[Federal Register Volume 89, Number 43 (Monday, March 4, 2024)]
[Proposed Rules]
[Pages 15531-15540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04127]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Part 42

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


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: Notice of proposed rulemaking.

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SUMMARY: The United States Patent and Trademark Office (Office or 
USPTO) proposes to update its rules 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). The 
Office proposes 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 proposes to revise the rules to clarify that a preponderance 
of 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. These 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 changes would apply to the existing 
consolidated set of rules relating 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: To ensure consideration, commenters must submit written comments 
on or before May 3, 2024.

ADDRESSES: For reasons of government efficiency, comments must be 
submitted through the Federal eRulemaking Portal at https://www.regulations.gov. To submit comments via the portal, enter docket 
number PTO-P-2020-0060 on the home page and select ``search.'' The site 
will provide a search results page listing all documents associated 
with this docket. Find a reference to this proposed rulemaking and 
select the ``Comment'' icon, complete the required fields, and enter or 
attach your comments. Attachments to electronic comments will be 
accepted in ADOBE[supreg] portable document format or MICROSOFT 
WORD[supreg] format. Because comments will be made available for public 
inspection, information that the submitter does not desire to make 
public, such as an address or phone number, should not be included in 
the comments.
    Visit the Federal eRulemaking Portal (https://www.regulations.gov) 
for additional instructions on providing comments via the portal. If 
the electronic submission of comments is not feasible due to lack of 
access to a computer and/or the internet, please contact the USPTO 
using the contact information below for special instructions regarding 
how to submit comments by mail or by hand delivery, based upon the 
public's ability to obtain access to USPTO facilities at the time.

[[Page 15532]]


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 Proposed 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 2018, the Office published a Request for Comments (RFC) on a 
proposed procedure for motions to amend filed in AIA proceedings before 
the PTAB. 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) (seeking 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)) (2018 
RFC). After considering the comments received in response, the Office 
implemented the MTA pilot program. See 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 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).

Preliminary Guidance and Revised Motions To Amend Under the MTA Pilot 
Program

    The MTA pilot program provides a patent owner with two independent 
options when proposing substitute claims for challenged patent claims 
during an AIA trial proceeding. Under the first option in the MTA pilot 
program, if requested by a patent owner in its original MTA, the Board 
will issue preliminary, non-binding guidance. Under the second option, 
a patent owner may file, without needing Board authorization, a revised 
MTA as discussed further below.
    The Board's preliminary guidance typically will come in the form of 
a short paper issued after a petitioner files its opposition to the MTA 
(or after the due date for a petitioner's opposition, if none is 
filed). The preliminary guidance provides, at a 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.
    Further, 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). A revised 
MTA replaces 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. Instead of filing a revised 
MTA, a patent owner may choose to file a reply to a petitioner's 
opposition to the MTA and/or the preliminary guidance (if requested). 
If preliminary guidance was issued at a patent owner's request, the 
patent owner may choose to take no action and wait for the petitioner's 
reply to the preliminary guidance and then file a sur-reply.
    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 neither, one, or both options 
under the 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 the 
additional briefing on the MTA.
    As described in the MTA pilot program notice and implemented by the 
Board, the preliminary guidance provides the Board's initial, 
preliminary views on the original MTA. With that in mind, 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), 42.221(d). 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, 2020 
WL 407145, at *1 (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 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 light of the amendments presented in those claims, in a 
patent owner's original MTA and will not address the patentability of 
the originally challenged claims.
    Similar to an institution decision, preliminary guidance on an MTA 
during an AIA trial will not be binding on 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 (FWD) was not 
arbitrary and capricious

[[Page 15533]]

and did not violate the Administrative Procedure Act). 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 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 or a revised MTA. 
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 a preliminary guidance was requested, a 
patent owner's reply may respond only 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 
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 sur-
reply also may respond to the preliminary guidance and is limited to 
responding to arguments made in the patent owner's reply brief, to 
commenting on reply declaration testimony, or pointing to cross-
examination testimony.
    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 respond only 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 
respond only to the petitioner's reply and may not be accompanied by 
new evidence.
    If a patent owner files an MTA, the patent owner may, without prior 
authorization from the Board, file one revised MTA after receiving a 
petitioner's opposition or the Board's preliminary guidance (if 
requested). 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.
    Further, 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 proposed 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 
proposed rule refers to an original, additional, or revised MTA.
    A patent owner is not required to exercise either option under the 
MTA pilot program. 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, 2020 WL 407145, 
at *1 (PTAB January 24, 2020) (precedential).
    The Office has tracked engagement with the MTA pilot program and 
published an updated study of the MTA pilot program, providing such 
data through March 31, 2023. See Patent Trial and Appeal Board Motion 
to Amend Study Installment 8, https://www.uspto.gov/patents/ptab/motions-amend-study (last visited August 23, 2023) (``Study''). The 
Study shows that, of 2,832 trials that were instituted during the MTA 
pilot program, 9% (264) of instituted trials included a MTA (very close 
to the rate of MTAs filed before the MTA pilot program, 10% of all 
trials). Further, of the 264 instituted trials with an MTA, 88% (232) 
included a request for preliminary guidance, i.e., the first of two MTA 
pilot program options. Still further, of those 232 trials with an MTA 
requesting preliminary guidance, 72% (168) filed either a Patent Owner 
Reply (41) or a Revised MTA (127), i.e., the second of two MTA pilot 
program options. Additionally, during the MTA pilot program study 
period, 24% of final determinations had at least one proposed 
substitute claim granted entry, as opposed to 14% of final 
determinations prior to the MTA pilot program. To-date, no final 
determination for an instituted proceeding has been extended beyond the 
one-year deadline based solely on the involvement of the MTA pilot 
program.

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

    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). These 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, these 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 may 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 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 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

[[Page 15534]]

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.'').
    Under the rules as currently written 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.
    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 provides an initial discussion about whether an MTA meets 
certain statutory and regulatory requirements (i.e., whether the 
amendment enlarges the scope of the claims of the patent or introduces 
new matter) and about the patentability of proposed substitute claims, 
for example, in light of prior art that was provided by the patent 
owner and/or obtained in prior art searches by the examiner. Id. As of 
issuance of this notice, the Board has not solicited examination 
assistance of this nature in exercising the Board's discretion to raise 
or not to raise grounds of unpatentability. This proposed rule 
clarifies that the examination assistance to the Board may be 
effectuated by requesting that the Office conduct a prior art search. 
The proposed rule also clarifies that the Board's request for the prior 
art search and the result of such a search by the Office will be made 
of record.

2023 RFC 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 another Request for Comments to 
seeking feedback on the public's experience with the program and the 
burden-allocation rules that apply to MTAs. See RFC Regarding MTA Pilot 
Program and Rules of Practice to Allocate 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''). The comments, and the rules proposed to 
address these comments and to enhance the Motions to Amend practice, 
are discussed below.

Revisions in This Proposed Rule

Response to Comments and Proposed Provisions on Preliminary Guidance 
and Revised Motions To Amend

    The MTA pilot program has been generally well-received, and one or 
both pilot program options are exercised in the vast majority of MTAs. 
Commenters to the 2023 RFC noted specifically that the option to 
request preliminary guidance has been popular among those participating 
in MTAs and has been effective, guiding patent owners to revise their 
MTAs in many cases. Although some commenters noted that motions to 
amend in general may not be as useful as other alternatives for claim 
amendments, none of the commenters stated that the Office should 
discontinue the options of issuing preliminary guidance and allowing 
the filing of a revised MTA as currently implemented. Some commenters, 
however, indicated that the Office

[[Page 15535]]

should consider providing more time for the MTA process. Commenters 
noted that parties may not have sufficient time after the preliminary 
guidance issues to address the preliminary guidance, secure expert 
testimony, and search for additional prior art. Proposals included 
having the Board hold a conference call to give parties an opportunity 
to offer a modified schedule.
    The Office appreciates the comments about the popularity and 
increased effectiveness of the MTA pilot program options, which are 
consistent with the Office's experience as supported by utilization 
data. In proceedings with MTAs filed under the pilot, at least 88% of 
patent owners have elected one or both pilot options (i.e., a request 
for preliminary guidance, a revised MTA, or both). Based on its 
experience with the pilot program for the four-year period from its 
effective date in 2019, consideration of the formal feedback received 
in response to the 2023 RFC, as well as additional feedback received 
from a variety of stakeholders during the operation of the MTA pilot 
program itself, the Office proposes to formalize the options available 
to patent owners under the MTA pilot program. Accordingly, the Office 
now issues this proposed rule to implement the two options in the MTA 
pilot program: (1) requesting preliminary guidance and (2) filing, 
without pre-authorization, a revised 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 proposes rule language clarifying the Board may extend deadlines 
in the MTA timeline. Such 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 6 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 beyond the statutory 
deadline (one year from the date a trial is instituted) by up to six 
months, particularly, for example, 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 evaluate a requested examination 
search report). 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 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 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 of 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, including whether to extend the deadline for 
the final written decision, which can only be granted by the Chief 
Administrative Patent Judge under 37 CFR 42.100(c) and 42.200(c). 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.

Response to Comments on the Reissue and Reexamination Options

    The 2023 RFC sought comments regarding whether reexamination and/or 
reissue proceedings are better options for patent owners seeking to 
amend claims in AIA proceedings as compared to the MTA pilot program. 
88 FR 33065-66. Although the majority of the comments supported use of 
the MTA pilot program, in response to this question some comments 
stated a preference to avoid the MTA process altogether. As to the 
desirability of pursuing reissue or reexamination in connection with an 
AIA trial proceeding, a summary of the alternatives for seeking claim 
amendments before, during, and after a post-grant proceeding has been 
provided in a prior notice. 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) (reissue 
and reexamination notice). The reissue and reexamination notice 
provides a summary of various pertinent practices regarding existing 
Office procedures that apply to reissue and reexamination, including 
after a petitioner files an AIA petition challenging claims of the same 
patent, after the Board institutes a trial, and after the Board issues 
a final written decision in an AIA trial proceeding. Id. at 16655-58. 
The notice also provides summary information about factors the Office 
currently considers when determining whether to stay or suspend a 
reissue proceeding, or stay a reexamination, that involves a patent 
involved in an AIA proceeding and when and whether to lift such a stay 
or suspension. Id. at 16656-58.
    Some commenters stated that the usefulness of a reissue and 
reexamination is reduced given the likelihood of their stay during the 
post-grant proceeding, including through appeals of the final written 
decision at the Federal Circuit. In the event a party is considering 
the impact of a possible stay of the reissue and reexamination 
proceedings, the reissue and reexamination notice states that a stay of 
an ex parte reexamination may be lifted ``notwithstanding a Federal 
Circuit appeal of a final written decision on the same patent.'' Id. at 
16658. The proposed rules do not change our current guidance in the 
reissue and reexamination notice.

Response to Comments and Proposed Provisions on Allocation of Burden 
and Evidence of Record for Proposed Amended Claims

    Regarding the burden-allocation rules, commenters favored 
continuing the exercise of discretion by the Board to raise new grounds 
of unpatentability. Some favored the exercise of discretion more 
broadly, i.e., for the Board to

[[Page 15536]]

consider all prior art of record and conduct a prior art search in each 
case where an MTA is filed. Other commenters favored the Board 
considering the entirety of the record, but did not favor the Board 
conducting a prior art search, primarily because of the compressed case 
timelines.
    In recognition of these comments, and in view of Office experience, 
the Office proposes changes to the rules to address comments in favor 
of the Board's authority to consider the entirety of the art of record 
and to request examination assistance in an appropriate manner when 
justified by circumstances. The Office agrees that the burden-
allocation rule should give the Board the ability to more broadly use 
its discretion to raise grounds of unpatentability and to consider all 
the prior art of record in the proceeding without limitation.
    Further, consistent with current practice reflected in the MTA 
pilot program, the Office proposes rules clarifying that the Board may 
seek examination assistance in certain circumstances. 84 FR 9502. For 
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. Id. 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 that provides an initial discussion 
of whether an MTA meets certain statutory and regulatory requirements 
(i.e., whether the amendment enlarges the scope of the claims of the 
patent or introduces new matter), as well as the patentability of 
proposed substitute claims in light of prior art that was provided by 
the patent owner and/or obtained in prior art searches by the examiner. 
Id. The proposed rule confirms the Board's discretion to seek 
examination assistance by clarifying that the Office may conduct a 
prior art search at the Board's request when no petitioner opposes or 
all petitioners cease to oppose an MTA. The proposed rule is intended 
to capture situations where no opposition is filed or an opposition is 
filed but other situations constitute a lack of opposition, such as the 
filing of an illusory opposition to the MTA or a petitioner filing that 
raises no prior art challenge. The proposed rule also clarifies that 
the Board may make of record any evidence identified through a prior 
art search undertaken at the Board's request. Additionally, the 
proposed rule provides that the Board's request and the prior art 
search report prepared by the Office at the request of the Board will 
be made of record.
    The 2023 RFC also resulted in comments concerning the burden of 
persuasion on Board-raised grounds. One commenter proposed that the 
post-grant proceeding scheme should remain strictly adversarial, with 
the burden of persuasion on unpatentability issues remaining with 
petitioner at all times. Another commenter proposed that on Board-
raised grounds, the Board has the ``burden.'' Other commenters noted 
that the statute is silent on this issue and that a patent owner must 
not bear this burden.
    The Board is a neutral tribunal and the notion of burden allocation 
to the Board in determining whether to grant or deny an MTA is 
incongruent with the discharge of its adjudicatory functions. 
Notwithstanding this incongruity, the Office recognizes the need for 
clarity and consistency in the application of the Board's exercise of 
discretion in connection with raising new grounds of unpatentability 
for proposed claims presented in an MTA. The proposed rule clarifies 
that the Board determines unpatentability on the new ground by 
reference to the evidence of record or made of record and based on a 
preponderance of the evidence. Support for the Board's responsibility 
in this regard has been established in current precedent of the Board. 
Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018-01129, 2020 WL 407145, at 
*1 (``The Board itself also may justify any finding of unpatentability 
by reference to evidence of record in the proceeding, for example, when 
a petitioner ceases to participate. . . . Thus, the Board determines 
whether substitute claims are unpatentable by a preponderance of the 
evidence based on the entirety of the record, including any opposition 
made by the petitioner.'').
    Furthermore, the Office proposes to broaden the body of evidence 
that the Board may consider and make of record, to now include 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 ``interests of 
justice'' and of considering ``only readily identifiable and 
persuasive'' evidence and no longer relying solely on the adversarial 
system, the proposed 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 proposed rule moves away 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 authority 
of the Board to raise grounds sua sponte. Accordingly, the Hunting 
Titan decision shall be de-designated from precedential status upon the 
effective date of the final rule.

Discussion of Specific Rules

Sections 42.121 and 42.221

    Sections 42.121(a) and 42.221(a) are proposed to be 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 proposed to be amended to 
clarify that the regulation applies to any motion to amend and that 
support in the original disclosure must be included for each proposed 
substitute claim.
    Sections 42.121(d) and 42.221(d) are proposed to be 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. The proposed amendment to each regulation 
further provides that the Board may consider, and may make of record, 
any evidence in a related proceeding before the Office and evidence 
that a district court can judicially notice. Each is also proposed to 
be amended to provide that the Board may, when no petitioner opposes or 
all petitioners cease to oppose the motion to amend, consider, and make 
of record, evidence identified through a prior art search conducted by 
the Office at the Board's request. The proposed provisions further 
require that when the Board exercises its discretion in connection with 
a motion to amend, the Board determine unpatentability on the new 
ground by reference to the

[[Page 15537]]

evidence of record or made of record and based on a preponderance of 
the evidence. The proposed revisions also require that the Board's 
request for and the result of a prior art search conducted by the 
Office at the Board's request will be made of record.
    Sections 42.121(e) and 42.221(e) are proposed to be 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 proposed provision provides that a patent owner will 
be permitted to file a reply to the petitioner's opposition to the 
motion to amend, preliminary guidance (if requested and no opposition 
is filed), 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. 
Moreover, the proposed provision provides 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 proposed provision provides that the Board may, upon 
issuing the preliminary guidance, for good cause and on a case-by-case 
basis, determine whether to extend the final written decision 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).
    The proposed rule adds Sec. Sec.  42.121(f) and 42.221(f) to 
provide for 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 
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, 
for good cause and on a case-by-case basis, determine whether to extend 
the final written decision 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 proposes changes to the consolidated set of rules 
relating to Office trial practice for IPR, PGR, CBM, and derivation 
proceedings. The changes proposed 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 proposed by 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 is publishing this proposed rule for 
comment to seek the benefit of the public's views on the Office's 
proposed regulatory changes.

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 proposed in this rulemaking will 
not have a significant economic impact on a substantial number of small 
entities. See 5 U.S.C. 605(b).
    The changes proposed in this rulemaking would revise 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 proposes to amend 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 proposed 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

[[Page 15538]]

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.), 
prior to issuing any final rule, the USPTO will submit a report 
containing the rule and other required information to the United States 
Senate, the United States House of Representatives, and the Comptroller 
General of the Government Accountability Office. The changes in this 
proposed rule 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 proposed 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 proposes to 
amend 37 CFR part 42 as follows:

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

0
1. The authority citation for 37 CFR 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.   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 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

[[Page 15539]]

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) When no petitioner opposes or all petitioners cease to oppose 
a motion to amend, prior art identified through a prior art search 
conducted by the Office at the Board's request. The request for and the 
results of a prior art search conducted by the Office at the Board's 
request 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 or made 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 extend the final written 
decision 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 and is not a final 
agency action.
    (3) In response to the Board's preliminary guidance, a patent owner 
may file a reply to the petitioner's opposition to the motion to amend, 
the preliminary guidance (if no opposition is filed), 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. 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 extend the final written decision 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 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

[[Page 15540]]

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 
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) When no petitioner opposes or all petitioners cease to oppose 
a motion to amend, prior art identified through a prior art search 
conducted by the Office at the Board's request. A request for and 
result of a prior art search conducted by the Office at the Board's 
request 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 or made 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 extend the final written 
decision 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, and is not a final 
agency action.
    (3) In response to the Board's preliminary guidance, a patent owner 
may file a reply to the petitioner's opposition to the motion to amend, 
preliminary guidance (no opposition is filed), 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. 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 extend the final written decision 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, if requested, 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. 2024-04127 Filed 3-1-24; 8:45 am]
BILLING CODE 3510-16-P