[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Rules and Regulations]
[Pages 52988-52991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20530]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Part 1

[Docket No. PTO-P-2021-0038]
RIN 0651-AD56


2021 Increase of the Annual Limit on Accepted Requests for Track 
One Prioritized Examination

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

ACTION: Interim rule.

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SUMMARY: The Leahy-Smith America Invents Act (America Invents Act) 
includes provisions for prioritized examination of patent applications 
that have been implemented by the United States Patent and Trademark 
Office (USPTO or Office) in previous rulemakings. The America Invents 
Act provides that the Office may not accept more than 10,000 requests 
for prioritization in any fiscal year (October 1 to September 30) until 
regulations setting another limit are prescribed. The Office published 
an interim rule in 2019 expanding the availability of prioritized 
examination by increasing the limit on the number of prioritized 
examination requests that may be accepted in a fiscal year to 12,000. 
The current interim rule further expands the availability of 
prioritized examination by increasing the limit on the number of 
prioritized examination requests that may be accepted in a fiscal year 
to 15,000.

DATES: 
    Effective Date: September 24, 2021.
    Applicability Date: The limit of 15,000 requests for prioritized 
examination accepted per year is applicable for fiscal year 2021.
    Comment Deadline Date: Written comments must be received on or 
before November 23, 2021.

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-2021-0038 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

[[Page 52989]]

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: Kery Fries, Senior Legal Advisor, 
Office of Patent Legal Administration, at 571-272-7757; or Parikha 
Mehta, Legal Advisor, Office of Patent Legal Administration, at 571-
272-3248.

SUPPLEMENTARY INFORMATION: 
    Executive Summary: Purpose: This interim rule expands prioritized 
examination (Track One) practice to increase the number of applications 
that may be accepted for prioritized examination in a fiscal year to 
15,000.
    Summary of Major Provisions: The prioritized examination provisions 
(37 CFR 1.102(e)) currently provide that a request for prioritized 
examination may be filed with an original utility or plant 
nonprovisional application under 35 U.S.C. 111(a). The America Invents 
Act provides that the Office may not accept more than 10,000 requests 
for prioritization in any fiscal year until regulations setting another 
limit are prescribed. The Office published an interim rule in 2019 
expanding the availability of prioritized examination by increasing the 
limit on the number of prioritized examination requests that may be 
accepted in a fiscal year to 12,000. The current interim rule further 
expands the availability of prioritized examination by increasing the 
limit on the number of prioritized examination requests that may be 
accepted in a fiscal year to 15,000.
    Background: Section 11(h) of the America Invents Act provides for 
prioritized examination of an application. See Public Law 112-29, 125 
Stat. 284, 324 (2011). Section 11(h)(1)(B)(i) of the America Invents 
Act also provides that the Office may, by regulation, prescribe 
conditions for the acceptance of a request for prioritized examination, 
and section 11(h)(1)(B)(iii) provides that ``[t]he Director may not 
accept in any fiscal year more than 10,000 requests for prioritization 
until regulations are prescribed under this subparagraph setting 
another limit.'' Id.
    The Office implemented the prioritized examination provision of the 
America Invents Act for applications on filing in a final rule 
published on September 23, 2011. See Changes to Implement the 
Prioritized Examination Track (Track I) of the Enhanced Examination 
Timing Control Procedures Under the Leahy-Smith America Invents Act, 76 
FR 59050 (Sept. 23, 2011) (codified in 37 CFR 1.102(e)). Following its 
implementation, the Office improved its processes for carrying out 
prioritized examination and expanded the scope of prioritized 
examination in view of those improvements. First, the Office 
implemented prioritized examination for pending applications after the 
filing of a proper request for continued examination under 35 U.S.C. 
132(b) and 37 CFR 1.114. See Changes to Implement the Prioritized 
Examination for Requests for Continued Examination, 76 FR 78566 (Dec. 
19, 2011). Next, the prioritized examination procedures further 
expanded to permit the delayed submission of certain filing 
requirements while maintaining the Office's ability to timely examine 
the patent application. See Changes to Permit Delayed Submission of 
Certain Requirements for Prioritized Examination, 79 FR 12386 (Mar. 5, 
2014).
    The number of requests for prioritized examination has been 
increasing steadily over the years. The Office published an interim 
rule in 2019 expanding the availability of prioritized examination by 
increasing the limit on the number of prioritized examination requests 
that may be accepted in a fiscal year from 10,000 to 12,000. See 
Increase of the Annual Limit on Accepted Requests for Track I 
Prioritized Examination, 84 FR 45907 (Sept. 3, 2019). The current 
interim rule further expands the availability of prioritized 
examination by increasing the limit on the number of prioritized 
examination requests that may be accepted in a fiscal year to 15,000. 
Through continued monitoring of the implementation of the Track One 
program, the Office has determined that the program may be further 
expanded to permit more applications to undergo prioritized examination 
while maintaining the ability to timely examine all prioritized 
applications. Quality metrics used by the Office continue to reveal no 
loss in examination quality for applications given prioritized 
examination. In addition, the number of applications accepted for 
prioritized examination will remain a small fraction of the patent 
examinations completed in a fiscal year (the Office examines 
approximately 640,000 applications and requests for continued 
examination in total per fiscal year). Accordingly, the Office is 
further expanding the availability of prioritized examination by 
increasing the limit on the number of prioritized examination requests 
that may be accepted in a fiscal year to 15,000, beginning in fiscal 
year 2021 (October 1, 2020, through September 30, 2021) and continuing 
every fiscal year thereafter until further notice.

Discussion of Specific Rules

    The following is a discussion of the amendments to 37 CFR part 1.
    Section 1.102: Section 1.102(e) is revised to increase the limit on 
the total number of requests for prioritized examination that may be 
accepted (granted) in any fiscal year from 12,000 to 15,000.

Rulemaking Considerations

    A. Administrative Procedure Act: This interim rule revises the 
procedures that apply to applications for which an applicant has 
requested Track One prioritized examination. The changes in this 
interim rule do not change the substantive criteria of patentability. 
Therefore, the changes in this rulemaking involve rules of agency 
practice and procedure, and/or interpretive rules. See JEM Broad. Co. 
v. F.C.C., 22 F.3d 320, 326 (D.C. Cir. 1994) (``[T]he `critical 
feature' of the procedural exception [in 5 U.S.C. 553(b)(A)] `is that 
it covers agency actions that do not themselves alter the rights or 
interests of parties, although [they] may alter the manner in which the 
parties present themselves or their viewpoints to the agency.''' 
(quoting Batterton v. Marshall, 648 F.2d 694, 707 (D.C. Cir. 1980))); 
see also Bachow Commc'ns Inc. v. F.C.C., 237 F.3d 683, 690 (D.C. Cir. 
2001) (rules governing an application process are procedural under the 
Administrative Procedure Act); Inova Alexandria Hosp. v. Shalala, 244 
F.3d 342, 350 (4th Cir. 2001) (rules for handling appeals were 
procedural where they did not change the substantive standard for 
reviewing claims). Accordingly, prior notice and opportunity for public 
comment are not required pursuant to 5 U.S.C. 553(b) or (c) (or any 
other law). See Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1336-37 
(Fed. Cir. 2008) (stating that 5 U.S.C. 553, and thus 35 U.S.C. 
2(b)(2)(B), do not require notice and comment rulemaking for 
``interpretative rules, general statements of policy, or rules of 
agency organization, procedure, or

[[Page 52990]]

practice'' (quoting 5 U.S.C. 553(b)(A)). In addition, the changes in 
this interim rule may be made immediately effective because this 
interim rule is not a substantive rule under 35 U.S.C. 553(d).
    Moreover, the Office, pursuant to authority at 5 U.S.C. 553(b)(B), 
finds good cause to adopt the changes in this interim rule without 
prior notice and an opportunity for public comment, as such procedures 
would be contrary to the public interest. Delay in the promulgation of 
this interim rule to provide prior notice and comment procedures would 
cause harm to those applicants who desire to file a request for Track 
One prioritized examination with a new application or request for 
continued examination. Immediate implementation of the changes in this 
interim rule is in the public interest because: (1) The public does not 
need time to conform its conduct, as the changes in this interim rule 
do not add any additional requirement for requesting prioritized 
examination of an application; and (2) those applicants who would 
otherwise be ineligible for prioritized examination will benefit from 
the immediate implementation of the changes in this interim rule. See 
Nat'l Customs Brokers & Forwarders Ass'n of Am., Inc. v. United States, 
59 F.3d 1219, 1223-24 (Fed. Cir. 1995). In addition, pursuant to 
authority at 5 U.S.C. 553(d)(3), the Office finds good cause to adopt 
the changes in this interim rule without the 30-day delay in 
effectiveness as such delay would be contrary to the public interest. 
Immediate implementation of the changes in this interim rule is in the 
public interest because: (1) The public does not need time to conform 
its conduct, as the changes in this interim rule do not add any 
additional requirement for requesting prioritized examination of an 
application; and (2) those applicants who would otherwise be ineligible 
for prioritized examination will benefit from the immediate 
implementation of the changes in this interim rule.
    B. Regulatory Flexibility Act: As prior notice and an opportunity 
for public comment are not required pursuant to 5 U.S.C. 553 or any 
other law, neither a regulatory flexibility analysis nor a 
certification under the Regulatory Flexibility Act (5 U.S.C. 601 et 
seq.) is required. See 5 U.S.C. 603.
    C. Executive Order 12866 (Regulatory Planning and Review): This 
rulemaking has been determined to be not significant for purposes of 
Executive Order 12866 (Sept. 30, 1993).
    D. Executive Order 13563 (Improving Regulation and Regulatory 
Review): The Office has complied with Executive Order 13563 (Jan. 18, 
2011). Specifically, the Office has, to the extent feasible and 
applicable: (1) Made a reasoned determination that the benefits justify 
the costs of the rule; (2) tailored the rule to impose the least burden 
on society consistent with obtaining the regulatory objectives; (3) 
selected a regulatory approach that maximizes net benefits; (4) 
specified performance objectives; (5) identified and assessed available 
alternatives; (6) involved the public in an open exchange of 
information and perspectives among experts in relevant disciplines, 
affected stakeholders in the private sector, and the public as a whole, 
and provided online access to the rulemaking docket; (7) attempted to 
promote coordination, simplification, and harmonization across 
Government agencies and identified goals designed to promote 
innovation; (8) considered approaches that reduce burdens and maintain 
flexibility and freedom of choice for the public; and (9) ensured the 
objectivity of scientific and technological information and processes.
    E. Executive Order 13132 (Federalism): This rulemaking does not 
contain policies with federalism implications sufficient to warrant 
preparation of a Federalism Assessment under Executive Order 13132 
(Aug. 4, 1999).
    F. Executive Order 13175 (Tribal Consultation): This rulemaking 
will not: (1) Have substantial direct effects on one or more Indian 
tribes, (2) impose substantial direct compliance costs on Indian tribal 
governments, or (3) preempt tribal law. Therefore, a tribal summary 
impact statement is not required under Executive Order 13175 (Nov. 6, 
2000).
    G. Executive Order 13211 (Energy Effects): This rulemaking is not a 
significant energy action under Executive Order 13211 because this 
rulemaking is not likely to have a significant adverse effect on the 
supply, distribution, or use of energy. Therefore, a Statement of 
Energy Effects is not required under Executive Order 13211 (May 18, 
2001).
    H. Executive Order 12988 (Civil Justice Reform): This rulemaking 
meets applicable standards to minimize litigation, eliminate ambiguity, 
and reduce burden as set forth in sections 3(a) and 3(b)(2) of 
Executive Order 12988 (Feb. 5, 1996).
    I. Executive Order 13045 (Protection of Children): This rulemaking 
does not concern an environmental risk to health or safety that may 
disproportionately affect children under Executive Order 13045 (Apr. 
21, 1997).
    J. Executive Order 12630 (Taking of Private Property): This 
rulemaking will not effect a taking of private property or otherwise 
have taking implications under Executive Order 12630 (Mar. 15, 1988).
    K. Congressional Review Act: Under the Congressional Review Act 
provisions of the Small Business Regulatory Enforcement Fairness Act of 
1996 (5 U.S.C. 801 et seq.), prior to issuing any final rule, the USPTO 
will submit a report containing the final rule and other required 
information to the United States Senate, the United States House of 
Representatives, and the Comptroller General of the Government 
Accountability Office. The changes in this rulemaking are not expected 
to result in an annual effect on the economy of $100 million or more; a 
major increase in costs or prices; or significant adverse effects on 
competition, employment, investment, productivity, innovation, or the 
ability of United States-based enterprises to compete with foreign-
based enterprises in domestic and export markets. Therefore, this 
rulemaking is not expected to result in a ``major rule'' as defined in 
5 U.S.C. 804(2).
    L. Unfunded Mandates Reform Act of 1995: The changes set forth in 
this rulemaking do not involve a Federal intergovernmental mandate that 
will result in the expenditure by State, local, and tribal governments, 
in the aggregate, of $100 million (as adjusted) or more in any one 
year, or a Federal private sector mandate that will result in the 
expenditure by the private sector of $100 million (as adjusted) or more 
in any one year, and will not significantly or uniquely affect small 
governments. Therefore, no actions are necessary under the provisions 
of the Unfunded Mandates Reform Act of 1995. See 2 U.S.C. 1501 et seq.
    M. National Environmental Policy Act of 1969: This rulemaking will 
not have any effect on the quality of the environment and is thus 
categorically excluded from review under the National Environmental 
Policy Act of 1969. See 42 U.S.C. 4321 et seq.
    N. National Technology Transfer and Advancement Act of 1995: The 
requirements of section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because 
this rulemaking does not contain provisions that involve the use of 
technical standards.
    O. Paperwork Reduction Act of 1995: The Paperwork Reduction Act of 
1995 (44 U.S.C. 3501 et seq.) requires that the Office consider the 
impact of paperwork and other information collection

[[Page 52991]]

burdens imposed on the public. This interim rule does not involve 
information collection requirements that are subject to review by the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501-3549). An applicant who wishes to participate 
in the prioritized examination program must submit a certification and 
request to participate in the program, preferably by using Form PTO/
AIA/424. However, OMB has determined that, under 5 CFR 1320.3(h), Form 
PTO/AIA/424 does not collect ``information'' within the meaning of the 
Paperwork Reduction Act of 1995. Therefore, this rulemaking does not 
impose any additional collection requirements under the Paperwork 
Reduction Act that are subject to further review by OMB.
    P. E-Government Act Compliance: The USPTO is committed to 
compliance with the E-Government Act to promote the use of the internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes.

List of Subjects in 37 CFR Part 1

    Administrative practice and procedure, Biologics, Courts, Freedom 
of information, Inventions and patents, Reporting and recordkeeping 
requirements, Small businesses.

    For the reasons set forth in the preamble, 37 CFR part 1 is amended 
as follows:

PART 1--RULES OF PRACTICE IN PATENT CASES

0
1. The authority citation for 37 CFR part 1 continues to read as 
follows:

    Authority: 35 U.S.C. 2(b)(2), unless otherwise noted.


0
2. Section 1.102 is amended by revising paragraph (e) introductory text 
to read as follows:


Sec.  1.102  Advancement of examination.

* * * * *
    (e) A request for prioritized examination under this paragraph (e) 
must comply with the requirements of this paragraph (e) and be 
accompanied by the prioritized examination fee set forth in Sec.  
1.17(c), the processing fee set forth in Sec.  1.17(i), and if not 
already paid, the publication fee set forth in Sec.  1.18(d). An 
application for which prioritized examination has been requested may 
not contain or be amended to contain more than four independent claims, 
more than thirty total claims, or any multiple dependent claim. 
Prioritized examination under this paragraph (e) will not be accorded 
to international applications that have not entered the national stage 
under 35 U.S.C. 371, design applications, reissue applications, 
provisional applications, or reexamination proceedings. A request for 
prioritized examination must also comply with the requirements of 
paragraph (e)(1) or (2) of this section. No more than 15,000 requests 
for such prioritized examination will be accepted in any fiscal year.
* * * * *

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. 2021-20530 Filed 9-23-21; 8:45 am]
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