[Federal Register Volume 87, Number 4 (Thursday, January 6, 2022)]
[Notices]
[Pages 776-780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28473]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2021-0033]


Deferred Subject Matter Eligibility Response Pilot Program

AGENCY: United States Patent and Trademark Office, Department of 
Commerce.

ACTION: Notice.

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SUMMARY: The United States Patent and Trademark Office (USPTO or 
Office) is implementing a pilot program to evaluate the effects of 
permitting applicants to defer responding to subject matter eligibility 
(SME) rejections in certain patent applications. Under this pilot 
program, applicants may receive invitations to participate if their 
applications meet the criteria for the program as specified in this 
notice, including a criterion that the claims in the application 
necessitate rejections on SME and other patentability-related grounds. 
An applicant who accepts the invitation to participate in this pilot 
program must still file a reply to every Office action mailed in the 
application, but is permitted to defer responding to SME rejections 
until the earlier of final disposition of the application, or the 
withdrawal or obviation of all other outstanding rejections. This 
notice outlines the conditions, eligibility requirements, and 
guidelines of the pilot program.

DATES: Comments must be received by March 7, 2022 to ensure 
consideration.
    Pilot Duration: Invitations to participate in the Deferred Subject 
Matter Eligibility Response (DSMER) Pilot Program will be mailed during 
the

[[Page 777]]

period beginning on February 1, 2022, and ending on July 30, 2022. The 
USPTO may extend the pilot program (with or without modifications) or 
terminate it depending on the workload and resources needed to 
administer the program, feedback from the public, and the effectiveness 
of the program. If the pilot program is extended or terminated, the 
USPTO will notify the public.

ADDRESSES: For reasons of Government efficiency, comments must be 
submitted through the Federal eRulemaking Portal at 
www.regulations.gov. To submit comments via the portal, enter docket 
number PTO-P-2021-0033 on the homepage and click ``Search.'' The site 
will provide a search results page listing all documents associated 
with this docket. Find a reference to this notice and click on the 
``Comment Now!'' icon, complete the required fields, and enter or 
attach your comments. Attachments to electronic comments will be 
accepted in ADOBE[supreg] portable document format or MICROSOFT 
WORD[supreg] format. 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.
    Visit the Federal eRulemaking Portal website (www.regulations.gov) 
for additional instructions on providing comments via the portal. If 
electronic submission of comments is not feasible due to a lack of 
access to a computer and/or the internet, please contact the USPTO 
using the contact information below for special instructions.

FOR FURTHER INFORMATION CONTACT: For questions or comments regarding 
this pilot program in general, please contact Nalini Mummalaneni, Legal 
Advisor, Office of Patent Legal Administration, Office of the Deputy 
Commissioner for Patents, USPTO, at 571-270-1647. Questions regarding a 
specific application should be directed to the Technology Center 
examining the application.

SUPPLEMENTARY INFORMATION: Patent examiners at the USPTO customarily 
practice compact prosecution when examining patent applications. See 
section 2103 of the Manual of Patent Examining Procedure (MPEP, Ninth 
Edition, Revision 10.2019). Under the principles of compact 
prosecution, as described in the MPEP, an examiner reviews each claim 
for compliance with every requirement for patentability in the initial 
review of the application, and identifies all the applicable grounds of 
rejection in the first Office action. See MPEP 2100 for a discussion of 
the requirements for patentability, including the SME, utility, 
inventorship, and double patenting requirements of 35 U.S.C. 101; the 
enablement, written description, and definiteness requirements of 35 
U.S.C. 112; and the prior art-based novelty and non-obviousness 
requirements of 35 U.S.C. 102 and 35 U.S.C. 103, respectively. The 
applicant must then respond to every ground of rejection in the Office 
action in order to continue prosecution and avoid abandonment of the 
application. 37 CFR 1.111(b); MPEP 714.02.
    On March 22, 2021, Senators Thom Tillis and Tom Cotton sent a 
letter to the Commissioner for Patents suggesting that the USPTO modify 
the compact prosecution process with respect to SME issues. This letter 
is available at https://www.uspto.gov/patents/initiatives/patent-application-initiatives/deferred-subject-matter-eligibility-response. 
In particular, the letter requested that the USPTO adopt a pilot 
program under which full prosecution of SME issues under 35 U.S.C. 101 
is deferred until a patent application satisfies the other 
patentability conditions, and that the USPTO also determine ``whether 
this approach is more effective, and produces higher quality patents'' 
than the traditional compact prosecution approach.
    In response to the Senators' requests, the USPTO is implementing 
the DSMER Pilot Program. Under this program, an applicant must still 
file a reply to every Office action mailed regarding a participating 
application, but is permitted to defer responding to SME rejections 
until the earlier of final disposition of the application, or the 
withdrawal or obviation of all other outstanding rejections. The DSMER 
Pilot Program thus deviates from traditional compact prosecution, 
because participating applicants may defer engaging with examiners on 
SME issues until after non-SME issues have been addressed.
    This pilot program provides the USPTO with the opportunity to 
evaluate how deferred applicant responses to SME rejections affect 
examination efficiency and patent quality as compared to traditional 
compact prosecution practice. Because satisfaction of non-SME 
conditions for patentability (e.g., novelty, non-obviousness, adequacy 
of disclosure, and definiteness) may resolve SME issues as well, the 
pilot program may result in improved examination efficiency and 
increased patent quality as compared to compact prosecution practice, 
particularly in certain technology areas.

I. Prospective Pilot Applications

    The USPTO may identify an application as a prospective pilot 
application if it satisfies the following conditions during the 
invitation phase: (1) The application is assigned to a participating 
examiner, as explained in section I.A.; (2) the application meets the 
procedural criteria specified in section I.B.; and (3) the claims meet 
the patentability-related criteria specified in section I.C. Such 
identification will be made in the first Office action on the merits, 
which will include a form paragraph identifying the application as a 
prospective pilot application, inviting the applicant to participate, 
and informing the applicant about how to accept or decline the 
invitation. See section II for more information on the invitation 
process. The USPTO will not accept requests to have a particular 
application identified as a prospective pilot application.

A. Participating Examiners

    This pilot program is open to primary examiners across the patent 
examining corps. While examiner participation is not mandatory, the 
USPTO will make efforts to ensure that a representative number of 
primary examiners are participating from each applicable Technology 
Center.

B. Procedural Criteria

1. Application Types
    A prospective pilot application must be an original nonprovisional 
utility application filed under 35 U.S.C. 111(a) or an international 
application that has entered the national stage under 35 U.S.C. 371, 
and must not claim the benefit of the earlier filing date, under 35 
U.S.C. 120 or 121, of any prior nonprovisional application. The 
application may claim the benefit of the earlier filing date, under 35 
U.S.C. 120, 121, 365(c), or 386(c), of any prior international 
application or international design application designating the United 
States, and may claim priority, under 35 U.S.C. 119, 365(a), 365(b), 
386(a), or 386(b), to any prior application filed in the United States 
or in a foreign country, including provisional applications, 
international applications, and international design applications that 
designate at least one country other than the United States. Plant and 
design applications do not qualify for participation in this pilot 
program because they are not governed by the SME requirements of 35 
U.S.C. 101.

[[Page 778]]

2. Application Status
    Because this pilot program is being implemented to study how 
applicant deferrals of responses to SME rejections affect examination 
efficiency, applications that have been advanced out of turn (accorded 
special status) do not qualify for participation in this pilot. Thus, 
applications that have been accorded special status under 37 CFR 1.102, 
or via participation in initiatives or pilot programs that advance 
applications out of turn and/or provide fast-track examination (e.g., 
the Collaborative Search Pilot Program or the COVID-19 Prioritized 
Examination Pilot Program), will not be invited to participate in this 
pilot program. Further, as a condition of entering this pilot program, 
an applicant must agree that they will not seek special status or 
expedited processing of a participating application until final 
disposition has been achieved in the application.
    Applications participating in this pilot program may participate in 
initiatives that expedite processing after final disposition, for 
example, the Fast-Track Appeals Pilot Program. Applicants of 
participating applications may also request prioritized examination 
under 37 CFR 1.102(e)(2) in connection with the filing of a request for 
continued examination (RCE). Additionally, applications participating 
in this pilot program may take part in other USPTO initiatives or pilot 
programs that do not advance applications out of turn, including the 
After Final Consideration Pilot 2.0 (AFCP 2.0) Program, the Pre-Appeal 
Brief Conference Pilot Program, and the Quick Path Information 
Disclosure Statement (QPIDS) Program. For more information about after-
final practice, please refer to section III.C below.

C. Patentability-Related Criteria

    The claims of the prospective pilot application must raise both SME 
issues and non-SME issues that necessitate rejections, and the first 
Office action on the merits must make both SME and non-SME rejections. 
The inclusion of SME rejections in this action will ensure that the 
applicant has sufficient information on which to make an educated 
decision about whether to participate in the pilot program. This 
program does not require that any individual claim be the subject of 
both SME and non-SME rejections. For the purposes of this pilot 
program, an ``SME rejection'' is a rejection under 35 U.S.C. 101 for 
lack of SME, and includes both step 1 rejections, where the claim as a 
whole does not fall within a statutory category, and step 2B 
rejections, where the claim as a whole is directed to a judicial 
exception without also including additional limitations amounting to 
significantly more than the exception. See MPEP 2106.07 for a 
discussion of SME rejections. Additional information about patent SME 
and the USPTO's evaluation of this requirement is provided in MPEP 2106 
et seq., and at www.uspto.gov/PatentEligibility. A ``non-SME 
rejection'' is a rejection based on any other condition for 
patentability, such as, for example, utility or inventorship under 35 
U.S.C. 101; enablement, written description, or definiteness under 35 
U.S.C. 112; novelty under 35 U.S.C. 102; non-obviousness under 35 
U.S.C. 103; or double patenting. See MPEP chapter 2100 for more 
information about these conditions for patentability.

II. Pilot Invitation and Election Process

A. Pilot Invitation

    As explained in section I, participating examiners may invite the 
applicant of a prospective pilot application to participate in the 
pilot program by including a form paragraph in the first Office action 
on the merits. The form paragraph will identify the application as a 
prospective pilot application, invite the applicant to participate, and 
inform the applicant about how to accept or decline the invitation. For 
purposes of issuing an invitation to participate in this program, the 
term ``first Office action on the merits'' does not include actions 
containing only a requirement for restriction and/or election of 
species. A copy of the invitation form paragraph is available on the 
pilot program website at https://www.uspto.gov/patents/initiatives/patent-application-initiatives/deferred-subject-matter-eligibility-response.

B. Election by the Applicant

    An applicant receiving an invitation to participate in the DSMER 
Pilot Program may elect to accept the invitation and participate in the 
program or to decline participation.
    If an applicant wishes to participate in the program, they must 
file a properly completed request form PTO/SB/456 concurrently with a 
timely response to the first Office action on the merits. The request 
form must be signed, in accordance with 37 CFR 1.33(b), by a person 
having the authority to prosecute the application, and must be 
submitted via the USPTO's patent electronic filing systems (EFS-Web or 
Patent Center). Use of this form will help the Office to quickly 
identify applications participating in this pilot program and improve 
the data generated on the effectiveness of the program. The form is 
available on the pilot program website at https://www.uspto.gov/patents/initiatives/patent-application-initiatives/deferred-subject-matter-eligibility-response. If the form is properly completed and 
timely received in a prospective pilot application, the application 
will be entered into the pilot program, and further prosecution will 
proceed as detailed below in section III. Form PTO/SB/456 does not 
collect ``information'' as defined in 5 CFR 1320.3(h) and therefore is 
exempt from the Paperwork Reduction Act of 1995.
    If the applicant does not timely file a properly completed PTO/SB/
456, the application will not be entered into the program. In this 
case, the application will undergo the normal prosecution process as 
described in MPEP chapter 700, and the applicant must file a complete 
reply to the first Office action on the merits, as required by 37 CFR 
1.111(b) and as described in MPEP 714.02.
    Once an applicant has elected to participate in the pilot program, 
there is no provision for them to withdraw a participating application. 
However, applicants may, at any time, choose not to avail themselves of 
the program's benefit (the ability to defer responding to SME 
rejections in certain circumstances) and may voluntarily reply to any 
outstanding SME rejections. Such action does not remove the application 
from the pilot program or terminate the waiver for that application.

III. Pilot Procedure

A. Applicant Replies

    Participation in this pilot program provides the applicant with a 
limited waiver of 37 CFR 1.111(b) with respect to SME rejections in the 
participating application, as set out below. Although the applicant 
must still file a reply to every Office action mailed in the 
participating application, the limited waiver permits the applicant to 
defer presenting arguments, evidence, or amendments in response to the 
SME rejection(s) until the earlier of final disposition of the 
participating application or the withdrawal or obviation of all other 
outstanding rejections. Other than this permitted deferral of 
responding to the SME rejection(s), the applicant's replies must be 
fully responsive to the Office action, as described in MPEP 714.02, and 
must be timely filed within the applicable period for reply, as 
extended under 37 CFR 1.136(a).

[[Page 779]]

    The phrase ``final disposition'' should be understood for a 
particular application as occurring upon the earliest of the: (1) 
Mailing of a notice of allowance, (2) mailing of a final Office action, 
(3) filing of a notice of appeal, (4) filing of an RCE, or (5) 
abandonment of the application. The phrase ``withdrawal or obviation of 
all other outstanding rejections'' refers to the situation in which a 
second or subsequent non-final Office action containing only the SME 
rejection(s) is mailed in a participating application, because the 
applicant has overcome, or the examiner has withdrawn, all the non-SME 
rejections that were previously made. Although such actions are not 
final dispositions, they are effective in terminating the limited 
waiver of 37 CFR 1.111(b) for that participating application. This 
termination is necessary because the applicant is required by 35 U.S.C. 
132 and 133 to respond to Office actions in order to prevent 
abandonment of the application.
    Prior to termination of the waiver (whether by final disposition or 
by the withdrawal or obviation of all other outstanding rejections), 
the applicant may defer responding to any particular SME rejection in a 
participating application. For example, if the applicant accepts the 
invitation to participate in the pilot program, in compliance with 
section II.B above, for an application having a first Office action on 
the merits setting forth a step 1 SME rejection, a step 2B SME 
rejection, and an anticipation rejection, an applicant may exercise any 
of the following options when filing a reply to the action:
    <bullet> Respond only to the anticipation rejection and remain 
silent on the SME rejections, pursuant to the limited waiver of 37 CFR 
1.111(b);
    <bullet> Respond to the anticipation rejection and one of the SME 
rejections, and remain silent on the other SME rejection, pursuant to 
the limited waiver of 37 CFR 1.111(b); or
    <bullet> Respond to all three rejections.
    Any of these three replies will be considered as an adequate reply 
to the SME rejection(s) for purposes of evaluating whether the 
applicant has made a bona fide attempt to advance the application to 
final action.
    Upon final disposition, or the withdrawal or obviation of all other 
outstanding rejections (which would normally occur in a final Office 
action but may, in some circumstances, occur in a second or subsequent 
non-final Office action), the limited waiver of 37 CFR 1.111(b) 
provided by this pilot program ends, and the applicant may no longer 
defer responding to any outstanding SME rejection(s). See section III.C 
below for more information on after-final practice.
    In the event that circumstances require the USPTO to remove an 
application from this pilot program, the limited waiver of 37 CFR 
1.111(b) ends, and the applicant may no longer defer responding to any 
outstanding SME rejection(s). Such circumstances may occur, for 
instance, if the application must be transferred upon the retirement of 
the original examiner. In the event of removal, the applicant will be 
notified that the application no longer qualifies for the pilot 
program.

B. Examiner Actions

    An examiner's or applicant's participation in this pilot program 
does not alter the normal prosecution process, as described in MPEP 
chapter 700, except for the SME response deferral outlined above in 
section III.A. Thus, for example, interviews conducted in participating 
applications must be made of record, in accordance with the normal 
interview procedure (see MPEP 713), and the written statement of the 
substance of the interview must capture all matters discussed 
(including any SME rejection-related discussions) between the applicant 
and the examiner, in accordance with normal interview practice (see 
MPEP 713.04).
    Even though the limited waiver of 37 CFR 1.111(b) permits the 
applicant to defer responding to an SME rejection, the examiner will 
consider whether the applicant's responses to other rejections (e.g., 
amendments made in response to an obviousness or indefiniteness 
rejection) overcome the SME rejection(s) of record. In cases where the 
applicant's reply overcomes all outstanding rejections, including the 
SME rejection(s) set forth in the Office action, and the application is 
otherwise in condition for allowance, the examiner will issue a Notice 
of Allowance. If the examiner believes that the record of the 
prosecution as a whole does not make clear their reasons for allowing a 
claim or claims, the examiner may set forth such reasoning in the 
Notice of Allowance, as described in MPEP 1302.14. Issuance of a Notice 
of Allowance is a final disposition that concludes the limited waiver 
of 37 CFR 1.111(b) for that particular application.
    In cases where the applicant's reply does not overcome all 
outstanding rejections, the examiner will issue a subsequent Office 
action setting forth all applicable rejections, including any 
applicable SME rejection(s), and addressing all amendments, arguments, 
and evidence provided by the applicant. In accordance with normal 
prosecution practice and as explained in MPEP 706.07(a), the subsequent 
action will typically be a final action, except in limited 
circumstances. Issuance of a final rejection is a final disposition 
that concludes the limited waiver of 37 CFR 1.111(b) for that 
particular application. If the subsequent Office action is a non-final 
action, and a non-SME rejection(s) remains outstanding, the applicant 
may continue deferring their response to any outstanding SME 
rejection(s) set forth in the subsequent Office action, as described 
above in section III.A. If the subsequent Office action is a non-final 
action, and there are no non-SME rejections outstanding, the limited 
waiver is terminated, and the applicant must respond to the outstanding 
SME rejection(s), as described above in section III.A.

C. After-Final and Appeal Practice

    As stated earlier, a final disposition of the application ends the 
limited waiver of 37 CFR 1.111(b) provided by this pilot program. Thus, 
the applicant may not defer responding to any outstanding SME 
rejection(s) after final disposition (e.g., after the mailing of a 
final Office action, filing of a notice of appeal, or filing of an 
RCE). If the applicant chooses to file an after-final response, it must 
be complete, in accordance with 37 CFR 1.111(b), and any amendment, 
affidavit, or other evidence submitted after a final Office action and 
prior to appeal must comply with 37 CFR 1.116. If the applicant chooses 
to file a Notice of Appeal, the application will be treated in 
accordance with the normal appeal procedure (see MPEP chapter 1200), 
and the applicant must present arguments with respect to each ground of 
rejection (including SME rejections) that is contested, pursuant to 37 
CFR 41.37(c)(1)(iv). Applicants are cautioned that participation in 
this program is not, in itself, a good and sufficient reason why an 
amendment or evidence was not earlier presented under 37 CFR 1.116 or 
41.33. See, e.g., MPEP 714.12 and MPEP 1206 regarding amendments and 
other replies after final rejection or appeal.
    If the applicant chooses to file an RCE, they must submit a 
complete response to the final Office action, including a response to 
any outstanding SME rejection(s), with the RCE as required by normal 
rules of practice.
    Because abandonment is a final disposition, it also ends the 
limited waiver of 37 CFR 1.111(b) provided by this pilot program. Thus, 
if a participating application is abandoned, the applicant may not 
defer responding to any outstanding SME rejection(s) if

[[Page 780]]

the application is later revived, even if the application was abandoned 
due to failure to respond to a non-final Office action. Accordingly, a 
grantable petition for revival of a participating application that is 
abandoned must be accompanied by a complete reply to any outstanding 
SME rejection(s) of record, in addition to the other requirements of 
such petitions under 37 CFR 1.137 and Office practice. Due to this 
particular response requirement, a petition for revival of a 
participating application may not be filed as an e-Petition and instead 
must be filed by: (1) Uploading the petition and accompanying papers 
using a USPTO electronic filing system (EFS-Web or Patent Center); (2) 
physical delivery to the USPTO by way of the United States Postal 
Service, another delivery service, or by hand delivery to the USPTO 
Customer Service Window; or (3) facsimile. More information about these 
delivery options is available at www.uspto.gov/patents/apply/petitions/02-where-file-petitions-requests-and-related-inquiries-office.
    An application participating in this pilot program may participate 
in other USPTO initiatives after final disposition of the application 
if it satisfies the conditions of those other initiatives. Such 
initiatives include, for example, the AFCP 2.0 Program, the Fast-Track 
Appeals Pilot Program, the Fast-Track for COVID-19-Related Appeals 
Pilot Program, the Pre-Appeal Brief Conference Pilot Program, and the 
QPIDS Program. An application participating in this pilot program may 
also request special status or expedited processing in connection with 
the filing of an RCE (e.g., prioritized examination under 37 CFR 
1.102(e)(2)).

Andrew Hirshfeld,
Commissioner for Patents, Performing the Functions and Duties of the 
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2021-28473 Filed 1-5-22; 8:45 am]
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