| Examination Instructions and Guidelines |
Referenced Items (219, 220, 221, 222, 223, 224, 225, 226, 227, 228, 229, 230, 231, 232, 233, 234, 235, 236, 237, 238) |
(219) 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.
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. Additionally 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: Eligibility2018@uspto.gov.
Electronic comments submitted in plain text are preferred, but also may
be submitted in ADOBE® portable document format or MICROSOFT WORD® format.
Comments not submitted electronically should be submitted on paper in a
format that facilitates convenient digital scanning into ADOBE® 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
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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.
\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).
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 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 § 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 § 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\
\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
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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").
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 § 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 § 2106.07(a) (Formulating a Rejection For
Lack of Subject Matter Eligibility) and MPEP § 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 § 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
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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.
\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).
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 applicant's challenge to official
notice are discussed in MPEP § 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.
April 18, 2018 ANDREI IANCU
Under Secretary of Commerce for Intellectual Property and
Director of the United States Patent and Trademark Office
[1450 OG 226]