Rules Governing Motion To Amend Practice and Procedures in Trial Proceedings Under the America Invents Act Before the Patent Trial and Appeal Board, 76421-76431 [2024-21134]

Agencies

• DEPARTMENT OF COMMERCE
• Patent and Trademark Office

[Federal Register Volume 89, Number 181 (Wednesday, September 18, 2024)]
[Rules and Regulations]
[Pages 76421-76431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21134]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Part 42

[Docket No. PTO-P-2020-0060]
RIN 0651-AD50


Rules Governing Motion To Amend Practice and Procedures in Trial 
Proceedings Under the America Invents Act Before the Patent Trial and 
Appeal Board

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

ACTION: Final rule.

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SUMMARY: The United States Patent and Trademark Office (Office or 
USPTO) modifies its rules of practice governing amendment practice in 
trial proceedings under the Leahy-Smith America Invents Act (AIA) to 
make permanent certain provisions of the Office's motion to amend pilot 
program (MTA pilot program) and to revise the rules that allocate 
burdens of persuasion in connection with motions to amend (MTAs). These 
rules provide a patent owner with the option of issuance of preliminary 
guidance in response to an MTA and the option of filing one additional 
revised MTA. Further, these rules clarify that a preponderance of 
evidence standard applies to any new ground of unpatentability raised 
by the Board, and that when exercising the discretion to grant or deny 
an MTA or to raise a new ground of unpatentability, the Board may 
consider all evidence of record in the proceeding. The rules further 
provide that the Board may consider information identified in response 
to a Board-initiated request for examination assistance, and that the 
results of that assistance will be added to the record. The rules 
better ensure the Office's role of issuing robust and reliable patents, 
and the predictability and certainty of post-grant trial proceedings 
before the Board. These rules relate to the Office trial practice for 
inter partes review (IPR), post-grant review (PGR), and derivation 
proceedings that implemented provisions of the AIA providing for trials 
before the Office.

DATES: This rule is effective October 18, 2024.

FOR FURTHER INFORMATION CONTACT: Miriam L. Quinn, Acting Senior Lead 
Administrative Patent Judge; or Melissa Haapala, Vice Chief 
Administrative Patent Judge, at 571-272-9797, [email protected] or 
[email protected], respectively.

SUPPLEMENTARY INFORMATION:

Background

Development of the Final Rule

    On September 16, 2011, the AIA was enacted into law (Pub. L. 112-
29, 125 Stat. 284 (2011)), and in 2012, the Office implemented rules to 
govern Office trial practice for AIA trials, including IPR, PGR, 
covered business method (CBM), and derivation proceedings pursuant to 
35 U.S.C. 135, 316, and 326 and AIA 18(d)(2). See 37 CFR part 42; Rules 
of Practice for Trials before the Patent Trial and Appeal Board and 
Judicial Review of Patent Trial and Appeal Board Decisions, 77 FR 48612 
(August. 14, 2012); Changes to Implement Inter Partes Review 
Proceedings, Post-Grant Review Proceedings, and Transitional Program 
for Covered Business Method Patents, 77 FR 48680 (August 14, 2012); 
Transitional Program for Covered Business Method Patents--Definitions 
of Covered Business Method Patent and Technological Invention, 77 FR 
48734 (August. 14, 2012). Additionally, the Office published a Patent 
Trial Practice Guide (Practice Guide) for the rules to advise the 
public on the general framework of the regulations, including the 
structure and times for taking action in each of the new proceedings. 
See 84 FR 64280 (November 21, 2019); https://www.uspto.gov/TrialPracticeGuideConsolidated. The Practice Guide provides a helpful 
overview of the Patent Trial and Appeal Board (PTAB or Board) process. 
See, e.g., Practice Guide at 5-8 (AIA trial process), 66-72 (motions to 
amend).
    In 2019, the Office implemented a pilot program (MTA Pilot Program) 
for motions to amend filed in AIA proceedings before the PTAB. Notice 
Regarding a New Pilot Program Concerning MTA Practice and Procedures in 
Trial Proceedings Under the America Invents Act Before the Patent Trial 
and Appeal Board, 84 FR 9497 (March 15, 2019) (MTA pilot program 
notice). The MTA Pilot Program addressed public comments on a 
previously proposed procedure for MTAs, the Board's MTA practice 
generally, and the allocation of burdens of persuasion after Aqua 
Products, Inc. v. Matal, 872 F.3d 1290 (Fed. Cir. 2017) (en banc) (Aqua 
Products)). See RFC on MTA Practice and Procedures in Trial Proceedings 
under the America Invents Act before the Patent Trial and Appeal Board, 
83 FR 54319 (October 29, 2018) (2018 RFC). The MTA pilot program was 
extended through September 16, 2024. Extension of the Patent Trial and 
Appeal Board Motion to Amend Pilot Program, 87 FR 60134 (October 4, 
2022).
    In 2020, the Office, through notice and comment rulemaking, 
published a final rule that allocated burdens of persuasion in relation 
to motions to amend and the patentability of substitute claims. See 37 
CFR 42.121(d), 42.221(d); Rules of Practice to Allocate the Burden of 
Persuasion on Motions to Amend in Trial Proceedings before the Patent 
Trial and Appeal Board, 85 FR 82936 (December 21, 2020) (``the burden-
allocation rules''). These burden-allocation rules assign the burden of 
persuasion to the patent owner to show, by a preponderance of the 
evidence, that an MTA complies with certain statutory and regulatory 
requirements. 37 CFR 42.121(d)(1), 42.221(d)(1). The burden-allocation 
rules also assign the burden of persuasion to the petitioner to show, 
by a preponderance of the evidence, that any proposed substitute claims 
are unpatentable. 37 CFR 42.121(d)(2), 42.221(d)(2).
    Finally, the burden-allocation rules further specify that 
irrespective of those burdens, the Board may, in the ``interests of 
justice,'' exercise its discretion to grant or deny an MTA, but ``only 
for reasons supported by readily identifiable and persuasive evidence 
of record.'' 37 CFR 42.121(d)(3), 42.221(d)(3); Hunting Titan, Inc. v. 
DynaEnergetics Europe GmbH, IPR2018-00600 (PTAB July 6, 2020) (Paper 
67) (Hunting Titan). Situations meeting the interests of justice 
standard were stated to include, for example, those in which ``the 
petitioner has ceased to participate in the proceeding or chooses not 
to oppose the motion to amend, or those in which certain evidence 
regarding unpatentability has not been raised by either party but is so 
readily identifiable and persuasive that the Board should take it up in 
the interest of supporting the integrity of the patent system, 
notwithstanding the adversarial nature of the proceedings.'' 85 FR 
82924, 82927 (citing Hunting Titan, Paper 67 at 12-13, 25-26). The 
burden-allocation rules further provide that in instances where the 
Board exercises its discretion in the interests of justice, the Board 
will provide the parties with an opportunity to respond before 
rendering a final decision on the

[[Page 76422]]

MTA. Id. at 82927; see also 37 CFR 42.121(d)(3), 42.221(d)(3).
    As noted in the final rule that allocated burdens of persuasion, 
``[i]n the vast majority of cases, the Board will consider only 
evidence a party introduces into the record of the proceeding.'' 85 FR 
82927. Thus, ``[i]n most instances, in cases where the petitioner has 
participated fully and opposed the motion to amend, the Office expects 
that there will be no need for the Board to independently justify a 
determination of unpatentability.'' Id. at 82927-28. That said, the 
Board may consider, for example ``readily identifiable and persuasive 
evidence already before the Office in a related proceeding (i.e., in 
the prosecution history of the challenged patent or a related patent or 
application, or in the record of another proceeding before the Office 
challenging the same patent or a related patent).'' Id. at 82927. 
Likewise, ``the Board may consider evidence that a district court can 
judicially notice under Federal Rule of Evidence 201.'' Id.; see also 
37 CFR 42.121(d)(3), 42.221(d)(3) (``[T]he Board may make of record 
only readily identifiable and persuasive evidence in a related 
proceeding before the Office or evidence that a district court can 
judicially notice.'').
    Subsequent to the issuance of the burden-allocation rules, the 
United States Court of Appeals for the Federal Circuit issued a 
precedential decision in Hunting Titan, Inc., v. DynaEnergetics Europe 
GmbH, 28 F.4th 1371 (Fed. Cir. 2022). The court confirmed that no court 
precedent has ``established that the Board maintains an affirmative 
duty, without limitation or exception, to sua sponte raise 
patentability challenges to a proposed substitute claim.'' Id. at 1381 
(citations omitted). The court also stated that ``confining the 
circumstances in which the Board should sua sponte raise patentability 
issues was not itself erroneous.'' Id. The court, however, found it 
``problematic'' that the USPTO confined the Board's discretion to only 
rare circumstances. Id. It also noted that the USPTO's ``substantial 
reliance on the adversarial system . . . overlooks the basic purpose of 
[inter partes review] proceedings: to reexamine an earlier agency 
decision and ensure that patent monopolies are kept within their 
legitimate scope.'' Id. (citations omitted); see id. at 1385 
(concurrence expressing concern that the burden-allocation rule's 
requirement for ``readily identifiable and persuasive evidence'' may 
prevent the Board from raising grounds ``even when no one is around to 
oppose a new patent monopoly grant.'').
2023 Request for Comments on MTA Pilot Program and Burden-Allocation 
Rules
    After four years of experience with the MTA pilot program and 
development of Federal Circuit case law concerning burden allocation in 
the MTA context, the Office issued a Request for Comments to seek 
feedback on the public's experience with the program and the burden-
allocation rules that apply to MTAs. See Request for Comments Regarding 
MTA Pilot Program and Rules of Practice to Allocate the Burdens of 
Persuasion on Motions to Amend in Trial Proceedings Before the Patent 
Trial and Appeal Board, 88 FR 33063 (May 23, 2023) (2023 RFC). The 
Office also sought feedback on when reexamination or reissue 
proceedings, also referred to as post-grant options, are better 
alternatives for patent owners seeking to amend claims. Id. at 33065-
66. Further, the Office sought comments on whether the MTA pilot 
program should be modified and what barriers the Office could address 
to increase the effectiveness of MTA procedures. Id. at 33066.
    The 2023 RFC also sought comments on the burden-allocation rules. 
In light of the Federal Circuit court's commentary on the current 
rules, as well as the Board's Hunting Titan decision, and given the 
Office's desire to support the integrity of the patent system and to 
issue robust and reliable patent rights, the Office sought public 
comments on whether the Board should more broadly use its discretion to 
raise sua sponte grounds in the MTA process. Id. Additionally, the 
Office sought public comments on whether, and under what circumstances, 
the Office should solicit patent examiner assistance regarding an MTA 
or conduct a prior art search in relation to proposed substitute 
claims. Id.
    Furthermore, the Office recognized that if the Board exercises its 
discretion and raises its own grounds of unpatentability under the 
current rule, 37 CFR 42.121(d)(3), the burden-allocation rules do not 
specifically state where the burden of persuasion lies for Board-raised 
grounds. The Office sought public comments on whether the burden-
allocation rules should be revised to clarify who bears the burden of 
persuasion for grounds of unpatentability raised by the Board under 37 
CFR 42.121(d)(3) or 42.221(d)(3). See 88 FR 33066; see also Nike, Inc. 
v. Adidas AG, No. 2021-1903, 2022 WL 4002668, at *4-10 (Fed. Cir. 
September 1, 2022) (leaving open the question ``whether, in an inter 
partes review, the petitioner or Board bears the burden of persuasion 
for an unpatentability ground raised sua sponte by the Board against 
proposed substitute claims'').
2024 Notice of Proposed Rulemaking
    On March 4, 2024, the Office published a notice of proposed 
rulemaking concerning Motion to Amend Practice and Procedures in Trial 
Proceedings Under the America Invents Act Before the Patent Trial and 
Appeal Board. 89 FR 15531 (``2024 NPRM''). The Office proposed to 
revise its rules of practice to provide for issuance of preliminary 
guidance in response to an MTA and to provide a patent owner with the 
option for filing one additional revised MTA. Further, the Office 
proposed to revise the rules to clarify that a preponderance of the 
evidence standard applies to any new ground of unpatentability raised 
by the Board and to clarify that when exercising the discretion to 
grant or deny an MTA or to raise a new ground of unpatentability, the 
Board may consider all evidence of record in the proceeding, including 
evidence identified through a prior art search conducted by the Office 
at the Board's request and added to the record. The comment period for 
the 2024 NPRM closed on May 3, 2024, and the Office received six public 
comments on the proposed rules.

Proposed Rule: Comments and Responses

    The Office received six public comments to the 2024 NPRM none of 
which opposed the proposal to make permanent the MTA pilot program 
options. Some commenters, however, stated that the Office should 
consider additional proposals. These additional proposals include: (1) 
expressly allowing extensions of time for the final written decision 
and for filing MTA-related briefs, (2) revising the proposed rules to 
allow petitioner to file a sur-reply, and (3) clarifying the manner in 
which patent owner identifies written description support for the 
proposed substitute claims. Some commenters also recommended expanding 
the proposed rules on discretion to request examination assistance such 
that the Board would exercise this discretion in every case with a 
motion to amend. Finally, one commenter expressed concerns with the 
proposed rules that revise the Board's limits on the discretion to 
raise grounds of unpatentability sua sponte. These comments, along with 
other stated ideas and concerns, are addressed more specifically below.

[[Page 76423]]

Extensions of Time for Issuing Final Written Decision and Other 
Deadlines

    A comment expressed support for an automatic extension of the 
deadline for issuing a final written decision in proceedings in which a 
motion to amend has been filed. A second comment raised the concern 
that any automatic extension of time might not be necessary in all 
cases and that there could be a potential for abuse of the motion to 
amend process if extensions were automatic. Another comment suggested 
that additional procedures, such as a Board-initiated conference call 
upon issuance of preliminary guidance, could provide an opportunity for 
a party to request an extension of time for the final written decision.
    The Office appreciates the comments and the concern with scheduling 
when a motion to amend is filed. After careful review of the comments, 
the Office does not adopt any changes to the proposed rules. The 
proposed rules do not modify the current procedures by which an 
extension may be granted, as discussed above, and an extension of the 
final written decision deadline may be granted by the Chief 
Administrative Patent Judge for good cause, and the deadline may be 
extended by not more than six months. These procedures allow for a 
case-by-case determination of whether an extension should be granted. 
In the Board's experience, most cases do not require an extension. With 
respect to automatic scheduling of a conference call upon issuance of 
preliminary guidance, the rules provide for an initial conference call 
upon the filing of a motion to amend at which a discussion of the 
schedule can occur, and panels of the Board generally honor any request 
by a party for a further conference call. See 37 CFR 42.121(a), 
42.221(a).
    With respect to the limitations on timing for post grant review 
proceedings with motions to amend, we acknowledge a comment suggesting 
that reexamination or reissue proceedings may be better options for 
pursing claim amendments if substantial changes that may require 
additional time are contemplated. See Notice Regarding Options for 
Amendments by Patent Owner Through Reissue or Reexamination During a 
Pending AIA Trial Proceeding (April 2019), 84 FR 16654 (April 22, 
2019).

Petitioner Sur-Reply

    A commenter expressed concern with the proposed rule as it relates 
to the preliminary guidance provided by the Board on an original motion 
to amend. In particular, the commenter noted that the proposed rule is 
silent as to whether the petitioner has an opportunity to file a sur-
reply to address the Board's preliminary guidance or any new evidence 
that may accompany the patent owner's reply filed in response to the 
Board's preliminary guidance. The commenter noted that the proposed 
rule allows the petitioner to file a reply to the Board's guidance only 
if the patent owner does not file a reply or revised motion to amend. 
The commenter urged the Office that the petitioner should be provided, 
expressly, with a sur-reply in order to afford due process to the 
petitioner.
    The Office appreciates the comment and agrees that the rule should 
expressly provide for a petitioner sur-reply. The final rule states 
that the petitioner may file a sur-reply that is limited to responding 
to the preliminary guidance and/or arguments made in the patent owner's 
reply brief. Further, although the sur-reply may not be accompanied by 
new evidence, it may comment on any new evidence filed with the reply 
and/or point to cross-examination testimony of a reply witness, if 
relevant to the arguments made in the reply brief.
    Moreover, if a patent owner does not file either a reply or a 
revised MTA after receiving preliminary guidance from the Board, a 
petitioner may file a reply to the preliminary guidance, but such a 
reply may only respond to the preliminary guidance and may not be 
accompanied by new evidence. If a petitioner files a reply in this 
context, a patent owner may file a sur-reply, but that sur-reply may 
only respond to the petitioner's reply and may not be accompanied by 
new evidence.

Written-Description Support

    A commenter raised a concern that proposed provisions in 37 CFR 
42.121(b) and 42.221(b), which relate to the content of a motion to 
amend, contain a possible ambiguity regarding whether the required 
support in the original disclosure or earlier-filed disclosure must be 
set forth in the motion to amend or should be set forth as part of the 
claim listing.
    The Office appreciates the comment. To improve clarity, this final 
rule amends those sections to state that the written description 
support for a proposed substitute claim must be set forth in the motion 
to amend, as opposed to the claim listing. This is consistent with 
current practice and the precedential decision in Lectrosonics: ``[t]he 
written description support must be set forth in the motion to amend 
itself, not the claim listing.'' Lectrosonics, Inc. v. Zaxcom, Inc., 
IPR2018-01129, 2019 WL 1118864, at *3 (precedential).

Examination Assistance

    The majority of commenters support the proposed rule's provision 
permitting the Board to request examination assistance from patent 
examiners when considering claim amendments. A commenter noted, 
however, that opinions vary on whether, and to what extent, the Board 
should request assistance to conduct a prior art search. Two commenters 
suggested that such assistance not be limited to situations in which no 
petitioner opposes, or all petitioners cease to oppose a motion to 
amend. These commenters highlighted the expertise of examiners in 
identifying prior art as reasons to expand the situations for which 
assistance may be requested. These commenters also expressed concern 
that Board panels may hesitate to use the proposed rule's full extent, 
because identifying a petitioner's filing as ``illusory opposition'' 
appears to imply that the petitioner is not acting in good faith, and 
such a standard may be difficult to assess. These commenters suggested 
that the benefit of ensuring that substitute claims are patentable 
would justify the relatively few additional prior art searches per 
year. A third commenter also agreed that having an examiner's search 
report for each MTA would alleviate concerns with the Office issuing 
``unexamined'' claims, finding such technical assistance to be of value 
to the panel in evaluating the parties' patentability arguments, 
although appreciating that such assistance may be perceived as a 
disincentive to filing motions to amend.
    Another commenter suggested that amended claims undergo review 
prior to a decision being made by the Board only in circumstances where 
the adversarial system fails to provide the Board with arguments for 
the unpatentability of the proposed substitute claims, and that both 
parties be afforded the opportunity to respond. A further commenter 
disagreed that the Board should be pressured to come up with rejections 
even when the adversarial process has not failed. That further 
commenter suggested that encouraging the Board to dig deeply into the 
records of other proceedings would disadvantage patent owners seeking 
to save patentable claim scope. That further commenter suggested that 
language be added to make clear that intervention is neither needed nor 
expected in a typical proceeding.
    The Office appreciates the robust discussion of the variety of 
viewpoints expressed in the comments. After

[[Page 76424]]

careful consideration, the Office does not adopt the suggestions to 
rely solely on the adversarial nature of the proceeding to determine 
when to request examination assistance. Rather, the Office revises the 
proposed rule to take into account the comments expressing concern 
about the narrow circumstances under which examination assistance would 
be requested. The final rule now states that a lack of opposition would 
be considered one of the reasons sufficient for the Board to seek 
examination assistance. As such, the final rule also encompasses the 
situation in which the Board determines that a deficient prior art 
challenge in an opposition warrants a search for additional prior art. 
The ability of the Board to seek examination assistance when warranted, 
including a prior art search, for amended claims preserves the Office's 
goal of ensuring that it adequately evaluates the patentability of 
claims before issuance. The final rule's clarification of appropriate 
situations for seeking examination assistance is designed to help 
panels identify when such examination assistance would further the 
Office's goal. The final rule also accounts for the adversarial motion 
to amend process that suffices for the vast majority of cases filed to-
date. The examination assistance typically would be appropriate in 
situations that are not duplicative of reasonable efforts expended by 
the petitioner, such as when an opposition lacks a prior art challenge 
or when there is no opposition, thus ensuring that the resources of the 
Office and the patent owner are not expended unnecessarily. Further 
because it relies on a determination that a deficient prior art 
challenge warrants a search for additional prior art, the Board would 
not need to address or inquire about the intent behind an opposition or 
bad faith efforts of a petitioner. As in the proposed rule, the final 
rule provides that when the Board requests examination assistance, that 
the request, as well as the results of the examination assistance will 
be made of record. The fact that the Board possesses, but has never 
used, its discretionary authority to request examination assistance 
reflects the Board's careful exercise of this authority to date. Based 
upon the comments and the Board's experience, the final rule fairly 
balances the interests of patent owners who desire to amend claims 
during an AIA proceeding and the Office's role in maintaining the 
integrity of the patent system by ensuring the issuance of robust and 
reliable patents.

Discretion To Raise Grounds Sua Sponte

    A commenter expressed concerns with the proposed revisions to the 
rule on the Board's discretion to raise grounds of unpatentability sua 
sponte. In particular, the commenter stated that the proposed changes 
would broaden the Board's discretion to raise grounds to an uncertain 
degree, even in cases where zealous advocacy against an amendment is 
present. The commenter urged the Office to revise the proposed changes 
to the Board's exercise of discretion to restrain its frequency and 
clarify that the Board's actions in this regard would neither be needed 
nor expected in ``run-of-the-mine proceedings.'' This commenter also 
urged that the Board consider retaining the prior rule's limitation to 
considering ``only readily identifiable and persuasive evidence in a 
related proceeding before the Office.'' Other commenters expressed 
support for the proposed rules that give the Board the ability to more 
broadly exercise its discretion to raise sua sponte grounds of 
unpatentability and to ensure that the parties are given the 
opportunity to respond to those grounds. The commenters noted that the 
Office's current rules, which rely solely on the adversarial process, 
are at odds with current Federal Circuit case law and undermine the 
Office's role of ensuring that newly issued claims are patentable.
    The Office appreciates the comments. After careful review of the 
comments made and in light of the careful balance of the various 
viewpoints on this issue and in alignment with the Office's goals of 
ensuring the issuance of robust and reliable patents, the Office does 
not adopt the suggestion to limit the exercise of discretion to raise 
grounds sua sponte, nor to retain the limit that only ``readily 
identifiable and persuasive evidence'' may be relied upon. The rule 
allows the Board to retain discretion to raise grounds of 
unpatentability with respect to proposed substitute claims in 
accordance with Federal Circuit precedent. See Nike, Inc. v. Adidas AG, 
955 F.3d 45, 53 (2020); Hunting Titan, 28 F.4th at 1381. Additionally, 
the commenter's proposed limitations on the Board's exercise of 
discretion in this regard are similar to those criticized by the 
Federal Circuit in Hunting Titan. 28 F.4th at 1381, 1385. Consequently, 
as noted further below, the Board's Hunting Titan decision, which 
places limitations on the Board's exercise of discretion to raise 
grounds, is de-designated from precedential status as of the effective 
date of this final rule. See PTAB Standard Operating Procedure 2 
(Revision 10), Publication of Decisions and Designation or De-
Designation of Decisions as Precedential or Informative, Part IV (SOP2) 
available at https://www.uspto.gov/sites/default/files/documents/SOP2%20R10%20FINAL.pdf.
    The Office notes that although the adversarial nature of the 
proceedings provides, in the majority of proceedings, the safeguards of 
a robust evaluation of proposed substitute claims, there may be 
situations in which, despite such advocacy, the Board will be able to 
identify or will be aware of additional reasons the proposed substitute 
claims may not be granted. It is better for the Office to maintain the 
integrity of the patent system by ensuring that where the Board 
determines sua sponte new reasons why a proposed substitute claim 
should not be granted, that in accordance with due process, the parties 
are notified of grounds of unpatentability not raised by the opposition 
and that the parties are given an opportunity to respond. The final 
rule provides that such notice may be included in the preliminary 
guidance if one is requested but does not place limitations on such a 
notice to be provided in other papers or at a different stage of the 
proceeding, such as after receiving a revised motion to amend. 37 CFR 
42.121(e), 42.221(e).
    Upon careful consideration of the public comments, the Office 
adopts the provisions in the proposed rule with minor changes for 
additional clarity and consistency.

Preliminary Guidance and Revised Motions To Amend

    The final rule, which implements the procedure set forth in the 
Motion to Amend Pilot Program, provides a patent owner with two options 
when proposing substitute claims for challenged patent claims during an 
AIA trial proceeding. First, if requested by a patent owner in its 
original MTA, the Board will issue preliminary, non-binding guidance. 
37 CFR 42.121(e), 42.221(e). Second, a patent owner may file, without 
needing Board authorization, a revised MTA. 37 CFR 42.121(f), 
42.221(f). These options are discussed further below.
Preliminary Guidance
    The Board's preliminary guidance, if requested, typically will come 
in the form of a short paper issued after a petitioner has filed its 
opposition to the MTA (or after the due date for a petitioner's 
opposition, if none is filed). According to the MTA pilot program, the 
preliminary guidance provides, at a

[[Page 76425]]

minimum, an initial discussion about whether there is a reasonable 
likelihood that the original MTA meets statutory and regulatory 
requirements for an MTA and whether the petitioner (or the record then 
before the Office, including any opposition to the MTA and accompanying 
evidence) establishes a reasonable likelihood that the substitute 
claims are unpatentable. See MTA pilot program notice, 84 FR 9500.
    Under the amended rules, preliminary guidance will provide the 
Board's initial, preliminary views on the original MTA. The preliminary 
guidance will provide an initial discussion about whether the parties 
have shown a reasonable likelihood of meeting their respective burdens. 
See Rules of Practice To Allocate the Burden of Persuasion on Motions 
To Amend in Trial Proceedings Before the Patent Trial and Appeal Board. 
85 FR 82923 (December 21, 2020); 37 CFR 42.121(d)(1) and (2), 
42.221(d)(1) and (2). In particular, the preliminary guidance will 
address whether there is a reasonable likelihood that the patent owner 
has shown that the MTA meets the statutory and regulatory requirements 
for an MTA. See 37 CFR 42.121(d)(1), 42.221(d)(1); see also 35 U.S.C. 
316(d), 326(d); Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018-01129, 2019 
WL 1118864, at *2 (precedential). The preliminary guidance will also 
provide an initial discussion about whether the petitioner (or the 
record then before the Office, including any opposition to the MTA and 
accompanying evidence) has established a reasonable likelihood that the 
proposed substitute claims are unpatentable. See 37 CFR 42.121(d)(2), 
42.221(d)(2). The preliminary guidance may also address any new grounds 
of unpatentability discretionarily raised by the Board, together with 
citations to the evidence of record supporting those new grounds. See 
37 CFR 42.121(d)(3) and (4), 42.221(d)(3) and (4). In general, the 
Board's preliminary guidance will address the proposed substitute 
claims in a patent owner's original MTA in light of the amendments 
presented in those claims and will not address the patentability of the 
originally challenged claims.
    Preliminary guidance on an MTA during an AIA trial does not bind 
the Board. See Medytox, Inc. v. Galderma S.A., 71 F.4th 990, 1000 (Fed. 
Cir. 2023) (holding that the Board's decision to change its claim 
construction between its Preliminary Guidance and the final written 
decision was not arbitrary and capricious and did not violate the 
Administrative Procedure Act (APA)). The Board's preliminary guidance 
is not a ``decision'' under 37 CFR 42.71(d), and thus parties may not 
file a request for rehearing or a request for Director Review of the 
preliminary guidance.
    The parties will have the opportunity to respond to the preliminary 
guidance. For example, a patent owner may file a reply to a 
petitioner's opposition to the MTA and/or the preliminary guidance or 
may file a revised MTA. If an opposition is filed and preliminary 
guidance was requested, the patent owner's reply may respond to the 
Board's preliminary guidance and/or to the petitioner's opposition to 
the MTA. If an opposition is not filed but preliminary guidance was 
requested, a patent owner's reply may only respond to the preliminary 
guidance. New evidence (including declarations) may be submitted with 
every paper in the MTA process, except with a sur-reply or in the 
special circumstance where a patent owner does not file either a reply 
or a revised MTA after receiving preliminary guidance from the Board as 
discussed below. Thus, a patent owner may file new evidence, including 
declarations, with its revised MTA or reply. See 84 FR 9500 (stating 
further that when filing new declarations, parties are expected to make 
their declarants available for depositions promptly and to make their 
attorneys available to take and defend such depositions; any 
unavailability will not be a reason to adjust the schedule for briefing 
on an MTA or revised MTA absent extraordinary circumstances). The 
petitioner may file a sur-reply that is limited to responding to the 
preliminary guidance and/or arguments made in the patent owner's reply 
brief. Although the sur-reply may not be accompanied by new evidence, 
it may comment on any new evidence filed with the reply and/or point to 
cross-examination testimony of a reply witness, if relevant to the 
arguments made in the reply brief.
    In the special circumstance of a patent owner not filing either a 
reply or a revised MTA after receiving preliminary guidance from the 
Board, a petitioner may file a reply to the preliminary guidance, but 
such a reply may only respond to the preliminary guidance and may not 
be accompanied by new evidence. If a petitioner files a reply in this 
context, a patent owner may file a sur-reply limited to responding to 
the petitioner's reply, and the sur-reply may not be accompanied by new 
evidence.
Revised MTA
    A patent owner may choose to file a revised MTA after receiving a 
petitioner's opposition to the original MTA or after receiving the 
Board's preliminary guidance (if requested). As stated in the rule, a 
patent owner may file either a reply or a revised motion to amend, but 
not both. That is, if the patent owner did not elect to receive 
preliminary guidance, the patent owner can still choose to file a 
revised MTA to address the petitioner's opposition to the original MTA.
    If a patent owner chooses to file a revised MTA, the revised MTA 
must include one or more new proposed substitute claims in place of 
previously presented substitute claims, where each new proposed 
substitute claim presents a new claim amendment. The new claim 
amendments, as well as arguments and evidence, must be responsive to 
issues raised in the preliminary guidance (if requested) or in 
petitioner's opposition. Particularly, the revised MTA may include new 
arguments and/or evidence as to why the revised MTA meets statutory and 
regulatory requirements for an MTA, as well as arguments and evidence 
relevant to the patentability of the new proposed substitute claims. 84 
FR 9501. Because a revised MTA replaces the original MTA filed earlier 
in the proceeding, a patent owner may not incorporate by reference 
substitute claims or arguments presented in the original MTA into the 
revised MTA; all proposed substitute claims a patent owner wishes the 
Board to consider must be presented in the revised MTA.
    A revised MTA is an additional MTA that is automatically authorized 
under 35 U.S.C. 316(d)(2) and 326(d)(2). The revisions therefore 
distinguish between additional MTAs under 37 CFR 42.121(c) and 
42.221(c), which require pre-authorization upon a showing of ``good 
cause,'' and a revised MTA, which may be filed without prior 
authorization. Where the term ``any motion to amend'' is used, the 
final rule refers to an original, additional, or revised MTA.
    A patent owner is not required to request preliminary guidance or 
file a revised motion to amend. Specifically, if a patent owner does 
not elect either to receive preliminary guidance on its original MTA or 
to file a revised MTA, the rules governing amendment of the patent are 
essentially unchanged from the practice prior to the MTA pilot program. 
See Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018-01129, 2019 WL 1118864 
(PTAB January 24, 2020) (precedential).

MTA Timeline and Extensions of Time

    The MTA pilot program notice set forth typical timelines and due 
dates for the filing or issuance of MTA-related papers, depending on 
whether a patent owner takes advantage of one, both, or neither of the 
options under the

[[Page 76426]]

program. See MTA pilot program notice, 84 FR 9506-9507, Appendices 1A 
(Patent Owner Reply Timeline) and 1B (Revised MTA Timeline). Where a 
revised MTA is filed, the Office issues a scheduling order that adjusts 
the deadline for oral hearing to accommodate additional briefing on the 
MTA.
    To address the concerns raised as to the ability of parties to have 
sufficient time to fully take advantage of the MTA procedure, the 
Office amends the rules to clarify that the Board may determine whether 
to request the Chief Administrative Patent Judge extend the final 
written decision deadline. The rules have also been amended to clarify 
that the Board may determine whether to extend deadlines in the MTA 
timeline pursuant to 37 CFR 42.5(c)(2). Extensions are not anticipated 
to be needed in most cases because the Board's experience is that the 
default timelines have been sufficient to permit full and fair briefing 
in cases under the MTA pilot program. Thus, the Office will continue to 
apply the existing timelines by default as currently implemented under 
the MTA pilot program unless an extension is granted as discussed 
further below. See 84 FR 9506-9507 (setting forth MTA pilot program 
timelines).
    The AIA provides the Director the discretion to extend the 
deadlines for issuing a final written decision for good cause and by 
not more than six months. 35 U.S.C. 316(a)(11), 326(a)(11). The 
Director's authority to extend the deadline of the final written 
decision has been delegated to the Chief Administrative Patent Judge. 
37 CFR 42.100(c), 42.200(c). Thus, pursuant to 37 CFR 42.100(c) and 
42.200(c), upon a showing of good cause, the Chief Administrative 
Patent Judge may extend the final written decision deadline beyond the 
statutory deadline (i.e., one year from the date a trial is instituted) 
by up to six months. For example, good cause may be present if one or 
more circumstances are present in a proceeding, such as: (1) complex 
issues; (2) unavailability of the panel; or (3) need to accommodate 
additional papers (such as additional briefing or a requested 
examination assistance). See e.g., Eden Park Illumination, Inc., v. S. 
Edward Neister, IPR2022-00381, Paper 51 (August 4, 2023 PTAB) 
(determining as good cause the involvement of a revised MTA with new 
prior art, resulting in a substantially compressed schedule, multiple 
postponements of the oral hearing due to scheduling conflicts, and 
additional briefing); Hope Medical Enterprises, Inc. v. Fennec 
Pharmaceuticals Inc., IPR2022-00125, Paper 35 (April 18, 2023 PTAB) 
(determining as good cause the involvement of a revised MTA, resulting 
in a compressed schedule, with the revised claims subject to asserted 
grounds of unpatentability based on a combination of at least four 
references); Snap, Inc., v. Palo Alto Research Center Inc., IPR2021-
00986, Paper 46 (November 7, 2022) (determining as good cause the 
substantial coordination of proceedings required by the Board due to 
multiple pending motions to amend).
    As for deadlines that are not for a final written decision, 
typically, a panel of the Board determines whether to grant a good-
cause extension under 37 CFR 42.5(c)(2) after request from, and 
conference with, the parties. In the context of the MTA timelines, the 
Board will continue to consider whether to grant extensions of those 
timelines as required by the Board's rules discussed above. In 
particular, the Board may determine at any time during the pendency of 
the case, but more specifically upon issuing the preliminary guidance 
or receiving a revised MTA, whether for good cause the particular 
circumstances raised by the parties to the proceeding warrant an 
extension of deadlines. When an extension is granted, the parties will 
be notified of the change in the due dates for the remainder of the 
deadlines and events in the proceeding.

Allocation of Burdens of Persuasion and Scope of the Record in Motions 
To Amend

    Under the rules prior to this final rule and under Federal Circuit 
case law, the Board retains discretion to raise, or to not raise, 
grounds of unpatentability with respect to proposed substitute claims. 
See Nike, Inc. v. Adidas AG, 955 F.3d 45, 53 (2020); Hunting Titan, 28 
F.4th at 1381.
    In the final rule, the body of evidence that the Board may consider 
and make of record now includes the entire evidence of record in the 
proceeding, without limitation, in accordance with Nike, Inc. v. Adidas 
AG, 955 F.3d at 54 (``[T]he Board may rely on prior art of record in 
considering the patentability of amended claims.''). By removing 
limitations of the prior rules, such as the ``interests of justice'' 
standard and the requirement for ``readily identifiable and 
persuasive'' evidence, the final rule alleviates the Federal Circuit's 
concern that the Board confined its discretion to only rare 
circumstances. See Hunting Titan, 28 F.4th at 1381 (noting that the 
USPTO's ``substantial reliance on the adversarial system . . . 
overlooks the basic purpose of [inter partes review] proceedings: to 
reexamine an earlier agency decision and ensure `that patent monopolies 
are kept within their legitimate scope.' ''); see also id. at 1385 
(concurrence expressing concern that the burden-allocation rule's 
requirement for ``readily identifiable and persuasive evidence'' may 
prevent the Board from raising grounds ``even when no one is around to 
oppose a new patent monopoly grant''). The final rule broadens the 
Board's authority to sua sponte raise grounds of unpatentability with 
respect to proposed substitute claims and provides for notification of 
those grounds to be given to the parties, typically in, but not limited 
to, preliminary guidance. 37 CFR 42.121(d)(3) and (4), 42.221(d)(3) and 
(4).
    The final rule therefore departs from the Board's precedential 
Hunting Titan decision. Hunting Titan, Inc. v. DynaEnergetics Europe 
GmbH, IPR2018-00600 (PTAB July 6, 2020) (Paper 67). That decision, 
criticized by the Federal Circuit, is at odds with the proposed broader 
discretion of the Board to raise grounds sua sponte. Accordingly, the 
Hunting Titan decision is de-designated from precedential status as of 
the effective date of this final rule. See (SOP2).

Examination Assistance

    Consistent with the Board's discretion to raise grounds of 
unpatentability, the MTA pilot program noted the Board's discretion to 
solicit patent examiner assistance regarding the MTA when ``petitioner 
cease[d] to participate altogether in an AIA trial in which the patent 
owner file[d] an MTA, and the Board nevertheless exercise[d] its 
discretion to proceed with the trial.'' 84 FR 9502. If solicited by the 
Board, the assistance could include the preparation of an advisory 
report that: (1) provides an initial discussion about whether an MTA 
meets certain statutory and regulatory requirements (e.g., whether the 
amendment enlarges the scope of the claims of the patent or introduces 
new matter) and/or (2) provides an initial discussion about the 
patentability of proposed substitute claims, for example, in light of 
prior art that was identified by the parties in their submissions and/
or obtained in prior art searches by the examiner. Id. As of issuance 
of this final rule, the Board has not exercised its discretion to 
solicit examination assistance.
    The final rule provides that the Board may request such examination 
assistance consistent with current practice reflected in the MTA pilot 
program. 37 CFR 42.121(d)(3)(ii), 42.221(d)(3)(ii); 84 FR 9502. For

[[Page 76427]]

example, the Board has discretion to solicit examination assistance if 
the petitioner ceases to participate altogether in an AIA trial in 
which the patent owner files an MTA and the Board nevertheless 
exercises its discretion to proceed with the trial thereafter. 84 FR 
9502. The Board may also solicit examination assistance when a 
petitioner continues to participate in the AIA trial but either does 
not oppose or has ceased to oppose an MTA. Examination assistance could 
include the preparation of an advisory report as outlined above. Id.
    The final rule thus confirms the Board's discretion to seek 
examination assistance at any time after any motion to amend has been 
filed if no petitioner opposes or all petitioners cease to oppose the 
MTA. The final rule also ensures that the Board retains the discretion 
to request examination assistance when the opposition is deficient such 
that a search for additional prior art is warranted. The final rule 
also clarifies that the Board may make of record information identified 
in response to the Board-initiated request for examination assistance. 
Additionally, the final rule provides that the Board's request for 
examination assistance and the results of that assistance will be made 
of record.

Changes From Proposed Rule

    In light of the received comments, this final rule makes the 
revisions to the 2024 NPRM as follows.
    Sections 42.121(b) and 42.221(b) have been revised further to 
clarify that the motion itself (not the claim listing) must set forth 
the support in the original disclosure of the patent for each proposed 
substitute claim and the support in an earlier-filed disclosure for 
each claim for which the benefit of the filing date of the earlier-
filed disclosure is sought.
    Sections 42.121(d)(3)(ii) and 42.221(d)(3)(ii) have been revised 
further to state that the Board also may consider and may make of 
record information identified in response to a Board-initiated request 
for examination assistance. These sections are revised further to 
expressly state that Board may request the examination assistance at 
any time after any motion to amend has been filed if no petitioner 
opposes or all petitioners cease to oppose the motion to amend, or if 
the Board determines that a deficient prior art challenge in an 
opposition to a motion to amend warrants a search for additional prior 
art. Further, the revised rules state that the Board's request for 
examination assistance and the results of such assistance will be made 
of record.
    Sections 42.121(e)(3) and 42.221(e)(3) have been revised further to 
clarify that in response to the preliminary guidance, a patent owner 
may file a reply that responds to the petitioner's opposition to the 
motion to amend and/or the preliminary guidance. The patent owner may 
file a revised motion to amend instead of a reply, as discussed in 
Sec. Sec.  42.121(f) and 42.221(f). These sections are also revised 
further to expressly provide for petitioner's filing of a sur-reply 
that is limited to responding to the preliminary guidance and/or 
arguments made in the patent owner's reply brief. Further, the revised 
rule specifies that the sur-reply may not be accompanied by new 
evidence, but may comment on any new evidence filed with the reply and/
or point to cross-examination testimony of a reply witness, if relevant 
to the arguments made in the reply brief.
    New Sec. Sec.  42.121(e)(4) and 42.221(e)(4) are a renumbering of 
unchanged provisions previously included in Sec. Sec.  42.121(e)(3) and 
42.221(e)(3).

Discussion of Specific Rules

Sections 42.121 and 42.221

    Sections 42.121(a) and 42.221(a) are amended to refer to original 
motions to amend and to allow for requests for preliminary guidance on 
an original motion to amend.
    Sections 42.121(b) and 42.221(b) are amended to clarify that the 
regulation applies to any motion to amend and that support in the 
original disclosure or earlier-filed disclosure must be included in the 
motion for each proposed substitute claim.
    Sections 42.121(d) and 42.221(d) are amended to provide that the 
Board may consider all evidence of record in the proceeding when 
exercising its discretion to grant or deny a motion to amend or raise a 
new ground of unpatentability in connection with a proposed substitute 
claim. These sections are further amended to provide that the Board may 
consider, and may make of record, any evidence in a related proceeding 
before the Office as well as evidence that a district court can 
judicially notice. These sections are also amended to provide that the 
Board may request examination assistance at any time after any motion 
to amend has been filed, if no petitioner opposes or all petitioners 
cease to oppose the motion to amend, or if the Board determines that a 
deficient prior art challenge in an opposition to a motion to amend 
warrants a search for additional prior art. These sections are further 
amended to state that information identified in response to the Board-
initiated request for examination assistance may be considered and made 
of record, and that the request and the results of the examination 
assistance will also be made of record. The sections further state that 
when the Board exercises discretion to raise a new ground in connection 
with a motion to amend, the Board will determine patentability on the 
new ground by reference to the evidence of record or made of record and 
based on a preponderance of the evidence. These sections do not alter 
the current rules on burden of persuasions of parties to the 
proceeding.
    Sections 42.121(e) and 42.221(e) are added to provide for an 
opportunity to request preliminary guidance, consistent with the MTA 
pilot program. Such guidance will not be binding on the Board, is not a 
``decision'' under 37 CFR 42.71(d), and is not a final agency action. 
The added sections permit a patent owner to file a reply to the 
petitioner's opposition to the motion to amend and/or the preliminary 
guidance (if requested), or a revised MTA as discussed in Sec. Sec.  
42.121(f) and 42.221(f). The reply or revised MTA may be accompanied by 
new evidence. Further, the petitioner may file a sur-reply that is 
limited to responding to the preliminary guidance and/or arguments made 
in the patent owner's reply brief. The sur-reply may not be accompanied 
by new evidence but may comment on any new evidence filed with the 
reply and/or point to cross-examination testimony of a reply witness, 
if relevant to the arguments made in the reply brief. Moreover, the 
added sections provide that, if a patent owner does not file either a 
reply or a revised MTA after receiving preliminary guidance from the 
Board, the petitioner may file a reply to the preliminary guidance, but 
such a reply may only respond to the preliminary guidance and may not 
be accompanied by new evidence. If the petitioner files a reply in this 
context, a patent owner may file a sur-reply, but that sur-reply may 
only respond to the petitioner's reply and may not be accompanied by 
new evidence.
    Further, the added sections provide that the Board may, upon 
issuing the preliminary guidance, for good cause and on a case-by-case 
basis, determine whether to request the Chief Administrative Patent 
Judge to extend the final written decision deadline more than one year 
from the date a trial is instituted in accordance with Sec. Sec.  
42.100(c) and 42.200(c) and whether to extend any remaining deadlines 
under Sec.  42.5(c).

[[Page 76428]]

    The final rule adds Sec. Sec.  42.121(f) and 42.221(f) to provide 
an opportunity for a patent owner to file one revised motion to amend, 
consistent with the MTA pilot program. Such a revised motion to amend 
must be responsive to issues raised in the preliminary guidance, or the 
petitioner's opposition to the motion to amend, and must include one or 
more new proposed substitute claims in place of previously presented 
substitute claims, where each new proposed substitute claim presents a 
new claim amendment. Any revised motion to amend replaces the original 
motion to amend in the proceeding.
    Further, the Board may, upon receiving the revised motion to amend, 
on a case-by-case basis, determine whether to request the Chief 
Administrative Patent Judge to extend the final written decision 
deadline more than one year from the date a trial is instituted in 
accordance with Sec. Sec.  42.100(c) and 42.200(c) and whether to 
extend any remaining deadlines under Sec.  42.5(c).

Rulemaking Considerations

A. Administrative Procedure Act (APA)

    This rulemaking makes changes to the consolidated set of rules 
relating to Office trial practice for IPR, PGR, and derivation 
proceedings. The changes in this rulemaking do not alter the 
substantive criteria of patentability. These changes involve rules of 
agency practice. See, e.g., 35 U.S.C. 316(a)(5), as amended. The 
changes in this rulemaking involve rules of agency practice and 
procedure, and/or interpretive rules, and do not require notice-and-
comment rulemaking. See Perez v. Mortg. Bankers Ass'n, 575 U.S. 92, 97, 
101 (2015) (explaining that interpretive rules ``advise the public of 
the agency's construction of the statutes and rules which it 
administers'' and do not require notice and comment when issued or 
amended); Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1336-37 (Fed. Cir. 
2008) (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''); and JEM Broadcasting Co. v. F.C.C., 22 F.3d 320, 328 (D.C. 
Cir. 1994) (explaining that rules are not legislative because they do 
not ``foreclose effective opportunity to make one's case on the 
merits.'').
    Nevertheless, the USPTO 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 
Legislative and Regulatory Affairs of the Office of General Law at 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 rule revises certain trial practice procedures before the 
Board. Specifically, the Office proposes to amend the rules of practice 
before the Board to reflect current Board practice, as set forth in 
various precedential and informative Board decisions, as well as the 
Office's Trial Practice Guide. Specifically, the Office amends the 
rules of practice to make permanent certain provisions of the Office's 
MTA pilot program. These changes are procedural in nature, and any 
requirements resulting from the proposed changes are of minimal or no 
additional burden to those practicing before the Board.
    For the foregoing reasons, the changes in this rulemaking 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 (September 30, 1993), as amended by 
Executive Order 14094 (April 6, 2023).

D. Executive Order 13563 (Improving Regulation and Regulatory Review)

    The Office has complied with Executive Order 13563 (January 18, 
2011). Specifically, and as discussed above, 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 pertains strictly to Federal agency procedures and 
does not contain policies with federalism implications sufficient to 
warrant preparation of a Federalism Assessment under Executive Order 
13132 (August 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 (November 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 (February 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 (April 21, 1997).

J. Executive Order 12630 (Taking of Private Property)

    This rulemaking will not affect a taking of private property or 
otherwise have taking implications under Executive Order 12630 (March 
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.), the 
USPTO will submit a report containing the final rule and other required 
information to

[[Page 76429]]

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 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. 3501-3549) requires 
that the Office consider the impact of paperwork and other information 
collection burdens imposed on the public.
    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the paperwork and other information 
collection burdens discussed in this rulemaking have already been 
approved under Office of Management and Budget (OMB) Control Number 
0651-0069 (Patent Review and Derivations).
    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 has valid OMB control number.

List of Subjects in 37 CFR Part 42

    Administrative practice and procedure, Inventions and patents, 
Lawyers.

    For the reasons set forth in the preamble, the Office amends 37 CFR 
part 42 as follows:

PART 42--TRIAL PRACTICE BEFORE THE PATENT TRIAL AND APPEAL BOARD

0
1. The authority citation for part 42 continues to read as follows:

    Authority:  35 U.S.C. 2(b)(2), 6, 21, 23, 41, 135, 311, 312, 
316, 321-326; Pub. L. 112-29, 125 Stat. 284; and Pub. L. 112-274, 
126 Stat. 2456.


0
2. Revise Sec.  42.121 to read as follows:


Sec.  42.121  Amendment of the patent.

    (a) Motion to amend--(1) Original motion to amend. A patent owner 
may file one original motion to amend a patent, but only after 
conferring with the Board.
    (i) Due date. Unless a due date is provided in a Board order, an 
original motion to amend must be filed no later than the filing of a 
patent owner response.
    (ii) Request for preliminary guidance. If a patent owner wishes to 
receive preliminary guidance from the Board as discussed in paragraph 
(e) of this section, the original motion to amend must include the 
patent owner's request for that preliminary guidance.
    (2) Scope. Any motion to amend may be denied where:
    (i) The amendment does not respond to a ground of unpatentability 
involved in the trial; or
    (ii) The amendment seeks to enlarge the scope of the claims of the 
patent or introduce new subject matter.
    (3) A reasonable number of substitute claims. Any motion to amend 
may cancel a challenged claim or propose a reasonable number of 
substitute claims. The presumption is that only one substitute claim 
will be needed to replace each challenged claim, and it may be rebutted 
by a demonstration of need.
    (b) Content. Any motion to amend claims must include a claim 
listing, which claim listing may be contained in an appendix to the 
motion, show the changes clearly, and the motion must set forth:
    (1) The support in the original disclosure of the patent for each 
proposed substitute claim; and
    (2) The support in an earlier-filed disclosure for each claim for 
which the benefit of the filing date of the earlier-filed disclosure is 
sought.
    (c) Additional motion to amend. Except as provided in paragraph (f) 
of this section, any additional motion to amend may not be filed 
without Board authorization. An additional motion to amend may be 
authorized when there is a good cause showing or a joint request of the 
petitioner and the patent owner to materially advance a settlement. In 
determining whether to authorize such an additional motion to amend, 
the Board will consider whether a petitioner has submitted supplemental 
information after the time period set for filing a motion to amend in 
paragraph (a)(1)(i) of this section.
    (d) Burden of persuasion. On any motion to amend:
    (1) Patent owner's burden. A patent owner bears the burden of 
persuasion to show, by a preponderance of the evidence, that the motion 
to amend complies with the requirements of paragraphs (1) and (3) of 35 
U.S.C. 316(d), as well as paragraphs (a)(2) and (3) and (b)(1) and (2) 
of this section;
    (2) Petitioner's burden. A petitioner bears the burden of 
persuasion to show, by a preponderance of the evidence, that any 
proposed substitute claims are unpatentable; and
    (3) Exercise of Board discretion. Irrespective of paragraphs (d)(1) 
and (2) of this section, the Board may exercise its discretion to grant 
or deny a motion to amend or raise a new ground of unpatentability in 
connection with a proposed substitute claim. Where the Board exercises 
its discretion to raise a new ground of unpatentability in connection 
with a proposed substitute claim, the parties will have notice and an 
opportunity to respond. In the exercise of this discretion under this 
paragraph (d)(3), the Board may consider all evidence of record in the 
proceeding. The Board also may consider and make of record:
    (i) Any evidence in a related proceeding before the Office and 
evidence that a district court can judicially notice; and
    (ii) Information identified in response to a Board-initiated 
examination assistance. The Board may request the examination 
assistance at any time after any motion to amend has been filed if no 
petitioner opposes or all petitioners

[[Page 76430]]

cease to oppose the motion to amend, or if the Board determines that a 
deficient prior art challenge in an opposition to the motion to amend 
warrants a search for additional prior art. The Board's request for 
examination assistance and the results of such assistance will be made 
of record.
    (4) Determination of unpatentability. Where the Board exercises its 
discretion under paragraph (d)(3) of this section, the Board must 
determine unpatentability based on a preponderance of the evidence of 
record.
    (e) Preliminary guidance. (1) In its original motion to amend, a 
patent owner may request that the Board provide preliminary guidance 
setting forth the Board's initial, preliminary views on the original 
motion to amend, including whether the parties have shown a reasonable 
likelihood of meeting their respective burdens of persuasion as set 
forth under paragraphs (d)(1) and (2) of this section and notice of any 
new ground of unpatentability discretionarily raised by the Board under 
paragraph (d)(3) of this section. The Board may, upon issuing the 
preliminary guidance, determine whether to request the Chief 
Administrative Patent Judge to extend the final written decision 
deadline more than one year from the date a trial is instituted in 
accordance with Sec.  42.100(c) and whether to extend any remaining 
deadlines under Sec.  42.5(c)(2).
    (2) Any preliminary guidance provided by the Board on an original 
motion to amend will not be binding on the Board in any subsequent 
decision in the proceeding, is not a ``decision'' under Sec.  42.71(d) 
that may be the subject of a request for rehearing or Director Review, 
and is not a final agency action.
    (3) In response to the Board's preliminary guidance, a patent owner 
may file a reply that responds to the petitioner's opposition to the 
motion to amend and/or the preliminary guidance, or a revised motion to 
amend as discussed in paragraph (f) of this section. The reply or 
revised motion to amend may be accompanied by new evidence. The 
petitioner may file a sur-reply that is limited to responding to the 
preliminary guidance and/or arguments made in the patent owner's reply 
brief. The sur-reply may not be accompanied by new evidence, but may 
comment on any new evidence filed with the reply and/or point to cross-
examination testimony of a reply witness, if relevant to the arguments 
made in the reply brief.
    (4) If a patent owner does not file either a reply or a revised 
motion to amend after receiving preliminary guidance from the Board, 
the petitioner may file a reply to the preliminary guidance, but such a 
reply may only respond to the preliminary guidance and may not be 
accompanied by new evidence. If the petitioner files a reply in this 
context, a patent owner may file a sur-reply, but that sur-reply may 
only respond to the petitioner's reply and may not be accompanied by 
new evidence.
    (f) Revised motion to amend. (1) Irrespective of paragraph (c) of 
this section, a patent owner may, without prior authorization from the 
Board, file one revised motion to amend after receiving an opposition 
to the original motion to amend or after receiving the Board's 
preliminary guidance. The Board may, upon receiving the revised motion 
to amend, determine whether to request the Chief Administrative Patent 
Judge to extend the final written decision deadline more than one year 
from the date a trial is instituted in accordance with Sec.  42.100(c) 
and whether to extend any remaining deadlines under Sec.  42.5(c)(2).
    (2) A revised motion to amend must be responsive to issues raised 
in the preliminary guidance or in the petitioner's opposition to the 
motion to amend and must include one or more new proposed substitute 
claims in place of the previously presented substitute claims, where 
each new proposed substitute claim presents a new claim amendment.
    (3) If a patent owner files a revised motion to amend, that revised 
motion to amend replaces the original motion to amend in the 
proceeding.


0
3. Revise Sec.  42.221 to read as follows:


Sec.  42.221  Amendment of the patent.

    (a) Motion to amend--(1) Original motion to amend. A patent owner 
may file one original motion to amend a patent, but only after 
conferring with the Board.
    (i) Due date. Unless a due date is provided in a Board order, an 
original motion to amend must be filed no later than the filing of a 
patent owner response.
    (ii) Request for preliminary guidance. If a patent owner wishes to 
receive preliminary guidance from the Board as discussed in paragraph 
(e) of this section, the original motion to amend must include the 
patent owner's request for that preliminary guidance.
    (2) Scope. Any motion to amend may be denied where:
    (i) The amendment does not respond to a ground of unpatentability 
involved in the trial; or
    (ii) The amendment seeks to enlarge the scope of the claims of the 
patent or introduce new subject matter.
    (3) A reasonable number of substitute claims. Any motion to amend 
may cancel a challenged claim or propose a reasonable number of 
substitute claims. The presumption is that only one substitute claim 
will be needed to replace each challenged claim, and it may be rebutted 
by a demonstration of need.
    (b) Content. Any motion to amend claims must include a claim 
listing, which claim listing may be contained in an appendix to the 
motion, show the changes clearly, and the motion must set forth:
    (1) The support in the original disclosure of the patent for each 
proposed substitute claim; and
    (2) The support in an earlier-filed disclosure for each claim for 
which the benefit of the filing date of the earlier-filed disclosure is 
sought.
    (c) Additional motion to amend. Except as provided by paragraph (f) 
of this section, any additional motion to amend may not be filed 
without Board authorization. An additional motion to amend may be 
authorized when there is a good cause showing or a joint request of the 
petitioner and the patent owner to materially advance a settlement. In 
determining whether to authorize such an additional motion to amend, 
the Board will consider whether a petitioner has submitted supplemental 
information after the time period set for filing a motion to amend in 
paragraph (a)(1)(i) of this section.
    (d) Burden of persuasion. On any motion to amend:
    (1) Patent owner's burden. A patent owner bears the burden of 
persuasion to show, by a preponderance of the evidence, that the motion 
to amend complies with the requirements of paragraphs (1) and (3) of 35 
U.S.C. 326(d), as well as paragraphs (a)(2) and (3) and (b)(1) and (2) 
of this section;
    (2) Petitioner's burden. A petitioner bears the burden of 
persuasion to show, by a preponderance of the evidence, that any 
proposed substitute claims are unpatentable; and
    (3) Exercise of Board discretion. Irrespective of paragraphs (d)(1) 
and (2) of this section, the Board may exercise its discretion to grant 
or deny a motion to amend or raise a new ground of unpatentability in 
connection with a proposed substitute claim. Where the Board exercises 
its discretion to raise a new ground of unpatentability in connection 
with a proposed substitute claim, the parties will have notice and an 
opportunity to respond. In the exercise of discretion under this

[[Page 76431]]

paragraph (d)(3), the Board may consider all evidence of record in the 
proceeding. The Board also may consider and may make of record:
    (i) Any evidence in a related proceeding before the Office and 
evidence that a district court can judicially notice; and
    (ii) Information identified in response to a Board-initiated 
examination assistance. The Board may request the examination 
assistance at any time after any motion to amend has been filed if no 
petitioner opposes or all petitioners cease to oppose the motion to 
amend, or if the Board determines that a deficient prior art challenge 
in an opposition to the motion to amend warrants a search for 
additional prior art. The Board's request for examination assistance 
and the results of such assistance will be made of record.
    (4) Determination of unpatentability. Where the Board exercises its 
discretion under paragraph (d)(3) of this section, the Board must 
determine unpatentability based on a preponderance of the evidence of 
record.
    (e) Preliminary guidance. (1) In its original motion to amend, a 
patent owner may request that the Board provide preliminary guidance 
setting forth the Board's initial, preliminary views on the original 
motion to amend, including whether the parties have shown a reasonable 
likelihood of meeting their respective burdens of persuasion as set 
forth under paragraphs (d)(1) and (2) of this section and notice of any 
new ground of unpatentability discretionarily raised by the Board under 
paragraph (d)(3) of this section. The Board may, upon issuing the 
preliminary guidance, determine whether to request the Chief 
Administrative Patent Judge extend the final written decision deadline 
more than one year from the date a trial is instituted in accordance 
with Sec.  42.200(c) and whether to extend any remaining deadlines 
under Sec.  42.5(c)(2).
    (2) Any preliminary guidance provided by the Board on an original 
motion to amend will not be binding on the Board in any subsequent 
decision in the proceeding, is not a ``decision'' under Sec.  42.71(d) 
that may be the subject of a request for rehearing or Director Review, 
and is not a final agency action.
    (3) In response to the Board's preliminary guidance, a patent owner 
may file a reply that responds to the petitioner's opposition to the 
motion to amend and/or the preliminary guidance, or a revised motion to 
amend as discussed in paragraph (f) of this section. The reply or 
revised motion to amend may be accompanied by new evidence. The 
petitioner may file a sur-reply that is limited to responding to the 
preliminary guidance and/or arguments made in the patent owner's reply 
brief. The sur-reply may not be accompanied by new evidence, but may 
comment on any new evidence filed with the reply and/or point to cross-
examination testimony of a reply witness, if relevant to the arguments 
made in the reply brief.
    (4) If a patent owner does not file either a reply or a revised 
motion to amend after receiving preliminary guidance from the Board, 
the petitioner may file a reply to the preliminary guidance, but such a 
reply may only respond to the preliminary guidance and may not be 
accompanied by new evidence. If the petitioner files a reply in this 
context, a patent owner may file a sur-reply, but that sur-reply may 
only respond to the petitioner's reply and may not be accompanied by 
new evidence.
    (f) Revised motion to amend. (1) Irrespective of paragraph (c) of 
this section, a patent owner may, without prior authorization from the 
Board, file one revised motion to amend after receiving an opposition 
to the original motion to amend or after receiving the Board's 
preliminary guidance. The Board may, upon receiving the revised motion 
to amend, determine whether to request the Chief Administrative Patent 
Judge to extend the final written decision deadline more than one year 
from the date a trial is instituted in accordance with Sec.  42.200(c) 
and whether to extend any remaining deadlines under Sec.  42.5(c)(2).
    (2) A revised motion to amend must be responsive to issues raised 
in the preliminary guidance or in the petitioner's opposition to the 
motion to amend, and must include one or more new proposed substitute 
claims in place of the previously presented substitute claims, where 
each new proposed substitute claim presents a new claim amendment.
    (3) If a patent owner files a revised motion to amend, that revised 
motion to amend replaces the original motion to amend in the 
proceeding.

Katherine K. Vidal,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2024-21134 Filed 9-17-24; 8:45 am]
BILLING CODE 3510-16-P