Request for Comments Regarding the Motion To Amend Pilot Program and Rules of Practice To Allocate the Burdens of Persuasion on Motions To Amend in Trial Proceedings Before the Patent Trial and Appeal Board, 33063-33066 [2023-10565]
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Federal Register / Vol. 88, No. 99 / Tuesday, May 23, 2023 / Proposed Rules
of manufacturing MDE that meets the
17-inch low transfer height. The Board
also seeks information about whether
transfer to a phlebotomy chair would be
necessary, or whether procedures can be
performed on patients while they
remain in their wheelchairs.
Question 4. How much time would
manufacturers need to be able to
develop a sufficient number of
examination chairs (other than dental
chairs) and tables with a minimum low
transfer height of 17 inches to meet
market demand? How long will it take
the market to adjust so that prices for
examination tables and chairs with a
minimum low transfer height of 17
inches are comparable to those that are
18 and 19 inches? Does this length of
time, if any, vary depending on the
specialty in which the equipment is
used?
Question 5. Are there other resources,
data, or information the Board should
consider with respect to its proposed
minimum low transfer height
requirement of 17 inches?
The Board asserts that the benefits
provided to the millions of Americans
that use mobility devices and medical
professionals and caregivers assisting
those individuals transfer outweighs the
potential costs of requiring a low
transfer height of 17 inches for medical
diagnostic equipment. Specifically, the
Board finds that there is a significant
need for accessible medical diagnostic
equipment and that the safety of both
the patient and caregiver are affected by
ensuring as many individuals as
possible that are capable of independent
transfer are provided the opportunity to
effectuate that transfer with a height of
medical diagnostic equipment that is
level to their current mobility device.
These benefits, which include the
health care cost savings from preventing
injuries to the patient and health care
worker outweigh the costs to comply
with the proposed 17-inch low height
provision, especially considering the
significant increase of MDE that
currently attains a lower transfer height
than even five years ago; However, as
noted above, the Access Board is
unaware of who would incur these
potential costs and to what extent, based
on the structure of this rulemaking.
Additionally, the Access Board expects
that when rulemaking agencies propose
to enforce the MDE Standards, they will
carry out regulatory assessments that
provide specific cost and benefit
estimates relevant to their rules.
entities, unless an agency certifies that
the rule will not have a significant
impact on a substantial number of small
entities. 5 U.S.C. 604, 605 (b). The MDE
Standards do not impose any mandatory
requirements on any entity, including
small entities. Therefore, we did not
prepare a final regulatory flexibility
analysis.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA)
requires Federal agencies to analyze the
impact of regulatory actions on small
For the reasons stated in the
preamble, and under the authority of 29
U.S.C. 794f, the Board proposes to
amend 36 CFR part 1195 as follows:
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C. Federalism (Executive Order 13132)
The Access Board has evaluated this
notice of proposed rulemaking in
accordance with the principles and
criteria set forth in Executive Order
13132. We have determined that this
action will not have a substantial direct
effect on the States, the relationship
between the Federal Government and
the States, or on the distribution of
power and responsibilities among the
various levels of government, and,
therefore, does not have federalism
implications.
D. Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act
of 1995 (codified at 2 U.S.C. 1531 et
seq.) (‘‘UMRA’’) generally requires that
Federal agencies assess the effects of
their discretionary regulatory actions
that may result in the expenditure of
$100 million (adjusted for inflation) or
more in any one year by the private
sector, or by state, local, and tribal
governments in the aggregate. The MDE
standards do not impose any mandatory
requirements on state, local, or tribal
governments or the private sector.
Therefore, the Unfunded Mandates
Reform Act does not apply.
PART 1195—STANDARDS FOR
ACCESSIBLE MEDICAL DIAGNOSTIC
EQUIPMENT
1. The authority citation for part 1195
continues to read as follows:
■
Authority: 29 U.S.C. 794f.
■
■
■
■
■
2. Amend appendix to part 1195 by:
a. Revising M301.2.1;
b. Removing M301.2.2;
c. Revising M302.2.1; and
d. Removing M302.2.2.
The revisions read as follows:
Appendix to Part 1195—Standards for
Accessible Medical Diagnostic
Equipment
*
*
*
*
*
M301 Diagnostic Equipment Used by
Patients in Supine, Prone, or Side-Lying
Position
*
*
*
*
*
M301.2.1 * * *
A. A low transfer position at a height of 17
inches (430 mm);
*
*
*
*
*
M302 Diagnostic Equipment Used by
Patients in Seated Position
M302.2.1 * * *
A. A low transfer position at a height of 17
inches (430 mm);
*
*
*
*
*
Approved by vote of the Access Board.
Christopher Kuczynski,
General Counsel.
[FR Doc. 2023–10827 Filed 5–22–23; 8:45 am]
BILLING CODE 8150–01–P
DEPARTMENT OF COMMERCE
E. Paperwork Reduction Act
Patent and Trademark Office
Under the Paperwork Reduction Act
(PRA), Federal agencies are generally
prohibited from conducting or
sponsoring a ‘‘collection of information:
as defined by the PRA, absent OMB
approval. See 44 U.S.C. 3507 et seq. The
MDE Standards do not impose any new
or revised collections of information
within the meaning of the PRA.
37 CFR Part 42
F. Congressional Review Act
List of Subjects in 36 CFR Part 1195
Health care, Individuals with
disabilities, Medical devices.
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Request for Comments Regarding the
Motion To Amend Pilot Program and
Rules of Practice To Allocate the
Burdens of Persuasion on Motions To
Amend in Trial Proceedings Before the
Patent Trial and Appeal Board
United States Patent and
Trademark Office, Commerce.
ACTION: Request for comments.
AGENCY:
This notice of proposed rulemaking is
not a major rule within the meaning of
the Congressional Review Act (5 U.S.C.
801 et seq.)
PO 00000
[Docket No.: PTO–P–2023–0024]
The United States Patent and
Trademark Office (USPTO or Office)
currently implements a pilot program
for motion to amend (MTA) practice and
procedures in trial proceedings under
the America Invents Act (AIA) before
the Patent Trial and Appeal Board
(PTAB or Board). The USPTO seeks
public comments on whether the MTA
Pilot Program’s procedures should be
SUMMARY:
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Federal Register / Vol. 88, No. 99 / Tuesday, May 23, 2023 / Proposed Rules
made permanent, and if so, whether any
modifications would be beneficial.
Additionally, the USPTO previously
issued rulemaking covering the
allocation of the burdens of persuasion
in MTA proceedings. The USPTO seeks
public input on the practical effects of
the rules on the parties and AIA
proceedings, and whether modifications
to the rules, or additional guidance on
implementing the rules, would be
beneficial. Lastly, the USPTO seeks
input on whether the Board should have
broader authority to raise sua sponte
grounds in the MTA process.
Comment Deadline Date: To
ensure consideration, commenters must
submit written comments on or before
July 24, 2023.
DATES:
For reasons of government
efficiency, comments must be submitted
through the Federal eRulemaking Portal
at www.regulations.gov. To submit
comments via the portal, enter docket
number PTO–P–2023–0024 on the
homepage and click ‘‘Search.’’ The site
will provide a search results page listing
all documents associated with this
docket. Find a reference to this
proposed rulemaking and click on the
‘‘Comment’’ icon, complete the required
fields, and enter or attach your
comments. Attachments to electronic
comments will be accepted in ADOBE®
portable document format (PDF) or
MICROSOFT WORD® 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
(www.regulations.gov) for additional
instructions on providing comments via
the portal. If electronic submission of
comments is not feasible due to a lack
of access to a computer and/or the
internet, please contact the USPTO
using the contact information below for
special instructions regarding how to
submit comments by mail or by hand
delivery, based on the public’s ability to
obtain access to USPTO facilities at the
time.
ADDRESSES:
lotter on DSK11XQN23PROD with PROPOSALS1
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
(Miriam.Quinn@uspto.gov or
Melissa.Haapala@uspto.gov,
respectively).
SUPPLEMENTARY INFORMATION:
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Background
Motion To Amend Pilot Program
In 2019, the Office implemented an
MTA Pilot Program based on public
feedback. See Notice Regarding a New
Pilot Program Concerning Motion To
Amend 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 provides a patent owner
with two options if it chooses to file an
MTA in an AIA trial. The MTA Pilot
Program notice (see 84 FR 9497–9507)
presents information regarding these
two options, timelines of due dates, and
other details, including replies to
comments received in response to a
prior request for comments published
on October 29, 2018 (see Request for
Comments on Motion To Amend
Practice and Procedures in Trial
Proceedings Under the America Invents
Act Before the Patent Trial and Appeal
Board (83 FR 54319)) (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).
Under the current program, as
discussed in the MTA Pilot Program
notice, a patent owner may choose to
request preliminary guidance from the
Board concerning the originally filed
MTA. This non-binding preliminary
guidance, typically in the form of a
short paper, provides feedback about
whether there is a reasonable likelihood
that the MTA meets statutory and
regulatory requirements for an MTA.
MTA Pilot Program notice at 9497,
9499. The preliminary guidance also
provides feedback on whether the
petitioner (or the record then before the
Office, including any opposition to the
MTA and accompanying evidence)
establishes a reasonable likelihood that
any of the substitute claims are
unpatentable based on the preliminary
record. Id. at 9497. The preliminary
guidance focuses on the limitations
added in the MTA and does not address
the patentability of the originally
challenged claims. Id.
The patent owner may additionally or
alternatively choose to file a revised
MTA after receiving the petitioner’s
opposition to the original MTA and/or
after receiving the Board’s preliminary
guidance (if requested). Id. at 9498. A
revised MTA includes one or more new
proposed substitute claims in place of
previously presented substitute claims
and also may provide new arguments
PO 00000
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and/or evidence, but only in a manner
that is responsive to issues raised in the
preliminary guidance and/or the
petitioner’s opposition to the MTA. Id.
A patent owner can avail itself of
either, both, or neither of these two
options. If the patent owner chooses
neither of the two options, the patent
owner can pursue an MTA in practically
the same way as before the pilot
program began. Id. at 9498.
The MTA Pilot Program is designed to
provide a standardized framework of
MTA procedures and timelines for
actions that would reasonably fit within
the one-year statutory period from
institution to a final written decision.
See, e.g., id. at 9506–07 (providing
Appendices 1A (PO Reply Timeline)
and 1B (Revised MTA Timeline)).
Shortly after the Office implemented
the MTA Pilot Program, it issued a
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
Office issued this notice in response to
comments and questions from
stakeholders requesting clarification
regarding existing reissue and
reexamination procedures at the Office
available while an AIA trial proceeding,
including any appeal to the U.S. Court
of Appeals for the Federal Circuit,
involving the patent is pending. Id. at
16654–55. 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 also
when and whether to lift such a stay or
suspension. Id. at 16656–58.
In determining whether the MTA
Pilot Program should be made
permanent in its current form, modified
in some manner, or replaced, the Office
seeks the benefit of the public’s
experience with the program.
Rules of Practice To Allocate the
Burdens of Persuasion on Motions To
Amend
In light of Aqua Products, as well as
public comments in response to the
2018 RFC and a relevant notice of
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proposed rulemaking dated October 22,
2019 (see Rules of Practice To Allocate
the Burden of Persuasion on Motions To
Amend in Trial Proceedings Before the
Patent Trial and Appeal Board (84 FR
56401)), in 2020 the Office revised the
rules of practice in AIA trials to allocate
the burdens of persuasion for MTAs
with respect to the patentability of
proposed substitute claims. 37 CFR
42.121(d), 42.221(d); 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) (MTA burdenallocation rules package). The rules
assign the burden of persuasion to the
patent owner to show, by a
preponderance of the evidence, that an
MTA complies with certain statutory
and regulatory requirements. 37 CFR
42.121(d)(1), 42.221(d)(1). The rules also
assign the burden of persuasion to the
petitioner to show, by a preponderance
of the evidence, that any proposed
substitute claims are unpatentable. 37
CFR 42.121(d)(2), 42.221(d)(2). Finally,
the 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). 85 FR
at 82924, 82926–27. The MTA burdenallocation rules package explained that
the Office expects the Board will
exercise its discretion only in ‘‘rare
circumstances.’’ 85 FR at 82928. Such
situations 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 at 82924, 82927 (citing Hunting
Titan, Paper 67 at 12–13, 25–26). In
instances in which 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) (‘‘Where the
Board exercises its discretion under this
paragraph, the parties will have an
opportunity to respond.’’).
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As noted in the MTA burdenallocation rules package, ‘‘[i]n the vast
majority of cases, the Board will
consider only evidence a party
introduces into the record of the
proceeding.’’ Id. Thus, ‘‘[i]n most
instances, in cases where the petitioner
has participated fully and opposed the
motion to amend, the Office expects that
there will be no need for the Board to
independently justify a determination of
unpatentability.’’ Id. at 82927–28. That
said, the Board may consider, for
example, ‘‘readily identifiable and
persuasive evidence already before the
Office in a related proceeding (i.e., in
the prosecution history of the
challenged patent or a related patent or
application, or in the record of another
proceeding before the Office challenging
the same patent or a related patent).’’ Id.
at 82927. Likewise, ‘‘the Board may
consider evidence that a district court
can judicially notice under Federal Rule
of Evidence 201.’’ Id.; see also 37 CFR
42.121(d)(3), 42.221(d)(3) (‘‘[T]he Board
may make of record only readily
identifiable and persuasive evidence in
a related proceeding before the Office or
evidence that a district court can
judicially notice.’’).
Subsequent to the issuance of the
burden-allocation rules, the United
States Court of Appeals for the Federal
Circuit issued a precedential decision in
Hunting Titan, Inc., v. DynaEnergetics
Europe GmbH, 28 F.4th 1371 (Fed. Cir.
2022). The court stated 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 burdenallocation 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 court also clarified that it was
‘‘not decid[ing] whether the Board has
an independent obligation to determine
PO 00000
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33065
patentability of proposed substitute
claims.’’ Id. at 1382. Under the rules as
currently written, the Board retains
discretion to raise, or to not raise,
grounds of unpatentability.
In light of the court’s commentary on
both the revised rules and the Board’s
Hunting Titan decision, and the Office’s
desire to support the integrity of the
patent system and to issue robust and
reliable patent rights, the Office seeks
public comments on whether the Board
should have broader authority to raise
sua sponte grounds in the MTA process.
Additionally, the Office seeks 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.
Furthermore, if the Board exercises its
discretion and raises its own grounds of
unpatentability under 37 CFR
42.121(d)(3), the burden-allocation rule
does not specifically state where the
burden of persuasion lies for Boardraised grounds. One interpretation of
current Board authority would be that,
because this scenario is outside of the
adversarial process, neither party bears
the burden of persuasion. The Office
seeks public comments on whether the
burden-allocation rule 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 also Nike, Inc. v.
Adidas AG, No. 2021–1903, 2022 WL
4002668, at *4–10 (Fed. Cir. Sept. 1,
2022) (finding ‘‘it unnecessary to
determine here 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,’’ after determining the
outcome in the case would be the same
regardless).
Questions Regarding the Pilot Program
and Burdens of Persuasion in Motions
To Amend
The Office welcomes any comments
from the public on the pilot program
and burdens of persuasion for MTAs,
and in particular, requests feedback on
the following questions:
(1) Has the MTA Pilot Program
positively or negatively impacted a
patent owner’s ability to successfully
amend claims in an AIA proceeding?
Has it made it more likely that a patent
owner will avail itself of the MTA
process?
(2) Are there circumstances in which
reexamination and/or reissue
proceedings are better options for patent
owners seeking to amend claims
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challenged in an AIA proceeding, as
compared to the MTA Pilot Program? Is
there anything more the Office can do
to make the MTA process more useful
to patent owners?
(3) Should the Office modify any
aspect of the MTA Pilot Program?
Should the Office continue to provide
the options of receiving preliminary
guidance and being able to revise an
MTA, as currently implemented?
(4) Assuming the MTA Pilot Program
should remain, should any aspect of
preliminary guidance, as currently
provided by the Board, be changed?
(5) What barriers, if any, exist that the
Office can address to increase the
effectiveness of the MTA procedure?
(6) Should the Office modify its
practice of when the Board can or
should raise a new ground of
unpatentability, and if so, how? For
example, should the PTAB’s decision in
the Hunting Titan case continue to
guide when and how the Board can and
should raise a new ground of
unpatentability? If so, why and how?
(7) Should the Office involve patent
examiner assistance in relation to
MTAs? Should the Office conduct a
prior art search in relation to proposed
substitute claims in certain situations? If
so, under what circumstances? And
should examiner assistance or prior art
searches be limited in any way?
(8) Should the Office clarify in its
rules where the burden of persuasion for
Board-raised grounds lies? Who should
bear that burden?
(9) Should any other aspects of the
MTA rules (37 CFR 42.121, 42.221),
including as they relate to the Board’s
discretion to grant or deny an MTA, be
changed, and if so, how?
Katherine K. Vidal,
Under Secretary of Commerce for Intellectual
Property and Director of the United States
Patent and Trademark Office.
[FR Doc. 2023–10565 Filed 5–22–23; 8:45 am]
BILLING CODE 3510–16–P
POSTAL SERVICE
39 CFR Part 111
Postal ServiceTM.
ACTION: Proposed rule.
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AGENCY:
The Postal Service is
proposing to amend Mailing Standards
of the United States Postal Service,
Domestic Mail Manual (DMM®) to
discontinue Priority Mail Express®
postage refunds for guaranteed service
for Alaska and Hawaii.
SUMMARY:
16:36 May 22, 2023
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attachments are part of the public record
and subject to disclosure. Do not
enclose any material in your comments
that you consider to be confidential or
inappropriate for public disclosure.
You may inspect and photocopy all
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only, at USPS® Headquarters Library,
475 L’Enfant Plaza SW, 11th Floor
North, Washington, DC, 20260. These
records are available for review on
Monday through Friday, 9 a.m.–4 p.m.,
by calling 202–268–2906.
FOR FURTHER INFORMATION CONTACT:
Catherine Knox at (202) 268–5636 or
Garry Rodriguez at (202) 268–7281.
SUPPLEMENTARY INFORMATION: Currently,
except as provided in DMM 604.9.5.5,
the Postal Service offers postage refunds
for guaranteed service.
The Postal Service has determined
that operationally we cannot meet the
service commitments for Priority Mail
Express expected by customers for
Alaska and Hawaii.
As a result, the Postal Service is
proposing to discontinue postage
refunds for guaranteed service for
Priority Mail Express pieces destined to
or originating from Alaska or Hawaii.
Postage refunds for loss will still be
available for pieces destined to or
originating from Alaska or Hawaii.
The Postal Service is proposing to
implement this change effective August
1, 2023.
We believe the proposed revision will
provide customers with a more efficient
mailing experience.
List of Subjects in 39 CFR Part 111
Priority Mail Express Refunds
VerDate Sep<11>2014
Submit comments on or before
June 22, 2023.
ADDRESSES: Mail or deliver written
comments to the Director, Product
Classification, U.S. Postal Service, 475
L’Enfant Plaza SW, Room 4446,
Washington, DC 20260–5015. If sending
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DATES:
Jkt 259001
Administrative practice and
procedure, Postal Service.
Although exempt from the notice and
comment requirements of the
Administrative Procedure Act (5 U.S.C.
553(b), (c)) regarding proposed
rulemaking by 39 U.S.C. 410(a), the
Postal Service invites public comment
on the following proposed revisions to
Mailing Standards of the United States
Postal Service, Domestic Mail Manual
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(DMM), incorporated by reference in the
Code of Federal Regulations. See 39 CFR
111.1.
We will publish an appropriate
amendment to 39 CFR part 111 to reflect
these changes.
Accordingly, 39 CFR part 111 is
proposed to be amended as follows:
PART 111—[AMENDED.]
1. The authority citation for 39 CFR
part 111 continues to read as follows:
■
Authority: 5 U.S.C. 552(a); 13 U.S.C. 301–
307; 18 U.S.C. 1692–1737; 39 U.S.C. 101,
401–404, 414, 416, 3001–3018, 3201–3220,
3401–3406, 3621, 3622, 3626, 3629, 3631–
3633, 3641, 3681–3685, and 5001.
2. Revise the Mailing Standards of the
United States Postal Service, Domestic
Mail Manual (DMM) as follows:
■
Mailing Standards of the United States
Postal Service, Domestic Mail Manual
(DMM)
*
*
*
*
*
600 Basic Standards for All Mailing
Services
*
*
*
*
*
604 Postage Payment Methods and
Refunds
*
*
*
9.0
Exchanges and Refunds
*
*
*
*
*
*
*
9.5 Priority Mail Express Postage and
Fees Refunds
*
9.5.5
*
*
*
*
Refunds Not Given
Postage will not be refunded if the
guaranteed service was not provided
due to any of the following
circumstances:
*
*
*
*
*
[Renumber items i and j as j and k,
and add new item i to read as follows:]
i. The postage refund requested is
other than for loss, and the Priority Mail
Express piece was destined to or
originated from Alaska or Hawaii.
*
*
*
*
*
Sarah Sullivan,
Attorney, Ethics and Legal Compliance.
[FR Doc. 2023–10911 Filed 5–22–23; 8:45 am]
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23MYP1
]]>Agencies
[Federal Register Volume 88, Number 99 (Tuesday, May 23, 2023)]
[Proposed Rules]
[Pages 33063-33066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10565]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
37 CFR Part 42
[Docket No.: PTO-P-2023-0024]
Request for Comments Regarding the Motion To Amend Pilot Program
and Rules of Practice To Allocate the Burdens of Persuasion on Motions
To Amend in Trial Proceedings Before the Patent Trial and Appeal Board
AGENCY: United States Patent and Trademark Office, Commerce.
ACTION: Request for comments.
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SUMMARY: The United States Patent and Trademark Office (USPTO or
Office) currently implements a pilot program for motion to amend (MTA)
practice and procedures in trial proceedings under the America Invents
Act (AIA) before the Patent Trial and Appeal Board (PTAB or Board). The
USPTO seeks public comments on whether the MTA Pilot Program's
procedures should be
[[Page 33064]]
made permanent, and if so, whether any modifications would be
beneficial. Additionally, the USPTO previously issued rulemaking
covering the allocation of the burdens of persuasion in MTA
proceedings. The USPTO seeks public input on the practical effects of
the rules on the parties and AIA proceedings, and whether modifications
to the rules, or additional guidance on implementing the rules, would
be beneficial. Lastly, the USPTO seeks input on whether the Board
should have broader authority to raise sua sponte grounds in the MTA
process.
DATES: Comment Deadline Date: To ensure consideration, commenters must
submit written comments on or before July 24, 2023.
ADDRESSES: For reasons of government efficiency, comments must be
submitted through the Federal eRulemaking Portal at
www.regulations.gov. To submit comments via the portal, enter docket
number PTO-P-2023-0024 on the homepage and click ``Search.'' The site
will provide a search results page listing all documents associated
with this docket. Find a reference to this proposed rulemaking and
click on 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 (PDF) 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 (www.regulations.gov) for
additional instructions on providing comments via the portal. If
electronic submission of comments is not feasible due to a lack of
access to a computer and/or the internet, please contact the USPTO
using the contact information below for special instructions regarding
how to submit comments by mail or by hand delivery, based on the
public's ability to obtain access to USPTO facilities at the time.
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
Motion To Amend Pilot Program
In 2019, the Office implemented an MTA Pilot Program based on
public feedback. See Notice Regarding a New Pilot Program Concerning
Motion To Amend 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
provides a patent owner with two options if it chooses to file an MTA
in an AIA trial. The MTA Pilot Program notice (see 84 FR 9497-9507)
presents information regarding these two options, timelines of due
dates, and other details, including replies to comments received in
response to a prior request for comments published on October 29, 2018
(see Request for Comments on Motion To Amend Practice and Procedures in
Trial Proceedings Under the America Invents Act Before the Patent Trial
and Appeal Board (83 FR 54319)) (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).
Under the current program, as discussed in the MTA Pilot Program
notice, a patent owner may choose to request preliminary guidance from
the Board concerning the originally filed MTA. This non-binding
preliminary guidance, typically in the form of a short paper, provides
feedback about whether there is a reasonable likelihood that the MTA
meets statutory and regulatory requirements for an MTA. MTA Pilot
Program notice at 9497, 9499. The preliminary guidance also provides
feedback on whether the petitioner (or the record then before the
Office, including any opposition to the MTA and accompanying evidence)
establishes a reasonable likelihood that any of the substitute claims
are unpatentable based on the preliminary record. Id. at 9497. The
preliminary guidance focuses on the limitations added in the MTA and
does not address the patentability of the originally challenged claims.
Id.
The patent owner may additionally or alternatively choose to file a
revised MTA after receiving the petitioner's opposition to the original
MTA and/or after receiving the Board's preliminary guidance (if
requested). Id. at 9498. A revised MTA includes one or more new
proposed substitute claims in place of previously presented substitute
claims and also may provide new arguments and/or evidence, but only in
a manner that is responsive to issues raised in the preliminary
guidance and/or the petitioner's opposition to the MTA. Id.
A patent owner can avail itself of either, both, or neither of
these two options. If the patent owner chooses neither of the two
options, the patent owner can pursue an MTA in practically the same way
as before the pilot program began. Id. at 9498.
The MTA Pilot Program is designed to provide a standardized
framework of MTA procedures and timelines for actions that would
reasonably fit within the one-year statutory period from institution to
a final written decision. See, e.g., id. at 9506-07 (providing
Appendices 1A (PO Reply Timeline) and 1B (Revised MTA Timeline)).
Shortly after the Office implemented the MTA Pilot Program, it
issued a 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 Office issued this notice in response to comments and
questions from stakeholders requesting clarification regarding existing
reissue and reexamination procedures at the Office available while an
AIA trial proceeding, including any appeal to the U.S. Court of Appeals
for the Federal Circuit, involving the patent is pending. Id. at 16654-
55. 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 also when and whether to lift such a stay or suspension. Id. at
16656-58.
In determining whether the MTA Pilot Program should be made
permanent in its current form, modified in some manner, or replaced,
the Office seeks the benefit of the public's experience with the
program.
Rules of Practice To Allocate the Burdens of Persuasion on Motions To
Amend
In light of Aqua Products, as well as public comments in response
to the 2018 RFC and a relevant notice of
[[Page 33065]]
proposed rulemaking dated October 22, 2019 (see Rules of Practice To
Allocate the Burden of Persuasion on Motions To Amend in Trial
Proceedings Before the Patent Trial and Appeal Board (84 FR 56401)), in
2020 the Office revised the rules of practice in AIA trials to allocate
the burdens of persuasion for MTAs with respect to the patentability of
proposed substitute claims. 37 CFR 42.121(d), 42.221(d); 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) (MTA burden-allocation rules package). The rules
assign the burden of persuasion to the patent owner to show, by a
preponderance of the evidence, that an MTA complies with certain
statutory and regulatory requirements. 37 CFR 42.121(d)(1),
42.221(d)(1). The rules also assign the burden of persuasion to the
petitioner to show, by a preponderance of the evidence, that any
proposed substitute claims are unpatentable. 37 CFR 42.121(d)(2),
42.221(d)(2). Finally, the 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). 85 FR at 82924, 82926-27. The MTA burden-allocation rules
package explained that the Office expects the Board will exercise its
discretion only in ``rare circumstances.'' 85 FR at 82928. Such
situations 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 at
82924, 82927 (citing Hunting Titan, Paper 67 at 12-13, 25-26). In
instances in which 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) (``Where the Board exercises its
discretion under this paragraph, the parties will have an opportunity
to respond.'').
As noted in the MTA burden-allocation rules package, ``[i]n the
vast majority of cases, the Board will consider only evidence a party
introduces into the record of the proceeding.'' Id. Thus, ``[i]n most
instances, in cases where the petitioner has participated fully and
opposed the motion to amend, the Office expects that there will be no
need for the Board to independently justify a determination of
unpatentability.'' Id. at 82927-28. That said, the Board may consider,
for example, ``readily identifiable and persuasive evidence already
before the Office in a related proceeding (i.e., in the prosecution
history of the challenged patent or a related patent or application, or
in the record of another proceeding before the Office challenging the
same patent or a related patent).'' Id. at 82927. Likewise, ``the Board
may consider evidence that a district court can judicially notice under
Federal Rule of Evidence 201.'' Id.; see also 37 CFR 42.121(d)(3),
42.221(d)(3) (``[T]he Board may make of record only readily
identifiable and persuasive evidence in a related proceeding before the
Office or evidence that a district court can judicially notice.'').
Subsequent to the issuance of the burden-allocation rules, the
United States Court of Appeals for the Federal Circuit issued a
precedential decision in Hunting Titan, Inc., v. DynaEnergetics Europe
GmbH, 28 F.4th 1371 (Fed. Cir. 2022). The court stated 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'').
The court also clarified that it was ``not decid[ing] whether the
Board has an independent obligation to determine patentability of
proposed substitute claims.'' Id. at 1382. Under the rules as currently
written, the Board retains discretion to raise, or to not raise,
grounds of unpatentability.
In light of the court's commentary on both the revised rules and
the Board's Hunting Titan decision, and the Office's desire to support
the integrity of the patent system and to issue robust and reliable
patent rights, the Office seeks public comments on whether the Board
should have broader authority to raise sua sponte grounds in the MTA
process. Additionally, the Office seeks 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.
Furthermore, if the Board exercises its discretion and raises its
own grounds of unpatentability under 37 CFR 42.121(d)(3), the burden-
allocation rule does not specifically state where the burden of
persuasion lies for Board-raised grounds. One interpretation of current
Board authority would be that, because this scenario is outside of the
adversarial process, neither party bears the burden of persuasion. The
Office seeks public comments on whether the burden-allocation rule
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 also Nike, Inc. v. Adidas AG, No.
2021-1903, 2022 WL 4002668, at *4-10 (Fed. Cir. Sept. 1, 2022) (finding
``it unnecessary to determine here 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,'' after determining the outcome in the case would be
the same regardless).
Questions Regarding the Pilot Program and Burdens of Persuasion in
Motions To Amend
The Office welcomes any comments from the public on the pilot
program and burdens of persuasion for MTAs, and in particular, requests
feedback on the following questions:
(1) Has the MTA Pilot Program positively or negatively impacted a
patent owner's ability to successfully amend claims in an AIA
proceeding? Has it made it more likely that a patent owner will avail
itself of the MTA process?
(2) Are there circumstances in which reexamination and/or reissue
proceedings are better options for patent owners seeking to amend
claims
[[Page 33066]]
challenged in an AIA proceeding, as compared to the MTA Pilot Program?
Is there anything more the Office can do to make the MTA process more
useful to patent owners?
(3) Should the Office modify any aspect of the MTA Pilot Program?
Should the Office continue to provide the options of receiving
preliminary guidance and being able to revise an MTA, as currently
implemented?
(4) Assuming the MTA Pilot Program should remain, should any aspect
of preliminary guidance, as currently provided by the Board, be
changed?
(5) What barriers, if any, exist that the Office can address to
increase the effectiveness of the MTA procedure?
(6) Should the Office modify its practice of when the Board can or
should raise a new ground of unpatentability, and if so, how? For
example, should the PTAB's decision in the Hunting Titan case continue
to guide when and how the Board can and should raise a new ground of
unpatentability? If so, why and how?
(7) Should the Office involve patent examiner assistance in
relation to MTAs? Should the Office conduct a prior art search in
relation to proposed substitute claims in certain situations? If so,
under what circumstances? And should examiner assistance or prior art
searches be limited in any way?
(8) Should the Office clarify in its rules where the burden of
persuasion for Board-raised grounds lies? Who should bear that burden?
(9) Should any other aspects of the MTA rules (37 CFR 42.121,
42.221), including as they relate to the Board's discretion to grant or
deny an MTA, be changed, and if so, how?
Katherine K. Vidal,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. 2023-10565 Filed 5-22-23; 8:45 am]
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