|Examination Instructions and Guidelines
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(221) DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
37 CFR Part 1
[Docket No.: PTO-P-2016-0003]
May 2016 Subject Matter Eligibility Update
AGENCY: United States Patent and Trademark Office, Commerce.
ACTION: Request for comments.
SUMMARY: The United States Patent and Trademark Office (USPTO) issued the
July 2015 Update: Subject Matter Eligibility (July 2015 Update) to provide
further guidance to examiners in determining subject matter eligibility
under 35 U.S.C. 101. The USPTO announced the July 2015 Update in the
Federal Register, and sought public comment on the July 2015 Update. The
USPTO has since issued a memorandum to the Patent Examining Corps titled
"Formulating a Subject Matter Eligibility Rejection and Evaluating the
Applicant's Response to a Subject Matter Eligibility Rejection" in response
to those public comments, which is available to the public on the USPTO's
Internet Web site. The memorandum seeks to improve examiner correspondence
with regard to subject matter eligibility rejections. Further, additional
life science examples to assist examiners in making eligibility
determinations have been published and are available on the USPTO's
Internet Web site. The USPTO is now seeking public comment on subject
matter eligibility on an on-going basis.
DATES: The comment period is open-ended, and comments will be accepted on
an ongoing basis.
ADDRESSES: Comments must be sent by electronic mail message over the
Internet addressed to: email@example.com. Electronic comments
submitted in plain text are preferred, but also may be submitted in ADOBE®
portable document format or MICROSOFT WORD® format. The comments will be
available for viewing via the Office's Internet Web site
(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: Regarding the examiner memorandum, contact
Matthew Sked, by telephone at 571-272-7627, or Carolyn Kosowski, by
telephone at 571-272-7688, both at the Office of Patent Legal
Administration. Regarding the life science examples, contact June Cohan, by
telephone at 571-272-7744, Ali Salimi, by telephone at 571-272-0909, or
Raul Tamayo, by telephone at 571-272-7728, all at the Office of Patent
SUPPLEMENTARY INFORMATION: On July 30, 2015, the USPTO issued the July 2015
Update to provide further guidance on subject matter eligibility in view of
public comments received in response to the 2014 Interim Guidance on Patent
Subject Matter Eligibility. An announcement was published in the Federal
Register seeking public comment on the July 2015 Update. See July 2015
Update on Subject Matter Eligibility, 80 FR 45429 (July 30, 2015).
In response, the USPTO received a total of thirty-seven submissions from
the public, which have been carefully considered by the USPTO. The USPTO
has issued a memorandum to the Patent Examining Corps titled "Formulating a
Subject Matter Eligibility Rejection and Evaluating the Applicant's
Response to a Subject Matter Eligibility Rejection" to improve examiner
correspondence regarding subject matter eligibility rejections. A copy of
the memorandum is available on the USPTO's Internet Web site, on the patent
examination guidance and training materials Web page (http://www.uspto.gov/
training-materials). In particular, the memorandum provides guidance to
examiners on (1) formulating a subject matter eligibility rejection; and
(2) evaluating a response to a subject matter eligibility rejection.
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The USPTO's guidance materials concerning the subject matter eligibility
requirements of 35 U.S.C. 101, including the above-mentioned memorandum, do
not constitute substantive rulemaking and do not have the force and effect
of law. These guidance materials set out examination policy on rejections
with respect to the Office's interpretation of the subject matter
eligibility requirements of 35 U.S.C. 101 in view of decisions by the U.S.
Supreme Court and the U.S. Court of Appeals for the Federal Circuit
(Federal Circuit). The guidance materials were developed as a matter of
internal Office management and are not intended to create any right or
benefit, substantive or procedural, enforceable by any party against the
Office. Rejections will continue to be based upon the substantive law, and
it is these rejections that are appealable. Failure of Office personnel to
follow the USPTO's guidance materials is not, in itself, a proper basis for
either an appeal or a petition.
Additionally, the USPTO has produced new life science examples. A copy
of the examples is available on the USPTO's Internet Web site, again on the
patent examination guidance and training materials Web page (http://www.
guidance-and-training-materials). The examples provide exemplary subject
matter eligibility analysis under 35 U.S.C. 101 of hypothetical claims and
claims drawn from case law. The examples are intended as a teaching tool to
assist examiners and the public in understanding how the Office would apply
the eligibility guidance in certain fact-specific situations.
The USPTO further solicited topics for study under the Topic Submission
for Case Studies Pilot Program. See Request for Submission of Topics for
USPTO Case Studies, 80 FR 79277 (Dec. 21, 2015). The case studies will
include a review of consistency of the application of subject matter
eligibility analyses under 35 U.S.C. 101 across the examining corps to
determine the quality of the work product and indicate where improvements
can be made to further improve consistency.
The July 2015 Update included an Appendix 3 containing select
eligibility decisions from the Supreme Court and the Federal Circuit. This
chart of decisions assists examiners in identifying the types of subject
matter courts have previously found to be ineligible. Appendix 3 will
continue to be updated with Federal Circuit decisions having opinions
(precedential or non-precedential). While non-precedential decisions are
not binding precedent, the opinions provide guidance and persuasive
reasoning as outlined in Fed. Cir. R. 32.1(d). Appendix 3 will also
continue to be updated with Federal Circuit decisions without opinion (Fed.
Cir. R. 36) on appeals originating from the Patent Trial and Appeal Board.
Federal Circuit decisions affirming a district court decision without
opinion (Fed. Cir. R. 36) will no longer be added to Appendix 3 because
they provide little benefit to examiners or the public.
As discussed previously, the memorandum and life science examples are
available to the public on the USPTO's Internet Web site. The USPTO is now
seeking public comment. The comment period is open-ended, and comments will
be accepted on an ongoing basis. When it is determined that the period will
close, advance notification will be made on the public comment Web page.
The USPTO is particularly interested in public comments addressing the
progress the USPTO is making in the quality of correspondence regarding
subject matter eligibility rejections.
May 2, 2016 MICHELLE K. LEE
Under Secretary of Commerce for Intellectual Property and
Director of the United States Patent and Trademark Office
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