Motion To Amend Practice and Procedures in Trial Proceedings Under the America Invents Act Before the Patent Trial and Appeal Board
| Published date | 04 March 2024 |
| Record Number | 2024-04127 |
| Citation | 89 FR 15531 |
| Court | Patent And Trademark Office |
| Section | Proposed rules |
Federal Register, Volume 89 Issue 43 (Monday, March 4, 2024)
[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
