1009 Page 1 of 907

Receipt date: 12/21/2012

Sheet 4 of 6

Substitute Form PTO-1449 U.S. Department of Commerce (Modified) Patent and Trademark Office

Information Disclosure Statement by Applicant

(Use several sheets if necessary()

(37 CFR §1.98(b))

Attorney Docket No.

10114-003US1 Application No.

13/397,398 Applicant

Francesco Viola Filing Date

February 15, 2012 Group Art Unit 1773 13397398 - AU: 1791

U.S. Patent Application Publications Examiner

Initial Desig.

ID Document Number

Publication Date Patentee Class Sub class

Filing Date If Appropriate

A80 20030204141 2003-10-30 Nock et al.

s) aoplieci A81 20040068184 2004-04-08 Trake9 et al.

lent, A82 20040167403 2004-08-26 Nightingale et al.

A83 20050004463 2005-01-06 Chen et al.

.015 A84 20050015001 2005-01-20 Lec et al.

A85 20050053305 05/2005

2002-01-31 Li et al.

A86 20050148899 2005-07-07 Walker et al.

A87 20070038095 '21: -I. - Greenleaf et al.

A88 20070059840 02/2007

2007-03-15 Cohen et al.

A89 20070184508 2007-08-09 Cohen et al.

A90 20070276236 2007-11-29 Jong

A91 20080038828 2008-02-14 Cohen et al.

A92 20080249408 2008-10-09 Palmeri et al.

A93 20080261261 2008-10-23 Grimes et al.

A94 20090112483 2009-04-30 Cohen

A95 20120252127 2012-10-04 Bansil et al.

Foreign Patent Documents or Published Foreign Patent Applications Examiner

Initial Desig.

ID Document

Number Publication

Date Country or

Patent Office Class SubclassYes Translation

No

A96 2011035162 2011-03-24 WO

Other Documents (include Author, Title, Date, and Place of Publication) Examiner

Initial Desig.

ID Document

A97 Beer: Center for Reproductive Immunology & Genetics, "Thrombophilia: Inherited and Acquired," 6 pages, Fap://repro-med.net/papers/thromb.php. NO DATE

A98 Bell, et al., "Thrombelastographic evaluation of coagulation in transurethral prostatectomy," British Journal of Urology, Vol. 78, No. 5, 1996, pp. 737-741.

A99 Bombeli, et al., "Updates in perioperative coagulation: physiology and management of thromboembolism and haemorrhage," British Journal of Anaesthesia; Vol. 93, No. 2, August 2004, pp. 275-287.

Examiner Signature /Brittany Fisher/

Date Considered11/02/2015

EXAMINER: Initials citation considered. Draw line through citation if not in conformance and not considered. Include copy of this form with next communication to applicant

Substitute Disclosure Form (PTO-1449)

ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH, /BF/

Ckange

to ciocu

/K.5/

IL Exhibit 1009 Page 2 of 907


Sheet 3 of 6



(Use several sheets if necessary)

(37 CFR §1.98(b))

Attorney Docket No.





U.S. Patents Examiner

Initial Desig.

ID Document Number



A55 6764448 2004-07-20 Trahey et al.

A56 6787363 2004-09-04 Cohen et al.

A57 6797519 2004-09-28 Cohen et al.

A58 6890299 2005-05-10 Cohen et al.

A59 6951544 2005-10-04 Trahey et al.

A60 7179652 2007-02-20 Cohen et al.

A61 7192726 2007-03-30 Carr, Jr. et al.

A62 7202048 2007-04-10 Carr, Jr.

A63 7207939 2007-04-24 Husher

A64 7261861 2007-08-28 Kautzky

A65 7374538 2008-05-20 Nightingale et al.

A66 7399637 2008-07-15 Wright et al.

A67 7422905 2008-09-09 Clague et al.

A68 7439069 2008-10-21 Nippoldt et al.

A69 7524670 2009-04-28 Cohen et al.

A70 7732213 2010-06-08 Cohen et al.

A71 7912661 2011-03-22 Zeng

A72 7972271 2011-07-05 Johnson et al.

A73 8058023 2011-11-15 Gurbel


Initial Desig.

ID Document Number Publication Date Patentee Class Sub

class Filing Date

If Appropriate

A74 20020013530 2002-01-31 Cespedes et al.

A75 20020040187 2002-04-04 Alam et al.

A76 20030013958 2003-01-16 Govari et al.

A77 20030073244 2003-04-17 Cohen et al.

A78 20030105398 2003-06-05 Vitek

A79 20030171676 2003-09-11 Trake,9 et al. Wall(cr ct al. 51Wrriiiiie7cSiignature lent, /Brittany Fisher/

Date Considered 11102/2015




Change

to clocu

AK.5/ 1 2/1 -1-,/



Sheet 2 of 6




(37 CFR §1.98(b))

Attorney Docket No.






Initial Desig.

ID Document Number



A28 6039691 2000-03-21 Walker et al.

A29 6083159 2000-07-04 Driscoll, Jr. et al.

A30 6114135 2000-09-05 Goldstein

A31 6117081 2000-09-12 Jago et al.

6,15 5,957 A32 2000-10-24 Cohen et al. 8135954

A33 6213950 2001-04-10 Cespedes et al.

A34 6225126 2001-05-01 Cohen et al.

A35 6264609 2001-07-24 Herrington et al.

A36 6270459 2001-08-07 Konofagou et al.

A37 6277074 2001-08-21 Chaturvedi et al.

A38 6283917 2001-09-04 Jago et al.

A39 6371912 2002-04-16 Nightinggale et al.

A40 6402704 2002-06-11 McMorrow

A41 6454714 2002-09-24 Ng et al.

A42 6494834 2002-12-14 Konofagou et al.

A43 6508768 2003-01-21 Hall et al.

A44 6514204 2003-02-04 Alam et al.

A45 6535835 2003-03-18 Rubin et al.

A46 6537819 2003-03-25 Cohen et al.

A47 6573104 2003-06-03 Carr, Jr. et al.

A48 6613573 2003-09-02 Cohen

A49 6632678 2003-10-14 Aiken et al.

A50 6685646 2004-02-03 Cespedes et al.

A51 6687625 2004-02-03 Srinivasan et al.

A52 6692439 2004-02-17 Walker et al.

,, 1,,,4 rr A53 6716166

400/2004 - Nock et al.

lent, A54 6726629 2004-04-27 Frinking et al.

Examiner Signature 015 /Brittany Fisher/

Date Considered 11/02/2015




Change

to clocu

/K.5/ 12/14/



Sheet 1 of 6




(37 CFR §1.98(b))

Attorney Docket No.






Initial Desig.

ID Document Number Publication Date

05/2001 Patentee

5r eke et al_ Class

Sub class


s) appiieci Al RE37171 -• -• McCormick et a1.

lent, A2 4112740 1978-09-12 Brandestini

A3 4558589 1985-12-17 Hemmes et al.

.015 A4 4695956 1987-09-22 Leveen et al.

A5 4705756 1987-11-10 Spilled et al.

A6 4814247 1989-03-31 Spilled et al.

A7 4852577 1989-08-01 Smith et al.

A8 4900679 1990-02-13 Spilled et al.

A9 5056357 1991-10-15 Dynnling et al.

A10 5104975 1992-04-14 McCormick et al.

Al 1 5205159 1993-04-27 Carr, Jr.

Al2 5234839 1993-08-10 McCormick et al.

A13 5273517 1993-12-28 Barone et al.

A14 531190 5/199+ - -II - l' Barone et al.

A15 5331964 1994-07-26 Trahey et al.

A16 5473536 1995-12-05 Wimmer

A17 5487387 1996-01-30 Trahey et al.

A18 5605154 1997-02-25 Ries et al.

A19 5606971 1997-03-04 Sarvazyan et al.

A20 5655535 1997-08-12 Friemel et al.

A21 5657760 1997-08-19 Ying et al.

A22 5673699 1997-10-07 Trahey et al.

A23 5744898 1998-04-28 Smith et al.

A24 5810731 1998-09-22 Sarvazyan et al.

A25 5854423 1998-12-29 Venegas

A26 5899861 1999-05-04 Friemel et al.

A27 5921928 1999-07-13 Greenleaf et al.

Examiner Signature /Brittany Fisher/ Date Considered

11/02/2015




Ckange

to clocu

AK.5/ 12/14/


PART B - FEE(S) TRANSMITTAL

Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE Commissioner for Patents P.O. Box 1450 Alexandria, Virginia 22313-1450

or Fax (571)-273-2885

INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks 1 through 5 should be completed where appropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as indicated unless corrected below or directed otherwise in Block 1, by (a) specifying a new correspondence address; and/or (b) indicating a separate "FEE ADDRESS" for maintenance fee notifications.

CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 for any change of address)

96039 7590 11/06/2015


Note: A certificate of mailing can only be used for domestic mailings of the Fee(s) Transmittal. This certificate cannot be used for any other accompanying papers. Each additional paper, such as an assignment or formal drawing, must have its own certificate of mailing or transmission.

Certificate of Mailing or Transmission I hereby certify that this Fee(s) Transmittal is being deposited with the United States Postal Service with sufficient postage for first class mail in an envelope addressed to the Mail Stop ISSUE FEE address above, or being facsimile transmitted to the USPTO (571) 273-2885, on the date indicated below.

(Depositor's name)

(Signature)

(Date)

APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.

13/397,398 02/15/2012 Francesco Viola 10114-003US1 1282

TITLE OF INVENTION: DEVICES, SYSTEMS AND METHODS FOR EVALUATION OF HEMOSTASIS

APPLN. TYPE ENTITY STATUS ISSUE FEE DUE PUBLICATION FEE DUE PREY. PAID ISSUE FEE TOTAL FEE(S) DUE DATE DUE

nonprovisional SMALL $480 $0 $0 $480 02/08/2016

EXAMINER ART UNIT CLASS-SUBCLASS

FISHER, BRITTANY I 1798 422-069000

1. Change of correspondence address or indication of "Fee Address" (37 CFR 1.363).

❑ Change of correspondence address (or Change of Correspondence Address form PTO/SB/122) attached.

❑ "Fee Address" indication (or "Fee Address" Indication form PTO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer Number is required.

2. For printing on the patent front page, list

(1) The names of up to 3 registered patent attorneys or agents OR, alternatively,

(2) The name of a single firm (having as a member a registered attorney or agent) and the names of up to 2 registered patent attorneys or agents. If no name is listed, no name will be printed.

1 Meunier Carlin & Curfman LLC

2

3

3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)

PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent. If an assignee is identified below, the document has been filed for recordation as set forth in 37 CFR 3.11. Completion of this form is NOT a substitute for filing an assignment.

(A) NAME OF ASSIGNEE (B) RESIDENCE: (CITY and STATE OR COUNTRY)

HemoSonics LLC Charlottesville, Virginia

Please check the appropriate assignee category or categories (will not be printed on the patent) : ❑ Individual 0 Corporation or other private group entity ❑ Government

4a. The following fee(s) are submitted:

0 Issue Fee

❑ Publication Fee (No small entity discount permitted)

❑ Advance Order - # of Copies

4b. Payment of Fee(s): (Please first reapply any previously paid issue fee shown above)

❑ A check is enclosed.

Payment by credit card. Form PTO-2038 is attached.

The director is hereby authorized to charge the required fee(s), any deficiency, or credits any overpayment, to Deposit Account Number 50-5226 (enclose an extra copy of this form).

5. Change in Entity Status (from status indicated above)

❑ Applicant certifying micro entity status. See 37 CFR 1.29

❑ Applicant asserting small entity status. See 37 CFR 1.27

❑ Applicant changing to regular undiscounted fee status.

NOTE: Absent a valid certification of Micro Entity Status (see forms PTO/SB/15A and 15B), issue fee payment in the micro entity amount will not be accepted at the risk of application abandonment.

NOTE: If the application was previously under micro entity status, checking this box will be taken to be a notification of loss of entitlement to micro entity status.

NOTE: Checking this box will be taken to be a notification of loss of entitlement to small or micro entity status, as applicable.

NOTE: This form must be signed in accordance with 37 CFR 1.31 and 1.33. See 37 CFR 1.4 for signature requirements and certifications.

Authorized Signature Is/ T. Paul Tanpitukpongse /s/

Typed or printed name T. Paul Tanpitukpongse

Date January 21, 2016

Registration No. 71,589

Page 2 of 3

PTOL-85 Part B (10-13) Approved for use through 10/31/2013. OMB 0651-0033 U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE


Electronic Patent Application Fee Transmittal

Application Number: 13397398

Filing Date: 15-Feb-2012

Title of Invention: DEVICES, SYSTEMS AND METHODS FOR EVALUATION OF HEMOSTASIS

First Named Inventor/Applicant Name: Francesco Viola

Filer: Teeporn Paul Tanpitukpongse/Amanda Thomason

Attorney Docket Number: 10114-003US1

Filed as Small Entity

Filing Fees for Utility under 35 USC 111(a)

Description Fee Code Quantity Amount Sub-Total in

USD($)

Basic Filing:

Pages:

Claims:

Miscellaneous-Filing:

Petition:

Patent-Appeals-and-Interference:

Post-Allowance-and-Post-Issuance:

Utility Appl Issue Fee 2501 1 480 480


Description Fee Code Quantity Amount Sub-Total in

USD($)

Extension-of-Time:

Miscellaneous:

Total in USD ($) 480


Electronic Acknowledgement Receipt

EFS ID: 24687346


International Application Number:

Confirmation Number: 1282



Customer Number: 96039


Filer Authorized By: Teeporn Paul Tanpitukpongse


Receipt Date: 21-JAN-2016

Filing Date: 15-FEB-2012

Time Stamp: 15:44:42

Application Type: Utility under 35 USC 111(a)

Payment information:

Submitted with Payment yes

Payment Type Credit Card

Payment was successfully received in RAM $480

RAM confirmation Number 2453

Deposit Account

Authorized User

The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:


File Listing:

Document Number

Document Description File Name File Size(Bytes)/ Message Digest

Multi Part /.zip

Pages (if appl.)

1 Issue Fee Payment (PTO-85B) 10114_003US1_IssueFee.pdf

147127

no 1

8dc822ba8ee6008dd980dee787930c0c06 e17d4

Warnings:

Information:

2 Fee Worksheet (SB06) fee-info.pdf

30603

no 2

6123d3e6a3e24e0181c784dbcdbffcaec340 17d9

Warnings:

Information:

Total Files Size (in bytes): 177730

This Acknowledgement Receipt evidences receipt characterized by the applicant, and including page Post Card, as described in MPEP 503.

New Applications Under 35 U.S.C. 111

on the noted date by the USPTO counts, where applicable.

includes the necessary components 1.54) will be issued in due date of the application.

35 U.S.C. 371

of the indicated documents, It serves as evidence of receipt similar to a

for a filing date (see 37 CFR course and the date shown on this

is compliant with the conditions of 35 acceptance of the application as a

Filing Receipt, in due course.

includes the necessary components for of the International Application Number

subject to prescriptions concerning establish the international filing date of

If a new application is being filed and the application 1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR Acknowledgement Receipt will establish the filing

National Stage of an International Application under If a timely submission to enter the national stage of an international application U.S.C. 371 and other applicable requirements a Form PCT/DO/E0/903 indicating national stage submission under 35 U.S.C. 371 will be issued in addition to the

New International Application Filed with the USPTO as a Receiving Office If a new international application is being filed and the international application an international filing date (see PCT Article 11 and MPEP 1810), a Notification and of the International Filing Date (Form PCT/RO/105) will be issued in due course, national security, and the date shown on this Acknowledgement Receipt will the application.


UNITED STATES PATENT AND TRADEMARK OFFICE


P.O.Box 1450 Alexandria, VirgLnia 22313-1450 www.uspto.gov

AP NUMBER PLICATION I 371(c) FILIN

DATE G or I G

UNIT I

IT FIL FEE RECD I ATTY.DOCKET.NO ITOT CLAIMS I IND CLAIMS

13/397,398 02/15/2012

96039 Meunier Carlin & Curfman LLC 999 Peachtree Street NE Suite 1300 Atlanta, GA 30309

1798 795 10114-003US1 20 2 CONFIRMATION NO. 1282

CORRECTED FILING RECEIPT

11111111111111111111111111A1411111 111111 1111111111111111111111

Date Mailed: 12/08/2015

Receipt is acknowledged of this non-provisional patent application. The application will be taken up for examination in due course. Applicant will be notified as to the results of the examination. Any correspondence concerning the application must include the following identification information: the U.S. APPLICATION NUMBER, FILING DATE, NAME OF APPLICANT, and TITLE OF INVENTION. Fees transmitted by check or draft are subject to collection. Please verify the accuracy of the data presented on this receipt. If an error is noted on this Filing Receipt, please submit a written request for a Filing Receipt Correction. Please provide a copy of this Filing Receipt with the changes noted thereon. If you received a "Notice to File Missing Parts" for this application, please submit any corrections to this Filing Receipt with your reply to the Notice. When the USPTO processes the reply to the Notice, the USPTO will generate another Filing Receipt incorporating the requested corrections

I nventor(s) Francesco Viola, Charlottesville, VA; William F. Walker, Charlottesville, VA; Gregory V. Browne, Victoria, CANADA; Robert S. Magyar, Victoria, CANADA; Bjarne Hansen, Victoria, CANADA; Christopher G. Denny, Victoria, CANADA, Deceased;

Applicant(s) Karen Platt, Victoria, BC, CANADA, Legal Representative;

Assignment For Published Patent Application HEMOSONICS LLC, Charlottesville, VA

Power of Attorney: None

Domestic Priority data as claimed by applicant This appin claims benefit of 61/443,088 02/15/2011

Foreign Applications for which priority is claimed (You may be eligible to benefit from the Patent Prosecution Highway program at the USPTO. Please see http://www.uspto.gov for more information.) - None. Foreign application information must be provided in an Application Data Sheet in order to constitute a claim to foreign priority. See 37 CFR 1.55 and 1.76.

Permission to Access Application via Priority Document Exchange: No

Permission to Access Search Results: No

page 1 of 4


Applicant may provide or rescind an authorization for access using Form PTO/SB/39 or Form PTO/SB/69 as appropriate.

If Required, Foreign Filing License Granted: 02/29/2012

The country code and number of your priority application, to be used for filing abroad under the Paris Convention, is US 13/397,398 Projected Publication Date: Not Applicable

Non-Publication Request: No

Early Publication Request: No ** SMALL ENTITY ** Title

DEVICES, SYSTEMS AND METHODS FOR EVALUATION OF HEMOSTASIS

Preliminary Class

422

Statement under 37 CFR 1.55 or 1.78 for AIA (First Inventor to File) Transition Applications:

PROTECTING YOUR INVENTION OUTSIDE THE UNITED STATES

Since the rights granted by a U.S. patent extend only throughout the territory of the United States and have no effect in a foreign country, an inventor who wishes patent protection in another country must apply for a patent in a specific country or in regional patent offices. Applicants may wish to consider the filing of an international application under the Patent Cooperation Treaty (PCT). An international (PCT) application generally has the same effect as a regular national patent application in each PCT-member country. The PCT process simplifies the filing of patent applications on the same invention in member countries, but does not result in a grant of "an international patent" and does not eliminate the need of applicants to file additional documents and fees in countries where patent protection is desired.

Almost every country has its own patent law, and a person desiring a patent in a particular country must make an application for patent in that country in accordance with its particular laws. Since the laws of many countries differ in various respects from the patent law of the United States, applicants are advised to seek guidance from specific foreign countries to ensure that patent rights are not lost prematurely.

Applicants also are advised that in the case of inventions made in the United States, the Director of the USPTO must issue a license before applicants can apply for a patent in a foreign country. The filing of a U.S. patent application serves as a request for a foreign filing license. The application's filing receipt contains further information and guidance as to the status of applicant's license for foreign filing.

Applicants may wish to consult the USPTO booklet, "General Information Concerning Patents" (specifically, the section entitled "Treaties and Foreign Patents") for more information on timeframes and deadlines for filing foreign patent applications. The guide is available either by contacting the USPTO Contact Center at 800-786-9199, or it can be viewed on the USPTO website at http://www.uspto.gov/web/offices/pac/doc/general/index.html.

For information on preventing theft of your intellectual property (patents, trademarks and copyrights), you may wish to consult the U.S. Government website, http://www.stopfakes.gov. Part of a Department of Commerce initiative, this website includes self-help "toolkits" giving innovators guidance on how to protect intellectual property in specific

page 2 of 4


countries such as China, Korea and Mexico. For questions regarding patent enforcement issues, applicants may call the U.S. Government hotline at 1-866-999-HALT (1-866-999-4258).

LICENSE FOR FOREIGN FILING UNDER

Title 35, United States Code, Section 184

Title 37, Code of Federal Regulations, 5.11 & 5.15

GRANTED

The applicant has been granted a license under 35 U.S.C. 184, if the phrase "IF REQUIRED, FOREIGN FILING LICENSE GRANTED" followed by a date appears on this form. Such licenses are issued in all applications where the conditions for issuance of a license have been met, regardless of whether or not a license may be required as set forth in 37 CFR 5.15. The scope and limitations of this license are set forth in 37 CFR 5.15(a) unless an earlier license has been issued under 37 CFR 5.15(b). The license is subject to revocation upon written notification. The date indicated is the effective date of the license, unless an earlier license of similar scope has been granted under 37 CFR 5.13 or 5.14.

This license is to be retained by the licensee and may be used at any time on or after the effective date thereof unless it is revoked. This license is automatically transferred to any related applications(s) filed under 37 CFR 1.53(d). This license is not retroactive.

The grant of a license does not in any way lessen the responsibility of a licensee for the security of the subject matter as imposed by any Government contract or the provisions of existing laws relating to espionage and the national security or the export of technical data. Licensees should apprise themselves of current regulations especially with respect to certain countries, of other agencies, particularly the Office of Defense Trade Controls, Department of State (with respect to Arms, Munitions and Implements of War (22 CFR 121-128)); the Bureau of Industry and Security, Department of Commerce (15 CFR parts 730-774); the Office of Foreign AssetsControl, Department of Treasury (31 CFR Parts 500+) and the Department of Energy.

NOT GRANTED

No license under 35 U.S.C. 184 has been granted at this time, if the phrase "IF REQUIRED, FOREIGN FILING LICENSE GRANTED" DOES NOT appear on this form. Applicant may still petition for a license under 37 CFR 5.12, if a license is desired before the expiration of 6 months from the filing date of the application. If 6 months has lapsed from the filing date of this application and the licensee has not received any indication of a secrecy order under 35 U.S.C. 181, the licensee may foreign file the application pursuant to 37 CFR 5.15(b).

SelectUSA

The United States represents the largest, most dynamic marketplace in the world and is an unparalleled location for business investment, innovation, and commercialization of new technologies. The U.S. offers tremendous resources and advantages for those who invest and manufacture goods here. Through SelectUSA, our nation works to promote and facilitate business investment. SelectUSA provides information assistance to the international investor community; serves as an ombudsman for existing and potential investors; advocates on behalf of U.S. cities, states, and regions competing for global investment; and counsels U.S. economic development organizations on investment attraction best practices. To learn more about why the United States is the best country in the world to develop

page 3 of 4


technology, manufacture products, deliver services, and grow your business, visit http://www.SelectUSA.gov or call +1-202-482-6800.

page 4 of 4


Attorney Docket No. 10114-003US1

IN THE UNITED STATES PATENT AND TRADEMARK OFFICE

Inventor(s) : Francesco Viola Art Unit : 1798 Application No. : 13/397,398 Examiner : Fisher, Brittany I Filed : February 15, 2012 Conf. No. : 1282 Title : DEVICES, SYSTEMS AND METHODS FOR EVALUATION OF

HEMOSTASIS

Mail Stop Missing Parts Commissioner for Patents P.O. Box 1450 Alexandria, VA 22313-1450

RESPONSE TO NOTICE TO FILE CORRECTED APPLICATION PAPERS

In response to the Notice to File Corrected Application Papers mailed November 19,

2015, Applicant submits herewith a corrected ADS, identifying the correspondence address for

the deceased inventor. This Response is timely and it perfects the application and no additional

papers or filing fees are required.

No fees are believed to be due in connection with this submission. However, the

Commissioner is hereby authorized to charge any fees that may be required, or credit any

overpayments, to Deposit Account No. 50-5226.

Respectfully submitted

MEUNIER CARLIN & CURFMAN LLC

Date: December 4, 2015 /s/ T. Paul Tanpitukpongse /s/ T. Paul Tanpitukpongse Reg. No. 71,589

Customer No. 96039 [email protected] 404.645.7700 Phone 404.645.7707 Fax



EFS ID: 24268894








Filer Authorized By: Teeporn Paul Tanpitukpongse


Receipt Date: 04-DEC-2015





Submitted with Payment no

File Listing:

Document Number


Multi Part /.zip

Pages (if appl.)

1 Application Data Sheet 10114_003US1_ADS.pdf

99122

no 6

0949818c04911e7f6c1eb4d821e50368d64 163e

Warnings:

Information: IL Exhibit 1009 Page 16 of 907

This is not an USPTO supplied ADS fillable form

16158

2 Transmittal Letter 10114_003US1_Response.pdf no 1

7232917.63423a290&476728965a195a 176369

Warnings:

Information:


This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents, characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a Post Card, as described in MPEP 503.

New Applications Under 35 U.S.C. 111 If a new application is being filed and the application includes the necessary components for a filing date (see 37 CFR 1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this Acknowledgement Receipt will establish the filing date of the application.

National Stage of an International Application under 35 U.S.C. 371 If a timely submission to enter the national stage of an international application is compliant with the conditions of 35 U.S.C. 371 and other applicable requirements a Form PCT/DO/E0/903 indicating acceptance of the application as a national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.

New International Application Filed with the USPTO as a Receiving Office If a new international application is being filed and the international application includes the necessary components for an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the International Application Number and of the International Filing Date (Form PCT/RO/105) will be issued in due course, subject to prescriptions concerning national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of the application.


Attorney Docket Number

Application Number

10114-003US1

13/397,398 Application Data Sheet 37 CFR 1.76

Title of Invention Devices, Systems and Methods For Evaluation of Hemostasis

The application data sheet is part of the provisional or nonprovisional application for which it is being submitted. The following form contains the bibliographic data arranged in a format specified by the United States Patent and Trademark Office as outlined in 37 CFR 1.76. This document may be completed electronically and submitted to the Office in electronic format using the Electronic Filing System (EFS) or the document may be printed and included in a paper filed application.

PTO/SB/14 (11-08) Approved for use through 09/30/2010. OMB 0651-0032

U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE

Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.

Secrecy Order 37 CFR 5.2 n Portions or all of the application associated with this Application Data Sheet may fall under a Secrecy Order pursuant to

37 CFR 5.2 (Paper filers only. Applications that fall under Secrecy Order may not be filed electronically.)

Applicant Information:

Applicant 1

Applicant Authority ()Inventor QLegal Representative under 35 U.S.C. 117 QParty of Interest under 35 U.S.C. 118

Prefix Given Name Middle Name Family Name Suffix

Francesco Viola

Residence Information (Select One) 0 US Residency 0 Non US Residency Q Active US Military Service

City Charlottesville State/Province VA Country of Residence US

Citizenship under 37 CFR 1.41(b) US

Mailing Address of Applicant:

Address 1 745 Walker Square

Address 2 #3C

City Charlottesville State/Province VA

Postal Code 22903 Country US

Applicant 2

Applicant Authority *Inventor QLegal Representative under 35 U.S.C. 117 QParty of Interest under 35 U.S.C. 118


William F. Walker

Residence Information (Select One) 0 US Residency Q Non US Residency Q Active US Military Service

City Charlottesville State/Province VA Country of Residence US

Citizenship under 37 CFR 1.41(b) US


Address 1 778 Belvedere Blvd.

Address 2


Postal Code 22901 Country US

Applicant 3

Applicant Authority ()Inventor QLegal Representative under 35 U.S.C. 117 0Party of Interest under 35 U.S.C. 118


Gregory V. Browne

Residence Information (Select One) 0 US Residency ® Non US Residency Q Active US Military Service

City Victoria Country Of Residence s CA

EFS Web 2.2.2



U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.

Application Data Sheet 37 CFR 1.76 Attorney Docket Number 10114-003US1

Application Number 13/397,398


Citizenship under 37 CFR 1.41(b) CA


Address 1 617 Pine Street

Address 2

City Victoria State/Province BC

Postal Code V8V 2P6 Country CA

Applicant 4

Applicant Authority ()Inventor °Legal Representative under 35 U.S.C. 117 0Party of Interest under 35 U.S.C. 118


Robert S. Magyar

Residence Information (Select One) 0 US Residency ® Non US Residency 0 Active US Military Service




Address 1 1826 Belmont Ave.

Address 2


Postal Code V8R 3Z2 Country CA

Applicant 5

Applicant Authority °Inventor °Legal Representative under 35 U.S.C. 117 0Party of Interest under 35 U.S.C. 118


Bjarne Hansen

Residence Information (Select One) 0 US Residency ® Non US Residency 0 Active US Military Service




Address 1 1000 DeCosta Place

Address 2


Postal Code V9A 6Y3 Country CA

Applicant 6

Applicant Authority °Inventor ()Legal Representative under 35 U.S.C. 117 0Party of Interest under 35 U.S.C. 118

If applicant is not an inventor, indicate the authority to file for the patent on behalf of the inventor, the inventor is:

Deceased


Christopher G. Denny

Residence Information (Select One) 0 US Residency (D Non US Residency 0 Active US Military Service

EFS Web 2.2.2







City Victoria Country Of Residences 96,



Address 1 170 Denison Road

Address 2


Postal Code V82 4K3 Country CA,

If the representative for the inventor is an Organization check here. ❑


Karen Platt

Residence Information of the Inventor's Representative:

Residence Information (Select One) Q US Residency ® Non US Residency 0 Active US Military Service

City Victoria Country Of Residence CA

Citizenship under 37 CFR 1.41(b)i CA

Mailing Address of the Inventor's Representative:

Address 1 170 Denison Road

Address 2


Postal Code V82 4K3 Country CA

All Inventors Must Be Listed Additional Inventor Information blocks be - may this form by the Add button. generated within selecting

Correspondence Information: Enter either Customer Number or complete the Correspondence Information section below. For further information see 37 CFR 1.33(a).

❑ An Address is being provided for the correspondence Information of this application.

Customer Number 96039

Email Address [email protected]

Application Information:

Title of the Invention Devices, Systems and Methods For Evaluation of Hemostasis

Attorney Docket Number 10114-003US1 Small Entity Status Claimed

Application Type Nonprovisional

Subject Matter Utility

Suggested Class (if any) Sub Class (if any)

Suggested Technology Center (if any)

Total Number of Drawing Sheets (if any) 16 Suggested Figure for Publication (if any)

EFS Web 2.2.2


Representative information should be provided for all practitioners having a power of attorney in the application. Providing this information in the Application Data Sheet does not constitute a power of attorney in the application (see 37 CFR 1.32). Enter either Customer Number or complete the Representative Name section below. If both sections are completed the Customer Number will be used for the Representative Information during processing.

Please Select One: ® Customer Number US Patent Practitioner 0 Limited Recognition (37 CFR 11.9)

Customer Number 96039






Publication Information: ❑ Request Early Publication (Fee required at time of Request 37 CFR 1.219)

Request Not to Publish. I hereby request that the attached application not be published under 35 U.S.

❑ C. 122(b) and certify that the invention disclosed in the attached application has not and will not be the subject of an application filed in another country, or under a multilateral international agreement, that requires publication at eighteen months after filing.

Representative Information:

Domestic Benefit/National Stage Information: This section allows for the applicant to either claim benefit under 35 U.S.C. 119(e), 120, 121, or 365(c) or indicate National Stage entry from a PCT application. Providing this information in the application data sheet constitutes the specific reference required by 35 U.S.C. 119(e) or 120, and 37 CFR 1.78(a)(2) or CFR 1.78(a)(4 , and need not otherwise be made part of the specification.

Prior Application Status Pending eErve

Application Number Continuity Type Prior Application Number Filing Date (YYYY-MM-DD)

ThisApplication non provisional of 61443088 2011-02-15

Additional Domestic Benefit/National Stage Data may be generated within this form by selecting the Add button.

Foreign Priority Information: This section allows for the applicant to claim benefit of foreign priority and to identify any prior foreign application for which priority is not claimed. Providing this information in the application data sheet constitutes the claim for priority as required by 35 U.S.C. 119(b) and 37 CFR 1.55(a).

Application Number Countryl Parent Filing Date (YYYY-MM-DD) Priority Claimed

0 Yes 0 No

Additional Foreign Priority Data may be generated within this form by selecting the Add button.

Assignee Information: Providing this information in the application data sheet does not substitute for compliance with any requirement of part 3 of Title 37 of the CFR to have an assignment recorded in the Office.

Assignee 1

EFS Web 2.2.2







If the Assignee is an Organization check here. 11 Organization Name HemoSonics LLC

Mailing Address Information:

Address 1 310 4th Street NE

Address 2 Suite 104


Country US Postal Code 22902

Phone Number 434-962-2269 Fax Number

Email Address

Additional Assignee Data may be generated within this form by selecting the Add button.

Signature: A signature of the applicant or representative is required in accordance with 37 CFR 1.33 and 10.18. Please see 37 CFR 1.4(d) for the form of the signature.

Signature /s/ T. Paul Tanpitukpongse /s/ Date (YYYY-MM-DD) 2015-12-04

First Name T. Paul Last Name Tanpitukpongse Registration Number 71589

This collection of information is required by 37 CFR 1.76. The information is required to obtain or retain a benefit by the public which is to file (and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 23 minutes to complete, including gathering, preparing, and submitting the completed application data sheet form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.

EFS Web 2.2.2


Privacy Act Statement

The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your submission of the attached form related to a patent application or patent. Accordingly, pursuant to the requirements of the Act, please be advised that: (1) the general authority for the collection of this information is 35 U.S.C. 2(b)(2); (2) furnishing of the information solicited is voluntary; and (3) the principal purpose for which the information is used by the U.S. Patent and Trademark Office is to process and/or examine your submission related to a patent application or patent. If you do not furnish the requested information, the U.S. Patent and Trademark Office may not be able to process and/or examine your submission, which may result in termination of proceedings or abandonment of the application or expiration of the patent.

The information provided by you in this form will be subject to the following routine uses:

The information on this form will be treated confidentially to the extent allowed under the Freedom of Information Act (5 U.S.C. 552) and the Privacy Act (5 U.S.C. 552a). Records from this system of records may be disclosed to the Department of Justice to determine whether the Freedom of Information Act requires disclosure of these records.

2. A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence to a court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of settlement negotiations.

3. A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a request involving an individual, to whom the record pertains, when the individual has requested assistance from the Member with respect to the subject matter of the record.

4. A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having need for the information in order to perform a contract. Recipients of information shall be required to comply with the requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).

5. A record related to an International Application filed under the Patent Cooperation Treaty in this system of records may be disclosed, as a routine use, to the International Bureau of the World Intellectual Property Organization, pursuant to the Patent Cooperation Treaty.

6. A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes of National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C. 218(c)).

7. A record from this system of records may be disclosed, as a routine use, to the Administrator, General Services, or his/her designee, during an inspection of records conducted by GSA as part of that agency's responsibility to recommend improvements in records management practices and programs, under authority of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the GSA regulations governing inspection of records for this purpose, and any other relevant (i.e., GSA or Commerce) directive. Such disclosure shall not be used to make determinations about individuals.

8. A record from this system of records may be disclosed, as a routine use, to the public after either publication of the application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35 U.S.C. 151. Further, a record may be disclosed, subject to the limitations of 37 CFR 1.14, as a routine use, to the public if the record was filed in an application which became abandoned or in which the proceedings were terminated and which application is referenced by either a published application, an application open to public inspections or an issued patent.

9. A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law enforcement agency, if the USPTO becomes aware of a violation or potential violation of law or regulation.

EFS Web 2.2.2


96039 7590 11/19/2015


EXAMINER

ART UNIT PAPER NUMBER

1798

NOTIFICATION DATE DELIVERY MODE

11/19/2015 ELECTRONIC

FISHER, BRITTANY I






Please find below and/or attached an Office communication concerning this application or proceeding.

The time period for reply, if any, is set in the attached communication.

Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es):

[email protected]

PTOL-90A (Rev. 04/07) IL Exhibit 1009 Page 24 of 907


Commissioner for Patents United States Patent and Trademark Office

P.O. Box 1450 Alexandria, VA 22313-1450

vvww.uspto.gov

Application No. : 13397398 Applicant : Viola

Filing Date : 02/15/2012 Date Mailed : 11/19/2015

NOTICE TO FILE CORRECTED APPLICATION PAPERS

Notice of Allowance Mailed

This application has been accorded an Allowance Date and is being prepared for issuance. The application, however, is incomplete for the reasons below.

Applicant is given two (2) months from the mail date of this Notice within which to respond. This time period for reply is extendable under 37 CFR 1.136(a) for only TWO additional MONTHS.

The informalities requiring correction are indicated in the attachment(s). If the informality pertains to the abstract, specification (including claims) or drawings, the informality must be corrected with an amendment in compliance with 37 CFR 1.121 (or, if the application is a reissue application, 37 CFR 1.173). Such an amendment may be filed after payment of the issue fee if limited to correction of informalities noted herein. See Waiver of 37 CFR 1.312 for Documents Required by the Office of Patent Publication, 1280 Off. Gaz. Patent Office 918 (March 23, 2004). In addition, if the informality is not corrected until after payment of the issue fee, for purposes of 35 U.S.C. 154(b)(1)(iv), "all outstanding requirements" will be considered to have been satisfied when the informality has been corrected. A failure to respond within the above-identified time period will result in the application being ABANDONED.

See attachment(s).

A copy of this notice MUST be returned with the reply. Please address response to "Mail Stop Issue Fee, Commissioner for Patents,

P.O. Box 1450, Alexandria, VA 22313-1450".

/Joanna Black/ Publication Branch Office of Data Management (571) 272-4200


Application No. 13397398

IDENTIFICATION OF APPLICATION DEFICIENCIES IN APPLICATION FILED BEFORE SEPTEMBER 16, 2012

Applicant must provide legible text for the following item(s).

Specification filed , page(s) .

Claims filed , claim(s) .

Other:

Applicant must provide missing information on the following page(s) of the specification by amending the specification to add the missing text. No new matter may be added. Page/line no(s).

The specification refers to one or more applications by attorney docket number and does not show the U.S. application number(s). Applicant must supply the U.S. application number in place of each attorney docket number. Page/line no(s).

Applicant must provide an Abstract of the Disclosure.

X The Application Data Sheet (ADS dated 02/15/2012) did not show the inventor's residence at all, or did not show both a city and state in the U.S. inventor's residence, or did not show both a city and country in the non-U.S. inventor's residence. Applicant must supply a Supplemental Application Data Sheet (ADS) that shows each U.S. inventor's city and state of residence and each non-U.S. inventor's city and country of residence. To be in compliance with 37 CFR 1.76, the Supplemental Application Data Sheet must identify the information being changed by using underlining for additions and strikethroughs or brackets for deletions.

X Other: ADS missing residence for Christopher G. Denny


ART UNIT

EXAMINER

FISHER, BRITTANY I

PAPER NUMBER

1798

96039 7590 11/06/2015


UNITED STA I ES PA I ENT AND TRADEMARK OFFICE



NOTICE OF ALLOWANCE AND FEE(S) DUE

DATE MAILED: 11/06/2015






THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT. PROSECUTION ON THE MERITS IS CLOSED. THIS NOTICE OF ALLOWANCE IS NOT A GRANT OF PATENT RIGHTS. THIS APPLICATION IS SUBJECT TO WITHDRAWAL FROM ISSUE AT THE INITIATIVE OF THE OFFICE OR UPON PETITION BY THE APPLICANT. SEE 37 CFR 1.313 AND MPEP 1308.

THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITHIN THREE MONTHS FROM THE MAILING DATE OF THIS NOTICE OR THIS APPLICATION SHALL BE REGARDED AS ABANDONED. THIS STATUTORY PERIOD CANNOT BE EXTENDED. SEE 35 U.S.C. 151. THE ISSUE FEE DUE INDICATED ABOVE DOES NOT REFLECT A CREDIT FOR ANY PREVIOUSLY PAID ISSUE FEE IN THIS APPLICATION. IF AN ISSUE FEE HAS PREVIOUSLY BEEN PAID IN THIS APPLICATION (AS SHOWN ABOVE), THE RETURN OF PART B OF THIS FORM WILL BE CONSIDERED A REQUEST TO REAPPLY THE PREVIOUSLY PAID ISSUE FEE TOWARD THE ISSUE FEE NOW DUE.

HOW TO REPLY TO THIS NOTICE:

I. Review the ENTITY STATUS shown above. If the ENTITY STATUS is shown as SMALL or MICRO, verify whether entitlement to that entity status still applies.

If the ENTITY STATUS is the same as shown above, pay the TOTAL FEE(S) DUE shown above.

If the ENTITY STATUS is changed from that shown above, on PART B - FEE(S) TRANSMITTAL, complete section number 5 titled "Change in Entity Status (from status indicated above)".

For purposes of this notice, small entity fees are 1/2 the amount of undiscounted fees, and micro entity fees are 1/2 the amount of small entity fees.

II. PART B - FEE(S) TRANSMITTAL, or its equivalent, must be completed and returned to the United States Patent and Trademark Office (USPTO) with your ISSUE FEE and PUBLICATION FEE (if required). If you are charging the fee(s) to your deposit account, section "4b" of Part B - Fee(s) Transmittal should be completed and an extra copy of the form should be submitted. If an equivalent of Part B is filed, a request to reapply a previously paid issue fee must be clearly made, and delays in processing may occur due to the difficulty in recognizing the paper as an equivalent of Part B.

III. All communications regarding this application must give the application number. Please direct all communications prior to issuance to Mail Stop ISSUE FEE unless advised to the contrary.

IMPORTANT REMINDER: Utility patents issuing on applications filed on or after Dec. 12, 1980 may require payment of maintenance fees. It is patentee's responsibility to ensure timely payment of maintenance fees when due.

Page 1 of 3 PTOL-85 (Rev. 02/11) IL Exhibit 1009 Page 27 of 907

PART B - FEE(S) TRANSMITTAL

Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE Commissioner for Patents P.O. Box 1450 Alexandria, Virginia 22313-1450

or Fax (571)-273-2885

INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks 1 through 5 should be completed where appropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as indicated unless corrected below or directed otherwise in Block 1, by (a) specifying a new correspondence address; and/or (b) indicating a separate "FEE ADDRESS" for maintenance fee notifications.

CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 for any change of address)

96039 7590 11/06/2015


Note: A certificate of mailing can only be used for domestic mailings of the Fee(s) Transmittal. This certificate cannot be used for any other accompanying papers. Each additional paper, such as an assignment or formal drawing, must have its own certificate of mailing or transmission.

Certificate of Mailing or Transmission I hereby certify that this Fee(s) Transmittal is being deposited with the United States Postal Service with sufficient postage for first class mail in an envelope addressed to the Mail Stop ISSUE FEE address above, or being facsimile transmitted to the USPTO (571) 273-2885, on the date indicated below.

(Depositor's name)

(Signature)

(Date)






EXAMINER ART UNIT CLASS-SUBCLASS

FISHER, BRITTANY I 1798 422-069000

1. Change of correspondence address or indication of "Fee Address" (37 CFR 1.363).

❑ Change of correspondence address (or Change of Correspondence Address form PTO/SB/122) attached.

❑ "Fee Address" indication (or "Fee Address" Indication form PTO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer Number is required.

2. For printing on the patent front page, list

(1) The names of up to 3 registered patent attorneys or agents OR, alternatively,

(2) The name of a single firm (having as a member a registered attorney or agent) and the names of up to 2 registered patent attorneys or agents. If no name is listed, no name will be printed.

1

2

3

3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)

PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent. If an assignee is identified below, the document has been filed for recordation as set forth in 37 CFR 3.11. Completion of this form is NOT a substitute for filing an assignment.

(A) NAME OF ASSIGNEE (B) RESIDENCE: (CITY and STATE OR COUNTRY)

Please check the appropriate assignee category or categories (will not be printed on the patent) : ❑ Individual ❑ Corporation or other private group entity ❑ Government

4a. The following fee(s) are submitted:

❑ Issue Fee

❑ Publication Fee (No small entity discount permitted)

❑ Advance Order - # of Copies

4b. Payment of Fee(s): (Please first reapply any previously paid issue fee shown above)

❑ A check is enclosed.

❑ Payment by credit card. Form PTO-2038 is attached.

❑ The director is hereby authorized to charge the required fee(s), any deficiency, or credits any overpayment, to Deposit Account Number (enclose an extra copy of this form).

5. Change in Entity Status (from status indicated above)

❑ Applicant certifying micro entity status. See 37 CFR 1.29

❑ Applicant asserting small entity status. See 37 CFR 1.27

❑ Applicant changing to regular undiscounted fee status.

NOTE: Absent a valid certification of Micro Entity Status (see forms PTO/SB/15A and 15B), issue fee payment in the micro entity amount will not be accepted at the risk of application abandonment.

NOTE: If the application was previously under micro entity status, checking this box will be taken to be a notification of loss of entitlement to micro entity status.

NOTE: Checking this box will be taken to be a notification of loss of entitlement to small or micro entity status, as applicable.

NOTE: This form must be signed in accordance with 37 CFR 1.31 and 1.33. See 37 CFR 1.4 for signature requirements and certifications.

Authorized Signature Date

Typed or printed name Registration No.

Page 2 of 3

PTOL-85 Part B (10-13) Approved for use through 10/31/2013. OMB 0651-0033 U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE


ART UNIT

EXAMINER

FISHER, BRITTANY I

PAPER NUMBER

1798

DATE MAILED: 11/06/2015

96039 7590 11/06/2015


UNITED STA IES PA PENT AND TRADEMARK OFFICE





Determination of Patent Term Adjustment under 35 U.S.C. 154 (b) (Applications filed on or after May 29, 2000)

The Office has discontinued providing a Patent Term Adjustment (PTA) calculation with the Notice of Allowance.

Section 1(h)(2) of the AIA Technical Corrections Act amended 35 U.S.C. 154(b)(3)(B)(i) to eliminate the requirement that the Office provide a patent term adjustment determination with the notice of allowance. See Revisions to Patent Term Adjustment, 78 Fed. Reg. 19416, 19417 (Apr. 1, 2013). Therefore, the Office is no longer providing an initial patent term adjustment determination with the notice of allowance. The Office will continue to provide a patent term adjustment determination with the Issue Notification Letter that is mailed to applicant approximately three weeks prior to the issue date of the patent, and will include the patent term adjustment on the patent. Any request for reconsideration of the patent term adjustment determination (or reinstatement of patent term adjustment) should follow the process outlined in 37 CFR 1.705.

Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the Office of Patent Legal Administration at (571)-272-7702. Questions relating to issue and publication fee payments should be directed to the Customer Service Center of the Office of Patent Publication at 1-(888)-786-0101 or (571)-272-4200.

Page 3 of 3 PTOL-85 (Rev. 02/11) IL Exhibit 1009 Page 29 of 907

OMB Clearance and PRA Burden Statement for PTOL-85 Part B

The Paperwork Reduction Act (PRA) of 1995 requires Federal agencies to obtain Office of Management and Budget approval before requesting most types of information from the public. When OMB approves an agency request to collect information from the public, OMB (i) provides a valid OMB Control Number and expiration date for the agency to display on the instrument that will be used to collect the information and (ii) requires the agency to inform the public about the OMB Control Number's legal significance in accordance with 5 CFR 1320.5(b).

The information collected by PTOL-85 Part B is required by 37 CFR 1.311. The information is required to obtain or retain a benefit by the public which is to file (and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 12 minutes to complete, including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, Virginia 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, Virginia 22313-1450. Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.

Privacy Act Statement

The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your submission of the attached form related to a patent application or patent. Accordingly, pursuant to the requirements of the Act, please be advised that: (1) the general authority for the collection of this information is 35 U.S.C. 2(b)(2); (2) furnishing of the information solicited is voluntary; and (3) the principal purpose for which the information is used by the U.S. Patent and Trademark Office is to process and/or examine your submission related to a patent application or patent. If you do not furnish the requested information, the U.S. Patent and Trademark Office may not be able to process and/or examine your submission, which may result in termination of proceedings or abandonment of the application or expiration of the patent.

The information provided by you in this form will be subject to the following routine uses: 1. The information on this form will be treated confidentially to the extent allowed under the Freedom of

Information Act (5 U.S.C. 552) and the Privacy Act (5 U.S.0 552a). Records from this system of records may be disclosed to the Department of Justice to determine whether disclosure of these records is required by the Freedom of Information Act.

2. A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence to a court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of settlement negotiations.

3. A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a request involving an individual, to whom the record pertains, when the individual has requested assistance from the Member with respect to the subject matter of the record.

4. A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having need for the information in order to perform a contract. Recipients of information shall be required to comply with the requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).

5. A record related to an International Application filed under the Patent Cooperation Treaty in this system of records may be disclosed, as a routine use, to the International Bureau of the World Intellectual Property Organization, pursuant to the Patent Cooperation Treaty.

6. A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes of National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C. 218(c)).

7. A record from this system of records may be disclosed, as a routine use, to the Administrator, General Services, or his/her designee, during an inspection of records conducted by GSA as part of that agency's responsibility to recommend improvements in records management practices and programs, under authority of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the GSA regulations governing inspection of records for this purpose, and any other relevant (i.e., GSA or Commerce) directive. Such disclosure shall not be used to make determinations about individuals.

8. A record from this system of records may be disclosed, as a routine use, to the public after either publication of the application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35 U.S.C. 151. Further, a record may be disclosed, subject to the limitations of 37 CFR 1.14, as a routine use, to the public if the record was filed in an application which became abandoned or in which the proceedings were terminated and which application is referenced by either a published application, an application open to public inspection or an issued patent.

9. A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law enforcement agency, if the USPTO becomes aware of a violation or potential violation of law or regulation.


Application No.

13/397,398

Examiner

BRITTANY FISHER

Applicant(s)

VIOLA ET AL.

Art Unit

1798

Applicant-Initiated Interview Summary

All participants (applicant, applicant's representative, PTO personnel):

(1) BRITTANY FISHER. (3)_.

(2) GREGORY CARLIN, appl. rep.. (4)

Date of Interview: 27 October 2015.

Type: Z Telephonic ❑ Video Conference ❑ Personal [copy given to: ❑ applicant ['applicant's representative]

Exhibit shown or demonstration conducted: ❑ Yes ❑ No. If Yes, brief description: .

Issues Discussed ❑101 ❑112 ❑102 ❑103 ®Others (For each of the checked box(es) above, please describe below the issue and detailed description of the discussion)

Claim(s) discussed: 79 and 80.

Identification of prior art discussed: .

Substance of Interview (For each issue discussed, provide a detailed description and indicate if agreement was reached. Some topics may include: identification or clarification of a reference or a portion thereof, claim interpretation, proposed amendments, arguments of any applied references etc...)

Applicant's representative called and requested cancellation of non-allowed claims 1-78 and allowance by examiner's previously allowed claims 79 and 80.

Applicant recordation instructions: The formal written reply to the last Office action must include the substance of the interview. (See MPEP section 713.04). If a reply to the last Office action has already been filed, applicant is given a non-extendable period of the longer of one month or thirty days from this interview date, or the mailing date of this interview summary form, whichever is later, to file a statement of the substance of the interview

Examiner recordation instructions: Examiners must summarize the substance of any interview of record. A complete and proper recordation of the substance of an interview should include the items listed in MPEP 713.04 for complete and proper recordation including the identification of the general thrust of each argument or issue discussed, a general indication of any other pertinent matters discussed regarding patentability and the general results or outcome of the interview, to include an indication as to whether or not agreement was reached on the issues raised.

❑ Attachment

/BRITTANY FISHER/ Examiner, Art Unit 1798

/JILL WARDEN/ Supervisory Patent Examiner, Art Unit 1798

U.S. Patent and Trademark Office

PTOL-413 (Rev. 8/11/2010) Interview Summary Paper No. 20151027


Summary of Record of Interview Requirements

Manual of Patent Examining Procedure (MPEP), Section 713.04, Substance of Interview Must be Made of Record A complete written statement as to the substance of any face-to-face, video conference, or telephone interview with regard to an application must be made of record in the application whether or not an agreement with the examiner was reached at the interview.

Title 37 Code of Federal Regulations (CFR) § 1.133 Interviews Paragraph (b)

In every instance where reconsideration is requested in view of an interview with an examiner, a complete written statement of the reasons presented at the interview as warranting favorable action must be filed by the applicant. An interview does not remove the necessity for reply to Office action as specified in §§ 1.111, 1.135. (35 U.S.C. 132)

37 CFR §1.2 Business to be transacted in writing. All business with the Patent or Trademark Office should be transacted in writing. The personal attendance of applicants or their attorneys or agents at the Patent and Trademark Office is unnecessary. The action of the Patent and Trademark Office will be based exclusively on the written record in the Office. No attention will be paid to any alleged oral promise, stipulation, or understanding in relation to which there is disagreement or doubt.

The action of the Patent and Trademark Office cannot be based exclusively on the written record in the Office if that record is itself incomplete through the failure to record the substance of interviews.

It is the responsibility of the applicant or the attorney or agent to make the substance of an interview of record in the application file, unless the examiner indicates he or she will do so. It is the examiner's responsibility to see that such a record is made and to correct material inaccuracies which bear directly on the question of patentability.

Examiners must complete an Interview Summary Form for each interview held where a matter of substance has been discussed during the interview by checking the appropriate boxes and filling in the blanks. Discussions regarding only procedural matters, directed solely to restriction requirements for which interview recordation is otherwise provided for in Section 812.01 of the Manual of Patent Examining Procedure, or pointing out typographical errors or unreadable script in Office actions or the like, are excluded from the interview recordation procedures below. Where the substance of an interview is completely recorded in an Examiners Amendment, no separate Interview Summary Record is required.

The Interview Summary Form shall be given an appropriate Paper No., placed in the right hand portion of the file, and listed on the "Contents" section of the file wrapper. In a personal interview, a duplicate of the Form is given to the applicant (or attorney or agent) at the conclusion of the interview. In the case of a telephone or video-conference interview, the copy is mailed to the applicant's correspondence address either with or prior to the next official communication. If additional correspondence from the examiner is not likely before an allowance or if other circumstances dictate, the Form should be mailed promptly after the interview rather than with the next official communication.

The Form provides for recordation of the following information: —Application Number (Series Code and Serial Number) —Name of applicant —Name of examiner — Date of interview —Type of interview (telephonic, video-conference, or personal) —Name of participant(s) (applicant, attorney or agent, examiner, other PTO personnel, etc.) —An indication whether or not an exhibit was shown or a demonstration conducted —An identification of the specific prior art discussed — An indication whether an agreement was reached and if so, a description of the general nature of the agreement (may be by

attachment of a copy of amendments or claims agreed as being allowable). Note: Agreement as to allowability is tentative and does not restrict further action by the examiner to the contrary.

—The signature of the examiner who conducted the interview (if Form is not an attachment to a signed Office action)

It is desirable that the examiner orally remind the applicant of his or her obligation to record the substance of the interview of each case. It should be noted, however, that the Interview Summary Form will not normally be considered a complete and proper recordation of the interview unless it includes, or is supplemented by the applicant or the examiner to include, all of the applicable items required below concerning the substance of the interview.

A complete and proper recordation of the substance of any interview should include at least the following applicable items: 1) A brief description of the nature of any exhibit shown or any demonstration conducted, 2) an identification of the claims discussed, 3) an identification of the specific prior art discussed, 4) an identification of the principal proposed amendments of a substantive nature discussed, unless these are already described on the

Interview Summary Form completed by the Examiner, 5) a brief identification of the general thrust of the principal arguments presented to the examiner,

(The identification of arguments need not be lengthy or elaborate. A verbatim or highly detailed description of the arguments is not required. The identification of the arguments is sufficient if the general nature or thrust of the principal arguments made to the examiner can be understood in the context of the application file. Of course, the applicant may desire to emphasize and fully describe those arguments which he or she feels were or might be persuasive to the examiner.)

6) a general indication of any other pertinent matters discussed, and 7) if appropriate, the general results or outcome of the interview unless already described in the Interview Summary Form completed by

the examiner. Examiners are expected to carefully review the applicant's record of the substance of an interview. If the record is not complete and

accurate, the examiner will give the applicant an extendable one month time period to correct the record.

Examiner to Check for Accuracy

If the claims are allowable for other reasons of record, the examiner should send a letter setting forth the examiner's version of the statement attributed to him or her. If the record is complete and accurate, the examiner should place the indication, "Interview Record OK" on the paper recording the substance of the interview along with the date and the examiner's initials.


Applicant(s) VIOLA ET AL.

Application No. 13/397,398

Notice of Allowability Examiner BRITTANY FISHER

Art Unit 1798

AIA (First Inventor to File) Status

No

-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address-- All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application. If not included herewith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed in due course. THIS NOTICE OF ALLOWABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative of the Office or upon petition by the applicant. See 37 CFR 1.313 and M PEP 1308.

1. [E] This communication is responsive to claims filed 7/17/2015.

❑ A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on

2. 0 An election was made by the applicant in response to a restriction requirement set forth during the interview on • the restriction requirement and election have been incorporated into this action.

3. [E] The allowed claim(s) is/are 79 and 80. As a result of the allowed claim(s), you may be eligible to benefit from the Patent Prosecution Highway program at a participating intellectual property office for the corresponding application. For more information, please see hitp://www.uspto.gov/patentslinit events/mhlindex.jsp or send an inquiry to PPHfeedbackusotaaav

4. 0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).

Certified copies:

a) 0 All b) 0 Some *c) 0 None of the:

1. 0 Certified copies of the priority documents have been received.

2. 0 Certified copies of the priority documents have been received in Application No.

3. 0 Copies of the certified copies of the priority documents have been received in this national stage application from the

International Bureau (PCT Rule 17.2(a)).

* Certified copies not received:

Applicant has THREE MONTHS FROM THE "MAILING DATE" of this communication to file a reply complying with the requirements noted below. Failure to timely comply will result in ABANDONMENT of this application. THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.

5. 0 CORRECTED DRAWINGS ( as "replacement sheets") must be submitted.

0 including changes required by the attached Examiner's Amendment / Comment or in the Office action of Paper No./Mail Date .

Identifying indicia such as the application number (see 37 CFR 1.84(c)) should be written on the drawings in the front (not the back) of each sheet. Replacement sheet(s) should be labeled as such in the header according to 37 CFR 1.121(d).

6. 0 DEPOSIT OF and/or INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the attached Examiner's comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.

Attachment(s) 1. 0 Notice of References Cited (PTO-892) 5. [E] Examiner's Amendment/Comment

2. [ZI Information Disclosure Statements (PTO/SB/08), 6. E] Examiner's Statement of Reasons for Allowance Paper No./Mail Date 12/21/2012

3. 0 Examiners Comment Regarding Requirement for Deposit 7. 0 Other of Biological Material

4. [E] Interview Summary (PTO-413), Paper No./Mail Date 10/28/2015 .


/JILL WARDEN/

Supervisory Patent Examiner, Art Unit 1798


PTOL-37 (Rev. 08-13) Notice of Allowability Part of Paper No./Mail Date 20151027


Application/Control Number: 13/397,398 Page 2

Art Unit: 1798

The present application is being examined under the pre-AIA first to invent provisions.

DETAILED ACTION

EXAMINER'S AMENDMENT

An examiner's amendment to the record appears below. Should the changes

and/or additions be unacceptable to applicant, an amendment may be filed as provided

by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be

submitted no later than the payment of the issue fee.

Authorization for this examiner's amendment was given in a telephone interview

with Gregory Carlin on October 27, 2015.

Claims 1-78 have been cancelled.

Allowable Subject Matter

Claims 79 and 80 are allowed.

The following is an examiner's statement of reasons for allowance: The closest

prior art of reference, Baugh (US 2003/0113929 Al), fails to disclose or fairly teach the

inclusion of one or both of abciximab or cytochalasin D within a test chamber that also

includes an activator of coagulation.

Any comments considered necessary by applicant must be submitted no later

than the payment of the issue fee and, to avoid processing delays, should preferably

accompany the issue fee. Such submissions should be clearly labeled "Comments on

Statement of Reasons for Allowance."



Art Unit: 1798

Conclusion

Any inquiry concerning this communication or earlier communications from the

examiner should be directed to BRITTANY FISHER whose telephone number is

(571)272-7156. The examiner can normally be reached on Monday - Friday, 8:00am -

5:00pm.

If attempts to reach the examiner by telephone are unsuccessful, the examiner's

supervisor, JILL WARDEN can be reached on (571) 272-1267. The fax phone number

for the organization where this application or proceeding is assigned is 571-273-8300.

Information regarding the status of an application may be obtained from the

Patent Application Information Retrieval (PAIR) system. Status information for

published applications may be obtained from either Private PAIR or Public PAIR.

Status information for unpublished applications is available through Private PAIR only.

For more information about the PAIR system, see http://pair-direct.uspto.gov. Should

you have questions on access to the Private PAIR system, contact the Electronic

Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a

USPTO Customer Service Representative or access to the automated information

system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.

/BRITTANY FISHER/ Examiner, Art Unit 1798 November 2, 2015


Application No.

13/397,398

Examiner

BRITTANY FISHER

Applicant(s)

VIOLA ET AL.

Art Unit

1798

Applicant-Initiated Interview Summary

All participants (applicant, applicant's representative, PTO personnel):

(1) BRITTANY FISHER. (3)_.

(2) GREGORY CARLIN, appl. rep.. (4)

Date of Interview: 27 October 2015.

Type: Z Telephonic ❑ Video Conference ❑ Personal [copy given to: ❑ applicant ['applicant's representative]

Exhibit shown or demonstration conducted: ❑ Yes ❑ No. If Yes, brief description: .

Issues Discussed ❑101 ❑112 ❑102 ❑103 ®Others (For each of the checked box(es) above, please describe below the issue and detailed description of the discussion)

Claim(s) discussed: 79 and 80.

Identification of prior art discussed: .

Substance of Interview (For each issue discussed, provide a detailed description and indicate if agreement was reached. Some topics may include: identification or clarification of a reference or a portion thereof, claim interpretation, proposed amendments, arguments of any applied references etc...)

Applicant's representative called and requested cancellation of non-allowed claims 1-78 and allowance by examiner's previously allowed claims 79 and 80.

Applicant recordation instructions: The formal written reply to the last Office action must include the substance of the interview. (See MPEP section 713.04). If a reply to the last Office action has already been filed, applicant is given a non-extendable period of the longer of one month or thirty days from this interview date, or the mailing date of this interview summary form, whichever is later, to file a statement of the substance of the interview

Examiner recordation instructions: Examiners must summarize the substance of any interview of record. A complete and proper recordation of the substance of an interview should include the items listed in MPEP 713.04 for complete and proper recordation including the identification of the general thrust of each argument or issue discussed, a general indication of any other pertinent matters discussed regarding patentability and the general results or outcome of the interview, to include an indication as to whether or not agreement was reached on the issues raised.

❑ Attachment


/JILL WARDEN/ Supervisory Patent Examiner, Art Unit 1798


PTOL-413 (Rev. 8/11/2010) Interview Summary Paper No. 20151027


Summary of Record of Interview Requirements

Manual of Patent Examining Procedure (MPEP), Section 713.04, Substance of Interview Must be Made of Record A complete written statement as to the substance of any face-to-face, video conference, or telephone interview with regard to an application must be made of record in the application whether or not an agreement with the examiner was reached at the interview.

Title 37 Code of Federal Regulations (CFR) § 1.133 Interviews Paragraph (b)

In every instance where reconsideration is requested in view of an interview with an examiner, a complete written statement of the reasons presented at the interview as warranting favorable action must be filed by the applicant. An interview does not remove the necessity for reply to Office action as specified in §§ 1.111, 1.135. (35 U.S.C. 132)

37 CFR §1.2 Business to be transacted in writing. All business with the Patent or Trademark Office should be transacted in writing. The personal attendance of applicants or their attorneys or agents at the Patent and Trademark Office is unnecessary. The action of the Patent and Trademark Office will be based exclusively on the written record in the Office. No attention will be paid to any alleged oral promise, stipulation, or understanding in relation to which there is disagreement or doubt.

The action of the Patent and Trademark Office cannot be based exclusively on the written record in the Office if that record is itself incomplete through the failure to record the substance of interviews.

It is the responsibility of the applicant or the attorney or agent to make the substance of an interview of record in the application file, unless the examiner indicates he or she will do so. It is the examiner's responsibility to see that such a record is made and to correct material inaccuracies which bear directly on the question of patentability.

Examiners must complete an Interview Summary Form for each interview held where a matter of substance has been discussed during the interview by checking the appropriate boxes and filling in the blanks. Discussions regarding only procedural matters, directed solely to restriction requirements for which interview recordation is otherwise provided for in Section 812.01 of the Manual of Patent Examining Procedure, or pointing out typographical errors or unreadable script in Office actions or the like, are excluded from the interview recordation procedures below. Where the substance of an interview is completely recorded in an Examiners Amendment, no separate Interview Summary Record is required.

The Interview Summary Form shall be given an appropriate Paper No., placed in the right hand portion of the file, and listed on the "Contents" section of the file wrapper. In a personal interview, a duplicate of the Form is given to the applicant (or attorney or agent) at the conclusion of the interview. In the case of a telephone or video-conference interview, the copy is mailed to the applicant's correspondence address either with or prior to the next official communication. If additional correspondence from the examiner is not likely before an allowance or if other circumstances dictate, the Form should be mailed promptly after the interview rather than with the next official communication.

The Form provides for recordation of the following information: —Application Number (Series Code and Serial Number) —Name of applicant —Name of examiner — Date of interview —Type of interview (telephonic, video-conference, or personal) —Name of participant(s) (applicant, attorney or agent, examiner, other PTO personnel, etc.) —An indication whether or not an exhibit was shown or a demonstration conducted —An identification of the specific prior art discussed — An indication whether an agreement was reached and if so, a description of the general nature of the agreement (may be by

attachment of a copy of amendments or claims agreed as being allowable). Note: Agreement as to allowability is tentative and does not restrict further action by the examiner to the contrary.

—The signature of the examiner who conducted the interview (if Form is not an attachment to a signed Office action)

It is desirable that the examiner orally remind the applicant of his or her obligation to record the substance of the interview of each case. It should be noted, however, that the Interview Summary Form will not normally be considered a complete and proper recordation of the interview unless it includes, or is supplemented by the applicant or the examiner to include, all of the applicable items required below concerning the substance of the interview.

A complete and proper recordation of the substance of any interview should include at least the following applicable items: 1) A brief description of the nature of any exhibit shown or any demonstration conducted, 2) an identification of the claims discussed, 3) an identification of the specific prior art discussed, 4) an identification of the principal proposed amendments of a substantive nature discussed, unless these are already described on the

Interview Summary Form completed by the Examiner, 5) a brief identification of the general thrust of the principal arguments presented to the examiner,

(The identification of arguments need not be lengthy or elaborate. A verbatim or highly detailed description of the arguments is not required. The identification of the arguments is sufficient if the general nature or thrust of the principal arguments made to the examiner can be understood in the context of the application file. Of course, the applicant may desire to emphasize and fully describe those arguments which he or she feels were or might be persuasive to the examiner.)

6) a general indication of any other pertinent matters discussed, and 7) if appropriate, the general results or outcome of the interview unless already described in the Interview Summary Form completed by

the examiner. Examiners are expected to carefully review the applicant's record of the substance of an interview. If the record is not complete and

accurate, the examiner will give the applicant an extendable one month time period to correct the record.

Examiner to Check for Accuracy

If the claims are allowable for other reasons of record, the examiner should send a letter setting forth the examiner's version of the statement attributed to him or her. If the record is complete and accurate, the examiner should place the indication, "Interview Record OK" on the paper recording the substance of the interview along with the date and the examiner's initials.


111 111

Search

11 11 1111

Notes

111 1 11

Application/Control No.

13397398

Applicant(s)/Patent Under Reexamination

VIOLA ET AL.

Examiner

BRITTANY FISHER

Art Unit

1773

CPC- SEARCHED

Symbol

Date Examiner

CPC COMBINATION SETS - SEARCHED

Symbol

Date Examiner

US CLASSIFICATION SEARCHED

Class Subclass Date Examiner

SEARCH NOTES

Search Notes Date Examiner 422/69,73,502,503,507,527,534,535,551 text searched 2/2/2013 BIF Consulted SPE Jill Warden about search strategy 2/2/2013 BIF Consulted PE Maureen Wallenhorst about search strategy and claim interpretation

2/2/2013 BIF

Consulted PE Joseph Drodge about search strategy 2/2/2013 BIF Consulted PE Arlen Soderquist about search strategy and claim interpretation

2/2/2013 BIF

PALM inventor search 2/2/2013 BIF See attached EAST search history 2/2/2013 BIF Consulted PE Neil Turk about claim interpretation 9/25/2013 BIF See attached BRS search history 9/26/2013 BIF Consulted PE Neil Turk about claim interpretation 3/23/2014 BIF See attached BRS search history 3/23/2014 BIF BOIL 3/5027 text searched 1/12/2015 BIF GO1N 27/07 and 33/86 text searched 1/12/2015 BIF See attached BRS search history 1/12/2015 BIF See updated EAST search history 6/1/2015 BIF See updated EAST search history 10/19/2015 BIF See updated EAST search history 10/28/2015 BIF

U.S. Patent and Trademark Office Part of Paper No.. 20151027 IL Exhibit 1009 Page 38 of 907

INTERFERENCE SEARCH

US Class/ CPC Symbol

US Subclass / CPC Group Date Examiner

b011 2200/04,0647; 3/5027,527; 2300/027,0654,0681,0867,123,1805

10/28/2015 BIF

b011 2400/0436,0439,0487,049 10/28/2015 BIF BRS text search 10/28/2015 BIF



Sheet 1 of 6




(37 CFR §1.98(b))

Attorney Docket No.






Initial Desig.

ID Document Number Publication Date Patentee Class

Sub class


Al RE37171 1996-03-05 McCormick et al.

A2 4112740 1978-09-12 Brandestini

A3 4558589 1985-12-17 Hemmes et al.

A4 4695956 1987-09-22 Leveen et al.

A5 4705756 1987-11-10 Spilled et al.

A6 4814247 1989-03-31 Spilled et al.

A7 4852577 1989-08-01 Smith et al.

A8 4900679 1990-02-13 Spilled et al.

A9 5056357 1991-10-15 Dynnling et al.

A10 5104975 1992-04-14 McCormick et al.

Al 1 5205159 1993-04-27 Carr, Jr.

Al2 5234839 1993-08-10 McCormick et al.

A13 5273517 1993-12-28 Barone et al.

A14 5311908 1994-03-17 Barone et al.

A15 5331964 1994-07-26 Trahey et al.

A16 5473536 1995-12-05 Wimmer

A17 5487387 1996-01-30 Trahey et al.

A18 5605154 1997-02-25 Ries et al.

A19 5606971 1997-03-04 Sarvazyan et al.

A20 5655535 1997-08-12 Friemel et al.

A21 5657760 1997-08-19 Ying et al.

A22 5673699 1997-10-07 Trahey et al.

A23 5744898 1998-04-28 Smith et al.

A24 5810731 1998-09-22 Sarvazyan et al.

A25 5854423 1998-12-29 Venegas

A26 5899861 1999-05-04 Friemel et al.

A27 5921928 1999-07-13 Greenleaf et al.

Examiner Signature /Brittany Fisher/ Date Considered

11/02/2015

EXAMINER: Initials citation considered. Draw line through citation if not in conformance and not considered. Include copy of this form with next communication to applicant.


ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH, /BF/ IL Exhibit 1009 Page 40 of 907


Sheet 2 of 6




(37 CFR §1.98(b))

Attorney Docket No.






Initial Desig.

ID Document Number



A28 6039691 2000-03-21 Walker et al.

A29 6083159 2000-07-04 Driscoll, Jr. et al.

A30 6114135 2000-09-05 Goldstein

A31 6117081 2000-09-12 Jago et al.

A32 6135954 2000-10-24 Cohen et al.

A33 6213950 2001-04-10 Cespedes et al.

A34 6225126 2001-05-01 Cohen et al.

A35 6264609 2001-07-24 Herrington et al.

A36 6270459 2001-08-07 Konofagou et al.

A37 6277074 2001-08-21 Chaturvedi et al.

A38 6283917 2001-09-04 Jago et al.

A39 6371912 2002-04-16 Nightinggale et al.

A40 6402704 2002-06-11 McMorrow

A41 6454714 2002-09-24 Ng et al.

A42 6494834 2002-12-14 Konofagou et al.

A43 6508768 2003-01-21 Hall et al.

A44 6514204 2003-02-04 Alam et al.

A45 6535835 2003-03-18 Rubin et al.

A46 6537819 2003-03-25 Cohen et al.

A47 6573104 2003-06-03 Carr, Jr. et al.

A48 6613573 2003-09-02 Cohen

A49 6632678 2003-10-14 Aiken et al.

A50 6685646 2004-02-03 Cespedes et al.

A51 6687625 2004-02-03 Srinivasan et al.

A52 6692439 2004-02-17 Walker et al.

A53 6716168 204-04-06 Nock et al.

A54 6726629 2004-04-27 Frinking et al.


Date Considered 11/02/2015





Sheet 3 of 6




(37 CFR §1.98(b))

Attorney Docket No.






Initial Desig.

ID Document Number



A55 6764448 2004-07-20 Trahey et al.

A56 6787363 2004-09-04 Cohen et al.

A57 6797519 2004-09-28 Cohen et al.

A58 6890299 2005-05-10 Cohen et al.

A59 6951544 2005-10-04 Trahey et al.

A60 7179652 2007-02-20 Cohen et al.

A61 7192726 2007-03-30 Carr, Jr. et al.

A62 7202048 2007-04-10 Carr, Jr.

A63 7207939 2007-04-24 Husher

A64 7261861 2007-08-28 Kautzky


A66 7399637 2008-07-15 Wright et al.

A67 7422905 2008-09-09 Clague et al.

A68 7439069 2008-10-21 Nippoldt et al.

A69 7524670 2009-04-28 Cohen et al.

A70 7732213 2010-06-08 Cohen et al.

A71 7912661 2011-03-22 Zeng

A72 7972271 2011-07-05 Johnson et al.

A73 8058023 2011-11-15 Gurbel


Initial Desig.

ID Document Number Publication Date Patentee Class Sub

class Filing Date

If Appropriate

A74 20020013530 2002-01-31 Cespedes et al.

A75 20020040187 2002-04-04 Alam et al.

A76 20030013958 2003-01-16 Govari et al.

A77 20030073244 2003-04-17 Cohen et al.

A78 20030105398 2003-06-05 Vitek

A79 20030171676 2003-09-11 Walker et al. Examiner Signature

/Brittany Fisher/ Date Considered 11102/2015





Sheet 4 of 6




(37 CFR §1.98(b))

Attorney Docket No.






Initial Desig.

ID Document Number



A80 20030204141 2003-10-30 Nock et al.

A81 20040068184 2004-04-08 Walker et al.


A83 20050004463 2005-01-06 Chen et al.

A84 20050015001 2005-01-20 Lec et al.

A85 20050053305 2002-01-31 Li et al.

A86 20050148899 2005-07-07 Walker et al.

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A88 20070059840 2007-03-15 Cohen et al.

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A90 20070276236 2007-11-29 Jong

A91 20080038828 2008-02-14 Cohen et al.

A92 20080249408 2008-10-09 Palmeri et al.

A93 20080261261 2008-10-23 Grimes et al.

A94 20090112483 2009-04-30 Cohen

A95 20120252127 2012-10-04 Bansil et al.

Foreign Patent Documents or Published Foreign Patent Applications Examiner

Initial Desig.

ID Document

Number Publication

Date Country or

Patent Office Class SubclassYes Translation

No

A96 2011035162 2011-03-24 WO


Initial Desig.

ID Document

A97 Beer: Center for Reproductive Immunology & Genetics, "Thrombophilia: Inherited and Acquired," 6 pages, Fap://repro-med.net/papers/thromb.php. NO DATE

A98 Bell, et al., "Thrombelastographic evaluation of coagulation in transurethral prostatectomy," British Journal of Urology, Vol. 78, No. 5, 1996, pp. 737-741.

A99 Bombeli, et al., "Updates in perioperative coagulation: physiology and management of thromboembolism and haemorrhage," British Journal of Anaesthesia; Vol. 93, No. 2, August 2004, pp. 275-287.


Date Considered11/02/2015





Sheet 5 of 6




(37 CFR §1.98(b))

Attorney Docket No.


13/397,398

Applicant

Francesco Viola

Filing Date



Initial Desig.

ID Document

A100 Chavez, J., "A novel thrombelastograph tissue factor/kaolin assay of activated clotting

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No. 2, May 1990, pp. 176-189.

A104 Ferraris, et al., "2011 Update to The Society of Thoracic Surgeons and the Society of

Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines," Annals

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A105 Freedman, et al., "A Meta-Analysis of Thromboembolic Prophylaxis Following Elective

Total Hip Arthroplasty," Journal of Bone and Joint Surgery, Vol. 82-A, 2000, pp. 929-938.

A106 Gaetano, G. de, et al., "Effect of Platelets on Clot Structuration, a Thrombelastographic

Study," Thrombosis Research, Vol. 3, No. 4, pp. 425-435, 1973.

A107 Ganter, et al., "Active, personalized, and balanced coagulation management saves lives in

patients with massive bleeding," Anesthesiology, Vol. 133, No. 5, November 2010, pp.

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A108 Ganter, et al., "Coagulation monitoring: current techniques and clinical use of viscoelastic

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pp. 1366-1375.

A109 Gauss, et al., "Adaptive Imagining in the Thyroid Using Fundamental and Harmonic Echo

Data," presented at IEEE Ultrasonics Symposium, 1999, pp. 1515-1519.

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Vascular Anesthesis, Vol. 13, No. 1, February, 1999, pp. 58-64.






Receipt date; 12/21/2012

Sheet 6 of 6




(37 CFR §1.98(b))

Attorney Docket No.






Initial Desig.

ID Document

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1834.

A115 Harris, et al., "Evaluation of recurrent thrombosis and hypercoagulability," American

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A118

Hirsh, et al., "Management of deep vein thrombosis and pulmonary embolism. A

statement for healthcare professionals," Council on Thrombosis (in consultation with the

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March 2006, pp. 383-388.






111

Index

111 11 11

of

1111

Claims

11 1 11


13397398


VIOLA ET AL.

Examiner

BRITTANY FISHER

Art Unit

1773

I Rejected

= Allowed

Cancelled

Restricted

N Non-Elected

I Interference

A Appeal

0 Objected

• Claims renumbered in the same order as presented by applicant • CPA • T.D. • R.1.47

CLAIM DATE

Final Original 02/02/2013 09/25/2013 03/11/2014 01/12/2015 06/01/2015 10/19/2015 10/28/2015

1 V V V V V V -

2 V V V V V V -

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U.S. Patent and Trademark Office Part of Paper No.: 20151027


111

Index

111 11 11

of

1111

Claims

11 1 11


13397398


VIOLA ET AL.

Examiner

BRITTANY FISHER

Art Unit

1773

I Rejected

= Allowed

Cancelled

Restricted

N Non-Elected

I Interference

A Appeal

0 Objected


CLAIM DATE

Final Original 02/02/2013 09/25/2013 03/11/2014 01/12/2015 06/01/2015 10/19/2015 10/28/2015

37 - - - - - - -

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111

Index

111 11 11

of

1111

Claims

11 1 11


13397398


VIOLA ET AL.

Examiner

BRITTANY FISHER

Art Unit

1773

I Rejected

= Allowed

Cancelled

Restricted

N Non-Elected

I Interference

A Appeal

0 Objected


CLAIM DATE

Final Original 02/02/2013 09/25/2013 03/11/2014 01/12/2015 06/01/2015 10/19/2015 10/28/2015

73 - - - - - - -

74 V V V V V -

75 V V V V V -

76 V V V V V -

77 V V V V V -

78 V V V - - -

1 79 = =

2 80 = =



Ref Hits Search Query D Bs Default Operator

OR

Plurals

S1 0 422/069.ccls.

EPO; JP()

US-PGPUB; USPAT;

ON

1148 422/69.ccls.

EPO; JP()

US-PGPUB; USPAT;

OR ON

1168 422/73.ccls. US-PGPUB; USPAT; EPO; JP()

OR ON

S4 61 and blood.ti,ab. US-PGPUB; USPAT; EPO; JP()

OR ON

134 and (separat$4 with (blood or plasma)) US-PGPUB; USPAT; EPO; JP()

OR ON

93 S5 and (duct or channel or groove) US-PGPUB; USPAT; EPO; JP()

OR

0

EPO; JP()

ON

4790 422/69,73,502,503,507,527,534,535,551.ccls. US-PGPUB; USPAT;

1121 S7 and (liquid with (purification or separat$4))

US-PGPUB; USPAT; EPO; JP()

OR ON

610 S8 and blood US-PGPUB; USPAT; EPO; JP()

OR ON

S10 2 ("20060133958" I "7104406").PN. US-PGPUB; USPAT; EPO; JP()

OR ON

S11 0 $-W02009112982-$.did. US-PGPUB; USPAT; EPO; JP()

OR ON

S12 0 $W02009112982-$.did. US-PGPUB; USPAT; EPO; JP()

OR ON

S13 1 WO-2009112982-$.did. US-PGPUB; USPAT; EPO; JPO

OR ON

S15 0 KR-1020080051011-$.did. US-PGPUB; USPAT; USOCR; FPRS; EPO; JPO; DERWENT I BM_TDB

OR ON

S16 23 "5254248" US-PGPUB; USPAT;

OR ON

2013/01/16 10:43

2013/01/16 10:44

2013/01/16 10:44

2013/01/16 12:07

2013/01/16 12:16

2013/01/16 12:23

2013/01/16 12:25

2013/01/16 13:43

2013/01/16 10:13

Time Stamp

2013/01/16 09:33

2013/01/16 09:33

2013/01/16 09:53

2013/01/16 10:09

2013/01/16 10:11

2013/01/16 13:46

EAST Search History

EAST Search History

EAST Search History (Prior Art)

EASTSearchHistory.13397398_AccessibleVersion.htm[10/28/2015 2:53:09 PM]


EAST Search History

USOCR; FPRS; EPO; JPO; DERWENT I BM_TDB

S17 0 WO-0124931-$.did. US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/17 10:39

S18 161 "4753776" US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/17 10:42


OR ON 2013/01/17 10:42

S20

S21

141

29

"5458852" US-PGPUB; USPAT; EPO; JPO

US-PGPUB; USPAT; EPO; JPO

OR

OR

ON

N

2013/01/17 10:43

2013/01/17 10:45

"6008059"

S22 15 "6069014"

EPO; JPO

US-PGPUB; USPAT;

OR ON 2013/01/17 10:45

S23 17 "6197598"

EPO; JPO

US-PGPUB; USPAT;

OR ON 2013/01/17 10:45


OR ON 2013/01/17 14:30


OR ON 2013/01/17 14:30


OR ON 2013/01/17 14:31

S27

S29

124 "4271119" US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/17 14:31


OR 2013/01/17 14:35


OR 2013/01/17 16:16

S30 1155 422/69.ccls. US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/24 15:05

S31 134 S30 and (separat$4 with (blood or plasma)) US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/24 15:05

S32 3 S31 and (polycarbonate with filter) US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/24 15:05

S33 16096 (separat$4 with (blood and plasma)) US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/24 15:06

21 (separat$4 with (blood and plasma)) same US-PGPUB; FOR FON 2013/01/24



EAST Search History

(filter with polycarbonate) EPO; JPO

USPAT; 15:07

5 6 (separat$4 with (blood and plasma)) same US-PGPUB; OR ON 2013/01/24 (filter with polycarbonate) and porosity USPAT; 15:14

EPO; JP()

S36 8 (separat$4 with (biological and fluid)) same US-PGPUB; OR ON 2013/01/24 (filter with porosity) USPAT; 15:22

EPO; JP()

S37 357 "5798031" US-PGPUB; OR ON 2013/01/24 USPAT; 15:24 EPO; JP()

S37 and (filter with porosity) US-PGPUB; 0 2013/01/24 USPAT; 15:24 EPO; JP()

S37 and (filter same porosity) US-PGPUB; 0 2013/01/24 USPAT; 15:24 EPO; JP()


S41 4 S40 and (filter same porosity) US-PGPUB; OR ON 2013/01/24 USPAT; 15:24 EPO; JP()



S44 10276 filter with porosity US-PGPUB; OR ON 2013/01/24 USPAT; 15:26 EPO; JP()

S45 886 S44 and "422".clas. US-PGPUB; OR ON 2013/01/24 USPAT; 15:26 EPO; JP()

7 S44 and 422/73.ccls. US-PGPUB; OR ON 2013/01/24 USPAT; 15:26 EPO; JP()

S47 0 (filter with polycarbone) same porosity US-PGPUB; OR ON 2013/01/24 USPAT; 15:27

EPO; JP()

S48 0 (filter with polycarbone) US-PGPUB; OR ON 2013/01/24 USPAT; 15:27 EPO; JP()

S49 8177 filter with polycarbonate US-PGPUB; OR ON 2013/01/24 USPAT; 15:27 EPO; JPO

S50 180 S49 same porosity US-PGPUB; OR ON 2013/01/24 USPAT; 15:27 EPO; JPO

26 550 and "422".clas. US-PGPUB; 0 2013/01/24 USPAT; 15:27 EPO; JPO

"20070082370" US-PGPUB; 0 2013/01/24 USPAT; 15:33 EPO; JPO

11 (US-20040191124-$ or US-20060076295-$ or US-PGPUB; OR ON 2013/01/24



EAST Search History

US-20070082370-$).did. or (US-5558834-$ or US-4753776-$ or US-6319719-$ or US-

5981294-$ or US-6936473-$ or US-4976270-$ or US-4131549-$).did. or (WO-2009112982-

$).did.

USPAT; EPO

15:44

S54 3 S53 and groove US-PGPUB; OR ON 2013/01/24 USPAT; 15:44 EPO; JPO

S55 1 S33 and (((channel or capillary) with groove) US-PGPUB; OR ON 2013/01/24 same laminate) USPAT; 15:46

EPO; JPO

S56 422 S33 and ((channel or capillary) with groove) US-PGPUB; OR ON 2013/01/24 USPAT; 15:47 EPO; JPO

S57 100 S33 and (((channel or capillary) with groove) US-PGPUB; OR ON 2013/01/24 same substrate) USPAT; 15:47

EPO; JPO

S58 18 (US-20040191124-$ or US-20060076295-$ or US-PGPUB; OR ON 2013/01/24 US-20070082370-$ or US-20030114785-$ or USPAT; 17:11 US-20070243111-$ or US-20080028821-$ or EPO US-20080047892-$ or US-20090107909-

5).did. or (US-5558834-$ or US-4753776-$ or US-6319719-$ or US-5981294-$ or US-

6936473-$ or US-4976270-$ or US-4131549-$ or US-7105354-$ or US-6607644-$).did. or WO-2009112982-$) .did.

S59 0 S58 and immunoassay US-PGPUB; OR ON 2013/01/24 USPAT; 17:11 EPO; JPO

S60 27 S57 and immunoassay US-PGPUB; OR N 2013/01/24 USPAT; 17:11 EPO; JPO

S61 1 S57 and (immunoassay with port) US-PGPUB; OR ON 2013/01/24 USPAT; 17:11

EPO; JPO

S62 3 S57 and (immunoassay with device) US-PGPUB; OR ON 2013/01/24 USPAT; 17:11

EPO; JPO

S63 1169 422/73.ccls. US-PGPUB; OR ON 2013/01/24 USPAT; 18:02

EPO; JPO

S64 126 S63 and (hemostasis or haemostasis) US-PGPUB; OR ON 2013/01/24 USPAT; 18:02 EPO; JPO

S65 8 S64 and viscoelastic$4 US-PGPUB; OR ON 2013/01/24 USPAT; 18:03 EPO; JPO

S66 95 ("20020013530" 1 "20020040187" 1 US-PGPUB; OR ON 2013/01/24 "20030013958" "20030073244" USPAT; 18:05 "20030105398" "20030171676" EPO; JPO "20030204141" "20040068184" "20040167403" "20050004463" "20050015001" "20050053305" "20050148899" "20070038095" "20070059840" "20070184508" "20070276236" "20080038828" "20080249408" "20080261261" "20090112483" "20120252127" "4112740"

"4558589" 1 "4695956" 1 "4705756"



EAST Search History

"4814247" "5056357" "5234839" "5331964" "5605154" "5657760" "5810731" "5921928" "6114135" "6213950" "6270459" "6371912" "6494834" "6535835" "6613573" "6687625" "6726629" "6797519" "7179652" "7207939" "7399637" "7524670" "7972271"

"4852577" "5104975" "5273517" "5473536" "5606971" "5673699" "5854423" "6039691" "6117081" "6225126" "6277074" "6402704" "6508768" "6537819" "6632678" "6692439" "6764448" "6890299" "7192726" "7261861" "7422905" "7732213" "8058023"

"4900679" "5205159" "5311908" "5487387" "5655535" "5744898" "5899861" "6083159" "6135945" "6264609" "6283917" "6454714" "6514204" "6573104" "6685646" "6716168" "6787363" "6951544" "7202048" "7374538" "7439069" "7912661" "RE37171").PN.

S67 26 S66 and (hemostasis or haemostasis) US-PGPUB; OR ON 2013/01/24 USPAT; 18:06

EPO; JPO


S69 1155 422/69.ccls. US-PGPUB; OR ON 2013/01/24 USPAT; 18:08 EPO; JPO

S70 10 S69 and (hemostasis or haemostasis) US-PGPUB; OR ON 2013/01/24 USPAT; 18:08 EPO; JPO

S71 4807 422/69,73,502,503,507,527,534,535,551.ccls. US-PGPUB; OR 2013/01/24 USPAT; 18:08 EPO; JPO

S72 157 S71 and (hemostasis or haemostasis) US-PGPUB; OR 2013/01/24 USPAT; 18:08 EPO; JPO


S74 100 (US-20050143675-$ or US-20060094986-$ or US-PGPUB; OR ON 2013/01/29 US-20070212258-$ or US-20060222567-$ or USPAT; 14:52 US-20060034728-$ or US-20040049355-$ or EPO; JPO US-20080021296-$ or US-20090156964-$ or US-20090209040-$ or US-20030223906-$ or US-20030191415-$ or US-20030116583-

$).did. or (US-7537571-$ or US-7575558-$ or US-7572237-$ or US-7347973-$ or US-

7150755-$ or US-7077328-$ or US-7041468-$ or US-6966880-$ or US-6958809-$ or US-




6997343-5).did. or (W0-9410558-$ or WO-



EAST Search History

2004063747-$).did. or (EP-1288653-$ or US- 20030089730-$).did. or ("20020104849" "20040178216" "6378702").PN. or (US-

20060099108-$ or US-20060024203-$ or US- 20060173380-$ or US-20030223906-$).did. or (US-7582063-$ or US-7150755-$ or US-

6228100-$ or US-6036924-$ or US-7303726- $).did. or (DE-10057832-$ or WO-0123885-$ or US-20030212345-$).did. or (US-

20020060247-$ or US-20030207454-5 or US- 20030185705-$ or US-20020057993-5 or US- 20030032190-$ or US-20030191415-5 or US- 20050143675-5 or US-20030089730-$).did. or (US-5628890-$ or US-6743635-$ or US-



6514460-$).did. or US-6472220-$ or US- 6036924-$ or US-5971941-$.did. or (US- 20080021296-$ or US-20040178216-5 or US- 20030212345-$ or US-20030175155-5 or US- 20020076349-$ or US-20020104849-5 or US- 20030002387-$ or US-20030116583-5 or US- 20080181818-5).did. or (US-5244116-$ or US- 7449148-$ or US-5335816-$ or US-7264139-$ or US-7138089-$ or US-5330716-$ or US-



6135314-$ or US-7552843-5).did. or (US- 1445563-$ or US-2551425-5).did. or (WO- 2006046701-$) .d id. (US-20080181818-$ or US-20090230144-5 or US-20030211619-5 or US-20100286563-$ or US-20110000933-5 or US-20110000932-5 or US-20080164280-$ or US-20030089730-5 or US-20020188224-$ or US-20020076349-5 or US-20020057993-5 or US-20070264165-$ or US-20030116583-


5513773-$ or US-7585464-$ or US-7552843-$ or US-6534017-$ or US-7887757-5).did.

S75 1

S76 100

"20120329082"

(US-20050143675-5 or US-20060094986-5 or US-20070212258-5 or US-20060222567-5 or US-20060034728-5 or US-20040049355-5 or US-20080021296-5 or US-20090156964-5 or US-20090209040-5 or US-20030223906-5 or US-20030191415-5 or US-20030116583-






6997343-$).did. or (W0-9410558-$ or WO-


OR ON 2013/01/30 13:47


OR ON 2013/01/30 14:16



EAST Search History

S77

2004063747-$).did. or (EP-1288653-$ or US-20030089730-$).did. or ("20020104849" "20040178216" "6378702").PN. or (US-

20060099108-$ or US-20060024203-$ or US-20060173380-$ or US-20030223906-$).did. or (US-7582063-$ or US-7150755-$ or US-

6228100-$ or US-6036924-$ or US-7303726-$).did. or (DE-10057832-$ or WO-0123885-$ or US-20030212345-$).did. or (US-

20020060247-$ or US-20030207454-5 or US-20030185705-$ or US-20020057993-5 or US-20030032190-$ or US-20030191415-5 or US-20050143675-5 or US-20030089730-$).did. or (US-5628890-$ or US-6743635-$ or US-



6514460-$).did. or US-6472220-$ or US-6036924-$ or US-5971941-$.did. or (US-20080021296-$ or US-20040178216-5 or US-20030212345-5 or US-20030175155-5 or US-20020076349-5 or US-20020104849-5 or US-20030002387-5 or US-20030116583-5 or US-20080181818-5).did. or (US-5244116-$ or US-7449148-$ or US-5335816-$ or US-7264139-$ or US-7138089-$ or US-5330716-$ or US-



6135314-$ or US-7552843-5).did. or (US-1445563-$ or US-2551425-5).did. or (WO-2006046701-$).did. (US-20080181818-$ or US-20090230144-5 or US-20030211619-5 or US-20100286563-5 or US-20110000933-5 or US-20110000932-5 or US-20080164280-5 or US-20030089730-5 or US-20020188224-5 or US-20020076349-5 or US-20020057993-5 or US-20070264165-5 or US-20030116583-



0

EPO; JP()

S76 and (haemostasis or hemostasis) US-PGPUB; USPAT;

2013/01/30 14:16

S78 1170 422/73.ccls. US-PGPUB; USPAT; EPO; JP()

OR ON 2013/01/30 14:21

S79 126 S78 and (haemostasis or hemostasis) US-PGPUB; USPAT; EPO; JP()

OR ON 2013/01/30 14:21

0 31 "5047211" US- PGPUB; USPAT; EPO; JP()

OR ON 2013/01/31 09:21

1 17 ("4067777" "4533519" "4599219" "4871677" "5302348" "5314826" "5366869" "5441892" "5534226" "5591403" "5686659" "5789664" "5800781" "5925319" "5951951" "5972712" "6221672"). PN.

US- PGPUB; USPAT; USOCR

OR ON 2013/01/31 14:51

1

1 1



EAST Search History

S82 8 ("6541262").URPN. USPAT OR ON 2013/01/31 14:54

S83 30 ("5047211") .URPN. USPAT OR ON 2013/01/31 16:02

4 5 (haemostasis or hemostasis) same (acoustic US-PGPUB; OR ON 2013/01/31 adj radiation) USPAT; 16:20

EPO; JPO

S85 22 (haemostasis or hemostasis) and (acoustic adj US-PGPUB; OR ON 2013/01/31 radiation) USPAT; 16:20

EPO; JPO

S86 1170 422/73.ccls. US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/31 16:26

S87

S8819

S89 S89

18 S86 and viscoelastic US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/31 16:26

S86 and viscoelastic$4 US-PGPUB; USPAT; EPO; JPO

OR 2013/01/31 16:26

14 (US-20050015001-$ or US-20080297169-$ or US-20030113929-$ or US-20020081741-$ or US-20100274130-$).did. or (US-5854423-$ or US-5628961-$ or US-8058023-$ or US-


5629209-$).did.

US-PGPUB; USPAT

0 ON2013/01/31 16:34

S90 6 S89 and viscoelastic$4

EPO; JPO

US-PGPUB; USPAT;

OR ON 2013/01/31 16:34

S91 2 S89 and acoustic US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/31 16:35

S92 4 S89 and (thermal$3) US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/31 18:55

S93 556 acrylic with (thermal$4 with conduct$4) US-PGPUB; USPAT

OR ON 2013/01/31 19:23

S94 1 S93 and "422".clas. US-PGPUB; USPAT

OR ON 2013/01/31 19:23

S95 0 S93 and "435".clas. USPAT

US-PGPUB; OR ON 2013/01/31 19:24

S96 3 S93 and "436".clas. USPAT

US-PGPUB; OR ON 2013/01/31 19:24

S97 16229 (thermal$4 with conduct$4) same polymer USPAT US-PGPUB; OR ON 2013/02/02

13:15

S98 1981 (thermal$4 with conduct$4) near2 polymer US-PGPUB; USPAT

OR ON 2013/02/02 13:15


OR ON 2013/02/02 13:15

S100 15 S98 and (haemostasis or hemostasis) US-PGPUB; USPAT

OR ON 2013/02/02 13:16

S101 204 S98 and blood US-PGPUB; USPAT

OR ON 2013/02/02 13:17

S102 1 "20030170883" US-PGPUB; USPAT

OR ON 2013/02/02 13:21

S103 15 (US-20050015001-$ or US-20080297169-$ or US-PGPUB; OR ON 2013/02/02



EAST Search History

S104 3

S105

S106

S107

S108

S109

1

0

1301

71

108




US-PGPUB; USPAT

US-PGPUB; USPAT

US-PGPUB; USPAT

USPAT 13:50

ON 2013/02/02 13:50

ON 2013/02/02 14:04

ON 2013/02/02 14:21

ON 2013/02/02 14:25

N 2013/02/02 14:25

ON 2013/02/02 14:33

OR

OR

OR

OR

0

OR

US-20030113929-$ or US-20020081741-$ or US-20100274130-$ or US-20030170883-


7745223-$ or US-5800781-$ or US-5591403-$ or US-5366869-$ or US-5629209-$).did.

S103 and ultrasound

S103 and (transducer and ultrasound)

S103 and (processor same coagulat$4)

processor with (coagulation or clot$4 or platelet or fibrino$6)

5107 and (haemostasis or hemostasis)

(processor and intrinsic and extrinsic and platelet and fibrinogen and fibrinolysis) and (coagulation or clot$4)

"20050015001"

(US-20050015001-$ or US-20080297169-$ or US-20030113929-5 or US-20020081741-5 or US-20100274130-5 or US-20030170883-



7857761-$).did.

US-PGPUB; OR ON 2013/02/02 USPAT 14:38

US-PGPUB; OR ON 2013/02/02 USPAT 14:49

S110 2

S111 16

S112 0 S111 and lyophili US-PGPUB; OR ON 2013/02/02 USPAT; 14:49 EPO; JP()

S113 5 S111 and lyophili$4 US-PGPUB; OR ON 2013/02/02 USPAT; 14:49 EPO; JP()


S115 102 ("20040167403" "20090112483" "4705756" "5657760" "5673699" "5744898" "6277074" "6454714" "6692439" "6726629" "6787363" "6797519" "7207939" "7399637" "7422905" "RE37171" "20050015001" "20070038095" "20080249408" "4695956"

"5234839" "6225126" "6371912" "7202048" "20080297169" "20050053305"

"20050148899" "4112740" "6270459" "6613573" "6632678" "7179652" "7192726" "7912661" "7972271" "20100274130" "5800781" "20040068184"

"20050004463" "20050015001" "20080261261" "5104975" "5487387" "5921928" "6083159" "6114135" "6117081" "6764448" "6890299" "7261861" "7374538" "20070184508" "4852577" "5311908" "5331964"


OR ON 2013/09/26 10:45



EAST Search History

"6135945" 1 "6213950" 1 "6264609" "6494834" 1 "6537819" 1 "6573104" "6951544" 1 "7732213" 1 "8058023" "20030170883" 1 "20020040187" 1 "20030013958" 1 "20030204141" I "20080038828" 1 "20120252127" 1 "5273517"

"5854423" 1 "20020013530" "20030073244" 1 "20030105393" "20030171676" 1 "5605154" 1 "5606971" "5810731" 1 "5899861" 1 "6039691" "6283917" 1 "6508768" 1 "6514204" "6535835" 1 "6685646" 1 "6687625" "6716168" 1 "7439069" 1 "20020081741" "20030113929" 1 "20070059840" I "20070276236" 1 "4558589" 1 "4814247" "4900679" 1 "5056357" 1 "5205159" "5473536" 1 "5655535" 1 "6402704" "7524670" 1 "20110151491").PN.

S116 56 S115 and ultrasound US-PGPUB; USPAT; EPO; JPO

OR ON 2013/09/26 10:46

S117 16 (US-20050015001-$ or US-20080297169-$ or US-20030113929-$ or US-20020081741-$ or US-20100274130-$ or US-20030170883-



7857761-$).did.

US-PGPUB; USPAT

OR ON 2014/03/09 19:41

S118 4 S117 and agonist US-PGPUB; USPAT; EPO; JPO

OR ON 2014/03/09 19:41

S119 0 (blood with cartridge) same (agonist and antagonist)


OR ON 2014/03/09 19:44

S120 27 (blood with cartridge) same (agonist or antagonist)


OR ON 2014/03/09 19:44

S121 151 (blood with chamber) same (agonist or antagonist)


OR ON 2014/03/09 19:49

S122 18 ("4756884" 1 "5601995" 1 "4861711" I "5039617" 1 "5656448" 1 "20100248394" 1 "20020119486" 1 "4094647" 1 "20060239859"

"20020187071" 1 "6451264" "20040072357" 1 "4632901" 1 "4943522" "5110727" 1 "5372946" 1 "20080176272" 1 "6156273") . PN.


OR ON 2015/03/21 22:48

S123 18 ("4756884" 1 "5601995" 1 "4861711" I "5039617" 1 "5656448" 1 "20100248394" 1 "20020119486" 1 "4094647" 1 "20060239859"

"20020187071" 1 "6451264" "20040072357" 1 "4632901" 1 "4943522" "5110727" 1 "5372946" 1 "20080176272" 1 "6156273") . PN.


OR ON 2015/03/21 23:18

S124 5 S123 and (projection) US-PGPUB; USPAT; EPO; JPO

OR ON 2015/03/21 23:18

S125 10 "5016469" US-PGPUB; USPAT;

OR ON 2015/05/16 20:35



EAST Search History

1 EPO; JPO 1 I I S126

S127

12 ("20040076546" "20040214337" 1 "20080194967" "20110034805"I "20110172661" "20110252352" 1 "20120232803" "20120294767" 1 "20130190584" "5016469" 1 "6412344" "8740818") . PN.


OR ON 2015/05/16 20:37

1551 g01n33/86.cpc. US-PGPUB; USPAT; EPO; JPO

OR 2015/05/16 20:57

S128 602 g01n33/49.cpc. US-PGPUB; USPAT; EPO; JPO

OR ON 2015/05/16 20:58

S129 1866 g01n33/4905,491.cpc. US-PGPUB; USPAT; EPO; JPO

OR ON 2015/05/16 20:58

S130 610 c12q1/56.cpc. US-PGPUB; USPAT; EPO; JPO

OR ON 2015/05/16 21:00

S131 539 a61b5/0048.cpc. US-PGPUB; USPAT; EPO; JPO

OR ON 2015/05/16 21:01

S132 339 S127 and ((chamber with reagent) same agonist or antagonist)


OR ON 2015/05/16 21:04


EPO; JPO

US-PGPUB; USPAT;

OR ON 2015/05/16 21:04


EPO; JPO

US-PGPUB; USPAT;

OR ON 2015/05/16 21:04

S135

1

8 S131 and ((chamber with reagent) same agonist or antagonist)


OR

1

ON

[

2015/05/16 21:04

S137 327 S132 and (coagulation or platelet or fibrinogen or fibrinolytic)


OR ON 2015/05/16 21:05



OR ON 2015/05/16 21:06

S140

S141

108 S136 and (coagulation or platelet or fibrinogen or fibrinolytic)


OR ON 2015/05/16 21:06


OR 2015/05/16 21:08

S142 15 ("6010911" 1 "20120329082" I "20080268483" 1 "4752449" 1 "6613573" 1 "5314826" 1 "5925319" 1 "5951951" I "6221672" 1 "6541262" 1 "6613286" "5174961" 1 "5441892" 1 "5629209" "4443408").PN.


OR ON 2015/05/16 21:09

S143 0 (blood near3 test$4 with catridge) same (agonist and antagonist)

EPO; JPO

US-PGPUB; USPAT;

OR ON 2015/05/30 12:38

S144 0 (blood with catridge) same (agonist and antagonist)


OR ON 2015/05/30 12:39



EAST Search History

S145 0 ON (blood with catridge) and (agonist and antagonist)


2015/05/30 12:39

OR

OR ON 2015/05/30 12:39

90 S146 catridge and (agonist and antagonist) US- PGPUB; USPAT; EPO; JP()

S147 114 ("20040167403" "20090112483" "4705756" "5657760" "5673699" "5744898" "6277074" "6454714" "6692439" "6726629" "6787363" "6797519" "7207939" "7399637" "7422905" "RE37171" "20050015001" "20080194967" "20110034805"I "20070038095" "20080249408" "4695956"

"5234839" "6225126" "6371912" "7202048" "20080297169" "20110172661"

"20130190584" "20050053305" "20050148899" "4112740" "6270459" "6613573" "6632678" "7179652" "7192726" "7912661" "7972271" "20100274130" "5800781" "20040076546"

"5016469" "20040068184" "20050004463" "20050015001"I "20080261261" "5104975" "5487387" "5921928" "6083159" "6114135"I "6117081" "6764448" "6890299"I "7261861" "7374538" "20070184508" "4852577" "5311908" "5331964"I "6135945" "6213950" "6264609"I "6494834" "6537819" "6573104" "6951544" "7732213" "8058023"I "20030170883" "20020040187" "20030013958" "20030204141"I "20080038828" "20120252127" "5273517"

"5854423" "20120232803" "8740818" "20020013530" "20030073244" "20030105398" "20030171676" "5605154"

"5606971" "5810731" "5899861" "6039691" "6283917" "6508768" "6514204" "6535835" "6685646" "6687625" "6716168" "7439069" "20020081741" "20030113929"I "20040214337" "20120294767" "6412344"

"20070059840" "20070276236" "4558589" "4814247" "4900679" "5056357" "5205159" "5473538" "5655535" "6402704" "7524670" "20110151491" "20110252352").PN.

2015/05/30 12:40

US- PGPUB; USPAT; EPO; JP()

ON "5016469" 2015/05/30 13:10

US- PGPUB; OR USPAT; EPO; JP()

2015/05/30 13:11

5148 10


OR ON

OR 5150 8 ("2008/0297169") . URPN. USPAT ON 2015/05/30 14:23

OR S151 1 "20080194967" USPAT ON 2015/05/30 15:24

S152 933 kaolin with platelet US-PGPUB; USPAT; EPO; JP()

OR ON 2015/10/19 07:07



EAST Search History

63 OR (kaolin with platelet) same (agonist or activator)


2015/10/19 07:08

ON S153

S154 10188 OR ON (heparin with platelet) same (antagonist or inhibit$4)


2015/10/19 07:13

5155 684 ON (heparin with (platelet and fibrinogen)) same (antagonist or inhibit$4)


2015/10/19 07:13

OR

5156 15 (kaolin with fibrinogen) same (agonist or activator)

US- PGPUB; 0 USPAT; EPO; JP()

2015/10/19 07:15

5157 OR ON 1575 (heparin with fibrinogen) same (antagonist or inhibit$4)


2015/10/19 07:30

5158 93 OR ON (heparin near3 fibrinogen) with (antagonist or inhibit$4)


2015/10/19 07:30

5159 7331 antiplatelet same heparin US-PGPUB; USPAT; EPO; JPO

OR ON 2015/10/19 07:37

5160 6409 antiplatelet with heparin US-PGPUB; USPAT; EPO; JPO

OR ON 2015/10/19 07:37

S161 683 antiplatelet near3 heparin US-PGPUB; USPAT; EPO; JPO

OR ON 2015/10/19 07:37

5162 21 (US-20050015001-$ or US-20080297169-$ or US-20030113929-$ or US-20020081741-$ or US-20100274130-$ or US-20030170883-$ or US-20040131500-$ or US-20120294767-



7857761-$ or US-7422905-$ or US-7399637-$ or US-6221672-$).did.

US-PGPUB; USPAT

OR ON 2015/10/19 07:42

5163 4 5162 and "abciximab"

EPO; JPO

US-PGPUB; USPAT;

OR ON 2015/10/19 07:42

5164 0 5162 and "cytochalasin D"

EPO; JPO

US-PGPUB; USPAT;

OR ON 2015/10/19 07:47

5165

1

0 5162 and "cytochalasin" US-PGPUB; USPAT; EPO; JPO

OR

1

ON

[

2015/10/19 07:48

5166 0 ("2012/0294767") . URPN. USPAT OR ON 2015/10/19 07:50

5167 0 (blood near3 chamber) same (kaolin near3 abciximab)

USPAT OR ON 2015/10/19 07:51

5168 0 (blood near3 chamber) same (kaolin with abciximab)

USPAT OR ON 2015/10/19 07:51

5169 1 (blood near3 chamber) and (kaolin with abciximab)

USPAT OR ON 2015/10/19 07:51

5170 1 (blood with chamber) and (kaolin with abciximab)

USPAT OR ON 2015/10/19 07:52

IS171 0 (blood with chamber) and (kaolin with USPAT FOR FON 2015/10/19



EAST Search History

1 [ [ cytochalasin) [ 1 1 [07:53

S172 0 (blood with chamber) and (kaolin same USPAT OR ON 2015/10/19 cytochalasin) 07:53

S173 1196 (activator or agonist) same (abciximab or USPAT OR ON 2015/10/19 cytochalasin) 07:56

S174 32 5173 and (blood near3 chamber) USPAT R N 2015/10/19 07:57

EAST Search History (Interference)

Ref Hits Search Query D Bs Default Plurals Time # Operator Stamp

L1 589 b0112200/04,0647.cpc. USPAT OR ON 2015/10/28 14:43

L4 24 L1 and (blood near3 chamber) USPAT OR ON 2015/10/28 14:44

L5 1674 b0113/5027,527.cpc. USPAT OR ON 2015/10/28 14:44

L6 127 L5 and (blood near3 chamber) USPAT 0 ON 2015/10/28 14:44

L7 2392 b0112300/027,0654,0681,0867,123,1805.cpc. USPAT 0 ON 2015/10/28 14:44


L9 1691 b0112400/0436,0439,0487,049.cpc. USPAT OR ON 2015/10/28 14:44


5175 1674 b0113/5027,527.cpc. USPAT OR ON 2015/10/28 07:52

5177 589 b0112200/04,0647.cpc. USPAT OR ON 2015/10/28 07:53

5178 2392 b0112300/027,0654,0681,0867,123,1805.cpc. USPAT OR ON 2015/10/28 07:53

5179 1691 b0112400/0436,0439,0487,049.cpc. USPAT OR ON 2015/10/28 07:54

5180 1 (blood near3 chamber) and (kaolin near3 USPAT OR ON 2015/10/28 abciximab) 08:09

10/ 28/ 2015 2:53:05 PM C:\ Users\ bfisher\ Documents\ EAST\ Workspaces\ 13397398 Hemostasis Eval. Device.wsp



Issue

111 111 11 11 1111

Classification

1 11 1 11


13397398


VIOLA ET AL.

Examiner

BRITTANY FISHER

Art Unit

1798

CPC

Symbol Type Version

B01 L 3 5027 F 2013-01-01

B01 L :i:i:i:i: 3 527 2013-01-01

GO1N 35 00 A 2013-01-01

B01 L ............ •••••• 2200 04 A 2013-01-01

B01 L 2200 0647 A 2013-01-01

B01 L 2300 027 A 2013-01-01

B01 L 2300 0654 A 2013-01-01

B01 L 111111

2300 0681 A 2013-01-01

B01 L 411111

2300 111111

0867 A 2013-01-01

B01 L 2300 123 A 2013-01-01

B01 L 411111

2300 111111

1805 A 2013-01-01

B01 L 111111

2400 0436 A 2013-01-01

B01 L 111111

2400 0439 A 2013-01-01

B01 L 111111

2400 0487 A 2013-01-01

B01 L 2400 049 A 2013-01-01

CPC Combination Sets

Symbol Type Set Ranking Version

yiyiyi

/BRITTANY FISHER/ Examiner.Art Unit 1798 10/28/2015

(Assistant Examiner) (Date)

Total Claims Allowed:

2

/JILL WARDEN/ Supervisory Patent Examiner.Art Unit 1798 10/29/2015

(Primary Examiner) (Date)

O.G. Print Claim(s)

79

O.G. Print Figure

1C

U.S. Patent and Trademark Office Part of Paper No. 20151027


Issue

111 111 11 11 1111

Classification

1 11 1 11


13397398


VIOLA ET AL.

Examiner

BRITTANY FISHER

Art Unit

1798

US ORIGINAL CLASSIFICATION INTERNATIONAL CLASSIFICATION

CLASS SUBCLASS CLAIMED NON-CLAIMED

422 69 G 0 1 N 30 / 96 (2006 01 01)

CROSS REFERENCE(S)

CLASS SUBCLASS (ONE SUBCLASS PER BLOCK)




2



O.G. Print Claim(s)

79

O.G. Print Figure

1C



Issue

111 111 11 11 1111

Classification

1 11 1 11


13397398


VIOLA ET AL.

Examiner

BRITTANY FISHER

Art Unit

1798

M Claims renumbered in the same order as presented by applicant M CPA • T.D. M R.1.47

Final Original Final Original Final Original Final Original Final Original Final Original Final Original Final Original

1 79

2 80




2



O.G. Print Claim(s)

79

O.G. Print Figure

1C



96039 7590 10/23/2015


EXAMINER


1798



FISHER, BRITTANY I

UNITED STA1ES PA PENT AND TRADEMARK OFFICE







Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): docketing @mcciplaw.com


Application No. Applicant(s) 13/397,398 VIOLA ET AL.

Office Action Summary Examiner Art Unit AIA (First Inventor to File)

BRITTANY FISHER 1798 Status

No

-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address --Period for Reply

A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTHS FROM THE MAILING DATE OF THIS COMMUNICATION.

- Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed after SIX (6) MONTHS from the mailing date of this communication.

- If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication. - Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).

Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any earned patent term adjustment. See 37 CFR 1.704(b).

Status

1)Z Responsive to communication(s) filed on July 17, 2015.


2a)Z This action is FINAL. 2b)EIThis action is non-final.

3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on

; the restriction requirement and election have been incorporated into this action.

4)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is

closed in accordance with the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.

Disposition of Claims*

5)E1 Claim(s) 1-13,15-17,20-22,25,74-77,79 and 80 is/are pending in the application.

5a) Of the above claim(s) is/are withdrawn from consideration.

6)Z Claim(s) 79 and 80 is/are allowed.

7)E1 Claim(s) 1-13,15-17,20-22,25,and 74-77 is/are rejected.

8)0 Claim(s) is/are objected to.

9)0 Claim(s) are subject to restriction and/or election requirement.

* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a

participating intellectual property office for the corresponding application. For more information, please see

httpliwwwusptagovipatents/init events/pphlindex.jsp or send an inquiry to PPI-lteedback@usptaaov.

Application Papers

10)0 The specification is objected to by the Examiner.

11)0 The drawing(s) filed on is/are: a)0 accepted or b)0 objected to by the Examiner.

Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).

Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).

Priority under 35 U.S.C. § 119

12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).

Certified copies:

b)E1Some** c)1=1 None of the:

1.0 Certified copies of the priority documents have been received.

2.0 Certified copies of the priority documents have been received in Application No. .

3.0 Copies of the certified copies of the priority documents have been received in this National Stage

application from the International Bureau (PCT Rule 17.2(a)).

** See the attached detailed Office action for a list of the certified copies not received.

Attachment(s)

1) Z Notice of References Cited (PTO-892)

2) ❑ Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)

Paper No(s)/Mail Date

3) ❑ Interview Summary (PTO-413)

Paper No(s)/Mail Date.

4) ❑ Other:

U.S. Patent and Trademark Office PTOL-326 (Rev. 11-13) Office Action Summary Part of Paper No./Mail Date 20151019 IL Exhibit 1009 Page 67 of 907


Art Unit: 1798


DETAILED ACTION

This is a FINAL action in response to applicant's claim amendments filed July 17, 2015.

Claims 79 and 80 have been newly added. Claims 1-13, 15-17, 20-22, 25, 74-77, 79,

and 80 are pending.

Response to Amendment

Rejection of claims 1, 2, 6-10, 15, 16 and 74-77 under 35 U.S.C. 102(b) as being

anticipated by Baugh (US 2003/0113929 Al) is maintained in view of applicant's

arguments.

Claim Rejections - 35 USC § 102

The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that

form the basis for the rejections under this section made in this Office action:

A person shall be entitled to a patent unless —

(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.

Claims 1, 2, 6-10, 15, 16 and 74-77 are rejected under 35 U.S.C. 102(b) as being

anticipated by Baugh (US 2003/0113929 Al).

With respect to claims 1 and 6-8, Baugh discloses a device that is used for the

testing of a whole blood sample comprising:

A plurality of test chambers that are bordered by a plug (523) (502-507,

see Fig. 5), each configured to receive blood of a test sample wherein each test



Art Unit: 1798

chamber comprises a reagent or a combination of reagents (See Paras. 0023-

0024);

Wherein a first chamber (503) of the plurality comprises a first reagent or a

combination of reagents that interacts with the blood received therein and

wherein the first reagent or a reagent included in the first combination of reagents

(kaolin) encourages clotting of blood in a sample (See Para. 0026 and Table 1);

Wherein a second chamber (504) of the plurality comprises a second

combination of reagents that interact with blood of the test sample received

therein and wherein the combination includes an agonist and antagonist of

hemostasis (kaolin and dried heparin) (See Paras. 0022, 0027 and Table 1).

With respect to claim 2 Baugh discloses a third and fourth channel

amongst the plurality comprising third and fourth reagents or combinations of

reagents that interact with blood of the test sample received therein (See Paras.

0024-0028, Table 1, and Fig. 5).

With respect to claim 9 Baugh describes the system as a single use

cartridge (See Para. 0022).

With respect to claims 10, 15, and 16 Baugh discloses a fluid pathway

(plunger, 519) that is communication with at least one test chamber and that

opens into the at least one test chamber at a tangent to the test chamber (524)

(See Para. 0024 and Fig. 5).



Art Unit: 1798

With respect to claims 74-77 Baugh discloses the inclusion of the

hemostatic agent kaolin in the first and second chambers and heparin in

combination with kaolin in the second chamber.


The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis

for all obviousness rejections set forth in this Office action:

(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.

The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148

USPQ 459 (1966), that are applied for establishing a background for determining

obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:

1. Determining the scope and contents of the prior art.

2. Ascertaining the differences between the prior art and the claims at issue.

3. Resolving the level of ordinary skill in the pertinent art.

4. Considering objective evidence present in the application indicating

obviousness or nonobviousness.

Claims 3-5 and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being

unpatentable over Baugh (US 2003/0113929 Al) in view of Braun, Sr. (US

2002/0081741 Al).

Refer above for the disclosure of Baugh.



Art Unit: 1798

With respect to claims 3-5 Baugh fails to disclose the inclusion of an interrogation

device that uses acoustic radiation force and transmits sound into one or more test

chambers. However, there is discussion that some type of analyzer is utilized to

analyze the samples during testing.

Braun Sr. discloses an apparatus for detecting changes in a property of a

liquid/reagent mixture, such as a whole blood sample wherein the interrogation

comprises measurement of at least one viscoelastic property of the test sample utilizing

transmission of sound into one or more test chamber (See Paras. 0039 and 0065).

It would have been obvious to one of ordinary skill in the art at the time of

invention to incorporate the interrogation means of Braun Sr. into the device of Baugh

such that a user can monitor the reaction of the reagents with the blood samples without

having to physically manipulate the samples.

With respect to claim 17 Baugh fails to disclose the inclusion of a magnetic

stirring structure.

Braun Sr. teaches the use of a magnetic stirring structure (See Paras. 0055 and

0066).


invention to incorporate the magnetic stirring structure of Braun Sr. to ensure even

mixing of the reagent within the administered blood sample.



Art Unit: 1798

Claims 11-13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable

over Baugh (US 2003/0113929 Al) in view of Braun, Sr. (US 2002/0081741 Al) and

Kleiman (US 2012/0244392 A2).

With respect to claims 11-13 Baugh fails to disclose the composition of the

cartridge.

Braun Sr. teaches that the cartridge housing (10) may be composed of acrylic

(See Para. 0042). Kleiman discloses that a battery pack can be composed of a

thermally conductive acrylic material. Thus, it is being interpreted that the use of acrylic

for the cartridge housing satisfies the stipulation that at least a portion of the housing is

thermally conductive. It is also depicted that the thermally conductive portion of the

housing defines at least a portion of the fluid pathway (See Para. 0042).


invention to incorporate the thermally conductive material of the cartridge of Braun Sr.

into the device of Baugh to help initiate a faster reaction time between the blood sample

and the reagents.

Claims 20 and 22 are rejected under 35 U.S.C. 103(a) as being unpatentable

over Baugh (US 2003/0113929 Al) in view of Anand (US 2010/0274130 Al).


With respect to claim 20, Baugh discloses the following from a system that is

used for evaluation of hemostasis comprising:



Art Unit: 1798

A plurality of test chambers that are bordered by a plug (523) (502-507, see Fig.

5), each configured to receive blood of a test sample wherein each test chamber

comprises a reagent or a combination of reagents (See Paras. 0023-0024);








hemostasis (kaolin and dried heparin) (See Paras. 0022, 0027 and Table 1). The

applicant is directed to review the disclosure of Baugh (US 6,221,671 B1)

wherein it is stated that kaolin is an activator of both coagulation and platelets

(See Col. 6, lines 1-33). Additionally, Thies (US 2005/0216987 Al) teaches that

sodium heparin and low molecular weight heparins can function as antiplatelets

(See Para. 0047).

Baugh fails to disclose that the system also contains:

a transducer for transmitting ultrasound into one or more test chambers and for

receiving reflected sound from the chamber and the sample therein; and

at least one processor configured to determine a hemostasis parameter from the

received sound.



Art Unit: 1798

Anand teaches the use of "systems and methods for tracking and guiding high

intensity focused ultrasound beams (HIFU). More particularly, the disclosed systems

and methods involve use of acoustic radiation force impulse (ARFI) imaging to detect

the focal position of an HIFU capable transducer relative to a target area.... The desired

treatment location may be dynamically determined using bleed detection and

localization (BD&L) techniques." A processor can be used to monitor bleed rate, and if

a diminishing bleed rate is not detected over a certain period of time, the processor may

stop HIFU therapy (See Abstract and Para. 0030).

It would have been obvious to one of ordinary skill in the art to incorporate the

function of the transducer and processor of Anand into the system of Baugh such that a

user can monitor the progress of clot formation within the device.

With respect to claim 22, Anand discloses that the processor is further configured

to determine a coagulation factors index (See Paras. 0027-0028).

Claim 21 are rejected under 35 U.S.C. 103(a) as being unpatentable over Baugh

(US 2003/0113929 Al) in view of Anand (US 2010/0274130 Al) and further in view of

Braun, Sr. (US 2002/0081741 Al).

With respect to claim 21, the combination of Baugh and Anand fail to teach that

the hemostasis parameter is selected from the group consisting of TC1, TC2, clot

stiffness, clot formation rate, TL1, TL2, baseline viscosity, and post lysis viscosity.

Braun Sr. teaches that the hemostasis parameter is selected from the group

consisting of TC1, TC2, clot stiffness, clot formation rate, TL1, TL2, baseline viscosity,

and post lysis viscosity (See Paras. 0011 and 0020).



Art Unit: 1798

It would have been obvious to one of ordinary skill in the art at the time invention

to incorporate the specific hemostasis parameters for detection into the modified Baugh

device such that a user can monitor a variety of conditions within the same test

cartridge, thus eliminating the use of additional cartridges and reducing the amount of

time used to diagnose a condition.

Claim 25 is rejected under 35 U.S.C. 103(a) as being unpatentable over Baugh

(US 2003/0113929 Al) and Anand (US 2010/0274130 Al) in view of Lec (US

2005/0015001 Al).

Refer above for the combined teaching of Baugh and Anand.

The combination of Baugh and Anand fail to teach that the processor is

configured to determine an intrinsic pathway coagulation factors index, an extrinsic

pathway coagulation factors index, a platelets index, a fibrinogen index, and a

fibrinolysis index.

Lec teaches the use of an acoustic blood analyzer used in the measurement of

various blood properties including "density, elasticity, viscosity, clot stiffness, platelet

concentration, platelet activation, platelet receptor activities, GPI lb/Illa function, GPlb

function, GPla/Ila function, blood hemostatic factor concentration, bleeding time,

activated clotting time, activated partial thromboplastin time, prothrombin time, thrombin

time, Fibrinogen, factor VIII deficiency, von Willebrand factor, tissue factor, specific drug

concentration, therapeutic effects of anticoagulation and antiplatelet or thrombin

inhibitor drug activities... characteristics which can be determined by measuring

interactions of native or intrinsic components of a blood sample such as, but not limited



Art Unit: 1798

to cells, proteins, DNAs, or enzymes in the blood or derived from the blood, as well as

interactions of extrinsic or foreign components such as, but not limited to, drugs, viruses

or bacteria in the blood or derived from the blood" (See Para. 0049). Additionally, in

some assays, fibrinolysis is stimulated to evaluate the potential for the sensor to detect

fibrinolytic tendency (See Para. 0089).


invention to incorporate the detection of the above blood properties into the processor

capabilities of the combined system of Baugh and Anand such that a user can use a

broad range of parameters to accurately monitor coagulation within a given blood

sample.

Response to Arguments

Applicant's arguments filed July 17, 2015 have been fully considered but they are

not persuasive. The applicant argues kaolin and heparin are agonists and antagonists

of coagulation but not specifically of platelets, fibrinogen, fibrinolytic factors, or plasma

coagulation factors. However, literature and other art (Baugh (US 6,221,671 B1), Thies

(US 2005/0216987 Al), and the Nature article) have been provided in the above

rejection to demonstrate that both kaolin and heparin act upon the claimed features and

not just generically that of coagulation.

Allowable Subject Matter

Claim 79 and 80 are allowed.



Art Unit: 1798

The following is an examiner's statement of reasons for allowance: The closest

prior art of reference, Baugh (US 2003/0113929 Al), fails to disclose or fairly teach the

inclusion of one or both of abciximab or cytochalasin D within a test chamber that also

includes an activator of coagulation.

Any comments considered necessary by applicant must be submitted no later

than the payment of the issue fee and, to avoid processing delays, should preferably

accompany the issue fee. Such submissions should be clearly labeled "Comments on

Statement of Reasons for Allowance."

Conclusion




5:00pm.






Art Unit: 1798










/BRITTANY FISHER/ /JILL WARDEN/ Examiner, Art Unit 1798 Supervisory Patent Examiner, Art Unit 1798

October 19, 2015


Notice of References Cited


13/397,398

Applicant(s)/Patent Under Reexamination VIOLA ET AL.

Examiner

BRITTANY FISHER

Art Unit

1798 Page 1 of 1

U.S. PATENT DOCUMENTS

* Document Number Country Code-Number-Kind Code

Date MM-YYYY Name CPC Classification US Classification

* A US-6,221,672 B1 04-2001 Baugh; Robert F. GO1N33/4905 422/73

* B US-2005/0216987 P1 09-2005 Murakami, Yasuyuki A01 H5/02 PLT/413

C US-

D US-

E US-

F US-

G US-

H US-

I US-

j US-

K US-

L US-

M US-

FOREIGN PATENT DOCUMENTS

* Document Number Country Code-Number-Kind Code

Date MM-YYYY Country Name CPC Classification

N

0

P

Q

R

S

T

NON-PATENT DOCUMENTS

* Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages)

U Hardisty R. M. et al, "Fibrinogen as a Co-factor in the Reaction of Platelets with Kaolin," 7 May 1966, Nautre Publishing Group, Edition 210, Volume 644 (http://www.nature.com/nature/journal/v210/n5036/abs/210644a0.html)

V

W

X

*A copy of th's reference is not being furnished with this Office action. (See MPEP § 707.05(a).) Dates in MM YYYY format are publication dates. Classifications may be US or foreign.


PTO-892 (Rev. 01-2001) Notice of References Cited Part of Paper No. 20151019


Ref Hits Search Query D Bs Default Plurals Time Operator Stamp

L2 933 kaolin with platelet US-PGPUB; OR ON 2015/10/19 USPAT; 07:07

EPO; JP()

L3 63 (kaolin with platelet) same (agonist or US-PGPUB; OR ON 2015/10/19 activator) USPAT; 07:08

EPO; JP()

L4 10188 (heparin with platelet) same (antagonist or US-PGPUB; OR ON 2015/10/19 inhibit$4) USPAT; 07:13

EPO; JP()

L5 684 (heparin with (platelet and fibrinogen)) same US-PGPUB; OR ON 2015/10/19 (antagonist or inhibit$4) USPAT; 07:13

EPO; JP()

L6 15 (kaolin with fibrinogen) same (agonist or US-PGPUB; OR ON 2015/10/19 activator) USPAT; 07:15

EPO; JP()

L7 1575 (heparin with fibrinogen) same (antagonist or US-PGPUB; OR ON 2015/10/19 inhibit$4) USPAT; 07:30

EPO; JP()

93 (heparin near3 fibrinogen) with (antagonist or US-PGPUB; 0 2015/10/19 inhibit$4) USPAT; 07:30

EPO; JP()

L9 7331 antiplatelet same heparin US-PGPUB; USPAT; EPO; JPO

OR ON 2015/10/19 07:37

L10 6409 antiplatelet with heparin US-PGPUB; USPAT; EPO; JPO

OR ON 2015/10/19 07:37

L11 683 antiplatelet near3 heparin US-PGPUB; USPAT; EPO; JPO

OR ON 2015/10/19 07:37

L12 21 (US-20050015001-$ or US-20080297169-$ or US-20030113929-$ or US-20020081741-$ or US-20100274130-$ or US-20030170883-$ or US-20040131500-$ or US-20120294767-



7857761-$ or US-7422905-$ or US-7399637-$ or US-6221672-$).did.

US-PGPUB; USPAT

OR ON 2015/10/19 07:42

L13 4 L12 and "abciximab" US-PGPUB; USPAT; EPO; JPO

OR ON 2015/10/19 07:42

L14 0 L12 and "cytochalasin D" US-PGPUB; USPAT; EPO; JPO

OR ON 2015/10/19 07:47

L15 0 L12 and "cytochalasin" US-PGPUB; USPAT;

OR ON 2015/10/19 07:48

EAST Search History

EAST Search History

EAST Search History (Prior Art)

EASTSearchHistory.13397398_AccessibleVersion.htm[10/19/2015 8:06:35 AM]


[ EPO; JPO

0 ("2012/0294767").URPN. USPAT OR ON

0 (blood near3 chamber) same (kaolin near3 abcixi mab)

USPAT

USPAT

OR

R

ON

N (blood near3 chamber) same (kaolin with abcixi mab)

(blood near3 chamber) and (kaolin with abcixi mab)

USPAT OR ON

1 (blood with chamber) and (kaolin with abcixi mab)

USPAT OR ON

0 (blood with chamber) and (kaolin with cytochalasin)

USPAT OR ON

0 (blood with chamber) and (kaolin same cytochalasin)

USPAT OR ON

1196 (activator or agonist) same (abciximab or cytochalasin)

USPAT OR

0

EPO; JP()

ON

32 L23 and (blood near3 chamber) USPAT

0 422/069.ccls. US-PGPUB; USPAT;


OR ON


OR ON

61 S2 and blood.ti,ab. US-PGPUB; USPAT; EPO; JP()

OR ON

134 S2 and (separat$4 with (blood or plasma)) US-PGPUB; USPAT; EPO; JP()

OR ON

93 S5 and (duct or channel or groove) US-PGPUB; USPAT; EPO; JPO

OR ON

4790 422/69,73,502,503,507,527,534,535,551.ccls. US- PGPUB; USPAT; EPO; JPO

OR ON

1121 S7 and (liquid with (purification or separat$4))

US- PGPUB; USPAT; EPO; JPO

OR ON

610 S8 and blood

EPO; JPO

US- PGPUB; USPAT;

OR ON

2 ("20060133958" "7104406").PN. US-PGPUB; USPAT; EPO; JPO

OR ON

0 $-W02009112982-$.did. US-PGPUB; USPAT; EPO; JPO

OR ON

0 $W02009112982-$.did. US-PGPUB; USPAT; EPO; JPO

OR ON

1 WO-2009112982-$.did. US-PGPUB; OR ON

EAST Search History

S4

S7

S10

S11

S12

1S13

L16

L17

L18

L19

L20

L21

L22

L23

2015/10/19 07:50

2015/10/19 07:51

2015/10/19 07:51

2015/10/19 07:51

2015/10/19 07:52

2015/10/19 07:53

2015/10/19 07:53

2015/10/19 07:56

2015/10/19 07:57

2013/01/16 09:33

2013/01/16 09:33

2013/01/16 09:53

2013/01/16 10:09

2013/01/16 10:11

2013/01/16 10:13

2013/01/16 10:43

2013/01/16 10:44

2013/01/16 10:44

2013/01/16 12:07

2013/01/16 12:16

2013/01/16 12:23

12013/01/16



EAST Search History

USPAT; EPO; JP()

12:25

S15 0 KR-1020080051011-$.d id . US- PGPUB; USPAT; USOCR; FPRS; EPO; JPO; DERWENT I BM_TDB

OR ON 2013/01/16 13:43

S16 23 "5254248" US- PGPUB; USPAT; USOCR; FPRS; EPO; JPO; DERWENT I BM_TDB

OR ON 2013/01/16 13:46

S17 0 WO-0124931-$.did. US- PGPUB; USPAT; EPO; JP()

OR ON 2013/01/17 10:39

S18 161 "4753776" US- PGPUB; USPAT; EPO; JP()

OR ON 2013/01/17 10:42

S19 105 "5135719"

EPO; JP()

US- PGPUB; USPAT;

OR ON 2013/01/17 10:42

S20 141 "5458852"

EPO; JP()

US- PGPUB; USPAT;

OR ON 2013/01/17 10:43


OR ON 2013/01/17 10:45


OR ON 2013/01/17 10:45


OR ON 2013/01/17 10:45

S24

S25

105 "5135719" US- PGPUB; USPAT; EPO; JP()

OR ON 2013/01/17 14:30

112 "5039617" US- PGPUB; USPAT; EPO; JP()

OR 2013/01/17 14:30


OR ON 2013/01/17 14:31


OR ON 2013/01/17 14:31


OR ON 2013/01/17 14:35

9 1 "20080040131" US- PGPUB; USPAT; EPO; JPO

OR ON 2013/01/17 16:16

S30 1155 422/ 69. ccl s. US- PGPUB; USPAT; EPO; JPO

OR ON 2013/01/24 15:05



EAST Search History

S31 134 S30 and (separat$4 with (blood or plasma)) US-PGPUB; OR ON 2013/01/24 USPAT; 15:05 EPO; JP()

S32 3 S31 and (polycarbonate with filter) US-PGPUB; OR ON 2013/01/24 USPAT; 15:05 EPO; JP()

S33 16096 (separat$4 with (blood and plasma)) US-PGPUB; OR ON 2013/01/24 USPAT; 15:06 EPO; JP()

21 (separat$4 with (blood and plasma)) same US-PGPUB; 0 2013/01/24 (filter with polycarbonate) USPAT; 15:07

EPO; JP()

S35 6 (separat$4 with (blood and plasma)) same US-PGPUB; OR ON 2013/01/24 (filter with polycarbonate) and porosity USPAT; 15:14

EPO; JP()

S36 8 (separat$4 with (biological and fluid)) same US-PGPUB; OR ON 2013/01/24 (filter with porosity) USPAT; 15:22

EPO; JP()

7 357 "5798031" US-PGPUB; OR ON 2013/01/24 USPAT; 15:24 EPO; JP()

8 0 S37 and (filter with porosity) US-PGPUB; OR ON 2013/01/24 USPAT; 15:24 EPO; JPO „„„„„„„„„„„„

9 0 S37 and (filter same porosity) US-PGPUB; OR ON 2013/01/24 USPAT; 15:24 EPO; JP()


4 S40 and (filter same porosity) US-PGPUB; OR ON 2013/01/24 USPAT; 15:24 EPO; JP()

S42 112 "5039617" US-PGPUB; OR ON 2013/01/24 USPAT; 15:25

EPO; JP()


S44 10276 filter with porosity US-PGPUB; OR ON 2013/01/24 USPAT; 15:26 EPO; JP()

S45 886 S44 and "422".clas. US-PGPUB; OR ON 2013/01/24 USPAT; 15:26 EPO; JPO

S44 and 422/73.ccls. US-PGPUB; 0 2013/01/24 USPAT; 15:26 EPO; JPO

(filter with polycarbone) same porosity US-PGPUB; 0 2013/01/24 USPAT; 15:27 EPO; JPO

S48 0 (filter with polycarbone) US-PGPUB; OR ON 2013/01/24 USPAT; 15:27 EPO; JPO

S49 8177 filter with polycarbonate US-PGPUB; OR ON 2013/01/24 USPAT; 15:27 EPO; JPO



EAST Search History

S50 180 S49 same porosity US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/24 15:27

S51 26 S50 and "422".clas. US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/24 15:27

S52

S53 S53


OR ON 2013/01/24 15:33

11 (US-20040191124-$ or US-20060076295-$ or US-20070082370-$).did. or (US-5558834-$ or US-4753776-$ or US-6319719-$ or US-

5981294-$ or US-6936473-$ or US-4976270-$ or US-4131549-$).did. or (WO-2009112982-

$).did.

US-PGPUB; USPAT; EPO

0 ON2013/01/24 15:44

S54 3 S53 and groove

EPO; JPO

US-PGPUB; USPAT;

OR ON 2013/01/24 15:44

S55 1 S33 and (((channel or capillary) with groove) same laminate)

EPO; JPO

US-PGPUB; USPAT;

OR ON 2013/01/24 15:46

S56 422 S33 and ((channel or capillary) with groove)

EPO; JPO

US-PGPUB; USPAT;

OR ON 2013/01/24 15:47

S57 100 S33 and (((channel or capillary) with groove) same substrate)


OR ON 2013/01/24 15:47

S58 18 (US-20040191124-$ or US-20060076295-$ or US-20070082370-$ or US-20030114785-$ or US-20070243111-$ or US-20080028821-$ or US-20080047892-$ or US-20090107909-


6936473-$ or US-4976270-$ or US-4131549-$ or US-7105354-$ or US-6607644-$).did. or WO-2009112982-$) .did.

US-PGPUB; USPAT; EPO

OR ON 2013/01/24 17:11

S59 0 S58 and immunoassay US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/24 17:11

S60 27 S57 and immunoassay US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/24 17:11

S61

S62

S63

1 S57 and (immunoassay with port) US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/24 17:11

3 S57 and (immunoassay with device) US-PGPUB; USPAT; EPO; JPO

OR 2013/01/24 17:11

1169 422/73.ccls. US-PGPUB; USPAT; EPO; JPO

OR 2013/01/24 18:02

S64 126 S63 and (hemostasis or haemostasis) US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/24 18:02

S65 8 S64 and viscoelastic$4 US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/24 18:03

S66 95 ("20020013530" 1 "20020040187" 1 US-PGPUB; OR ON 2013/01/24



EAST Search History

"20030013958" "20030105398" "20030204141" "20040167403" "20050015001" "20050148899" "20070059840" "20070276236" "20080249408" "20090112483"

"4558589" "4814247" "5056357" "5234839" "5331964" "5605154" "5657760" "5810731" "5921928" "6114135" "6213950" "6270459" "6371912" "6494834" "6535835" "6613573" "6687625" "6726629" "6797519" "7179652" "7207939" "7399637" "7524670" "7972271"

"4695956" "4852577" "5104975" "5273517" "5473536" "5606971" "5673699" "5854423" "6039691" "6117081" "6225126" "6277074" "6402704" "6508768" "6537819" "6632678" "6692439" "6764448" "6890299" "7192726" "7261861" "7422905" "7732213" "8058023"

"20030073244" "20030171676" "20040068184" "20050004463" "20050053305" "20070038095" "20070184508" "20080038828" "20080261261" "20120252127"

"4705756" "4900679" "5205159" "5311908" "5487387" "5655535" "5744898" "5899861" "6083159" "6135945" "6264609" "6283917" "6454714" "6514204" "6573104" "6685646" "6716168" "6787363" "6951544" "7202048" "7374538" "7439069" "7912661" "RE37171").PN.

"4112740"

USPAT; EPO; JPO

18:05

S67 26 S66 and (hemostasis or haemostasis) US-PGPUB; OR ON 2013/01/24 USPAT; 18:06 EPO; JP()

8 6 S67 and viscoelastic$4 US-PGPUB; OR ON 2013/01/24 USPAT; 18:06 EPO; JP()

9 1155 422/69.ccls. US-PGPUB; OR ON 2013/01/24 USPAT; 18:08 EPO; JP()

S70 0 S69 and (hemostasis or haemostasis) US-PGPUB; 0 N 2013/01/24 USPAT; 18:08 EPO; JP()

571 4807 422/69,73,502,503,507,527,534,535,551.ccls. US-PGPUB; OR ON 2013/01/24 USPAT; 18:08

EPO; JP()

S72 157 S71 and (hemostasis or haemostasis) US-PGPUB; OR ON 2013/01/24 USPAT; 18:08

EPO; JP()

S73 8 S72 and viscoelastic$4 US-PGPUB; OR ON 2013/01/24 USPAT; 18:08 EPO; JP()

S74 100 (US-20050143675-$ or US-20060094986-$ or US-PGPUB; OR ON 2013/01/29 US-20070212258-$ or US-20060222567-$ or USPAT; 14:52 US-20060034728-$ or US-20040049355-$ or EPO; JP() US-20080021296-$ or US-20090156964-$ or US-20090209040-$ or US-20030223906-$ or US-20030191415-$ or US-20030116583-



EAST Search History






6997343-$).did. or (WO-9410558-$ or WO- 2004063747-$).did. or (EP-1288653-$ or US- 20030089730-$).did. or ("20020104849" "20040178216" "6378702").PN. or (US-

20060099108-$ or US-20060024203-$ or US- 20060173380-$ or US-20030223906-$).did. or (US-7582063-$ or US-7150755-$ or US-

6228100-$ or US-6036924-$ or US-7303726- $).did. or (DE-10057832-$ or WO-0123885-$ or US-20030212345-$).did. or (US-

20020060247-$ or US-20030207454-5 or US- 20030185705-$ or US-20020057993-5 or US- 20030032190-$ or US-20030191415-5 or US- 20050143675-5 or US-20030089730-$).did. or (US-5628890-$ or US-6743635-$ or US-



6514460-$).did. or US-6472220-$ or US- 6036924-$ or US-5971941-$.did. or (US- 20080021296-$ or US-20040178216-5 or US- 20030212345-$ or US-20030175155-5 or US- 20020076349-$ or US-20020104849-5 or US- 20030002387-$ or US-20030116583-5 or US- 20080181818-5).did. or (US-5244116-$ or US- 7449148-$ or US-5335816-$ or US-7264139-$ or US-7138089-$ or US-5330716-$ or US-



6135314-$ or US-7552843-5).did. or (US- 1445563-$ or US-2551425-5).did. or (WO- 2006046701-$).did. (US-20080181818-$ or US-20090230144-5 or US-20030211619-5 or US-20100286563-$ or US-20110000933-5 or US-20110000932-5 or US-20080164280-$ or US-20030089730-5 or US-20020188224-5 or US-20020076349-5 or US-20020057993-5 or US-20070264165-5 or US-20030116583-



S75 1

S76 100

"20120329082"

(US-20050143675-$ or US-20070212258-$ or US-20060034728-$ or US-20080021296-$ or US-20090209040-$ or US-20030191415-$ or

US-20060094986-$ or US-20060222567-$ or US-20040049355-$ or US-20090156964-$ or US-20030223906-$ or US-20030116583-


OR ON 2013/01/30 13:47


OR ON 2013/01/30 14:16








6997343-$).did. or (WO-9410558-$ or WO-2004063747-$).did. or (EP-1288653-$ or US-20030089730-$).did. or ("20020104849" "20040178216" "6378702").PN. or (US-

20060099108-$ or US-20060024203-$ or US-20060173380-$ or US-20030223906-$).did. or (US-7582063-$ or US-7150755-$ or US-

6228100-$ or US-6036924-$ or US-7303726-$).did. or (DE-10057832-$ or WO-0123885-$ or US-20030212345-$).did. or (US-

20020060247-$ or US-20030207454-5 or US-20030185705-5 or US-20020057993-5 or US-20030032190-5 or US-20030191415-5 or US-20050143675-5 or US-20030089730-$).did. or (US-5628890-$ or US-6743635-$ or US-



6514460-$).did. or US-6472220-$ or US-6036924-$ or US-5971941-$.did. or (US-20080021296-$ or US-20040178216-5 or US-20030212345-5 or US-20030175155-5 or US-20020076349-5 or US-20020104849-5 or US-20030002387-5 or US-20030116583-5 or US-20080181818-5).did. or (US-5244116-$ or US-7449148-$ or US-5335816-$ or US-7264139-$ or US-7138089-$ or US-5330716-$ or US-



6135314-$ or US-7552843-5).did. or (US-1445563-$ or US-2551425-5).did. or (WO-2006046701-$).did. (US-20080181818-$ or US-20090230144-5 or US-20030211619-5 or US-20100286563-5 or US-20110000933-5 or US-20110000932-5 or US-20080164280-5 or US-20030089730-5 or US-20020188224-$ or US-20020076349-5 or US-20020057993-5 or US-20070264165-$ or US-20030116583-

5).did. or (US-7138089-$ or US-6908008-$ or US-5941414-$ or US-5383569-$ or US

5513773-$ or US-7585464-5 or US-7552843-5 or US-6534017-$ or US-7887757-5).did.

S76 and (haemostasis or hemostasis) S77 0

S78 1170 422/73.ccls.

S78 and (haemostasis or hemostasis) S79 126

EAST Search History

2013/01/30 14:16


OR ON


OR ON 2013/01/30 14:21

US-PGPUB; USPAT;

OR ON 2013/01/30 14:21



EAST Search History

1 [ [ EPO; JPO 1 I I S80 31 "5047211" US-PGPUB;

USPAT; EPO; JPO

OR ON 2013/01/31 09:21

S81 17 ("4067777" 1 "4533519" 1 "4599219" "4871677" "5302348" 1 "5314826" "5366869" "5441892" 1 "5534226" "5591403" "5686659" 1 "5789664" "5800781" "5925319" 1 "5951951" "5972712" "6221672") . PN.

US-PGPUB; USPAT; USOCR

OR ON 2013/01/31 14:51

S82 8 ("6541262").URPN. USPAT OR ON 14:54

2013/01/31

S83

S84

30 ("5047211").URPN. USPAT OR ON 16:02

2013/01/31

(haemostasis or hemostasis) same (acoustic adj radiation)


OR 2013/01/31 16:20

S85 22 (haemostasis or hemostasis) and (acoustic adj radiation)


OR ON 2013/01/31 16:20

S86 1170 422/ 73. ccls. US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/31 16:26

S87 18 S86 and viscoelastic US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/31 16:26

S88 19 S86 and viscoelastic$4 US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/31 16:26

S89

S90

14 (US-20050015001-$ or US-20080297169-$ or US-20030113929-$ or US-20020081741-$ or US-20100274130-$).did. or (US-5854423-$ or US-5628961-$ or US-8058023-$ or US-


5629209-$).did.

US-PGPUB; USPAT

OR ON 2013/01/31 16:34

6 S89 and viscoelastic$4 US-PGPUB; USPAT; EPO; JPO

OR 2013/01/31 16:34

S91 2 S89 and acoustic US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/31 16:35

S92 4 S89 and (thermal$3) US-PGPUB; USPAT; EPO; JPO

OR ON 2013/01/31 18:55

S93 556 acrylic with (thermal$4 with conduct$4) US-PGPUB; USPAT

OR ON 2013/01/31 19:23


OR ON 2013/01/31 19:23


OR ON 19:24

2013/01/31

S96

S97

S98

3 S93 and "436".clas. US-PGPUB; USPAT

OR ON 19:24

2013/01/31

16229 (thermal$4 with conduct$4) same polymer US-PGPUB; USPAT

OR 13:15

2013/02/02

1981 (thermal$4 with conduct$4) near2 polymer US-PGPUB; USPAT

OR ON 2013/02/02 13:15



599 45 US-PGPUB; USPAT

S98 and "422".clas.


OR ON 2013/02/02 13:16

S101 204 S98 and blood US-PGPUB; USPAT

OR ON 2013/02/02 13:17

S102 1 "20030170883" USPAT US-PGPUB; OR ON 2013/02/02

13:21



7745223-$ or US-5800781-$ or US-5591403-$ or US-5366869-$ or US-5629209-$).did.

US-PGPUB; USPAT

OR ON 2013/02/02 13:50

S104 3 S103 and ultrasound US-PGPUB; USPAT; EPO; JPO

OR ON 2013/02/02 13:50

S105 1 S103 and (transducer and ultrasound) US-PGPUB; USPAT; EPO; JPO

OR ON 2013/02/02 14:04

S106 0 S103 and (processor same coagulat$4)

EPO; JPO

US-PGPUB; USPAT;

OR ON 2013/02/02 14:21

S107 1301 processor with (coagulation or clot$4 or platelet or fibrino$6)

US-PGPUB; USPAT

OR ON 2013/02/02 14:25


OR ON 2013/02/02 14:25

S109 108 (processor and intrinsic and extrinsic and platelet and fibrinogen and fibrinolysis) and (coagulation or clot$4)

US-PGPUB; USPAT

OR ON 2013/02/02 14:33

5110 2 "20050015001" US-PGPUB; USPAT

OR ON 2013/02/02 14:38




7857761-$).did.

US-PGPUB; USPAT

OR ON 2013/02/02 14:49

S112 0 5111 and lyophili US-PGPUB; USPAT; EPO; JPO

OR ON 2013/02/02 14:49

S113 5 5111 and lyophili$4 US-PGPUB; USPAT; EPO; JPO

OR ON 2013/02/02 14:49


OR ON 2013/06/12 09:52

S115 102 ("20040167403" 1 "20090112483" I "4705756" "5657760" "5673699" I "5744898" "6277074" "6454714" I "6692439" "6726629" "6787363" 1 "6797519" "7207939" "7399637" "7422905" "RE37171" 1 "20050015001" "20070038095" 1 "20080249408" 1 "4695956"

"5234839" 1 "6225126" 1 "6371912"

US-PGP1JB; USPAT; EPO; JPO

OR ON 2013/09/26 10:45

2013/02/02 13:15

0

EAST Search History



EAST Search History

"7202048" "20050148899"

"6613573" "7192726" "20100274130"

"20050004463" "20080261261" "5921928" "6117081" "7261861" "4852577" "6135945" "6494834" "6951544" "20030170883" "20030013958" "20080038828"

"5854423" "20030073244" "20030171676" "5810731" "6283917" "6535835" "6716168" "20030113929" "20070276236" "4900679" "5473536" "7524670"1

"20080297169"

"6632678" "7912661"

"5800781"

"5104975" "6083159" "6764448" "7374538" "5311908" "6213950" "6537819" "7732213"

"20020013530"

"5605154" "5899861" "6508768" "6685646" "7439069"

"4558589" "5056357" "5655535" "20110151491").PN.

"4112740"

"20050015001"

"20020040187" "20030204141"I "20120252127"

"20030105398"I

"20070059840"I

"20050053305" "6270459"

"7179652" "7972271"

"20040068184"

"5487387" "6114135"I "6890299"I "20070184508" "5331964"I "6264609"I "6573104" "8058023"I

"5273517"

"5606971" "6039691" "6514204" "6687625" "20020081741"

"4814247" "5205159" "6402704"

2013/09/26 10:46

S116 56 S115 and ultrasound

EPO; JP()

US-PGPUB; USPAT;

OR ON

S117 16 (US-20050015001-$ or US-20080297169-$ or US-20030113929-$ or US-20020081741-$ or

US-PGPUB; USPAT

OR ON 2014/03/09 19:41

US-20100274130-$ or US-20030170883- $).did. or (US-5854423-$ or US-5628961-$ or US-8058023-$ or US-7202048-$ or US


7857761-$).did.

S118 4 S117 and agonist US-PGPUB; OR ON 2014/03/09 USPAT; 19:41 EPO; JP()

S119 0 (blood with cartridge) same (agonist and US-PGPUB; 0 N 2014/03/09 antagonist) USPAT; 19:44

EPO; JP()

S120 27 (blood with cartridge) same (agonist or US-PGPUB; OR ON 2014/03/09 antagonist) USPAT; 19:44

EPO; JP()

S121 151 (blood with chamber) same (agonist or US-PGPUB; OR ON 2014/03/09 antagonist) USPAT; 19:49

EPO; JP()

S122 18 ("4756884" "5601995" "4861711" US- PGPUB; OR ON 2015/03/21 "5039617" "5656448" "20100248394" USPAT; 22:48 "20020119486" "4094647" "20060239859" EPO; JP()

"20020187071" "6451264" "20040072357" "4632901" "4943522" "5110727" "5372946" "20080176272" "6156273") . PN.

S123 18 ("4756884" "5601995" "4861711" US- PGPUB; OR ON 2015/03/21 "5039617" "5656448" "20100248394" USPAT; 23:18



EAST Search History

"20020119486" 1 "4094647" 1 "20060239859" "20020187071" 1 "6451264"

"20040072357" 1 "4632901" 1 "4943522" "5110727" 1 "5372946" 1 "20080176272" 1 "6156273").PN.

EPO; JPO

S124 5 S123 and (projection) US-PGPUB; USPAT; EPO; JPO

OR ON 2015/03/21 23:18


OR ON 2015/05/16 20:35

S126 12 ("20040076546" "20040214337" 1 "20080194967" "20110034805"I "20110172661" "20110252352" 1 "20120232803" "20120294767" 1 "20130190584" "5016469" 1 "6412344" "8740818") . PN.


OR ON 2015/05/16 20:37

S127 1551 g01n33/86.cpc. US-PGPUB; USPAT; EPO; JPO

OR ON 2015/05/16 20:57

S128

S129

S130

602

1866

g01n33/49.cpc. US-PGPUB; USPAT;

US-PGPUB; USPAT;

EPO; JPO

EPO; JPO

OR

OR

ON 2015/05/16 20:58

2015/05/16 20:58

gO1n33/4905,491.cpc.

610 c12q1/56.cpc. US-PGPUB; USPAT; EPO; JPO

OR 2015/05/16 21:00

S131 539 a61b5/0048.cpc. US-PGPUB; USPAT; EPO; JPO

OR ON 2015/05/16 21:01



OR ON 2015/05/16 21:04



OR ON 2015/05/16 21:04



OR ON 2015/05/16 21:04



OR ON 2015/05/16 21:04



OR ON 2015/05/16 21:05



OR ON 2015/05/16 21:06


EPO; JPO

US-PGPUB; USPAT;

OR ON 2015/05/16 21:06


OR ON 2015/05/16 21:08

S142 15 ("6010911" 1 "20120329082" I "20080268483" 1 "4752449" 1 "6613573" 1

US-PGPUB; USPAT;

OR ON 2015/05/16 21:09



5144 0 (blood with catridge) same (agonist and antagonist)


OR ON 2015/05/30 12:39

2015/05/30 12:39

5145 0 (blood with catridge) and (agonist and antagonist)

EPO; JPO

US-PGPUB; USPAT;

OR ON

5146 90 catridge and (agonist and antagonist)

EPO; JPO

US-PGPUB; USPAT;

OR ON 2015/05/30 12:39

5147 114 ("20040167403" 1 "20090112483" I US-PGPUB; OR ON 2015/05/30 "4705756" 1 "5657760" 1 "5673699" I USPAT; 12:40 "5744898" 1 "6277074" 1 "6454714" I EPO; JPO "6692439" 1 "6726629" 1 "6787363" "6797519" 1 "7207939" 1 "7399637" "7422905" 1 "RE37171" 1 "20050015001" "20080194967" 1 "20110034805" "20070038095" 1 "20080249408" 1 "4695956"

"5234839" 1 "6225126" 1 "6371912" "7202048" 1 "20080297169" 1 "20110172661" 1 "20130190584" 1 "20050053305" 1 "20050148899" 1 "4112740" 1 "6270459" "6613573" 1 "6632678" 1 "7179652" "7192726" 1 "7912661" 1 "7972271" "20100274130" 1 "5800781" 1 "20040076546"

"5016469" 1 "20040068184" "20050004463" 1 "20050015001" "20080261261" 1 "5104975" 1 "5487387" "5921928" "6083159" "6114135"I "6117081" "6764448" "6890299"I "7261861" "7374538" "20070184508"1 "4852577" "5311908" "5331964"I "6135945" "6213950" "6264609"I "6494834" "6537819" "6573104"1 "6951544" "7732213" "8058023"I "20030170883" 1 "20020040187" 1 "20030013958" 1 "20030204141" "20080038828" 1 "20120252127" 1 "5273517"

"5854423" 1 "20120232803" 1 "8740818" "20020013530" 1 "20030073244" "20030105398" 1 "20030171676" 1 "5605154"

"5606971" 1 "5810731" 1 "5899861" "6039691" 1 "6283917" 1 "6508768" "6514204" 1 "6535835" 1 "6685646" "6687625" 1 "6716168" 1 "7439063" "20020081741" 1 "20030113929" "20040214337" 1 "20120294767" 1 "6412344"

"20070059840" 1 "20070276236" "4558589" 1 "4814247" 1 "4900679" "5056357" 1 "5205159" 1 "5473536" "5655535" 1 "6402704" 1 "7524670" "20110151491" 1 "20110252352").PN.

5148 10 "5016469" US-PGPUB; OR ON 2015/05/30 USPAT; 13:10 EPO; JPO

15149 2 "20040072357" US-PGPUB; OR ON 2015/05/30

"5314826" "5925319" "5951951" "6221672" "6541262" "6613286" "5174961" "5441892" "5629209" "4443408").PN.

EPO; JPO

(blood near3 test$4 with catridge) same (agonist and antagonist)


2015/05/30 12:38

S143 0 OR ON

EAST Search History



EPO; JPO USPAT; 13:11

S150 8 ("2008/0297169").URPN. USPAT OR ON 2015/05/30 14:23

S151 1 "20080194967" USPAT OR ON 2015/05/30 15:24

EAST Search History

EAST Search History (Interference)

<This search history is empty>

10/ 19/ 2015 8:06:32 AM C:\ Users\ bfisher\ Documents\ EAST\ Workspaces\ 13397398 Hemostasis Eval. Device.wsp



111 111

Search

11 11 1111

Notes

111 1 11


13397398


VIOLA ET AL.

Examiner

BRITTANY FISHER

Art Unit

1773

CPC- SEARCHED

Symbol

Date Examiner


Symbol

Date Examiner



SEARCH NOTES


2/2/2013 BIF


2/2/2013 BIF

PALM inventor search 2/2/2013 BIF See attached EAST search history 2/2/2013 BIF Consulted PE Neil Turk about claim interpretation 9/25/2013 BIF See attached BRS search history 9/26/2013 BIF Consulted PE Neil Turk about claim interpretation 3/23/2014 BIF See attached BRS search history 3/23/2014 BIF BOIL 3/5027 text searched 1/12/2015 BIF GO1N 27/07 and 33/86 text searched 1/12/2015 BIF See attached BRS search history 1/12/2015 BIF See updated EAST search history 6/1/2015 BIF See updated EAST search history 10/19/2015 BIF


INTERFERENCE SEARCH

US Class/ US Subclass / CPC Group Date Examiner CPC Symbol


111

Index

111 11 11

of

1111

Claims

11 1 11


13397398


VIOLA ET AL.

Examiner

BRITTANY FISHER

Art Unit

1773

I Rejected

= Allowed

Cancelled

Restricted

N Non-Elected

I Interference

A Appeal

0 Objected


CLAIM DATE

Final Original 02/02/2013 09/25/2013 03/11/2014 01/12/2015 06/01/2015 10/19/2015

1 V V V V V V

2 V V V V V V

3 V V V V V V

4 V V V V V V

5 V V V V V V

6 V V V V V V

7 V V V V V V

8 V V V V V V

9 V V V V V V

10 V V V V V V

11 V V V V V V

12 V V V V V V

13 V V V V V V

14 - V V - - -

15 V V V V V V

16 V V V V V V

17 V V V V V V

18 - - - - - -

19 - - - - - -

20 V V V V V V

21 V V V V V V

22 V V V V V V

23 - - - - - -

24 - - - - - -

25 V V V V V V

26 - - - - - -

27 - - - - - -

28 - - - - - -

29 - - - - - -

30 - - - - - -

31 - - - - - -

32 - - - - - -

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34 - - - - - -

35 - - - - - -

36 - - - - - -



111

Index

111 11 11

of

1111

Claims

11 1 11


13397398


VIOLA ET AL.

Examiner

BRITTANY FISHER

Art Unit

1773

I Rejected

= Allowed

Cancelled

Restricted

N Non-Elected

I Interference

A Appeal

0 Objected


CLAIM DATE

Final Original 02/02/2013 09/25/2013 03/11/2014 01/12/2015 06/01/2015 10/19/2015

37 - - - - - -

38 - - - - - -

39 - - - - - -

40 - - - - - -

41 - - - - - -

42 - - - - - -

43 - - - - - -

44 - - - - - -

45 - - - - - -

46 - - - - - -

47 - - - - - -

48 - - - - - -

49 - - - - - -

50 - - - - - -

51 - - - - - -

52 - - - - - -

53 - - - - - -

54 - - - - - -

55 - - - - - -

56 - - - - - -

57 - - - - - -

58 - - - - - -

59 - - - - - -

60 - - - - - -

61 - - - - - -

62 - - - - - -

63 - - - - - -

64 - - - - - -

65 - - - - - -

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67 - - - - - -

68 - - - - - -

69 - - - - - -

70 - - - - - -

71 - - - - - -

72 - - - - - -



111

Index

111 11 11

of

1111

Claims

11 1 11


13397398


VIOLA ET AL.

Examiner

BRITTANY FISHER

Art Unit

1773

I Rejected

= Allowed

Cancelled

Restricted

N Non-Elected

I Interference

A Appeal

0 Objected


CLAIM DATE

Final Original 02/02/2013 09/25/2013 03/11/2014 01/12/2015 06/01/2015 10/19/2015

73 - - - - - -

74 V V V V V

75 V V V V V

76 V V V V V

77 V V V V V

78 V V V - -

79 =

80 =



Attorney Docket No. 10114-003US1

IN THE UNITED STATES PATENT AND TRADEMARK OFFICE

Inventors : Francesco Viola et al. Art Unit : 1798

Serial No. : 13/397,398 Examiner : Fisher, Brittany I. Filed : February 15, 2012 Conf. No. • 1282 Title : DEVICES, SYSTEMS AND METHODS FOR EVALUATION OF

HEMOSTASIS

Commissioner for Patents P.O. Box 1450 Alexandria, VA 22313-1450

RESPONSE TO NON-FINAL OFFICE ACTION

In response to the Office Action mailed June 8, 2015, please amend the above-identified

application as follows and consider the following remarks.

Amendments to the claims begin on page 2.

Remarks begin on page 7.


Inventors : Francesco Viola et al. Attorney Docket No. 10114-003US1 Serial No. : 13/397,398 Filed : February 15, 2012 Page : 2 of 9

AMENDMENTS TO THE CLAIMS

This listing of claims replaces all prior versions and listings of claims in the application:

Listing of Claims:

1 (Previously Presented) A device for evaluation of hemostasis, comprising:

a plurality of test chambers each configured to receive blood of a test sample,

each test chamber comprising a reagent or combination of reagents, wherein each

chamber is configured to be interrogated to determine a hemostatic parameter of the

blood received therein;

a first chamber of the plurality comprising a first reagent or a first combination of

reagents that interact with the blood received therein, wherein the first reagent, or a

reagent included in the first combination of reagents, is an agonist of hemostasis; and

a second chamber of the plurality comprising a second combination of reagents

that interact with blood of the test sample received therein, the combination including an

agonist and an antagonist of hemostasis, wherein the agonist and antagonist of the second

combination are agonists and antagonists of at least two of plasma coagulation factors,

platelets, fibrinogen, and fibrinolytic factors.

2. (Previously Presented) The device of claim 1, further comprising:

a third chamber comprising a third reagent or combination of reagents that

interact with blood of the test sample received therein;

a fourth chamber comprising a fourth reagent or combination of reagents that

interact with blood of the test sample received therein; and

wherein the third and fourth chambers are configured to be interrogated to

determine a hemostatic parameter of the test sample.

3. (Previously Presented) The device of claim 1, further comprising an interrogation device

that measures at least one viscoelastic property of the test sample.

4. (Previously Presented) The device of claim 3, wherein the interrogation device uses

acoustic radiation force.

2



5. (Previously Presented) The device of claim 1, further comprising an interrogation device

that transmits sound into one or more test chamber.

6. (Previously Presented) The device of claim 1, wherein the first reagent, first combination

of reagents, and/or second combination of reagents comprise reagents selected from the

group consisting of kaolin, celite, glass, abciximab, cytochalasin D, thrombin,

recombinant tissue factor, ADP, arachidonic acid, reptilase, and combinations thereof

7. (Original) The device of claim 6, wherein the reagents are lyophilized prior to interacting

with the test samples.

8. (Previously Presented) The device of claim 1, wherein each test chamber is at least

partially defined by a housing.

9. (Original) The device of claim 8, wherein the device is configured for use with a single

test sample.

10. (Previously Presented) The device of claim 9, further comprising a fluid pathway having

an inlet for receiving a test sample, wherein the fluid pathway is in communication with

at least one test chamber to deliver the test sample, or a portion thereof, to one or more of

the test chambers.

11. (Previously Presented) The device of claim 10, wherein the housing defines at least a

portion of the fluid pathway, and wherein at least a portion of the housing is thermally

conductive.

12. (Previously Presented) The device of claim 11, wherein the thermally conductive portion

of the housing defines at least a portion of the fluid pathway.

13. (Original) The device of claim 12, wherein the thermally conductive portion comprises a

thermally conductive polymer.

14. (Canceled)

15. (Previously Presented) The device of claim 10, wherein the fluid pathway further

comprises a channel in communication with a least one test chamber, and wherein sample

3



delivered from the channel into the test chamber results in mixing of at least a portion of

the sample and the reagent within the test chamber.

16. (Previously Presented) The device of claim 15, wherein the fluid pathway further

comprises a channel that opens into at least one test chamber on the side and at a tangent

to the test chamber.

17. (Previously Presented) The device of claim 1, wherein one or more test chamber further

comprises a magnetic stirring structure.

18. (Canceled)

19. (Canceled)

20. (Previously Presented) A system for evaluation of hemostasis comprising:

a plurality of test chambers each configured to receive blood of a test sample,

each test chamber comprising a reagent or combination of reagents;

wherein a first chamber of the plurality comprises an activator of coagulation a

that interact with the blood received therein;

wherein a second chamber of the plurality comprises an activator of coagulation

and an inhibitor of platelet function that interact with blood of the test sample received

therein;

wherein the first chamber is configured to be interrogated with ultrasound to

determine a hemostatic parameter of the blood received therein;

wherein the second chamber is configured to be interrogated with ultrasound to

determine a hemostatic parameter of the blood received therein;

a transducer for transmitting ultrasound into one or more test chamber and for


at least one processor in communication with the transducer, the processor being

configured to determine the hemostatic parameters from signals transmitted to the

processor from the transducer.

4



21. (Previously Presented) The system of claim 20, wherein the hemostasis parameters are

selected from the group consisting of TC1, TC2, clot stiffness, clot formation rate (CFR),

TL1, TL2, baseline viscosity and post lysis viscosity.

22. (Original) The system of claim 20, wherein the processor is further configured to

determine a coagulation factors index.

23. (Canceled)

24. (Canceled)

25. (Original) The system of claim 20, wherein the processor is further configured to

determine an intrinsic pathway coagulation factors index, an extrinsic pathway

coagulation factors index, a platelets index, a fibrinogen index, and a fibrinolysis index.

26-73. (Canceled)

74. (Previously Presented) The device of claim 1, wherein the second chamber comprises a

combination of reagents that includes a reagent comprised by the first chamber.

75. (Previously Presented) The device of claim 1, wherein the first chamber comprises a

clotting initiator.

76. (Previously Presented) The device of claim 75, wherein the second chamber comprises a

platelet inhibitor.

77. (Previously Presented) The device of claim 1, wherein the first chamber comprises an

agonist of hemostasis that is a coagulation, platelet or fibrinolysis agonist.

78. (Canceled).

79. (New) A device for evaluation of hemostasis, comprising:

a plurality of test chambers each configured to receive blood of a test sample, each test

chamber comprising a reagent or combination of reagents, wherein each chamber is configured

to be interrogated to determine a hemostatic parameter of the blood received therein;

a first chamber of the plurality comprising a first reagent or a first combination of

reagents that interact with the blood received therein, wherein the first reagent, or a reagent

included in the first combination of reagents, is an activator of coagulation; and

5



a second chamber of the plurality comprising a second combination of reagents that

interact with blood of the test sample received therein, the combination including an activator of

coagulation and one or both of abciximab and cytochalasin D.

80. (New) The device of claim 79, wherein the first chamber comprises a first combination

of reagents including one or more of kaolin, celite, glass, thrombin, ellagic acid, and tissue

factor, and wherein the second chamber comprises a second combination of reagents including

one or more of kaolin, celite, glass, thrombin, ellagic acid, and tissue factor.

6



REMARKS

Applicant submits these Remarks in response to the non-final Office Action of June 8,

2015. In the Office Action, claims 1, 2, 6-10, 15, 16, and 74-77 were rejected under 35 U.S.C.

§ 102(b) as allegedly being anticipated by U.S. Patent Pub. No. 2003/0113929 ("Baugh").

Claims 3-5, 11-13, and 17 were rejected under 35 U.S.C. § 103(a) based on Baugh and U.S.

Patent Pub. No. 2002/0081741 ("Braun"); claims 11-13 were rejected under 35 U.S.C. § 103(a)

based on Baugh, Braun, and U.S. Patent Pub. No. 2012/0244392 ("Kleiman"); claims 20 and 22

were rejected under 35 U.S.C. § 103(a) based on Baugh and U.S. Patent Pub. No. 2010/0274130

("Anand"); claim 21 was rejected under 35 U.S.C. § 103(a) based on Baugh, Anand, and Braun;

claim 25 was rejected under 35 U.S.C. § 103(a) based on Baugh, Anand, and U.S. Patent Pub.

No. 2005/0015001 ("Lec").

With this response, Applicant adds new claims 79 and 80. No new matter has been

added; as an example, support for this claim can be found at least at paragraphs [009] and [0101]

and Table 1 of the specification. Applicant respectfully requests that the Examiner consider the

pending claims and remarks herein and issue a Notice of Allowance for this application.

Examiner Interview

Applicant thanks Examiner Fisher for the courtesy extended in the telephone interview

with Applicant's representative on July 7, 2015. During the interview, at least some of the issues

below were discussed. For example, Applicant pointed out that the Office Action never

addressed the subject matter most recently added to the claims via amendment. The Examiner

noted that, if the claims remained rejected after further search and consideration, a non-final

Office Action may be appropriate.

Unaddressed Subject Matter

In Applicant's previous response filed April 8, 2005, Applicant amended claim 1 to

recite, in part, "a second chamber of the plurality comprising a second combination of

reagents . . . including an agonist and an antagonist . . . of at least two of plasma coagulation

factors, platelets, fibrinogen, and fibrinolytic factors." (Emphasis added).

7



The Office Action of June 8, 2015, does not address this subject matter. Instead, the

Office Action recites the previous version of the claim and cites to Baugh as allegedly disclosing

that previous subject matter. In particular, the Office Action states:

Wherein a second chamber (504) of the plurality comprises a second combination of reagents that interact with blood of the test sample received therein and wherein the combination includes an agonist and antagonist of hemostasis (kaolin and dried heparin) (See Paras. 0022, 0027 and Table 1).

Office Action at 3.

During the interview, Applicant pointed out that kaolin and heparin are an activator and

inhibitor, respectively, of coagulation. But the claim requires an agonist and antagonist of at

least two of plasma coagulation factors, platelets, fibrinogen, and fibrinolytic factors. The

Examiner responded that at least one of kaolin and heparin is also an agonist/antagonist of

platelets, fibrinogen, and fibrinolytic factors. Applicant noted that none of the cited references

support this contention, and that the contention itself has not been set forth in an Office Action.

The Examiner agreed that further search and consideration may be appropriate on this point.

Applicant appreciates the Examiner's willingness to provide additional clarification

regarding this rejection. Applicant incorporates the arguments and reasoning set forth in the

April 8, 2015 response in support of the patentability of the above-recited subject matter of claim

1 (as well as claims 2-13, 15-17, 20-22, 25, and 74-77).

New Claims

During the interview, the Examiner pointed out subject matter in the pending application

that she believes would be allowable over the art of record. Applicant appreciates the Examiner's

helpful comments. Applicant adds independent claim 79, which recites, in part, "a second

chamber of the plurality comprising a second combination . . . including an activator of

coagulation and one or both of abciximab and cytochalasin D." (Emphasis added).

None of the references cited by the Office Action disclose or render obvious the above-

recited subject matter of claim 79. The Examiner appears to agree (pending further search and

consideration). As a result, Applicant respectfully requests that claim 79 be passed to allowance.

Claim 80 has also been added and should be allowed at least due to its dependence from claim

8



79. Claim 80 is additionally allowable because it recites similar subject matter as claim 1,

discussed supra.

Conclusion

In view of the foregoing remarks, Applicant submits that the pending claims are in

condition for allowance. Applicant therefore respectfully requests that the claims be allowed to

issue. The absence of additional comments regarding the Office Action does not signify

agreement with or concession of any characterization or requirement. In addition, because the

arguments and comments herein may not be exhaustive, there may be additional arguments and

comments that have not been expressed. If the Examiner wishes to discuss the application or the

remarks provided herein, the Examiner is urged to contact the undersigned.

No additional fees are believed to be due; however, the Commissioner is hereby

authorized to charge any additional fees that may be required, or credit any overpayment, to

Deposit Account No. 50-5226.

Date: July 17, 2015

Respectfully submitted

MEUNIER CARLIN & CURFMAN, LLC

/Armon Shandadi/

Armon Shandadi Reg. No. 70,728

Customer No. 96039 docketing mcciplaw.com 404.645.7700 Phone 404.645.7707 Fax

9



EFS ID: 22949752




Title of Invention: Devices, Systems and Methods For Evaluation of Hemostasis



Filer: Armon Bryan Shandadi/Montrell McCaskill

Filer Authorized By: Armon Bryan Shandadi


Receipt Date: 17-JUL-2015





Submitted with Payment no

File Listing:

Document Number


Multi Part /.zip

Pages (if appl.)

1 10114_003US1_2015_07_17_R

esponse.pdf

104454

yes 9 fle8aab619d8f0e44.6fe989f53db5b14145

744


Multipart Description/PDF files in .zip description

Document Description Start End

Amendment/Req. Reconsideration-After Non-Final Reject 1 1

Claims 2 6

Applicant Arguments/Remarks Made in an Amendment 7 9

Warnings:

Information:


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96039 7590 06/08/2015


EXAMINER


1798



FISHER, BRITTANY I

UNITED STA1ES PA PENT AND TRADEMARK OFFICE







Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): docketing @mcciplaw.com


Application No. Applicant(s) 13/397,398 VIOLA ET AL.

Office Action Summary Examiner Art Unit AIA (First Inventor to File)

BRITTANY FISHER 1798 Status

No

-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address --Period for Reply

A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTHS FROM THE MAILING DATE OF THIS COMMUNICATION.

- Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed after SIX (6) MONTHS from the mailing date of this communication.

- If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication. - Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).

Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any earned patent term adjustment. See 37 CFR 1.704(b).

Status 1)Z Responsive to communication(s) filed on 4/8/2015, claims filed.


2a)1=1 This action is FINAL. 2b)Z This action is non-final. 3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on

; the restriction requirement and election have been incorporated into this action. 4)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is

closed in accordance with the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.

Disposition of Claims* 5)Z Claim(s) 1-13,15-17,20-22,25 and 74-77 is/are pending in the application.

5a) Of the above claim(s) is/are withdrawn from consideration. 6)0 Claim(s) is/are allowed.

7 )Z Claim(s) 1-13,15-17,20-22,25 and 74-77 is/are rejected. 8)0 Claim(s) is/are objected to. 9)0 Claim(s) are subject to restriction and/or election requirement.

* If any claims have been determined allowable you may be eligible to benefit from the Patent Prosecution Highway program at a

participating intellectual property office for the corresponding application. For more information, please see

httpliwwwusptagovipatents/nit eventsipphlindex.jsp or send an inquiry to PRF-Ifeedback@usptaaov.

Application Papers 10)0 The specification is objected to by the Examiner. 11)0 The drawing(s) filed on is/are: a)1=1 accepted or b)1=1 objected to by the Examiner.

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Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).

Priority under 35 U.S.C. § 119 12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f). Certified copies:

b)E1Some** c)EINone of the: 1.0 Certified copies of the priority documents have been received. 2.0 Certified copies of the priority documents have been received in Application No. . 3.0 Copies of the certified copies of the priority documents have been received in this National Stage

application from the International Bureau (PCT Rule 17.2(a)). ** See the attached detailed Office action for a list of the certified copies not received.

Attach ment(s)

1) ❑ Notice of References Cited (PTO-892)

2) Z Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b) Paper No(s)/Mail Date 5/5/2015.

3) ❑ Interview Summary (PTO-413)

Paper No(s)/Mail Date.

4) ❑ Other:

U.S. Patent and Trademark Office PTOL-326 (Rev. 11-13) Office Action Summary Part of Paper No./Mail Date 20150601 IL Exhibit 1009 Page 112 of 907


Art Unit: 1798


DETAILED ACTION

This is a NON-FINAL action in response to applicant's claim amendments filed April 8,

2015. Claims 1 and 20 are currently amended. Claim 78 has been newly cancelled.

Claims 1-13, 15-17, 20-22, 25, and 74-77 are pending.

Response to Amendment

Rejection of claims 1 and 74-78 under 35 U.S.C. 102(b) as being anticipated by

Greenquist is withdrawn in view of applicant's amendments.

Rejection of claims 1 and 2 under 35 U.S.C. 103(a) as being unpatentable over Baugh

in view of Greenquist is withdrawn in view of applicant's amendments.

Rejection of claims 1-3, 5-12, and 15-17 under 35 U.S.C. 103(a) as being unpatentable

over Braun in view of Greenquist is withdrawn in view of applicant's amendments.

Rejection of claim 20 under 35 U.S.C. 103(a) as being unpatentable over Braun in view

of Greenquist and further in view of Anand is withdrawn in view of applicant's

amendments.


1. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that

form the basis for the rejections under this section made in this Office action:

A person shall be entitled to a patent unless —

(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.



Art Unit: 1798

Claims 1, 2, 6-10, 15, 16 and 74-77 are rejected under 35 U.S.C. 102(b) as being

anticipated by Baugh (US 2003/0113929 Al).

With respect to claims 1 and 6-8, Baugh discloses a device that is used for the

testing of a whole blood sample comprising:

A plurality of test chambers that are bordered by a plug (523) (502-507,

see Fig. 5), each configured to receive blood of a test sample wherein each test

chamber comprises a reagent or a combination of reagents (See Paras. 0023-

0024);









With respect to claim 2 Baugh discloses a third and fourth channel

amongst the plurality comprising third and fourth reagents or combinations of

reagents that interact with blood of the test sample received therein (See Paras.

0024-0028, Table 1, and Fig. 5).

With respect to claim 9 Baugh describes the system as a single use

cartridge (See Para. 0022).



Art Unit: 1798

With respect to claims 10, 15, and 16 Baugh discloses a fluid pathway

(plunger, 519) that is communication with at least one test chamber and that

opens into the at least one test chamber at a tangent to the test chamber (524)

(See Para. 0024 and Fig. 5).

With respect to claims 74-77 Baugh discloses the inclusion of the

hemostatic agent kaolin in the first and second chambers and heparin in

combination with kaolin in the second chamber.


The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis

for all obviousness rejections set forth in this Office action:

(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.

The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148

USPQ 459 (1966), that are applied for establishing a background for determining

obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:

1. Determining the scope and contents of the prior art.

2. Ascertaining the differences between the prior art and the claims at issue.

3. Resolving the level of ordinary skill in the pertinent art.

4. Considering objective evidence present in the application indicating

obviousness or nonobviousness.



Art Unit: 1798

Claims 3-5, 11-13, and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being

unpatentable over Baugh (US 2003/0113929 Al) in view of Braun, Sr. (US

2002/0081741 Al).


With respect to claims 3-5 Baugh fails to disclose the inclusion of an interrogation

device that uses acoustic radiation force and transmits sound into one or more test

chambers. However, there is discussion that some type of analyzer is utilized to

analyze the samples during testing.

Braun Sr. discloses an apparatus for detecting changes in a property of a

liquid/reagent mixture, such as a whole blood sample wherein the interrogation

comprises measurement of at least one viscoelastic property of the test sample utilizing

transmission of sound into one or more test chamber (See Paras. 0039 and 0065).


invention to incorporate the interrogation means of Braun Sr. into the device of Baugh

such that a user can monitor the reaction of the reagents with the blood samples without

having to physically manipulate the samples.

Claims 11-13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable

over Baugh (US 2003/0113929 Al) in view of Braun, Sr. (US 2002/0081741 Al) and

Kleiman (US 2012/0244392 A2).

With respect to claims 11-13 Baugh fails to disclose the composition of the

cartridge.



Art Unit: 1798

Braun Sr. teaches that the cartridge housing (10) may be composed of acrylic

(See Para. 0042). Kleiman discloses that a battery pack can be composed of a

thermally conductive acrylic material. Thus, it is being interpreted that the use of acrylic

for the cartridge housing satisfies the stipulation that at least a portion of the housing is

thermally conductive. It is also depicted that the thermally conductive portion of the

housing defines at least a portion of the fluid pathway (See Para. 0042).


invention to incorporate the thermally conductive material of the cartridge of Braun Sr.

into the device of Baugh to help initiate a faster reaction time between the blood sample

and the reagents.

With respect to claim 17 Baugh fails to disclose the inclusion of a magnetic

stirring structure.

Braun Sr. teaches the use of a magnetic stirring structure (See Paras. 0055 and

0066).


invention to incorporate the magnetic stirring structure of Braun Sr. to ensure even

mixing of the reagent within the administered blood sample.

Claims 20 and 22 are rejected under 35 U.S.C. 103(a) as being unpatentable

over Baugh (US 2003/0113929 Al) in view of Anand (US 2010/0274130 Al).


With respect to claim 20, Baugh discloses the following from a system that is

used for evaluation of hemostasis comprising:



Art Unit: 1798

A plurality of test chambers that are bordered by a plug (523) (502-507, see Fig.

5), each configured to receive blood of a test sample wherein each test chamber

comprises a reagent or a combination of reagents (See Paras. 0023-0024);









Baugh fails to disclose that the system also contains:

a transducer for transmitting ultrasound into one or more test chambers and for


at least one processor configured to determine a hemostasis parameter from the

received sound.

Anand teaches the use of "systems and methods for tracking and guiding high

intensity focused ultrasound beams (HIFU). More particularly, the disclosed systems

and methods involve use of acoustic radiation force impulse (ARFI) imaging to detect

the focal position of an HIFU capable transducer relative to a target area.... The desired

treatment location may be dynamically determined using bleed detection and

localization (BD&L) techniques." A processor can be used to monitor bleed rate, and if



Art Unit: 1798

a diminishing bleed rate is not detected over a certain period of time, the processor may

stop HIFU therapy (See Abstract and Para. 0030).

It would have been obvious to one of ordinary skill in the art to incorporate the

function of the transducer and processor of Anand into the system of Baugh such that a

user can monitor the progress of clot formation within the device.

With respect to claim 22, Anand discloses that the processor is further configured

to determine a coagulation factors index (See Paras. 0027-0028).

Claim 21 are rejected under 35 U.S.C. 103(a) as being unpatentable over Baugh

(US 2003/0113929 Al) in view of Anand (US 2010/0274130 Al) and further in view of

Braun, Sr. (US 2002/0081741 Al).

With respect to claim 21, the combination of Baugh and Anand fail to teach that

the hemostasis parameter is selected from the group consisting of TC1, TC2, clot

stiffness, clot formation rate, TL1, TL2, baseline viscosity, and post lysis viscosity.

Braun Sr. teaches that the hemostasis parameter is selected from the group

consisting of TC1, TC2, clot stiffness, clot formation rate, TL1, TL2, baseline viscosity,

and post lysis viscosity (See Paras. 0011 and 0020).

It would have been obvious to one of ordinary skill in the art at the time invention

to incorporate the specific hemostasis parameters for detection into the modified Baugh

device such that a user can monitor a variety of conditions within the same test

cartridge, thus eliminating the use of additional cartridges and reducing the amount of

time used to diagnose a condition.



Art Unit: 1798

Claim 25 is rejected under 35 U.S.C. 103(a) as being unpatentable over Baugh

(US 2003/0113929 Al) and Anand (US 2010/0274130 Al) in view of Lec (US

2005/0015001 Al).

Refer above for the combined teaching of Baugh and Anand.

The combination of Baugh and Anand fail to teach that the processor is

configured to determine an intrinsic pathway coagulation factors index, an extrinsic

pathway coagulation factors index, a platelets index, a fibrinogen index, and a

fibrinolysis index.

Lec teaches the use of an acoustic blood analyzer used in the measurement of

various blood properties including "density, elasticity, viscosity, clot stiffness, platelet

concentration, platelet activation, platelet receptor activities, GPI lb/Illa function, GPlb

function, GPla/Ila function, blood hemostatic factor concentration, bleeding time,

activated clotting time, activated partial thromboplastin time, prothrombin time, thrombin

time, Fibrinogen, factor VIII deficiency, von Willebrand factor, tissue factor, specific drug

concentration, therapeutic effects of anticoagulation and antiplatelet or thrombin

inhibitor drug activities... characteristics which can be determined by measuring

interactions of native or intrinsic components of a blood sample such as, but not limited

to cells, proteins, DNAs, or enzymes in the blood or derived from the blood, as well as

interactions of extrinsic or foreign components such as, but not limited to, drugs, viruses

or bacteria in the blood or derived from the blood" (See Para. 0049). Additionally, in

some assays, fibrinolysis is stimulated to evaluate the potential for the sensor to detect

fibrinolytic tendency (See Para. 0089).



Art Unit: 1798


invention to incorporate the detection of the above blood properties into the processor

capabilities of the combined system of Baugh and Anand such that a user can use a

broad range of parameters to accurately monitor coagulation within a given blood

sample.

Conclusion




5:00pm.






Art Unit: 1798










/BRITTANY FISHER/ /JILL WARDEN/ Examiner, Art Unit 1798 Supervisory Patent Examiner, Art Unit 1798

June 1, 2015


Receipt date: 05/05/2015 13397398 - GAU: 1798

Sheet 1 of 3




(37 CFR §1.98(b))

Attorney Docket No.


13/397,398 Inventor(s)

Francesco Viola et al. Filing Date

February 15, 2012 Group Art Unit

1798


Initial Desig.

ID Document Number



L1 5,016,469 1991-05-21 Henderson

L2 6,412,344 2002-07-02 Danicich et al.

L3 8,740,818 2014-06-03 Walker et al.


Initial Desig.

ID Document Number



L4 2004/0076546 2004-04-22 Bissett

L5 2004/0214337 2004-10-28 Kautzky

L6 2008/0194967 2008-08-14 Sliwa et al.

L7 2011/0034805 2011-02-10 Walker et al.

L8 2011/0172661 2011-07-14 Designer et al.

L9 2011/0252352 2011-10-13 Viola et al.

L10 2012/0232803 2012-09-13 Viola et al.

L11 2012/0294767 2012-11-22 Viola et al.

L12 2013/0190584 2013-07-25 Walker et al.

Foreign Patent Documents or Published Foreign Patent

Sub Classclass

Applications Translation

Examiner Initial

Desig . ID

Document Number

Publication Date

Country or Patent Office

Yes No

L13 2011/237383 2014-07-10 AU

L14 101035479 2007-09-12 CN X

L15 2555704 2013-02-13 EP Corresponds to

US 20110252352

Examiner Signature

/Brittany Fisher/ Date Considered

1 6/2015 051



ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. IBF/ IL Exhibit 1009 Page 123 of 907

Receipt date: 05/05/2015 13397398 - GAU: 1798

Sheet 2 of 3




(37 CFR §1.98(b))

Attorney Docket No.





1798


Sub Classclass


Examiner Initial

Desig .ID

Document Number

Publication Date


Yes No


US 20120232803

L17 2011/127436 2011-10-13 WO

L18 2012/159021 2012-02-21 WO

L19 2013/105987 2013-10-10 WO


Initial Desig

. ID Document

L20 Libgot, R., et al., "High frequency ultrasound characterization of the blood clotting process:

intra- and inter-individual variations," 2005 IEEE Ultrasonics Symposium, IEEE, Vol. 4, 2005,

pp. 2259-2262.

L21 Mauldin, Jr., F.W., et al., "Adaptive Force Sonorheometry for Assessment of Whole Blood

Coagulation," Clin Chim Acta, Vol. 411, Issues 9-10, 2010, pp. 638-644.

L22 Schmitt, C., et al., "Characterization of blood clot viscoelasticity by dynamic ultrasound

elastography and modeling of the rheological behavior," Journal of Biomechanics, Vol. 44,

No. 4, 2011, pp. 622-629.

L23 Shih, C-C, et al., "In Vitro Assessments of Viscoelastic Properties of Fibrin Clot by Using

Acoustic Radiation Force on a Solid Sphere," International Ultrasonics Symposium

Proceedings, IEEE, 2010, pp. 479-482.

L24 Viola, Francesco, et al., "A Novel Ultrasound-Based Method to Evaluate Hemostatic

Function of Whole Blood," Clin Chim Acta, Vol. 411, Nos. 1-2, 2010, pp. 106-113.

L25 VoleiSis, A., et al., "Ultrasonic method for the whole blood coagulation analysis,"

Ultrasonics, Vol. 40, May 2002, pp. 101-107.

L26 International Preliminary Report on Patentability and Written Opinion, dated October 8,

2013, in connection with International Application No. PCT/US2012/025270.


Date Considered

05/16/2015 EXAMINER: Initials citation considered. Draw line through citation if not in conformance and not considered. Include copy of this form with next communication to applicant.



Receipt date: 05/05/2015 13397398 - GAU: 1798

Sheet 3 of 3




(37 CFR §1.98(b))

Attorney Docket No.





1798


Initial Desig . ID

Document

L27 International Search Report, dated September 30, 2013, in connection with International

Application No. PCT/US2012/025270.

L28 International Preliminary Report on Patentability and Written Opinion, dated August 27,


L29 International Search Report, dated August 20, 2013, in connection with International


L30 International Preliminary Report on Patentability and Written Opinion, dated November

19, 2013, in connection with International Application No. PCT/US2012/038553.

L31 International Search Report, dated January 2, 2013, in connection with International




L33 International Preliminary Report on Patentability and Written Opinion, dated March 20,


Examiner Signature

/Brittany Fisher/ Date Considered

05/-1612015




111

Index

111 11 11

of

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13397398


VIOLA ET AL.

Examiner

BRITTANY FISHER

Art Unit

1773

I Rejected

= Allowed

Cancelled

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A Appeal

0 Objected


CLAIM DATE Final Original 02/02/2013 09/25/2013 03/11/2014 01/12/2015 06/01/2015

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A Appeal

0 Objected



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BRITTANY FISHER

Art Unit

1773

CPC- SEARCHED

Symbol

Date Examiner


Symbol

Date Examiner



SEARCH NOTES


2/2/2013 BIF


2/2/2013 BIF

PALM inventor search 2/2/2013 BIF See attached EAST search history 2/2/2013 BIF Consulted PE Neil Turk about claim interpretation 9/25/2013 BIF See attached BRS search history 9/26/2013 BIF Consulted PE Neil Turk about claim interpretation 3/23/2014 BIF See attached BRS search history 3/23/2014 BIF BOIL 3/5027 text searched 1/12/2015 BIF GO1N 27/07 and 33/86 text searched 1/12/2015 BIF See attached BRS search history 1/12/2015 BIF See updated EAST search history 6/1/2015 BIF


INTERFERENCE SEARCH

US Class/ US Subclass / CPC Group Date Examiner CPC Symbol


Sheet 1 of 3




(37 CFR §1.98(b))

Attorney Docket No.





1798


Initial Desig.

ID Document Number



L1 5,016,469 1991-05-21 Henderson

L2 6,412,344 2002-07-02 Danicich et al.

L3 8,740,818 2014-06-03 Walker et al.


Initial Desig.

ID Document Number



L4 2004/0076546 2004-04-22 Bissett

L5 2004/0214337 2004-10-28 Kautzky

L6 2008/0194967 2008-08-14 Sliwa et al.

L7 2011/0034805 2011-02-10 Walker et al.

L8 2011/0172661 2011-07-14 Designer et al.

L9 2011/0252352 2011-10-13 Viola et al.

L10 2012/0232803 2012-09-13 Viola et al.

L11 2012/0294767 2012-11-22 Viola et al.

L12 2013/0190584 2013-07-25 Walker et al.


Sub Classclass


Examiner Initial

Desig . ID

Document Number

Publication Date


Yes No

L13 2011/237383 2014-07-10 AU

L14 101035479 2007-09-12 CN X


US 20110252352

Examiner Signature Date Considered




Sheet 2 of 3




(37 CFR §1.98(b))

Attorney Docket No.





1798


Sub Classclass


Examiner Initial

Desig .ID

Document Number

Publication Date


Yes No


US 20120232803

L17 2011/127436 2011-10-13 WO

L18 2012/159021 2012-02-21 WO

L19 2013/105987 2013-10-10 WO


Initial Desig

. ID Document

L20 Libgot, R., et al., "High frequency ultrasound characterization of the blood clotting process:

intra- and inter-individual variations," 2005 IEEE Ultrasonics Symposium, IEEE, Vol. 4, 2005,

pp. 2259-2262.

L21 Mauldin, Jr., F.W., et al., "Adaptive Force Sonorheometry for Assessment of Whole Blood

Coagulation," Clin Chim Acta, Vol. 411, Issues 9-10, 2010, pp. 638-644.

L22 Schmitt, C., et al., "Characterization of blood clot viscoelasticity by dynamic ultrasound

elastography and modeling of the rheological behavior," Journal of Biomechanics, Vol. 44,

No. 4, 2011, pp. 622-629.

L23 Shih, C-C, et al., "In Vitro Assessments of Viscoelastic Properties of Fibrin Clot by Using

Acoustic Radiation Force on a Solid Sphere," International Ultrasonics Symposium

Proceedings, IEEE, 2010, pp. 479-482.

L24 Viola, Francesco, et al., "A Novel Ultrasound-Based Method to Evaluate Hemostatic

Function of Whole Blood," Clin Chim Acta, Vol. 411, Nos. 1-2, 2010, pp. 106-113.

L25 VoleiSis, A., et al., "Ultrasonic method for the whole blood coagulation analysis,"

Ultrasonics, Vol. 40, May 2002, pp. 101-107.







Sheet 3 of 3




(37 CFR §1.98(b))

Attorney Docket No.





1798


Initial Desig . ID

Document

L27 International Search Report, dated September 30, 2013, in connection with International


L28 International Preliminary Report on Patentability and Written Opinion, dated August 27,


L29 International Search Report, dated August 20, 2013, in connection with International


L30 International Preliminary Report on Patentability and Written Opinion, dated November

19, 2013, in connection with International Application No. PCT/US2012/038553.

L31 International Search Report, dated January 2, 2013, in connection with International




L33 International Preliminary Report on Patentability and Written Opinion, dated March 20,






(12) STANDARD PATENT (11) Application No. AU 2011237383 B2 (19) AUSTRALIAN PATENT OFFICE

(54) Title Hemostatic parameter display

(51) International Patent Classification(s) A61B 19/00 (2006.01) GO8B 21/02 (2006.01) A61B 1/04 (2006.01)

(21) Application No: 2011237383 (22) Date of Filing: 2011.04.08

(87) WIPO No: W011/127436

(30) Priority Data

(31) Number (32) Date (33) Country 61/322,049 2010.04.08 US

(43) Publication Date: 2011.10.13 (44) Accepted Journal Date: 2014.03.27

(71) Applicant(s) Hemosonics, LLC

(72) Inventor(s) Viola, Francesco;Walker, William F.;Browne, Gregory V.;Looker, Adam;Roy, Bryan;Hansen, Bjarne

(74) Agent / Attorney Pizzeys Patent and Trade Mark Attorneys, GPO Box 1374, BRISBANE, QLD, 4001

(56) Related Art US 2003/0073244 US 5473536


PCT

111 111 111111111 111111 11111 1 1 11111111111111111111111111111 111 11 11111 1111 1111111 III 1 1111 II II

(10) International Publication Number

WO 2011/127436 A3

(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)

(19) World Intellectual Property Organization International Bureau.

(43) International Publication Date 13 October 2011 (13.10.2011)

(51) International Patent Classification: A 61B 19/00 (2006.01) GO8B 21/02 (2006.01) A 6IB 1/04(2006.01)

(21) International Application Number: PCT/US2011/031832

(22) International Filing Date: 8 April 2011 (08.04.2011)

(25) Filing Language: English

(26) Publication Language: English

(30) Priority Data: 61/322,049 8 April 2010 (08.04.2010) US

(71) Applicant (for all designated States except US): HEN1OSONICS, LLC [US/US]; 310 4th Street NE, Suite 104, Charlottesville, Virginia 22902 (US).

(72) Inventors; and (71) Applicants : VIOLA, Francesco [—ITS]; 745 Walker

Square, #3C, Charlottesville, Virginia 22903 (US). WALKER, William F. [ ;US]; 778 Belvedere Boule-vard, Charlottesville, Virginia 22901 (US). BROWNE, Gregory V. [—/CA]; 617 Pine Street, Victoria, British Columbia V8V 2P6 (CA). LOOKER, Adam [—/CA];

1-146 Clarence Street, Victoria, British Columbia V8V 2J2 (CA). ROY, Bryan [—ICA]; 709 Aros Road, Cobble Hill, British Columbia VOR 1L4 (CA). HANSEN, Bjarne [—/CA]; 1000 DeCosta Place, Victoria, British Columbia V9A 6Y3 (CA).

(74) Agents: CARIJN, Gregory J. et al.; McKeon, Meunier, Carlin & Curfman, LLC, Suite 900, 817 W. Peachtree Street NW, Atlanta, Georgia 30308 (US).

(81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GII, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, L12, LS, LT, LU, LY, MA, MU, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, SE, SO, SK, SL, SM, ST, SV, SY, TI I, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.

(84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GLI, GM, KE, LR, LS, MW, 'VIZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ,

[Continued on next paged

(54) Title: HEMOSTATIC PARAMETER DISPLAY

30

(57) Abstract: A system for displaying a plurality of hemostatic indexes is disclosed. The system includes a communication receiver configured to receive the hemo-static indexes and a graphical user interface (GUI) con-nected to the communication receiver and configured to si-multaneously display the hemostatic indexes. The hemo-static indexes are derived from a plurality of independent measurements, such as the mechanical measurements de-termined using the sonorheometry systems and processes.

WO

2011

/127

436 A

3

22 24

Fig


WO 2011/127436 A3 111 111 1111E11 11 111111 11E1 11111 11111111 1E11111 1111111 III 11111 111111111 11111111111 11111111

TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, EI, FR, GB, GR, HR, HU, IF, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, OW, ML, MR, NE, SN, TD, TG).

Published:

— with international search report (Art. 21(3))

— Nfore the expiration of the time limit for amending the claims and to he republished in the event of receipt of amendments (Rule 48.2(1))

(88) Date of publication of the international search report: 2 February 2012


WO 2011/127436 PCT/1JS2011/031832

HEMOSTATIC PARAMETER DISPLAY

CROSS-REFERENCE 0 RELATED APPLICA'T'IONS

[0001]The present application claims priority to and hereby incorporates by reference

in its entirety U.S. provisional patent application no. 61/322,049 entitled "Novel

Technology for Point-of-Care Assessment of Hemostasis" and filed on April 8, 2010.

FIELD OF THE IN VENTION

[0002]The present invention relates to displays for physiologic parameters and more

particularly displays with graphical user interfaces (GUI) for intuitively presenting

physiologic parameters for easy use and interpretation by healthcare personnel.

BACKGROUND

[0003]The formation of a blood clot and its successive dissolution, referred to as the

hemostatic process, is required to arrest blood loss from an injured vessel. This

process is the result of a delicate functional balance between plasma coagulation

factors (including fibrinogen), platelets, and fibrinolytic proteins. Each of these

elements plays an important role in activating/deactivating the others, and the

appropriate stimuli are necessary to prevent excessive blood loss without causing

inappropriate thrombosis, see Laposata M., et al., The Clinical Hemostasis Handbook,

Year Book Medical Publisher 1989.

[0004]The hemostatic process is initiated by the activation and subsequent adhesion

of platelets to the site of injury within the vessel wall. Activated platelets recruit other

platelets and interact with fibrinogen in the blood plasma via the glycoprotein

receptor to form a platelet-plug that serves as the initial response to stop blood loss.

Hemostasis then proceeds with a cascade of proteolytic reactions of the plasma

coagulation proteins that ultimately form a three-dimensional network of fibrin that

strengthens the platelet-plug. The fibrin chains are cross-linked and stabilized by the

plasma factor XIlla (FX111a). Platelets also have a central role in regulating the

process of fibrin polymerization. The final step of hemostasis (i.e., fibrinolysis)

involves the activation of the plasma protein plasmin, which dissolves the blood clot

when its useful life is over. This cell-based model of hemostasis closely reflects the in

vivo physiological process, e.g., see Hoffman et al., -A cell-based model of

hemostasis;" Thromb. Haemost. 2001; 85:958-965 and Becker, "Cell-Based Models

1


WO 2011/127436 PCT/1JS2011/031832

of Coagulation: A Paradigm in Evolution;" J. Thromb. Thrombolysis 2005: 20:65-68.

[0005]The mechanical properties of blood clots have implications for its function of

stopping blood loss. Alterations in clot structure and its underlying mechanical

properties have been implicated in thrombotic disease and other life threatening

pathologies, see Weisel, J.W., "Enigmas of Blood Clot Elasticity;" Science 2008;

320:456. Recently, it was shown that fibrin clots of patients affected by premature

coronary artery disease have a different structure and higher stiffness compared to the

fibrin clots of healthy age-matched controls, see Collet et al, "Altered Fibrin

Architecture is Associated with Hypofibrinloysis and Premature Coronary

Atherothrombosis;" Arterioscler. Thromb. Vase. Biol. 2006; 26:2567-2573.

[0006]The mechanics of fibrin networks have been studied extensively at the

macroscopic level see Ryan et al., "Structural Origins of Fibrin Clot Rheology";

Biophys. J. 1999; 77:2813-2826 and Jen et al., "The Structural Properties and

Contractile Force of a Clot;" Cell Motil. 1982; 2:445-455. The viscoelastic properties

of individual fibrin strands have also been investigated by means of AFM (see Liu et

al., "Fibrin Fibers Have Extraordinary Extensibility and Elasticity;" Science 2006;

313:634) and "optical tweezers," see Collet et al., "The elasticity of an individual

fibrin fiber in a clot;" Proc. Natl. Acad. Sci. USA 2005; 102:9133-9137.

[0007]Disruption of the hemostatic balance plays a role in the onset of potentially

fatal conditions, including myocardial infarction, stroke, deep vein thrombosis,

pulmonary embolism, and excessive bleeding, see Hoyert et al., "Deaths: preliminary

data for 2003", Natl. Vital Stat. Rep. 2005; 53:1-48 and Hambleton et al.,

"Coagulation: Consultative Hemostasis"; Hematology 2002; 1:335-352. These

conditions account for over 30% of all deaths in the developed world. The ability to

recognize and quantify defects of the hemostatic process may reduce mortality and

implement appropriate treatment.

[0008]Further improvements in the detection and treatment of hemostatic defects are

therefore desired.

SUMMARY

[0009]In one embodiment, the present invention includes a system for displaying one

or more of a plurality of hemostatic indexes, the system having a communication

receiver and a GUI. The communication receiver is configured to receive the

hemostatic indexes. The GUI is connected to the communication receiver and

configured to display one, or simultaneously at least two, of the hemostatic indexes.

2


WO 2011/127436 PCT/1JS2011/031832

The hemostatic indexes arc derived from one or more of a plurality of independent

measurements.

[0010]In one example, one of the indexes may be calculated from two of the

independent measurements, such as from ultrasound measurements on two sample

wells containing different reagents.

[0011]The hemostatic indexes may include a coagulation factor function, a fibrinogen

concentration, a fibrinogen function, a platelet function and a fibrinolysis function.

The coagulation factor may include at least one of an intrinsic activiation factor or an

extrinsic activation factor. The GUI may be further configured to display hematocrit,

hemoglobin concentration and red cell count simultaneously with the two hemostatic

indexes.

[0012]Also, the GUI may be configured to display the functional hemostasis indexes

as a numerical score or a graphical depiction or with varying colors.

[0013]In another embodiment, the GUI is further configured to display a history of

the hemostatic indexes and clinical interventions overlaid on the history. At least one

portion of the history may include an array of graphical indicators, with each of the

graphical indicators representing one of the hemostatic indexes at some time in the

history. The graphical indicators may have a relative positioning configured to

communicate a hemostatic condition of the subject at that time in history.

[0014]In yet another embodiment, the GUI may be further configured to display a

treatment recommendation based on the at least two hemostatic indexes. For

example, the treatment recommendation may be guiding transfusion of platelets,

cryoprecipitate, plasma, red cells or anti fibrinolytics. Or, the treatment

recommendation is for guiding therapies of at least one of an anti-platelet drug, anti-

coagulant drug or pro-fibrinolysis drug.

[0015]In another embodiment, a method includes deriving a plurality of hemostatic

indexes from a plurality of independent measurements and displaying at least two of

the hemostatic indexes.

[0016]In another embodiment, a system for measuring hemostatic characteristics of a

blood sample includes a processor and a GUI. The processor is configured to receive

a data stream of stiffness measurements of the blood sample and to estimate a possible

range of a functional hemostatic index based on the data stream. The GUI is

connected in communication with the processor and is configured to display the

possible range of the functional hemostatic index.

3


WO 2011/127436 PCT/1JS2011/031832

[0017]Also, the processor may be configured to determine changes in the possible

range as new data is received from the data stream and the GUI is configured to

dynamically adapt a graphical element to express those changes.

[0018]Advantages of embodiments of the present invention include the ability to

show two or more hemostatic indexes at the same time wherein the prior art is limited

to serial tests. Another advantage is the ability for healthcare personnel to see the past

history of various hemostatic indexes and the impact of various treatments.

Additionally, healthcare personnel may benefit from display of trends in the

hemostatic indexes and are able to more quickly apply preventive treatment in urgent

care situations.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0019]Fig. 1 is a perspective view of a functional hemostatic index determination and

display system;

[0020]Figs. 2A and 2B are diagrams of sonorheometry to determine the hemostatic

indexes displayed in Fig. 1;

[0021]Figs. 3A-3F show a plurality of GUI display configurations of the system of

Fig. 1 indicating different patient conditions;

[0022]Fig. 4 shows a historical display of test results with multiple hemostatic

indexes at various points in history;

[0023]Fig. 5 shows a historical display with a single functional hemostatic index as it

changes during the history;


display system testing two subjects in parallel;


display system operating a surface activation test;

[0026]Fig. 8 is a GUI showing use of color to indicate normal and abnormal test

results;

[0027]Fig. 9 is a method for determining and displaying a plurality of hemostatic

indexes;

[0028]Figs. 10-18 show a graphical display of a graphical element (a bar) that

dynamically shrinks as measurement confidence increases during determination of a

funcational hemostatic index; and

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WO 2011/127436 PCT/1JS2011/031832

[0029]Fig. 19 is a schematic of a functional hemostatic index determination and

display system as a network entity.

DETAILED DESCRIPTION

[0030]The inventors have made the following observations. Unregulated hemostasis,

manifested either as thrombotic disease or excessive bleeding, represents one of the

leading causes of morbidity and mortality in the developed world. For example,

millions of patients in the United States are currently prescribed anti-platelet

medications (such as aspirin or clopidogrel) or anti-coagulation drugs (such as

coumadin, heparin or direct thrombin inhibitors) to prevent the occurrence of

thrombotic conditions. However, it has been estimated that 5-60% of these patients

may not respond adequately to aspirin and 4-30% to clopidogrel, for example, leading

to higher risks of recurring thrombotic events or excessive bleeding.

[0031] Excessive bleeding often occurs during trauma, major surgical procedures, and

on the battlefield. In these cases, transfusion of blood and its derived products are

used in clinical practice to manage excessive bleeding. Generally, there arc four

treatment options available, each corresponding to a specific hemostatic defect: (a)

fresh frozen plasma (FFP) to restore the plasma coagulation proteins, (b) platelet

concentrate to restore platelets, (c) cryoprecipitate to restore fibrinogen, and (d) anti-

fibrinolytics to slow the activity of the clot-dissolving proteins. Additionally, packed

red blood cells (RBCs) are administered if hematocrit or hemoglobin falls within a

certain threshold level.

[0032]While transfusions of blood products have had a great impact in saving lives,

blood and its derived products are scarce and have to be carefully optimized.

Furthermore, transfusion therapies carry the risks of possible allergic reactions, a

variety of viral and bacterial infections, and worsened outcomes. The use of blood

products is particularly intensive in cardiac surgery involving cardio-pulmonary

bypass (CPB), where over 60% of patients experience excessive intra and post-

operative bleeding.

[0033]It has been estimated that CPB surgeries account for roughly 20% of the total

blood products used in the United States, with significant variations in protocols and

guidelines among different institutions. Intra- and post-operative bleeding in CPB is

often the result of blood being heavily anti-coagulated and exposed to the foreign

surfaces of the extracorporeal circuitry. Loss of platelets, abnormal platelet function,

5


WO 2011/127436 PCT/1JS2011/031832

hemodilution, inadequate function of the fibrinolytic system, and patients'

cooling/warming also contribute to failure of the hemostatic system, which has to be

corrected with allogenic blood products.

[0034]Several protocols and guidelines have been developed in the past years to

optimize transfusion therapies in order to minimize the likelihood of negative

outcomes, save valuable resources, and generate financial savings to the healthcare

systems. Chief among those is a recent report from The Society of Thoracic Surgeons

Blood Conservation Guideline Task Force in combination with The Society of

Cardiovascular Anesthesiologists Special Task Force on Blood Transfusions. One of

the key components of these protocols regards the use of POC diagnostic tests of

coagulation and platelet function to recognize abnormalities of the hemostatic

process. In clinical practice, however, empirical approaches are often used, and

transfusions are administered with little or no quantitative guidance. Table I below

summarizes some of the available treatments.

Table I

Problem with Coagulation

Factors

Transfuse Fresh Frozen

Plasma

Administer Anti-coagulant

(coumadin, heparin, direct

thrombin inhibitor, etc)

Problem with Fibrinogen Transfuse Cryoprecipitate N/A

Problem with Platelets Transfuse PlateletsAdminister Anti-platelet

therapy (aspirin, Plavix, etc)

Administer Anti-fibrinolytic Administer Pro-fibrinolysis

Problem with Fibrinolysis (aminocaproic acid or (tissue plasminogen activator,

tranexamic acid, etc) etc)

[0035]Current tests of hemostasis can be divided into three broad categories: endpoint

biochemical assays, mechanical/viscoelastic analyzers, and platelet-specific tests.

Endpoint assays arc traditionally performed on blood plasma and include such tests as

the pro-thrombin time (PT/INR), activated partial thromboplastin time (aPTT), and

the activated clotting time (ACT). A variety of methodologies, ranging from optical

detection to flow impediment, are employed to determine the time required to reach a

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WO 2011/127436 PCT/1JS2011/031832

pre-defined endpoint that represents the clotting time. The output of these tests is

generally the clotting time expressed in seconds (or minutes) or a single number

selected from an arbitrary scale such as in the case of the INR (International

Normalized Ratio).

[0036]While each of these assays measures a different aspect of the coagulation

factors, even in combination they do not provide a complete representation of overall

hemostasis. See, Gravlee et al., "Predictive value of blood clotting tests in cardiac

surgical patients"; Ann. Thorac. Surg. 1994; 58:216-221 and Bajaj et al., "New

insights into how blood clots: Implication for the use of APTT and PT as coagulation

screening tests and in monitoring anticoagulant therapy"; Semin. Thromb. Hemost.

1999; 25:407-418.

[0037]Fibrinogen level, for example, is typically measured using the standard Clauss

method, another end-point assay. The clotting time of platelet free plasma is measured

in the presence of thrombin and compared to a calibration curve to determine

fibrinogen level. The output of this test is the concentration of fibrinogen, typically

expressed in units of mg/dl. The end point tests arc further limited by the absence of

active platelets.

[0038]In contrast, mechanical methods, such as the TEG° (Haemoscope), ROTEW)

(Pentapharm), HAS (Hemodyne) and SonoClot° (Sienco), measure the contribution

of all the components of hemostasis in whole blood. These methods have been widely

studied and shown to offer valuable clinical and scientific insights, see Ganter et al.,

"Coagulation Monitoring: Current Techniques and Clinical Use of Viscoelastic Point-

of-Care Coagulation Devices"; Anesth. Analg. 2008; 106:1366-1374.

[0039]Existing mechanical methods, however, utilize complex and expensive

mechanical transducers, resulting in instruments that are difficult to operate and to

interpret. The output of these systems is generally a curve that describes the overall

hemostatic process along with some numerical scores. Further, the large mechanical

strains (in the range of 8% to 16%) applied to the blood samples have been shown to

interfere with clot formation and limit sensitivity and speed of the measurements, see

Evans et al., "Rheometry and associated techniques for blood coagulation studies";

Med. Eng. Phys. 2008; 30:671-679 and Burghardt et al., "Nonlinear viscoelasticity

and thromboelastograph: Studies on bovine plasma clots"; Biorheology 1995; 32:621-

630.

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WO 2011/127436 PCT/1JS2011/031832

[0040]Thc most common platelet tests arc the platelet count and platelet aggregation.

In a healthy patient, platelet count is between 150K and 400K platelets per mm3.

Platelet aggregation measures the ability of platelets to stick together and form small

clumps. These tests are typically performed in central laboratories using platelet rich

plasma (PRP), even though whole blood assays have recently emerged. Limitations

include the necessity to perform the measurements with anticoagulated blood, which

does not represent actual physiology, and the long turn-around-times (>45 minutes) to

obtain results from the central lab.

[0041]Embodiments of the present invention disclosed herein include systems and

methods for intuitively displaying a plurality of functional hemostasis indexes that are

directly related to the therapies available for both the hypo-coagulable (i.e., bleeding)

and hyper-coagulable (i.e., clotting) patient. The term "hemostasis indexes" as used

herein indicates a series of measures that are related to physiological components or

parameters involved directly or indirectly in the physiological process of hemostasis

(as opposed to raw mechanical parameters). Knowledge of the function of these

physiological components of hemostasis can enable diagnostic decisions by

healthcare professionals. For example, these functional hemostasis indexes may

include: (1) coagulation factor function, (2) fibrinogen concentration and/or function,

(3) platelet function and (4) fibrinolytic function. As discussed above, the inventors

have also recognized that transfusion of packed red cells is common in a bleeding

patient. Therefore, an additional hemostasis index represented by the hematocrit,

hemoglobin concentration or red cell count so that the system can provide information

about additional possible transfusion products.

[0042] In one embodiment, the hemostatic indexes are determined using

sonorheometry. Coagulation factor function (when determined by sonorheometry) is

the time at which significant fibrin formation occurs which is measured as the time at

which clot stiffening starts. It is determined by finding the point on the time-stiffness

curve where stiffness rises by an order of magnitude above baseline. Normal values

are about 3.5 minutes with +/- 10% or .35 minutes. Pathological values can fall as

low as 1 minute.

[0043]Fibrinogen function (when determined by sonorheometry) is the maximum clot

stiffness in the absence of platelet function. Either stiffness units or traditional mg/dL

units may be used. It is determined as the maximum stiffness in a test well having

kaolin plus ReoPro®. Normal values are 104 in stiffness which corresponds to about

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WO 2011/127436 PCT/1JS2011/031832

300 mg/dL. Normal variation is about +7- 5%. Pathological values range from 15

mg/dL to above 450 mg/dL.

[0044]Platelet function (when determined by sonorheometry) is the multiplicative

increase in clot stiffness that is attributed to platelets. It is determined by dividing the

maximum stiffness in a test well with kaolin by the test well with kaolin plus ReoPro.

It yields a dimensionless number that normally is 10 +/- 1 with pathological values

ranging as low as 1.

[0045]Fibrinolytic function (when determined by sonorheometry) is the time at which

fibrinolysis begins, and in some cases may include the effect of an accelerant.

Without an accelerant, it is determined to be the point on the time-stiffness curve

where stiffness falls by 50%. Normal is generally defined as 90 minutes with

pathological values ranging as low as 10 minutes. An expected range is about 60 to

120 minutes based on prior experience.

[0046]With reference now to Fig. 1, embodiments of the present invention include a

system 10 for displaying a plurality of hemostatic indexes 12. The system includes a

communication receiver 14 configured to receive the hemostatic indexes 12 and a

graphical user interface (GUI) 16 connected to the communication receiver 14 and

configured to display one, or simultaneously at least two, of the hemostatic indexes

12. The hemostatic indexes 12 are derived from a plurality of independent

measurements, such as the mechanical measurements determined using the

sonorheometry systems and processes described in more detail below.

[0047]The term "GUI" or "graphical user interface" as used herein includes any

hardware, software, firmware or combination thereof, or even non-electronic

interfaces, capable of generating graphical depictions such as liquid-crystal displays,

computer monitors, cell phone or PDA screens, televisions, tablet computers etc.

[0048]Thc term "independent measurement" as used herein refers to separate tests,

sonorheometry or otherwise, which may be performed on a single sample, such as a

series ultrasound tests using the same instrument, or on multiple samples, such as

parallel tests by multiple instruments or sensors.

[0049]The terminology used herein is for the purpose of describing particular

embodiments only and is not intended to be limiting of the invention. As used herein,

the singular forms "a", "an" and "the" are intended to include the plural forms as well,

unless the context clearly indicates otherwise. It will be further understood that the

terms "comprises" and/or "comprising," when used in this specification, specify the

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WO 2011/127436 PCT/1JS2011/031832

presence of stated features, integers, steps, operations, elements, and/or components,

but do not preclude the presence or addition of one or more other features, integers,

steps, operations, elements, components, and/or groups thereof.

[0050]The corresponding structures, materials, acts, and equivalents of all means or

step plus function elements in the claims below are intended to include any structure,

material, or act for performing the function in combination with other claimed

elements as specifically claimed. The description of the present invention has been

presented for purposes of illustration and description, but is not intended to be

exhaustive or limited to the invention in the form disclosed. Many modifications and

variations will be apparent to those of ordinary skill in the art without departing from

the scope and spirit of the invention. The embodiment was chosen and described in

order to best explain the principles of the invention and the practical application, and

to enable others of ordinary skill in the art to understand the invention for various

embodiments with various modifications as are suited to the particular use

contemplated.

[0051]Any combination of one or more computer readable medium(s) may be

utilized. The computer readable medium may be a computer readable signal medium

or a computer readable storage medium. A computer readable storage medium may

be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic,

infrared, or semiconductor system, apparatus, or device, or any suitable combination

of the foregoing. More specific examples (a non-exhaustive list) of the computer

readable storage medium would include the following: an electrical connection having

one or more wires, a portable computer diskette, a hard disk, a random access

memory (RAM), a read-only memory (ROM), an erasable programmable read-only

memory (EPROM or Flash memory), an optical fiber, a portable compact disc read-

only memory (CD-ROM), an optical storage device, a magnetic storage device, or any

suitable combination of the foregoing. In the context of this document, a computer

readable storage medium may be any tangible medium that can contain, or store a

program for use by or in connection with an instruction execution system, apparatus,

or device.

[0052]A computer readable signal medium may include a propagated data signal with

computer readable program code embodied therein, for example, in baseband or as

part of a carrier wave. Such a propagated signal may take any of a variety of forms,

including, but not limited to, electro-magnetic, optical, or any suitable combination

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WO 2011/127436 PCT/1JS2011/031832

thereof. A computer readable signal medium may be any computer readable medium

that is not a computer readable storage medium and that can communicate, propagate,

or transport a program for use by or in connection with an instruction execution

system, apparatus, or device.

[0053]Program code embodied on a computer readable medium may be transmitted

using any appropriate medium, including but not limited to wireless, wireline, optical

fiber cable, RF, etc., or any suitable combination of the foregoing.

[0054]Computer program code for carrying out operations for aspects of the present

invention may be written in any combination of one or more programming languages,

including an object oriented programming language such as Java, Smalltalk, C++ or

the like and conventional procedural programming languages, such as the "C"

programming language or similar programming languages. The program code may

execute entirely on the user's computer, partly on the user's computer, as a stand-alone

software package, partly on the user's computer and partly on a remote computer or

entirely on the remote computer or server. In the latter scenario, the remote computer

may be connected to the user's computer through any type of network, including a

local area network (LAN) or a wide area network (WAN), or the connection may be

made to an external computer (for example, through the Internet using an Internet

Service Provider).

[0055] Aspects of the present invention are described below with reference to

flowchart illustrations and/or block diagrams of methods, apparatus (systems) and

computer program products according to embodiments of the invention. It will be

understood that each block of the flowchart illustrations and/or block diagrams, and

combinations of blocks in the flowchart illustrations and/or block diagrams, can be

implemented by computer program instructions. These computer program

instructions may be provided to a processor of a general purpose computer, special

purpose computer, or other programmable data processing apparatus to produce a

machine, such that the instructions, which execute via the processor of the computer

or other programmable data processing apparatus, create means for implementing the

functions/acts specified in the flowchart and/or block diagram block or blocks.

[0056]These computer program instructions may also be stored in a computer

readable medium that can direct a computer, other programmable data processing

apparatus, or other devices to function in a particular manner, such that the

instructions stored in the computer readable medium produce an article of

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WO 2011/127436 PCT/1JS2011/031832

manufacture including instructions which implement the function/act specified in the

flowchart and/or block diagram block or blocks.

[0057] The computer program instructions may also be loaded onto a computer, other

programmable data processing apparatus, or other devices to cause a series of

operational steps to be performed on the computer, other programmable apparatus or

other devices to produce a computer implemented process such that the instructions

which execute on the computer or other programmable apparatus provide processes

for implementing the functions/acts specified in the flowchart and/or block diagram

block or blocks.

[0058]Some embodiments of the present invention use an ultrasound-based

technology ("sonorheometry") to quantify the dynamic changes in mechanical

properties of whole blood during the process of coagulation and clot dissolution. This

provides information about the role of the coagulation factors, fibrinogen, platelets,

and fibrinolytic proteins to overall hemostatic function.

[0059]Sonorheometry uses the phenomenon of acoustic radiation force to make

repeated viscoclastic measurements of a whole blood sample. Acoustic radiation force

can be described as the transfer of momentum between an acoustic wave (or pulse)

and a reflection or absorbing target. As a result of the transferred momentum, the

target experiences a small unidirectional force in the direction of the wave (or pulse)

propagation. For a perfect absorber, this can be mathematically defined as follows:

p=2a(1(t)) 2aPII PRF

(1)

[0060]where is acoustic radiation force (in units of m'), a is the attenuation

coefficient of the medium, c (in units of rn/s) is the speed of sound in the medium, 1(t)

(in units of W/m2) is the instantaneous intensity of the beam (e.g., ultrasound beam),

P11 is pulse intensity integral, and PRF is pulse repetition frequency (typically

measured in hertz), which characterizes the time interval between pulse or wave

firings.

[0061]In order to exploit the acoustic radiation force phenomenon as a means to

discern material properties of tissue, sonorhcometry can be performed as a series of

pulses transmitted so that the temporal characteristic of the acoustic radiation force

approximates a step-function. In this step-wise radiation force that is applied, the

resultant displacement profiles mimic responses observed in viscoelastic creep tests

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WO 2011/127436 PCT/1JS2011/031832

and can be described by viscoclastic models such as the Voigt or Kelvin models.

Parameters such as steady-state displacement or time constants can be extracted

which characterize material properties of the tissue that the acoustic force radiation is

applied to. When the target tissue is whole blood, sonorheometry as described herein

can be used to monitor coagulation and clot dissolution properties (i.e., the hemostatic

process).

[0062]Sonorheometry is performed using acoustic radiation force as a means to

generate small and localized displacements within a sample, e.g., a whole blood

sample. Returned echoes are processed to measure the induced displacements and

determine viscoelastic properties of the sample. In at least one embodiment,

displacements arc quantified using a principal component-based estimator technique,

such as is described in Mauldin, Jr. et al., "Reduction of echo decorrelation via

complex principal component filtering," Ultrasound Med. Biol., vol. 35, no. 8, pp.

1325-1343, 2009 and in U.S. Application Serial No.12.467,216 filed May 15, 2009

and titled "Reduction of Echo Decorrelation in Ultrasonic Motion Estimation."

[0063]In performing sonorheometry according to the present invention, for each

measurement a series of N ultrasound pulses (where N=a positive integer) are fired

toward a specified location within a blood sample at time intervals AT, e.g., see

Figure 2A. Each pulse generates radiation force as energy is absorbed and reflected

during propagation. This radiation force induces displacements within the blood

sample that depend upon local force application and mechanical properties of the

blood. Each pulse also returns an echo as a portion of its energy is reflected from

cell/plasma interfaces within the blood. Because the tissue (blood) moves slightly

from one transmission to the next, the path length between the ultrasound transducer

and any given region within the target (blood) changes with pulse number. This

change in path length can be readily estimated from differences in the arrival times of

echoes from the same region, thereby accomplishing motion tracking of the sample.

The series of N acoustic pulses are sent into the blood sample at a specified pulse

repetition frequency (PRF). These pulses generate acoustic radiation force that

induces a deformation field within the sample. The deformation field can be estimated

from the time delays of the N returning echoes.

[0064]The ensemble of the time delays forms a time-displacement curve that

describes the viscoelastic properties of the sample being analyzed. This process is

then repeated M times (where M is a positive integer), with intervening relaxation

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WO 2011/127436 PCT/1JS2011/031832

periods, to provide data about the dynamics of clot formation and dissolution. As

blood coagulates reduction in displacement is observed. The values of the M steady-

state displacements are combined to form a relative stiffness curve that is

representative of the hemostatic process, e.g., see Figure 2B. The stiffness parameter

is referred to as "relative" since the absolute magnitude of the radiation force is

unknown due to its dependency on blood acoustic properties which change

throughout coagulation. Alternatively the changes in acoustic properties (i.e., changes

in acoustic attenuation a and speed of sound c) can be measured using a known

reflector so that acoustic radiation force can be calculated and absolute stiffness

values can be calculated.

[0065]in Figure 2B, the relative stiffness curve shows characteristic features labeled

Time to Clot (TC1), Time to Final Clot (TC2), Angle (0), Final Stiffness (S),

Beginning of Fibrinolysis (TL1) and End of Fibrinolysis (TL2). The hemostasis

parameters indicated in Figure 2B are calculated by first fitting the sonorheometry

relative stiffness data to a modified sigmoidal function such as, for example, the

following model (although other models may be alternatively used to accomplish

these calculations, such as a combination of linear trends or a combination of skewed

error functions):

f (t) = atB

1+e— 5 a (2)

[0066]where t is experimental time (in seconds) and a, 13, T, d and a are parameters

determined to best fit the model curve to the data.

[0067]The parameter TC1 corresponds to the rapid increase in relative stiffness,

indicating the beginning of fibrin polymerization. Similarly, the parameter TC2

represents the ending of fibrin polymerization. TC1 and TC2 are calculated based on a

threshold value of the derivative curve of the relative stiffness (20()/0 of the minimum

value). The angle 0 is the slope of the relative stiffness during fibrin polymerization,

which extends generally between TC1 and TC2. The angle, defined as the slope of the

line between TC1 and TC2, is indicative of the rate of fibrin polymerization. The final

stiffness S (maximum stiffness) corresponding to the maximum stiffness of the clot.

The maximum stiffness S depends upon platelet function and the stiffness of the fibrin

network. The times TL1 and TL2 can be defined to represent the initial and final

+E

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WO 2011/127436 PCT/1JS2011/031832

phases of the fibrinolytic process and the consequent dissolution of the fibrin network

(time to lysis). TL1, indicating the "lysis initiation time", and TL2, indicating the

"end of lysis time", can be calculated by defining a new sigmoidal curve similar to

that defined by equation (2), calculating the curve derivative, and estimating the times

corresponding, for example, to twenty percent of the minimum of the derivative. A

summary of the parameters generated is presented in Table T1 below:

Table II

TC1, rit:2 Measure initial and final fibrin formation

Function of fibrinogen and other coagulation factors

S Fibrin and platelet activity Function of fibrin network and platelet aggregation

0 Rate of fibrin polymerization Function of fibrinogen and other coagulation factors

TL1, TL2 Clot dissolving process Function of fibrinolytic proteins of the plasma

[006811n order to isolate the four main components of hemostasis, four sonorheometry

measurements can be performed in parallel using a combination of agonists and

antagonists reagents. In a possible embodiment, test well 1 may have kaolin powder

to activate coagulation through the intrinsic pathway. Test well 2 may have a

combination of kaolin and abciximab (ReoPro) to inhibit platelet aggregation. Test

well 3 may have abciximab and thrombin to activate coagulation through the common

pathway. Test well 4 may have tissue factor to activate coagulation through the

extrinsic pathway. In one embodiment, the measurements in each well can be

combined to form hemostatic indexes as shown in the Table III below:

Table III Coagulation factors function (Intrinsic Pathway) Time to clot TC1 in well #1

Coagulation factors function (Extrinsic Pathway) Time to clot TC1 in well #4

Platelets function Stiffness S differential between well #1 and well #2

Fibrinogen function Stiffness S in well #3

Fibrinolysis function Time to lysis TL1 in well #4

[0069]The measurements of hematocrit (HCT), hemoglobin concentration (HGB) and

red cell count (RBC) can be performed using ultrasound signals by methods such as

those disclosed in U.S. Prov. Pat. App. No. 61/443,084 filed on February 15th, 2011

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WO 2011/127436 PCT/1JS2011/031832

and entitled "CHARACTERIZATION OF BLOOD PARAMETERS INCLUDING

HEMATOCRIT AND HEMOSTASIS," and hereby incorporated in its entirety by

reference.

[0070]Tn other embodiments, the hemostatic indexes may be obtained for display

from one or more diagnostic devices that provide information regarding the process of

coagulation and fibrinolysis (i.e., the hemostatic process). Such devices include, for

example, methods based on direct measurements of blood viscoelasticity such as the

TEG® (Haemoscope), ROTEM® (Pentapharm), HAS (Hemodyne) and SonoClot(k)

(Sienco).

[0071]Referring again to Fig. 1, the system 10 of the present invention includes a base

18, a housing 20 containing various electronic components and software such as the

communication receiver 14, a pair of consumable receptacles 22 holding consumables

24, and the GUI 16.

[0072]The base 18 is constructed of a molded plastic and includes a foot 26 or flange

for resting upon a flat surface, such as a patient's bedside, and a post 28 extending

upwards therefrom to support the housing 20. Advantageously, the space between the

bottom edge of the housing 20 and the top of the foot 26 provides room for resting a

storage container of the consumables 24. The base 18 may also function as a passage

for wiring, power, communication or otherwise, connecting to the electronics within

the housing 20 or the GUI 16.

[0073]The housing 20 includes a plurality of walls in a rectangular arrangement that

is supported by the post 28 of the base 18 in an inclined, near vertical orientation for

easy viewing by and interaction with healthcare personnel. Contained within the

housing 20 may be various combinations of hardware, software, firmware and other

electronics to support the application of sonorheometry to the consumables 24,

operation of the GUI 16 (such as through a video card or driver) and other functions.

[0074]For example. selected components of Fig. 19 (described in more detail below)

may be included within the housing 20 to enable the functions and processes

described herein. Alternatively, the housing 20 may only contain very basic

components for displaying the results of sonorheometry. For example, the

communication receiver 14 may be a video card or video driver, a wireless receiver or

basic hardware and software for communicating with cloud-based or other distributed

processing power to receive the hemostatic indexes 12 and other information.

[0075]The housing 20 includes a front screen 30 comprised of a transparent plastic

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WO 2011/127436 PCT/1JS2011/031832

that includes a central raised portion and a pair of lateral portions. The portions

define planar surfaces. The lateral portions are on either side of the central raised

portion and are recessed or spaced behind the central raised portion. The recessed

position of the lateral portions provides clearance for the consumables 24 and defines

the consumable receptacles 22, as shown in Fig. 1. The pair of consumable

receptacles 22 are defined by the lateral portions of the front screen 30 and generally

are slots or openings sized to receive the consumables 24 to provide testing access

(such as by sonorheometry) to one or more blood samples.

[0076]The central portion houses a display or other screen or device upon which the

GUI is presented.

[0077]For example, the consumables 24 may include a cartridge or card 32 connected

to a syringe 34. The card 32 includes an array of multiple chambers or wells 36 in a

side-by-side or serial relationship that are accessible by the syringe 34 via an inlet and

channels defined in the card 32 that distribute portions of the blood into the wells.

Within each of the wells 36 is a blood sample dispensed by the syringe 34 and usually

one or more reagents, such as is described in U.S. Prov. Pat. App. No. 61/443,088

filed on February 15, 2011 and entitled, "Devices, Systems and Methods for

Evaluation of Hemostasis," hereby incorporated in its entirety herein by reference.

Different numbers of wells are possible, such as 2, 3 or 4 wells.

[0078]The term "blood sample" as used herein should be construed broadly to include

such things as plasma or whole blood or some component of whole blood. For

example, a blood sample may include blood, platelet poor plasma (PPP) or platelet

rich plasma (PRP). If PPP or PRP are used for sonorheometry, however, ultrasound

scattering material may be used in order to provide adequate ultrasound scattering to

perform the measurements. For example, polystyrene beads can be used as they have

neutral buoyancy in plasma.

[0079]Generally, when used herein the term "array" refers to spaced objects

extending in a particular direction. The array configuration, however, could be any

cluster or arrangement of the wells 36, not necessarily a linear one, wherein spacing

along one axis is generally regular. Thus, the other axes could be somewhat offset

from each other wherein the objects in the array extend in a common direction on one

axis but are staggered above and below that axis. In the embodiment of Fig. 1, the

wells 36 are in a serial array where they are not only regularly spaced, but in a straight

line.

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WO 2011/127436 PCT/1JS2011/031832

[0080]Disposcd on one side of each of the wells 36 is a lens for coupling with and

focusing sound or sonic energy emitted by corresponding sensors with operation

supported by the electronics of the housing 20. This sonic energy is used to detect the

mechanical parameters of the blood samples in the wells 36 which in turn are used to

determine the hemostatic indexes using the principals described hereinabove.

[0081]in some embodiments of the present invention the GUI 16, includes a plurality

of display portions 38 that are adjacent to and in a similar orientation to the sample

wells 36. For example, the hemostatic indexes 12 may be depicted by an array of a

similar number and orientation of graphical elements.

[0082]Each of the display portions 38 is configured to readily depict for easy

interpretation, such as through numbers, colors or images, one of the hemostatic

indexes 12. For example, the display portions 38 may include horizontal colored bars

and percentage numbers that show parameters that include a coagulation factor

function, a fibrinogen function (or concentration), a platelet function and/or a

fibrinolysis function.

[0083]The colors of the colored bars may be used as a theme throughout the display

and accompanying instructions and/or written documentation to associate information

on a single one of the hemostatic indexes 12. For example, all items and

documentation regarding the coagulation factor could be shown in red, the fibrinogen

function in yellow, platelet function in purple and fibrinolytic function in light blue.

In this manner, a healthcare person has a way to quickly associate various display

items and documentation with the single function under stressful and fast-moving

conditions.

[0084]The GUI 16 may also include a normal line 40 that when reached by the

display portion visual indicator evidences a normal condition of the sample being

tested.

[0085]Advantageously, the GUI is configured, through its display of the relative

positioning of multiple (such as four) hemostatic indexes 12, to characterize

hemostatic function and guide medical treatment. Fig. 3A, for example, shows a GUI

from a hypothetical normal patient with no hemostatic defect. All of the hemostaic

indexes 12 are at the same 100% (middle) level.

[0086]Fig. 3B shows a GUI from a hypothetical patient with reduced function of the

coagulation factors (below 100%). This could be the consequence of anti-coagulation

drugs, for example. Otherwise, in the case of a bleeding patient, fresh-frozen plasma

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WO 2011/127436 PCT/1JS2011/031832

can be administered to restore function of the coagulation factors.

[0087]Fig. 3C shows a GUI of a hypothetical patient with reduced platelet function,

such as in the case of the patient receiving clopidogrel (Plavix*) or aspirin therapy.

Otherwise, in the case of a bleeding patient, this readout indicates that platelet

concentrates should be administered to restore platelet number and function to the

patient.

[0088]Fig. 3D shows a GUI of a hypothetical patient with increased fibrinolytic

function. In this case, a bleeding patient should be administered an anti-fibrinolytic

drug such as aminocaproic acid or tranexamic acid.

[0089]Fig. 3E shows a GUI of a hypothetical patient with reduced function of both

coagulation factors and platelets. The reduction in platelet function is more severe

than that showed previously in Fig. 3C. In the case of a bleeding patient, the GUI of

Fig. 3E indicates the need to transfuse fresh frozen plasma along with platelet

concentrates.

[0090]Fig. 3F shows a GUI of a hypothetical patient with an increased function of the

coagulation factors. The GUI is thus indicating a need for administration of anti-

coagulant drugs such as coumadin, heparin, or direct thrombin inhibitors, for

example, to restore normal function.

[0091]In another potential embodiment, the display of coagulation factors is divided

into intrinsic and extrinsic coagulation factors to indicate defects that are specific to

each activation pathway. The function of the intrinsic and extrinsic coagulation

factors would be displayed along with the function of platelets, fibrinogen and

fibrinolysi s.

[0092]Figs. 6 and 7 show other embodiments in which numerical scores are presented

to quantify the function of the hemostatic components. Numerical scores can be

presented as an arbitrary percentage or on an arbitrary numerical scale. In Figs. 6 and

7, for example, the GUI displays 100% for normal physiological function. Also

shown (except for fibrinogen) is display of an arbitrary scale going from 0 to 10 with

5.0 representing normal physiological function. Also, a light gray bar across the

display represents the line 40 of normal physiological hemostasis.

[0093]Units of measure could also be used to quantify the absolute concentration or

number of some of the output parameters. In Figs. 6 and 7, functional fibrinogen

concentration is quantified in units of mg/dl, for example.

[0094]The GUI 16 may also be configured to display the type of test administered to

19


WO 2011/127436 PCT/1JS2011/031832

the blood samples. In Fig. 7, a Surface Activation Test is performed with the use of

kaolin or celite, for example, to activate coagulation through the intrinsic (i.e.,

contact) activation pathway. Different types of tests and activations can be performed

by selecting the appropriate reagent set which is detected by the system 10 from the

pre-loaded consumables 24, such as through an RFID tag, and then communicated

through the GUI 16.

[0095]Fig. 6 shows an embodiment simultaneously using two consumable receptacles

22 for parallel testing of blood samples. As in prior embodiments, the solid normal

line 40 across the GUI 16 indicates normal physiological conditions.

[0096]The GUI 16 may also be configured to dynamically change colors depending

upon the status of the various hemostatic indexes 12. As shown in Fig. 8 for example,

the graphical elements and numbers are color-coded with green representing normal,

red representing increased function, and yellow representing reduced function.

[009711n yet another embodiment, the GUI 16 may be configured to display

additional hemostatic parameters such as: hematocrit (HCT), hemoglobin

concentration (HGB) and/or red cell count (RBC). Display of the HCT, HGB or RBC

values may inform the healthcare personnel to transfuse packed red blood cell units

into a bleeding patient. Therefore, combining HCT, HGB, or RBC with the

hemostatic indexes 12 can provide information about every possible transfusion

product.

10098J1n other embodiments, the GUI 16 may be configured to display temporal

progression of the hemostatic parameters. Such a display illustrates the progression of

each hemostatic parameter as a function of procedure time, administered treatment

(transfusions) and other landmark events.

[0099]Fig. 4, for example, shows three tests performed at three times (9:32 AM;

10:17 AM and 10:51 AM) during an hypothetical procedure in which both

consumable receptacles (A and B) are used. Time relative to the beginning of the

procedure is shown in the bottom scale, whereas absolute time is on the top scale. For

each test performed there is an array of four color-coded symbols representing the

four hemostatic indexes 12.

[00100]Fig. 5 shows an embodiment wherein a single hemostatic parameter can be

selected for temporal display by the GUI 16. In this case fibrinogen in mg/dL is

shown as a function of procedure time.

[00101]In another embodiment, as shown in Fig. 9, the present invention includes a

20


WO 2011/127436 PCT/1JS2011/031832

method for deriving and displaying hemostatic indexes. Mechanical properties of

blood samples are measured 100 to generate independent measurements. The

hemostatic indexes are derived 110 from the independent measurements. For

example, one or more of a coagulation factor function, a fibrinogen concentration, a

Fibrinogen function, a platelet function and a fibrinolysis function may be derived in

step 110. Also derived 110 from the independent measurements may be a hematocrit,

hemoglobin concentration and/or red cell count.

[00102] Deriving 110 may also include deriving each of the hemostatic indexes from a

plurality of the independent measurements. Also, deriving 110 may include deriving

each of the hemostatic indexes from a corresponding one of the independent

measurements.

[00103]The method may also include displaying 120 the hemostatic indexes, such as

by using the GUI 16. For example, displaying 120 may include displaying a

numerical score and/or a graphical element for the hemostatic indexes. Also,

displaying 120 may include displaying a changing color to indicate dynamic changes

in the hemostatic indexes or a same color to associate the hemostatic indexes with

other information.

[00104]The method may also include estimating or calculating 125 and displaying

130 hematocrit, hemoglobin concentration and/or red cell count simultaneously with

the at least two hemostatic indexes.

[00105]The method may also include displaying 140 a history of the hemostatic

indexes and overlaying 150 one or more clinical interventions on the history. For

example, displaying 140 the history may include displaying an array of graphical

indicators each representing one of the hemostatic indexes at some time in the history.

The graphical indicators may be positioned relative to each other to communicate a

hemostatic condition of a subject at that point in time.

[00106]The method may also include displaying 160 a treatment recommendation

based on the at least two hemostatic indexes. For example, the GUI 16 could display

information guiding transfusion of at least one of platelets, cryoprecipitate, plasma,

red cells or antifibrinolytics, or guiding therapies using an anti-platelet drug, anti-

coagulant drug or pro-fibrinolysis drug.

[00107]In another embodiment, the system 10 is configured to determine a range of

possible values given the current results of the measurements of the blood sample. In

this manner, the healthcare personnel may receive early indication of trend without

21


WO 2011/127436 PCT/1JS2011/031832

having to wait the fully elapsed time. For example, as shown by the progression from

Figs. 10-18, determination of coagulation factor function becomes progressively more

confident as indicated by the vertical bar displayed by the GUI 16 on the right and the

as so ci ated num eri cal information.

[00108]Each of the figures is a 60 second interval, starting with time zero in Fig. 10

wherein a zero to infinite range of the possible 100% normalized index is shown. As

each time interval passes, the range and accompanying height of the bar shrinks to

express increasing certainty around the projected result. At 1 minute the range is 0-

300; at 2 minutes 0-200; at 3 minutes 0-100 (since normal is 3.5 minutes +/- 10% CF

will definitely not be high with no change in the stiffness); at 4 minutes 0-75 (now the

patient must be in low territory because they're outside the normal range at the 3.85

minute high end); at 5 minutes the range drops to 0-60; at 6 minutes 0-50; at 7

minutes 0-43 and with the final result at 8 minutes of 38.

[00109]Notably, the GUI 16 is configured to continuously shrink the height of the bar

(or other visual characteristic) to show increasing confidence with the final minimum

thickness and a white line indicating the final result.

[00110]Referring now to Fig. 19, a schematic diagram of a central server 500, or

similar network entity, configured to implement a VPD system, according to one

embodiment of the invention, is provided. As used herein, the designation "central"

merely serves to describe the common functionality the server provides for multiple

clients or other computing devices and does not require or infer any centralized

positioning of the server relative to other computing devices.

[00111]As may be understood from Fig. 19, in this embodiment, the central server

500 may include a processor 510 that communicates with other elements within the

central server 500 via a system interface or bus 545. Also included in the central

server 500 may be a display device/input device 520 for receiving and displaying

data, such as via the GUI 16 described above. This display device/input device 520

may be, for example, a keyboard or pointing device that is used in combination with a

monitor. The central server 500 may further include memory 505, which may include

both read only memory (ROM) 535 and random access memory (RAM) 530. The

server's ROM 535 may be used to store a basic input/output system 540 (BIOS),

containing the basic routines that help to transfer information across the one or more

networks.

22


WO 2011/127436 PCT/1JS2011/031832

[00112]ln addition, the central server 500 may include at least one storage device 515,

such as a hard disk drive, a floppy disk drive, a CD Rom drive, or optical disk drive,

for storing information on various computer-readable media, such as a hard disk, a

removable magnetic disk, or a CD-ROM disk. As will be appreciated by one of

ordinary skill in the art, each of these storage devices 515 may be connected to the

system bus 545 by an appropriate interface. The storage devices 515 and their

associated computer-readable media may provide nonvolatile storage for a central

server. It is important to note that the computer-readable media described above could

be replaced by any other type of computer-readable media known in the art. Such

media include, for example, magnetic cassettes, flash memory cards and digital video

disks.

[00113]A number of program modules may be stored by the various storage devices

and within RAM 530. Such program modules may include an operating system 550

and a plurality of one or more (N) modules 560. The modules 560 may control certain

aspects of the operation of the central server 500, with the assistance of the processor

510 and the operating system 550. For example, the modules may include a

measurement module 562 for measuring mechanical properties of a blood sample, a

hemostatic index determination module 564 and a display module 566.

[00114]The flowchart and block diagrams, such as in Figs. 9 and 19, illustrate the

architecture, functionality, and operation of possible implementations of systems,

methods and computer program products according to various embodiments of the

present invention. In this regard, each block in the flowchart or block diagrams may

represent a module, segment, or portion of code, which comprises one or more

executable instructions for implementing the specified logical function(s). It should

also be noted that, in some alternative implementations, the functions noted in the

block may occur out of the order noted in the figures. For example, two blocks shown

in succession may, in fact, be executed substantially concurrently, or the blocks may

sometimes be executed in the reverse order, depending upon the functionality

involved. It will also be noted that each block of the block diagrams and/or flowchart

illustration, and combinations of blocks in the block diagrams and/or flowchart

illustration, can be implemented by special purpose hardware-based systems that

perform the specified functions or acts, or combinations of special purpose hardware

and computer instructions.

23


WO 2011/127436 PCT/1JS2011/031832

[00115]Thc corresponding structures, materials, acts, and equivalents of all means or

step plus function elements in the claims below are intended to include any structure,

material, or act for performing the function in combination with other claimed

elements as specifically claimed. The description of the present invention has been

presented for purposes of illustration and description, but is not intended to be

exhaustive or limited to the invention in the form disclosed. Many modifications and

variations will be apparent to those of ordinary skill in the art without departing from

the scope and spirit of the invention. The embodiment was chosen and described in

order to best explain the principles of the invention and the practical application, and

to enable others of ordinary skill in the art to understand the invention for various

embodiments with various modifications as arc suited to the particular use

contemplated.

24


29 J

an 2

013

20

1123

7383

CLAIMS

1. A system for displaying a hemostatic index, the system comprising:

a communication receiver configured to receive the hemostatic index; and

a graphical user interface (GUI) connected to the communication receiver and configured

to display a hemostatic index;

wherein the hemostatic index is derived from a plurality of independent measurements.

2. A system of Claim 1, wherein the communication receiver is configured to

receive at least two hemostatic indexes and the GUI is configured to display the at least two

hemostatic indexes simultaneously.

3. A system of Claim 2, wherein at least one of the hemostatic indexes is derived

from a combination of at least two of the independent measurements.

4. A system of Claim 2, wherein each of the hemostatic indexes is derived from a

corresponding one of the independent measurements.

5. A system of Claim 2, wherein the independent measurement is a measurement of

mechanical properties.

6. A system of Claim 5, wherein the functional hemostasis indexes include at least

one of a group consisting of a coagulation factor function, a fibrinogen concentration, a

fibrinogen function, a platelet function and a fibrinolysis function.

7. A system of Claim 6, wherein the functional hemostasis indexes include a

numerical score.

8. A system of Claim 6, wherein the functional hemostasis indexes include a

graphical depiction.

25


29 J

an 2

013

20

1123

7383

9. A system of Claim 6, wherein the coagulation factor function includes at least one

of an intrinsic activation factor or an extrinsic activation factor.

10. A system of Claim 6, wherein the GUI is further configured to display at least one

of a group consisting of a hematocrit, hemoglobin concentration and red cell count.

11. A system of Claim 10, wherein the GUI is further configured to display the at

least one of the group consisting of the hematocrit, hemoglobin concentration and red cell count

simultaneously with the at least two hemostatic indexes.

12. A system of Claim 2, further comprising a consumable receptacle configured to

receive a consumable holding at least two blood samples, wherein the blood samples are used to

generate the independent measurements.

13. A system of Claim 12, wherein each of the blood samples is used to generate a

corresponding one of the independent measurements.

14. A system of Claim 10, wherein the consumable receptacle is configured to

position the at least two blood samples in a spatial arrangement corresponding to the display of

the at least two hemostatic indexes.

15. A system of Claim 2, wherein the GUI further comprises a visual element

associating the display of each of the at least two hemostatic indexes with the at least two blood

samples.

16. A system of Claim 14, wherein the visual element includes at least one of lines or

colors.

17. A system of Claim 2, wherein the GUI is further configured to display a treatment

recommendation based on the at least two hemostatic indexes.

26


O

18. A system of Claim 17, wherein the treatment recommendation is for guiding ti transfusion of at least one of platelets, cryoprecipitate, plasma, red cells or antifibrinolytics.

("1 19. A system of Claim 17, wherein the treatment recommendation is for guiding

therapies of at least one of anti-platelet drug, anti-coagulant drug or pro-fibrinolysis drug.

20. A system of Claim 2, wherein GUI is configured to display information for

guiding transfusion or therapy.

2011

23738

3


24

WO 2011/127436 PCT/US2011/031832

1/15

10 30

Fig. 1


Ultrasound Blood Received Echoes Transmit Pulse Transducer Sample

Beam

Range / Time

t=t 0

t=t0+

(N-1)LT

. . .

Coagulation Fibrinolysis > <

F:o,irzogeo:.!

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102

Beginning of Fibrinoiyals Clot Oiseciving Proteins]

0 5 10 15 20 25 Time (min)

WO 2011/127436 PCT/US2011/031832

2/15

Fig. 2


WO 2011/127436 PCT/US2011/031832

•••••••••••••!::!;!;:!;•.:!:

3/15

(A) Normal

..!k:,.:,,-- ": u '

- - --!: - • •:-.:K::::.:•* 'm

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Function

Fibrinogen Function

Platelet Function

Fibrinolytic Function

(B) Reduced Coag Factors Function ...

•:. ••:::.: • •::•• •:•::•:••:•::•:••:•: :::: OF :•:::

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Function

Fibrinogen Function

Piatelet Function


(C) Reduced Platelet Function

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Function

(D) Increased Fibrinolytic Function

. ' ' " ..: 4,>•:: ..: •'''''

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Function

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(E) Reduced Coagulation Factors and Platelet Function

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(F) Increased Coag Factors Function

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Fig. 3

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WO 2011/127436 PCT/US2011/031832

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WO 2011/127436 PCT/US2011/031832

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Fig. 5


WO 2011/127436 PCT/US2011/031832

6/15

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Fig. 6


WO 2011/127436 PCT/US2011/031832

7/15

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\`. NNiVA:K"t' \;•.Nw: ks" \‘‘..• ‘" szt., " .. • \ :k. ...... N..\\\ ..

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Fig. 8

WO 2011/127436 PCT/US2011/031832

8/15


WO 2011/127436 PCT/US2011/031832

9/15

Fig. 9

Measure Mechanical Properties 100

Derive Hemostatic Indexes 110

Display Hemostatic Indexes 120

Calc. HCT, HGB or RBC 125

Display HCT, HGB or RBC 130

Display History of Indexes 140

Overlay Clinical Interventions 150

Display Treatment Recommendations

160


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