[Federal Register Volume 87, Number 132 (Tuesday, July 12, 2022)]
[Proposed Rules]
[Pages 41267-41271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14668]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Part 1

[Docket No. PTO-P-2022-0008]
RIN 0651-AD60


Standardization of the Patent Term Adjustment Statement Regarding 
Information Disclosure Statements

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

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The United States Patent and Trademark Office (USPTO or 
Office) proposes to revise the rules of practice pertaining to patent 
term adjustment to require that the patent term adjustment statement 
regarding information disclosure statements be submitted on an Office 
form. Use of the Office form will streamline certain aspects of 
prosecution by more accurately capturing and accounting for the patent 
term adjustment without unnecessary back-and-forth between the USPTO 
and applicant. It will also save resources by eliminating the need for 
a manual review of the patent term adjustment statement.

DATES: Comments must be received by September 12, 2022 to ensure 
consideration.

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-2022-0008 on the

[[Page 41268]]

homepage and click ``Search.'' The site will provide a search results 
page listing all documents associated with this docket. Find a 
reference to this document 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 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 
(at FOR FURTHER INFORMATION CONTACT) for special instructions.

FOR FURTHER INFORMATION CONTACT: Kery Fries, Senior Legal Advisor, 
Office of Patent Legal Administration, at 571-272-7757. You can also 
send inquiries by email to [email protected].

SUPPLEMENTARY INFORMATION: This rulemaking pertains to the patent term 
adjustment regulations establishing the circumstances that will, or 
will not, be considered a failure of an applicant to engage in 
reasonable efforts to conclude prosecution (processing or examination) 
of an application and any resulting reduction of patent term adjustment 
(37 CFR 1.704).
    Regulations establishing the circumstances that constitute a 
failure of an applicant to engage in reasonable efforts to conclude 
processing or examination of an application and the resulting reduction 
of any patent term adjustment are set forth in 37 CFR 1.704(c)(1) 
through (14).
    Additionally, 37 CFR 1.704(d)(1) provides a safe harbor by setting 
forth the circumstances that will not be considered a failure to engage 
in reasonable efforts to conclude processing or examination of the 
application. Specifically, 37 CFR 1.704(d)(1) provides that a paper 
containing only an information disclosure statement in compliance with 
Sec. Sec.  1.97 and 1.98 will not be considered a failure to engage in 
reasonable efforts to conclude prosecution (processing or examination) 
of the application under 37 CFR 1.704(c)(6), (8), (9), or (10) if it is 
accompanied by the required statement. The provision at 37 CFR 
1.704(d)(1) also provides that a request for continued examination in 
compliance with Sec.  1.114 with no submission other than an 
information disclosure statement in compliance with Sec. Sec.  1.97 and 
1.98 will not be considered a failure to engage in reasonable efforts 
to conclude prosecution (processing or examination) of the application 
under 37 CFR 1.704(c)(12) if it is accompanied by the required 
statement. The statement required to accompany the paper or request for 
continued examination must state that each item of information 
contained in the information disclosure statement (1) was first cited 
in any communication from a patent office in a counterpart foreign or 
international application or from the Office, and this communication 
was not received by any individual designated in Sec.  1.56(c) more 
than thirty days prior to the filing of the information disclosure 
statement; or (2) is a communication that was issued by a patent office 
in a counterpart foreign or international application or by the Office, 
and this communication was not received by any individual designated in 
Sec.  1.56(c) more than thirty days prior to the filing of the 
information disclosure statement.
    This rulemaking proposes amending 37 CFR 1.704(d) to include new 
paragraph (d)(3) requiring that filers submit the patent term 
adjustment statement under 37 CFR 1.704(d)(1) on the Office form (PTO/
SB/133) to derive benefit under 37 CFR 1.704(d). The changes proposed 
in this rulemaking facilitate the current patent term adjustment 
statement requirement through the use of an existing Office form.
    Form PTO/SB/133 includes the patent term adjustment statement 
required by 37 CFR 1.704(d)(1). Specifically, the form includes the 
statement that ``[e]ach item of information contained in the 
information disclosure statement was first cited in any communication 
from a patent office in a counterpart foreign or international 
application or from the Office, and this communication was not received 
by any individual designated in 37 CFR 1.56(c) more than thirty days 
prior to the filing of the information disclosure statement.'' The form 
also includes the alternative statement that ``[e]ach item of 
information contained in the information disclosure statement is a 
communication that was issued by a patent office in a counterpart 
foreign or international application or by the Office, and this 
communication was not received by any individual designated in 37 CFR 
1.56(c) more than thirty days prior to the filing of the information 
disclosure statement.'' The filer of the form could select one or both 
of these statements.
    Use of form PTO/SB/133 aims to: (1) ensure the accurate capture of 
the presence of a patent term adjustment statement under 37 CFR 
1.704(d)(1) by the USPTO's IT system, and (2) eliminate the need to 
manually review an applicant's patent term adjustment statement to 
determine whether it is proper under 37 CFR 1.704(d)(1). Furthermore, 
as a result of using the form, the USPTO's automated process for 
calculating patent term adjustment will be more likely to account for 
the patent term adjustment statement, thereby eliminating the need to 
file a request for reconsideration of patent term adjustment under 37 
CFR 1.705(b). Form PTO/SB/133 is available at www.uspto.gov/sites/default/files/documents/sb0133.pdf. The Office of Management and Budget 
(OMB) has determined that, under 5 CFR 1320.3(h), form PTO/SB/133 does 
not collect ``information'' within the meaning of the Paperwork 
Reduction Act of 1995.
    Filers who submit a 37 CFR 1.704(d)(1) patent term adjustment 
statement without using Office form PTO/SB/133 and filers who submit 
Office form PTO/SB/133 with any modification to the patent term 
adjustment statement (that is, modifications to either or both of the 
statements indicated on the form) will not receive the benefit of the 
safe harbor under 37 CFR 1.704(d). Under such circumstances, the 
concurrently filed paper containing only an information disclosure 
statement, in compliance with Sec. Sec.  1.97 and 1.98, or the 
concurrently filed paper containing a request for continued 
examination, in compliance with Sec.  1.114, with no submission other 
than an information disclosure statement, in compliance with Sec. Sec.  
1.97 and 1.98, will be treated as not accompanied by a patent term 
adjustment statement under 37 CFR 1.704(d)(1).
    Additionally, the USPTO's patent term adjustment algorithm is being 
modified to detect when a patent term adjustment statement under 37 CFR 
1.704(d)(1) is filed using the Office form. The Office has created a 
particular document code for the filing of this patent term adjustment 
statement form under 37 CFR 1.704(d). Once modified, the patent term 
adjustment algorithm will recognize that the Office form (PTO/SB/133) 
has been filed concurrently with (i.e., on the same date as) the 
information disclosure statement and, accordingly, will not assess a 
reduction in patent term adjustment under the applicable applicant 
delay sections of 37 CFR 1.704(c) for the patent.

[[Page 41269]]

    The Office reviewed a sampling of patent term adjustment statements 
that were independently submitted without the use of Office form PTO/
SB/133 and found that a portion of those statements were deficient by 
failing to meet the required language of 37 CFR 1.704(d). Requiring the 
use of the form will eliminate these types of deficiencies, and use of 
Office form PTO/SB/133 will thus ensure legal compliance, so long as 
the patent term adjustment statement is not modified. Because the 
USPTO's patent term adjustment algorithm will now automatically 
determine that a reduction in patent term should not be assessed in 
view of a submitted form PTO/SB/133, the Office will also not need to 
expend resources to manually review the provided patent term adjustment 
statement under 37 CFR 1.704(d). The Office will rely on the 
presentation to the Office (whether by signing, filing, submitting, or 
later advocating) of this form, whether by a practitioner or non-
practitioner, as a certification under 37 CFR 11.18(b) that the 
existing text and any certification statements on the form have not 
been altered.
    The submission of a patent term adjustment statement under 37 CFR 
1.704(d) does not require a fee. However, in certain cases, a fee is 
required. Specifically, the Office has provided a procedure for 
applicants to seek a waiver under 37 CFR 1.183 to allow for a late-
filed patent term adjustment statement under 37 CFR 1.704(d). Section 
1.183 provides for an applicant to petition for suspension of rules and 
requires the fee under 37 CFR 1.17(f). If accompanied by a petition 
under 37 CFR 1.183, an applicant may submit the patent term adjustment 
statement under 37 CFR 1.704(d) after the timely filing of the 
information disclosure statement. Applicants have additionally 
submitted such a patent term adjustment statement under 37 CFR 1.704(d) 
accompanied by a petition under 37 CFR 1.183 along with the filing of a 
request for reconsideration of the patent term adjustment indicated on 
the patent (37 CFR 1.705(b)) in order to receive the benefit of the 
safe harbor under 37 CFR 1.704(d). The Office has generally granted 
such 37 CFR 1.183 petitions.
    Once the USPTO's patent term adjustment algorithm is modified to 
automatically detect when a patent term adjustment statement form under 
37 CFR 1.704(d) is filed, the Office may consider eliminating the 
procedure of generally granting such 37 CFR 1.183 petitions. 
Additionally, applicants should keep in mind that a petition under 37 
CFR 1.183 may only be used to request acceptance of the late-filed 
patent term adjustment statement under 37 CFR 1.704(d)(1). Under no 
circumstances may the information disclosure statement be filed more 
than 30 days from the applicable communication under 37 CFR 
1.704(d)(1)(i) or (ii), the 30-day period being non-extendable per 37 
CFR 1.704(d)(2).

Discussion of Specific Rules

    The following is a discussion of the proposed amendments to 37 CFR 
part 1.
    Section 1.704: Section 1.704(d) is proposed to be amended to 
include new paragraph (d)(3) requiring that the statement under 
paragraph (d)(1) of this section be submitted on a form provided by the 
Office (PTO/SB/133). Absent the patent term adjustment statement under 
37 CFR 1.704(d) provided on the Office form, submitted concurrently 
with the information disclosure statement, an applicant will be 
assessed a reduction of the period of patent term adjustment under the 
appropriate provision in Sec.  1.704. Newly proposed Sec.  1.704(d)(3) 
also includes language, mirroring that in existing Sec.  1.4(d)(5), 
regarding the prohibition of changing an existing form's text and 
patent term adjustment statements.

Rulemaking Considerations

    A. Administrative Procedure Act: The changes proposed by this 
rulemaking involve rules of agency practice and procedure, and/or 
interpretive rules. See Perez v. Mortg. Bankers Ass'n, 135 S. Ct. 1199, 
1204 (2015) (Interpretive rules ``advise the public of the agency's 
construction of the statutes and rules which it administers.'' 
(citation and internal quotation marks omitted)); Nat'l Org. of 
Veterans' Advocates v. Sec'y of Veterans Affairs, 260 F.3d 1365, 1375 
(Fed. Cir. 2001) (rule that clarifies interpretation of a statute is 
interpretive); Bachow Commc'ns Inc. v. FCC, 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.). Specifically, this rulemaking proposes to revise 
Office rules to require the use of the provided Office form for filing 
statements under 37 CFR 1.704(d).
    The proposed revision creates paragraph 37 CFR 1.704(d)(3) 
requiring that the ``statement under paragraph (d)(1) of this section 
must be submitted on the Office form (PTO/SB/133) provided for such a 
patent term adjustment statement.''
    Accordingly, prior notice and opportunity for public comment for 
the changes proposed by this rulemaking are not required pursuant to 5 
U.S.C. 553(b) or (c), or any other law. See Perez, 135 S. Ct. at 1206 
(Notice-and-comment procedures are required neither when an agency 
``issue[s] an initial interpretive rule'' nor ``when it amends or 
repeals that interpretive rule.''); 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 practice'' (quoting 5 U.S.C. 
553(b)(A))). However, the Office has chosen to seek public comment 
before implementing the rule to benefit from the public's input.
    B. Regulatory Flexibility Act: For the reasons set forth herein, 
the Senior Counsel for Regulatory and Legislative Affairs, Office of 
General Law, of the USPTO has certified to the Chief Counsel for 
Advocacy of the Small Business Administration that changes in this 
proposed rule will not have a significant economic impact on a 
substantial number of small entities. See 5 U.S.C. 605(b).
    This rulemaking does not propose to impose any additional fees on 
applicants. This rulemaking specifically proposes to revise Office 
rules to require the use of an Office form for statements under 37 CFR 
1.704(d)(1) through the creation of paragraph 37 CFR 1.704(d)(3). This 
new requirement only seeks to facilitate the current statement 
requirement, pursuant to 37 CFR 1.704(d)(1) and set forth in the Manual 
of Patent Examining Procedure 2732, through the use of an existing 
Office form containing the required statement language.
    For the foregoing reasons, the changes in this proposed rule will 
not have a significant economic impact on a substantial number of small 
entities.
    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 proposed rule to impose the 
least burden on society consistent with obtaining the regulatory 
objectives; (3) selected a regulatory approach that

[[Page 41270]]

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. 801-808), the USPTO 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. 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 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 burdens imposed on 
the public. The rules of practice pertaining to patent term adjustment 
and extension have been reviewed and approved by the OMB under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) under OMB 
control number 0651-0020. Although this action proposes a requirement 
to use Office form PTO/SB/133 when making a statement under 37 CFR 
1.704(d), OMB has determined that, under 5 CFR 1320.3(h), form PTO/SB/
133 does not collect ``information'' within the meaning of the 
Paperwork Reduction Act of 1995. Because the changes proposed in this 
rulemaking would not affect the information collection requirements or 
fees associated with the information collections approved under OMB 
control number 0651-0020 or any other information collection, the 
Office is not resubmitting an information collection package to OMB for 
its review and approval.
    Notwithstanding any other provision of law, no person is required 
to respond to, nor shall any 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.
    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 record keeping 
requirements, Small businesses.

    For the reasons set forth in the preamble, USPTO proposes to amend 
37 CFR part 1 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 1.704 is amended by adding new paragraph (d)(3) to read as 
follows:


Sec.  1.704   Reduction of period of adjustment of patent term.

* * * * *
    (d) * * *
    (3) The statement under paragraph (d)(1) of this section must be 
submitted on the Office form (PTO/SB/133) provided for such a patent 
term adjustment statement. Otherwise, the paper or request for 
continued examination will be treated as not accompanied by a statement 
under paragraph (d)(1) of this section. No changes to statements on 
this Office form may be made. The presentation to

[[Page 41271]]

the Office (whether by signing, filing, submitting, or later 
advocating) of this form, whether by a practitioner or non-
practitioner, constitutes a certification under Sec.  11.18(b) of this 
chapter that the existing text and any certification statements on this 
form have not been altered.
* * * * *

Katherine K. Vidal,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2022-14668 Filed 7-11-22; 8:45 am]
BILLING CODE 3510-16-P