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
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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
E BOSTON PATENT LAW ASSOCIATION
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
THE BOSTON PATENT LAW AS
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
THHE BOSTON PATENT LAW ASSSOCIATION
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
E BOSTON PATENT LAW ASSOCIATION
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
THE BOSTON PATENT LAW AS
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
THHE BOSTON PATENT LAW ASSSOCIATION
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.
One Batterymarch Park SSuite 101 Quincy, MA 02169 Ph. 617-507-5570 wwww.bpla.org
E BOSTON PATENT LAW ASSOCIATION
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 .
THE BOSTON PATENT LAW AS
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_
THHE BOSTON PATENT LAW ASSSOCIATION
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.
One Batterymarch Park SSuite 101 Quincy, MA 02169 Ph. 617-507-5570 wwww.bpla.org
E BOSTON PATENT LAW ASSOCIATION
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
THE BOSTON PATENT LAW AS
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
THHE BOSTON PATENT LAW ASSSOCIATION
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).
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E BOSTON PATENT LAW ASSOCIATION
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,
THE BOSTON PATENT LAW AS
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
THHE BOSTON PATENT LAW ASSSOCIATION
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).
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E BOSTON PATENT LAW ASSOCIATION
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.
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.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).
THE BOSTON PATENT LAW AS
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
THHE BOSTON PATENT LAW ASSSOCIATION
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).
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E BOSTON PATENT LAW ASSOCIATION
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
THE BOSTON PATENT LAW AS
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
THHE BOSTON PATENT LAW ASSSOCIATION
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 . . . .).
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E BOSTON PATENT LAW ASSOCIATION
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.
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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
THE BOSTON PATENT LAW AS
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
THHE BOSTON PATENT LAW ASSSOCIATION
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.
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E BOSTON PATENT LAW ASSOCIATION
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
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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
THE BOSTON PATENT LAW AS
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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
THHE BOSTON PATENT LAW ASSSOCIATION
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.
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E BOSTON PATENT LAW ASSOCIATION
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 §
THE BOSTON PATENT LAW AS
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
THHE BOSTON PATENT LAW ASSSOCIATION
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).
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E BOSTON PATENT LAW ASSOCIATION
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
THE BOSTON PATENT LAW AS
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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
THHE BOSTON PATENT LAW ASSSOCIATION
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).
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E BOSTON PATENT LAW ASSOCIATION
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
THE BOSTON PATENT LAW AS
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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
THHE BOSTON PATENT LAW ASSSOCIATION
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.
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E BOSTON PATENT LAW ASSOCIATION
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
THE BOSTON PATENT LAW AS
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
THHE BOSTON PATENT LAW ASSSOCIATION
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.
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E BOSTON PATENT LAW ASSOCIATION
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.
THE BOSTON PATENT LAW AS
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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
THHE BOSTON PATENT LAW ASSSOCIATION
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.
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E BOSTON PATENT LAW ASSOCIATION
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
THE BOSTON PATENT LAW AS
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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
THHE BOSTON PATENT LAW ASSSOCIATION
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.
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E BOSTON PATENT LAW ASSOCIATION
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.
THE BOSTON PATENT LAW AS
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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
THHE BOSTON PATENT LAW ASSSOCIATION
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.
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