[Federal Register Volume 83, Number 77 (Friday, April 20, 2018)]
[Notices]
[Pages 17536-17538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08428]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No.: PTO-P-2018-0033]
Request for Comments on Determining Whether a Claim Element Is
Well-Understood, Routine, Conventional for Purposes of Subject Matter
Eligibility
AGENCY: United States Patent and Trademark Office, Commerce.
ACTION: Request for comments.
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SUMMARY: The U.S. Court of Appeals for the Federal Circuit (Federal
Circuit) recently issued a decision regarding the inquiry of whether a
claim limitation represents well-understood, routine, conventional
activities (or elements) to a skilled artisan in the relevant field.
Specifically, the Federal Circuit found that whether a claim element,
or combination of elements, represents well-understood, routine,
conventional activities to a skilled artisan in the relevant field is a
question of fact. The United States Patent and Trademark Office (USPTO)
has implemented this decision in a memorandum recently issued to the
Patent Examining Corps (the Berkheimer memorandum). The Berkheimer
memorandum is available to the public on the USPTO's internet website.
Examiners had been previously instructed to conclude that an element
(or combination of elements) is well-understood, routine, conventional
activity only when the examiner can readily conclude that the
element(s) is widely prevalent or in common use in the relevant
industry. The Berkheimer memorandum now clarifies that such a
conclusion must be based upon a factual determination that is supported
as discussed in the memorandum. Aditionally the Berkheimer memorandum
now also specifies that the analysis for determining whether an element
(or combination of elements) is widely prevalent or in common use is
the same as the analysis under 35 U.S.C. 112(a) as to whether an
element is so well-known that it need not be described in detail in the
patent specification. The USPTO is now seeking public comment on its
subject matter eligibility guidance, and particularly its guidance in
the Berkheimer memorandum to the Patent Examining Corps.
DATES: Comment Deadline Date: Written comments must be received on or
before August 20, 2018.
ADDRESSES: Comments must be sent by electronic mail message over the
internet addressed to: [email protected].
Electronic comments submitted in plain text are preferred, but also
may be submitted in ADOBE[supreg] portable document format or MICROSOFT
WORD[supreg] format. Comments not submitted electronically should be
submitted on paper in a format that facilitates convenient digital
scanning into ADOBE[supreg] portable document format. The comments will
be available for viewing via the USPTO's internet website (http://www.uspto.gov). Because comments will be made available for public
inspection, information that the submitter does not desire to make
public, such as an address or phone number, should not be included in
the comments.
FOR FURTHER INFORMATION CONTACT: Carolyn Kosowski, Senior Legal
Advisor, at 571-272-7688 or Matthew Sked, Senior Legal Advisor, at 571-
272-7627, both with the Office of Patent Legal Administration.
SUPPLEMENTARY INFORMATION:
I. Federal Circuit Decision in Berkheimer: The Federal Circuit
recently issued a precedential decision holding that the question of
whether certain claim limitations are well-understood, routine,
conventional elements raised a disputed factual issue, which precluded
summary judgment that all of the claims at issue were not patent
eligible. See Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018).
Shortly thereafter, the Federal Circuit reaffirmed the Berkheimer
standard in the context of a judgment on the pleadings and judgment as
a matter of law.\1\ While summary judgment, judgment on the pleadings,
and judgment as a matter of law standards in civil litigation are
generally inapplicable during the patent examination process, these
decisions inform the inquiry into whether an additional element (or
combination of additional elements) represents well-understood,
routine, conventional activity. The USPTO has implemented this decision
in the Berkheimer memorandum, which was recently issued to the Patent
Examining Corps and is available to the public on the USPTO's internet
website.
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\1\ See Aatrix Software, Inc. v. Green Shades Software, Inc.,
882 F.3d 1121 (Fed. Cir. 2018) (reversing a judgment on the
pleadings of ineligibility, finding that whether the claims in the
challenged patent perform well-understood, routine, conventional
activities is an issue of fact); Exergen Corp. v. Kaz USA, Inc.,
Nos. 2016-2315, 2016-2341, 2018 WL 1193529, at *1 (Fed. Cir. Mar. 8,
2018) (non-precedential) (affirming a district court's denial of a
motion for judgment as a matter of law of patent ineligibility, thus
upholding the district court's conclusion that the claims were drawn
to a patent eligible invention, concluding that the district court's
fact finding that the claimed combination was not proven to be well-
understood, routine, conventional was not clearly erroneous).
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The USPTO recognizes that unless careful consideration is given to
the particular contours of subject matter eligibility (35 U.S.C. 101),
it could ``swallow all of patent law.'' Alice Corp. v. CLS Bank
International, 573 U.S. ___, ___, 134 S. Ct. 2347, 2352 (2014) (citing
Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71
(2012)). The Berkheimer memorandum provides additional USPTO guidance
that will further clarify how the USPTO is determining subject matter
eligibility in accordance with prevailing jurisprudence. Specifically,
the Berkheimer memorandum addresses the limited question of whether an
additional element (or combination of additional elements) represents
well-understood, routine, conventional activity. The USPTO is
determined to continue its mission to provide clear and predictable
patent rights in accordance with this rapidly evolving area of the law
and, to that end, may issue further guidance in the future.
II. Well-Understood, Routine, Conventional Activity: The USPTO's
current understanding of the judicial framework distinguishing patents
and applications that claim laws of nature, natural phenomena, and
abstract ideas from those that claim patent-eligible
[[Page 17537]]
applications of those concepts--the Mayo-Alice framework--is set forth
in section 2106 of the Manual of Patent Examining Procedure (MPEP).
While the Berkheimer decision does not change the basic subject matter
eligibility framework as set forth in MPEP Sec. 2106, it does provide
clarification as to the inquiry into whether an additional element (or
combination of additional elements) represents well-understood,
routine, conventional activity. Specifically, the Federal Circuit held
that ``[w]hether something is well-understood, routine, and
conventional to a skilled artisan at the time of the patent is a
factual determination.'' Berkheimer, 881 F.3d at 1369.
As set forth in MPEP Sec. 2106.05(d)(I), an examiner should
conclude that an element (or combination of elements) represents well-
understood, routine, conventional activity only when the examiner can
readily conclude that the element(s) is widely prevalent or in common
use in the relevant industry. The Berkheimer memorandum clarifies that
such a conclusion must be based upon a factual determination that is
supported as discussed in section III below. The Berkheimer memorandum
further clarifies that the analysis as to whether an element (or
combination of elements) is widely prevalent or in common use is the
same as the analysis under 35 U.S.C. 112(a) as to whether an element is
so well-known that it need not be described in detail in the patent
specification.\2\
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\2\ See Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1377
(Fed. Cir. 2016) (supporting the position that amplification was
well-understood, routine, conventional for purposes of subject
matter eligibility by observing that the patentee expressly argued
during prosecution of the application that amplification was a
technique readily practiced by those skilled in the art to overcome
the rejection of the claim under 35 U.S.C. 112, first paragraph);
see also Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co.,
730 F.2d 1452, 1463 (Fed. Cir. 1984) (``[T]he specification need not
disclose what is well known in the art.''); In re Myers, 410 F.2d
420, 424 (CCPA 1969) (``A specification is directed to those skilled
in the art and need not teach or point out in detail that which is
well-known in the art.''); Exergen Corp., 2018 WL 1193529, at *4
(holding that ``[l]ike indefiniteness, enablement, or obviousness,
whether a claim is directed to patent eligible subject matter is a
question of law based on underlying facts,'' and noting that the
Supreme Court has recognized that ``the inquiry `might sometimes
overlap' with other fact-intensive inquiries like novelty under 35
U.S.C. 102'').
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The question of whether additional elements represent well-
understood, routine, conventional activity is distinct from
patentability over the prior art under 35 U.S.C. 102 and 103. This is
because a showing that additional elements are obvious under 35 U.S.C.
103, or even that they lack novelty under 35 U.S.C. 102, is not by
itself sufficient to establish that the additional elements are well-
understood, routine, conventional activities or elements to those in
the relevant field. See MPEP Sec. 2106.05. As the Federal Circuit
explained: ``[w]hether a particular technology is well-understood,
routine, and conventional goes beyond what was simply known in the
prior art. The mere fact that something is disclosed in a piece of
prior art, for example, does not mean it was well-understood, routine,
and conventional.'' Berkheimer, 881 F.3d at 1369.
III. Impact on Examination Procedure: The Berkheimer memorandum
revises the procedures set forth in MPEP Sec. 2106.07(a) (Formulating
a Rejection For Lack of Subject Matter Eligibility) and MPEP Sec.
2106.07(b) (Evaluating Applicant's Response).
A. Formulating Rejections: In a step 2B analysis, an additional
element (or combination of elements) is not well-understood, routine or
conventional unless the examiner finds, and expressly supports a
rejection in writing with, one or more of the following:
1. A citation to an express statement in the specification or to a
statement made by an applicant during prosecution that demonstrates the
well-understood, routine, conventional nature of the additional
element(s). A specification demonstrates the well-understood, routine,
conventional nature of additional elements when it describes the
additional elements as well-understood or routine or conventional (or
an equivalent term), as a commercially available product, or in a
manner that indicates that the additional elements are sufficiently
well-known that the specification does not need to describe the
particulars of such additional elements to satisfy 35 U.S.C. 112(a). A
finding that an element is well-understood, routine, or conventional
cannot be based only on the fact that the specification is silent with
respect to describing such element.
2. A citation to one or more of the court decisions discussed in
MPEP Sec. 2106.05(d)(II) as noting the well-understood, routine,
conventional nature of the additional element(s).
3. A citation to a publication that demonstrates the well-
understood, routine, conventional nature of the additional element(s).
An appropriate publication could include a book, manual, review
article, or other source that describes the state of the art and
discusses what is well-known and in common use in the relevant
industry. It does not include all items that might otherwise qualify as
a ``printed publication'' as used in 35 U.S.C. 102.\3\ Whether
something is disclosed in a document that is considered a ``printed
publication'' under 35 U.S.C. 102 is a distinct inquiry from whether
something is well-known, routine, conventional activity. A document may
be a printed publication but still fail to establish that something it
describes is well-understood, routine, conventional activity. See
Exergen Corp., 2018 WL 1193529, at *4 (the single copy of a thesis
written in German and located in a German university library considered
to be a ``printed publication'' in Hall ``would not suffice to
establish that something is `well-understood, routine, and conventional
activity previously engaged in by scientists who work in the field'
''). The nature of the publication and the description of the
additional elements in the publication would need to demonstrate that
the additional elements are widely prevalent or in common use in the
relevant field, comparable to the types of activity or elements that
are so well-known that they do not need to be described in detail in a
patent application to satisfy 35 U.S.C. 112(a). For example, while U.S.
patents and published applications are publications, merely finding the
additional element in a single patent or published application would
not be sufficient to demonstrate that the additional element is well-
understood, routine, conventional, unless the patent or published
application demonstrates that the additional element are widely
prevalent or in common use in the relevant field.
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\3\ See, e.g., In re Klopfenstein, 380 F.3d 1345 (Fed. Cir.
2004) (publicly displayed slide presentation); In re Hall, 781 F.2d
897 (Fed. Cir. 1986) (doctoral thesis shelved in a library); Mass.
Inst. of Tech. v. AB Fortia, 774 F.2d 1104, 1108-09 (Fed. Cir. 1985)
(paper orally presented at a scientific meeting and distributed upon
request); In re Wyer, 655 F.2d 221 (CCPA 1981) (patent application
laid open to public inspection).
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4. A statement that the examiner is taking official notice of the
well-understood, routine, conventional nature of the additional
element(s). This option should be used only when the examiner is
certain, based upon his or her personal knowledge, that the additional
element(s) represents well-understood, routine, conventional activity
engaged in by those in the relevant art, in that the additional
elements are widely prevalent or in common use in the relevant field,
comparable to the types of activity or elements that are so well-known
that they do not need to be described in detail in a patent application
to satisfy 35 U.S.C. 112(a). Procedures for taking official notice and
addressing an
[[Page 17538]]
applicant's challenge to official notice are discussed in MPEP Sec.
2144.03.
B. Evaluating Applicant's Response: If an applicant challenges the
examiner's position that the additional element(s) is well-understood,
routine, conventional activity, the examiner should reevaluate whether
it is readily apparent that the additional elements are in actuality
well-understood, routine, conventional activities to those who work in
the relevant field. If the examiner has taken official notice per
paragraph (4) of section (III)(A) above that an element(s) is well-
understood, routine, conventional activity, and the applicant
challenges the examiner's position, specifically stating that such
element(s) is not well-understood, routine, conventional activity, the
examiner must then provide one of the items discussed in paragraphs (1)
through (3) of section (III)(A) above, or an affidavit or declaration
under 37 CFR 1.104(d)(2) setting forth specific factual statements and
explanation to support his or her position. As discussed previously, to
represent well-understood, routine, conventional activity, the
additional elements must be widely prevalent or in common use in the
relevant field, comparable to the types of activity or elements that
are so well-known that they do not need to be described in detail in a
patent application to satisfy 35 U.S.C. 112(a).
The MPEP will be updated in due course to incorporate the changes
put into effect the Berkheimer memorandum.
As discussed previously, the Berkheimer memorandum is available to
the public on the USPTO's internet website. The USPTO is seeking public
comment on its subject matter eligibility guidance, and particularly
its guidance in the Berkheimer memorandum.
Dated: April 18, 2018.
Andrei Iancu,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. 2018-08428 Filed 4-19-18; 8:45 am]
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