81 FR 71485 - Notice of Roundtables and Request for Comments Related to Patent Subject Matter Eligibility

DEPARTMENT OF COMMERCE
Patent and Trademark Office

Federal Register Volume 81, Issue 200 (October 17, 2016)

Page Range		71485-71489
FR Document		2016-24888
The United States Patent and Trademark Office (``USPTO'') seeks public input on patent subject matter eligibility in view of recent decisions by the Supreme Court and Court of Appeals for the Federal Circuit. The USPTO remains interested in feedback from members of the public to improve the USPTO's existing subject matter eligibility guidance and training examples. The USPTO is also interested in facilitating a discussion among members of the public regarding the legal contours of eligible subject matter in the U.S. patent system. The USPTO will be facilitating these discussions by hosting two roundtable events. The first roundtable will be directed to receiving feedback from members of the public to improve the USPTO's existing subject matter eligibility guidance and training examples. The second roundtable will be focused on receiving feedback regarding larger questions concerning the legal contours of eligible subject matter in the U.S. patent system. The roundtables will provide a forum for discussion of the topics identified in this notice.
Federal Register, Volume 81 Issue 200 (Monday, October 17, 2016)
[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Notices]
[Pages 71485-71489]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-24888]


-----------------------------------------------------------------------

DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No.: PTO-P-2016-0041]


Notice of Roundtables and Request for Comments Related to Patent 
Subject Matter Eligibility

AGENCY: United States Patent and Trademark Office, Department of 
Commerce.

ACTION: Notice of public roundtables and request for comments related 
to patent subject matter eligibility.

-----------------------------------------------------------------------

SUMMARY: The United States Patent and Trademark Office (``USPTO'') 
seeks public input on patent subject matter eligibility in view of 
recent decisions by the Supreme Court and Court of Appeals for the 
Federal Circuit. The USPTO remains interested in feedback from members 
of the public to improve the USPTO's existing subject matter 
eligibility guidance and training examples. The USPTO is also 
interested in facilitating a discussion among members of the public 
regarding the legal contours of eligible subject matter in the U.S. 
patent system. The USPTO will be facilitating these discussions by 
hosting two roundtable events. The first roundtable will be directed to 
receiving feedback from members of the public to improve the USPTO's 
existing subject matter eligibility guidance and training examples. The 
second roundtable will be focused on receiving feedback regarding 
larger questions concerning the legal contours of eligible subject 
matter in the U.S. patent system. The roundtables will provide a forum 
for discussion of the topics identified in this notice.

DATES: The meeting dates are:
    1. November 14, 2016, 1 p.m. to 5 p.m., Alexandria, VA.
    Written comments will be accepted on an ongoing basis.
    2. December 5, 2016, 8 a.m. to 5 p.m., Stanford, CA.
    Written comments are due by January 18, 2017.

ADDRESSES: The meeting locations are:
    1. United States Patent and Trademark Office, Madison Building, 
Madison Auditorium, 600 Dulany Street, Alexandria, Virginia 22314.
    2. Paul Brest Hall, 555 Salvatierra Walk, Stanford University, 
Stanford, California 94305.
    Submit written comments to: [email protected].

FOR FURTHER INFORMATION CONTACT: Requests for additional information 
regarding registration and speaker presentations should be directed to 
the attention of Elizabeth Shaw, by telephone at 571-272-9300, or by 
email at [email protected]. Requests for additional information 
regarding the topics for written comments and discussion at Roundtable 
1 should be directed to Carolyn Kosowski, by telephone at 571-272-7688, 
or by email at [email protected]. Requests for additional 
information regarding the topics for written comments and discussion at 
Roundtable 2 should be directed to Amy Nelson, by telephone at 571-272-
8978, or by email at [email protected].

SUPPLEMENTARY INFORMATION:

Roundtable 1: USPTO Subject Matter Eligibility Guidelines

    Instructions and Information on Roundtable 1: Roundtable 1 will be 
held on November 14, 2016, at the United States Patent and Trademark 
Office, Madison Building, Madison Auditorium, 600 Dulany Street, 
Alexandria, Virginia 22314. The roundtable will begin at 1:00 p.m., 
Eastern Standard Time (``EST'') and end at 5:00 p.m., EST. The 
roundtable will also be available via webcast enabling individuals who 
cannot attend in person to watch the roundtable via the Internet in 
real time. The agenda and webcast information will be available before 
the roundtable on the USPTO's Roundtable 1 Web page www.uspto.gov/patent/notice-roundtables-and-request-comments-related-patent-subject-matter-eligibility. On-line registration will be available from that 
Web page, and attendees may register at the door. Attendees are 
encouraged to register on-line before the roundtable.
    Written Comments: The USPTO continues to accept comments on its 
subject matter eligibility guidance and training examples on an ongoing 
basis. Those comments, as well as any written comments on the topics 
for discussion in Roundtable 1, should be sent by electronic mail 
message via the Internet addressed to [email protected]. 
Because comments will be made available for public inspection, 
information that is not desired to be made public, such as an address 
or phone number, should not be included in the comments.

Roundtable 2: Exploring the Legal Contours of Patent Subject Matter 
Eligibility

    Instructions and Information on Roundtable 2: Roundtable 2 will be 
held on December 5, 2016, at Paul Brest Hall, 555 Salvatierra Walk, 
Stanford University, Stanford, California 94305. The roundtable will 
begin at 8:00 a.m., Pacific Standard Time (``PST'') and end

[[Page 71486]]

at 5:00 p.m. PST. The roundtable will also be available via webcast 
enabling individuals who cannot attend in person to watch the 
roundtable via the Internet in real time. The agenda and webcast 
information will be available before the roundtable on the USPTO's 
Roundtable 2 Web page www.uspto.gov/patent/laws-and-regulations/comments-public/notice-roundtables-and-request-comments-related-patent. 
On-line registration will be available from that Web page, and 
attendees may register at the door. Attendees are encouraged to 
register on-line before the roundtable.
    Written Comments: For those wishing to submit written comments on 
the topics to be addressed by Roundtable 2, the deadline for receipt of 
those comments for consideration by the USPTO is January 18, 2017. 
Written comments should be sent by electronic mail message via the 
Internet addressed to [email protected].
    Because comments will be made available for public inspection, 
information that is not desired to be made public, such as an address 
or phone number, should not be included in the comments.

1. Background

    As the world's most innovative economy, the United States relies 
heavily on intellectual property to support economic growth and 
business development. The U.S. patent system is a critical piece of the 
nation's robust system of intellectual property rights. To obtain 
patent protection, the requirement of subject matter eligibility under 
35 U.S.C. 101 must be satisfied. Over the past six years, the Supreme 
Court has issued a series of decisions--Bilski,\1\ Mayo,\2\ Myriad,\3\ 
and Alice \4\--that have significantly impacted patent eligibility law 
and continue to generate substantial public debate. These cases are 
briefly summarized below.
---------------------------------------------------------------------------

    \1\ Bilski v. Kappos, 561 U.S. 593 (2010).
    \2\ Mayo Collaborative Servs. v. Prometheus Labs., Inc., 
__U.S.__, 132 S. Ct. 1289 (2012).
    \3\ Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 
__U.S.__, 133 S. Ct. 2107 (2013).
    \4\ Alice Corp. v. CLS Bank Int'l, __U.S.__, 134 S. Ct. 2347 
(2014).
---------------------------------------------------------------------------

    Bilski, decided in 2010, involved a business method for hedging 
risk.\5\ In analyzing patent eligibility, the Supreme Court recognized 
that section 101 specifies four independent categories of inventions or 
discoveries that are eligible for patent protection (processes, 
machines, manufactures, and compositions of matter), but judicial 
precedent provides three specific exceptions to patent eligibility for 
laws of nature, physical phenomena, and abstract ideas.\6\ The Court 
rejected the view of the U.S. Court of Appeals for the Federal Circuit 
(``Federal Circuit'') that the so-called ``machine or transformation 
test'' is the exclusive test for assessing patent eligibility of a 
process.\7\ Under that test, a process claim is patent eligible 
provided it is (1) tied to a particular machine or apparatus, or (2) 
transforms a particular article into a different state or thing.\8\ The 
Court explained that although the machine or transformation test ``is a 
useful and important clue,'' it is ``not the sole test for deciding 
whether an invention is a patent-eligible `process.' '' \9\ The Court 
held that the claims at issue were invalid because they were directed 
to the unpatentable abstract idea of hedging risk in the energy market 
and added only token post-solution components, namely, use of well-
known random analysis techniques to establish inputs.\10\ The Court 
observed that hedging is a long prevalent fundamental economic 
practice, and that allowing the patent claims ``would pre-empt use of 
[risk hedging] in all fields'' and ``effectively grant a monopoly over 
an abstract idea.'' \11\ The Court, however, left open the possibility 
that at least some business methods are patent eligible.\12\
---------------------------------------------------------------------------

    \5\ Bilski v. Kappos, 561 U.S. 593, 599 (2010).
    \6\ Id. at 601.
    \7\ Id. at 604.
    \8\ Id. at 602.
    \9\ Id. at 604.
    \10\ Id. at 612.
    \11\ Id. at 611-12.
    \12\ Id. at 606-07.
---------------------------------------------------------------------------

    Following Bilski, the Supreme Court in Mayo addressed a method for 
optimizing drug dosages for treatment of autoimmune diseases in 
humans.\13\ The inventors discovered the relationship between the 
concentration of a metabolite in the blood following administration of 
the drug and the likelihood that the administered dosage would be 
ineffective or produce harmful side effects.\14\ The inventors obtained 
a patent claiming a method of determining whether a given dosage level 
is too low or too high based on the metabolite level.\15\
---------------------------------------------------------------------------

    \13\ Mayo, 132 S. Ct. at 1294-95.
    \14\ Id. at 1294.
    \15\ Id.
---------------------------------------------------------------------------

    The Court held the claims to be patent ineligible.\16\ In analyzing 
the claims, the Court introduced a two-step framework for 
distinguishing patent ineligible concepts from patent eligible 
applications of those concepts.\17\ The first step is to consider 
whether the claims are directed to a judicially recognized exception to 
patentability, i.e., abstract ideas, laws of nature, or natural 
phenomena.\18\ If so, then the second question is ``whether the claims 
do significantly more than simply describe these natural relations,'' 
i.e., whether additional elements considered separately or as an 
ordered combination ``transform the nature of the claim'' into ``a 
patent-eligible application'' of the judicial exception.\19\ Applying 
the first step of this framework to the claims at issue, the Court 
found that the claims were directed to a law of nature: The 
relationship between the concentration of a particular metabolite in 
the blood and the likelihood that a dosage of a drug will be 
ineffective or harmful.\20\ Assessing the second step, the Court 
determined that the claims did not do ``significantly more'' than 
describe this natural relationship, i.e., the additional elements 
considered separately and as an ordered combination did not ``transform 
the nature of the claim'' into ``a patent-eligible application'' of the 
judicial exception.\21\
---------------------------------------------------------------------------

    \16\ Id. at 1305.
    \17\ Id. at 1296-98; see Alice, 134 S. Ct. at 2355 (summarizing 
two-part test in Mayo).
    \18\ Id. at 1296-97, 1293; see Alice 134 S. Ct. at 2355.
    \19\ Id. at 1297-98; see Alice 134 S. Ct. at 2355.
    \20\ Id. at 1296.
    \21\ Id. at 1297-98.
---------------------------------------------------------------------------

    At issue in Myriad was the patent eligibility of claims to isolated 
DNA (genes) associated with an increased risk of breast cancer, and 
synthetic DNA created from RNA known as complementary DNA (cDNA).\22\ 
The Supreme Court held that the isolated genes ``fell squarely within 
the law of nature exception.'' \23\ The Court explained that 
discovering the location of the genes does not render the genes patent 
eligible, nor does the act of separating them from their surrounding 
genetic material.\24\ While acknowledging that claims to a product 
``with markedly different characteristics from any found in nature'' 
may be patent eligible,\25\ the Court explained that Myriad's claims to 
isolated genes lacked such characteristics because they do not rely on 
any chemical changes resulting from isolation, and are not even 
expressed in terms of chemical composition.\26\ The Court did, however, 
rule that the claimed cDNAs were patent eligible because they differed 
from naturally occurring DNA by the absence of intron regions (i.e., 
non-coding nucleotide sequences).\27\
---------------------------------------------------------------------------

    \22\ Myriad, 133 S. Ct. at 2112-13.
    \23\ Id. at 2117.
    \24\ Id. at 2117-18.
    \25\ Id. at 2117 (quoting Diamond v. Chakrabarty, 447 U.S. 303, 
310 (1980)).
    \26\ Id. at 2118.
    \27\ Id. at 2119.

---------------------------------------------------------------------------

[[Page 71487]]

    Finally, in Alice, the Court reaffirmed the Mayo two-step framework 
and applied it to claims reciting a computer-implemented process, 
computer system, and computer readable medium for mitigating settlement 
risk.\28\ Under step one of the framework, the Court concluded that the 
claims were directed to the abstract idea of intermediated 
settlement.\29\ In assessing step two, the Court considered whether the 
claim elements, individually or as an ordered combination, ```transform 
the nature of the claim' into a patent-eligible application.'' \30\ The 
Court referred to the second step as ``a search for an inventive 
concept--i.e., an element or combination of elements that is sufficient 
to ensure that the patent in practice amounts to significantly more 
than a patent upon the ineligible concept itself.'' \31\ Looking at the 
claims at issue, the Court concluded that mere generic computer 
implementation does not transform the abstract idea into a patent-
eligible invention.\32\ Thus, the court held the process claims, as 
well as the claims to the computer system and computer-readable medium, 
to be patent ineligible.\33\
---------------------------------------------------------------------------

    \28\ Alice, 134 S. Ct. at 2355, 2352.
    \29\ Id. at 2355-57.
    \30\ Id. at 2355 (quoting Mayo, 132 S. Ct. at 1294).
    \31\ Id. (internal quotation marks omitted).
    \32\ Id. at 2357-60.
    \33\ Id. at 1260.
---------------------------------------------------------------------------

    These cases continue to have a substantial effect on patent 
eligibility in the United States. On the one hand, they have overturned 
decades-old USPTO practice regarding patent eligibility of isolated 
genes, placing the United States at odds with the practices of major 
trading partners, including Europe.\34\ On the other hand, the Mayo 
two-step test has generally raised the bar for patent eligibility in 
all fields of technology.
---------------------------------------------------------------------------

    \34\ Directive 98/44/EC of the European Parliament and of the 
Council of 6 July 1998 on the legal protection of biotechnological 
inventions, 1998 O.J. (L 213) 18 (Art. 5(2) provides ``[a]n element 
isolated from the human body or otherwise produced by means of a 
technical process, including the sequence or partial sequence of a 
gene, may constitute a patentable invention, even if the structure 
of that element is identical to that of a natural element.'').
---------------------------------------------------------------------------

    In the wake of these cases, the Federal Circuit has issued several 
decisions applying the Supreme Court test to a broad spectrum of 
subject matter, from the life sciences \35\ to computer-related 
inventions (including business methods).\36\ Although most of the 
Federal Circuit decisions have held claims to be patent ineligible, 
several of the decisions have held claims to be patent eligible.\37\ In 
addition, the USPTO has issued and updated guidance documents to aid 
the public and patent examiners in understanding how these cases apply 
to the patent examination process. In light of the changing landscape 
regarding subject matter eligibility in the United States, the USPTO is 
interested in inviting public discussion on these issues to help 
refine, if necessary, its guidance and to obtain views on the legal 
contours of subject matter eligibility.
---------------------------------------------------------------------------

    \35\ See, e.g., In re Roslin Inst.(Edinburgh), 750 F.3d 1333 
(Fed. Cir. 2014); Univ. of Utah Research Found. v. Ambry Genetics 
Corp., 774 F.3d 755 (Fed. Cir. 2014); Ariosa Diagnostics, Inc. v. 
Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015); Genetic Techs., Ltd. 
v. Merial LLC, 818 F.3d 1369 (Fed. Cir. 2016); Rapid Litigation 
Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016).
    \36\ See, e.g., Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709 
(Fed. Cir. 2014); DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 
1245 (Fed. Cir. 2014); Versata Dev. Group, Inc. v. SAP Am., Inc., 
793 F.3d 1306 (Fed. Cir. 2015); Enfish, LLC v. Microsoft Corp., 822 
F.3d 1327 (Fed. Cir. 2016); Bascom Global Internet Servs., Inc. v. 
AT&T Mobility LLC, 827 F.3d 1341 (Fed. Cir. 2016); McRO, Inc. dba 
Planet Blue v. Bandai Namco Games Am. Inc., No. 2015-1080, 2016 WL 
4896481 (Fed. Cir. September 13, 2016).
    \37\ DDR Holdings, 773 F.3d 1245; Enfish, 822 F.3d 1327; Bascom, 
827 F.3d 1341; Rapid Litigation, 827 F.3d 1042; McRO, 2016 WL 
4896481.
---------------------------------------------------------------------------

2. Topics for Public Comment and Discussion At Roundtable 1: USPTO 
Subject Matter Eligibility Guidelines

    The USPTO has issued a series of guidance documents and training 
examples to instruct examiners on how to apply section 101 during 
examination, which incorporates previously received public input.\38\ 
The most recent documents include the May 2016 Life Sciences examples 
and three memoranda to the Patent Examining Corps: The May 4, 2016 
memorandum titled ``Formulating a Subject Matter Eligibility Rejection 
and Evaluating the Applicant's Response to a Subject Matter Eligibility 
Rejection''; the May 19, 2016 memorandum titled ``Recent Subject Matter 
Eligibility Decisions (Enfish, LLC v. Microsoft Corp. and TLI 
Communications LLC v. A.V. Automotive, LLC); and the July 14, 2016 
memorandum titled ``Recent Subject Matter Eligibility Rulings (Rapid 
Litigation Management v. CellzDirect and Sequenom v. Ariosa).'' The 
USPTO remains interested in feedback from interested stakeholders or 
members of the public to improve the USPTO's subject matter eligibility 
guidance and training examples, and is already accepting comments on 
those documents.\39\ For discussion at Roundtable 1, the Office is 
particularly seeking views and comments on the following:
---------------------------------------------------------------------------

    \38\ See, e.g., 2014 Interim Guidance on Patent Subject Matter 
Eligibility, 79 FR 74,618 (Dec. 16, 2014); July 2015 Update on 
subject Matter Eligibility, 80 FR 45,429 (July 30, 2015); May 2016 
Subject Matter Eligibility Update, 81 FR 27,381 (May 6, 2016); see 
also additional guidance materials available at http://www.uspto.gov/patent/laws-and-regulations/examination-policy/2014-interim-guidance-subject-matter-eligibility-0.
    \39\ May 2016 Subject Matter Eligibility Update, 81 FR 27381 
(May 6, 2016); available at https://www.thefederalregister.org/fdsys/pkg/FR-2016-05-06/pdf/2016-10724.pdf.
---------------------------------------------------------------------------

    1. Suggestions to how to improve the Office's subject matter 
eligibility guidance, particularly the three recent memoranda discussed 
above;
    2. Comments on the May 2016 Life Sciences examples and their effect 
on prosecution of patent applications in the life sciences, and 
suggestions of additional examples, or technology areas in which 
examples would be helpful;
    3. Suggestions on how best to make examiners aware of newly issued 
judicial decisions, and how best to incorporate recent decisions 
holding claims eligible, such as Enfish, Bascom, Rapid Litigation 
Management, and McRO, into the Office's subject matter eligibility 
guidance; and
    4. Concerns on how the Office's subject matter eligibility guidance 
and training examples, or how court decisions, are being applied by 
examiners.

3. Topics for Public Comment and Discussion At Roundtable 2: Exploring 
the Legal Contours of Patent Subject Matter Eligibility

    The public is invited to submit comments on any topics related to 
patent subject matter eligibility under 35 U.S.C. 101 that they deem 
relevant. This roundtable event is not seeking additional input on the 
examiner guidance and training examples referenced above. Instead, the 
USPTO is seeking to promote conversation on how the current section 101 
jurisprudence is evolving; what the optimum legal contours for patent 
eligibility should be; and how best to achieve these goals. 
Specifically, the USPTO would like to facilitate discussion and create 
a public record with relevant information on the actual or perceived 
impact of existing law on particular technology areas, and the effects 
on investment in research and development, and innovation generally. 
The USPTO would appreciate comments on whether developments in patent-
eligibility law should be left primarily to the courts or whether other 
administrative initiatives are desirable. In addition, the USPTO would 
appreciate comments on whether legislative changes are desirable and, 
if so, views on the elements of such changes.

[[Page 71488]]

    To facilitate the launch of this data-gathering exercise, the USPTO 
is particularly interested in receiving views and comments on questions 
presented below. However, the tenor of the questions should not be 
taken as an indication that the USPTO is predisposed to any particular 
views, positions, or actions. The USPTO also invites the public to 
share their views and insights on other aspects of patent subject 
matter eligibility that are not addressed in the questions.

Impact of Judicial Interpretation of Section 101

    1. How has the Supreme Court's interpretation of 35 U.S.C. 101 in 
the past several years affected the enforcement of patents and the 
development of subject-matter-eligibility law? In your response please:
    a. Identify the scope of the problem, including specific examples;
    b. identify any legal and/or technical inaccuracies;
    c. suggest possible changes and/or solutions to any problems with 
section 101; and
    d. provide explanations and/or any legal, policy, or economic 
analyses supporting your comments.

Statutory Categories of Patentable Subject Matter

    To be eligible for patent protection, an invention must comply with 
section 101 of the Patent Act, which limits entitlement to a patent to 
``whoever invents or discovers any new and useful process, machine, 
manufacture, or composition of matter.'' The four categories of 
invention enumerated in the statute--process, machine, manufacture, and 
composition of matter--exhaust the possible types of inventions for 
which a patent may be obtained.
    2. Should the patent statute be amended to further define the 
statutory categories of invention, i.e., process, machine, manufacture, 
and composition of matter? If so, please identify possible legislative 
changes, including which sections of title 35 should be amended, e.g., 
sections 100 or 101.

Exceptions to Patentable Subject Matter

    The Supreme Court has articulated three exceptions to patent 
eligibility under section 101: Laws of nature, natural phenomena, and 
abstract ideas.
    3. Do you think there should be exceptions to patentable subject 
matter?
    a. If no, how should section 101 or other patentability provisions 
operate to address subject matter currently considered to fall within 
judicial exceptions?
    b. If yes, please explain whether the judicial exceptions are 
sufficient in scope and if not, please identify other exceptions that 
should be included in the determination of patent eligible subject 
matter.
    4. Should the patent statute be amended to define the judicial 
exceptions? If so, please suggest possible legislative changes, 
including which sections of title 35 should be amended, e.g., sections 
100 or 101.
    5. If you identified other exceptions in your response to 3(b), 
please suggest possible legislative changes, including which sections 
of title 35 should be amended, e.g., sections 100 or 101.
    6. Other jurisdictions, e.g., Europe and Japan, provide examples of 
subject matter that does not qualify as an invention or discovery for 
purposes of patent eligibility. For example, in Europe, scientific 
theories, methods for performing mental acts, computer programs per se, 
and presentations of information are not regarded as inventions.
    a. Do you think that title 35 should be amended to revise the 
definition for the term ``invention'' and/or provide a definition for 
the term ``discovery'' along with specific examples of subject matter 
that should not be treated as an invention and/or discovery?
    b. If so, please suggest possible legislative changes, including 
which sections of title 35 should be amended, e.g., sections 100 or 
101.
    7. Does the concept of preemption, either separately or in the 
context of the Mayo two-step framework, capture useful insight in 
guarding against the issuance of overly broad patents? If so, please 
suggest possible legislative changes to capture those insights.

Patentable Subject Matter in the Life Sciences

    8. What does the term ``discovery'' in sections 100 and 101 mean, 
and to what extent should a ``discovery'' be eligible for a patent? 
Please provide specific examples.
    9. What does the term ``invention'' in sections 100 and 101 mean, 
and to what extent should a non-naturally occurring product of human 
ingenuity qualify as an ``invention'' to be eligible for a patent? 
Please provide specific examples.
    10. To what extent should products that have been isolated from 
their natural surroundings as a result of human ingenuity be eligible 
for a patent? Please provide specific examples as well as scientific 
explanations and/or legal analyses to support your response.
    11. To what extent should a ``diagnostic method'' be eligible for a 
patent? Please provide specific examples.
    12. Are there lines that can or should be drawn scientifically or 
legislatively between different types of compositions of matter for 
purposes of obtaining patent protection (e.g., between human genes and 
genes of other species)?
    13. What particular inventions or specific types of technologies 
that should be patent eligible are not patent eligible, or are likely 
to be challenged as patent ineligible, under Mayo/Myriad? Please 
provide specific examples and explain why you believe claim drafting 
strategies will not be sufficient to avoid patent eligibility problems.

Process Patents and the Machine or Transformation Test

    14. Should patents be available for methods that do not involve a 
machine or a transformation? If so, please provide specific examples.
    15. If you support some form of ``machine or transformation test,'' 
please identify the best expression of such a test.
    a. Should incorporation of the use of a general purpose computer be 
enough to satisfy the ``machine'' part of the test? If not, what more 
should be required?
    b. Should a transformation that occurs in the human body as a 
result of a claimed process be enough to satisfy the ``transformation'' 
part of the test? If not, what more should be required?

Patentability of Business Methods

    16. To what extent should an invention that involves a business 
method be eligible for a patent? Please provide specific examples.

Patentability of Software/Computer-Related Inventions

    17. To what extent should an invention that involves computer 
software be eligible for a patent? Please provide specific examples.
    18. What mechanisms, other than the judicial exceptions, can be 
used to prevent issuance of overly broad software or computer-related 
patents that cover wide swaths of economic activity? Do you think that 
other provisions of title 35 (enablement, written description, 
definiteness, novelty, non-obviousness) could be used more effectively 
to achieve this goal? If not, please explain why.

Roundtable 1: USPTO Subject Matter Eligibility Guidelines

    Requests to Speak: Individuals interested in speaking at Roundtable 
1 must complete the on-line registration

[[Page 71489]]

no later than October 26, 2016, and include their name, contact 
information (telephone number and email address), the organization(s) 
the person represents, if any, the topics they wish to address, and the 
approximate length of the presentation. To ensure a balanced array of 
views, there is the possibility that not all persons who wish to make a 
presentation will be able to do so given time constraints; however, the 
USPTO will do its best to try to accommodate as many persons as 
possible. Selected speakers will be notified thereafter. However, all 
members of the public are encouraged to submit written comments by 
electronic mail message via the Internet addressed to 
[email protected].
    The public is invited to speak at Roundtable 1 by appearing, in 
person, at the USPTO in Alexandria, Virginia or one of the following 
USPTO Regional Offices: the Midwest Regional Office, 300 River Place 
Drive, Suite 2900, Detroit, Michigan 48207; The Rocky Mountain Regional 
Office, 1961 Stout Street, Denver, Colorado 80294; the West Coast 
Regional Office, 26 S. Fourth Street, San Jose, California 95113; or 
the Texas Regional Office, 207 South Houston Street, Suite 159, Dallas, 
Texas 75202. Individuals requesting to speak at one of the 
aforementioned Regional Offices will be provided with the opportunity 
to speak at the roundtable and engage with USPTO representatives in 
Alexandria, Virginia in real time. If requesting to speak at this 
roundtable, please check the appropriate location when completing the 
on-line registration.
    Public Availability of Transcripts and Public Comments: The 
transcript of Roundtable 1 and the written comments submitted on the 
USPTO's subject matter eligibility guidance and training examples will 
be made available for public inspection upon request at the Office of 
the Commissioner for Patents, located at 600 Dulany Street, Madison 
East Building, Tenth Floor, Alexandria, Virginia and via address: 
http://www.uspto.gov.

Roundtable 2: Exploring the Legal Contours of Patent Subject Matter 
Eligibility

    Requests to Speak: Individuals interested in speaking at Roundtable 
2 must complete the on-line registration no later than November 14, 
2016, and include their name, contact information (telephone number and 
email address), the organization(s) the person represents, if any, the 
topics they wish to address, and the approximate length of the 
presentation. To ensure a balanced array of views, there is the 
possibility that not all persons who wish to make a presentation will 
be able to do so given time constraints; however, the USPTO will do its 
best to try to accommodate as many persons as possible. Selected 
speakers will be notified thereafter. However, all members of the 
public are encouraged to submit written comments by electronic mail 
message via the Internet addressed to [email protected].
    The public is invited to speak at Roundtable 2 by appearing, in 
person, at Stanford University, Stanford, California or at one of the 
following USPTO Regional Offices: The Midwest Regional Office, 300 
River Place Drive, Suite 2900, Detroit, Michigan 48207; the Rocky 
Mountain Regional Office, 1961 Stout Street, Denver, Colorado 80294; or 
the Texas Regional Office, 207 South Houston Street, Suite 159, Dallas, 
Texas 75202. Individuals requesting to speak at one of the 
aforementioned Regional Offices will be provided with the opportunity 
to speak at the roundtable and engage with USPTO representatives in 
Stanford, California in real time. If requesting to speak at this 
roundtable, please check the appropriate location when completing the 
on-line registration.
    Public Availability of Transcripts and Public Comments: The 
transcript of Roundtable 2 and the written comments submitted will be 
made available for public inspection upon request at the Office of 
Policy and International Affairs in the Executive Library located at 
600 Dulany Street, Madison West Building, Tenth Floor, Alexandria, 
Virginia, 22314, telephone number 571-272-9300 and via the Roundtable 2 
Web page www.uspto.gov/patent/laws-and-regulations/comments-public/notice-roundtables-and-request-comments-related-patent.
    Special Accommodations for Roundtables 1 and 2: The roundtables 
will be physically accessible to people with disabilities. Individuals 
requiring accommodation, such as sign language interpretation or other 
ancillary aids, should communicate their needs to Elizabeth Shaw, by 
telephone at 571-272-9300, by email at [email protected], or by 
postal mail addressed to: Mail Stop OPIA, United States Patent and 
Trademark Office, P.O. Box 1450, Alexandria, Virginia 22313-1450, ATTN: 
Elizabeth Shaw, at least seven (7) business days prior to the 
roundtable.

     Dated: October 11, 2016.
Michelle K. Lee,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2016-24888 Filed 10-14-16; 8:45 am]
 BILLING CODE 3510-16-P
71486 Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices

at 5:00 p.m. PST. The roundtable will and abstract ideas.6 The Court rejected recognized exception to patentability,
also be available via webcast enabling the view of the U.S. Court of Appeals for i.e., abstract ideas, laws of nature, or
individuals who cannot attend in the Federal Circuit (‘‘Federal Circuit’’) natural phenomena.18 If so, then the
person to watch the roundtable via the that the so-called ‘‘machine or second question is ‘‘whether the claims
Internet in real time. The agenda and transformation test’’ is the exclusive test do significantly more than simply
webcast information will be available for assessing patent eligibility of a describe these natural relations,’’ i.e.,
before the roundtable on the USPTO’s process.7 Under that test, a process whether additional elements considered
Roundtable 2 Web page www.uspto.gov/ claim is patent eligible provided it is (1) separately or as an ordered combination
patent/laws-and-regulations/comments- tied to a particular machine or ‘‘transform the nature of the claim’’ into
public/notice-roundtables-and-request- apparatus, or (2) transforms a particular ‘‘a patent-eligible application’’ of the
comments-related-patent. On-line article into a different state or thing.8 judicial exception.19 Applying the first
registration will be available from that The Court explained that although the step of this framework to the claims at
Web page, and attendees may register at machine or transformation test ‘‘is a issue, the Court found that the claims
the door. Attendees are encouraged to useful and important clue,’’ it is ‘‘not were directed to a law of nature: The
register on-line before the roundtable. the sole test for deciding whether an relationship between the concentration
Written Comments: For those wishing invention is a patent-eligible of a particular metabolite in the blood
to submit written comments on the ‘process.’ ’’ 9 The Court held that the and the likelihood that a dosage of a
topics to be addressed by Roundtable 2, claims at issue were invalid because drug will be ineffective or harmful.20
the deadline for receipt of those they were directed to the unpatentable Assessing the second step, the Court
comments for consideration by the abstract idea of hedging risk in the determined that the claims did not do
USPTO is January 18, 2017. Written energy market and added only token ‘‘significantly more’’ than describe this
comments should be sent by electronic post-solution components, namely, use natural relationship, i.e., the additional
mail message via the Internet addressed of well-known random analysis elements considered separately and as
to 101Roundtable2@uspto.gov. techniques to establish inputs.10 The an ordered combination did not
Because comments will be made Court observed that hedging is a long ‘‘transform the nature of the claim’’ into
available for public inspection, prevalent fundamental economic ‘‘a patent-eligible application’’ of the
information that is not desired to be practice, and that allowing the patent judicial exception.21
made public, such as an address or claims ‘‘would pre-empt use of [risk
phone number, should not be included hedging] in all fields’’ and ‘‘effectively At issue in Myriad was the patent
in the comments. grant a monopoly over an abstract eligibility of claims to isolated DNA
idea.’’ 11 The Court, however, left open (genes) associated with an increased risk
1. Background of breast cancer, and synthetic DNA
the possibility that at least some
As the world’s most innovative business methods are patent eligible.12 created from RNA known as
economy, the United States relies Following Bilski, the Supreme Court complementary DNA (cDNA).22 The
heavily on intellectual property to in Mayo addressed a method for Supreme Court held that the isolated
support economic growth and business optimizing drug dosages for treatment of genes ‘‘fell squarely within the law of
development. The U.S. patent system is autoimmune diseases in humans.13 The nature exception.’’ 23 The Court
a critical piece of the nation’s robust inventors discovered the relationship explained that discovering the location
system of intellectual property rights. between the concentration of a of the genes does not render the genes
To obtain patent protection, the metabolite in the blood following patent eligible, nor does the act of
requirement of subject matter eligibility administration of the drug and the separating them from their surrounding
under 35 U.S.C. 101 must be satisfied. likelihood that the administered dosage genetic material.24 While
Over the past six years, the Supreme would be ineffective or produce harmful acknowledging that claims to a product
Court has issued a series of decisions— side effects.14 The inventors obtained a ‘‘with markedly different characteristics
Bilski,1 Mayo,2 Myriad,3 and Alice 4—that patent claiming a method of from any found in nature’’ may be
have significantly impacted patent determining whether a given dosage patent eligible,25 the Court explained
eligibility law and continue to generate level is too low or too high based on the that Myriad’s claims to isolated genes
substantial public debate. These cases metabolite level.15 lacked such characteristics because they
are briefly summarized below. The Court held the claims to be patent do not rely on any chemical changes
Bilski, decided in 2010, involved a ineligible.16 In analyzing the claims, the resulting from isolation, and are not
business method for hedging risk.5 In Court introduced a two-step framework even expressed in terms of chemical
analyzing patent eligibility, the for distinguishing patent ineligible composition.26 The Court did, however,
Supreme Court recognized that section concepts from patent eligible rule that the claimed cDNAs were
101 specifies four independent applications of those concepts.17 The patent eligible because they differed
categories of inventions or discoveries first step is to consider whether the from naturally occurring DNA by the
that are eligible for patent protection claims are directed to a judicially absence of intron regions (i.e., non-
(processes, machines, manufactures, coding nucleotide sequences).27
and compositions of matter), but 6 Id. at 601.

judicial precedent provides three 7 Id. at 604. 18 Id. at 1296–97, 1293; see Alice 134 S. Ct. at

specific exceptions to patent eligibility 8 Id. at 602. 2355.
for laws of nature, physical phenomena, 9 Id. at 604. 19 Id. at 1297–98; see Alice 134 S. Ct. at 2355.
10 Id. at 612. 20 Id. at 1296.
jstallworth on DSK7TPTVN1PROD with NOTICES

1 Bilski 11 Id. at 611–12. 21 Id. at 1297–98.
v. Kappos, 561 U.S. 593 (2010).
2 Mayo Collaborative Servs. v. Prometheus Labs., 12 Id. at 606–07. 22 Myriad, 133 S. Ct. at 2112–13.

Inc., __U.S.__, 132 S. Ct. 1289 (2012). 13 Mayo, 132 S. Ct. at 1294–95. 23 Id. at 2117.

3 Ass’n for Molecular Pathology v. Myriad 14 Id. at 1294. 24 Id. at 2117–18.

Genetics, Inc., __U.S.__, 133 S. Ct. 2107 (2013). 15 Id. 25 Id. at 2117 (quoting Diamond v. Chakrabarty,
4 Alice Corp. v. CLS Bank Int’l, __U.S.__, 134 S. 16 Id. at 1305. 447 U.S. 303, 310 (1980)).
Ct. 2347 (2014). 17 Id. at 1296–98; see Alice, 134 S. Ct. at 2355 26 Id. at 2118.
5 Bilski v. Kappos, 561 U.S. 593, 599 (2010). (summarizing two-part test in Mayo). 27 Id. at 2119.

VerDate Sep<11>2014 14:22 Oct 14, 2016 Jkt 241001 PO 00000 Frm 00012 Fmt 4703 Sfmt 4703 E:\FR\FM\17OCN1.SGM 17OCN1
Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices 71489

no later than October 26, 2016, and possibility that not all persons who Dated: October 11, 2016.
include their name, contact information wish to make a presentation will be able Michelle K. Lee,
(telephone number and email address), to do so given time constraints; Under Secretary of Commerce for Intellectual
the organization(s) the person however, the USPTO will do its best to Property and Director of the United States
represents, if any, the topics they wish try to accommodate as many persons as Patent and Trademark Office.
to address, and the approximate length possible. Selected speakers will be [FR Doc. 2016–24888 Filed 10–14–16; 8:45 am]
of the presentation. To ensure a notified thereafter. However, all BILLING CODE 3510–16–P
balanced array of views, there is the members of the public are encouraged to
possibility that not all persons who submit written comments by electronic
wish to make a presentation will be able DEPARTMENT OF DEFENSE
mail message via the Internet addressed
to do so given time constraints;
to 101Roundtable2@uspto.gov.
however, the USPTO will do its best to Department of the Army
try to accommodate as many persons as The public is invited to speak at
Roundtable 2 by appearing, in person, at [Docket ID: USA–2015–0015]
possible. Selected speakers will be
notified thereafter. However, all Stanford University, Stanford, California Submission for OMB Review;
members of the public are encouraged to or at one of the following USPTO Comment Request
submit written comments by electronic Regional Offices: The Midwest Regional
mail message via the Internet addressed Office, 300 River Place Drive, Suite ACTION: Notice.
to 2014_interim_guidance@uspto.gov. 2900, Detroit, Michigan 48207; the
The public is invited to speak at Rocky Mountain Regional Office, 1961 SUMMARY: The Department of Defense
Roundtable 1 by appearing, in person, at Stout Street, Denver, Colorado 80294; or has submitted to OMB for clearance, the
the USPTO in Alexandria, Virginia or following proposal for collection of
the Texas Regional Office, 207 South
one of the following USPTO Regional information under the provisions of the
Houston Street, Suite 159, Dallas, Texas
Offices: the Midwest Regional Office, Paperwork Reduction Act.
75202. Individuals requesting to speak
300 River Place Drive, Suite 2900, DATES: Consideration will be given to all
at one of the aforementioned Regional
Detroit, Michigan 48207; The Rocky comments received by November 16,
Mountain Regional Office, 1961 Stout Offices will be provided with the
2016.
Street, Denver, Colorado 80294; the opportunity to speak at the roundtable
and engage with USPTO representatives FOR FURTHER INFORMATION CONTACT: Fred
West Coast Regional Office, 26 S. Fourth Licari, 571–372–0493.
Street, San Jose, California 95113; or the in Stanford, California in real time. If
requesting to speak at this roundtable, SUPPLEMENTARY INFORMATION:
Texas Regional Office, 207 South
please check the appropriate location Title, Associated Form and OMB
Houston Street, Suite 159, Dallas, Texas
when completing the on-line Number: Recreation Area and Visitor
75202. Individuals requesting to speak
registration. Center Visitor Comment Cards; OMB
at one of the aforementioned Regional
Control Number 0710–XXXX.
Offices will be provided with the Public Availability of Transcripts and Type of Request: New.
opportunity to speak at the roundtable Public Comments: The transcript of Number of Respondents: 45,000.
and engage with USPTO representatives Roundtable 2 and the written comments Responses per Respondent: 1.
in Alexandria, Virginia in real time. If submitted will be made available for Annual Responses: 45,000.
requesting to speak at this roundtable, public inspection upon request at the Average Burden per Response: 5
please check the appropriate location minutes.
Office of Policy and International
when completing the on-line Annual Burden Hours: 3,750.
registration. Affairs in the Executive Library located
Needs and Uses: The information
Public Availability of Transcripts and at 600 Dulany Street, Madison West
collection requirement is necessary to
Public Comments: The transcript of Building, Tenth Floor, Alexandria,
understand and determine the
Roundtable 1 and the written comments Virginia, 22314, telephone number 571–
satisfaction of recreation visitors to US
submitted on the USPTO’s subject 272–9300 and via the Roundtable 2 Web Army Corps of Engineers managed
matter eligibility guidance and training page www.uspto.gov/patent/laws-and- recreation areas.
examples will be made available for regulations/comments-public/notice- Affected Public: Individuals or
public inspection upon request at the roundtables-and-request-comments- households.
Office of the Commissioner for Patents, related-patent. Frequency: On occasion.
located at 600 Dulany Street, Madison Special Accommodations for Respondent’s Obligation: Voluntary.
East Building, Tenth Floor, Alexandria, Roundtables 1 and 2: The roundtables OMB Desk Officer: Ms. Jasmeet
Virginia and via address: http:// will be physically accessible to people Seehra.
www.uspto.gov. Comments and recommendations on
with disabilities. Individuals requiring
the proposed information collection
Roundtable 2: Exploring the Legal accommodation, such as sign language should be emailed to Ms. Jasmeet
Contours of Patent Subject Matter interpretation or other ancillary aids, Seehra, DoD Desk Officer, at Oira_
Eligibility should communicate their needs to submission@omb.eop.gov. Please
Requests to Speak: Individuals Elizabeth Shaw, by telephone at 571– identify the proposed information
interested in speaking at Roundtable 2 272–9300, by email at elizabeth.shaw2@ collection by DoD Desk Officer and the
must complete the on-line registration uspto.gov, or by postal mail addressed Docket ID number and title of the
no later than November 14, 2016, and to: Mail Stop OPIA, United States Patent
jstallworth on DSK7TPTVN1PROD with NOTICES

information collection.
include their name, contact information and Trademark Office, P.O. Box 1450, You may also submit comments and
(telephone number and email address), Alexandria, Virginia 22313–1450, recommendations, identified by Docket
the organization(s) the person ATTN: Elizabeth Shaw, at least seven ID number and title, by the following
represents, if any, the topics they wish (7) business days prior to the method:
to address, and the approximate length roundtable. • Federal eRulemaking Portal: http://
of the presentation. To ensure a www.regulations.gov. Follow the
balanced array of views, there is the instructions for submitting comments.

VerDate Sep<11>2014 14:22 Oct 14, 2016 Jkt 241001 PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 E:\FR\FM\17OCN1.SGM 17OCN1
Document Created: 2016-10-15 01:52:11
Document Modified: 2016-10-15 01:52:11
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of public roundtables and request for comments related to patent subject matter eligibility.
Dates		The meeting dates are:
Contact		Requests for additional information regarding registration and speaker presentations should be directed to the attention of Elizabeth Shaw, by telephone at 571-272-9300, or by email at [email protected] Requests for additional information regarding the topics for written comments and discussion at Roundtable 1 should be directed to Carolyn Kosowski, by telephone at 571-272-7688, or by email at [email protected] Requests for additional information regarding the topics for written comments and discussion at Roundtable 2 should be directed to Amy Nelson, by telephone at 571-272- 8978, or by email at [email protected]
FR Citation		81 FR 71485
81 FR 71485 - Notice of Roundtables and Request for Comments Related to Patent Subject Matter Eligibility

DEPARTMENT OF COMMERCEPatent and Trademark Office

Federal Register Volume 81, Issue 200 (October 17, 2016)

DEPARTMENT OF COMMERCE
Patent and Trademark Office
