[Federal Register Volume 88, Number 115 (Thursday, June 15, 2023)]
[Rules and Regulations]
[Pages 39172-39177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12712]


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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: Final rule.

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SUMMARY: The United States Patent and Trademark Office (USPTO or 
Office) is revising 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 using the appropriate document code. The use of the Office form 
and document code will streamline certain aspects of prosecution by 
more accurately capturing and accounting for the patent term adjustment 
statement without unnecessary back-and-forth between the Office and 
applicant. It will also conserve resources by eliminating the need for 
a manual review of the patent term adjustment statement. Applicants who 
submit a patent term adjustment statement regarding information 
disclosure statements without using the Office form or the appropriate 
document code will need to request reconsideration of the patent term 
adjustment for the information disclosure statement to not be 
considered a failure to engage in reasonable efforts to conclude the 
prosecution (processing or examination) of the application. The Office 
conducts

[[Page 39173]]

a redetermination of patent term adjustment in response to this 
request, and the redetermination will include the Office's manual 
review of the patent term adjustment statement.

DATES: This final rule is effective July 17, 2023, and is applicable to 
any statement under 37 CFR 1.704(d) filed on or after July 17, 2023.

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

SUPPLEMENTARY INFORMATION: Section 532(a) of the Uruguay Round 
Agreements Act (URAA) (Pub. L. 103-465, 108 Stat. 4809 (1994)) amended 
35 U.S.C. 154 to provide that the term of a patent ends on the date 
that is 20 years from the filing date of the application, or the 
earliest filing date for which a benefit is claimed under 35 U.S.C. 
120, 121, or 365(c). The URAA also contained provisions, codified at 35 
U.S.C. 154(b), for patent term extension due to certain examination 
delays. Under the patent term extension provisions of 35 U.S.C. 154(b) 
as amended by the URAA, an applicant is entitled to patent term 
extension for delays due to interference (which has since been replaced 
by derivation proceedings), secrecy orders, or successful appellate 
review. See 35 U.S.C. 154(b) (1995). The Office implemented the patent 
term extension provisions of the URAA in a final rule published in 
April of 1995. See Changes To Implement 20-Year Patent Term and 
Provisional Applications, 60 FR 20195 (Apr. 25, 1995).
    The American Inventors Protection Act of 1999 (AIPA) (Pub. L. 106-
113, 113 Stat. 1501, 1501A-552 through 1501A-591 (1999)) further 
amended 35 U.S.C. 154(b) to include additional bases for patent term 
extension (which is characterized as ``patent term adjustment'' in the 
AIPA). Original utility and plant patents issuing from applications 
filed on or after May 29, 2000, may be eligible for patent term 
adjustment if issuance of the patent is delayed due to one or more of 
the enumerated administrative delays listed in 35 U.S.C. 154(b)(1). 
Specifically, under the patent term adjustment provisions of 35 U.S.C. 
154(b) as amended by the AIPA, an applicant is entitled to patent term 
adjustment for the following reasons: (1) if the Office fails to take 
certain actions during the examination and issue process within 
specified time frames (35 U.S.C. 154(b)(1)(A)); (2) if the Office fails 
to issue a patent within three years of the actual filing date of the 
application (35 U.S.C. 154(b)(1)(B)); and (3) for delays due to 
interference (and now for delays due to derivation proceedings), 
secrecy orders, or successful appellate review (35 U.S.C. 
154(b)(1)(C)). See 35 U.S.C. 154(b)(1). However, the AIPA sets forth a 
number of conditions and limitations on any patent term adjustment 
accrued under 35 U.S.C. 154(b)(1). Specifically, 35 U.S.C. 154(b)(2)(C) 
provides, in part, that ``[t]he period of adjustment of the term of a 
patent under [35 U.S.C. 154(b)(1)] shall be reduced by a period equal 
to the period of time during which the applicant failed to engage in 
reasonable efforts to conclude prosecution of the application,'' and 
that ``[t]he Director shall prescribe regulations establishing the 
circumstances that constitute a failure of an applicant to engage in 
reasonable efforts to conclude processing or examination of an 
application'' (35 U.S.C. 154(b)(2)(C)(i) and (iii)). The Office 
implemented the patent term adjustment provisions of 35 U.S.C. 154(b) 
as amended by the AIPA, including setting forth circumstances that 
constitute a failure of an applicant to engage in reasonable efforts to 
conclude processing or examination of an application, in a final rule 
published in September of 2000. See Changes To Implement Patent Term 
Adjustment Under Twenty-Year Patent Term, 65 FR 56365 (Sept. 18, 2000) 
(AIPA patent term adjustment final rule). The 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).
    This final rule revises the patent term adjustment regulations at 
37 CFR 1.704 establishing the circumstances that constitute a failure 
of an applicant to engage in reasonable efforts to conclude the 
prosecution (processing or examination) of an application and any 
resulting reduction of patent term adjustment. These regulations 
include a ``safe harbor'' in 37 CFR 1.704(d), which provides that a 
paper containing only an information disclosure statement in compliance 
with 37 CFR 1.97 and 1.98 will not be considered a failure to engage in 
reasonable efforts to conclude the prosecution (processing or 
examination) of the application under 37 CFR 1.704(c)(6), (8), (9), or 
(10) if accompanied by the required statement. The ``safe harbor'' in 
37 CFR 1.704(d) also provides that a request for continued examination, 
in compliance with 37 CFR 1.114, with no submission other than an 
information disclosure statement, in compliance with 37 CFR 1.97 and 
1.98, will not be considered a failure to engage in reasonable efforts 
to conclude the prosecution (processing or examination) of the 
application under 37 CFR 1.704(c)(12) if accompanied by the required 
statement. The 37 CFR 1.704(d) ``safe harbor'' requires a statement 
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 37 CFR 1.56(c) more than 30 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 37 CFR 1.56(c) more than 30 days prior 
to the filing of the information disclosure statement. 37 CFR 
1.704(d)(1).
    This final rule specifically revises 37 CFR 1.704(d) to include a 
new paragraph (d)(3) requiring applicants to submit the statement, 
under 37 CFR 1.704(d)(1), as required for the ``safe harbor'' of 37 CFR 
1.704(d), on Office form PTO/SB/133 using the appropriate document code 
(PTA.IDS). The Office makes the patent term adjustment determination 
indicated in the patent with a computer program that uses the 
information recorded in the Office's patent application data 
repository, except when an applicant requests reconsideration pursuant 
to 37 CFR 1.705. See AIPA patent term adjustment final rule, 65 FR at 
56381. When an applicant uses the Office form and document code, the 
patent term adjustment computer program will be able to determine when 
the statement under 37 CFR 1.704(d)(1), as required for the ``safe 
harbor'' of 37 CFR 1.704(d), has been filed in the application.
    Applicants who submit their own statement under 37 CFR 1.704(d)(1), 
as required for the ``safe harbor'' of 37 CFR 1.704(d), without using 
the Office form or the appropriate document code will need to request 
reconsideration of the patent term adjustment under 37 CFR 1.705(b) for 
the information disclosure statement to not be considered a failure to 
engage in reasonable efforts to conclude the prosecution (processing or 
examination) of the application. The Office conducts a manual 
redetermination of patent term adjustment in response to a request for 
reconsideration of the patent term adjustment. See Revisions To

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Implement the Patent Term Adjustment Provisions of the Leahy-Smith 
America Invents Act Technical Corrections Act, 79 FR 27755, 27757 (May 
15, 2014). The redetermination of patent term adjustment will be based 
on the Office's manual review of the statement under 37 CFR 
1.704(d)(1). A manual review of the statement under 37 CFR 1.704(d)(1), 
as required for the ``safe harbor'' of 37 CFR 1.704(d), is necessary 
when an applicant does not use Office form PTO/SB/133.
    The Office has reviewed a sampling of statements under 37 CFR 
1.704(d)(1) that were independently submitted without the use of Office 
form PTO/SB/133 and has determined that a number of those statements 
were deficient for failing to meet the required language of 37 CFR 
1.704(d)(1). Therefore, the Office has determined that there is a need 
for the reconsideration procedure where the Office form PTO/SB/133 is 
not used.
    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.'' Either one or both of these statements may be 
selected on form PTO/SB/133.
    The Office has also created a particular document code (PTA.IDS) 
for the filing of Office form PTO/SB/133 (statement under 37 CFR 
1.704(d)(1)) to facilitate the accurate electronic capture of a 
statement under 37 CFR 1.704(d)(1) by the Office's patent application 
data repository when filed using Office form PTO/SB/133. Thus, the 
Office's patent term adjustment computer program now determines when 
the Office form PTO/SB/133 has been filed concurrently with (i.e., on 
the same date as) the information disclosure statement based on the 
application data in the Office's Patent Application Locating and 
Monitoring (PALM) system and will take the statement under 37 CFR 
1.704(d)(1) into account when calculating patent term adjustment. The 
document code (PTA.IDS) is included on Office form PTO/SB/133. While 
the Office encourages the filing of correspondence via the USPTO patent 
electronic filing system, the inclusion of this document code (PTA.IDS) 
on the form PTO/SB/133 satisfies the ``using the appropriate document 
code (PTA.IDS)'' requirement of 37 CFR 1.704(d)(3) for statements under 
37 CFR 1.704(d)(1) not submitted via the USPTO patent electronic filing 
system.
    Use of form PTO/SB/133 and its document code (PTA.IDS) aims to: (1) 
ensure the accurate capture by the Office's PALM system of the presence 
of a statement under 37 CFR 1.704(d)(1), as required for the ``safe 
harbor'' of 37 CFR 1.704(d); and (2) eliminate the need to manually 
review an applicant's statement under 37 CFR 1.704(d)(1) to determine 
whether it is proper under 37 CFR 1.704(d)(1). Furthermore, as a result 
of using form PTO/SB/133 and its document code (PTA.IDS), the Office's 
automated process for calculating patent term adjustment will be more 
likely to account for the statement under 37 CFR 1.704(d)(1), thereby 
reducing the situations in which a request for reconsideration of 
patent term adjustment under 37 CFR 1.705(b) is necessary. 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.
    Applicants may no longer use the document code PTA.IDS, which is 
specific to Office form PTO/SB/133, for filing a statement under 37 CFR 
1.704(d)(1) unless they are using Office form PTO/SB/133. Applicants 
filing a statement under 37 CFR 1.704(d)(1) without Office form PTO/SB/
133 may only use the document code PTA.IDS for the submission of an 
information disclosure statement. The presentation to the Office 
(whether by signing, filing, submitting, or later advocating) of form 
PTO/SB/133, whether by a practitioner or non-practitioner, is a 
certification under 37 CFR 11.18(b) that the existing text and any 
certification statements on the form have not been altered. The use of 
the document code PTA.IDS specifically for form PTO/SB/133 is a 
representation that the applicant is filing form PTO/SB/133 with no 
alterations to the text of the form.
    Applicants who submit a statement under 37 CFR 1.704(d)(1) in any 
manner other than on Office form PTO/SB/133 will be treated as not 
having submitted the statement, under 37 CFR 1.704(d)(1), as required 
for the ``safe harbor'' of 37 CFR 1.704(d). In addition, applicants who 
submit a statement under 37 CFR 1.704(d)(1) on Office form PTO/SB/133 
with any modification to the statement under 37 CFR 1.704(d)(1) on the 
form (that is, modifications to either or both of the statements 
indicated on the form) will be treated as not having submitted the 
statement, under 37 CFR 1.704(d)(1), as required for the ``safe 
harbor'' of 37 CFR 1.704(d). Under such circumstances, applicants will 
need to request reconsideration of the patent term adjustment, under 37 
CFR 1.705(b) for the paper or request for continued examination, to be 
treated as having been filed concurrently with the statement, under 37 
CFR 1.704(d)(1), as required for the ``safe harbor'' of 37 CFR 
1.704(d).
    The submission of a statement under 37 CFR 1.704(d)(1) does not 
require a fee. However, in certain cases, a fee is required for the 
Office to consider a statement under 37 CFR 1.704(d)(1) in a patent 
term adjustment determination. Specifically, the Office has provided a 
procedure for applicants to seek a waiver under 37 CFR 1.183 to allow 
for a late-filed statement under 37 CFR 1.704(d)(1). A petition under 
37 CFR 1.183 provides for suspension of rules and requires the fee 
under 37 CFR 1.17(f). If an applicant submits an information disclosure 
statement within the 30-day period set forth in 37 CFR 1.704(d)(1) but 
does not include a statement under 37 CFR 1.704(d)(1) with the 
information disclosure statement, the applicant should consider filing 
a request for reconsideration of the patent term adjustment indicated 
on the patent (37 CFR 1.705(b)), along with a statement under 37 CFR 
1.704(d)(1) (if not previously filed) and petition under 37 CFR 1.183 
requesting that the Office consider a statement under 37 CFR 
1.704(d)(1) when making the patent term adjustment determination. 
However, the Office will reevaluate the practice of considering such 
petitions under 37 CFR 1.183 now that the patent term adjustment 
computer program has been updated to account for submission via Office 
form PTO/SB/133. The Office will provide notice prior to making any 
changes to this procedure.
    Applicants should keep in mind that a petition under 37 CFR 1.183 
may only be used to request acceptance of the late-filed statement 
under 37 CFR 1.704(d)(1). Under no circumstances will an information 
disclosure statement filed more than 30 days from the applicable 
communication under 37

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CFR 1.704(d)(1)(i) or (ii) be treated as filed within the ``safe 
harbor'' of 37 CFR 1.704(d). In addition, the 30-day period in 37 CFR 
1.704(d)(1) is not extendable (see 37 CFR 1.704(d)(2)).

Discussion of Specific Rules

    The following is a discussion of the amendment to 37 CFR part 1 in 
this final rule.
    Section 1.704: Section 1.704(d) as amended in this final rule 
includes a new Sec.  1.704(d)(3) requiring that the statement under 
Sec.  1.704(d)(1) be submitted on a form provided by the Office (PTO/
SB/133) using the appropriate document code (PTA.IDS). New Sec.  
1.704(d)(3) also provides that if the statement under Sec.  1.704(d)(1) 
is not submitted on a form provided by the Office (PTO/SB/133) using 
the appropriate document code (PTA.IDS), the paper or request for 
continued examination will be treated as not accompanied by a statement 
under Sec.  1.704(d)(1), unless an application for patent term 
adjustment in compliance with Sec.  1.705(b) is filed, establishing 
that the paper or request for continued examination was accompanied by 
a statement in compliance with Sec.  1.704(d)(1). New Sec.  1.704(d)(3) 
provides that: (1) no changes to statements on this Office form may be 
made; and (2) the presentation of this form to the Office, whether by 
signing, filing, submitting, or later advocating, and whether by a 
practitioner or non-practitioner, constitutes a certification under 37 
CFR 11.18(b) that the existing text and any certification statements on 
this form have not been altered.

Changes From the Proposed Rule

    This final rule contains two changes from the proposed rule. First, 
the final rule replaces the proposed provision that a statement under 
Sec.  1.704(d)(1) must be submitted on the Office form (PTO/SB/133) or 
the paper or request for continued examination will be treated as not 
accompanied by a statement under Sec.  1.704(d)(1), with a new 
provision that a statement under Sec.  1.704(d)(1) must be submitted on 
the Office form (PTO/SB/133) or the paper or request for continued 
examination will be treated as not accompanied by a statement under 
Sec.  1.704(d)(1) unless an application for patent term adjustment 
(Sec.  1.705(b)) is filed, establishing that the paper or request for 
continued examination was accompanied by a statement in compliance with 
Sec.  1.704(d)(1). Thus, this final rule allows applicants who provided 
a statement under Sec.  1.704(d)(1) not using the Office form PTO/SB/
133 with an avenue to have the statement given effect when determining 
the patent term adjustment. Second, this final rule clarifies that the 
form provided by the Office (PTO/SB/133) must be submitted using the 
appropriate document code (PTA.IDS).

Comments and Responses to Comments

    Comment 1: One commenter suggested that the Office continue the 
current practice of permitting an applicant to make the required safe 
harbor statement(s) in any paper filed on the same date as the 
information disclosure statement, but require the applicant to request 
reconsideration of the patent term adjustment under Sec.  1.705(b) to 
invoke the safe harbor if form PTO/SB/133 was not used. Another 
commenter expressed sympathy for the purpose of the rule change but 
opposed it because the Office has plenty of alternative methods to 
educate the public in reducing errors in the certificate statement.
    Response: Section 1.704(d)(3), as adopted in this final rule, 
requires that the statement under Sec.  1.704(d)(1) be submitted on a 
form provided by the Office (PTO/SB/133) using the appropriate document 
code (PTA.IDS). Section 1.704(d)(3) also provides that if the applicant 
does not use the Office form and its document code (PTA.IDS), the paper 
or request for continued examination will be treated as not accompanied 
by a statement under Sec.  1.704(d)(1) unless an application for patent 
term adjustment in compliance with Sec.  1.705(b) is filed, 
establishing that the paper or request for continued examination was 
accompanied by a statement in compliance with Sec.  1.704(d)(1). 
Moreover, the Office will provide additional information and educate 
the public by providing examples in which the Office deemed the 
statement not sufficient to comply with the requirements of Sec.  
1.704(d)(1).
    Comment 2: One commenter advised the Office that the electronic 
form would not allow for checking both boxes, and thus they had to file 
two forms to address statements under each provision.
    Response: In response to this comment, the Office form PTO/SB/133 
has been revised so an applicant can make the statement under Sec.  
1.704(d)(1)(i) or (ii), or both Sec. Sec.  1.704(d)(1)(i) and (ii).
    Comment 3: Two commenters suggested that the Office consider 
modifying the language of the form PTO/SB/133 to address concerns about 
what is being asserted when both boxes on the form are checked.
    Response: Sections 1.704(d)(i) and 1.704(d)(ii) are distinct 
conditions. When an applicant checks both boxes on form PTO/SB/133, the 
applicant is asserting that each cited reference meets the conditions 
of Sec.  1.704(d)(1)(i) or 1.704(d)(1)(ii).
    In 2011, the Office added Sec.  1.704(d)(1)(ii) to extend the 
``safe harbor'' provision of Sec.  1.704(d) to embrace information 
first cited in a communication from the Office, as well as the 
communication. See Revision of Patent Term Adjustment Provisions 
Relating to Information Disclosure Statements, 76 FR 74700 (Dec. 1, 
2011).
    Comment 4: One commenter asked whether the rule change would be 
retroactively applied. The commenter further asked what an applicant 
should do if they had previously filed a statement under Sec.  
1.704(d).
    Response: The changes to the rules of practice pertaining to patent 
term adjustment are set to go into effect on the effective date of this 
final rule, and are applicable to any statement under Sec.  1.704(d) 
filed on or after the effective date of this final rule. The Office 
will apply the interim procedure for patentees to request a 
recalculation of their patent term adjustment determination for alleged 
failure to recognize that an information disclosure statement was 
accompanied by a safe harbor statement, by submitting a request for 
recalculation of patent term adjustment using Office form PTO/SB/134, 
for applicants who filed a statement under Sec.  1.704(d) prior to the 
effective date of the change to Sec.  1.704(d) in this final rule. See 
Interim Procedure for Requesting Recalculation of the Patent Term 
Adjustment With Respect to Information Disclosure Statements 
Accompanied by a Safe Harbor Statement, 83 FR 55102 (Nov. 2, 2018).
    Comment 5: One commenter presented a number of scenarios and 
requested advice on whether an applicant could file a statement under 
Sec.  1.704(d)(1) in these scenarios. The commenter also requested 
clarification of the definition of certain terms found in Sec.  
1.704(d)(1).
    Response: The Office did not propose any changes to the statement 
required by Sec.  1.704(d)(1) and is not adopting any changes to the 
statement required by Sec.  1.704(d)(1) in this final rule. As such, 
this comment is outside the scope of this action. However, for 
information on the terms used in, and the application of, Sec.  
1.704(d)(1), the Office refers the commenter to the Office's guidance 
on patent term adjustment. Specifically, the statement required by 
Sec.  1.704(d)(1) to take advantage of the ``safe harbor'' of Sec.  
1.704(d) is set forth in chapter 2700 of the Manual of Patent Examining 
Procedure (MPEP) (9th ed., rev. 7.2022,

[[Page 39176]]

February 2023), which may be viewed or downloaded free of charge from 
the USPTO website at https://www.uspto.gov/MPEP and is available to 
search online at https://mpep.uspto.gov.

Rulemaking Considerations

    A. Administrative Procedure Act: The changes in 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.). This final rule 
revises 37 CFR 1.704(d) to require that the statement under 37 CFR 
1.704(d)(1) be submitted on the Office form PTO/SB/133 using the 
appropriate document code (PTA.IDS). This final rule also provides 
that, if an applicant submits their own statement under 37 CFR 
1.704(d)(1), as required for the ``safe harbor'' of 37 CFR 1.704(d), an 
applicant will need to request reconsideration of the patent term 
adjustment under 37 CFR 1.705(b) for the Office to consider a statement 
under 37 CFR 1.704(d)(1) when making a determination of the patent term 
adjustment.
    Accordingly, prior notice of and an opportunity for public comments 
on the changes in 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 chose to seek public comments before 
implementing the rule to benefit from the public's input.
    B. Regulatory Flexibility Act: For the reasons set forth in this 
notice, 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 
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 impose any additional fees on applicants. 
This final rule revises 37 CFR 1.704(d) to require that the statement 
under 37 CFR 1.704(d)(1) be submitted on the Office form PTO/SB/133 
using the appropriate document code (PTA.IDS), and to provide that if 
an applicant submits their own statement under 37 CFR 1.704(d)(1), as 
required for the ``safe harbor'' of 37 CFR 1.704(d), the applicant will 
need to request reconsideration of the patent term adjustment under 37 
CFR 1.705(b) for the Office to consider a statement under 37 CFR 
1.704(d)(1) when making a determination of the patent term adjustment. 
This new requirement only seeks to facilitate the current statement 
requirement, pursuant to 37 CFR 1.704(d)(1) and set forth in MPEP 2732, 
subsection IV, through the use of an existing Office form containing 
the required statement language.
    For the foregoing reasons, the changes in this 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 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. 801-808), 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

[[Page 39177]]

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 final rule requires the use of 
Office form PTO/SB/133 when making a statement under 37 CFR 
1.704(d)(1), the 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 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 the 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, the USPTO amends 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 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 using the appropriate document code 
(PTA.IDS). Otherwise, the paper or request for continued examination 
will be treated as not accompanied by a statement under paragraph 
(d)(1) of this section unless an application for patent term 
adjustment, in compliance with Sec.  1.705(b), is filed, establishing 
that the paper or request for continued examination was accompanied by 
a statement in compliance with paragraph (d)(1) of this section. No 
changes to statements on this Office form may be made. The presentation 
to 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. 2023-12712 Filed 6-14-23; 8:45 am]
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