Information Disclosure Statement Practice Before … Disclosure Statement Practice Before the U.S....

Information Disclosure Statement Practice

Before the U.S. Patent and Trademark OfficeTrademark Office

A North Carolina CLE Presentation on May 10 2010 A North Carolina CLE Presentation on May 10, 2010

based in part on an NCBA Paralegal Intellectual Property Institute CLE Presentation on April 22, 2010

Sherry L. MurphyMyers Bigel Sibley & Sajovec, P.A., Raleigh

Duty of DisclosureDuty of Disclosure

37 C FR 1 56 37 C.F.R. 1.56

Public interest Public interest

Duty to disclose information Duty to disclose information material to patentability

Duty of DisclosureDuty of Disclosure Information material to patentability of any examined claim Establishes, itself or in combination with other information, a prima

facie case of unpatentability of any claimfacie case of unpatentability of any claim Refutes a position taken during prosecution

A h l i d i i As to each claim under examination Until canceled or withdrawn Information material to a canceled or withdrawn claim need not be

submittedsubmitted

Duty deemed satisfied if information submitted on Information Disclosure Statement IDSDisclosure Statement – IDS

No duty to perform a search for relevant art

Who Owes the DutyWho Owes the Duty

Individuals associated with the filing Individuals associated with the filing or prosecution of a patent application Inventors (Oath or Declaration) Inventors (Oath or Declaration) Attorneys/Agents who prepare and prosecute the application Every other person substantively involved in the preparation

or prosecution and associated with the inventor or assignee

Avid Identification Systems, Inc. v. Crystal Import Corp. (Fed. Cir. 2010)Crystal Import Corp. (Fed. Cir. 2010)

Individuals “substantively involved” in the preparation or Individuals substantively involved in the preparation or prosecution of a patent application under Rule 56

U.S. Patent No. 5,235,326, multi-mode radio frequency ID system for reading encoded biocompatible chips

Found valid and willfully infringedB f bl f bl d But unenforceable for inequitable conduct


Dr. Hannis Stoddard Dr. Hannis Stoddard a veterinarian decided to form the Avid Corporation after visiting an animal

shelter to reclaim his own lost dog

St dd d hi d th i t d l hi d Stoddard hired three engineers to develop a chip and reader system, where the reader could read both the unencrypted chips on the market as well as encrypted yp p ypchips produced by Avid


Dr. Stoddard had a demonstration at a trade show in A il 1990April 1990

Patent application was filed in August 1991 on the multi-mode system naming the three engineers as inventors mode system, naming the three engineers as inventors

Court found Dr. Stoddard’s trade show demonstration was material prior art under section 102(b) and that it p ( )was withheld from the PTO with deceptive intent

On appeal, Avid argues that 1) the demonstration was not material and that 2) Dr. Stoddard did not have a duty of candor under Rule 56

Avid Identification Systems, Inc. v. Crystal Import Corp (Fed Cir 2010)Crystal Import Corp. (Fed. Cir. 2010) Materiality under Rule 56 The demonstration was related to a precursor product that The demonstration was related to a precursor product that

did not contain all of the elements of the ‘326 patent claims A jury was presented with the trade show information and still found

the patent validthe patent valid

Held: “material” should not be confused with “invalidating” A reasonable examiner may find a particular piece of information

important to a determination of patentability, even if that information does not actually invalidate the patent

District court found that the precursor product, while not invalidating, reflected the closest prior art, and thus was highly material


Duty of Candor under Rule 56y Every other person substantively involved and associated with

the inventor or assignee

Held: “substantively involved” means the involvement: relates to the content of the application or decisions related thereto, pp

and is not wholly administrative or secretarial in nature

What to DiscloseWhat to Disclose

Publications dated prior to effective filing date dated prior to effective filing date dated after effective filing date Patents and non-patent literature Not cumulative

Public Use, Sale or Offer for Sale h i ff i fili d more than one year prior to effective filing date

Other issues inventorship disputes inventorship disputes

Scripps Clinic & Research Found. v. Genentech, Inc., 927 F.2d 1565 (1991) Genentech, Inc., 927 F.2d 1565 (1991) A reference that is simply cumulative to other references

does not meet the threshold of materiality that is does not meet the threshold of materiality that is predicate to a holding of inequitable conduct Meyer abstract published more than a year prior to filing was

not disclosed, but the examiner found it during prosecution Manuscript published less than a year prior to filing was

disclosed and considered by the examiner y

When a reference was before the examiner, whether through the examiner’s search or the applicant’s disclosure, it can not be deemed to have been withheld from the examiner

Timing of DisclosureTiming of Disclosure

1) W h 3 h f h 1) Within 3 months or prior to first action on the merits, whichever is later; orAfter or with the filing of an RCE After or with the filing of an RCE

2) After first action on the merits, but prior to final action Fee OR Statement Fee OR Statement

3) After final action or allowance Fee AND Statement

Timing of DisclosureTiming of Disclosure

Statement: Each item of information contained in the information disclosure

statement was first cited in any communication from a foreign patent ff f l h h hoffice in a counterpart foreign application not more than three months

prior to the filing of the information disclosure statement; OR

No item of information contained in the information disclosure No item of information contained in the information disclosure statement was cited in a communication from a foreign patent office in a counterpart foreign application, and, to the knowledge of the person signing the certification after making reasonable inquiry, no item of information contained in the information disclosure item of information contained in the information disclosure statement was known to any individual designated in §1.56(c) more than three months prior to the filing of the information disclosure statement

Practical ConsiderationsPractical Considerations

Different Attorneys have different styles Submit only the most relevant references

vsvs.

Submit everything even remotely related

Different Clients have different wants and needs Important to submit everything

vs.

Watch costs

Practical ConsiderationsPractical Considerations

Consider submitting non-traditional references l newspaper articles

references relevant to enablement or best mode

Submit references that may be used as evidence Submit references that may be used as evidence against a rejection during prosecution, or on appeal

Submit remarks with the Information Disclosure Statement or in a Response

R k l f Remarks to explain a reference Remarks when submission of a reference is inadequate Remarks on current status of related applications Remarks on current status of related applications

IDS Timing and Patent Term AdjustmentIDS Timing and Patent Term Adjustment

IDS filed prior to First Action on the Merits No PTA reduction

IDS fil d ft t Offi A ti IDS filed after a response to Office Action Considered a Supplemental Response Tip: file with the Response when practical Tip: file with the Response when practical Statement under Rule 704(d):

each item of information contained in the information disclosure fi i d i i i f f i statement was first cited in any communication from a foreign patent

office in a counterpart application and that this communication was not received by any individual designated in §1.56(c) more than thirty days prior to the filing of the information disclosure statementdays prior to the filing of the information disclosure statement.

Information Disclosure Information Disclosure S P iS P iStatement Practice:Statement Practice:

Recent Decisions RegardingRecent Decisions Regardingg gg gInequitable ConductInequitable Conduct

A North Carolina CLE Presentation on May 10 2010 A North Carolina CLE Presentation on May 10, 2010

based in part on an NCBA Paralegal Intellectual Property Institute CLE Presentation on April 22, 2010

Bruce E. Owens, Jr.Myers Bigel Sibley & Sajovec, P.A.

Raleigh NCRaleigh, NC

Consequences of Breach of Rule 56 DutyConsequences of Breach of Rule 56 Duty

37 C.F.R. 1.56 : “[N]o patent will be granted on an application in connection with which … the duty of disclosure was violated through bad faith or intentional misconduct.”

Subsequent litigation may result in a finding of inequitable Subsequent litigation may result in a finding of inequitable conduct, rendering entire patent – and possibly related patents as well – unenforceable

Inequitable conduct may include affirmative misrepresentation of a material fact, failure to disclose material information, or submission , ,of false material information, coupled with an intent to deceive.

Determining Inequitable ConductDetermining Inequitable Conduct

Party asserting inequitable conduct must prove threshold level of materiality and intent

Court then determines inequitable conduct by balancing the levels of materiality and intentof materiality and intent In other words, a greater showing of one factor may make up for a

lesser showing of the other

Because penalty for inequitable conduct is so severe, courts attempt to maintain a high standard so as not to punish “the patentee… [who] committed minor missteps or acted with minimal culpability or in good faith.” Therasense, Inc. v. Becton (Fed. Cir. 2010).

Inequitable Conduct Inequitable Conduct -- MaterialityMateriality

Different standards applied to determine materiality Objective “but for” – the misrepresentation is material if, but for the

i i h ld h b i dmisrepresentation, the patent would not have been issued.

Subjective “but for” – the misrepresentation is material if it caused the examiner to approve the application for patent when he would not otherwise have done so

“But it may have been” – information material if it might reasonably have affected y g ythe examiner's decision as to patentability

“Reasonable examiner” standard – based on pre-1992 version of Rule 56; requires a substantial likelihood that a reasonable examiner would consider the information important in deciding whether to allow the application to issue as a patentimportant in deciding whether to allow the application to issue as a patent.

Present-day Rule 56

“Merely cumulative” references are not material and need not be discloseddisclosed

Inequitable Conduct Inequitable Conduct -- IntentIntent

Independent from materiality Materiality does not presume intenty p

Must be shown that applicant had the ifi i t t t i l d d i th specific intent to mislead or deceive the

USPTO In a case involving nondisclosure of

information, evidence must show that the applicant made a deliberate decision to withhold a known material

freference

Materiality Materiality –– Recent DecisionsRecent Decisions

Dayco Products, Inc. v. Total Containment, Inc (Fed. Cir. 2003) CAFC indicates for first time that an office action from one patent p

application might be material to an examiner of a separate, related application.

Two families of patent applications were pendingp pp p g ‘196 family of applications was before Examiner Nicholson

Issued rejections 3 times based on Wilson reference

Application family resulting in patents-in-suit was before Examiner Arolapp y g p The two application families had substantially identical claims

Nicholson was made aware of patents-in-suit Arola though was not informed of the existence of ‘196 applications of Arola, though, was not informed of the existence of 196 applications, of

Nicholson’s rejections, or of the Wilson reference


Dayco Products, Inc. v. Total Containment, Inc (Fed. Cir. 2003) (continued)( ) District Court (W.D. Mo.) granted summary judgment of

unenforceability based on the three items not disclosed to Arola CAFC (Mayer Michel and Dyk) – SJ was improper CAFC (Mayer, Michel, and Dyk) SJ was improper

Co-pendency of applications was material because Arola could have issued double-patenting rejection if he had been made aware, but intent not found because the patents-in-suit were disclosed to Nicholsonp

Nicholson’s reliance on the Wilson reference not dispositive of materiality –more factual analysis required; intent not found because attorney affidavit explaining conclusion that Wilson not material was supplied

CAFC did note that contrary decision of another examiner reviewing a substantially similar claim may be material under both the “reasonable examiner” and Rule 56 standards.


McKesson Info. Solutions v. Bridge Medical (Fed. Cir. 2007) Three applications pending, related to similar subject matter

‘527 Application, which matured into patent-in-suit, was before Examiner Trafton

‘149 Application was before Examiner Lev Had Baker reference before him

I d j i Issued rejections

‘195 Application, which shared parent application with ‘527 Application, was also before Examiner Trafton

Baker reference were not disclosed to Examiner Trafton in ‘527 Applicationa e e e e ce we e ot sc ose to a e a to 5 7 pp cat o Examiner Lev’s rejections in ‘149 Application were not disclosed to Examiner

Trafton in ‘527 Application Examiner Trafton’s allowance of ‘195 Application were not cited back to Trafton pp

in ‘527 Application


McKesson Info. Solutions v. Bridge Medical (Fed. Cir. 2007) (continued)(continued) District Court (E.D. Ca.) found patent-in-suit unenforceable CAFC (Newman, Bryson, Clevenger) affirmed

B k f l d h l Baker reference was noncumulative art and thus material Regarding Examiner Lev’s rejections: showing substantial similarity between

the rejected claims and the claims at issue was sufficient to show materiality, but not necessary – rejected claims in co pending application need not be but not necessary – rejected claims in co-pending application need not be substantially similar in order to be material.

Examiner Trafton’s allowance was material because materiality not limited to info that would invalidate the claims under investigationg

Allowance of ‘195 application could have given rise to double-patenting rejection, so allowance was material

Applicant could not assume that Examiner Trafton would remember his decision to grant one application while examining claims of different decision to grant one application while examining claims of different application


Larson Mfg. Co. v. Aluminart Prods. Ltd. (Fed. Cir. 2009) Larson asserted ‘998 Patent against Aluminart Larson asserted 998 Patent against Aluminart Aluminart requested reexamination, which was granted, and litigation

was stayed ‘039 Continuation of ‘988 Patent was prosecuted while reexamination of 039 Continuation of 988 Patent was prosecuted while reexamination of

‘988 Patent was pending Two office actions in ‘039 Continuation were cited to the reexam panel Third and fourth office actions were not cited Third and fourth office actions were not cited

Reexamination concluded with issuance of reexam certificate, and stay of litigation was lifted

Al i t th t d i it bl d t i t L f f il t Aluminart then asserted inequitable conduct against Larson for failure to disclose third and fourth office actions and three prior art references to reexam panel


Larson Mfg. Co. v. Aluminart Prods. Ltd. (Fed. Cir. 2009) (continued)(continued) District Court (S.D.) held ‘998 Patent unenforceable CAFC (Schall, Clevenger, Linn) remanded

U i d i f l l i Uncited prior art references were merely cumulative Uncited office actions were material because they contained adverse

decisions by another examiner that refuted or was inconsistent with the patentability of substantially similar claims patentability of substantially similar claims.

In particular, the fourth office action contained a new rejection with an interpretation of a reference that was different from the reexamination panel’s interpretation of the same reference

Case was remanded for s determination of whether withholding of office actions alone constituted inequitable conduct

Court noted that materiality does not presume intent and nondisclosure by itself cannot satisfy deceptive intent requirementitself cannot satisfy deceptive intent requirement.


Therasense, Inc. v. Becton (Fed. Cir. 2010) Abbott (successor to Therasense) was owner of ’551 Patent for an ( )

electrochemical sensor for testing whole blood without any membrane over the electrode

‘382 Patent, initially filed by one of Abbott’s predecessors, was cited as y y pprior art during prosecution of the application that matured into the ‘551 Patent ‘382 Patent broadly claimed a membraneless sensor, and its specification

disclosed membraneless sensors The ‘382 Patent specification expressly noted: “Optionally, but preferably

when being used on live blood, a protective membrane surrounds both the en me and the mediat r la ers ermeable t ater and l c se m lec les”enzyme and the mediator layers, permeable to water and glucose molecules.”


Therasense, Inc. v. Becton (Fed. Cir. 2010) (continued) In prosecuting the application that matured into ‘551 patent, Abbott In prosecuting the application that matured into 551 patent, Abbott

submitted a declaration purporting to distinguish the above-quoted portion of the ‘382 Patent specification: “[O]ne of skill in the art would have felt that an active electrode comprising [O] e o s t e a t wou ave e t t at a act ve e ect o e co p s g

an enzyme and a mediator would require a protective membrane if it were to be used with a whole blood sample. Therefore, he is sure that one skilled in the art would not read [the ‘382 Patent specification] to teach that the use of t ti b ith h l bl d l i ti ll l a protective membrane with a whole blood sample is optionally or merely

preferred.”

Patent attorney further stated that the “optionally, but preferably” language would have been read as “mere patent phraseology”language would have been read as mere patent phraseology.


Therasense, Inc. v. Becton (Fed. Cir. 2010) (continued) However, during prosecution of European Patent ‘636 (a counterpart to However, during prosecution of European Patent 636 (a counterpart to

the ‘382 Patent, having a virtually identical specification), Abbot argued with respect to the above-quoted portion of the ‘382 Patent specification:p “It is submitted that this disclosure is unequivocally clear. The protective

membrane is optional, however, it is preferred when used on live blood … .”

Abbott did not disclose the arguments made to the EPO to the USPTO gduring prosecution of the application that matured into the ‘551 Patent


Therasense, Inc. v. Becton (Fed. Cir. 2010) (continued) District Court (N.D. Ca.) found ‘551 Patent unenforceable( )

Statements made to EPO contradicted statements to PTO in two ways By describing the “optionally, but preferably” language as “unequivocally

clear,” Abbott contradicted its representation that the phrase was mere “patent phraseology” that did not convey a clear meaning to a skilled artisan

Statements to EPO clearly explained that the membranes were merely y p ypreferred for live blood

The contradictory statements were material, and the fact that no credible explanation given for withholding statements suggested i d iintent to deceive


Therasense, Inc. v. Becton (Fed. Cir. 2010) (continued) CAFC (Linn, Friedman, Dyk) affirmed CAFC (Linn, Friedman, Dyk) affirmed

Statements to the EPO were material “The ‘unequivocally clear’ statement is tied directly to the optional nature of

the membrane when used with whole blood and other fluids.” Distinguished Abbott’s cited caselaw regarding attorney argument to PTO –

here, contradictory arguments were made in another forum and not disclosed to the PTO

“An applicant’s earlier statements about prior art, especially one’s own prior An applicant s earlier statements about prior art, especially one s own prior art, are material to the PTO when those statements directly contradict the applicant’s position regarding that prior art in the PTO.”

No clear error in determination of intent


Therasense, Inc. v. Becton (Fed. Cir. 2010) (continued) On April 26, 2010, the CAFC decided that the appeal warrants en banc On April 26, 2010, the CAFC decided that the appeal warrants en banc

consideration. Issues to be addressed in new briefs submitted by parties:

Should the materiality-intent-balancing framework for inequitable conduct be Should the materiality-intent-balancing framework for inequitable conduct be modified or replaced?

If so, how? In particular, should the standard be tied directly to fraud or unclean hands? If so, what is the appropriate standard for fraud or unclean pp phands?

What is the proper standard for materiality? What role should the USPTO’s rules play in defining materiality? Should a finding of materiality require that b f h ll d i d l i ld h i d?but for the alleged misconduct, one or more claims would not have issued?


Therasense, Inc. v. Becton (Fed. Cir. 2010) (continued) Issues to be addressed in new briefs submitted by parties: Issues to be addressed in new briefs submitted by parties:

Under what circumstances is it proper to infer intent from materiality? Should the balancing inquiry (balancing materiality and intent) be abandoned? Whether the standards for materiality and intent in other federal agency Whether the standards for materiality and intent in other federal agency

contexts or at common law shed light on the appropriate standards to be applied in the patent context.

Practical SuggestionsPractical Suggestions

Cite existence of related applications to corresponding examinersexaminers

Cite references and office actions from related applications, if material

Document reasons for any decisions not to cite prior art references

Be vigilant about documenting associated applications Consider keeping separate art file references common to

l t d li tirelated applications

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