[Federal Register Volume 81, Number 88 (Friday, May 6, 2016)]
[Proposed Rules]
[Pages 27381-27382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10724]


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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.

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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 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. 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 Legal Administration.

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/patent/laws-and-regulations/examination-policy/examination-guidance-and-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.

[[Page 27382]]

    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.uspto.gov/patent/laws-and-regulations/examination-policy/examination-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.

    Dated: May 2, 2016.
Michelle K. Lee,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2016-10724 Filed 5-5-16; 8:45 am]
 BILLING CODE 3510-16-P