[Federal Register Volume 84, Number 170 (Tuesday, September 3, 2019)]
[Rules and Regulations]
[Pages 45907-45910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18994]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Part 1

[Docket No. PTO-P-2019-0020]
RIN 0651-AD39


Increase of the Annual Limit on Accepted Requests for Track I 
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, 
which 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 are prescribed setting another limit. This interim rule 
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 from 10,000 to 12,000.

DATES: Effective Date: September 3, 2019.
    Applicability Date: The limit of 12,000 granted requests for 
prioritized examination per year becomes effective for fiscal year 
2019.
    Comment Deadline Date: Written comments must be received on or 
before November 4, 2019.

ADDRESSES: Comments should be sent by email addressed to: 
[email protected]. Comments also may be submitted by postal mail 
addressed to: Mail Stop Comments--Patents, Commissioner for Patents, 
P.O. Box 1450, Alexandria, VA 22313-1450, marked to the attention of 
Kery Fries, Senior Legal Advisor, Office of Patent Legal 
Administration.
    Comments further may be sent via the Federal eRulemaking Portal. 
Visit the Federal eRulemaking Portal website (http://www.regulations.gov) for additional instructions on providing comments 
via the Federal eRulemaking Portal.
    Although comments may be submitted by postal mail, the Office 
prefers to receive comments by email. Emailed comments are preferred to 
be submitted in plain text, but also may be submitted in ADOBE[supreg] 
portable

[[Page 45908]]

document format or MICROSOFT WORD[supreg] format. Comments not 
submitted by email or via the Federal eRulemaking Portal should be 
submitted on paper in a format that facilitates convenient digital 
scanning into ADOBE[supreg] portable document format.
    The comments will be available for viewing via the Office's 
internet website (https://www.uspto.gov/patent/laws-and-regulations/comments-public-response-specific-requests-uspto). 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: 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 I'') practice to increase the number of 
applications that may be accorded prioritized examination in a fiscal 
year.
    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 are prescribed 
setting another limit. This interim rule increases the limit on the 
number of prioritized examination requests that may be accepted in a 
fiscal year from 10,000 to 12,000.
    Costs and Benefits: This rulemaking is not economically significant 
under Executive Order 12866 (Sept. 30, 1993).
    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 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 (referred to as ``Track 
I'') 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 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 increased 
steadily over the last few years to the point that the Office will 
reach the limit of 10,000 requests for prioritized examination that may 
be accepted (granted) in any fiscal year if the limit is not increased. 
Through continued monitoring of the implementation of the Track I 
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 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 650,000 
applications and requests for continued examination in total per fiscal 
year). Accordingly, the Office is 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, beginning in fiscal year 2019 (October 1, 2018, 
through September 30, 2019) and continuing every fiscal year thereafter 
until further notice.

Discussion of Specific Rules

    The following is a discussion of the amendments to title 37 of the 
Code of Federal Regulations, 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 10,000 to 12,000.

Rulemaking Considerations

    A. Administrative Procedure Act: This interim rule revises the 
procedures that apply to applications for which an applicant has 
requested Track I 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), does not require notice and comment rulemaking for 
``interpretative rules, general statements of policy, or rules of 
agency organization, procedure, or 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

[[Page 45909]]

procedures would cause harm to those applicants who desire to file a 
request for Track I 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)(1), the changes in this interim rule 
may be made immediately effective because they relieve restrictions in 
the requirements for requesting prioritized examination of an 
application.
    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 on-line 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 13771 (Reducing Regulation and Controlling 
Regulatory Costs): This rulemaking is not an Executive Order 13771 
(Jan. 30, 2017) regulatory action because the rulemaking is not 
significant under Executive Order 12866 (Sept. 30, 1993).
    F. 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).
    G. 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).
    H. 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).
    I. Executive Order 13783 (Promoting Energy Independence and 
Economic Growth): This rulemaking does not potentially burden the 
development or use of domestically produced energy resources, with 
particular attention to oil, natural gas, coal, and nuclear energy 
resources under Executive Order 13783 (Mar. 28, 2017).
    J. Executive Order 13772 (Core Principles for Regulating the United 
States Financial System): This rulemaking does not involve regulation 
of the United States financial system under Executive Order 13772 (Feb. 
3, 2017).
    K. 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).
    L. 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).
    M. 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).
    N. Congressional Review Act: Under the Congressional Review Act 
provisions of the Small Business Regulatory Enforcement Fairness Act of 
1996 (5 U.S.C. 801-808), the United States Patent and Trademark Office 
will submit a report containing any final rule resulting from this 
rulemaking and other required information to the U.S. Senate, the U.S. 
House of Representatives, and the Comptroller General of the Government 
Accountability Office.
    O. 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 dollars (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 dollars (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.
    P. National Environmental Policy Act: 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.
    Q. National Technology Transfer and Advancement Act: 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 which involve the use of 
technical standards.
    R. Paperwork Reduction Act: 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 burdens imposed on the 
public. This interim rule involves information collection requirements 
which 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 
prioritized examination program, preferably by using Form PTO/AIA/424. 
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. This rulemaking does not impose any

[[Page 45910]]

additional collection requirements under the Paperwork Reduction Act 
which are subject to further review by OMB.
    Notwithstanding any other provision of law, no person is required 
to respond to, nor shall a person be subject to a penalty for failure 
to comply with, a collection of information subject to the requirements 
of the Paperwork Reduction Act unless that collection of information 
displays a currently valid OMB control number.

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 the introductory text of 
paragraph (e) 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 12,000 requests 
for such prioritized examination will be accepted in any fiscal year.
* * * * *

    Dated: August 27, 2019.
Andrei Iancu,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2019-18994 Filed 8-30-19; 8:45 am]
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