Federal Register / Vol. 89, No. 181 / Wednesday, September 18, 2024 / Rules and Regulations 76421 

rain date scheduled on September 22, 

2024. 

J.J. Schock, 

Commander, U.S. Coast Guard, Acting 

Captain of the Port Sector Boston. 

[FR Doc. 2024–21158 Filed 9–17–24; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF COMMERCE 

Patent and Trademark Office 

37 CFR Part 42 

[Docket No. PTO–P–2020–0060] 

RIN 0651–AD50 

Rules Governing Motion To Amend 

Practice and Procedures in Trial 

Proceedings Under the America 

Invents Act Before the Patent Trial and 

Appeal Board 

AGENCY: Patent Trial and Appeal Board, 

United States Patent and Trademark 

Office, Department of Commerce. 

ACTION: Final rule. 

SUMMARY: The United States Patent and 

Trademark Office (Office or USPTO) 

modifies its rules of practice governing 

amendment practice in trial proceedings 

under the Leahy-Smith America Invents 

Act (AIA) to make permanent certain 

provisions of the Office’s motion to 

amend pilot program (MTA pilot 

program) and to revise the rules that 

allocate burdens of persuasion in 

connection with motions to amend 

(MTAs). These rules provide a patent 

owner with the option of issuance of 

preliminary guidance in response to an 

MTA and the option of filing one 

additional revised MTA. Further, these 

rules clarify that a preponderance of 

evidence standard applies to any new 

ground of unpatentability raised by the 

Board, and that when exercising the 

discretion to grant or deny an MTA or 

to raise a new ground of unpatentability, 

the Board may consider all evidence of 

record in the proceeding. The rules 

further provide that the Board may 

consider information identified in 

response to a Board-initiated request for 

examination assistance, and that the 

results of that assistance will be added 

to the record. The rules better ensure the 

Office’s role of issuing robust and 

reliable patents, and the predictability 

and certainty of post-grant trial 

proceedings before the Board. These 

rules relate to the Office trial practice 

for inter partes review (IPR), post-grant 

review (PGR), and derivation 

proceedings that implemented 

provisions of the AIA providing for 

trials before the Office. 

DATES: This rule is effective October 18, 

2024. 

FOR FURTHER INFORMATION CONTACT: 

Miriam L. Quinn, Acting Senior Lead 

Administrative Patent Judge; or Melissa 

Haapala, Vice Chief Administrative 

Patent Judge, at 571–272–9797, 

Miriam.Quinn@uspto.gov or 

Melissa.Haapala@uspto.gov, 

respectively. 

SUPPLEMENTARY INFORMATION: 

Background 

Development of the Final Rule 

On September 16, 2011, the AIA was 

enacted into law (Pub. L. 112–29, 125 

Stat. 284 (2011)), and in 2012, the Office 

implemented rules to govern Office trial 

practice for AIA trials, including IPR, 

PGR, covered business method (CBM), 

and derivation proceedings pursuant to 

35 U.S.C. 135, 316, and 326 and AIA 

18(d)(2). See 37 CFR part 42; Rules of 

Practice for Trials before the Patent Trial 

and Appeal Board and Judicial Review 

of Patent Trial and Appeal Board 

Decisions, 77 FR 48612 (August. 14, 

2012); Changes to Implement Inter 

Partes Review Proceedings, Post-Grant 

Review Proceedings, and Transitional 

Program for Covered Business Method 

Patents, 77 FR 48680 (August 14, 2012); 

Transitional Program for Covered 

Business Method Patents—Definitions 

of Covered Business Method Patent and 

Technological Invention, 77 FR 48734 

(August. 14, 2012). Additionally, the 

Office published a Patent Trial Practice 

Guide (Practice Guide) for the rules to 

advise the public on the general 

framework of the regulations, including 

the structure and times for taking action 

in each of the new proceedings. See 84 

FR 64280 (November 21, 2019); https:// 

www.uspto.gov/TrialPracticeGuide

Consolidated. The Practice Guide 

provides a helpful overview of the 

Patent Trial and Appeal Board (PTAB or 

Board) process. See, e.g., Practice Guide 

at 5–8 (AIA trial process), 66–72 

(motions to amend). 

In 2019, the Office implemented a 

pilot program (MTA Pilot Program) for 

motions to amend filed in AIA 

proceedings before the PTAB. Notice 

Regarding a New Pilot Program 

Concerning MTA Practice and 

Procedures in Trial Proceedings Under 

the America Invents Act Before the 

Patent Trial and Appeal Board, 84 FR 

9497 (March 15, 2019) (MTA pilot 

program notice). The MTA Pilot 

Program addressed public comments on 

a previously proposed procedure for 

MTAs, the Board’s MTA practice 

generally, and the allocation of burdens 

of persuasion after Aqua Products, Inc. 

v. Matal, 872 F.3d 1290 (Fed. Cir. 2017) 

(en banc) (Aqua Products)). See RFC on 

MTA Practice and Procedures in Trial 

Proceedings under the America Invents 

Act before the Patent Trial and Appeal 

Board, 83 FR 54319 (October 29, 2018) 

(2018 RFC). The MTA pilot program 

was extended through September 16, 

2024. Extension of the Patent Trial and 

Appeal Board Motion to Amend Pilot 

Program, 87 FR 60134 (October 4, 2022). 

In 2020, the Office, through notice 

and comment rulemaking, published a 

final rule that allocated burdens of 

persuasion in relation to motions to 

amend and the patentability of 

substitute claims. See 37 CFR 42.121(d), 

42.221(d); Rules of Practice to Allocate 

the Burden of Persuasion on Motions to 

Amend in Trial Proceedings before the 

Patent Trial and Appeal Board, 85 FR 

82936 (December 21, 2020) (‘‘the 

burden-allocation rules’’). These 

burden-allocation rules assign the 

burden of persuasion to the patent 

owner to show, by a preponderance of 

the evidence, that an MTA complies 

with certain statutory and regulatory 

requirements. 37 CFR 42.121(d)(1), 

42.221(d)(1). The burden-allocation 

rules also assign the burden of 

persuasion to the petitioner to show, by 

a preponderance of the evidence, that 

any proposed substitute claims are 

unpatentable. 37 CFR 42.121(d)(2), 

42.221(d)(2). 

Finally, the burden-allocation rules 

further specify that irrespective of those 

burdens, the Board may, in the 

‘‘interests of justice,’’ exercise its 

discretion to grant or deny an MTA, but 

‘‘only for reasons supported by readily 

identifiable and persuasive evidence of 

record.’’ 37 CFR 42.121(d)(3), 

42.221(d)(3); Hunting Titan, Inc. v. 

DynaEnergetics Europe GmbH, 

IPR2018–00600 (PTAB July 6, 2020) 

(Paper 67) (Hunting Titan). Situations 

meeting the interests of justice standard 

were stated to include, for example, 

those in which ‘‘the petitioner has 

ceased to participate in the proceeding 

or chooses not to oppose the motion to 

amend, or those in which certain 

evidence regarding unpatentability has 

not been raised by either party but is so 

readily identifiable and persuasive that 

the Board should take it up in the 

interest of supporting the integrity of the 

patent system, notwithstanding the 

adversarial nature of the proceedings.’’ 

85 FR 82924, 82927 (citing Hunting 

Titan, Paper 67 at 12–13, 25–26). The 

burden-allocation rules further provide 

that in instances where the Board 

exercises its discretion in the interests 

of justice, the Board will provide the 

parties with an opportunity to respond 

before rendering a final decision on the 


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76422 Federal Register / Vol. 89, No. 181 / Wednesday, September 18, 2024 / Rules and Regulations 

MTA. Id. at 82927; see also 37 CFR 

42.121(d)(3), 42.221(d)(3). 

As noted in the final rule that 

allocated burdens of persuasion, ‘‘[i]n 

the vast majority of cases, the Board will 

consider only evidence a party 

introduces into the record of the 

proceeding.’’ 85 FR 82927. Thus, ‘‘[i]n 

most instances, in cases where the 

petitioner has participated fully and 

opposed the motion to amend, the 

Office expects that there will be no need 

for the Board to independently justify a 

determination of unpatentability.’’ Id. at 

82927–28. That said, the Board may 

consider, for example ‘‘readily 

identifiable and persuasive evidence 

already before the Office in a related 

proceeding (i.e., in the prosecution 

history of the challenged patent or a 

related patent or application, or in the 

record of another proceeding before the 

Office challenging the same patent or a 

related patent).’’ Id. at 82927. Likewise, 

‘‘the Board may consider evidence that 

a district court can judicially notice 

under Federal Rule of Evidence 201.’’ 

Id.; see also 37 CFR 42.121(d)(3), 

42.221(d)(3) (‘‘[T]he Board may make of 

record only readily identifiable and 

persuasive evidence in a related 

proceeding before the Office or evidence 

that a district court can judicially 

notice.’’). 

Subsequent to the issuance of the 

burden-allocation rules, the United 

States Court of Appeals for the Federal 

Circuit issued a precedential decision in 

Hunting Titan, Inc., v. DynaEnergetics 

Europe GmbH, 28 F.4th 1371 (Fed. Cir. 

2022). The court confirmed that no 

court precedent has ‘‘established that 

the Board maintains an affirmative duty, 

without limitation or exception, to sua 

sponte raise patentability challenges to 

a proposed substitute claim.’’ Id. at 1381 

(citations omitted). The court also stated 

that ‘‘confining the circumstances in 

which the Board should sua sponte raise 

patentability issues was not itself 

erroneous.’’ Id. The court, however, 

found it ‘‘problematic’’ that the USPTO 

confined the Board’s discretion to only 

rare circumstances. Id. It also noted that 

the USPTO’s ‘‘substantial reliance on 

the adversarial system . . . overlooks 

the basic purpose of [inter partes 

review] proceedings: to reexamine an 

earlier agency decision and ensure that 

patent monopolies are kept within their 

legitimate scope.’’ Id. (citations 

omitted); see id. at 1385 (concurrence 

expressing concern that the 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.’’). 

2023 Request for Comments on MTA 

Pilot Program and Burden-Allocation 

Rules 

After four years of experience with 

the MTA pilot program and 

development of Federal Circuit case law 

concerning burden allocation in the 

MTA context, the Office issued a 

Request for Comments to seek feedback 

on the public’s experience with the 

program and the burden-allocation rules 

that apply to MTAs. See Request for 

Comments Regarding MTA Pilot 

Program and Rules of Practice to 

Allocate the Burdens of Persuasion on 

Motions to Amend in Trial Proceedings 

Before the Patent Trial and Appeal 

Board, 88 FR 33063 (May 23, 2023) 

(2023 RFC). The Office also sought 

feedback on when reexamination or 

reissue proceedings, also referred to as 

post-grant options, are better 

alternatives for patent owners seeking to 

amend claims. Id. at 33065–66. Further, 

the Office sought comments on whether 

the MTA pilot program should be 

modified and what barriers the Office 

could address to increase the 

effectiveness of MTA procedures. Id. at 

33066. 

The 2023 RFC also sought comments 

on the burden-allocation rules. In light 

of the Federal Circuit court’s 

commentary on the current rules, as 

well as the Board’s Hunting Titan 

decision, and given the Office’s desire to 

support the integrity of the patent 

system and to issue robust and reliable 

patent rights, the Office sought public 

comments on whether the Board should 

more broadly use its discretion to raise 

sua sponte grounds in the MTA process. 

Id. Additionally, the Office sought 

public comments on whether, and 

under what circumstances, the Office 

should solicit patent examiner 

assistance regarding an MTA or conduct 

a prior art search in relation to proposed 

substitute claims. Id. 

Furthermore, the Office recognized 

that if the Board exercises its discretion 

and raises its own grounds of 

unpatentability under the current rule, 

37 CFR 42.121(d)(3), the burdenallocation rules do not specifically state 

where the burden of persuasion lies for 

Board-raised grounds. The Office sought 

public comments on whether the 

burden-allocation rules should be 

revised to clarify who bears the burden 

of persuasion for grounds of 

unpatentability raised by the Board 

under 37 CFR 42.121(d)(3) or 

42.221(d)(3). See 88 FR 33066; see also 

Nike, Inc. v. Adidas AG, No. 2021–1903, 

2022 WL 4002668, at *4–10 (Fed. Cir. 

September 1, 2022) (leaving open the 

question ‘‘whether, in an inter partes 

review, the petitioner or Board bears the 

burden of persuasion for an 

unpatentability ground raised sua 

sponte by the Board against proposed 

substitute claims’’). 

2024 Notice of Proposed Rulemaking 

On March 4, 2024, the Office 

published a notice of proposed 

rulemaking concerning Motion to 

Amend Practice and Procedures in Trial 

Proceedings Under the America Invents 

Act Before the Patent Trial and Appeal 

Board. 89 FR 15531 (‘‘2024 NPRM’’). 

The Office proposed to revise its rules 

of practice to provide for issuance of 

preliminary guidance in response to an 

MTA and to provide a patent owner 

with the option for filing one additional 

revised MTA. Further, the Office 

proposed to revise the rules to clarify 

that a preponderance of the evidence 

standard applies to any new ground of 

unpatentability raised by the Board and 

to clarify that when exercising the 

discretion to grant or deny an MTA or 

to raise a new ground of unpatentability, 

the Board may consider all evidence of 

record in the proceeding, including 

evidence identified through a prior art 

search conducted by the Office at the 

Board’s request and added to the record. 

The comment period for the 2024 NPRM 

closed on May 3, 2024, and the Office 

received six public comments on the 

proposed rules. 

Proposed Rule: Comments and 

Responses 

The Office received six public 

comments to the 2024 NPRM none of 

which opposed the proposal to make 

permanent the MTA pilot program 

options. Some commenters, however, 

stated that the Office should consider 

additional proposals. These additional 

proposals include: (1) expressly 

allowing extensions of time for the final 

written decision and for filing MTArelated briefs, (2) revising the proposed 

rules to allow petitioner to file a surreply, and (3) clarifying the manner in 

which patent owner identifies written 

description support for the proposed 

substitute claims. Some commenters 

also recommended expanding the 

proposed rules on discretion to request 

examination assistance such that the 

Board would exercise this discretion in 

every case with a motion to amend. 

Finally, one commenter expressed 

concerns with the proposed rules that 

revise the Board’s limits on the 

discretion to raise grounds of 

unpatentability sua sponte. These 

comments, along with other stated ideas 

and concerns, are addressed more 

specifically below. 


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Extensions of Time for Issuing Final 

Written Decision and Other Deadlines 

A comment expressed support for an 

automatic extension of the deadline for 

issuing a final written decision in 

proceedings in which a motion to 

amend has been filed. A second 

comment raised the concern that any 

automatic extension of time might not 

be necessary in all cases and that there 

could be a potential for abuse of the 

motion to amend process if extensions 

were automatic. Another comment 

suggested that additional procedures, 

such as a Board-initiated conference call 

upon issuance of preliminary guidance, 

could provide an opportunity for a party 

to request an extension of time for the 

final written decision. 

The Office appreciates the comments 

and the concern with scheduling when 

a motion to amend is filed. After careful 

review of the comments, the Office does 

not adopt any changes to the proposed 

rules. The proposed rules do not modify 

the current procedures by which an 

extension may be granted, as discussed 

above, and an extension of the final 

written decision deadline may be 

granted by the Chief Administrative 

Patent Judge for good cause, and the 

deadline may be extended by not more 

than six months. These procedures 

allow for a case-by-case determination 

of whether an extension should be 

granted. In the Board’s experience, most 

cases do not require an extension. With 

respect to automatic scheduling of a 

conference call upon issuance of 

preliminary guidance, the rules provide 

for an initial conference call upon the 

filing of a motion to amend at which a 

discussion of the schedule can occur, 

and panels of the Board generally honor 

any request by a party for a further 

conference call. See 37 CFR 42.121(a), 

42.221(a). 

With respect to the limitations on 

timing for post grant review proceedings 

with motions to amend, we 

acknowledge a comment suggesting that 

reexamination or reissue proceedings 

may be better options for pursing claim 

amendments if substantial changes that 

may require additional time are 

contemplated. See Notice Regarding 

Options for Amendments by Patent 

Owner Through Reissue or 

Reexamination During a Pending AIA 

Trial Proceeding (April 2019), 84 FR 

16654 (April 22, 2019). 

Petitioner Sur-Reply 

A commenter expressed concern with 

the proposed rule as it relates to the 

preliminary guidance provided by the 

Board on an original motion to amend. 

In particular, the commenter noted that 

the proposed rule is silent as to whether 

the petitioner has an opportunity to file 

a sur-reply to address the Board’s 

preliminary guidance or any new 

evidence that may accompany the 

patent owner’s reply filed in response to 

the Board’s preliminary guidance. The 

commenter noted that the proposed rule 

allows the petitioner to file a reply to 

the Board’s guidance only if the patent 

owner does not file a reply or revised 

motion to amend. The commenter urged 

the Office that the petitioner should be 

provided, expressly, with a sur-reply in 

order to afford due process to the 

petitioner. 

The Office appreciates the comment 

and agrees that the rule should 

expressly provide for a petitioner surreply. The final rule states that the 

petitioner may file a sur-reply that is 

limited to responding to the preliminary 

guidance and/or arguments made in the 

patent owner’s reply brief. Further, 

although the sur-reply may not be 

accompanied by new evidence, it may 

comment on any new evidence filed 

with the reply and/or point to crossexamination testimony of a reply 

witness, if relevant to the arguments 

made in the reply brief. 

Moreover, if a patent owner does not 

file either a reply or a revised MTA after 

receiving preliminary guidance from the 

Board, a petitioner may file a reply to 

the preliminary guidance, but such a 

reply may only respond to the 

preliminary guidance and may not be 

accompanied by new evidence. If a 

petitioner files a reply in this context, a 

patent owner may file a sur-reply, but 

that sur-reply may only respond to the 

petitioner’s reply and may not be 

accompanied by new evidence. 

Written-Description Support 

A commenter raised a concern that 

proposed provisions in 37 CFR 

42.121(b) and 42.221(b), which relate to 

the content of a motion to amend, 

contain a possible ambiguity regarding 

whether the required support in the 

original disclosure or earlier-filed 

disclosure must be set forth in the 

motion to amend or should be set forth 

as part of the claim listing. 

The Office appreciates the comment. 

To improve clarity, this final rule 

amends those sections to state that the 

written description support for a 

proposed substitute claim must be set 

forth in the motion to amend, as 

opposed to the claim listing. This is 

consistent with current practice and the 

precedential decision in Lectrosonics: 

‘‘[t]he written description support must 

be set forth in the motion to amend 

itself, not the claim listing.’’ 

Lectrosonics, Inc. v. Zaxcom, Inc., 

IPR2018–01129, 2019 WL 1118864, at 

*3 (precedential). 

Examination Assistance 

The majority of commenters support 

the proposed rule’s provision permitting 

the Board to request examination 

assistance from patent examiners when 

considering claim amendments. A 

commenter noted, however, that 

opinions vary on whether, and to what 

extent, the Board should request 

assistance to conduct a prior art search. 

Two commenters suggested that such 

assistance not be limited to situations in 

which no petitioner opposes, or all 

petitioners cease to oppose a motion to 

amend. These commenters highlighted 

the expertise of examiners in identifying 

prior art as reasons to expand the 

situations for which assistance may be 

requested. These commenters also 

expressed concern that Board panels 

may hesitate to use the proposed rule’s 

full extent, because identifying a 

petitioner’s filing as ‘‘illusory 

opposition’’ appears to imply that the 

petitioner is not acting in good faith, 

and such a standard may be difficult to 

assess. These commenters suggested 

that the benefit of ensuring that 

substitute claims are patentable would 

justify the relatively few additional 

prior art searches per year. A third 

commenter also agreed that having an 

examiner’s search report for each MTA 

would alleviate concerns with the Office 

issuing ‘‘unexamined’’ claims, finding 

such technical assistance to be of value 

to the panel in evaluating the parties’ 

patentability arguments, although 

appreciating that such assistance may be 

perceived as a disincentive to filing 

motions to amend. 

Another commenter suggested that 

amended claims undergo review prior to 

a decision being made by the Board only 

in circumstances where the adversarial 

system fails to provide the Board with 

arguments for the unpatentability of the 

proposed substitute claims, and that 

both parties be afforded the opportunity 

to respond. A further commenter 

disagreed that the Board should be 

pressured to come up with rejections 

even when the adversarial process has 

not failed. That further commenter 

suggested that encouraging the Board to 

dig deeply into the records of other 

proceedings would disadvantage patent 

owners seeking to save patentable claim 

scope. That further commenter 

suggested that language be added to 

make clear that intervention is neither 

needed nor expected in a typical 

proceeding. 

The Office appreciates the robust 

discussion of the variety of viewpoints 

expressed in the comments. After 


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careful consideration, the Office does 

not adopt the suggestions to rely solely 

on the adversarial nature of the 

proceeding to determine when to 

request examination assistance. Rather, 

the Office revises the proposed rule to 

take into account the comments 

expressing concern about the narrow 

circumstances under which 

examination assistance would be 

requested. The final rule now states that 

a lack of opposition would be 

considered one of the reasons sufficient 

for the Board to seek examination 

assistance. As such, the final rule also 

encompasses the situation in which the 

Board determines that a deficient prior 

art challenge in an opposition warrants 

a search for additional prior art. The 

ability of the Board to seek examination 

assistance when warranted, including a 

prior art search, for amended claims 

preserves the Office’s goal of ensuring 

that it adequately evaluates the 

patentability of claims before issuance. 

The final rule’s clarification of 

appropriate situations for seeking 

examination assistance is designed to 

help panels identify when such 

examination assistance would further 

the Office’s goal. The final rule also 

accounts for the adversarial motion to 

amend process that suffices for the vast 

majority of cases filed to-date. The 

examination assistance typically would 

be appropriate in situations that are not 

duplicative of reasonable efforts 

expended by the petitioner, such as 

when an opposition lacks a prior art 

challenge or when there is no 

opposition, thus ensuring that the 

resources of the Office and the patent 

owner are not expended unnecessarily. 

Further because it relies on a 

determination that a deficient prior art 

challenge warrants a search for 

additional prior art, the Board would 

not need to address or inquire about the 

intent behind an opposition or bad faith 

efforts of a petitioner. As in the 

proposed rule, the final rule provides 

that when the Board requests 

examination assistance, that the request, 

as well as the results of the examination 

assistance will be made of record. The 

fact that the Board possesses, but has 

never used, its discretionary authority to 

request examination assistance reflects 

the Board’s careful exercise of this 

authority to date. Based upon the 

comments and the Board’s experience, 

the final rule fairly balances the 

interests of patent owners who desire to 

amend claims during an AIA proceeding 

and the Office’s role in maintaining the 

integrity of the patent system by 

ensuring the issuance of robust and 

reliable patents. 

Discretion To Raise Grounds Sua 

Sponte 

A commenter expressed concerns 

with the proposed revisions to the rule 

on the Board’s discretion to raise 

grounds of unpatentability sua sponte. 

In particular, the commenter stated that 

the proposed changes would broaden 

the Board’s discretion to raise grounds 

to an uncertain degree, even in cases 

where zealous advocacy against an 

amendment is present. The commenter 

urged the Office to revise the proposed 

changes to the Board’s exercise of 

discretion to restrain its frequency and 

clarify that the Board’s actions in this 

regard would neither be needed nor 

expected in ‘‘run-of-the-mine 

proceedings.’’ This commenter also 

urged that the Board consider retaining 

the prior rule’s limitation to considering 

‘‘only readily identifiable and 

persuasive evidence in a related 

proceeding before the Office.’’ Other 

commenters expressed support for the 

proposed rules that give the Board the 

ability to more broadly exercise its 

discretion to raise sua sponte grounds of 

unpatentability and to ensure that the 

parties are given the opportunity to 

respond to those grounds. The 

commenters noted that the Office’s 

current rules, which rely solely on the 

adversarial process, are at odds with 

current Federal Circuit case law and 

undermine the Office’s role of ensuring 

that newly issued claims are patentable. 

The Office appreciates the comments. 

After careful review of the comments 

made and in light of the careful balance 

of the various viewpoints on this issue 

and in alignment with the Office’s goals 

of ensuring the issuance of robust and 

reliable patents, the Office does not 

adopt the suggestion to limit the 

exercise of discretion to raise grounds 

sua sponte, nor to retain the limit that 

only ‘‘readily identifiable and 

persuasive evidence’’ may be relied 

upon. The rule allows the Board to 

retain discretion to raise grounds of 

unpatentability with respect to 

proposed substitute claims in 

accordance with Federal Circuit 

precedent. See Nike, Inc. v. Adidas AG, 

955 F.3d 45, 53 (2020); Hunting Titan, 

28 F.4th at 1381. Additionally, the 

commenter’s proposed limitations on 

the Board’s exercise of discretion in this 

regard are similar to those criticized by 

the Federal Circuit in Hunting Titan. 28 

F.4th at 1381, 1385. Consequently, as 

noted further below, the Board’s 

Hunting Titan decision, which places 

limitations on the Board’s exercise of 

discretion to raise grounds, is dedesignated from precedential status as 

of the effective date of this final rule. 

See PTAB Standard Operating 

Procedure 2 (Revision 10), Publication 

of Decisions and Designation or DeDesignation of Decisions as Precedential 

or Informative, Part IV (SOP2) available 

at https://www.uspto.gov/sites/default/

files/documents/SOP2%20R10%20

FINAL.pdf. 

The Office notes that although the 

adversarial nature of the proceedings 

provides, in the majority of proceedings, 

the safeguards of a robust evaluation of 

proposed substitute claims, there may 

be situations in which, despite such 

advocacy, the Board will be able to 

identify or will be aware of additional 

reasons the proposed substitute claims 

may not be granted. It is better for the 

Office to maintain the integrity of the 

patent system by ensuring that where 

the Board determines sua sponte new 

reasons why a proposed substitute claim 

should not be granted, that in 

accordance with due process, the parties 

are notified of grounds of 

unpatentability not raised by the 

opposition and that the parties are given 

an opportunity to respond. The final 

rule provides that such notice may be 

included in the preliminary guidance if 

one is requested but does not place 

limitations on such a notice to be 

provided in other papers or at a 

different stage of the proceeding, such 

as after receiving a revised motion to 

amend. 37 CFR 42.121(e), 42.221(e). 

Upon careful consideration of the 

public comments, the Office adopts the 

provisions in the proposed rule with 

minor changes for additional clarity and 

consistency. 

Preliminary Guidance and Revised 

Motions To Amend 

The final rule, which implements the 

procedure set forth in the Motion to 

Amend Pilot Program, provides a patent 

owner with two options when 

proposing substitute claims for 

challenged patent claims during an AIA 

trial proceeding. First, if requested by a 

patent owner in its original MTA, the 

Board will issue preliminary, nonbinding guidance. 37 CFR 42.121(e), 

42.221(e). Second, a patent owner may 

file, without needing Board 

authorization, a revised MTA. 37 CFR 

42.121(f), 42.221(f). These options are 

discussed further below. 

Preliminary Guidance 

The Board’s preliminary guidance, if 

requested, typically will come in the 

form of a short paper issued after a 

petitioner has filed its opposition to the 

MTA (or after the due date for a 

petitioner’s opposition, if none is filed). 

According to the MTA pilot program, 

the preliminary guidance provides, at a 


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minimum, an initial discussion about 

whether there is a reasonable likelihood 

that the original MTA meets statutory 

and regulatory requirements for an MTA 

and whether the petitioner (or the 

record then before the Office, including 

any opposition to the MTA and 

accompanying evidence) establishes a 

reasonable likelihood that the substitute 

claims are unpatentable. See MTA pilot 

program notice, 84 FR 9500. 

Under the amended rules, preliminary 

guidance will provide the Board’s 

initial, preliminary views on the 

original MTA. The preliminary 

guidance will provide an initial 

discussion about whether the parties 

have shown a reasonable likelihood of 

meeting their respective burdens. See 

Rules of Practice To Allocate the Burden 

of Persuasion on Motions To Amend in 

Trial Proceedings Before the Patent Trial 

and Appeal Board. 85 FR 82923 

(December 21, 2020); 37 CFR 

42.121(d)(1) and (2), 42.221(d)(1) and 

(2). In particular, the preliminary 

guidance will address whether there is 

a reasonable likelihood that the patent 

owner has shown that the MTA meets 

the statutory and regulatory 

requirements for an MTA. See 37 CFR 

42.121(d)(1), 42.221(d)(1); see also 35 

U.S.C. 316(d), 326(d); Lectrosonics, Inc. 

v. Zaxcom, Inc., IPR2018–01129, 2019 

WL 1118864, at *2 (precedential). The 

preliminary guidance will also provide 

an initial discussion about whether the 

petitioner (or the record then before the 

Office, including any opposition to the 

MTA and accompanying evidence) has 

established a reasonable likelihood that 

the proposed substitute claims are 

unpatentable. See 37 CFR 42.121(d)(2), 

42.221(d)(2). The preliminary guidance 

may also address any new grounds of 

unpatentability discretionarily raised by 

the Board, together with citations to the 

evidence of record supporting those 

new grounds. See 37 CFR 42.121(d)(3) 

and (4), 42.221(d)(3) and (4). In general, 

the Board’s preliminary guidance will 

address the proposed substitute claims 

in a patent owner’s original MTA in 

light of the amendments presented in 

those claims and will not address the 

patentability of the originally 

challenged claims. 

Preliminary guidance on an MTA 

during an AIA trial does not bind the 

Board. See Medytox, Inc. v. Galderma 

S.A., 71 F.4th 990, 1000 (Fed. Cir. 2023) 

(holding that the Board’s decision to 

change its claim construction between 

its Preliminary Guidance and the final 

written decision was not arbitrary and 

capricious and did not violate the 

Administrative Procedure Act (APA)). 

The Board’s preliminary guidance is not 

a ‘‘decision’’ under 37 CFR 42.71(d), 

and thus parties may not file a request 

for rehearing or a request for Director 

Review of the preliminary guidance. 

The parties will have the opportunity 

to respond to the preliminary guidance. 

For example, a patent owner may file a 

reply to a petitioner’s opposition to the 

MTA and/or the preliminary guidance 

or may file a revised MTA. If an 

opposition is filed and preliminary 

guidance was requested, the patent 

owner’s reply may respond to the 

Board’s preliminary guidance and/or to 

the petitioner’s opposition to the MTA. 

If an opposition is not filed but 

preliminary guidance was requested, a 

patent owner’s reply may only respond 

to the preliminary guidance. New 

evidence (including declarations) may 

be submitted with every paper in the 

MTA process, except with a sur-reply or 

in the special circumstance where a 

patent owner does not file either a reply 

or a revised MTA after receiving 

preliminary guidance from the Board as 

discussed below. Thus, a patent owner 

may file new evidence, including 

declarations, with its revised MTA or 

reply. See 84 FR 9500 (stating further 

that when filing new declarations, 

parties are expected to make their 

declarants available for depositions 

promptly and to make their attorneys 

available to take and defend such 

depositions; any unavailability will not 

be a reason to adjust the schedule for 

briefing on an MTA or revised MTA 

absent extraordinary circumstances). 

The petitioner may file a sur-reply that 

is limited to responding to the 

preliminary guidance and/or arguments 

made in the patent owner’s reply brief. 

Although the sur-reply may not be 

accompanied by new evidence, it may 

comment on any new evidence filed 

with the reply and/or point to crossexamination testimony of a reply 

witness, if relevant to the arguments 

made in the reply brief. 

In the special circumstance of a patent 

owner not filing either a reply or a 

revised MTA after receiving preliminary 

guidance from the Board, a petitioner 

may file a reply to the preliminary 

guidance, but such a reply may only 

respond to the preliminary guidance 

and may not be accompanied by new 

evidence. If a petitioner files a reply in 

this context, a patent owner may file a 

sur-reply limited to responding to the 

petitioner’s reply, and the sur-reply may 

not be accompanied by new evidence. 

Revised MTA 

A patent owner may choose to file a 

revised MTA after receiving a 

petitioner’s opposition to the original 

MTA or after receiving the Board’s 

preliminary guidance (if requested). As 

stated in the rule, a patent owner may 

file either a reply or a revised motion to 

amend, but not both. That is, if the 

patent owner did not elect to receive 

preliminary guidance, the patent owner 

can still choose to file a revised MTA to 

address the petitioner’s opposition to 

the original MTA. 

If a patent owner chooses to file a 

revised MTA, the revised MTA must 

include one or more new proposed 

substitute claims in place of previously 

presented substitute claims, where each 

new proposed substitute claim presents 

a new claim amendment. The new claim 

amendments, as well as arguments and 

evidence, must be responsive to issues 

raised in the preliminary guidance (if 

requested) or in petitioner’s opposition. 

Particularly, the revised MTA may 

include new arguments and/or evidence 

as to why the revised MTA meets 

statutory and regulatory requirements 

for an MTA, as well as arguments and 

evidence relevant to the patentability of 

the new proposed substitute claims. 84 

FR 9501. Because a revised MTA 

replaces the original MTA filed earlier 

in the proceeding, a patent owner may 

not incorporate by reference substitute 

claims or arguments presented in the 

original MTA into the revised MTA; all 

proposed substitute claims a patent 

owner wishes the Board to consider 

must be presented in the revised MTA. 

A revised MTA is an additional MTA 

that is automatically authorized under 

35 U.S.C. 316(d)(2) and 326(d)(2). The 

revisions therefore distinguish between 

additional MTAs under 37 CFR 

42.121(c) and 42.221(c), which require 

pre-authorization upon a showing of 

‘‘good cause,’’ and a revised MTA, 

which may be filed without prior 

authorization. Where the term ‘‘any 

motion to amend’’ is used, the final rule 

refers to an original, additional, or 

revised MTA. 

A patent owner is not required to 

request preliminary guidance or file a 

revised motion to amend. Specifically, if 

a patent owner does not elect either to 

receive preliminary guidance on its 

original MTA or to file a revised MTA, 

the rules governing amendment of the 

patent are essentially unchanged from 

the practice prior to the MTA pilot 

program. See Lectrosonics, Inc. v. 

Zaxcom, Inc., IPR2018–01129, 2019 WL 

1118864 (PTAB January 24, 2020) 

(precedential). 

MTA Timeline and Extensions of Time 

The MTA pilot program notice set 

forth typical timelines and due dates for 

the filing or issuance of MTA-related 

papers, depending on whether a patent 

owner takes advantage of one, both, or 

neither of the options under the 


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program. See MTA pilot program notice, 

84 FR 9506–9507, Appendices 1A 

(Patent Owner Reply Timeline) and 1B 

(Revised MTA Timeline). Where a 

revised MTA is filed, the Office issues 

a scheduling order that adjusts the 

deadline for oral hearing to 

accommodate additional briefing on the 

MTA. 

To address the concerns raised as to 

the ability of parties to have sufficient 

time to fully take advantage of the MTA 

procedure, the Office amends the rules 

to clarify that the Board may determine 

whether to request the Chief 

Administrative Patent Judge extend the 

final written decision deadline. The 

rules have also been amended to clarify 

that the Board may determine whether 

to extend deadlines in the MTA 

timeline pursuant to 37 CFR 42.5(c)(2). 

Extensions are not anticipated to be 

needed in most cases because the 

Board’s experience is that the default 

timelines have been sufficient to permit 

full and fair briefing in cases under the 

MTA pilot program. Thus, the Office 

will continue to apply the existing 

timelines by default as currently 

implemented under the MTA pilot 

program unless an extension is granted 

as discussed further below. See 84 FR 

9506–9507 (setting forth MTA pilot 

program timelines). 

The AIA provides the Director the 

discretion to extend the deadlines for 

issuing a final written decision for good 

cause and by not more than six months. 

35 U.S.C. 316(a)(11), 326(a)(11). The 

Director’s authority to extend the 

deadline of the final written decision 

has been delegated to the Chief 

Administrative Patent Judge. 37 CFR 

42.100(c), 42.200(c). Thus, pursuant to 

37 CFR 42.100(c) and 42.200(c), upon a 

showing of good cause, the Chief 

Administrative Patent Judge may extend 

the final written decision deadline 

beyond the statutory deadline (i.e., one 

year from the date a trial is instituted) 

by up to six months. For example, good 

cause may be present if one or more 

circumstances are present in a 

proceeding, such as: (1) complex issues; 

(2) unavailability of the panel; or (3) 

need to accommodate additional papers 

(such as additional briefing or a 

requested examination assistance). See 

e.g., Eden Park Illumination, Inc., v. S. 

Edward Neister, IPR2022–00381, Paper 

51 (August 4, 2023 PTAB) (determining 

as good cause the involvement of a 

revised MTA with new prior art, 

resulting in a substantially compressed 

schedule, multiple postponements of 

the oral hearing due to scheduling 

conflicts, and additional briefing); Hope 

Medical Enterprises, Inc. v. Fennec 

Pharmaceuticals Inc., IPR2022–00125, 

Paper 35 (April 18, 2023 PTAB) 

(determining as good cause the 

involvement of a revised MTA, resulting 

in a compressed schedule, with the 

revised claims subject to asserted 

grounds of unpatentability based on a 

combination of at least four references); 

Snap, Inc., v. Palo Alto Research Center 

Inc., IPR2021–00986, Paper 46 

(November 7, 2022) (determining as 

good cause the substantial coordination 

of proceedings required by the Board 

due to multiple pending motions to 

amend). 

As for deadlines that are not for a 

final written decision, typically, a panel 

of the Board determines whether to 

grant a good-cause extension under 37 

CFR 42.5(c)(2) after request from, and 

conference with, the parties. In the 

context of the MTA timelines, the Board 

will continue to consider whether to 

grant extensions of those timelines as 

required by the Board’s rules discussed 

above. In particular, the Board may 

determine at any time during the 

pendency of the case, but more 

specifically upon issuing the 

preliminary guidance or receiving a 

revised MTA, whether for good cause 

the particular circumstances raised by 

the parties to the proceeding warrant an 

extension of deadlines. When an 

extension is granted, the parties will be 

notified of the change in the due dates 

for the remainder of the deadlines and 

events in the proceeding. 

Allocation of Burdens of Persuasion and 

Scope of the Record in Motions To 

Amend 

Under the rules prior to this final rule 

and under Federal Circuit case law, the 

Board retains discretion to raise, or to 

not raise, grounds of unpatentability 

with respect to proposed substitute 

claims. See Nike, Inc. v. Adidas AG, 955 

F.3d 45, 53 (2020); Hunting Titan, 28 

F.4th at 1381. 

In the final rule, the body of evidence 

that the Board may consider and make 

of record now includes the entire 

evidence of record in the proceeding, 

without limitation, in accordance with 

Nike, Inc. v. Adidas AG, 955 F.3d at 54 

(‘‘[T]he Board may rely on prior art of 

record in considering the patentability 

of amended claims.’’). By removing 

limitations of the prior rules, such as the 

‘‘interests of justice’’ standard and the 

requirement for ‘‘readily identifiable 

and persuasive’’ evidence, the final rule 

alleviates the Federal Circuit’s concern 

that the Board confined its discretion to 

only rare circumstances. See Hunting 

Titan, 28 F.4th at 1381 (noting that the 

USPTO’s ‘‘substantial reliance on the 

adversarial system . . . overlooks the 

basic purpose of [inter partes review] 

proceedings: to reexamine an earlier 

agency decision and ensure ‘that patent 

monopolies are kept within their 

legitimate scope.’ ’’); see also id. at 1385 

(concurrence expressing concern that 

the burden-allocation rule’s requirement 

for ‘‘readily identifiable and persuasive 

evidence’’ may prevent the Board from 

raising grounds ‘‘even when no one is 

around to oppose a new patent 

monopoly grant’’). The final rule 

broadens the Board’s authority to sua 

sponte raise grounds of unpatentability 

with respect to proposed substitute 

claims and provides for notification of 

those grounds to be given to the parties, 

typically in, but not limited to, 

preliminary guidance. 37 CFR 

42.121(d)(3) and (4), 42.221(d)(3) and 

(4). 

The final rule therefore departs from 

the Board’s precedential Hunting Titan 

decision. Hunting Titan, Inc. v. 

DynaEnergetics Europe GmbH, 

IPR2018–00600 (PTAB July 6, 2020) 

(Paper 67). That decision, criticized by 

the Federal Circuit, is at odds with the 

proposed broader discretion of the 

Board to raise grounds sua sponte. 

Accordingly, the Hunting Titan decision 

is de-designated from precedential 

status as of the effective date of this 

final rule. See (SOP2). 

Examination Assistance 

Consistent with the Board’s discretion 

to raise grounds of unpatentability, the 

MTA pilot program noted the Board’s 

discretion to solicit patent examiner 

assistance regarding the MTA when 

‘‘petitioner cease[d] to participate 

altogether in an AIA trial in which the 

patent owner file[d] an MTA, and the 

Board nevertheless exercise[d] its 

discretion to proceed with the trial.’’ 84 

FR 9502. If solicited by the Board, the 

assistance could include the preparation 

of an advisory report that: (1) provides 

an initial discussion about whether an 

MTA meets certain statutory and 

regulatory requirements (e.g., whether 

the amendment enlarges the scope of 

the claims of the patent or introduces 

new matter) and/or (2) provides an 

initial discussion about the patentability 

of proposed substitute claims, for 

example, in light of prior art that was 

identified by the parties in their 

submissions and/or obtained in prior art 

searches by the examiner. Id. As of 

issuance of this final rule, the Board has 

not exercised its discretion to solicit 

examination assistance. 

The final rule provides that the Board 

may request such examination 

assistance consistent with current 

practice reflected in the MTA pilot 

program. 37 CFR 42.121(d)(3)(ii), 

42.221(d)(3)(ii); 84 FR 9502. For 


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example, the Board has discretion to 

solicit examination assistance if the 

petitioner ceases to participate 

altogether in an AIA trial in which the 

patent owner files an MTA and the 

Board nevertheless exercises its 

discretion to proceed with the trial 

thereafter. 84 FR 9502. The Board may 

also solicit examination assistance when 

a petitioner continues to participate in 

the AIA trial but either does not oppose 

or has ceased to oppose an MTA. 

Examination assistance could include 

the preparation of an advisory report as 

outlined above. Id. 

The final rule thus confirms the 

Board’s discretion to seek examination 

assistance at any time after any motion 

to amend has been filed if no petitioner 

opposes or all petitioners cease to 

oppose the MTA. The final rule also 

ensures that the Board retains the 

discretion to request examination 

assistance when the opposition is 

deficient such that a search for 

additional prior art is warranted. The 

final rule also clarifies that the Board 

may make of record information 

identified in response to the Boardinitiated request for examination 

assistance. Additionally, the final rule 

provides that the Board’s request for 

examination assistance and the results 

of that assistance will be made of 

record. 

Changes From Proposed Rule 

In light of the received comments, this 

final rule makes the revisions to the 

2024 NPRM as follows. 

Sections 42.121(b) and 42.221(b) have 

been revised further to clarify that the 

motion itself (not the claim listing) must 

set forth the support in the original 

disclosure of the patent for each 

proposed substitute claim and the 

support in an earlier-filed disclosure for 

each claim for which the benefit of the 

filing date of the earlier-filed disclosure 

is sought. 

Sections 42.121(d)(3)(ii) and 

42.221(d)(3)(ii) have been revised 

further to state that the Board also may 

consider and may make of record 

information identified in response to a 

Board-initiated request for examination 

assistance. These sections are revised 

further to expressly state that Board may 

request the examination assistance at 

any time after any motion to amend has 

been filed if no petitioner opposes or all 

petitioners cease to oppose the motion 

to amend, or if the Board determines 

that a deficient prior art challenge in an 

opposition to a motion to amend 

warrants a search for additional prior 

art. Further, the revised rules state that 

the Board’s request for examination 

assistance and the results of such 

assistance will be made of record. 

Sections 42.121(e)(3) and 42.221(e)(3) 

have been revised further to clarify that 

in response to the preliminary guidance, 

a patent owner may file a reply that 

responds to the petitioner’s opposition 

to the motion to amend and/or the 

preliminary guidance. The patent owner 

may file a revised motion to amend 

instead of a reply, as discussed in 

§§ 42.121(f) and 42.221(f). These 

sections are also revised further to 

expressly provide for petitioner’s filing 

of a sur-reply that is limited to 

responding to the preliminary guidance 

and/or arguments made in the patent 

owner’s reply brief. Further, the revised 

rule specifies that the sur-reply may not 

be accompanied by new evidence, but 

may comment on any new evidence 

filed with the reply and/or point to 

cross-examination testimony of a reply 

witness, if relevant to the arguments 

made in the reply brief. 

New §§ 42.121(e)(4) and 42.221(e)(4) 

are a renumbering of unchanged 

provisions previously included in 

§§ 42.121(e)(3) and 42.221(e)(3). 

Discussion of Specific Rules 

Sections 42.121 and 42.221 

Sections 42.121(a) and 42.221(a) are 

amended to refer to original motions to 

amend and to allow for requests for 

preliminary guidance on an original 

motion to amend. 

Sections 42.121(b) and 42.221(b) are 

amended to clarify that the regulation 

applies to any motion to amend and that 

support in the original disclosure or 

earlier-filed disclosure must be included 

in the motion for each proposed 

substitute claim. 

Sections 42.121(d) and 42.221(d) are 

amended to provide that the Board may 

consider all evidence of record in the 

proceeding when exercising its 

discretion to grant or deny a motion to 

amend or raise a new ground of 

unpatentability in connection with a 

proposed substitute claim. These 

sections are further amended to provide 

that the Board may consider, and may 

make of record, any evidence in a 

related proceeding before the Office as 

well as evidence that a district court can 

judicially notice. These sections are also 

amended to provide that the Board may 

request examination assistance at any 

time after any motion to amend has 

been filed, if no petitioner opposes or all 

petitioners cease to oppose the motion 

to amend, or if the Board determines 

that a deficient prior art challenge in an 

opposition to a motion to amend 

warrants a search for additional prior 

art. These sections are further amended 

to state that information identified in 

response to the Board-initiated request 

for examination assistance may be 

considered and made of record, and that 

the request and the results of the 

examination assistance will also be 

made of record. The sections further 

state that when the Board exercises 

discretion to raise a new ground in 

connection with a motion to amend, the 

Board will determine patentability on 

the new ground by reference to the 

evidence of record or made of record 

and based on a preponderance of the 

evidence. These sections do not alter the 

current rules on burden of persuasions 

of parties to the proceeding. 

Sections 42.121(e) and 42.221(e) are 

added to provide for an opportunity to 

request preliminary guidance, 

consistent with the MTA pilot program. 

Such guidance will not be binding on 

the Board, is not a ‘‘decision’’ under 37 

CFR 42.71(d), and is not a final agency 

action. The added sections permit a 

patent owner to file a reply to the 

petitioner’s opposition to the motion to 

amend and/or the preliminary guidance 

(if requested), or a revised MTA as 

discussed in §§ 42.121(f) and 42.221(f). 

The reply or revised MTA may be 

accompanied by new evidence. Further, 

the petitioner may file a sur-reply that 

is limited to responding to the 

preliminary guidance and/or arguments 

made in the patent owner’s reply brief. 

The sur-reply may not be accompanied 

by new evidence but may comment on 

any new evidence filed with the reply 

and/or point to cross-examination 

testimony of a reply witness, if relevant 

to the arguments made in the reply 

brief. Moreover, the added sections 

provide that, if a patent owner does not 

file either a reply or a revised MTA after 

receiving preliminary guidance from the 

Board, the petitioner may file a reply to 

the preliminary guidance, but such a 

reply may only respond to the 

preliminary guidance and may not be 

accompanied by new evidence. If the 

petitioner files a reply in this context, a 

patent owner may file a sur-reply, but 

that sur-reply may only respond to the 

petitioner’s reply and may not be 

accompanied by new evidence. 

Further, the added sections provide 

that the Board may, upon issuing the 

preliminary guidance, for good cause 

and on a case-by-case basis, determine 

whether to request the Chief 

Administrative Patent Judge to extend 

the final written decision deadline more 

than one year from the date a trial is 

instituted in accordance with 

§§ 42.100(c) and 42.200(c) and whether 

to extend any remaining deadlines 

under § 42.5(c). 


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The final rule adds §§ 42.121(f) and 

42.221(f) to provide an opportunity for 

a patent owner to file one revised 

motion to amend, consistent with the 

MTA pilot program. Such a revised 

motion to amend must be responsive to 

issues raised in the preliminary 

guidance, or the petitioner’s opposition 

to the motion to amend, and must 

include one or more new proposed 

substitute claims in place of previously 

presented substitute claims, where each 

new proposed substitute claim presents 

a new claim amendment. Any revised 

motion to amend replaces the original 

motion to amend in the proceeding. 

Further, the Board may, upon 

receiving the revised motion to amend, 

on a case-by-case basis, determine 

whether to request the Chief 

Administrative Patent Judge to extend 

the final written decision deadline more 

than one year from the date a trial is 

instituted in accordance with 

§§ 42.100(c) and 42.200(c) and whether 

to extend any remaining deadlines 

under § 42.5(c). 

Rulemaking Considerations 

A. Administrative Procedure Act (APA) 

This rulemaking makes changes to the 

consolidated set of rules relating to 

Office trial practice for IPR, PGR, and 

derivation proceedings. The changes in 

this rulemaking do not alter the 

substantive criteria of patentability. 

These changes involve rules of agency 

practice. See, e.g., 35 U.S.C. 316(a)(5), as 

amended. The changes in this 

rulemaking involve rules of agency 

practice and procedure, and/or 

interpretive rules, and do not require 

notice-and-comment rulemaking. See 

Perez v. Mortg. Bankers Ass’n, 575 U.S. 

92, 97, 101 (2015) (explaining that 

interpretive rules ‘‘advise the public of 

the agency’s construction of the statutes 

and rules which it administers’’ and do 

not require notice and comment when 

issued or amended); Cooper Techs. Co. 

v. Dudas, 536 F.3d 1330, 1336–37 (Fed. 

Cir. 2008) (5 U.S.C. 553, and thus 35 

U.S.C. 2(b)(2)(B), do not require noticeand-comment rulemaking for 

‘‘interpretative rules, general statements 

of policy, or rules of agency 

organization, procedure, or practice’’); 

and JEM Broadcasting Co. v. F.C.C., 22 

F.3d 320, 328 (D.C. Cir. 1994) 

(explaining that rules are not legislative 

because they do not ‘‘foreclose effective 

opportunity to make one’s case on the 

merits.’’). 

Nevertheless, the USPTO has chosen 

to seek public comment before 

implementing the rule to benefit from 

the public’s input. 

B. Regulatory Flexibility Act 

For the reasons set forth herein, the 

Senior Counsel for Legislative and 

Regulatory Affairs of the Office of 

General Law at the USPTO has certified 

to the Chief Counsel for Advocacy of the 

Small Business Administration that 

changes in this rule will not have a 

significant economic impact on a 

substantial number of small entities. See 

5 U.S.C. 605(b). 

This rule revises certain trial practice 

procedures before the Board. 

Specifically, the Office proposes to 

amend the rules of practice before the 

Board to reflect current Board practice, 

as set forth in various precedential and 

informative Board decisions, as well as 

the Office’s Trial Practice Guide. 

Specifically, the Office amends the rules 

of practice to make permanent certain 

provisions of the Office’s MTA pilot 

program. These changes are procedural 

in nature, and any requirements 

resulting from the proposed changes are 

of minimal or no additional burden to 

those practicing before the Board. 

For the foregoing reasons, the changes 

in this rulemaking will not have a 

significant economic impact on a 

substantial number of small entities. 

C. Executive Order 12866 (Regulatory 

Planning and Review) 

This rulemaking has been determined 

to be not significant for purposes of 

Executive Order 12866 (September 30, 

1993), as amended by Executive Order 

14094 (April 6, 2023). 

D. Executive Order 13563 (Improving 

Regulation and Regulatory Review) 

The Office has complied with 

Executive Order 13563 (January 18, 

2011). Specifically, and as discussed 

above, the Office has, to the extent 

feasible and applicable: (1) made a 

reasoned determination that the benefits 

justify the costs of the rule; (2) tailored 

the rule to impose the least burden on 

society consistent with obtaining the 

regulatory objectives; (3) selected a 

regulatory approach that maximizes net 

benefits; (4) specified performance 

objectives; (5) identified and assessed 

available alternatives; (6) involved the 

public in an open exchange of 

information and perspectives among 

experts in relevant disciplines, affected 

stakeholders in the private sector, and 

the public as a whole and provided 

online access to the rulemaking docket; 

(7) attempted to promote coordination, 

simplification, and harmonization 

across government agencies and 

identified goals designed to promote 

innovation; (8) considered approaches 

that reduce burdens and maintain 

flexibility and freedom of choice for the 

public; and (9) ensured the objectivity of 

scientific and technological information 

and processes. 

E. Executive Order 13132 (Federalism) 

This rulemaking pertains strictly to 

Federal agency procedures and does not 

contain policies with federalism 

implications sufficient to warrant 

preparation of a Federalism Assessment 

under Executive Order 13132 (August 4, 

1999). 

F. Executive Order 13175 (Tribal 

Consultation) 

This rulemaking will not: (1) have 

substantial direct effects on one or more 

Indian tribes; (2) impose substantial 

direct compliance costs on Indian Tribal 

governments; or (3) preempt Tribal law. 

Therefore, a Tribal summary impact 

statement is not required under 

Executive Order 13175 (November 6, 

2000). 

G. Executive Order 13211 (Energy 

Effects) 

This rulemaking is not a significant 

energy action under Executive Order 

13211 because this rulemaking is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. Therefore, a Statement of Energy 

Effects is not required under Executive 

Order 13211 (May 18, 2001). 

H. Executive Order 12988 (Civil Justice 

Reform) 

This rulemaking meets applicable 

standards to minimize litigation, 

eliminate ambiguity, and reduce burden 

as set forth in sections 3(a) and 3(b)(2) 

of Executive Order 12988 (February 5, 

1996). 

I. Executive Order 13045 (Protection of 

Children) 

This rulemaking does not concern an 

environmental risk to health or safety 

that may disproportionately affect 

children under Executive Order 13045 

(April 21, 1997). 

J. Executive Order 12630 (Taking of 

Private Property) 

This rulemaking will not affect a 

taking of private property or otherwise 

have taking implications under 

Executive Order 12630 (March 15, 

1988). 

K. Congressional Review Act 

Under the Congressional Review Act 

provisions of the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (5 U.S.C. 801 et seq.), the USPTO 

will submit a report containing the final 

rule and other required information to 


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Federal Register / Vol. 89, No. 181 / Wednesday, September 18, 2024 / Rules and Regulations 76429 

the United States Senate, the United 

States House of Representatives, and the 

Comptroller General of the Government 

Accountability Office. The changes in 

this rulemaking are not expected to 

result in an annual effect on the 

economy of $100 million or more, a 

major increase in costs or prices, or 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or the ability 

of United States-based enterprises to 

compete with foreign-based enterprises 

in domestic and export markets. 

Therefore, this rulemaking is not a 

‘‘major rule’’ as defined in 5 U.S.C. 

804(2). 

L. Unfunded Mandates Reform Act of 

1995 

The changes set forth in this 

rulemaking do not involve a Federal 

intergovernmental mandate that will 

result in the expenditure by State, local, 

and Tribal governments, in the 

aggregate, of $100 million (as adjusted) 

or more in any one year, or a Federal 

private sector mandate that will result 

in the expenditure by the private sector 

of $100 million (as adjusted) or more in 

any one year, and will not significantly 

or uniquely affect small governments. 

Therefore, no actions are necessary 

under the provisions of the Unfunded 

Mandates Reform Act of 1995. See 2 

U.S.C. 1501 et seq. 

M. National Environmental Policy Act of 

1969 

This rulemaking will not have any 

effect on the quality of the environment 

and is thus categorically excluded from 

review under the National 

Environmental Policy Act of 1969. See 

42 U.S.C. 4321 et seq. 

N. National Technology Transfer and 

Advancement Act of 1995 

The requirements of section 12(d) of 

the National Technology Transfer and 

Advancement Act of 1995 (15 U.S.C. 

272 note) are not applicable because this 

rulemaking does not contain provisions 

that involve the use of technical 

standards. 

O. Paperwork Reduction Act of 1995 

The Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3549) requires that the 

Office consider the impact of paperwork 

and other information collection 

burdens imposed on the public. 

In accordance with section 3507(d) of 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.), the paperwork 

and other information collection 

burdens discussed in this rulemaking 

have already been approved under 

Office of Management and Budget 

(OMB) Control Number 0651–0069 

(Patent Review and Derivations). 

Notwithstanding any other provision 

of law, no person is required to respond 

to, nor shall any person be subject to, a 

penalty for failure to comply with a 

collection of information subject to the 

requirements of the Paperwork 

Reduction Act unless that collection of 

information has valid OMB control 

number. 

List of Subjects in 37 CFR Part 42 

Administrative practice and 

procedure, Inventions and patents, 

Lawyers. 

For the reasons set forth in the 

preamble, the Office amends 37 CFR 

part 42 as follows: 

PART 42—TRIAL PRACTICE BEFORE 

THE PATENT TRIAL AND APPEAL 

BOARD 

■ 1. The authority citation for part 42 

continues to read as follows: 

Authority: 35 U.S.C. 2(b)(2), 6, 21, 23, 41, 

135, 311, 312, 316, 321–326; Pub. L. 112–29, 

125 Stat. 284; and Pub. L. 112–274, 126 Stat. 

2456. 

■ 2. Revise § 42.121 to read as follows: 

§ 42.121 Amendment of the patent. 

(a) Motion to amend—(1) Original 

motion to amend. A patent owner may 

file one original motion to amend a 

patent, but only after conferring with 

the Board. 

(i) Due date. Unless a due date is 

provided in a Board order, an original 

motion to amend must be filed no later 

than the filing of a patent owner 

response. 

(ii) Request for preliminary guidance. 

If a patent owner wishes to receive 

preliminary guidance from the Board as 

discussed in paragraph (e) of this 

section, the original motion to amend 

must include the patent owner’s request 

for that preliminary guidance. 

(2) Scope. Any motion to amend may 

be denied where: 

(i) The amendment does not respond 

to a ground of unpatentability involved 

in the trial; or 

(ii) The amendment seeks to enlarge 

the scope of the claims of the patent or 

introduce new subject matter. 

(3) A reasonable number of substitute 

claims. Any motion to amend may 

cancel a challenged claim or propose a 

reasonable number of substitute claims. 

The presumption is that only one 

substitute claim will be needed to 

replace each challenged claim, and it 

may be rebutted by a demonstration of 

need. 

(b) Content. Any motion to amend 

claims must include a claim listing, 

which claim listing may be contained in 

an appendix to the motion, show the 

changes clearly, and the motion must 

set forth: 

(1) The support in the original 

disclosure of the patent for each 

proposed substitute claim; and 

(2) The support in an earlier-filed 

disclosure for each claim for which the 

benefit of the filing date of the earlierfiled disclosure is sought. 

(c) Additional motion to amend. 

Except as provided in paragraph (f) of 

this section, any additional motion to 

amend may not be filed without Board 

authorization. An additional motion to 

amend may be authorized when there is 

a good cause showing or a joint request 

of the petitioner and the patent owner 

to materially advance a settlement. In 

determining whether to authorize such 

an additional motion to amend, the 

Board will consider whether a petitioner 

has submitted supplemental 

information after the time period set for 

filing a motion to amend in paragraph 

(a)(1)(i) of this section. 

(d) Burden of persuasion. On any 

motion to amend: 

(1) Patent owner’s burden. A patent 

owner bears the burden of persuasion to 

show, by a preponderance of the 

evidence, that the motion to amend 

complies with the requirements of 

paragraphs (1) and (3) of 35 U.S.C. 

316(d), as well as paragraphs (a)(2) and 

(3) and (b)(1) and (2) of this section; 

(2) Petitioner’s burden. A petitioner 

bears the burden of persuasion to show, 

by a preponderance of the evidence, that 

any proposed substitute claims are 

unpatentable; and 

(3) Exercise of Board discretion. 

Irrespective of paragraphs (d)(1) and (2) 

of this section, the Board may exercise 

its discretion to grant or deny a motion 

to amend or raise a new ground of 

unpatentability in connection with a 

proposed substitute claim. Where the 

Board exercises its discretion to raise a 

new ground of unpatentability in 

connection with a proposed substitute 

claim, the parties will have notice and 

an opportunity to respond. In the 

exercise of this discretion under this 

paragraph (d)(3), the Board may 

consider all evidence of record in the 

proceeding. The Board also may 

consider and make of record: 

(i) Any evidence in a related 

proceeding before the Office and 

evidence that a district court can 

judicially notice; and 

(ii) Information identified in response 

to a Board-initiated examination 

assistance. The Board may request the 

examination assistance at any time after 

any motion to amend has been filed if 

no petitioner opposes or all petitioners 


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76430 Federal Register / Vol. 89, No. 181 / Wednesday, September 18, 2024 / Rules and Regulations 

cease to oppose the motion to amend, or 

if the Board determines that a deficient 

prior art challenge in an opposition to 

the motion to amend warrants a search 

for additional prior art. The Board’s 

request for examination assistance and 

the results of such assistance will be 

made of record. 

(4) Determination of unpatentability. 

Where the Board exercises its discretion 

under paragraph (d)(3) of this section, 

the Board must determine 

unpatentability based on a 

preponderance of the evidence of 

record. 

(e) Preliminary guidance. (1) In its 

original motion to amend, a patent 

owner may request that the Board 

provide preliminary guidance setting 

forth the Board’s initial, preliminary 

views on the original motion to amend, 

including whether the parties have 

shown a reasonable likelihood of 

meeting their respective burdens of 

persuasion as set forth under paragraphs 

(d)(1) and (2) of this section and notice 

of any new ground of unpatentability 

discretionarily raised by the Board 

under paragraph (d)(3) of this section. 

The Board may, upon issuing the 

preliminary guidance, determine 

whether to request the Chief 

Administrative Patent Judge to extend 

the final written decision deadline more 

than one year from the date a trial is 

instituted in accordance with 

§ 42.100(c) and whether to extend any 

remaining deadlines under § 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 § 42.71(d) that may be the subject 

of a request for rehearing or Director 

Review, and is not a final agency action. 

(3) In response to the Board’s 

preliminary guidance, a patent owner 

may file a reply that responds to the 

petitioner’s opposition to the motion to 

amend and/or the preliminary guidance, 

or a revised motion to amend as 

discussed in paragraph (f) of this 

section. The reply or revised motion to 

amend may be accompanied by new 

evidence. The petitioner may file a surreply that is limited to responding to the 

preliminary guidance and/or arguments 

made in the patent owner’s reply brief. 

The sur-reply may not be accompanied 

by new evidence, but may comment on 

any new evidence filed with the reply 

and/or point to cross-examination 

testimony of a reply witness, if relevant 

to the arguments made in the reply 

brief. 

(4) If a patent owner does not file 

either a reply or a revised motion to 

amend after receiving preliminary 

guidance from the Board, the petitioner 

may file a reply to the preliminary 

guidance, but such a reply may only 

respond to the preliminary guidance 

and may not be accompanied by new 

evidence. If the petitioner files a reply 

in this context, a patent owner may file 

a sur-reply, but that sur-reply may only 

respond to the petitioner’s reply and 

may not be accompanied by new 

evidence. 

(f) Revised motion to amend. (1) 

Irrespective of paragraph (c) of this 

section, a patent owner may, without 

prior authorization from the Board, file 

one revised motion to amend after 

receiving an opposition to the original 

motion to amend or after receiving the 

Board’s preliminary guidance. The 

Board may, upon receiving the revised 

motion to amend, determine whether to 

request the Chief Administrative Patent 

Judge to extend the final written 

decision deadline more than one year 

from the date a trial is instituted in 

accordance with § 42.100(c) and 

whether to extend any remaining 

deadlines under § 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. 

■ 3. Revise § 42.221 to read as follows: 

§ 42.221 Amendment of the patent. 

(a) Motion to amend—(1) Original 

motion to amend. A patent owner may 

file one original motion to amend a 

patent, but only after conferring with 

the Board. 

(i) Due date. Unless a due date is 

provided in a Board order, an original 

motion to amend must be filed no later 

than the filing of a patent owner 

response. 

(ii) Request for preliminary guidance. 

If a patent owner wishes to receive 

preliminary guidance from the Board as 

discussed in paragraph (e) of this 

section, the original motion to amend 

must include the patent owner’s request 

for that preliminary guidance. 

(2) Scope. Any motion to amend may 

be denied where: 

(i) The amendment does not respond 

to a ground of unpatentability involved 

in the trial; or 

(ii) The amendment seeks to enlarge 

the scope of the claims of the patent or 

introduce new subject matter. 

(3) A reasonable number of substitute 

claims. Any motion to amend may 

cancel a challenged claim or propose a 

reasonable number of substitute claims. 

The presumption is that only one 

substitute claim will be needed to 

replace each challenged claim, and it 

may be rebutted by a demonstration of 

need. 

(b) Content. Any motion to amend 

claims must include a claim listing, 

which claim listing may be contained in 

an appendix to the motion, show the 

changes clearly, and the motion must 

set forth: 

(1) The support in the original 

disclosure of the patent for each 

proposed substitute claim; and 

(2) The support in an earlier-filed 

disclosure for each claim for which the 

benefit of the filing date of the earlierfiled disclosure is sought. 

(c) Additional motion to amend. 

Except as provided by paragraph (f) of 

this section, any additional motion to 

amend may not be filed without Board 

authorization. An additional motion to 

amend may be authorized when there is 

a good cause showing or a joint request 

of the petitioner and the patent owner 

to materially advance a settlement. In 

determining whether to authorize such 

an additional motion to amend, the 

Board will consider whether a petitioner 

has submitted supplemental 

information after the time period set for 

filing a motion to amend in paragraph 

(a)(1)(i) of this section. 

(d) Burden of persuasion. On any 

motion to amend: 

(1) Patent owner’s burden. A patent 

owner bears the burden of persuasion to 

show, by a preponderance of the 

evidence, that the motion to amend 

complies with the requirements of 

paragraphs (1) and (3) of 35 U.S.C. 

326(d), as well as paragraphs (a)(2) and 

(3) and (b)(1) and (2) of this section; 

(2) Petitioner’s burden. A petitioner 

bears the burden of persuasion to show, 

by a preponderance of the evidence, that 

any proposed substitute claims are 

unpatentable; and 

(3) Exercise of Board discretion. 

Irrespective of paragraphs (d)(1) and (2) 

of this section, the Board may exercise 

its discretion to grant or deny a motion 

to amend or raise a new ground of 

unpatentability in connection with a 

proposed substitute claim. Where the 

Board exercises its discretion to raise a 

new ground of unpatentability in 

connection with a proposed substitute 

claim, the parties will have notice and 

an opportunity to respond. In the 

exercise of discretion under this 


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Federal Register / Vol. 89, No. 181 / Wednesday, September 18, 2024 / Rules and Regulations 76431 

paragraph (d)(3), the Board may 

consider all evidence of record in the 

proceeding. The Board also may 

consider and may make of record: 

(i) Any evidence in a related 

proceeding before the Office and 

evidence that a district court can 

judicially notice; and 

(ii) Information identified in response 

to a Board-initiated examination 

assistance. The Board may request the 

examination assistance at any time after 

any motion to amend has been filed if 

no petitioner opposes or all petitioners 

cease to oppose the motion to amend, or 

if the Board determines that a deficient 

prior art challenge in an opposition to 

the motion to amend warrants a search 

for additional prior art. The Board’s 

request for examination assistance and 

the results of such assistance will be 

made of record. 

(4) Determination of unpatentability. 

Where the Board exercises its discretion 

under paragraph (d)(3) of this section, 

the Board must determine 

unpatentability based on a 

preponderance of the evidence of 

record. 

(e) Preliminary guidance. (1) In its 

original motion to amend, a patent 

owner may request that the Board 

provide preliminary guidance setting 

forth the Board’s initial, preliminary 

views on the original motion to amend, 

including whether the parties have 

shown a reasonable likelihood of 

meeting their respective burdens of 

persuasion as set forth under paragraphs 

(d)(1) and (2) of this section and notice 

of any new ground of unpatentability 

discretionarily raised by the Board 

under paragraph (d)(3) of this section. 

The Board may, upon issuing the 

preliminary guidance, determine 

whether to request the Chief 

Administrative Patent Judge extend the 

final written decision deadline more 

than one year from the date a trial is 

instituted in accordance with 

§ 42.200(c) and whether to extend any 

remaining deadlines under § 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 § 42.71(d) that may be the subject 

of a request for rehearing or Director 

Review, and is not a final agency action. 

(3) In response to the Board’s 

preliminary guidance, a patent owner 

may file a reply that responds to the 

petitioner’s opposition to the motion to 

amend and/or the preliminary guidance, 

or a revised motion to amend as 

discussed in paragraph (f) of this 

section. The reply or revised motion to 

amend may be accompanied by new 

evidence. The petitioner may file a surreply that is limited to responding to the 

preliminary guidance and/or arguments 

made in the patent owner’s reply brief. 

The sur-reply may not be accompanied 

by new evidence, but may comment on 

any new evidence filed with the reply 

and/or point to cross-examination 

testimony of a reply witness, if relevant 

to the arguments made in the reply 

brief. 

(4) If a patent owner does not file 

either a reply or a revised motion to 

amend after receiving preliminary 

guidance from the Board, the petitioner 

may file a reply to the preliminary 

guidance, but such a reply may only 

respond to the preliminary guidance 

and may not be accompanied by new 

evidence. If the petitioner files a reply 

in this context, a patent owner may file 

a sur-reply, but that sur-reply may only 

respond to the petitioner’s reply and 

may not be accompanied by new 

evidence. 

(f) Revised motion to amend. (1) 

Irrespective of paragraph (c) of this 

section, a patent owner may, without 

prior authorization from the Board, file 

one revised motion to amend after 

receiving an opposition to the original 

motion to amend or after receiving the 

Board’s preliminary guidance. The 

Board may, upon receiving the revised 

motion to amend, determine whether to 

request the Chief Administrative Patent 

Judge to extend the final written 

decision deadline more than one year 

from the date a trial is instituted in 

accordance with § 42.200(c) and 

whether to extend any remaining 

deadlines under § 42.5(c)(2). 

(2) A revised motion to amend must 

be responsive to issues raised in the 

preliminary guidance or in the 

petitioner’s opposition to the motion to 

amend, and must include one or more 

new proposed substitute claims in place 

of the previously presented substitute 

claims, where each new proposed 

substitute claim presents a new claim 

amendment. 

(3) If a patent owner files a revised 

motion to amend, that revised motion to 

amend replaces the original motion to 

amend in the proceeding. 

Katherine K. Vidal, 

Under Secretary of Commerce for Intellectual 

Property and Director of the United States 

Patent and Trademark Office. 

[FR Doc. 2024–21134 Filed 9–17–24; 8:45 am] 

BILLING CODE 3510–16–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Inspector General 

42 CFR Part 1007 

Performance Standards for Medicaid 

Fraud Control Units 

AGENCY: Office of Inspector General 

(OIG), Department of Health and Human 

Services (HHS). 

ACTION: Notice of final revised 

performance standards. 

SUMMARY: This document sets forth OIG 

guidance regarding standards OIG will 

apply in assessing the performance of 

Medicaid Fraud Control Units (MFCUs 

or Units). Based on its experience in 

overseeing MFCUs, and after 

consultation with key stakeholders, OIG 

is revising the standards. These 

standards replace and supersede 

standards published on June 1, 2012. 

DATES: Effective Date: These standards 

are effective upon publication. 

FOR FURTHER INFORMATION CONTACT: 

Susan Burbach, OIG Office of 

Evaluation and Inspections, 202–731– 

8516, susan.burbach@oig.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The mission of MFCUs is to 

investigate and prosecute (or refer for 

prosecution): (1) fraud committed by 

Medicaid providers, (2) fraud in the 

administration of the Medicaid program, 

and (3) patient abuse or neglect of 

residents in health care facilities and 

board and care facilities and of 

Medicaid enrollees in noninstitutional 

or other settings. MFCUs receive most of 

their funding from the Federal 

Government, and each MFCU operates 

as ‘‘a single, identifiable entity of State 

government.’’ Each of the 50 States has 

a MFCU, as well as the District of 

Columbia, Puerto Rico, and the U.S. 

Virgin Islands. Except for four States, 

each MFCU is organized as part of the 

State Attorney General’s office. 

HHS–OIG has been delegated 

authority under sections 1903(q) and 

1903(a)(6) of the Social Security Act (the 

Act) to certify and annually recertify 

Units as eligible for Federal financial 

participation (FFP), and to reimburse 

States for costs incurred in operating a 

MFCU. Through the certification and 

recertification process, OIG ensures that 

the Units meet the requirements for FFP 

set forth in section 1903(q) of the Act 

and in Federal regulations found at 42 

CFR part 1007. As part of this process, 

OIG applies a series of performance 

standards, as required by section 


khammond on DSKJM1Z7X2PROD with RULES