[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]gov.
    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]
 BILLING CODE 3510-16-P