Nicole Palmer Sent: Monday, July 28, 2014 1:08 PM To ... · From: Nicole Palmer Sent: Monday, July...

From: Nicole Palmer Sent: Monday, July 28, 2014 1:08 PM To: myriad-mayo_2014 Subject: BPLA Comments Submission re: Examination Guidance Pertaining to Patent-Eligible Subject Matter

Dear Sirs: Please find comments attached for your consideration on behalf of the Boston Patent Law Association.

Sincerely, Nicole

Nicole A. Palmer

One Main Street Cambridge, MA 02142 Direct: +1-617-395-7009 Main: +1-617-395-7000 Fax: +1-617-395-7070 Email: [email protected] www.LALaw.com

Confidentiality Note: This e-mail message and any attachments may contain confidential or privileged information. If you are not the intended recipient, please notify me immediately by replying to this message. Please destroy all copies of this message and any attachments.

Thank you.

This email has been scanned for email related threats and delivered safely by Mimecast. For more information please visit http://www.mimecast.com

E BOSTON PATENT LAW ASSOCIATION

01

14

l:

yo

atent Legal Administration

tes Patent and Trademark Office

450

, VA 22313

mments on

tter Eligibility of Claims Reciting or Involving Laws of Nature,

tural Phen

ments at 79 Fed. Reg.

g.

e Boston Patent Law Association (“BPLA”) thanks the United

nt and Trademark Office (“USPTO”) for the opportunity to

n

laws of nature, natural phenomena, and natural products

n association of intellectual property professionals, providing

l programs and a forum for the exchange of ideas and

n concerning patent, trademark, and copyright laws in the

a. These comments were prepared with the assistance of the

ice Practice Committee of the BPLA. These comments are

by the BPLA solely as its consensus view. The

the views of any individual member, any firm, or any client.

um from Andrew H. Hirschfeld, Deputy Comm’r for Patent Examination

Procedure for Subject Matter Eligibility Analysis of Claims Reciting or

ws of Nature/Natural Principles, Natural Phenomena, and/or Natural

ar. 4

nce.pdf (the “Guidance”).

T OCIATION

Suite .org

, 2

a

Raul Tam

of

United St

P.O. Box

Alexandri

C ing Subject

Laws of Nature,

N se to request

co

R

T nks the United

States Pat portunity to

comment f patent claims

concernin l products

BPLA is als, providing

education as and

rmati aws in the

Boston ar istance of the

Patent Of mments are

submitted

necessaril or any client.

Memoran nt Examination

Policy, 201 ms Reciting or

Involving L /or Natural

Products ( w/exam/myriad

mayo_guid

THE BOSTON PATENT LAW AS

www.bpl

Guidance for Determi

atter Eligibility of Claims Reciting or Involving

in respon

, 2014)

The Boston Patent Law Association (“BPLA”) th

States Patent and Trademark Office (“USPTO”) for the o

ance for the examination

concerning laws of nature, natural phenomena, and natur

BPLA is an association of intellectual property professio

educational programs and a forum for the exchange of id

rmation concerning patent, trademark, and copyright

Boston area. These comments were prepared with the as

Patent Office Practice Committee of the BPLA. These c

submitted by the BPLA solely as its consensus view. Th

necessarily the views of any individual member, any firm

Memorandum from Andrew H. Hirschfeld, Deputy Comm’r for Pat

Policy, 2014 Procedure for Subject Matter Eligibility Analysis of Cla

Involving Laws of Nature/Natural Principles, Natural Phenomena, an

http://www.uspto.gov/patents/l

PRESIDENT

Donna M. Meuth Eisai Inc. 4 Corporate Drive Andover, MA 01810-2441 Phone: (978) 837-4862 E-mail: [email protected]

PRESIDENT - ELECT Gregory J. Sieczkiewicz , Ph.D. Assuerus Strategic Consulting, LLC Phone: (617) 407-6915 E-mail: [email protected]

VICE PRESIDENT Erik Paul Belt McCarter & English, LLP 265 Franklin Street Boston, MA 02110 Phone: (617) 449-6506 Email: [email protected]

TREASURER Monica Grewal Wilmer Cutler Pickering Hale & Dorr, LLP 60 State Street Boston, MA 02109 Phone: (617) 526-6223 E-mail: [email protected]

SECRETARY Rory P. Pheiffer Nutter McClennen & Fish LLP Seaport West 155 Seaport Boulevard Boston, MA 02210-2604 Phone: (617) 439-2879 E-mail: [email protected]

BOARD OF GOVERNORS Joseph M. Maraia Burns & Levinson LLP 125 Summer Street Boston, MA 02110-1624 Phone: (617) 345-3241 E-mail: [email protected]

Deirdre E. Sanders Hamilton, Brook, Smith & Reynolds, P.C. 530 Virginia Road P.O. Box 9133 Concord, MA 01742-9133 Phone: (978) 341-0036 E-mail: [email protected]

Michael Bergman Bergman and Song LLP P.O. Box 400198 Cambridge, MA 02140-0002 Phone: (617) 625-8870 E-mail: [email protected]

Daniel W. Young Wolf, Greenfield & Sacks, P.C. 600 Atlantic Avenue Boston, MA 02210-2206 Phone: (617) 646-8245 E-mail: [email protected]

THHE BOSTON PATENT LAW ASSSOCIATION

July 28, 20014

Via E-Maiil: [email protected]

Raul Tama ayo, Senior Legal Advisor

Office of P Patent Legal Administration

United Sta ates Patent and Trademark Office

P.O. Box 11450

Alexandriaa, VA 22313-1450

Re: Co omments on Examination Guidance for Determin ning Subject

Maatter Eligibility of Claims Reciting or Involving Laws of Nature,

Na atural Phenomena & Natural Products, in respon se to request for

com mments at 79 Fed. Reg. 21736 (April 17, 2014) and 79 Fed.

Reeg. 36786 (June 30, 2014)

Dear Sir:

Th he Boston Patent Law Association (“BPLA”) tha anks the United

States Pate ent and Trademark Office (“USPTO”) for the op pportunity to

comment o on the USPTO’s Guidance for the examination o of patent claims

concerning g laws of nature, natural phenomena, and natura al products.1 The

BPLA is a an association of intellectual property profession nals, providing

educationa al programs and a forum for the exchange of ide eas and

informatio on concerning patent, trademark, and copyright l laws in the

Boston are ea. These comments were prepared with the ass sistance of the

Patent Off fice Practice Committee of the BPLA. These coomments are

submitted by the BPLA solely as its consensus view. The ey are not

necessarilyy the views of any individual member, any firm,, or any client.

1

Memorand dum from Andrew H. Hirschfeld, Deputy Comm’r for Pate ent Examination

Policy, 2014 4 Procedure for Subject Matter Eligibility Analysis of Claiims Reciting or

Involving La aws of Nature/Natural Principles, Natural Phenomena, andd/or Natural

Products (M Mar. 4, 2014), available at http://www.uspto.gov/patents/la aw/exam/myriad

mayo_guida ance.pdf (the “Guidance”).

One Batterymarch Park Suite 1 101 Quincy, MA 02169 Ph. 617-507-5570 www.bpla a.org


uite 101

’s efforts to further improve the examination of claims

l phenomena, and natural products

matter decisions. We offer the comments below in an attempt

rts.

ERLY RESTRICTIVE OF

to offer clarity in light of recent changes to the scope of

s to overreach in several key ways. First, the Guidance goes

preme Court case law, sweeping too many t

ularly those that merely “involve” natural products. Second,

ests that

atent el

tivity in important fields, and appears to contravene

to certain classes of natural products.

de Products Under the Guidanc

preme Court Case Law

road to the extent that it pulls claims

ding, for example, those directed to derivatives of natural

nt using natural products, have not been the subject of the

le subject matter decisions. Accordingly, there is no reason for

differently in light of

, shortcoming of the Guidance stems from the scope of its

the claim recite

holdings, ho

shadows that render claims that merely

rotection.

xplained that §

against “read[ing] into the patent laws limitations and

as not expressed.”

3, 308 (1980).

Condenser Corp.

Ct. 1289, 1305 (2012) (“[W]e must hesitate before departing from

protective rule that seems to suit the needs of on

T OCIATION

.bpla.org

We appreciate the USPT f claims

concerning laws of nature, natur of the Supreme

Court’s recent patentable subjec in an attempt

to assist the USPTO in these eff

IS O SUBJECT

The Guidance, in strivin scope of

patentable subject matter, appea uidance goes

further than required by recent S s of claims into

101 analysis, parti cts. Second,

sug different from

products found in nature are not ntial to

unnecessarily hinder inventive a vene

congressional intent with respec

M Test Is

Inconsistent with S

The Guidance is overly atural products

into its scope. Such claims, incl of natural

s and methods of treatm ject of the

Supreme Court’s recent patenta is no reason for

the USPTO to treat these claims id before these

A fundamental, and costl scope of its

Does exceptions?

Nothing in the Supreme Court’s l exceptions to

patentable subject matter cast an

exceptions ineligible for patent

The Supreme Court has ave a “wide

It has further cautione ns and

conditions which the legislature xceptions to

, 447 U.S. 3

United States v. Dubilier yo Collaborative

, 132 rting from

established general legal rules lest a ne produce unforeseen


ww

We appreciate the USPTO’s efforts to further improve the examination

in the wake

Court’s recent patentable subject matter decisions. We offer the comments belo

PATENTABL

The Guidance, in striving to offer clarity in light of recent changes to the

patentable subject matter, appears to overreach in several key ways. First, the

yp

101 analysis, particularly those that merely “involve” natural prod

that are functionall

. Third, the Guidance has the pot

unnecessarily hinder inventive activity in important fields, and appears to contr

e’s Multipar

into its scope. Such claims, including, for example, those directed to derivative

s and methods of treatment using natural products, have not been the su

Supreme Court’s recent patentable subject matter decisions. Accordingly, there

n it

A fundamental, and costly, shortcoming of the Guidance stems from the

one or more judicial

wever, suggests that the few judici

involv

d does,

It has further cautioned against “read[ing] into the patent laws limitati

Accordingly, the judicial

M

, 132 S. Ct. 1289, 1305 (2012) (“[W]e must hesitate before dep

e field


We appreciate the USPTO O’s efforts to further improve the examination o of claims

concerning laws of nature, natura al phenomena, and natural products in the wake of the Supreme

Court’s recent patentable subject t matter decisions. We offer the comments beloww in an attempt

to assist the USPTO in these effoorts.

I. THE GUIDANCE IS OVVERLY RESTRICTIVE OF PATENTABLE E SUBJECT

MATTER

The Guidance, in striving g to offer clarity in light of recent changes to the scope of

patentable subject matter, appear rs to overreach in several key ways. First, the G Guidance goes

further than required by recent Suupreme Court case law, sweeping too many type es of claims into

the detailed § 101 analysis, partic cularly those that merely “involve” natural produucts. Second,

the Guidance unnecessarily sugg gests that claims to products that are functionally y different from

products found in nature are not ppatent eligible. Third, the Guidance has the poteential to

unnecessarily hinder inventive ac ctivity in important fields, and appears to contra avene

congressional intent with respect t to certain classes of natural products.

A. Examining Man-Ma ade Products Under the Guidance’s Multipartt Test Is

Inconsistent with Su upreme Court Case Law

The Guidance is overly b broad to the extent that it pulls claims involving nnatural products

into its scope. Such claims, inclu uding, for example, those directed to derivatives s of natural

products and methods of treatme ent using natural products, have not been the sub bject of the

Supreme Court’s recent patentab ble subject matter decisions. Accordingly, there is no reason for

the USPTO to treat these claims differently in light of Mayo and Myriad than it d did before these

decisions.

A fundamental, and costlyy, shortcoming of the Guidance stems from the scope of its

“Question 2,” which asks “Does the claim recite or involve one or more judicial exceptions?”2

Nothing in the Supreme Court’s holdings, however, suggests that the few judicia al exceptions to

patentable subject matter cast anyy shadows that render claims that merely involvee these judicial

exceptions ineligible for patent p protection.

The Supreme Court has e explained that § 101 was intended to, and does, h have a “wide

scope.”3 It has further cautioned d against “read[ing] into the patent laws limitatio ons and

conditions which the legislature hhas not expressed.”4 Accordingly, the judicial e exceptions to

2 Guidance at 3.

3Diamond v. Chakrabarty, 447 U.S. 30 03, 308 (1980).

4Id. (quoting United States v. Dubilier Condenser Corp., 289 U.S. 178, 199 (1933)); see also Ma ayo Collaborative

Servs. v. Prometheus Labs., Inc., 132 SS.. Ct. 1289, 1305 (2012) (“[W]e must hesitate before depa arting from

established general legal rules lest a new w protective rule that seems to suit the needs of one field produce unforeseen

results in another.”).

One Batterymarch Park SSuite 101 Quincy, MA 02169 Ph. 617-507-5570 wwww.bpla.org


uite 101

broad an interp

able subject matter decisions have illustrated the narrow scope

lved claims to two types of products: naturally occurring,

segments are not eligible for patent protection under §

o meet the statute’s eligibility requirements.

analysis looking only at whether cDNA occurs in nature:

esent the same obstacles to patentability as

g, isolated DNA segments. As already explained,

A se

ot naturally occurring. . . . cDNA retains the

g exons of DNA, but it is distinct from the DNA

derived. As a result, cDNA is not a “product of

nt eligible under §

s not itself a natural product, the Court did not resort to a

stances analysis. Rather, it found the man

d

s not at issue in these cases. In explaining that it was

plicated by this decision

applications of knowledge about the covered genes were

[h]

CA1 and BRCA2 genes,

d Judge Bryson’s conclusion, the Federal Circuit opinion, that

patent protection under §

s of knowledge about the covered genes

t assumed that such claims were patent eligible without any h

ce Corp. Pty. Ltd. v. CLS Bank Int’l

ing this exclusionary principle lest it swallow all

iad Genetics, Inc.

T OCIATION

.bpla.org

oo ciple could

The Court’s recent paten e narrow scope

inv occurring,

ated DNA segments and ma ncluded that

naturally occurring, isolated DN under §

concluded that cDNA segments reached this

conclusion with a straightforwar in nature:

cDNA does not p

naturally occurri ,

creation of a cD y

molecule that is

naturally occurri

from which it wa

t

Having concluded that cDNA w esort to a

of the circu e origin of

Myri ld not be read to

apply to other categories of clai it was

i inted out that no

method claims nor patents on ne enes were

before it. The Court noted that anipulating

genes while searching for the B sought a method

Similarly, it commend it opinion, that

application ly accepting that

igible for ims involving

the covered genes and applicatio e

Cou without any h

of a deeper, multifactor analysis

Al L 2765283, at *5

(2014) (“[W]e tread carefully in constr t law.”).

Ass’n for Molecular Pathology v. My


ww

retation of this exclusionary pri

The Court’s recent patentable subject matter decisions have illustrated t

involved claims to two types of products: naturally

Although the Court c

naturally occurring, isolated DNA segments are not eligible for patent protectio

I

conclusion with a straightforward analysis looking only at whether cDNA occur

naturally occurring, isolated DNA segments. As already explaine

on

naturally occurring exons of DNA, but it is distinct from the DN

from which it was derived. As a result, cDNA is not a “product o

Having concluded that cDNA was not itself a natural product, the Court did not

ma

emphasized that their holdings sho

apply to other categories of claims not at issue in these cases. In explaining that

urt p

method claims nor patents on new applications of knowledge about the covered

ad Myriad created an innovative method of

it could possibly hav

Similarly, it commended Judge Bryson’s conclusion, the Federal Circ

of knowledge about the covered genes, implici

101. Both method cl

invol

Court assumed that such claims were patent eligible

, 573 U.S. __, 2014

of pate


patentability are narrow. “[T]oo broad an interpretation of this exclusionary prin nciple could

eviscerate patent law.”5

The Court’s recent patent table subject matter decisions have illustrated th he narrow scope

of these exceptions. Myriad invo olved claims to two types of products: naturally occurring,

isolated DNA segments and man n-made cDNA segments.6 Although the Court cooncluded that

naturally occurring, isolated DNAA segments are not eligible for patent protection n under § 101, it

concluded that cDNA segments d do meet the statute’s eligibility requirements. It t reached this

conclusion with a straightforwardd analysis looking only at whether cDNA occurss in nature:

cDNA does not pr resent the same obstacles to patentability as

naturally occurrin ng, isolated DNA segments. As already explainedd,

creation of a cDN NA sequence from mRNA results in an exons-only l

molecule that is n not naturally occurring. . . . cDNA retains the

naturally occurrin ng exons of DNA, but it is distinct from the DNA A

from which it was s derived. As a result, cDNA is not a “product off

nature” and is pateent eligible under § 101 . . . .7

Having concluded that cDNA wa as not itself a natural product, the Court did not rresort to a

multifactor, totality of the circum mstances analysis. Rather, it found the man-mad de origin of

cDNA dispositive on its own.

Significantly, both Myria ad and Mayo emphasized that their holdings shou uld not be read to

apply to other categories of claim ms not at issue in these cases. In explaining that it was

“important to note what is not im mplicated by this decision,”8 the Myriad Court po ointed out that no

method claims nor patents on new w applications of knowledge about the covered genes were g

before it. The Court noted that “ “[h]ad Myriad created an innovative method of m manipulating

genes while searching for the BR RCA1 and BRCA2 genes, it could possibly have e sought a method

patent.”9 Similarly, it commende ed Judge Bryson’s conclusion, the Federal Circu uit opinion, that

Myriad could claim applications s of knowledge about the covered genes, implicittly accepting that

such applications are eligible for patent protection under § 101. Both method cla aims involving

the covered genes and applicationns of knowledge about the covered genes involv ve a judicial

exception. Yet, the Myriad Cour rt assumed that such claims were patent eligible without any hint

of a deeper, multifactor analysis..

5

Mayo, 132 S. Ct. at 1293; see also Ali ice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. __, 2014 W WL 2765283, at *5

(2014) (“[W]e tread carefully in constru uing this exclusionary principle lest it swallow all of paten nt law.”).

6Ass’n for Molecular Pathology v. Myr riad Genetics, Inc., 133 S. Ct. 2107, 2112-14 (2013)

7Id. at 2119.

8Id.

9Id.



uite 101

nships between the concentration in the blood of certain

e

claims to methods instructing physicians to

ished two types of claims that

new way of using an existing drug

not claim the natural law; it did not say that a patent applicant

involve the natural law, and

ry to evaluate patent eligibility.

st recent patentable subject matter opinion,

only a subset of claims should be subject to

ntive concept” analysis,

e whether the claims at issue are

ligible concepts

bstract ideas

ms

nts of each claim both

on” to determine whether the additional

m the nature of the claim” into a patent

nation instructions in view of

opinion,

eption,

ves an abstract concept

claims that in any way

nt” test, the Guidance imposes a requirement that goes beyond,

Court holdings. By including broad “or involve” languag

y regarding the claims “as a whole” until Step 3 of its analysis,

s that plainly are not directed to natural products or natural laws

clear example of

(quoting

irschfeld, Deputy Comm’r for Patent Examination Policy, Preliminary

Supreme Court Decision in

ailable at

T OCIATION

.bpla.org

May in that case were

natural laws describing the relati of certain

thiopurine metabolites and the li r induce harmful

In finding ineligibl ply

law, the Court explicitly disting ral law: cl

holding was

simply that a patent applicant ca atent applicant

cannot seek claims that someho if they did so, a

multifactor test would be necess

The Supreme Court’s m e Corp. v. CLS

, supports tha yo

“significantly different” or “inv patent

, we determi e

in

phenomena, and se

is there in the cla

consider the elem

ordered combinat

elements “transfo

The USPTO’s preliminary exam knowledge this

in the Supreme Court’ whether the

is directed to a judicial ex endered

ineligible simply because it invo

hannelin and natural

laws into its “significantly differ at goes beyond,

and contravenes, these Supreme ” languag

Step 2, and postponing the inqui of its analysis,

the Guidance sweeps many clai s or natural laws

into its costly multifactor test. ance relating to

, 2014 WL 2765283, at *

Andrew H. , Preliminary

Examination Instructions in View of th v. CLS Bank

a ec_25jun2014.pdf .


ww

. The underlying judicial exceptions addressed

natural laws describing the relationships between the concentration in the blood

drug dosage will be ineffective

a

the nat

’s

simply that a patent applicant cannot claim the natural law; it did not say that a

it did not say that

Ali

M

a

o

, we then ask, “[w]hat e

To answer that question, we

eligibl

appear to a

etermine

that “an invention is not

natural product

laws into its “significantly different” test, the Guidance imposes a requirement t

and contravenes, these Supreme Court holdings. By including broad “or involv

Step 2, and postponing the inquiry regarding the claims “as a whole” until Step

the Guidance sweeps many claims that plainly are not directed to natural produc

this is Example C of the Gui

Andrew H. Hirschfeld, Deputy Comm’r for Patent Examination Polic

Alice Corporation Pty. Ltd.

v/patents/announce/alice_


The same is true of Mayo o. The underlying judicial exceptions addressed in that case were

natural laws describing the relatioonships between the concentration in the blood of certain

thiopurine metabolites and the likkelihood that a drug dosage will be ineffective o or induce harmful

side-effects. In finding ineligible e claims to methods instructing physicians to ap pply the natural

law, the Court explicitly distingu uished two types of claims that involved the natu ural law: claims

to a “new drug” and claims to “aa new way of using an existing drug.”10

Mayo’s holding was

simply that a patent applicant can nnot claim the natural law; it did not say that a p patent applicant

cannot seek claims that somehow w involve the natural law, and it did not say that, , if they did so, a

multifactor test would be necessa ary to evaluate patent eligibility.

The Supreme Court’s mo ost recent patentable subject matter opinion, Alic ce Corp. v. CLS

Bank International, supports that t only a subset of claims should be subject to Ma ayo’s

“significantly different” or “inve entive concept” analysis, i.e., those directed to a patent-ineligible

concept:

First, we determin ne whether the claims at issue are directed to on ne

of those patent-ineeligible concepts [laws of nature, natural

phenomena, and a abstract ideas]. . . . If so, we then ask, “[w]hat el lse

is there in the clai ims before us?” . . . To answer that question, we

consider the elemeents of each claim both individually and “as an

ordered combinatiion” to determine whether the additional

elements “transforrm the nature of the claim” into a patent-eligible e

application.11

The USPTO’s preliminary examiination instructions in view of Alice appear to ac cknowledge this

language in the Supreme Court’s s opinion,12

instructing examiners to “determine whether the

claim is directed to a judicial exc ception,”13

and stating that “an invention is not r rendered

ineligible simply because it invollves an abstract concept.”14

In contrast, by channeling g claims that in any way involve natural productss and natural

laws into its “significantly differeent” test, the Guidance imposes a requirement thhat goes beyond,

and contravenes, these Supreme Court holdings. By including broad “or involve e” language in

Step 2, and postponing the inquir ry regarding the claims “as a whole” until Step 3 3 of its analysis,

the Guidance sweeps many claim ms that plainly are not directed to natural productts or natural laws

into its costly multifactor test. AA clear example of this is Example C of the Guid dance relating to

10

Mayo, 132 S. Ct. at 1302.

11Alice Corp., 2014 WL 2765283, at *6 6 (quoting Mayo) (emphasis added).

12See Memorandum from Andrew H. H Hirschfeld, Deputy Comm’r for Patent Examination Policyy, Preliminary

Examination Instructions in View of thee Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank

International, et al. (June 25, 2014), av vailable at http://www.uspto.gov/patents/announce/alice_p pec_25jun2014.pdf .

13Id. at 2.

14Id.



uite 101

al

ork composition. Neither

suggests any reason why such a claim should be subject to

ipart test to determine whether it constitutes patentable subject

he elements calcium chloride and gunpowder. The existence of

use housing multiple components of the firework composition

hould make clear, without applying a special test or weighing

atter is not a product of nature

factor test set forth in the Guidance.

are illustrative: derivatives of natural products and method of

ce discusses three c

roduct compound; (2) a claim to “purified 5

e derivative of a natural product compound; and (3) a method

pecific dose of amazonic acid at a specified frequency and for a

idance analyzes each of these three claims under the

cluding that the first claim recites a judicial exception and that

ve a judicial exception. Yet, subjecting these latter two claims

t is unnecessary and inconsistent with the Supreme Court’s

ites a man

recite) a judicial exception, i.e., amazonic acid is a naturally

eaves of Amazonian cherry trees

ted to patentable subject matter under the “significantly

structural and functional differences from naturally occurring

e Court’s case law, however, these conclusions were

question. 5

product] from which it was derived.”

analogous to the cDNA that the Supreme

Subjecting derivatives of natural products to the 12

erefore unnecessary and wasteful, at best (

irectly co

hich recites a specific method of treatment using amazonic acid,

n, the Guidance concludes that this claim “

naturally occurring chemical

ntable subject matter, but it does so under the “significantly

ssing cDNA).

T OCIATION

.bpla.org

a claimed firework including a d nition fuse

component fire vides guidance

lone subject to

heightened scrutiny under a mul entable subject

matter simply because it recites he existence of

the cardboard body with plastic k composition

arranged in a particular manner t or weighing

factors, that the claimed subject unnecessary to

sweep such claims into the mult

Two other types of cases nd method of

Example B of the Guida d amazonic

acid,” which contains a natural thyl amazonic

ma (3) a method

a uency and for a

specified period of time. The G r the

“significantly different” test, co eption and that

the second and third claims invo tter two claims

to the “significantly different” te eme Court’s

Claim 2 of Example B re . The Guidance

recites (or ma is a naturally

occurring chemical found in the s to conclude

is dire ficantly

different” test because it has bot rally occurring

amazonic acid. Under the Supre s were

101 ally occurring”

and “is distinct from the [natural all other

derivatives of natural products, i t summarily

. 12

“significantly different” test is t f the examiner

ultimately allows the claim), or xaminer rejects

Claim 3 of Example B, g amazonic acid,

presents a similar problem. Aga es a judicial

, amazonic acid is s to correctly

conclude that this claim is to pat significantly

, 133 S. Ct. at 2119 (disc


ww

compartment cardboard body with plastic i

pr

lone suggests any reason why such a claim should b

heightened scrutiny under a multipart test to determine whether it constitutes pa

matter simply because it recites the elements calcium chloride and gunpowder.

the cardboard body with plastic fuse housing multiple components of the firewo

arranged in a particular manner should make clear, without applying a special te

. It is costly an

Two other types of cases are illustrative: derivatives of natural products

laims: (1) a claim to “purifi

m

made derivative of a natural product compound; an

a specific dose of amazonic acid at a specified fre

specified period of time. The Guidance analyzes each of these three claims und

“significantly different” test, concluding that the first claim recites a judicial ex

the second and third claims involve a judicial exception. Yet, subjecting these l

to the “significantly different” test is unnecessary and inconsistent with the Sup

of a natural produc

recites (or may recite) a judicial exception, i.e., amazonic acid

,” then procee

is directed to patentable subject matter under the “sign

different” test because it has both structural and functional differences from nat

amazonic acid. Under the Supreme Court’s case law, however, these conclusio

methyl amazonic acid “is not natu

It, like

Cou

. Subjecting derivatives of natural products to th

,

, if the

Claim 3 of Example B, which recites a specific method of treatment usi

reci

.” It then procee

conclude that this claim is to patentable subject matter, but it does so under the


a claimed firework including a duual-compartment cardboard body with plastic ig gnition fuse

housing a multi-component firew work composition. Neither Myriad nor Mayo proovides guidance

regarding such a claim, let alone suggests any reason why such a claim should bee subject to

heightened scrutiny under a mult tipart test to determine whether it constitutes pat tentable subject

matter simply because it recites t the elements calcium chloride and gunpowder. TThe existence of

the cardboard body with plastic f fuse housing multiple components of the firewor rk composition

arranged in a particular manner s should make clear, without applying a special tesst or weighing

factors, that the claimed subject m matter is not a product of nature. It is costly and d unnecessary to

sweep such claims into the multi ifactor test set forth in the Guidance.

Two other types of cases are illustrative: derivatives of natural products a and method of

treatment claims.

Example B of the Guidan nce discusses three claims: (1) a claim to “purifie ed amazonic

acid,” which contains a natural p product compound; (2) a claim to “purified 5-me ethyl amazonic

acid,” which contains a man-mad de derivative of a natural product compound; andd (3) a method

of treating colon cancer using a s specific dose of amazonic acid at a specified freq quency and for a

specified period of time. The Gu uidance analyzes each of these three claims unde er the

“significantly different” test, con ncluding that the first claim recites a judicial exc ception and that

the second and third claims invollve a judicial exception. Yet, subjecting these la atter two claims

to the “significantly different” tesst is unnecessary and inconsistent with the Supr reme Court’s

holdings.

Claim 2 of Example B reccites a man-made derivative of a natural productt. The Guidance

concludes that it “recites (or may y recite) a judicial exception, i.e., amazonic acid is a naturally

occurring chemical found in the lleaves of Amazonian cherry trees,” then proceed ds to conclude

(correctly) that the claim is direc cted to patentable subject matter under the “signi ificantly

different” test because it has both h structural and functional differences from natu urally occurring

amazonic acid. Under the Supremme Court’s case law, however, these conclusionns were

unnecessary to resolve the § 101 question. 5-methyl amazonic acid “is not naturrally occurring”

and “is distinct from the [natural product] from which it was derived.”15

It, like all other

derivatives of natural products, is s analogous to the cDNA that the Supreme Courrt summarily

found patent eligible in Myriad. Subjecting derivatives of natural products to the e 12-factor

“significantly different” test is th herefore unnecessary and wasteful, at best (i.e., i if the examiner

ultimately allows the claim), or d directly contrary to Myriad, at worst (i.e., if the e examiner rejects

the claim).

Claim 3 of Example B, w which recites a specific method of treatment usin ng amazonic acid,

presents a similar problem. Agaiin, the Guidance concludes that this claim “recit tes a judicial

exception, i.e., amazonic acid is aa naturally occurring chemical.” It then proceed ds to correctly

conclude that this claim is to pateentable subject matter, but it does so under the “ “significantly

15

Cf. Myriad, 133 S. Ct. at 2119 (discu ussing cDNA).



uite 101

ncludes that because the claim

r length of time

onventional to use amazonic acid (either isolated or in leaf

claim is patent eligible under §

analysis for this or many other method of treatment claims.

ims using a natural product from claims to the natural product

ims do not present the same §

tail of the claim may improperly suggest to Examiners that

ining fewer limitations regardin

lso suggests, without expressly saying, that claim 3 of Example

hat amazonic acid exhibiting efficacy against colon cancer is a

imately concludes that this does not place claim 3 outside the

analysis that led the Guidance to this conclusion was

methods of using a drug that acted according to a natura

tural law itself. Accordingly, the method of treatment claim in

er §

ifferent” analysis.

ible under §

ly illustrative of how the Guidance’s overly inclusive Step 2

y meet §

igorous and costly “significantly different” analysis.

es Between a Claimed Composition and a Natural Product

dance suggests that claimed pr

natural products are not patentable subject matter, this result

t or other case law. The USPTO’s position in the Guidance

ference between a claimed product and a natural product is not,

claimed product patent eligible under §

matter. Functional differences between claimed compositions

pecific method claims in its hypothetical (

the methods “‘were well understood, widely used, and fairly uniform

earch for a gene would likely have utilized a similar approach,’”

02 F. Supp.

r §

visor, Office of Patent Legal Admin,

nder 35 USC §

T OCIATION

.bpla.org

different” test. The Guidance c lar dosage of

for a particul because “[i]

known, routine or d or in leaf

” the nce, however,

does not need to go through this ent claims.

distinguished method cl atural product

itself, suggesting that method cl

of the analysis and the level of d miners that

method of treatment claims cont imen would not

Similarly, the Guidance m 3 of Example

, lon cancer is a

The Guidance ul 3 outside the

scope of § 101. Yet, the lengthy was

distinguishe o a natura

from a method of applying the n atment claim in

Example B is patent eligible un ers to subject it

to the multifactor “significantly w provides no

reason to find such a claim ineli

These examples are mer usive Step 2

results in many claims that clear reme Court

case law, being subjected to the ysis.

Functional Differen tural Product

To the extent that the Gu ly functionally,

but not structurally, different fro tter, this result

is not required by Supreme Cou e Guidance

l di l product is not,

on its own, sufficient to make th

goes beyond the requirements of law in

icting patent eligible subjec compositions

concludes that the ethods of isolating

vailable becaus airly uniform

insofar as any scientist engaged in the oach,’”

20 (quoting the district court opinion, opinion does not

suggest that this presents a barrier und

, Raul Tamayo, Sr. Legal A mark Office,

Evaluating Subject Matter Eligibility ss’n, at 26 (June 11,


ww

partic

,” and

known, routine or conventional to use amazonic acid (either isolat

101. The Guid

does not need to go through this analysis for this or many other method of treat

distinguished method claims using a natural product from claims to the

of the analysis and the level of detail of the claim may improperly suggest to Ex

g the dosing re

Similarly, the Guidance also suggests, without expressly saying, that cla

, that amazonic acid exhibiting efficacy against c

The Guidance ultimately concludes that this does not place clai

scope of § 101. Yet, the lengthy analysis that led the Guidance to this conclusio

distinguished methods of using a drug that acted according

from a method of applying the natural law itself. Accordingly, the method of tr

101 on its face; there is no need for exami

The Supreme Court’s case l

These examples are merely illustrative of how the Guidance’s overly inc

g Su

case law, being subjected to the rigorous and costly “significantly different” ana

Functional Differences Between a Claimed Composition and a N

oducts that are o

but not structurally, different from natural products are not patentable subject m

is not required by Supreme Court or other case law. The USPTO’s position in t

l difference between a claimed product and a natur

and other patentable subject matter cas

icting patent eligible subject matter. Functional differences between claime

, claims to

vailable because the methods “‘were well understood, widely used, and

insofar as any scientist engaged in the search for a gene would likely have utilized a similar app

03), suggesting prior art issues, th

Trad

101, Presentation to Boston Patent Law


different” test. The Guidance co oncludes that because the claim recites a “particu ular dosage of

amazonic acid . . . for a particula ar length of time . . . to a particular patient,” and because “[i]t

was not well-known, routine or c conventional to use amazonic acid (either isolateed or in leaf

form) to treat colon cancer,” the claim is patent eligible under § 101. The Guidaance, however,

does not need to go through this analysis for this or many other method of treatm ment claims.

Myriad distinguished method cla aims using a natural product from claims to the n natural product

itself, suggesting that method cla aims do not present the same § 101 problems.16

Indeed, the rigor

of the analysis and the level of de etail of the claim may improperly suggest to Exa aminers that

method of treatment claims conta aining fewer limitations regarding the dosing reg gimen would not

be patent eligible.

Similarly, the Guidance a also suggests, without expressly saying, that clai im 3 of Example

B involves a law of nature (i.e., t that amazonic acid exhibiting efficacy against co olon cancer is a

law of nature). The Guidance ulttimately concludes that this does not place claimm 3 outside the

scope of § 101. Yet, the lengthy analysis that led the Guidance to this conclusionn was

unnecessary. Mayo distinguishedd methods of using a drug that acted according t to a natural law

from a method of applying the na atural law itself. Accordingly, the method of tre eatment claim in

Example B is patent eligible und der § 101 on its face; there is no need for examin ners to subject it

to the multifactor “significantly d different” analysis. The Supreme Court’s case laaw provides no

reason to find such a claim inelig gible under § 101.

These examples are mere ely illustrative of how the Guidance’s overly incllusive Step 2

results in many claims that clearl ly meet § 101’s requirements, under existing Suppreme Court

case law, being subjected to the r rigorous and costly “significantly different” anallysis.

B. Functional Differenc ces Between a Claimed Composition and a Na atural Product

May Satisfy § 101

To the extent that the Guiidance suggests that claimed products that are onnly functionally,

but not structurally, different from m natural products are not patentable subject ma atter, this result

is not required by Supreme Cour rt or other case law. The USPTO’s position in th he Guidance

appears to be that a functional diffference between a claimed product and a natura al product is not,

on its own, sufficient to make the e claimed product patent eligible under § 101.17

This reading

goes beyond the requirements of Myriad and other patentable subject matter case e law in

restricting patent eligible subjectt matter. Functional differences between claimedd compositions

16

Although Myriad concludes that the s specific method claims in its hypothetical (i.e., claims to m methods of isolating

DNA) were likely not available because e the methods “‘were well understood, widely used, and f fairly uniform

insofar as any scientist engaged in the s search for a gene would likely have utilized a similar appr roach,’” id. at 2119

20 (quoting the district court opinion, 7 702 F. Supp. 2d at 202-03), suggesting prior art issues, the e opinion does not

suggest that this presents a barrier unde er § 101.

17See, e.g., Raul Tamayo, Sr. Legal Ad dvisor, Office of Patent Legal Admin, U.S. Patent & Trade emark Office,

Evaluating Subject Matter Eligibility U Under 35 USC § 101, Presentation to Boston Patent Law A Ass’n, at 26 (June 11,

2014).



uite 101

een held sufficient to support patentability, and nothing in the

s has changed that.

d that a functional difference is insufficient to support

itted in

ck of a structural difference.

. The Court stated that the claims were “not expressed in terms

ther “focus[ed] on the genetic information” in the claimed

y

een the isolated genes and the natural genes. Put differently,

atter how pure or concentrated its medium is. By construing the

Court im

them. Furthermore, in explaining why the

er §

t ‘capacity for degrading oil

ces between the

e in rendering a claimed invention patent eligible under §

nctional differences can impart patent eligibility without so

urts have long found functional diff

ficient to meet

concluded

the first to make it available for any use by

the other gland

e possible logically to call this a purification of

came for every practical

therapeutically

ional, not

Its Own Amount To A Marked Difference? Our interpretation of

. Briefs submitted to the Supreme Court argued that the isolated DNA of

ns and new utilities that native DNA cannot perform. Arguments did not

hinged on a markedly different structural change.”).

7 U.S. at 305 n.1).

o.

T OCIATION

.bpla.org

and natural products have long nothing in the

Supreme Court’s recent decisio

contend upport

patentability because briefs sub rt ignored it

and rested its reasoning on the l eads too much

into the Supreme Court’s silenc ressed in terms

of chemical composition,” but r e claimed

Characterized in this w ound

functional difference existed bet ut differently,

information is information, no y construing the

claims in this manner, th ifferences and

therefore did not need to addres krabarty

bacterium was patent eligible un “

d resulta e to

structural and functional differe ural bacteria

suggests that both may play a ro e under §

There is also little reason ished and much

cited case law recognizing that f y without so

much as a passing reference. C een a claimed

product and a natural product su ple, in

Davis & Co. v. H.K. Mulford C e context of a

claim to purified adrenaline. He

[the inventor] wa

removing it from ,

while it is of cour

it b

commercially an

thus discusses func laimed subject

(“Can A Functional Difference O etation of

to conclude that the answer is n solated DNA of

’s claims performed new functi guments did not

it

, 4

Davis & Co. v. H.K. Mulford mphasis added).


ww

and natural products have long been held sufficient to support patentability, and

contended that a functional difference is insufficient to

made this argument, yet the Co

This, however,

into the Supreme Court’s silence. The Court stated that the claims were “not ex

of chemical composition,” but rather “focus[ed] on the genetic information” in t

emical com

functional difference existed between the isolated genes and the natural genes.

information is information, no matter how pure or concentrated its medium is.

plicitly did away with the functional

Ch

Court noted that this was

This referen

bacterium and na

suggests that both may play a role in rendering a claimed invention patent eligib

to conclude that the Court would dismiss estab

cited case law recognizing that functional differences can impart patent eligibili

erences bet

101’s requirements. For exa

, Judge Learned Hand addressed this issue in t

tissue in which it was found, an

while it is of course possible logically to call this a purification o

. That was a good ground for

in finding the

(“Can A Functional Difference On Its Own Amount To A Marked Difference? Our interp

to conclude that the answer is no. Briefs submitted to the Supreme Court argued that the

’s claims performed new functions and new utilities that native DNA cannot perform. A

04 (C.C.S.D.N.Y. 1911) (Hand, J.) (e


and natural products have long b been held sufficient to support patentability, and nothing in the

Supreme Court’s recent decision ns has changed that.

The USPTO has contende ed that a functional difference is insufficient to s support

patentability because briefs subm mitted in Myriad made this argument, yet the Couurt ignored it

and rested its reasoning on the la ack of a structural difference.18

This, however, r reads too much

into the Supreme Court’s silence e. The Court stated that the claims were “not exp pressed in terms

of chemical composition,” but ra ather “focus[ed] on the genetic information” in thhe claimed

genes. 19

Characterized in this wa ay—as information, rather than a chemical comppound—no

functional difference existed betw ween the isolated genes and the natural genes. P Put differently,

information is information, no m matter how pure or concentrated its medium is. B By construing the

Myriad claims in this manner, the de Court implicitly did away with the functional differences and

therefore did not need to address s them. Furthermore, in explaining why the Cha akrabarty

bacterium was patent eligible undder § 101, the Myriad Court noted that this was “due to the

additional plasmids and resultan nt ‘capacity for degrading oil.’”20

This referenc ce to both

structural and functional differen nces between the Chakrabarty bacterium and nattural bacteria

suggests that both may play a rol le in rendering a claimed invention patent eligiblle under § 101.

There is also little reason to conclude that the Court would dismiss establlished and much-

cited case law recognizing that fu unctional differences can impart patent eligibilit ty without so

much as a passing reference. Co ourts have long found functional differences betw ween a claimed

product and a natural product suf fficient to meet § 101’s requirements. For exam mple, in Parke-

Davis & Co. v. H.K. Mulford Coo.., Judge Learned Hand addressed this issue in thhe context of a

claim to purified adrenaline. He concluded that

[the inventor] was s the first to make it available for any use by

removing it from the other gland-tissue in which it was found, andd,

while it is of coursse possible logically to call this a purification of f

the principle, it be ecame for every practical purpose a new thing

commercially and d therapeutically. That was a good ground for a a 21

patent.

Parke-Davis thus discusses functtional, not structural, differences in finding the c claimed subject

matter patentable.

18

Id. (“Can A Functional Difference Onn Its Own Amount To A Marked Difference? Our interpr retation of Myriad

led us to conclude that the answer is no o. Briefs submitted to the Supreme Court argued that the i isolated DNA of

Myriad’s claims performed new functio ons and new utilities that native DNA cannot perform. Ar rguments did not

alter the Court’s decision that eligibility y hinged on a markedly different structural change.”).

19Myriad, at 2118.

20Id. at 2117 (quoting Chakrabarty, 44 47 U.S. at 305 n.1).

21Parke-Davis & Co. v. H.K. Mulford C Co., 189 F. 95, 103-04 (C.C.S.D.N.Y. 1911) (Hand, J.) (e mphasis added).



uite 101

only case to recognize that functional differences between a

duct

ourth Circuit concluded that “[t]he fact . . . that a new

cesses of extraction, concentration and purification of natural

ntability.”

rt

ity, the USPTO should not infer that decades of practice and

edent have been discarded. Accordingly, the Guidance should

ces between a claimed product and a natural product

he

rbroad Approach Will Unnecessarily Hinder In

t Fields and Conflicts with Congressional Intent

stem Should Promote Inventive Activity to the Greatest

le, Particularly in Important Fields Such as Medicine

tioned in both

r apply laws of nature, natural phenomena, or abstract ideas.”

to strike a balance between the inventions that are patentable

rving “incentives that lead to creation, invention, and

ce requires tailoring the size of each of the patent system’s

e novelty requirement of §

cription and enablement requirements of §

e doors too much threatens to upset the delicate balance that

merican innovation.

. Corp.

C.C.P.A. 1979),

abarty

28 (Fed. Cir. 2012),

nom. Ass’n for Molecular Pathology v. Myriad Genetics, Inc.

2 S. Ct. at 1293.

2 S. Ct. at 1305.

2, 960 (C.C.P.A. 1979),

v. Chakrabarty

nalogy, having the separate keys to open in succession the three doors of

T OCIATION

.bpla.org

was not the s between a

claimed product and a natural pr Co. v. Olin

, the a new

useful product is the result of pr ion of natural

materials does not defeat its pat arke

Because the Supreme Co ifference alone

is sufficient to support patentabi practice and

pre idance should

nize that functional differe oduct

sufficient, on their own, to meet Court holds

The Guidance’s Ov In

Activity in Importa ent

The Patent S he Greatest

Extent Possi edicine

As the Supreme Court ca s at some level

embody, use, reflect, rest upon, bstract ideas.”

It is the role of the patent syste re patentable

are not while pres n, and

Striking this bala t system’s

101, but also t sness

103, and the de

Blocking any of the balance that

Congress has struck to promote

. v. Olin Mathieson Che

, 596 F.2d 952, 975 n.13 akrabarty

aff’d sub nom. Diamond v. Chak ogy v. U.S. Patent

, 689 F.3d 1303, 1 (2012),

part, rev’d in part on other grounds su , Inc.

, 1

, 1

, 596 F.2d 9 nd v. Chakrabarty

aff’d sub nom. Diamon ing the ultimate

goal of a patent . . . involves, to use an e three doors of


ww

was not the only case to recognize that functional differenc

Merck

, the Fourth Circuit concluded that “[t]he fact . . . tha

useful product is the result of processes of extraction, concentration and purifica

silent on whether a functional

is sufficient to support patentability, the USPTO should not infer that decades o

precedent have been discarded. Accordingly, the G

nize that functional differences between a claimed product and a natural pr

, unless and until the Suprem

The Guidance’s Overbroad Approach Will Unnecessarily Hinde

Activity in Important Fields and Conflicts with Congressional In

The Patent System Should Promote Inventive Activity to

Extent Possible, Particularly in Important Fields Such as

, “all inventio

embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or

It is the role of the patent system to strike a balance between the inventions that

are not while preserving “incentives that lead to creation, inventi

Striking this balance requires tailoring the size of each of the pate

obvio

11

Blocking any of these doors too much threatens to upset the delicat

vacated in part sub nom. Diamond v. C

for Molecular Patho

, 133 S. Ct. 694

part, rev’d in part on other grounds sub nom. Ass’n for Molecular Pathology v. Myriad Genetic

vacated in part sub nom. Diam

, 447 U.S. 303 (1980) (Rich, J.) (“Achie

goal of a patent . . . involves, to use an analogy, having the separate keys to open in succession t


Parke-Davis was not the only case to recognize that functional difference es between a

claimed product and a natural pro oduct may confer patent eligibility. In Merck & & Co. v. Olin

Mathieson Chemical Corp., the F Fourth Circuit concluded that “[t]he fact . . . that t a new and

useful product is the result of pro ocesses of extraction, concentration and purificattion of natural

materials does not defeat its pate entability.”22

Courts have repeatedly cited both PParke-Davis and

Merck & Co. approvingly.23

Because the Supreme Couurt has remained silent on whether a functional ddifference alone

is sufficient to support patentabil lity, the USPTO should not infer that decades of f practice and

highly regarded lower court prec cedent have been discarded. Accordingly, the Guuidance should

recognize that functional differen nces between a claimed product and a natural pr oduct may be

sufficient, on their own, to meet tthe § 101 standard, unless and until the Supreme e Court holds

otherwise.

C. The Guidance’s Ove erbroad Approach Will Unnecessarily Hinder r Inventive

Activity in Importan nt Fields and Conflicts with Congressional Inttent

1. The Patent Syystem Should Promote Inventive Activity to t the Greatest

Extent Possib ble, Particularly in Important Fields Such as MMedicine

As the Supreme Court cauutioned in both Myriad and Mayo, “all invention ns at some level

embody, use, reflect, rest upon, o or apply laws of nature, natural phenomena, or a abstract ideas.”24

It is the role of the patent system m to strike a balance between the inventions that aare patentable

and those that are not while prese erving “incentives that lead to creation, inventio on, and

discovery.”25

Striking this balan nce requires tailoring the size of each of the paten nt system’s

doors—not just § 101, but also th he novelty requirement of § 102, the non-obviou usness

requirement of § 103, and the desscription and enablement requirements of § 112 2—as Congress

has done.26

Blocking any of thes se doors too much threatens to upset the delicate e balance that

Congress has struck to promote AAmerican innovation.

22

Merck & Co. v. Olin Mathieson Chem m. Corp., 253 F.2d 156, 163-64 (4th Cir. 1958).

23In re Bergy, 596 F.2d 952, 975 n.13 ( (C.C.P.A. 1979), vacated in part sub nom. Diamond v. Ch hakrabarty, 444 U.S.

1028, aff’d sub nom. Diamond v. Chakr rabarty, 447 U.S. 303 (1980); Ass’n for Molecular Pathollogy v. U.S. Patent

& Trademark Office, 689 F.3d 1303, 13 328 (Fed. Cir. 2012), cert. granted in part, 133 S. Ct. 694 (2012), aff’d in

part, rev’d in part on other grounds sub b nom. Ass’n for Molecular Pathology v. Myriad Genetics s, Inc., 133 S. Ct.

2107 (2013).

24Myriad, 133 S. Ct. at 2116; Mayo, 13 32 S. Ct. at 1293.

25Myriad, 133 S. Ct. at 2116; Mayo, 13 32 S. Ct. at 1305.

26Cf. Application of Bergy, 596 F.2d 95 52, 960 (C.C.P.A. 1979), vacated in part sub nom. Diamo ond v. Chakrabarty,

444 U.S. 1028, aff’d sub nom. Diamond d v. Chakrabarty, 447 U.S. 303 (1980) (Rich, J.) (“Achiev ving the ultimate

goal of a patent . . . involves, to use an aanalogy, having the separate keys to open in succession th he three doors of

sections 101, 102, and 103 . . . .).



uite 101

subject matter more than is required by Congress and Supreme

eatens to suppress innovation in industries that are particularly

ing to natural products and laws of nat

s are biotechnology and biopharmaceuticals. Compositions

their derivatives have historically been, and continue to be,

d as treatments for

mong many other

of continued innovation. For example, antibiotic resistance will

alth without the development of new drugs. The director of the

and Prevention (“CDC”) recently warned that “[w]

re even s

ry, which uses these molecules as tools and building blocks to

man condition.

changes to patent policy that restrict the scope of patent

nty in the patenting process threaten to slow innovation in these

he USPTO should limit patentable subject matter no

nd Supreme Court case law.

l Intent Supports Promoting Innovation, Particularly in

dance creates a higher burden for patenting biological products,

al intent. Section 287(c) of the Patent Act, which Congress

against a medical practitioner

al context

statute,

ory o

e a broad meaning, “includ[ing]

ials, including treatment using those materials, where those

ex vivo at t

tent Act also show that Congress contemplated specific types

e

ordon M. Cragg,

Products 311 (2012).

ention, Director’s Briefing: Serious Health

.gov/about/cdcdirector/

562036, at 855.

T OCIATION

.bpla.org

By restricting patentable s and Supreme

Court case law, the Guidance th re particularly

dependent upon innovations rela eir

breakthroughs. Notable exampl ompositions

comprising natural products and tinue to be,

vitally important as antibiotics a ders

, ons

these areas are in desperate need ic resistance will

uman h e director of the

U.S. Centers for Disease Contro [w]

antibiotic era wh g that, “[w]

few bacteria, we’re already ther tives lie at the

heart of the biotechnology indus ding blocks to

improve human health and the h

r overbroa of patent

protection and introduce uncerta ovation in these

industries. To avoid that result, r no

expressly required by Congress

Congression ticularly in

Biotechnolo

To the extent that the Gu ogical products,

it also conflicts with congressio h Congress

preclude actions ise

activities performed in the medi xistence of

in thi cy of granting

The legislative his rstood

“biotechnology patent[s]” to ha a process of

making or using biological mate where those

manipulate

Other provisions of the P specific types

271 biological

David J. Newman & ugs over the 30

, 75 J. Natural

Centers for Disease Control and Pre ibiotic

Germs (Sept. 16, 2013), http://www.cd

863, 1996 W


ww

By restricting patentable subject matter more than is required by Congre

Court case law, the Guidance threatens to suppress innovation in industries that

ure for t

breakthroughs. Notable examples are biotechnology and biopharmaceuticals.

comprising natural products and their derivatives have historically been, and co

diso

important medical condit

these areas are in desperate need of continued innovation. For example, antibio

uman health without the development of new drugs. T

U.S. Centers for Disease Control and Prevention (“CDC”) recently warned that

imple infections can be deadly,” noti

Similarly, natural products and their deriv

heart of the biotechnology industry, which uses these molecules as tools and bui

r overbroad changes to patent policy that restrict the scop

protection and introduce uncertainty in the patenting process threaten to slow in

industries. To avoid that result, the USPTO should limit patentable subject matt

Congressional Intent Supports Promoting Innovation, Pa

To the extent that the Guidance creates a higher burden for patenting bio

it also conflicts with congressional intent. Section 287(c) of the Patent Act, whi

other

Congress expressly recognized the

implicitly ratifying the USPTO’s pol

287(c) makes clear that Congress und

a patent on

making or using biological materials, including treatment using those materials,

Other provisions of the Patent Act also show that Congress contemplate

)(1) carves out “new animal drug or veterinar

Natural Products as Sources of New D

Threat of An


By restricting patentable subject matter more than is required by Congres ss and Supreme

Court case law, the Guidance thr reatens to suppress innovation in industries that a are particularly

dependent upon innovations relatting to natural products and laws of nature for th heir

breakthroughs. Notable example es are biotechnology and biopharmaceuticals. CCompositions

comprising natural products and their derivatives have historically been, and con ntinue to be,

vitally important as antibiotics an nd as treatments for cancer, cardiovascular disor rders, visual

disorders, and parasite diseases, aamong many other[s] important medical conditiions.27

Many of

these areas are in desperate need of continued innovation. For example, antibiot tic resistance will

pose a profound risk to human he ealth without the development of new drugs. Th he director of the

U.S. Centers for Disease Control l and Prevention (“CDC”) recently warned that “ “[w]e risk

entering a post-antibiotic era whe ere even simple infections can be deadly,” notin ng that, “[w]ith a

few bacteria, we’re already there e.”28

Similarly, natural products and their deriva atives lie at the

heart of the biotechnology indust try, which uses these molecules as tools and buillding blocks to

improve human health and the hu uman condition.

Unnecessary or overbroadd changes to patent policy that restrict the scope e of patent

protection and introduce uncertaiinty in the patenting process threaten to slow inn novation in these

industries. To avoid that result, t the USPTO should limit patentable subject matteer no more than

expressly required by Congress a and Supreme Court case law.

2. Congressiona al Intent Supports Promoting Innovation, Par rticularly in

Biotechnologygy

To the extent that the Guiidance creates a higher burden for patenting biollogical products,

it also conflicts with congression nal intent. Section 287(c) of the Patent Act, whicch Congress

passed in 1996, preclude actions against a medical practitioner for certain otherw wise-infringing

activities performed in the medic cal context. Congress expressly recognized the e existence of

“biotechnology patent[s]” in this s statute, 29

implicitly ratifying the USPTO’s poli icy of granting

such patents. The legislative histtory of § 287(c) makes clear that Congress unde erstood

“biotechnology patent[s]” to hav ve a broad meaning, “includ[ing] . . . a patent on a process of

making or using biological mater rials, including treatment using those materials, where those

materials have been manipulated d ex vivo at the cellular or molecular level.”30

Other provisions of the Paatent Act also show that Congress contemplated d specific types

of biotechnology patents. § 271((e)(1) carves out “new animal drug or veterinary y biological

27

See generally David J. Newman & G Gordon M. Cragg, Natural Products as Sources of New Drrugs over the 30

Years from 1981 to 2010, 75 J. Natural Products 311 (2012).

28Centers for Disease Control and Prev vention, Director’s Briefing: Serious Health Threat of Ant tibiotic-Resistant

Germs (Sept. 16, 2013), http://www.cdcc.gov/about/cdcdirector/

briefings.html.

29See 35 U.S.C. § 287(c)(2)(A)(iii).

30See H.R. Rep. No. 104-863, 1996 WL L 562036, at 855.



uite 101

tured using recombinant DNA, recombinant RNA, hybridoma

volving site specific genetic manipulation techniques” from the

ubject to the regulatory submission safe harbor.

use of action for infringement where a foreign manufacturer

ring a DNA molecule comprising a specific genetic sequence,”

nted protein outside the Unite

upport for biotechnology patents in responding to the USPTO’s

ith the Biotechnological Process Patents Act of 1995.

nt Act

es] of genetically altering . . . a single

es,” and methods of using products produced by suc

gain reflects a

clearly expressed congressional policy, the USPTO should go

d by the Supreme Court’s

elates to biotechnology.

TAILORED APPROACH WOULD BE CONSISTENT

D LESS BURDENSOME ON THE USPTO AND PATENT

uidance

rected to man

This approach has at least two significant adverse effects on

osecution costs and the potential for significantly increased

at the “significantly different” test will be applied in a manner

, such that the examiner has the initia

ther the claimed invention is patentable subject matter. In the

is required to “

closure

.

95); 141 Cong. Rec. S11201

“modif[y] the test for obtaining a process patent by clarifying

has since been further amended and the 1995 Act’s provisions have been

s implemented by the America Invents Act. However, nothing in the

ts Act suggests a change in cong

T OCIATION

.bpla.org

primarily manufa A, hybridoma

technology, or other processes i iques” from the

“patented invention[s]” that are

a specific c anufacturer

uses a patented “process of prep etic sequence,”

uses the DNA to make an unpat sells the protein

Congress also expressed to the USPTO’s

1995.

of the Pat iotechnological

process[es],” including “process

organism,” “cell fusion procedu suc

This amendment on biological

In light of this strong an TO should go

no farther than absolutely requir g patentable

subject matter, particularly as it

A MORE NARROWL NSISTENT

WITH CASE LAW A ND PATENT

As discussed above, the necessary in

funneling many claims clearly d he multifactor

“significantly different” analysis rse effects on

amination: increased p ly increased

The Guidance explains t ed in a manner

factor establish a

reasonable basis to question wh matter. In the

enablement context, an examine r accuracy of

any statement in a supporting di h acceptable

763 F.2d 1406, 1411 (Fed. Cir. 1985

41, 109 Stat. 351 (1 . Orrin Hatch)

(explaining that the Act was intended t fying

§ 10 isions have been

removed as part of the sweeping chang othing in the

legislative history of the America Inve biotechnology


ww

primarily manufactured using recombinant DNA, recombinant R

technology, or other processes involving site specific genetic manipulation tech

“patented invention[s]” that are subject to the regulatory submission safe harbor

a specific cause of action for infringement where a foreign

uses a patented “process of preparing a DNA molecule comprising a specific ge

d States, and then

Congress also expressed support for biotechnology patents in respondin

with the Biotechnological Process Patents Act o

the obviousness analysis of “

organism,” “cell fusion procedures,” and methods of using products produced b

patents

In light of this strong and clearly expressed congressional policy, the US

decisions in restricti

A MORE NARROWLY TAILORED APPROACH WOULD BE C

WITH CASE LAW AND LESS BURDENSOME ON THE USPTO

adopts an approach that is broader tha

made products or processes into

“significantly different” analysis. This approach has at least two significant adv

amination: increased prosecution costs and the potential for significan

The Guidance explains that the “significantly different” test will be appl

l burden t

reasonable basis to question whether the claimed invention is patentable subject

it doubts the truth

and to back up assertions of its own wi

03 (1995) (statement of Se

(explaining that the Act was intended to “modif[y] the test for obtaining a process patent by clar

§ 103 has since been further amended and the 1995 Act’s pro

removed as part of the sweeping changes implemented by the America Invents Act. However,

ressional policy toward


product[s] . . . primarily manufac ctured using recombinant DNA, recombinant RN NA, hybridoma

technology, or other processes in nvolving site specific genetic manipulation techn niques” from the

“patented invention[s]” that are s subject to the regulatory submission safe harbor. . § 271(g)

likewise establishes a specific ca ause of action for infringement where a foreign m manufacturer

uses a patented “process of prepa aring a DNA molecule comprising a specific gen netic sequence,”

uses the DNA to make an unpate ented protein outside the United States, and then sells the protein

in the United States.

Congress also expressed ssupport for biotechnology patents in responding g to the USPTO’s

interpretation of In re Durden31

wwith the Biotechnological Process Patents Act off 1995.32

The

Act amended § 103(b) of the Pateent Act to address the obviousness analysis of “bbiotechnological

process[es],” including “process[ [es] of genetically altering . . . a single- or multi--celled

organism,” “cell fusion procedur res,” and methods of using products produced by y such

procedures.33

This amendment a again reflects a strong policy in favor of patents on biological

products.

In light of this strong and d clearly expressed congressional policy, the USPPTO should go

no farther than absolutely require ed by the Supreme Court’s decisions in restrictin ng patentable

subject matter, particularly as it r relates to biotechnology.

II. A MORE NARROWLY Y TAILORED APPROACH WOULD BE CO ONSISTENT

WITH CASE LAW AN ND LESS BURDENSOME ON THE USPTO A AND PATENT

APPLICANTS

As discussed above, the G Guidance adopts an approach that is broader than n necessary in

funneling many claims clearly di irected to man-made products or processes into tthe multifactor

“significantly different” analysis.. This approach has at least two significant adveerse effects on

patent examination: increased pr rosecution costs and the potential for significant tly increased

delay.

The Guidance explains th hat the “significantly different” test will be appli ied in a manner

similar to the In re Wands factors os, such that the examiner has the initial burden to establish a

reasonable basis to question whe ether the claimed invention is patentable subject matter. In the

enablement context, an examiner r is required to “explain why it doubts the truth o or accuracy of

any statement in a supporting dissclosure and to back up assertions of its own wit th acceptable

31

763 F.2d 1406, 1411 (Fed. Cir. 1985)).

32 Pub. L. No. 104-41, 109 Stat. 351 (19 995); 141 Cong. Rec. S11201-03 (1995) (statement of Sen n. Orrin Hatch)

(explaining that the Act was intended to o “modif[y] the test for obtaining a process patent by clariifying In re

Durden”).

33See 35 U.S.C. § 103(b) (2006). § 1033 has since been further amended and the 1995 Act’s prov visions have been

removed as part of the sweeping change es implemented by the America Invents Act. However, n nothing in the

legislative history of the America Inven nts Act suggests a change in congressional policy toward biotechnology

patents.



uite 101

gh this does not require the examiner to go through each of the

ner to “

e claims are not patent eligible.

of analysis in office actions. Generating such rejections takes

uired for examination.

text, the Guidance suggests that the burden will shift to the

bility after the examiner issues such a rejection. Because of the

uiry required to overcome such a rejection, preparing

significant “trouble and expense.”

h of the factors in the test, “

re necessary,” includin

a response is a labor

ney and, accordingly, increasing the prosecution costs required

ses like the “significantly different” test increase the time and

t, they should be deployed only in narrow circumstances. The

in a patent application,

t to respond to a rejection under this test.

ever, appears to be overbroad by design and will capture many

eligible, as the examples contained in the Guidance

t by necessity must probe some breadth around the actual

adly sweeping in claimed inventions such as fireworks

of man

sarily overbroad. The adverse time and cost effects of

erica’s innovators, and it will unduly burden the USPTO’s own

here

osts are minimized.

ee also

e and expense of responding to enablement rejection);

24.

2, 3; Ex. C; Ex. E, cl. 2; Ex. F; Ex. G, cl. 3 (all eligible under §

T OCIATION

.bpla.org

Altho ugh each of the

factors, it does require the exam ence that lead

” that t ejections

commonly require several pages jections takes

time, increasing the resources re

co shift to the

applicant to establish patent elig Because of the

intensive and multifactor in aring

response subjects the applicant t t practitioner

must consider and respond to ea ive arguments,

uitable proofs wh al affidavits and

Preparing suc any hours of

work from a patent agent or atto costs required

Because multifactor anal e the time and

money required to obtain a pate stances. The

enablement analysis turns to the the objective

the “trouble and

expense” required for an applica Guidance’s

est, ho ll capture many

claims that ultimately are patent nce

Although any te the actual

patent eligibility, br reworks

containing a particular assembly nclude one or

more natural products is unnece ects of

approach will act as a tax on A USPTO’s own

examiners. The USPTO should hat enter its

multifactor test, such that these

71).

2164.04 (recognizing troub

F.2d 220, 224 (C.C.P.A. 1971) (same); 217, at *3 (B.P.A.I.

, 439 F.2d at

Ex. B, cls nder §


ww

Although this does not require the examiner to go thr

focus on those factors, reasons, and evi

Enablement

commonly require several pages of analysis in office actions. Generating such r

context, the Guidance suggests that the burden wil

applicant to establish patent eligibility after the examiner issues such a rejection

intensive and multifactor inquiry required to overcome such a rejection, pre

A dilige

persua

g but not limited to fact

intensive task, requiring

work from a patent agent or attorney and, accordingly, increasing the prosecutio

Because multifactor analyses like the “significantly different” test increa

money required to obtain a patent, they should be deployed only in narrow circu

is a reason to doub

expressly because of

Th

est, however, appears to be overbroad by design and w

claims that ultimately are patent eligible, as the examples contained in the Guid

Although any test by necessity must probe some breadth around

patent eligibility, broadly sweeping in claimed inventions such as f

made components that happens also to

more natural products is unnecessarily overbroad. The adverse time and cost ef

approach will act as a tax on America’s innovators, and it will unduly burden th

ore seek to narrow the universe of claims

, 439 F.2d 220, 224 (C.C.P.A. 1

In

0918, 2003 WL 2301

Ex. B, cls. 2, 3; Ex. C; Ex. E, cl. 2; Ex. F; Ex. G, cl. 3 (all eligible


evidence or reasoning.”34

Althou ugh this does not require the examiner to go thro ough each of the

factors, it does require the exami iner to “focus on those factors, reasons, and evid dence that lead

the examiner to conclude” that th he claims are not patent eligible.35

Enablement rrejections

commonly require several pages of analysis in office actions. Generating such reejections takes

time, increasing the resources req quired for examination.

As in the enablement con ntext, the Guidance suggests that the burden will l shift to the

applicant to establish patent eligi ibility after the examiner issues such a rejection. . Because of the

fact-intensive and multifactor inq quiry required to overcome such a rejection, prepparing such a

response subjects the applicant to o significant “trouble and expense.”36

A diligen nt practitioner

must consider and respond to eac ch of the factors in the test, “present[ing] persuassive arguments,

supported by suitable proofs whe ere necessary,” including but not limited to factu ual affidavits and

other evidence.37

Preparing such h a response is a labor-intensive task, requiring m many hours of

work from a patent agent or attor rney and, accordingly, increasing the prosecutionn costs required

to obtain patent protection.

Because multifactor analy yses like the “significantly different” test increasse the time and

money required to obtain a paten nt, they should be deployed only in narrow circummstances. The

enablement analysis turns to the Wands factors only if “there is a reason to doubtt the objective

truth of the statements contained”” in a patent application,38

expressly because of the “trouble and

expense” required for an applicannt to respond to a rejection under this test.39

Thee Guidance’s

“significantly different” test, how wever, appears to be overbroad by design and wiill capture many

claims that ultimately are patent eligible, as the examples contained in the Guida ance

demonstrate.40

Although any tes st by necessity must probe some breadth around the actual

boundary of patent eligibility, brooadly sweeping in claimed inventions such as fiireworks

containing a particular assembly of man-made components that happens also to iinclude one or

more natural products is unneces ssarily overbroad. The adverse time and cost eff fects of this

approach will act as a tax on Am merica’s innovators, and it will unduly burden the e USPTO’s own

examiners. The USPTO should ttherefore seek to narrow the universe of claims tthat enter its

multifactor test, such that these ccosts are minimized.

34

MPEP § 2164.04 (emphasis added); ssee also In re Marzocchi, 439 F.2d 220, 224 (C.C.P.A. 19 971).

35 MPEP § 2164.04.

36 MPEP § 2164.04 (recognizing troubl le and expense of responding to enablement rejection); In re Marzocchi, 439

F.2d 220, 224 (C.C.P.A. 1971) (same); Ex parte Sredni, Appeal No. 2001-0918, 2003 WL 23013 3217, at *3 (B.P.A.I.

2003) (same).

37 MPEP § 2164.05.

38Id. § 2164.04.

39Id.; see also Marzocchi, 439 F.2d at 2 224.

40See Guidance Ex. A, cl. 2; Ex. B, cls. . 2, 3; Ex. C; Ex. E, cl. 2; Ex. F; Ex. G, cl. 3 (all eligible u under § 101).



uite 101

NS TO THE GUIDANCE TO PROMOTE

EXAMINERS AND PATENT APPLICANTS

ions to the Guidance, as outlined below, would further the

patent examination.

onsiste

Industries

, and particular the life science industries, heavily rely on the

stify significant investments in research and d

acting investments and recouping the significant early

hard work, and ingenuity required to create and develop

years may pass between th

ity and consistency in the patent system are paramount concerns

e Court has recognized that these values are key for the patent

gnizing in

s in [patent] rules risk destroying the legitimate expectations of

cordingly, as the USPTO begins to implement the Supreme

matter decisions and craft its final Guidance (and the MPEP), it

dictability and consistency.

s Applying the US

ote Consistent Examination

ope of Examples Is Necessary for Examiners to Consistently

r the Innovation Industries to Understand, the Scope of the

pears to affect nearly all inventions involving or touching on

crete hints of what inventions are patent eligible going forward

hough they provide some assistance, the examples in the

ient range of subject matter and claim language to afford

attempting to implement its broad scope. This inserts great

process. That uncertainty, in turn, c

r them to predict which projects may generate returns on

ong investors.

rizes just a few of the gray areas left by the examples in the

ies represent significant areas of research and development

ance of predictability in the USPTO’s approach to patentable

T OCIATION

.bpla.org

ESTED ADDITI

UNDERSTANDING B S

BPLA suggests that addi further the

important goal of consistency in

Predictability and Key Concerns

Base

The innovation industrie ly rely on the

prospect of patent protection to j velopment.

Patent protection is critical to att t early

expenditures for the type of skill develop

inventions in these fields. Man ents and their

returns. Accordingly, predictabi amount concerns

for these industries. The Supre for the patent

y, rec yo Kabushiki

that “[f]undamental alteratio expectations of

the Supreme

Court’s recent patentable subjec d the MPEP), it

maintain pr

Additional Exampl preme Court

Case Law Will Pro

A Broader S to Consistently

Apply, and f e Scope of the

ce a r touching on

natural products, it offers few di going forward

and what inventions are not. Al les in the

Guidance do not address a suffi to afford

sufficient guidance to examiners inserts great

uncertainty into the examination over innovator

companies, making it difficult f turns on

investments and causing doubt a

The following list summ mples in the

Guidance. All of these technolo evelopment

activity, underscoring the signifi to patentable


ww

ESTED ADDITIONS TO THE GUIDANCE TO PROMOTE

UNDERSTANDING BY EXAMINERS AND PATENT APPLICAN

BPLA suggests that additions to the Guidance, as outlined below, would

ncy in Patentable Subject Matter Are

The innovation industries, and particular the life science industries, heav

Patent protection is critical to attracting investments and recouping the significa

expenditures for the type of skill, hard work, and ingenuity required to create an

ese research invest

returns. Accordingly, predictability and consistency in the patent system are pa

for these industries. The Supreme Court has recognized that these values are ke

Festo Corp. v. Shoketsu Kinzoku Ko

that “[f]undamental alterations in [patent] rules risk destroying the legitimat

Accordingly, as the USPTO begins to implement

Court’s recent patentable subject matter decisions and craft its final Guidance (a

PTO’s Interpretation of S

A Broader Scope of Examples Is Necessary for Examiner

Apply, and for the Innovation Industries to Understand, t

ce appears to affect nearly all inventions involving

natural products, it offers few discrete hints of what inventions are patent eligibl

and what inventions are not. Although they provide some assistance, the examp

Guidance do not address a sufficient range of subject matter and claim language

sufficient guidance to examiners attempting to implement its broad scope. This

asts a clou

companies, making it difficult for them to predict which projects may generate r

The following list summarizes just a few of the gray areas left by the ex

Guidance. All of these technologies represent significant areas of research and

activity, underscoring the significance of predictability in the USPTO’s approac


III. SUGGESTED ADDITIOONS TO THE GUIDANCE TO PROMOTE

UNDERSTANDING BY Y EXAMINERS AND PATENT APPLICANT TS

BPLA suggests that addit tions to the Guidance, as outlined below, would further the

important goal of consistency in patent examination.

A. Predictability and C Consistency in Patentable Subject Matter Are Key Concerns

for Innovation-Basedd Industries

The innovation industries s, and particular the life science industries, heaviily rely on the

prospect of patent protection to juustify significant investments in research and deevelopment.

Patent protection is critical to attrracting investments and recouping the significan nt early

expenditures for the type of skill,, hard work, and ingenuity required to create andd develop

inventions in these fields. Manyy years may pass between these research investm ments and their

returns. Accordingly, predictabillity and consistency in the patent system are par ramount concerns

for these industries. The Suprem me Court has recognized that these values are key y for the patent

system to function properly, reco ognizing in Festo Corp. v. Shoketsu Kinzoku Kog gyo Kabushiki

Co. that “[f]undamental alterationns in [patent] rules risk destroying the legitimate e expectations of

inventors in their property.”41

AAcccordingly, as the USPTO begins to implement the Supreme

Court’s recent patentable subject t matter decisions and craft its final Guidance (annd the MPEP), it

should take steps to maintain pre edictability and consistency.

B. Additional Example es Applying the USPTO’s Interpretation of Su upreme Court

Case Law Will Prommote Consistent Examination

1. A Broader Sc cope of Examples Is Necessary for Examiners s to Consistently

Apply, and fo or the Innovation Industries to Understand, thhe Scope of the

Guidance

Although the Guidance apppears to affect nearly all inventions involving o or touching on

natural products, it offers few dis screte hints of what inventions are patent eligiblee going forward

and what inventions are not. Alt though they provide some assistance, the examp les in the

Guidance do not address a suffic cient range of subject matter and claim language to afford

sufficient guidance to examiners attempting to implement its broad scope. This inserts great

uncertainty into the examination process. That uncertainty, in turn, casts a cloud d over innovator

companies, making it difficult fo or them to predict which projects may generate reeturns on

investments and causing doubt ammong investors.

The following list summa arizes just a few of the gray areas left by the exa amples in the

Guidance. All of these technolog gies represent significant areas of research and d development

activity, underscoring the significcance of predictability in the USPTO’s approachh to patentable

41

535 U.S. 722, 739 (2002).



uite 101

LA suggests that the USPTO suppl

atent eligible claims in at least the following areas.

Medicinal Substances.

substances: Example B, dealing with “amazo

ample, however, provides insufficient guidance to this large

relative concept, s

ce

ertain purity. The Guidance is silent as to whether this

new §

ds generally are not patent eligible. Second, many c

armaceutical

e additional requirements that distinguish the claimed

se that exist in nature. For example, pharmaceutical

y should not contain toxic components. The Guidance does not

istinction affects the patentability analysis.

owledged, in training documents, that certain purification of

be sufficient to cr

he USPTO gave an example of a claim to pasteurized pomelo

lo juice being a natural product, the slides deem the claim

1 because “[n]

“[t]he specification describes the pasteurization process as

l structure of the vitamin C and flavonoids in the juice.”

slides conclude that “the paste

rom what exists in nature.”

o juice example in these slides is different from the purified

n Example B of the Guidance. If t

t “purified” means in the particular specification, then further

ples in this regard should be provided. The USPTO would help

by issuing additional examples addressing and

xamples of patent eligible claims to purified compositions

useful for applicants.

al Products.

g discovery

e proteins that many biologics seek to imitate; and they are the

or many vaccines and for gene therapy developments. The

luating Subject Matter Eligibility Under 35 USC §

v/patents/law/exam/myriad

T OCIATION

.bpla.org

subject matter in these fields. B uidance with

additional concrete examples of eas.

Isolated or Purified ly one example

of purified medicinal acid.” This

single hypothetical e to this large

field. First, purity is her components

in the claimed substa

active substance of a ther this

distinction affects th g to examiners

that purified compou any c

p rity. Such

compositions may ha laimed

compositions from t utical

eral idance does not

address whether this

The USPTO has ack rification of

natural products may its March 19,

2014 training slides, rized pomelo

Despite pom the claim

1 ontains vitamin

” an n process as

damaging the chemic e juice.”

From this, the trainin ice is markedly

different in structure r exactly how

the pasteurized pome the purified

amazonic acid claim the

specification, and wh n, then further

information and exa PTO would help

promote predictabilit

distinctions. Further mpositions

would be particularl

Derivatives of Natu pounds for

countless areas of dr all molecule

discovery; they are t nd they are the

building blocks used ments. The

U.S. Patent & Trademark Office, Ev t 75

www.uspto.g


ww

ement the

additional concrete examples of patent eligible claims in at least the following a

The Guidance offers o

ni

single hypothetical example, however, provides insufficient guidanc

the presence of ot

active substance of a certain purity. The Guidance is silent as to wh

101 analysis, instead improperly implyi

that purified compounds generally are not patent eligible. Second,

compositions having a certain p

compositions may have additional requirements that distinguish the

compositions from those that exist in nature. For example, pharmac

erally should not contain toxic components. The G

The USPTO has acknowledged, in training documents, that certain p

eate a patentable invention. I

2014 training slides, the USPTO gave an example of a claim to paste

Despite pomelo juice being a natural product, the slides dee

urring pomelo juice

” and “[t]he specification describes the pasteurizati

damaging the chemical structure of the vitamin C and flavonoids in t

urized pomelo j

It remains uncle

the pasteurized pomelo juice example in these slides is different fro

he focus is o

specification, and what “purified” means in the particular specificati

information and examples in this regard should be provided. The U

promote predictability by issuing additional examples addressing an

distinctions. Further examples of patent eligible claims to purified c

Natural products serve as lead co

. They serve as starting points for s

discovery; they are the proteins that many biologics seek to imitate;

building blocks used for many vaccines and for gene therapy develo

101,

mayo_slides_20140319.pdf


subject matter in these fields. BP PLA suggests that the USPTO supplement the G Guidance with

additional concrete examples of ppatent eligible claims in at least the following arreas.

• Isolated or Purified Medicinal Substances. The Guidance offers onnly one example

of purified medicinal substances: Example B, dealing with “amazonic c acid.” This

single hypothetical ex xample, however, provides insufficient guidance e to this large

field. First, purity is a a relative concept, suggesting the presence of ot her components

in the claimed substan nce. Many claims are therefore to compositionss comprising an

active substance of a ccertain purity. The Guidance is silent as to whe ether this

distinction affects the e new § 101 analysis, instead improperly implyin ng to examiners

that purified compoun nds generally are not patent eligible. Second, m many claims are

currently drafted to phharmaceutical compositions having a certain pu urity. Such

compositions may havve additional requirements that distinguish the c claimed

compositions from thhoose that exist in nature. For example, pharmace eutical

compositions generallly should not contain toxic components. The Guuidance does not

address whether this d distinction affects the patentability analysis.

The USPTO has ackn nowledged, in training documents, that certain puurification of

natural products may be sufficient to create a patentable invention. In n its March 19,

2014 training slides, t the USPTO gave an example of a claim to pasteuurized pomelo

juice.42

Despite pome elo juice being a natural product, the slides deem m the claim

patentable under § 10 01 because “[n]aturally occurring pomelo juice c contains vitamin

C and flavonoids” andd “[t]he specification describes the pasteurizatio on process as

damaging the chemicaal structure of the vitamin C and flavonoids in thhe juice.”43

From this, the training g slides conclude that “the pasteurized pomelo juuice is markedly

different in structure ffrom what exists in nature.”44

It remains unclea ar exactly how

the pasteurized pomello juice example in these slides is different from m the purified

amazonic acid claim iin Example B of the Guidance. If the focus is onn the

specification, and whaat “purified” means in the particular specificatio on, then further

information and exam mples in this regard should be provided. The US SPTO would help

promote predictability y by issuing additional examples addressing and d explaining the

distinctions. Further eexamples of patent eligible claims to purified co ompositions

would be particularly useful for applicants.y

• Derivatives of Natur ral Products. Natural products serve as lead commpounds for

countless areas of dru ug discovery. They serve as starting points for smmall molecule

discovery; they are th he proteins that many biologics seek to imitate; a and they are the

building blocks used ffor many vaccines and for gene therapy develop pments. The

42

U.S. Patent & Trademark Office, Eva aluating Subject Matter Eligibility Under 35 USC § 101, a at 75-78 (Mar. 19,

2014), available at http://www.uspto.go ov/patents/law/exam/myriad-mayo_slides_20140319.pdf. .

43Id. at 77.

44Id.



uite 101

a single example

olecule natural product. Although useful, this example

y about the state of patent protection for the following other

ct derivatives:

of natural products, including both enantiomers and

gen

lin monomers;

tides, such as epitopes;

onucleotides, derived from naturally occ

is derived from naturally occurring genes and is central to

ogy;

e primers, which are derived from naturally occurring genes;

luding both oligonucleic acid and peptide aptamers;

ns, including both recombinant tagged proteins and synthetically

s (

s.

pes of molecules are derived, in some way, from natural

o the natural product, so

f an entirely new compound. The Guidance’s single example

fficient to allow for consistent examination and provide any

y in all of these related, yet

gible claims would be useful.

tural Products.

conomically significant. These may include salts, powders,

colloids, and other types of mixtures. Significantly, this

pharmaceutical compositions, which frequently are mixtures of

products. For example, a synthetic drug that is formulated in

ncludes natural products in addition to the synthetic active

al products may include excipients

in, and chemicals like magnesium stearate. Although the

e example

works

pharmaceuticals.

T OCIATION

.bpla.org

Guidance offers only : a methylated

derivative of a small example

provides little certain lowing other

types of natural prod

somer and

diastereomers

ragment ant from

immunoglob

Truncated pe

Antisense oli genes;

siRNA, whic s central to

RNAi techno

Oligonucleoti urring genes;

Aptamers, in ers;

and synthetically

tagged protei

Fusion protei

All of these diverse t natural

products. Some add nd some use it

to guide the creation ingle example

of methylation is ins provide any

degree of predictabili in, additional

examples of patent el

Combinations of N cts with other

compounds are also ts, powders,

, suspensions ntly, this

category also include y are mixtures of

mad formulated in

mmonly etic active

ingredient. The natu harides,

polysaccharides, gela hough the

Guidance provides o ural product, the

fir ther fields, such

as biotechnology and


ww

addressing this important are

derivative of a small molecule natural product. Although useful, this

provides little certainty about the state of patent protection for the fol

somers of natural products, including both enantiomer

(Fab) fragments, which are derive

urring

siRNA, which is derived from naturally occurring genes and

Oligonucleotide primers, which are derived from naturally oc

Aptamers, including both oligonucleic acid and peptide apta

ins, including both recombinant tagged proteins

All of these diverse types of molecules are derived, in some way, fro

me take away from it,

to guide the creation of an entirely new compound. The Guidance’s

of methylation is insufficient to allow for consistent examination an

distinct, areas. Ag

Combinations of natural prod

compounds are also economically significant. These may include sa

, suspensions, colloids, and other types of mixtures. Signific

category also includes pharmaceutical compositions, which frequent

made products. For example, a synthetic drug that i

mmonly includes natural products in addition to the synt

, disac

polysaccharides, gelatin, and chemicals like magnesium stearate. Al

of a manufacture claim reciting a na

offers little to inform examination in


Guidance offers only a single example addressing this important area a: a methylated

derivative of a small m molecule natural product. Although useful, this example

provides little certaintty about the state of patent protection for the fol lowing other

types of natural produ uct derivatives:

o Stereoisomers s of natural products, including both enantiomers s and

diastereomers;;

o Fragment anti igen-binding (Fab) fragments, which are derived d from

immunoglobu ulin monomers;

o Truncated pep ptides, such as epitopes;

o Antisense olig gonucleotides, derived from naturally occurring genes;

o siRNA, which h is derived from naturally occurring genes and i is central to

RNAi technol logy;

o Oligonucleotidde primers, which are derived from naturally occcurring genes;

o Aptamers, inc cluding both oligonucleic acid and peptide aptam mers;

o Tagged proteiins, including both recombinant tagged proteins and synthetically

tagged protein ns (e.g., PEGylated proteins); and

o Fusion protein ns.

All of these diverse ty ypes of molecules are derived, in some way, from m natural

products. Some add t to the natural product, some take away from it, a and some use it

to guide the creation o of an entirely new compound. The Guidance’s s single example

of methylation is insu ufficient to allow for consistent examination and d provide any

degree of predictabilitty in all of these related, yet distinct, areas. Aga ain, additional

examples of patent eliigible claims would be useful.

• Combinations of Na atural Products. Combinations of natural produ ucts with other

compounds are also e economically significant. These may include sal lts, powders,

aerosols, suspensions,, colloids, and other types of mixtures. Significaantly, this

category also includess pharmaceutical compositions, which frequentl ly are mixtures of

natural and man-madee products. For example, a synthetic drug that iss formulated in

pill form commonly i includes natural products in addition to the synth hetic active

ingredient. The natur ral products may include excipients—e.g., disacccharides,

polysaccharides, gelattin, and chemicals like magnesium stearate. Alt though the

Guidance provides on ne example of a manufacture claim reciting a nattural product, the

chosen example—fire eworks—offers little to inform examination in oother fields, such

as biotechnology and pharmaceuticals.



uite 101

s more complex in situations where the combination consists

cts. A frequent embodiment of this problem will be formulated

e ingredient itself is a natural product. Although the Guidance

discussing claims to combinations of natural products, that

ected to a combination of bacteria) is of limited use to the

rely recites the facts and outcome of one Supreme Court case.

firming the patent eligibility of man

atural components (like the firework, or a pharmaceutical

e helpful to both applicants and examiners.

d Applicants Require More Complete Examples of How the

o Be Implemented in Prosecution

be enhanced by adding either stand

examples demonstrating what type of response by a patent

vercome a rejection under the “significantly different” test

n how the examining corps should review applications to make

but they provide little information regarding arguments or

to rebut rejections under the

nal instruction on how to apply the Guidance in back

that “[t]

ce

he claims themselves, and possibly even outside the four

rmine patent eligibility under §

’s test, patent practitioners will be faced with the decision of

im language or specification, and/or submit additional

by the examiner, to make a case for patent eligib

instruction on what evidence that might be or the threshold to

rder to overcome the rejection. Without such examples,

their own standards, which

or examiners in related contexts, such as for rejections under

ncy and efficiency in prosecution, examples addressing how

nses to rejections under the Guidance’s test is important.

T OCIATION

.bpla.org

his problem becom ation consists

multiple natural prod ill be formulated

drugs where the acti the Guidance

includes one exampl oducts, that

example (which is di use to the

industry because it m me Court case.

Further examples co ositions that

one or more aceutical

composition) would

Examiners a ples of How the

Guidance Is

ance could also ples or

additional material to the existin by a patent

applicant would be sufficient to ferent” test

The examples, as written, focus cations to make

101 issues guments or

evidence that would be sufficien he examining

corps would benefit from additi back

The Guidance recognize consider every

or and related evide emplates some

examination of material outside the four

corners of the application, to det ly, in response

on under the Guidanc e decision of

whether to argue based on the cl itional

evidence, beyond that considere ib

examples, however, do not offer e threshold to

which the evidence must rise in xamples,

examiners will be left to develo he USPTO has

provided such interpretive tools ections under

112’s enablement requirement f evidence that

an applicant may submit to over ch evidence

must meet). To promote consist dressing how

examiners should consider resp portant.


ww

his problem becomes more complex in situations where the combi

multiple natural products. A frequent embodiment of this problem

drugs where the active ingredient itself is a natural product. Althoug

includes one example discussing claims to combinations of natural p

example (which is directed to a combination of bacteria) is of limite

industry because it merely recites the facts and outcome of one Supr

made com

one or more natural components (like the firework, or a phar

Examiners and Applicants Require More Complete Exa

alone exa

additional material to the existing examples demonstrating what type of respons

applicant would be sufficient to overcome a rejection under the “significantly di

The examples, as written, focus on how the examining corps should review appl

101 issues, but they provide little information regarding a

Guidance’s test.

corps would benefit from additional instruction on how to apply the Guidance i

he examiner’s analysis should carefull

This makes clear that the Guidance con

examination of material outside the claims themselves, and possibly even outsid

101. Accordin

on under the Guidance’s test, patent practitioners will be faced with t

whether to argue based on the claim language or specification, and/or submit ad

evidence, beyond that considered by the examiner, to make a case for patent eli

examples, however, do not offer instruction on what evidence that might be or t

which the evidence must rise in order to overcome the rejection. Without such

may vary widely.

provided such interpretive tools for examiners in related contexts, such as for re

2164.05 (discussing types

ome a rejection and explaining standard that s

must meet). To promote consistency and efficiency in prosecution, examples a

examiners should consider responses to rejections under the Guidance’s test is i


This problem become es more complex in situations where the combin nation consists of

multiple natural produ ucts. A frequent embodiment of this problem w will be formulated

drugs where the activ ve ingredient itself is a natural product. Althoughh the Guidance

includes one example e discussing claims to combinations of natural pr roducts, that

example (which is dir rected to a combination of bacteria) is of limited d use to the

industry because it meerely recites the facts and outcome of one Supre eme Court case.

Further examples con nfirming the patent eligibility of man-made comp positions that

include one or more n natural components (like the firework, or a pharm maceutical

composition) would b be helpful to both applicants and examiners.

2. Examiners an nd Applicants Require More Complete Exam mples of How the

Guidance Is t to Be Implemented in Prosecution

The Guidance could also be enhanced by adding either stand-alone exam mples or

additional material to the existing g examples demonstrating what type of response e by a patent

applicant would be sufficient to o overcome a rejection under the “significantly diffferent” test.

The examples, as written, focus o on how the examining corps should review appliications to make

initial rejections for § 101 issues,, but they provide little information regarding ar rguments or

evidence that would be sufficientt to rebut rejections under the Guidance’s test. T The examining

corps would benefit from additio onal instruction on how to apply the Guidance in n back-and-forth

exchanges with applicants.

The Guidance recognizes s that “[t]he examiner’s analysis should carefully y consider every

relevant factor and related eviden nce.”45

This makes clear that the Guidance cont templates some

examination of material outside t the claims themselves, and possibly even outsidee the four

corners of the application, to dete ermine patent eligibility under § 101. Accordinggly, in response

to a rejection under the Guidance e’s test, patent practitioners will be faced with th he decision of

whether to argue based on the cla aim language or specification, and/or submit add ditional

evidence, beyond that considered d by the examiner, to make a case for patent eliggibility. The

examples, however, do not offer instruction on what evidence that might be or th he threshold to

which the evidence must rise in o order to overcome the rejection. Without such e examples,

examiners will be left to develop p their own standards, which may vary widely. T The USPTO has

provided such interpretive tools ffor examiners in related contexts, such as for rej jections under

§ 112’s enablement requirement. . See, e.g., MPEP § 2164.05 (discussing types o of evidence that

an applicant may submit to overc come a rejection and explaining standard that su uch evidence

must meet). To promote consiste ency and efficiency in prosecution, examples ad ddressing how

examiners should consider respoonses to rejections under the Guidance’s test is im mportant.

45

Guidance at 4.



uite 101

ion of How Examiners Are to Apply the Guidance’s Test

tency

panded in other ways to further promote consistency in

ent” analysis, a standard that includes significant room for

on point in the test represents another opportuni

does the outcome of the overall balancing between the 12

ent” analysis.

sistency, more explanation could be provided regarding how the

promote consistency in deciding what applications proceed to

art, the Guidance could provide further definitions of the

e, natural principle, natural phenomena, and natural

iners. To the extent that these terms do not easily lend

, the Guidance could impose an interpretive methodology that

ple, the Guidance could suggest

r reasons noted above, a broad interpretation could promote

ope of patentable subject matter).

vent the unde

arkedly different levels of patent protection simply because of

pplications.

ld promote consistency by explaining in m

ome examiners may see each example as reflecting a totality of

others may see them as checklists for various types of claims.

. One p

roduct is permissible if it does not preclude all uses of a

nother reading, however, is that a method of treatment claim

le under §

e of patient, and is directed toward treating a disease that the

reviously known to treat. To the contrary, for exam

patient population should be sufficient to render a claim to

ct patent eligible. BPLA suggests that the Guidance emphasize

strative, and th

inguishing the claimed subject matter from a judicial exception

scussed above, providing further examples of patent eligible

uage relating to, for example, methods of treatment, would be

ers.

sts that the USPTO adopt a narrow construction of these threshold terms.

mmendation, it should expressly take a position on how these terms are to

T OCIATION

.bpla.org

ana ance’s Test

Will Promote Consi

The Guidance could be e tency in

applying the “significantly diffe t room for

examiner discretion. Each decis

reasonable examiners to differ, een the 12

factors in the “significantly diffe

To reduce potential inco garding how the

, to ns proceed to

Step 3 of the Guidance’s flow c ns of the

law of natu tural

as they are to be applied by exa ily lend

themselves to precise definition hodology that

examiners should use. For exa be construed

narrowly or broadly (although, f uld promote

unnecessary restrictions on the s ional

interpretative guidance could pr petitors with

similar technologies receiving ply because of

the examiners assigned to their

, the Guidance co etail how its

examples are to be interpreted. ting a totality of

the circumstances analysis, whil ypes of claims.

Example B, claim 3 is illustrativ method of

treatment claim using a natural ses of a

naturally occurring compound. eatment claim

oduct is allowa , a narrow

dosage period, and a specific ty ease that the

natural product was not known xam

limitation as to a newly identifie er a claim to

administration of a natural prod ance emphasize

that the examples are merely ill types of claims

with one or more limitations dis icial exception

also can be patent eligible. As d atent eligible

rying scope and lan ent, would be

helpful for applicants and exami

As explained above, the BPLA sugg threshold terms.

Yet, even if the USPTO rejects that rec these terms are to


ww

anation of How Examiners Are to Apply the Gui

The Guidance could be expanded in other ways to further promote consi

applying the “significantly different” analysis, a standard that includes significa

examiner discretion. Each decision point in the test represents another opportun

reasonable examiners to differ, as does the outcome of the overall balancing bet

To reduce potential inconsistency, more explanation could be provided r

, to promote consistency in deciding what applicati

Step 3 of the Guidance’s flow chart, the Guidance could provide further definiti

law of nature, natural principle, natural phenomena, and n

as they are to be applied by examiners. To the extent that these terms do not ea

themselves to precise definitions, the Guidance could impose an interpretive me

that these term

narrowly or broadly (although, for reasons noted above, a broad interpretation c

Such addi

sirable situation of two market co

similar technologies receiving markedly different levels of patent protection si

ore

examples are to be interpreted. Some examiners may see each example as refle

the circumstances analysis, while others may see them as checklists for various

ossible reading of this example is that

treatment claim using a natural product is permissible if it does not preclude all

naturally occurring compound. Another reading, however, is that a method of t

101 if it recites a narrow dose rang

dosage period, and a specific type of patient, and is directed toward treating a di

natural product was not known previously known to treat. To the contrary, for

limitation as to a newly identified patient population should be sufficient to ren

administration of a natural product patent eligible. BPLA suggests that the Gui

at many other similar or differen

with one or more limitations distinguishing the claimed subject matter from a ju

also can be patent eligible. As discussed above, providing further examples of

rying scope and language relating to, for example, methods of treat

As explained above, the BPLA suggests that the USPTO adopt a narrow construction of these

Yet, even if the USPTO rejects that recommendation, it should expressly take a position on how


C. Additional Explanat tion of How Examiners Are to Apply the Guid dance’s Test

Will Promote Consis stency

The Guidance could be exxpanded in other ways to further promote consis stency in

applying the “significantly differ rent” analysis, a standard that includes significan nt room for

examiner discretion. Each decisiion point in the test represents another opportuniity for

reasonable examiners to differ, aass does the outcome of the overall balancing betw ween the 12

factors in the “significantly differrent” analysis.

To reduce potential incon nsistency, more explanation could be provided reegarding how the

Guidance is to be used. First, to promote consistency in deciding what applicatio ons proceed to

Step 3 of the Guidance’s flow ch hart, the Guidance could provide further definitio ons of the

judicial exceptions—law of naturre, natural principle, natural phenomena, and na atural product—

as they are to be applied by exam miners. To the extent that these terms do not eas sily lend

themselves to precise definitions s, the Guidance could impose an interpretive metthodology that

examiners should use. For exam mple, the Guidance could suggest that these termss be construed

narrowly or broadly (although, fo or reasons noted above, a broad interpretation co ould promote

unnecessary restrictions on the sc cope of patentable subject matter).46

Such addit tional

interpretative guidance could pre event the undesirable situation of two market com mpetitors with

similar technologies receiving m markedly different levels of patent protection sim mply because of

the examiners assigned to their a applications.

Second, the Guidance cou uld promote consistency by explaining in more ddetail how its

examples are to be interpreted. S Some examiners may see each example as reflec cting a totality of

the circumstances analysis, while e others may see them as checklists for various t types of claims.

Example B, claim 3 is illustrative e. One possible reading of this example is that a a method of

treatment claim using a natural p product is permissible if it does not preclude all u uses of a

naturally occurring compound. A Another reading, however, is that a method of tr reatment claim

using a natural product is allowabble under § 101 if it recites a narrow dose range e, a narrow

dosage period, and a specific typ pe of patient, and is directed toward treating a dis sease that the

natural product was not known p previously known to treat. To the contrary, for e example, a simple

limitation as to a newly identifiedd patient population should be sufficient to rend der a claim to

administration of a natural produ uct patent eligible. BPLA suggests that the Guid dance emphasize

that the examples are merely illu ustrative, and that many other similar or differentt types of claims

with one or more limitations dist tinguishing the claimed subject matter from a juddicial exception

also can be patent eligible. As diiscussed above, providing further examples of p patent eligible

claims of varying scope and lang guage relating to, for example, methods of treatm ment, would be

helpful for applicants and examinners.

46

As explained above, the BPLA sugge ests that the USPTO adopt a narrow construction of these threshold terms.

Yet, even if the USPTO rejects that recoommendation, it should expressly take a position on how these terms are to

be interpreted to promote consistency.



uite 101

e opportunity to comment on the USPTO’s proposed

ms c

ring our comments.

LA

T OCIATION

.bpla.org

The BPLA appreciates t osed

for the examination of patent cla na, and natural

. Thank you for consid

n

B rs

q.

q.


ww

The BPLA appreciates the opportunity to comment on the USPTO’s pro

oncerning laws of nature, natural phenom

Boston Patent Law Associati

Cha

Emily R. Whelan, E

Nicole A. Palmer, E


IV. CONCLUSION

The BPLA appreciates th he opportunity to comment on the USPTO’s prop posed Guidance

for the examination of patent claiims concerning laws of nature, natural phenome ena, and natural

products. Thank you for consideering our comments.

Sincerely,

Boston Patent Law Associatioon

By:

BPPLA Patent Office Practice Committee Co-Chaiirs

Emily R. Whelan, Es sq.

Nicole A. Palmer, Es sq.


Date post:	21-Jun-2020
Category:	Documents
Upload:	others
View:	0 times
Download:	0 times

Nicole Palmer Sent: Monday, July 28, 2014 1:08 PM To ... · From: Nicole Palmer Sent: Monday, July...

Documents