Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Rules and Regulations 82923 

P. Paperwork Reduction Act of 1995: 

The Paperwork Reduction Act of 1995 

(44 U.S.C. 3501) requires that the Office 

consider the impact of paperwork and 

other information collection burdens 

imposed on the public. This rulemaking 

does not involve any new information 

collection requirements that are subject 

to review by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.). 

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 a valid OMB control 

number. 

List of Subjects in 37 CFR Part 1 

Administrative practice and 

procedure, Biologics, Courts, Freedom 

of information, Inventions and patents, 

Reporting and recordkeeping 

requirements, Small businesses. 

For the reasons stated in the 

preamble, 37 CFR part 1 is amended as 

follows: 

PART 1—RULES OF PRACTICE IN 

PATENT CASES 

■ 1. The authority citation for 37 CFR 

part 1 continues to read as follows: 

Authority: 35 U.S.C. 2(b)(2), unless 

otherwise noted. 

■ 2. Section 1.27 is amended by revising 

paragraph (a)(4) to read as follows: 

§ 1.27 Definition of small entities and 

establishing status as a small entity to 

permit payment of small entity fees; when 

a determination of entitlement to small 

entity status and notification of loss of 

entitlement to small entity status are 

required; fraud on the Office. 

(a) * * * 

(4) Federal Government Use License 

Exceptions. In a patent application filed, 

prosecuted, and if patented, maintained 

at no expense to the Government, with 

the exception of any expense taken to 

deliver the application and fees to the 

Office on behalf of the applicant: 

(i) For persons under paragraph (a)(1) 

of this section, claiming small entity 

status is not prohibited by: 

(A) A use license to the Government 

resulting from a rights determination 

under Executive Order 10096 made in 

accordance with § 501.6 of this title; 

(B) A use license to the Government 

resulting from Federal agency action 

pursuant to 15 U.S.C. 3710d(a) allowing 

the Federal employee-inventor to obtain 

or retain title to the invention; or 

(C) A use license to a Federal agency 

resulting from retention of rights under 

35 U.S.C. 202(d) by an inventor 

employed by a small business concern 

or nonprofit organization contractor, 

provided the license is equivalent to the 

license under 35 U.S.C. 202(c)(4) the 

Federal agency would have received 

had the contractor elected to retain title, 

and all the conditions applicable under 

§ 401.9 of this title to an employee/ 

inventor are met. 

(ii) For small business concerns and 

nonprofit organizations under 

paragraphs (a)(2) and (3) of this section, 

a use license to a Federal agency 

resulting from a funding agreement with 

that agency pursuant to 35 U.S.C. 

202(c)(4) does not preclude claiming 

small entity status, provided that: 

(A) The subject invention was made 

solely by employees of the small 

business concern or nonprofit 

organization; or 

(B) In the case of a Federal employee 

co-inventor, the Federal agency 

employing such co-inventor took action 

pursuant to 35 U.S.C. 202(e)(1) to 

exclusively license or assign whatever 

rights currently held or that it may 

acquire in the subject invention to the 

small business concern or nonprofit 

organization, subject to the license 

under 35 U.S.C. 202(c)(4). 

(iii) For small business concerns and 

nonprofit organizations under 

paragraphs (a)(2) and (3) of this section 

that have collaborated with a Federal 

agency laboratory pursuant to a 

cooperative research and development 

agreement (CRADA) under 15 U.S.C. 

3710a(a)(1), claiming small entity status 

is not prohibited by a use license to the 

Government pursuant to: 

(A) 15 U.S.C. 3710a(b)(2) that results 

from retaining title to an invention 

made solely by the employee of the 

small business concern or nonprofit 

organization; or 

(B) 15 U.S.C. 3710a(b)(3)(D), provided 

the laboratory has waived in whole any 

right of ownership the Government may 

have to the subject invention made by 

the small business concern or nonprofit 

organization, or has exclusively licensed 

whatever ownership rights the 

Government may acquire in the subject 

invention to the small business concern 

or nonprofit organization. 

(iv) Regardless of whether an 

exception under this paragraph (a)(4) 

applies, no refund under § 1.28(a) is 

available for any patent fee paid by the 

Government. 

* * * * * 

■ 3. Section 1.29 is amended by revising 

paragraphs (a)(1) and (d)(1) to read as 

follows: 

§ 1.29 Micro entity status. 

(a) * * * 

(1) The applicant qualifies as a small 

entity as defined in § 1.27 without 

relying on a government use license 

exception under § 1.27(a)(4); 

* * * * * 

(d) * * * 

(1) The applicant qualifies as a small 

entity as defined in § 1.27 without 

relying on a government use license 

exception under § 1.27(a)(4); and 

* * * * * 

Andrei Iancu, 

Under Secretary of Commerce for Intellectual 

Property and Director of the United States 

Patent and Trademark Office. 

[FR Doc. 2020–27049 Filed 12–18–20; 8:45 am] 

BILLING CODE 3510–16–P 

DEPARTMENT OF COMMERCE 

Patent and Trademark Office 

37 CFR Part 42 

[Docket No. PTO–P–2019–0011] 

RIN 0651–AD34 

Rules of Practice To Allocate the 

Burden of Persuasion on Motions To 

Amend in Trial Proceedings Before the 

Patent Trial and Appeal Board 

AGENCY: United States Patent and 

Trademark Office, Department of 

Commerce. 

ACTION: Final rule. 

SUMMARY: The United States Patent and 

Trademark Office (USPTO or Office) 

revises the rules of practice in inter 

partes review (IPR), post-grant review 

(PGR), and the transitional program for 

covered business method patents (CBM) 

(collectively post-grant trial) 

proceedings before the Patent Trial and 

Appeal Board (PTAB or Board) to 

allocate the burdens of persuasion in 

relation to motions to amend and the 

patentability of substitute claims 

proposed therein. In light of Federal 

Circuit case law, and to better ensure 

the predictability and certainty of postgrant trial proceedings before the Board, 

the Office revises the rules of practice 

governing motions to amend, to 

expressly assign to the petitioner the 

burden of showing the unpatentability 

of substitute claims proposed in a 

motion to amend. In addition, the Office 

revises the rules to expressly assign to 

the patent owner the burden of showing 

that a motion to amend complies with 

certain statutory and regulatory 

requirements for such a motion. 

Notwithstanding the adversarial nature 

82924 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Rules and Regulations 

1Under Section 18 of the AIA, the transitional 

program for post-grant review of covered business 

method patents sunset on September 16, 2020. AIA 

§ 18(a). Although the program has sunset, existing 

CBM proceedings, based on petitions filed before 

September 16, 2020, are still pending. For those 

pending CBM proceedings, the final rule applies to 

any motion to amend filed after the effective date. 

of the proceedings and the burdens 

described above, however, the Office 

further revises its rules to expressly 

provide that the Board itself may, in the 

interests of justice, exercise its 

discretion to grant or deny a motion to 

amend only for reasons supported by 

readily identifiable and persuasive 

evidence of record in the proceeding. 

The Office anticipates the Board will 

exercise its discretion in the interests of 

justice only in rare circumstances. In 

doing so, the 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. Where the 

Board exercises its discretion in such 

circumstances, the parties will have an 

opportunity to respond. 

DATES: 

Effective date: The changes in this 

final rule are effective January 20, 2021. 

Applicability date: This final rule 

applies to all motions to amend filed in 

an IPR, PGR, or CBM proceeding on or 

after January 20, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Christopher L. Crumbley, Lead 

Administrative Patent Judge, or Susan L. 

C. Mitchell, Lead Administrative Patent 

Judge, by telephone at 571–272–9797. 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

Purpose: This final rule amends the 

rules of practice for IPR, PGR, and CBM 

proceedings that implement provisions 

of the Leahy-Smith America Invents 

Act, Public Law 112–29, 125 Stat. 284 

(2011) (AIA) providing for post-grant 

trials before the Office.1

Pursuant to the AIA, during the 

course of an IPR, PGR, or CBM 

proceeding, a patent owner may file a 

motion to amend the patent by 

canceling any challenged patent claim 

or by proposing a reasonable number of 

substitute claims for each challenged 

claim. 35 U.S.C. 316(d)(1), 326(d)(1). 

Previously, relying on a general rule 

that a movant bears the burden of proof 

with respect to motions before the Board 

(37 CFR 42.20(c)), the Office placed the 

burden of showing the patentability of 

proposed substitute claims on the patent 

owner moving to amend a patent in a 

trial proceeding. On October 4, 2017, 

the United States Court of Appeals for 

the Federal Circuit issued an en banc 

decision in Aqua Prods., Inc. v. Matal, 

872 F.3d 1290 (Fed. Cir. 2017) (en banc) 

(Aqua Products), in which a majority of 

the judges concluded that the Office had 

not adopted a rule allocating the burden 

of persuasion with respect to the 

patentability of proposed substitute 

claims and that, in the absence of any 

rulemaking, the burden of proving the 

unpatentability of the proposed 

substitute claims could not be placed on 

the patent owner. 

In light of Aqua Products, as well as 

public comments provided in response 

to a request for comments (see 83 FR 

54319), the Office issued a notice of 

proposed rulemaking, which proposed 

specific rules allocating the burdens of 

persuasion in relation to motions to 

amend (see 84 FR 56401). The proposed 

rule, as modified herein, is now made 

final. 

The final rule assigns the burden of 

persuasion to the patent owner to show, 

by a preponderance of the evidence, that 

a motion to amend complies with 

certain statutory and regulatory 

requirements for a motion to amend 

(i.e., 35 U.S.C. 316(d) or 326(d); 37 CFR 

42.121(a)(2), (a)(3), (b)(1), (b)(2), or 

42.221(a)(2), (a)(3), (b)(1), (b)(2)). The 

final rule also assigns the burden of 

persuasion to the petitioner to show, by 

a preponderance of the evidence, that 

any proposed substitute claims are 

unpatentable. The final rule further 

specifies, however, irrespective of those 

burdens and the adversarial nature of 

the proceeding, that the Board may, in 

the interests of justice, exercise its 

discretion to grant or deny a motion to 

amend, but only for reasons supported 

by readily identifiable and persuasive 

evidence of record in the proceeding. In 

doing so, the 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. Where the 

Board exercises its discretion in such 

circumstances, the parties will have an 

opportunity to respond. 

The Office anticipates that the Board 

will exercise its discretion in the 

context of motions to amend only in 

rare circumstances. Specifically, the 

‘‘interests of justice’’ in the final rule 

means that the Board will apply the 

same standards articulated in Hunting 

Titan, Inc. v. DynaEnergetics Europe 

GmbH, IPR2018–00600 (PTAB July 6, 

2020) (Paper 67) (Hunting Titan). Thus, 

the phrase ‘‘in the interests of justice’’ 

in the final rule refers to situations in 

which the adversarial process fails to 

provide the Board with potential 

arguments relevant to granting or 

denying a motion to amend. Id. at 12– 

13, 25–26. 

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. Id. Similarly, such 

situations may also include those in 

which a patent owner does not 

expressly address or establish every 

statutory and regulatory requirement for 

a motion to amend in its briefing, but 

evidence of compliance with those 

requirements 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. 

Thus, the final rule clarifies the rules 

of practice for amending claims in an 

IPR, PGR, or CBM and is consistent with 

Aqua Products and also with current 

Board practice as described in the 

precedential Board decisions in Hunting 

Titan and Lectrosonics, Inc. v. Zaxcom, 

Inc., IPR2018–01129 (PTAB Feb. 25, 

2019) (Paper 15) (Lectrosonics). In 

response to comments seeking 

clarification, the final rule also provides 

additional details to the scope of 

‘‘readily identifiable and persuasive 

evidence of record’’ to include only 

evidence that the Board may make of 

record, namely, evidence in a related 

proceeding before the Office (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), or evidence 

that a district court can judicially notice 

under Federal Rule of Evidence 201. 

The final rule further expressly states 

that in instances where the Board 

exercises its discretion in the interests 

of justice, the Board will provide the 

parties an opportunity to respond before 

rendering a final decision on the motion 

to amend. As such, the final rule does 

not reflect a change from current 

practice. 

Costs and Benefits: This rulemaking is 

not economically significant under 

Executive Order 12866 (Sept. 30, 1993). 

Background 

On September 16, 2011, the AIA was 

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

Stat. 284 (2011)), and within one year, 

the Office implemented rules to govern 

Office practice for AIA trials, including 

IPR, PGR, CBM, and derivation 

Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Rules and Regulations 82925 

proceedings pursuant to 35 U.S.C. 135, 

316, and 326 and AIA sec. 18(d)(2). See 

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 

(Aug. 14, 2012); Changes to Implement 

Inter Partes Review Proceedings, PostGrant Review Proceedings, and 

Transitional Program for Covered 

Business Method Patents, 77 FR 48680 

(Aug. 14, 2012); Transitional Program 

for Covered Business Method Patents— 

Definitions of Covered Business Method 

Patent and Technological Invention, 77 

FR 48734 (Aug. 14, 2012). Additionally, 

the Office published a Trial Practice 

Guide 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 Office Patent Trial 

Practice Guide, 77 FR 48756 (Aug. 14, 

2012); see also Office Patent Trial 

Practice Guide, August 2018 Update, 83 

FR 39989 (Aug. 13, 2018); Office Patent 

Trial Practice Guide, July 2019 Update, 

84 FR 33925 (July 16, 2019); 

Consolidated Trial Practice Guide, 84 

FR 64280 (Nov. 21, 2019). 

In prescribing these regulations, the 

Office considered ‘‘the effect of any 

such regulation on the economy, the 

integrity of the patent system, the 

efficient administration of the Office, 

and the ability of the Office to timely 

complete proceedings instituted’’ as 

required by statute. 35 U.S.C. 316(b), 

326(b). The Office also considered the 

public comments carefully and 

responded to the comments in these 

final rules. Among the final rules, the 

Office promulgated § 42.20(c), which 

states that a ‘‘moving party has the 

burden of proof to establish that it is 

entitled to the requested relief.’’ 37 CFR 

42.20(c). 

Previously, the Board interpreted the 

burden of proof requirement of 

§ 42.20(c) to apply to motions to amend 

filed pursuant to 35 U.S.C. 316 and 326, 

including the requirement to show that 

the proposed substitute claims were 

patentable over the prior art of record. 

MasterImage 3D, Inc. v. RealD Inc., 

IPR2015–00040 (PTAB July 15, 2015) 

(Paper 42) (MasterImage). Under 

MasterImage, which was subsequently 

made precedential, the patent owner in 

a proceeding, as the moving party in a 

motion to amend, bore the burden of 

showing that the proposed substitute 

claims were patentable. Id. 

On October 4, 2017, the Federal 

Circuit issued its en banc decision in 

Aqua Products, addressing the burden 

of persuasion regarding the patentability 

of substitute claims presented in a 

motion to amend. The lead opinion of 

the decision explains that, in the 

absence of rulemaking, the USPTO may 

not place the burden of persuasion on 

the patent owner to show that proposed 

substitute claims are patentable. 

The only legal conclusions that support 

and define the judgment of the court are: (1) 

The PTO has not adopted a rule placing the 

burden of persuasion with respect to the 

patentability of amended claims on the 

patent owner that is entitled to deference; 

and (2) in the absence of anything that might 

be entitled deference, the PTO may not place 

that burden on the patentee. 

872 F.3d at 1327 (O’Malley, J.). 

A separate opinion joined-in-part by a 

majority of the en banc court observed 

that ‘‘it is well settled that regardless of 

which party bears the ultimate burden 

of persuasion, the movant bears a 

burden of production’’ and that ‘‘the 

Patent Office has adopted regulations 

that address what a patent owner must 

submit in moving to amend the patent.’’ 

Id. at 1340–41 (Reyna, J., concurring in 

part) (citing 37 CFR 42.20(a), 42.22(a), 

42.121(a)(2)(i)). The opinion explains 

that these regulations require a patent 

owner to ‘‘assist[ ] the Board to perform 

its statutory obligation to ‘issue a final 

written decision with respect to the 

patentability of . . . any new claim 

added under section 316(d).’ ’’ Id. at 

1341 (omission in original) (quoting 35 

U.S.C. 318(a)). 

In view of the Federal Circuit’s 

decision in Aqua Products, on 

November 21, 2017, the Office issued 

formal guidance through a 

memorandum from the Chief 

Administrative Patent Judge, explaining 

that, in light of the Aqua Products 

decision, the Board would no longer 

place the burden of persuasion on a 

patent owner with respect to the 

patentability of any proposed substitute 

claims presented in a motion to amend. 

See Guidance on Motions to Amend in 

view of Aqua Products, https://

go.usa.gov/xQGAA (Guidance Memo). 

The Guidance Memo also notes that a 

motion to amend must continue to 

satisfy the requirements of 37 CFR 

42.121 or 42.221 (e.g., provide a 

reasonable number of substitute claims 

and written description support in 

relation to each substitute claim), as 

applicable, that all parties continue to 

have a duty of candor under 37 CFR 

42.11, and that the page limits, type, 

and timing of briefs remain unchanged. 

Id. 

On December 22, 2017, the Federal 

Circuit issued a related decision in 

Bosch Auto. Serv. Solutions, LLC v. 

Matal, 878 F.3d 1027 (Fed. Cir. 2017) 

(Bosch). In that decision, because the 

petitioner had settled with the patent 

owner who had proposed substitute 

claims, the Federal Circuit remanded 

the case to the Board to evaluate the 

patentability of the proposed substitute 

claims. Id. (‘‘[W]here the challenger 

ceases to participate in the IPR and the 

Board proceeds to final judgment, it is 

the Board that must justify any finding 

of unpatentability by reference to the 

evidence of record in the IPR.’’) 

(emphasis in original) (quoting Aqua 

Products, 872 F.3d at 1311 (O’Malley, 

J.)). 

In view of the decisions by the 

Federal Circuit regarding motion to 

amend practice and procedure in AIA 

trials, the Board de-designated as 

precedential MasterImage, as well as dedesignated as informative a prior 

decision of the Board in Idle Free Sys., 

Inc. v. Bergstrom, Inc., IPR2012–00027 

(PTAB June 11, 2013) (Paper 26), 

decisions in which the Board panels 

stated that ‘‘[t]he burden is not on the 

petitioner to show unpatentability, but 

on the patent owner to show patentable 

distinction over the prior art of record 

and also prior art known to the patent 

owner.’’ Id. at 7; see also MasterImage, 

Paper 42 at 2 (quoting Idle Free). 

Concurrently, the Board designated an 

order issued in Western Digital Corp. v. 

SPEX Techs., Inc., IPR2018–00082, 

–00084 (PTAB Apr. 25, 2018) (Paper 13) 

(Western Digital) as informative to 

provide an example of how panels can 

handle several aspects of the motion to 

amend practice under the Aqua 

Products and Bosch precedent. With 

respect to the burden of persuasion, the 

Western Digital order explained that 

under the current state of the law, ‘‘the 

burden of persuasion will ordinarily lie 

with the petitioner to show that any 

proposed substitute claims are 

unpatentable’’ and that the ‘‘Board itself 

may justify any finding of 

unpatentability by reference to evidence 

of record in the proceeding.’’ Id. at 4. 

On March 7, 2018, the Board 

designated as precedential an order in 

Lectrosonics and de-designated Western 

Digital. The Lectrosonics order provides 

guidance regarding statutory and 

regulatory requirements for a motion to 

amend in light of Federal Circuit case 

law. For example, the Lectrosonics order 

notes that prior to considering the 

patentability of any substitute claims, 

the Board must first determine whether 

the patent owner has met the statutory 

and regulatory requirements set forth in 

35 U.S.C. 316(d) and 37 CFR 42.121, 

such as the requirements that the 

motion proposes a reasonable number of 

substitute claims and that the 

amendments do not broaden the scope 

of the claims. Lectrosonics, Paper 15 at 

4–5. The Lectrosonics order also sets out 

that ‘‘the burden of persuasion 

82926 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Rules and Regulations 

2The October 2018 Request for Comments was 

published before Western Digital was superseded by 

Lectrosonics and thus referred only to the Western 

Digital order. Both orders are identical in their 

discussion of the burden of persuasion. Therefore, 

Questions 15 and 16 of the Request for Comments, 

and the public comments provided thereto, were 

equally pertinent to the current Board precedent of 

Lectrosonics. 

3The October 2018 Request for Comments also 

sought comments on a proposed amendment 

procedure in post-grant trial proceedings that 

included the Board providing preliminary nonbinding guidance on the merits of a motion to 

amend, and an opportunity for a patent owner to 

revise its motion to amend thereafter. The Office 

addressed that portion of the Request for Comments 

separately in a 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 (Mar. 15, 2019). 

4 In response to the October 2018 Request for 

Comments, the Office also received comments and 

questions relating to reissue or reexamination as an 

alternative vehicle for claim amendments. The 

Office addressed those comments and questions 

separately in a Notice Regarding Options for 

Amendments by Patent Owner Through Reissue or 

Reexamination During a Pending AIA Trial 

Proceeding. 84 FR 16654 (Apr. 22, 2019). 

ordinarily will lie with the petitioner to 

show that any proposed substitute 

claims are unpatentable by a 

preponderance of the evidence.’’ Id. at 

4. 

On October 29, 2018, the Office 

published a 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 in the 

Federal Register (Request for 

Comments), seeking public comment on 

various aspects of the Board’s 

amendment practice. 83 FR 54319. 

Among the questions on which the 

Board sought public input were the 

following, directed to the allocation of 

the burden of persuasion: 

15. Should the Office engage in rulemaking 

to allocate the burden of persuasion 

regarding the patentability of proposed 

substitute claims in a motion to amend as set 

forth in the Western Digital order? What are 

the advantages or disadvantages of doing so? 

16. If the Office continues to allocate the 

burden as set forth in the Western Digital 

order, under what circumstances should the 

Board itself be able to justify findings of 

unpatentability? Only if the petitioner 

withdraws from the proceeding? Or are there 

situations where the Board itself should be 

able to justify findings of unpatentability 

when the petitioner remains in the 

proceeding? What are the advantages or 

disadvantages? 

Id. at 54325.2

In response to the October 2018 

Request for Comments, the Office 

received 49 comments as of December 

21, 2018 (the closing date for 

comments), from intellectual property 

organizations, trade organizations, other 

organizations, and individuals. See 

https://go.usa.gov/xyeFy (collected 

responses to Request for Comments).3 4

Approximately 25 of the commenters 

provided specific responses to 

Questions 15 and 16 of the Request for 

Comments. In response to Question 15, 

the majority of commenters were in 

favor of the Office engaging in 

rulemaking to allocate the burden of 

persuasion as set forth in Western 

Digital (as discussed in more detail 

below). Only three commenters believed 

rulemaking was unnecessary (either 

because the Board could simply 

continue to apply its own precedent or 

because the statute already allocates the 

burden of persuasion). A minority of 

commenters stated that the Office 

should engage in rulemaking but that 

the burden of persuasion should be 

placed on the patent owner. 

Additionally, in response to Question 

15, some commenters suggested that 

even if the Office promulgates rules to 

place the burden of persuasion on the 

petitioner on the issue of patentability 

of the proposed substitute claims, the 

patent owner continues to bear the 

burden to show that the motion to 

amend complies with the statutory 

requirements of 35 U.S.C. 316(d) or 

326(d) (for example, that the 

amendment may not enlarge the scope 

of the claims), as well as the regulatory 

requirements of 37 CFR 42.121 or 

42.221 (for example, that the motion set 

forth the support for the amendment in 

the original disclosure of the patent). 

In response to Question 16, the 

majority of responsive comments stated 

that the Board should be able to justify 

findings of unpatentability in any 

circumstance, for example, even when 

the petitioner remains in the 

proceeding. Two commenters 

responded that the Board should never 

be able to assume the burden of 

persuasion on unpatentability itself, and 

three commenters believed that the 

Board should be permitted to justify 

findings of unpatentability of proposed 

substitute claims itself only in certain 

circumstances, for example, when a 

petitioner ceases to participate in a 

proceeding. 

In light of the generally positive 

support for rulemaking to allocate the 

burden of persuasion as set forth in the 

Western Digital order (and subsequently 

made precedential in Lectrosonics), and 

in the interest of providing greater 

clarity, certainty, and predictability to 

parties participating in AIA trial 

proceedings before the Board, the Office 

issued a proposed rule allocating the 

burden of persuasion. 

In the notice of proposed rulemaking 

issued on October 22, 2019, the Office 

sought comments on a specific proposed 

rule clarifying the burdens of persuasion 

in relation to motions to amend. 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. The 

proposed rule allocated the burdens of 

persuasion regarding the patentability of 

proposed substitute claims as set forth 

in Lectrosonics and Western Digital. The 

proposed rule also stated that, 

irrespective of the burdens of 

persuasion, the Board may, in the 

interests of justice, exercise its 

discretion to grant or deny a motion to 

amend for any reason supported by the 

evidence of record. The Office invited 

the public to provide comments by 

December 23, 2019. As discussed in 

more detail below, the Office received a 

total of 18 comments in response. See 

https://go.usa.gov/xGXCN (collected 

responses to notice of proposed 

rulemaking). 

On April 9, 2020, the Federal Circuit 

issued its opinion in Nike, Inc. v. 

Adidas AG, 955 F.3d 45 (Fed. Cir. 2020) 

(Nike). In that case, the Federal Circuit 

concluded that ‘‘the Board should not 

be constrained to arguments and 

theories raised by the petitioner in its 

petition or opposition to the motion to 

amend. . . . Otherwise, were a 

petitioner not to oppose a motion to 

amend, the Patent Office would be left 

with no ability to examine the new 

claims.’’ Id. at 51. As such, the Federal 

Circuit held that ‘‘the Board may sua 

sponte identify a patentability issue for 

a proposed substitute claim based on 

the prior art of record.’’ Id. 

Also, on July 6, 2020, the Board’s 

Precedential Opinion Panel (POP) 

issued a precedential decision in 

Hunting Titan. This decision addressed 

two questions: (1) Under what 

circumstances and at what time during 

an IPR may the Board raise a ground of 

unpatentability that a petitioner did not 

advance or insufficiently developed 

against substitute claims proposed in a 

motion to amend; and (2) whether the 

Board must provide the parties notice 

and an opportunity to respond to a 

ground of unpatentability it raises 

before making a final determination. 

Hunting Titan, Paper 67 at 3. In Hunting 

Titan, the POP determined that the 

Board may, in certain rare 

circumstances, raise a ground of 

unpatentability that a petitioner did not 

advance, or insufficiently developed, 

against substitute claims proposed in a 

motion to amend. Id. at 4. Those 

circumstances are typically limited to 

situations in which the adversarial 

Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Rules and Regulations 82927 

process fails to provide the Board with 

potential patentability arguments with 

respect to the proposed substitute 

claims. Id. at 25. 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 of unpatentability is 

not raised by the petitioner 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. 

Id. at 12–13, 25–26. 

The POP also determined that due 

process requires that a patent owner 

receive notice of how the prior art 

allegedly discloses the newly-added 

limitations of each proposed substitute 

claim, as well as any theory of 

unpatentability asserted against those 

claims, and the patent owner must have 

the opportunity to respond to those 

factual allegations and legal theories. Id. 

at 15. In addition, the POP cited two 

examples of adequate notice and 

opportunity to respond, namely, 

requesting supplemental briefing from 

the parties regarding the proposed 

ground for unpatentability or requesting 

that the parties be prepared to discuss 

the prior art in connection with the 

substitute claims at an oral hearing. Id. 

at 15–16 (citing Nike, 955 F.3d at 54). 

The final rule adopts, with 

modifications, the proposed rule 

allocating the burden of persuasion on 

motions to amend. The final rule 

specifies that the burden of persuasion 

as to patentability of substitute claims 

proposed in a motion to amend is on the 

petitioner. In addition, the final rule 

specifies that the burden of persuasion 

is on the patent owner to show that the 

motion complies with the requirements 

of 35 U.S.C. 316(d) or 326(d) (requiring 

that a motion to amend propose a 

reasonable number of substitute claims, 

and that substitute claims do not enlarge 

scope of the original claims of the patent 

or introduce new matter), as well as 37 

CFR 42.121(a)(2), (a)(3), (b)(1), and 

(b)(2), or 42.221(a)(2), (a)(3), (b)(1), and 

(b)(2) (indicating, for example, that a 

motion to amend must set forth written 

description support and support for the 

benefit of a filing date in relation to each 

substitute claim, and respond to 

grounds of unpatentability involved in 

the trial). 

Notwithstanding the adversarial 

nature of the proceedings and 

irrespective of the burdens of 

persuasion discussed above, the Board 

may, in the interests of justice, exercise 

its discretion to grant or deny a motion 

to amend. But the Board will do so only 

in rare circumstances (as described 

below) and only for reasons supported 

by readily identifiable and persuasive 

evidence of record. Thus, in instances 

where a party has not met its burden in 

relation to a motion to amend or any 

substitute claims proposed therein, the 

Board may, in the interests of justice, 

reach a determination regarding 

patentability, or compliance with 

statutory and regulatory requirements, 

supported by readily identifiable and 

persuasive evidence made of record in 

the proceeding. In such 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 motion to amend. 

In the vast majority of cases, the 

Board will consider only evidence a 

party introduces into the record of the 

proceeding. However, the Board may 

also consider 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). See 

MaxLinear, Inc. v. CF CRESPE LLC, 880 

F.3d 1373 (Fed. Cir. 2018) (stating that 

the Board must consider prior art raised 

in a related IPR in determining the 

patentability of dependent claims); see 

also Emerson Elec. Co. v. SIPCO, LLC, 

745 F. App’x 369, 373–374 (Fed. Cir. 

2018) (non-precedential) (directing the 

Board to explain its application of prior 

art cited in a related IPR). Likewise, the 

Board may consider evidence that a 

district court can judicially notice under 

Federal Rule of Evidence 201. See 37 

CFR 42.62 (making the Federal Rules of 

Evidence applicable to AIA trial 

proceedings and noting that ‘‘judicial 

notice’’ as used in the Federal Rules of 

Evidence shall be construed as ‘‘official 

notice’’). This approach is consistent 

with the current practice of the Board, 

under which the Board may take official 

notice of facts in appropriate 

circumstances. See, e.g., RPX Corp. v. 

Iridescent Networks, Inc., IPR2018– 

00254 (PTAB Dec. 10, 2018) (Paper 20) 

(taking official notice of how the URL of 

the internet Archive provides the date 

the website was captured); Ericsson Inc. 

v. Intellectual Ventures I LLC, IPR2014– 

00527, (PTAB May 18, 2015) (Paper 41) 

(taking official notice that members in 

the scientific and technical 

communities who both publish and 

engage in research rely on the 

information published on the copyright 

line of IEEE publications). 

As used in the final rule, the 

‘‘interests of justice’’ in the final rule 

means that, irrespective of the burdens 

of persuasion on the parties, the Board 

may exercise its discretion in rare 

circumstances where the adversarial 

process fails to provide the Board with 

potential arguments relevant to granting 

or denying a motion to amend. Hunting 

Titan, Paper 67 at 12–13, 25–26. 

Such circumstances may include 

those in which a patent owner does not 

expressly address or establish every 

statutory and regulatory requirement for 

a motion to amend in its briefing, but 

evidence of compliance with those 

requirements is so readily identifiable 

and persuasive that the Board should 

address that evidence in the interest of 

supporting the integrity of the patent 

system, notwithstanding the adversarial 

nature of the proceedings. Thus, for 

example, the Board may, in the interests 

of justice, exercise its discretion to 

determine that a motion to amend 

complies with the statutory and 

regulatory requirements of 35 U.S.C. 

316(d) or 326(d) and 37 CFR 

42.121(a)(2), (a)(3), (b)(1), and (b)(2), or 

42.221(a)(2), (a)(3), (b)(1), and (b)(2), 

even if a patent owner does not 

expressly address every requirement in 

its briefing. The Board will do so only 

when there is readily identifiable and 

persuasive evidence that the motion 

complies with the statutory and 

regulatory requirements, when 

addressing that evidence would be in 

the interests of supporting the integrity 

of the patent system, and only when the 

petitioner has been afforded the 

opportunity to respond to that evidence. 

Such circumstances also may include 

those in which a petitioner has ceased 

to participate in the proceeding 

altogether (for example, as a result of 

settlement); those in which the 

petitioner remains in the proceeding but 

does not oppose the motion to amend, 

in whole or in part (for example, does 

not oppose some proposed substitute 

claims); or those in which the petitioner 

previously made an argument (for 

example, in opposition to a motion to 

amend) but then later ceases to 

participate (for example, does not 

oppose a revised motion to amend). The 

interests of justice may also support the 

Board exercising its discretion in the 

rare circumstances in which the 

petitioner continues participating in the 

proceeding, but fails to raise certain 

evidence of unpatentability that 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. In 

most instances, in cases where the 

petitioner has participated fully and 

opposed the motion to amend, the 

82928 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Rules and Regulations 

Office expects that there will be no need 

for the Board to independently justify a 

determination of unpatentability. 

In sum, the Office expects that the 

Board will exercise its discretion in the 

interests of justice to reach a 

determination of patentability or 

unpatentability only in rare 

circumstances and only when the 

parties have been afforded notice and 

the opportunity to respond. 

Discussion of Specific Rules 

37 CFR part 42 is amended as follows: 

Section 42.121: § 42.121 is amended 

by adding a new paragraph (d) to state 

that a patent owner bears the burden of 

persuasion to show that a motion to 

amend complies with certain statutory 

and regulatory requirements, but that 

the petitioner bears the burden of 

persuasion to show that any proposed 

substitute claims are unpatentable. The 

new paragraph (d) also states that in 

cases in which a party does not meet its 

burden, the Board may, in the interests 

of justice, exercise its discretion to grant 

or deny a motion to amend only for 

reasons supported by readily 

identifiable and persuasive evidence of 

record. In doing so, the 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. Where the Board exercises its 

discretion under this paragraph, the 

parties will have an opportunity to 

respond. 

Section 42.221: § 42.221 is amended 

by adding a new paragraph (d) to state 

that a patent owner bears the burden of 

persuasion to show that a motion to 

amend complies with certain statutory 

and regulatory requirements, but that 

the petitioner bears the burden of 

persuasion to show that any proposed 

substitute claims are unpatentable. The 

new paragraph (d) also states that in 

cases in which a party does not meet its 

burden, the Board may, in the interests 

of justice, exercise its discretion to grant 

or deny a motion to amend only for 

reasons supported by readily 

identifiable and persuasive evidence of 

record. In doing so, the 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. Where the Board exercises its 

discretion under this paragraph, the 

parties will have an opportunity to 

respond. 

Differences Between the Final Rule and 

the Proposed Rule 

In response to comments seeking 

clarification, the final rule seeks to 

further clarify the circumstances in 

which the Board may exercise its 

discretion to grant or deny a motion to 

amend, irrespective of whether a party 

has met its burden on a particular issue 

and notwithstanding the adversarial 

nature of the proceeding. The final rule 

clarifies that the Board may exercise this 

discretion when it is in the interests of 

justice, and only for reasons supported 

by readily identifiable and persuasive 

evidence of record. 

Additionally, in response to 

comments seeking clarification, the final 

rule provides additional details 

regarding the scope of evidence the 

Board may consider in deciding a 

motion to amend. The 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. 

Lastly, the final rule clarifies that 

where the Board exercises its discretion 

in appropriate circumstances, the 

parties will have an opportunity to 

respond. (§§ 42.121(d) and 42.221(d)). 

Response to Comments 

In response to the notice of proposed 

rulemaking pertaining to the burdens of 

persuasion in relation to motions to 

amend, the Office received a total of 18 

written submissions of comments from 

intellectual property organizations, 

businesses, patent practitioners, and 

others. The comments provided support 

for, opposition to, and diverse 

recommendations on the proposed rule. 

The large majority of the comments 

were supportive of placing the burden 

of showing compliance with the 

statutory and regulatory requirements of 

a motion to amend on the patent owner, 

along the lines presented in the 

proposed rule. Comments on the 

question of whether the burden of 

showing unpatentability should be 

placed on the petitioner, as in the 

proposed rule, were mixed in their 

support and opposition. Similarly, the 

Office received mixed comments in 

support and opposition to the question 

of whether the Board, regardless of the 

respective burdens on the parties, could 

exercise its discretion to grant or deny 

a motion to amend. The Office 

appreciates the thoughtful comments 

and has considered and analyzed them 

thoroughly. 

All the comments are posted on the 

PTAB website at https://go.usa.gov/ 

xGXrx. The Office’s responses address 

the comments that are directed to the 

proposed changes set forth in the notice 

of proposed rulemaking. Any comments 

directed to topics beyond the scope of 

the notice of proposed rulemaking will 

not be addressed at this time. 

A. Burden on the Patent Owner 

Comment 1: Of the comments 

addressing this aspect of the proposed 

rule, almost all supported allocating the 

burden of persuasion to the patent 

owner to show a motion to amend 

complies with statutory and regulatory 

requirements. Comments noted that the 

patent owner, as the party drafting the 

proposed substitute claims, is in the 

best position to explain how the 

proposed substitute claims comply with 

the statutory and regulatory 

requirements. For example, the 

comments pointed out that because the 

patent owner is the party amending a 

claim, the patent owner is in the best 

position to identify the subject matter 

disclosed in the challenged patent’s 

specification that is being incorporated 

into the proposed substitute claim, 

thereby addressing the prohibition on 

new matter. 

Response 1: The Office agrees with 

these comments. The statutory 

requirements of 35 U.S.C. 316(d) specify 

that the patent owner may file a motion 

to amend that ‘‘propose[s] a reasonable 

number of substitute claims’’ and, 

further, that amendments ‘‘may not 

enlarge the scope of the claims or 

introduce new matter.’’ Thus, the statute 

already places the burden on the patent 

owner to show that its motion to amend 

meets those requirements. The 

regulatory requirements set forth in 

section 42.121(a) or 42.221(a) of 37 CFR 

part 42 reflect those statutory 

requirements and further specify that a 

motion to amend must respond to a 

ground of unpatentability involved in 

the trial, include a claim listing clearly 

showing the amendments, and set forth 

support in the original patent disclosure 

for each claim added or amended, as 

well as support in an earlier-filed 

disclosure for each claim for which the 

patent owner seeks the benefit of the 

filing date of the earlier-filed disclosure. 

Because the patent owner is the party 

proposing amendments to the claims of 

its patent, it follows that the patent 

owner should be the party with the 

burden to show that the motion 

complies with these statutory and 

regulatory requirements. As commenters 

have noted, the patent owner 

necessarily incorporates subject matter 

from the challenged patent’s 

specification into one or more proposed 

substitute claims and, thus, the patent 

owner is in the best position to identify 

where the specification supports such 

subject matter and how such subject 

matter does not enlarge the scope of the 

claims. Similarly, because the patent 

Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Rules and Regulations 82929 

owner is the party proposing the 

substitute claims, the patent owner is in 

a better position to explain why the 

number of substitute claims is 

reasonable, especially when the patent 

owner proposes more than one 

substitute claim for each challenged 

claim. Likewise, it makes sense for the 

patent owner to explain why the 

amendment responds to a ground of 

unpatentability involved in the trial, 

given that the patent owner proposes 

the substitute claims to overcome one or 

more asserted unpatentability grounds 

as to the original claims of the 

challenged patent. 

Comment 2: A few comments 

supporting the requirement that the 

patent owner bears the burden to show 

a motion to amend complies with 

statutory and regulatory requirements 

expressed the view that the burden 

should be an initial burden of 

production, but that the burden of 

persuasion should lie with the 

petitioner. One comment stated that 

placing a burden of persuasion on the 

patent owner unduly limits the patent 

owner’s ability to amend the claims. 

Another comment stated that allocating 

a burden of persuasion to the patent 

owner in a motion to amend is 

inconsistent with the Federal Circuit’s 

guidance in In re Magnum Oil Tools 

Int’l, Ltd., 829 F.3d 1364 (Fed. Cir. 2016) 

on shifting burdens in an AIA trial 

proceeding. The comment was further 

concerned that requiring the patent 

owner to maintain a burden of 

persuasion to show statutory and 

regulatory compliance may lead the 

Board to deny a motion to amend for 

procedural reasons unrelated to the 

substance of the proposed substitute 

claims. 

Response 2: The Office appreciates 

these thoughtful comments. 35 U.S.C. 

316(d) appears to specify a burden of 

persuasion on the patent owner, not 

merely a burden of production. For 

example, section 316(d) provides that 

the patent owner may ‘‘[f]or each 

challenged claim, propose a reasonable 

number of substitute claims’’ and that 

‘‘[a]n amendment . . . may not enlarge 

the scope of the claims or introduce new 

matter.’’ 35 U.S.C. 316(d)(1)(B), (d)(3). 

The patent owner proposes an 

amendment; therefore, it would appear 

to be the patent owner’s burden of 

persuasion to show that the amendment 

proposes a reasonable number of 

substitute claims, does not enlarge the 

scope of the claims, and does not 

introduce new matter. This is also 

consistent with the lead opinion of 

Aqua Products, which states that the 

‘‘patent owner must satisfy the Board 

that the statutory criteria in 

§ 316(d)(1)(a)–(b) and § 316(d)(3) are met 

and that any reasonable procedural 

obligations imposed by the Director are 

satisfied before the amendment is 

entered into the IPR.’’ 872 F.3d at 1306 

(emphasis added). Because the statutory 

and regulatory requirements largely 

overlap, it also makes sense to place the 

burden of showing compliance with the 

regulatory requirements on the patent 

owner. It is unclear how placing this 

burden on the patent owner limits the 

patent owner’s ability to amend claims. 

Further, allocating this burden of 

persuasion to the patent owner is not 

inconsistent with Magnum Oil Tools 

because, in that case, the Federal Circuit 

addressed the burden of persuasion as 

to patentability, not the burden of 

persuasion as to statutory and regulatory 

requirements of a motion to amend. As 

noted above, the lead opinion in Aqua 

Products differentiated between meeting 

the requirements of a motion to amend 

and the burden of demonstrating the 

unpatentability of substitute claims. Id. 

Magnum Oil Tools addressed situations 

in which it was and was not appropriate 

to shift burdens of production. See 829 

F.3d at 1375–76. The Federal Circuit 

explained that a shifting burden of 

production may be warranted in a 

situation in which a party asserts an 

affirmative defense for the first time 

(e.g., an earlier priority date) after the 

party who carries the ultimate burden of 

persuasion challenges patentability. As 

further noted in Magnum Oil Tools, 

however, ‘‘a burden-shifting framework 

. . . would introduce unnecessary 

confusion’’ when a party bears the 

ultimate burden of persuasion on a 

particular issue. Id. at 1376. Here, 

because the statute already appears to 

place the ultimate burden of persuasion 

on the patent owner regarding the 

statutory and regulatory requirements, 

and the Board makes a determination 

after considering all evidence provided 

by both parties, a shifting burden of 

production is not appropriate. Id. 

(‘‘Applying a burden-shifting framework 

here would introduce unnecessary 

confusion because the ultimate burden 

of persuasion of obviousness must 

remain on the patent challenger and ‘a 

fact finder must consider all evidence of 

obviousness and nonobviousness before 

reaching a determination.’ ’’) (citation 

omitted). 

Finally, in March 2019, the Office 

issued a notice of a pilot program for 

motion to amend practice and 

procedures that allows a patent owner 

to request preliminary guidance from 

the Board on a motion to amend and to 

file a revised motion to amend 

(regardless of whether the patent owner 

requests preliminary guidance). 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 (Mar. 15, 2019) (pilot program). 

Under the pilot program, which applies 

to all AIA trial proceedings instituted on 

or after March 15, 2019, the patent 

owner is able to request preliminary 

non-binding guidance from the Board 

regarding the amendment’s compliance 

with the statutory and regulatory 

requirements. See id. at 9497–98. The 

patent owner may address that 

preliminary guidance in responsive 

briefing or by providing new proposed 

substitute claims in a revised motion to 

amend. Id.; see also id. at 9499–9500 

(setting forth options for preliminary 

guidance and a revised motion to amend 

in more detail). These aspects of the 

pilot program likewise support placing 

the burden of persuasion on the patent 

owner in relation to the statutory and 

regulatory requirements for a motion to 

amend. 

Comment 3: A comment noted that 

previous Office guidance and Board 

decisions did not allocate the burden of 

persuasion to the patent owner and 

requested an explanation as to why the 

proposed rule allocates the burden of 

persuasion to the patent owner. 

Response 3: As many commenters 

have requested and noted, clarifying the 

burdens in the amendment process is 

desired. Because 35 U.S.C. 316(d) 

appears to place the burden of 

persuasion on the patent owner to show 

statutory compliance, the Office takes 

this opportunity to bring clarity and 

predictability to the amendment process 

through rulemaking specifically 

assigning that burden. 

B. Burden on the Petitioner 

Comment 4: The Office received a mix 

of comments supporting or opposing the 

provision of the proposed rule placing 

the burden of persuasion on the 

petitioner to show that the substitute 

claims proposed in a motion to amend 

are unpatentable, with a slight majority 

of comments opposing placing the 

burden on the petitioner. Among the 

comments supporting the proposed rule, 

one noted that placing the burden of 

persuasion on the petitioner is 

consistent with 35 U.S.C. 282(a), which 

governs burdens of proof in patent 

infringement actions in federal court 

and states that ‘‘[t]he burden of 

establishing invalidity of a patent or any 

claim thereof shall rest on the party 

asserting such invalidity.’’ Another 

comment stated that allocating the 

burden of persuasion to the petitioner is 

consistent with the Federal Circuit 

82930 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Rules and Regulations 

holding in Aqua Products. One 

comment, which neither agreed nor 

disagreed with the proposed rule, noted 

that the proposed rule is generally 

consistent with the allocation of 

burdens set forth in Lectrosonics and the 

Office’s prior ‘‘Guidance on Motions to 

Amend in view of Aqua Products.’’ 

Response 4: The Office appreciates 

and has carefully considered the 

comments both supporting and 

opposing placing the burden on the 

petitioner to show that the proposed 

substitute claims are unpatentable. 

Regardless of whether the comments 

supported the proposed rule or not, 

commenters overwhelmingly agreed 

that notice-and-comment rulemaking to 

allocate the burdens was appreciated 

and that doing so improves clarity and 

consistency in AIA trials. Previously, 

the Office requested comments relating 

to the assignment of burdens in the 

October 29, 2018, Request for Comments 

(83 FR 54319). Among other questions, 

the Office asked whether it should 

engage in rulemaking to allocate the 

burden of persuasion regarding the 

patentability of proposed substitute 

claims in a motion to amend as set forth 

in the order issued in Western Digital 

(superseded by Lectrosonics), which 

allocates the burden of persuasion 

regarding the patentability of proposed 

substitute claims to the petitioner. Id. at 

54325. Of the roughly 20 comments the 

Office received in 2018 in response to 

the Request for Comments, a clear 

majority of comments favored placing 

the burden to show that the proposed 

substitute claims are unpatentable on 

the petitioner, consistent with the rule 

the Office now adopts. 

After carefully considering all 

relevant comments, the Office’s efforts 

to provide predictability and clarity, the 

Federal Circuit’s decision in Aqua 

Products, the Office’s post-Aqua 

Products Guidance Memo, and the 

Board’s experience administering AIA 

trials since the Aqua Products decision, 

the Office determines that the most 

balanced approach is to place the 

burden on the petitioner to show that 

the proposed substitute claims are 

unpatentable. Placing the burden of 

proving unpatentability on the 

challenger is consistent with other 

statutory approaches to patentability. As 

commenters have pointed out, under 35 

U.S.C. 282, the ‘‘burden of establishing 

invalidity of a patent or any claim 

thereof shall rest on the party asserting 

such invalidity.’’ Although the decision 

in Aqua Products left unresolved the 

question of whether 35 U.S.C. 282 

applies only to original claims or also 

proposed amended claims, placing the 

burden on the petitioner via this rule 

would resolve any ambiguity. 

Additionally, although patent 

examination differs from an AIA trial in 

many respects, it is worth noting that 

the Office, not the applicant, has the 

burden of showing unpatentability 

during examination. See In re Oetiker, 

977 F.2d 1443, 1445 (Fed. Cir. 1992) 

(‘‘[T]he examiner bears the initial 

burden . . . of presenting a prima facie 

case of unpatentability.’’). Further, as 

multiple commenters have noted, 

placing the burden to show 

unpatentability on the petitioner 

maintains consistency with current 

Board practice described in the 

precedential Board decision 

Lectrosonics and the post-Aqua 

Products Guidance Memo. Changing the 

procedure the Board has been using 

since 2017 would be disruptive to 

procedures that the Board and parties 

have been following for several years. 

Moreover, the rule is consistent with the 

lead opinion in Aqua Products, which 

stated, ‘‘we believe that Congress 

intended that the petitioner bear the 

burden of persuasion as to all claims in 

an IPR, whether original or amended.’’ 

872 F.3d at 1315 (O’Malley, J.). Aqua 

Products held that the Office had not 

adopted a rule placing the burden of 

persuasion with respect to the 

patentability of proposed substitute 

claims on any party. See id. at 1327. The 

Office responds to that holding and 

adopts this rule, placing the burden to 

show unpatentability of substitute 

claims on the petitioner. 

Comment 5: Commenters opposing 

the proposed rule placing the burden on 

the petitioner to show that proposed 

substitute claims are unpatentable 

suggested that, instead, the patent 

owner should bear the burden of 

proving patentability. Comments stated 

that the patent owner, as the party 

drafting the substitute claims, is best 

positioned to explain how the proposed 

substitute claims are patentable over 

prior art and should provide a detailed 

explanation of how the substitute claims 

distinguish over the prior art of record 

and other prior art known to the patent 

owner. Comments also stated that 

placing the burden on the petitioner is 

inconsistent with the common practice 

that the moving party bears the burden 

of proof. Further, at least one comment 

stated that the Federal Circuit’s Aqua 

Products decision does not prohibit the 

Office from placing the burden on the 

patent owner. That comment further 

noted that the Office has eliminated 

claim construction under the broadest 

reasonable interpretation, which is one 

of the safeguards Aqua Products 

identified as helping to prevent the 

Office from issuing untested claims. 

Response 5: Currently, the Office 

believes that the fair approach is to 

place the burden on the petitioner to 

show that the proposed substitute 

claims are unpatentable, for the reasons 

discussed above. In presenting proposed 

substitute claims to the Board, the 

patent owner already has ‘‘a duty of 

candor and good faith’’ (37 CFR 

42.11(a)), meaning that the patent owner 

must ‘‘disclose to the Board information 

of which the patent owner is aware that 

is material to the patentability of the 

substitute claims.’’ Lectrosonics, Paper 

15 at 9–10. 

In the Board’s experience, requiring 

the patent owner to prove patentability 

of amended claims in AIA trials has led 

to confusion because it places duties on 

the patent owner that are inconsistent 

with those applied during examination. 

During examination, for example, 

although a patent applicant must 

comply with the duty of candor, there 

is no separate obligation to prove 

patentability over prior art ‘‘known’’ to 

the patent applicant, as the Board’s 

prior approach to amended claims in 

AIA trials required. MasterImage, Paper 

42 at 2–3 (citing Idle Free, Paper 26 at 

7) (referring to ‘‘prior art of record and 

also prior art known to the patent 

owner’’ in relation to the patent owner’s 

burden for motions to amend in AIA 

trials). Much like an examiner during 

patent examination, the petitioner 

typically conducts a prior art search 

before filing an AIA petition, and in 

most cases is well-positioned and 

incentivized to identify any 

patentability issues arising from the 

proposed amended claims. 

Moreover, to the extent one opinion 

in Aqua Products identified the 

broadest reasonable interpretation 

standard as relevant to the review of 

proposed substitute claims, it did so in 

its analysis of ‘‘untested’’ claims. 872 

F.3d at 1314–1315 (O’Malley, J.). 

Although the Board’s claim construction 

standard has changed from the broadest 

reasonable interpretation to the standard 

used in district court proceedings, the 

statute and regulation governing 

amendments still require that the claim 

scope of any proposed amended claims 

be narrower and require written 

description support for the proposed 

amended claims. 35 U.S.C. 316(d)(3); 37 

CFR 42.121(a)(2), (b). The same opinion 

in Aqua Products also identified the 

preponderance of evidence standard as 

relevant to the review of proposed 

substitute claims; that standard has not 

changed. 35 U.S.C. 316(e). In addition, 

any issued amended claims would be 

subject to intervening rights and various 

Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Rules and Regulations 82931 

other review mechanisms that remain 

open to challenge the amended claims 

(e.g., subsequent IPRs, ex parte 

reexamination, and district court 

litigation). Furthermore, as explained 

elsewhere in this rulemaking, the rule 

allows the Board to exercise its 

discretion to reach a determination 

regarding patentability in instances in 

which the interests of justice warrant 

such a determination, including those in 

which the petitioner has ceased to 

participate in the proceeding altogether 

or remains in the proceeding but does 

not oppose a motion to amend. Thus, 

the rule further limits the likelihood of 

issuing amended claims that are 

‘‘untested.’’ 

C. Board Discretion To Grant or Deny a 

Motion To Amend 

Comment 6: Of the comments 

addressing the proposed rule providing 

that the Board may, in the interests of 

justice, grant or deny a motion to amend 

for any reason supported by the 

evidence of record, a majority supported 

the proposed rule. For example, one 

comment stated that the Board should 

not procedurally deny a motion to 

amend for failing to comply with the 

statutory or regulatory requirements if 

the lack of compliance can be cured by 

reference to the evidence of record. 

Similarly, a comment stated that if a 

petitioner does not oppose the proposed 

substitute claims, the Board should have 

the discretion to deny the motion to 

amend for any reason supported by the 

evidence of record rather than 

automatically adding the proposed 

substitute claims to the challenged 

patent. 

Response 6: The Office agrees with 

these comments. Under the proposed 

rule, as modified in the final rule, the 

Board will have the discretion to grant 

or deny a motion to amend only for 

reasons supported by readily 

identifiable and persuasive evidence of 

record, when it is in the interests of 

justice. The Office anticipates that the 

Board will exercise this discretion only 

in rare circumstances, such as discussed 

in Hunting Titan. 

As noted by the commenters, this 

discretion allows the Board to address 

situations in which it would be unjust 

to deny a motion to amend for a 

procedural defect, such as those in 

which a patent owner does not 

expressly address or establish every 

statutory and regulatory requirement in 

its briefing. Where there is readily 

identifiable and persuasive evidence 

that the motion complies with the 

statutory and regulatory requirements, 

the Board may determine that it is in the 

interests of justice to nevertheless grant 

the motion to amend. 

The Office also agrees with the 

comments that the Board should have 

discretion to address the patentability of 

substitute claims under certain rare 

circumstances in which substitute 

claims might otherwise issue without 

any consideration of patentability by the 

Office, regardless of what is in the 

record before the Board. In this vein, the 

final rule permits the Board to address 

circumstances in which, as explained in 

Hunting Titan, the adversarial process 

has failed to provide the Board with 

potential arguments of patentability 

with respect to the proposed substitute 

claims. Such circumstances could 

include, for example, those in which the 

petitioner ceases to participate in the 

proceeding altogether (for example, as a 

result of settlement) or remains in the 

proceeding but does not oppose the 

motion to amend, in whole or in part 

(for example, does not oppose some 

proposed substitute claims), or those in 

which the petitioner previously made 

an argument (for example, in opposition 

to a motion to amend) but then later 

ceases to participate (for example, does 

not oppose a revised motion to amend). 

In such circumstances, the absence of 

two actively participating opposing 

parties (at least in relation to a motion 

to amend) signals a situation in which 

the adversarial process may have failed 

to provide the Board with potential 

arguments of patentability or 

unpatentability. In such a situation, the 

Board will, in the interests of justice, 

typically independently evaluate the 

patentability of the proposed substitute 

claims and exercise its discretion to 

grant or deny only for reasons supported 

by readily identifiable and persuasive 

evidence of record. 

As a general matter in the vast 

majority of cases, the Board will 

consider only evidence a party 

introduces into the record of the 

proceeding. However, the Board may 

consider readily identifiable and 

persuasive evidence already before the 

Office (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). Likewise, the Board may 

consider evidence that a district court 

can judicially notice under Federal Rule 

of Evidence 201. Thus, when referring 

to the interests of justice, the rule 

affords the Board the flexibility to 

address the rare circumstances in which 

certain evidence of unpatentability has 

not been raised by the petitioner 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, as 

explained in Hunting Titan. 

As noted above, the Office expects 

that the Board will exercise its 

discretion in the interests of justice to 

reach a determination of unpatentability 

only in rare circumstances, and only 

where the patent owner has been 

afforded the opportunity to respond. In 

most instances, in cases where the 

petitioner has participated fully and 

opposed the motion to amend, the 

Office expects that the petitioner will 

bear the burden of persuasion, and there 

will be no need for the Board to 

independently justify a determination of 

unpatentability. 

Comment 7: One commenter 

expressed general support for the 

proposed rule’s codification of the 

Board’s discretion to grant or deny a 

motion to amend and the application of 

the interests of justice standard to 

govern the exercise of that discretion. 

The commenter observed that the 

preamble of the Notice of Proposed 

Rulemaking identified three exemplary 

circumstances that may satisfy the 

interests of justice standard: (1) The 

petitioner has ceased to participate in 

the proceeding; (2) the petitioner 

remains in the proceeding but does not 

oppose the motion to amend; and (3) the 

petitioner opposes the motion to amend 

and has failed to meet the burden of 

persuasion, but there is easily identified 

and persuasive evidence of 

unpatentability in the record. The 

commenter suggested, however, that the 

final rule should provide further 

guidance on the contours of the Board’s 

discretion under the interests of justice 

standard, preferably in the rules 

themselves. The commenter also 

requested that the final rule clarify the 

rare circumstances in which the Board 

will exercise its discretion. 

Response 7: The Office appreciates 

these comments and has modified the 

final rule to more clearly specify the 

circumstances in which the Board will 

exercise its discretion to grant or deny 

a motion to amend. The final rule thus 

clarifies that such discretion may be 

used when it is in the interests of justice 

and when there is readily identifiable 

and persuasive evidence of record. The 

final rule language thus follows the 

formulation set forth in Hunting Titan, 

which focuses on situations in which 

the adversarial process has failed to 

provide the Board with potential 

arguments of patentability with respect 

to the proposed substitute claims. 

Hunting Titan provides express 

examples of such situations, including 

when the petitioner has ceased to 

82932 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Rules and Regulations 

participate in the proceeding altogether 

or remains in the proceeding but does 

not oppose the motion to amend, or 

when certain evidence has not been 

raised by a 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. Hunting 

Titan, Paper 67 at 12–13, 25–26. The 

POP noted in Hunting Titan that these 

examples are not exhaustive, and that 

the Board will address any other factspecific situations that satisfy the 

interests of justice standard as they 

arise. Id. at 12–13. 

To the extent that the commenter 

requested that the final rule explicitly 

set forth all possible circumstances that 

may satisfy the interests of justice 

standard, the comment is not adopted. 

As modified, the final rule specifies that 

the Board may exercise its discretion 

only when its reasons are supported by 

readily identifiable and persuasive 

evidence of record. However, the Board 

may consider readily identifiable and 

persuasive evidence already before the 

Office (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). Likewise, the Board may 

consider evidence that a district court 

can judicially notice under Federal Rule 

of Evidence 201. In such 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 motion to amend. 

Regulatory language is not the 

appropriate vehicle for specifying the 

exact factual situations that will satisfy 

the interests of justice standard. Rather, 

as discussed above, the precedential 

Hunting Titan decision sets forth 

general categories of situations in which 

the standard may be satisfied. The 

decision also provides a specific 

example of a situation in which the 

standard is not met, namely the facts of 

the Hunting Titan case itself. The Office 

expects that future decisions of the 

Board applying the final rule will 

continue to provide the public with 

guideposts as to factual circumstances 

in which the interests of justice 

standard is either satisfied or not 

satisfied, and the Office may designate 

these decisions as informative or 

precedential, as appropriate. 

Comment 8: Some comments 

supported the proposed rule providing 

for Board discretion to grant or deny a 

motion to amend but advocated that the 

Board’s discretion to deny a motion to 

amend should be limited. For example, 

some comments stated that the Board 

should be limited to addressing grounds 

of unpatentability raised by the 

petitioner in opposition to the motion to 

amend. Two commenters expressed the 

view that, even in situations in which 

the petitioner does not oppose the 

motion to amend, the Board should be 

limited to addressing grounds of 

unpatentability raised by the petitioner 

against the original claims. 

Additionally, one comment stated that 

the scope of the Board’s discretion 

should be limited to the new claim 

limitations proposed by the motion to 

amend. 

Response 8: Although the Office 

appreciates the commenters’ interest in 

further articulating the scope of the 

Board’s discretion, the Office has, 

through the issuance of the precedential 

Hunting Titan decision, clarified the 

situations in which the Board may 

exercise its discretion. Therefore, the 

Office does not adopt the changes to the 

rules proposed by the comments. The 

proposed rule, as modified in the final 

rule, limits the Board’s discretion to 

situations in which the interests of 

justice support the Board exercising that 

discretion. As set forth in the 

commentary to the proposed rule, and 

as further explained in Hunting Titan, 

the Office anticipates that this standard 

will be met only in ‘‘rare 

circumstances’’ and provides for certain 

exemplary situations that may justify an 

exercise of the Board’s discretion. For 

example, the Board may exercise its 

discretion to grant a motion to amend 

only when supported by readily 

identifiable and persuasive evidence of 

record that the motion complies with 

the statutory and regulatory 

requirements. Alternatively, where there 

is readily identifiable and persuasive 

evidence in support of its decision, the 

Board may exercise its discretion to 

deny a motion to amend in situations in 

which the adversarial process fails to 

provide the Board with potential 

arguments of patentability with respect 

to the proposed substitute claims, such 

as when the petitioner has ceased to 

participate in the proceeding altogether 

(for example, as a result of settlement) 

or remains in the proceeding but does 

not oppose the motion to amend. 

Under the proposed rule, as modified 

in the final rule, the Board may evaluate 

each motion to amend on a case-by-case 

basis to determine whether the facts of 

the case support the interests of justice 

standard. 

Further limitations on the Board’s 

discretion, such as those proposed by 

the commenters, that set bright-line 

prohibitions on certain exercises of the 

Board’s discretion, are not adopted. For 

example, in cases in which the 

petitioner is not participating or does 

not oppose the motion to amend, 

limiting the Board to addressing only 

the grounds of unpatentability raised by 

a petitioner against the original claims 

may unduly limit the Board’s ability to 

assess the patentability of the amended 

claims in situations where there is 

readily identifiable and persuasive 

evidence of unpatentability. See Nike, 

955 F.3d at 51 (‘‘[T]he Board should not 

be constrained to arguments and 

theories raised by the petitioner in its 

petition or opposition to the motion to 

amend. . . . Otherwise, were a 

petitioner not to oppose a motion to 

amend, the Patent Office would be left 

with no ability to examine the new 

claims.’’). Such a limit would increase 

the risk of the Office issuing amended 

claims that are unpatentable over the 

existing record in the proceeding. In 

addition, an amended claim may add a 

limitation not present in the original 

claims and not addressed by a ground 

of unpatentability in the petition, but 

the limitation (and reason to combine 

limitations, as relevant) may be 

disclosed elsewhere in the record before 

the Board. In such circumstances, the 

Board may determine that the interests 

of justice warrant denying the motion to 

amend on a ground of unpatentability 

not articulated in the original petition. 

The Board, however, will not make such 

a determination without first ensuring 

that the parties have been given notice 

and an opportunity to respond to any 

new factual allegation or legal theory. 

Nor does the Office adopt a 

recommendation that the Board’s 

exercise of discretion in the interests of 

justice to deny a motion to amend 

should be restricted to new limitations 

added by the proposed amendment. 

Generally, the Office anticipates that 

this will usually be the case because the 

limitations of the original claims will 

have been addressed by the grounds of 

unpatentability raised in the petition, 

and the Board is more likely to exercise 

its discretion when assessing newly 

added limitations to substitute claims. 

That said, evaluating the patentability of 

a claim requires consideration of the 

claim ‘‘as a whole.’’ 35 U.S.C. 103 (‘‘the 

claimed invention as a whole would 

have been obvious’’); 84 FR at 55 (2019 

Revised Patent Subject Matter Eligibility 

Guidance) (‘‘consider the claim as a 

whole when evaluating whether the 

judicial exception is meaningfully 

limited by integration into a practical 

application of the exception’’). 

Restricting the Board’s ability to 

exercise its discretion to evaluate the 

Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Rules and Regulations 82933 

patentability of proposed substitute 

claims to only portions of the proposed 

claim is inconsistent with the holistic 

evaluation of the patentability of a 

claim. 

Comment 9: A minority of 

commenters opposed the proposed rule 

providing that the Board may, in the 

interests of justice, grant or deny a 

motion to amend for any reason 

supported by the evidence of record. 

According to these commenters, the 

Board must independently assess the 

potential unpatentability of any 

proposed substitute claim and has no 

discretion to grant a motion to amend in 

the absence of its independent 

assessment of patentability. One 

commenter stated that the ‘‘interests of 

justice’’ standard of the proposed rule is 

too high and would unduly limit the 

Board’s ability to address the 

patentability of proposed substitute 

claims. The commenter expressed the 

view that the Office should compel the 

Board to always independently confirm 

patentability before granting a motion to 

amend, regardless of what a petitioner 

argues and presents to the Board, rather 

than providing for Board discretion in 

the interests of justice. 

Response 9: These comments are not 

adopted. Removing the Board’s 

discretion to evaluate each proceeding 

on a case-by-case basis, and requiring 

the Board to independently examine the 

patentability of every proposed 

substitute claim regardless of whether or 

not (or how) the motion to amend is 

opposed by a petitioner, is not 

consistent with the nature of inter partes 

proceedings. AIA trials are, by their 

nature, adversarial. As stated in Hunting 

Titan, ‘‘relying on the adversarial 

process to frame the issues for the Board 

properly places the incentives on the 

parties to identify the pertinent 

evidence and make the best arguments 

for their desired outcome.’’ Hunting 

Titan, Paper 67 at 11. Thus, in most 

instances, the Board will ‘‘rely on the 

incentives the adversarial system 

creates, and expect that the petitioner 

will usually have an incentive to set 

forth the reasons why the proposed 

substitute claims are unpatentable. In 

most circumstances, then, the Board 

need not raise its own arguments of 

unpatentability.’’ Id. at 12. The Office 

believes, however, that taking into 

account rare instances that satisfy the 

interests of justice standard, as set forth 

above and in Hunting Titan, provides a 

safeguard against the Office issuing 

unpatentable claims when there is 

readily identifiable and persuasive 

evidence of unpatentability while also 

relying, in most instances, on the 

adversarial process to surface potential 

patentability challenges against a 

proposed substitute claim. 

Comment 10: One commenter agreed 

with the proposed rule to the extent that 

the Board has discretion to deny a 

motion to amend when supported by 

the record, but disagreed that the Board 

should have discretion to grant a motion 

to amend. The commenter stated that 

discretion to deny a motion to amend is 

consistent with the Board’s role to 

protect the public against overly broad 

patent claims, but that the Board should 

not be able to grant an unwarranted 

motion to amend. 

Response 10: The Office agrees with 

the first part of the comment and 

believes that Board discretion to deny a 

motion to amend, regardless of the 

burdens on the parties, when in the 

interests of justice, is consistent with 

the goal of ensuring that claims issued 

by the Office have appropriate scope. 

The Office disagrees, however, that the 

Board should not have similar 

discretion to grant a motion to amend. 

Such discretion, when exercised in the 

interests of justice, protects against 

denial of a meritorious motion to amend 

that is supported by the evidence of 

record for purely procedural reasons, 

such as when a motion to amend sets 

forth the basis for concluding that a 

patent owner has carried its burden but, 

through inadvertence, fails to state that 

the motion meets a statutory or 

regulatory requirement. 

D. Evidence of Record 

Comment 11: The Office received 

several comments regarding the use of 

the term ‘‘evidence of record’’ in the 

proposed rule. Some commenters 

requested clarification of the rule and 

whether the Board would be permitted 

to introduce its own evidence into the 

record. Other commenters expressed the 

view that the Board should be permitted 

to supplement the record, if necessary, 

to support its determination whether to 

grant or deny the motion to amend. 

Other commenters stated that the 

evidence of record should be limited to 

evidence introduced by the parties. 

Response 11: The Office appreciates 

and has carefully considered these 

thoughtful comments and has modified 

the rule to state that the Board has the 

discretion to, when in the interests of 

justice, grant or deny a motion to amend 

only for reasons supported by readily 

identifiable and persuasive evidence of 

record. The rule also has been modified 

to state that the 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. 

In response to the comments seeking 

clarification as to the scope of the 

‘‘evidence of record,’’ the final rule has 

been modified to provide additional 

details as to the scope of evidence upon 

which the Board may base its decision 

to grant or deny a motion to amend. The 

use of ‘‘evidence of record’’ in the rule 

as adopted signifies that the evidence on 

which the Board bases its determination 

on a motion to amend will be entered 

into the record of the proceeding. In the 

vast majority of cases, the parties will 

enter that evidence into the record of 

the proceeding. The final rule as 

modified, however, specifies that the 

Board may make of record only readily 

identifiable and persuasive evidence in 

a related proceeding before the Office 

(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). 

These rare situations, in which the 

Board may itself introduce evidence 

from the record of another proceeding 

before the Office, help ensure that the 

Office acts consistently and is cognizant 

of the complete record before the 

agency. 

Likewise, in response to comments 

seeking clarification, the final rule as 

modified specifies that the Board may 

consider evidence that a district court 

can judicially notice under Federal Rule 

of Evidence 201. This provision is 

consistent with the Board’s ability to, 

when appropriate (e.g., when necessary 

to decide issues of claim construction), 

introduce and rely on well-known 

dictionaries or treatises, even when the 

parties have not raised such evidence, 

or to take official notice of facts as 

permitted by Federal Rule of Evidence 

201. The Board’s existing rules make the 

Federal Rules of Evidence applicable to 

AIA trial proceedings and explain that 

‘‘judicial notice’’ as used in the Federal 

Rules of Evidence shall be construed in 

AIA trial proceedings as ‘‘official 

notice.’’ See 37 CFR 42.62. Thus, the 

final rule as modified reflects current 

Board practice and regulations, 

pursuant to which the Board may take 

official notice of facts in appropriate 

circumstances. See, e.g., RPX Corp. v. 

Iridescent Networks, Inc., IPR2018– 

00254 (PTAB Dec. 10, 2018) (Paper 20) 

(taking official notice of how the URL of 

the internet Archive provides the date 

the website was captured); Ericsson Inc. 

v. Intellectual Ventures I LLC, IPR2014– 

00527, (PTAB May 18, 2015) (Paper 41) 

(taking official notice that members in 

the scientific and technical 

communities who both publish and 

engage in research rely on the 

82934 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Rules and Regulations 

information published on the copyright 

line of IEEE publications). 

Furthermore, as modified in the final 

rule, the Board will exercise its 

discretion only for reasons supported by 

evidence of record that is ‘‘readily 

identifiable and persuasive.’’ In the 

context of the final rules, ‘‘readily 

identifiable and persuasive’’ has the 

same meaning articulated in Hunting 

Titan and refers to evidence that is so 

clear from the record that failing to 

consider it, although it has not been 

raised by a party, would be inconsistent 

with the goal of supporting the integrity 

of the patent system. Hunting Titan, 

Paper 67 at 13. 

Entry of the evidence into the record 

provides to the parties notice of all 

relevant evidence and the ability to 

respond to such evidence before the 

Board, and also permits appellate 

review of the Board’s final decision 

should a dissatisfied party appeal. The 

rule’s statement that the Board’s 

decision shall be based on the 

‘‘evidence of record’’ also signifies that 

the Board will consider the entirety of 

the record in the proceeding, including 

all papers and exhibits, when exercising 

its discretion to grant or deny a motion 

to amend. See Aqua Products, 872 F.3d 

at 1325 (‘‘[A]n agency’s refusal to 

consider evidence bearing on the issue 

before it is, by definition, arbitrary and 

capricious within the meaning of 5 

U.S.C. 706, which governs review of 

agency adjudications. . . . That means 

that the agency must take account of all 

the evidence of record, including that 

which detracts from the conclusion the 

agency ultimately reaches.’’) (O’Malley, 

J.) (internal citations omitted). 

Comments that the ‘‘evidence of 

record’’ should be limited to evidence 

introduced by the parties and that the 

Board should not be permitted to 

introduce evidence itself are not 

adopted. Absent the rare circumstances 

described herein, the Board will not 

supplement the evidence of record with, 

for example, additional prior art 

references not introduced by a party. 

Further, the Board itself will not 

undertake its own search for prior art in 

light of a motion to amend. Prohibiting 

the Board from introducing its own 

evidence in any and all instances, 

however, may risk unduly restricting 

the Board’s ability to fully evaluate the 

patentability of proposed substitute 

claims in light of readily identifiable 

and persuasive evidence known or 

available to the Office. 

E. Opportunity To Respond 

Comment 12: Although commenters 

generally appear to agree that the Board 

may, in the interests of justice, exercise 

its discretion to grant or deny a motion 

to amend for any reason supported by 

the evidence of record, several 

commenters suggested that the rules 

should expressly provide that the 

parties have notice and an opportunity 

to respond to the Board’s exercise of 

such discretion before any such 

decision is made final to ensure 

compliance with due process, the 

interests of justice standard, and the 

Administrative Procedure Act (APA). 

One commenter stated that in addition 

to providing notice to the parties 

concerning the Board’s proposed 

exercise of discretion, the Board should 

give written notice of its initial 

determination to both parties as well as 

provide an opportunity for each party to 

respond in writing. One commenter also 

suggested that the lack of any express 

provisions concerning the parties’ 

opportunity to be heard concerning any 

new ground or evidence upon which the 

Board relies provides insufficient 

guidelines for any reviewing court to 

assess whether the Board’s exercise of 

such discretion is an abuse of 

discretion. 

Response 12: In the notice of 

proposed rulemaking concerning the 

allocation of the burden of persuasion 

on a motion to amend, the Office 

expressly acknowledged the 

requirement that any exercise of 

discretion to grant or deny a motion to 

amend would involve providing the 

parties with notice and an opportunity 

to be heard on those issues not 

previously addressed by the parties. For 

instance, if the Board, in the interests of 

justice, exercises its discretion to 

determine that a motion to amend 

complies with all statutory and 

regulatory requirements, it will do so 

only ‘‘where the petitioner has been 

afforded the opportunity to respond to 

that evidence.’’ 84 FR at 56404. 

Likewise, if the Board decides to 

exercise its discretion to deny a motion 

to amend, it will do so ‘‘only where the 

patent owner has been afforded the 

opportunity to respond to that evidence 

and related grounds of unpatentability.’’ 

Id. As the commenters have noted, and 

as the Federal Circuit recognized in 

Nike, such notice and opportunity to be 

heard by all involved parties is required 

by due process and expressly set forth 

in the APA. See Nike, 955 F.3d at 52 

(‘‘[T]he notice provisions of the APA 

and our case law require that the Board 

provide notice of its intent to rely on 

[newly raised references] and an 

opportunity for the parties to respond 

before issuing a final decision relying on 

[those references].’’). This requirement 

was also recently reaffirmed in the 

Board’s precedential Hunting Titan 

decision. Hunting Titan, Paper 67 at 14– 

15. Hunting Titan also cited two 

examples of adequate notice and 

opportunity to respond, namely, the 

Board requesting supplemental briefing 

from the parties regarding the proposed 

ground of unpatentability or requesting 

that the parties be prepared to discuss 

the prior art in connection with the 

substitute claims at an oral hearing. Id. 

at 15–16 (citing Nike, 955 F.3d at 55). 

In order to provide further clarity and in 

response to public comments seeking an 

express regulatory provision providing 

for an opportunity to be heard, the final 

rule as modified expressly provides 

that, where the Board exercises its 

discretion to grant or deny a motion to 

amend, the parties will have an 

opportunity to respond. 

Rulemaking Considerations 

A. Regulatory Flexibility Act: For the 

reasons provided herein, the Senior 

Counsel for Regulatory and Legislative 

Affairs, Office of General Law, United 

States Patent and Trademark Office, has 

certified to the Chief Counsel for 

Advocacy of the Small Business 

Administration that changes set forth in 

this rulemaking would not have a 

significant economic impact on a 

substantial number of small entities. See 

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

The changes in this rulemaking are 

intended to set forth expressly the 

respective burdens of persuasion on the 

parties regarding a motion to amend in 

an AIA proceeding. These changes are 

consistent with relevant precedential 

decisions of the Board and Federal 

Circuit, and as such, do not reflect a 

change from current practice. The 

changes do not create additional 

procedures or requirements or impose 

any additional compliance measures on 

any party, nor do these changes cause 

any party to incur additional cost. 

Therefore, any requirements resulting 

from these changes are of minimal or no 

additional burden to those practicing 

before the Board. 

B. Executive Order 12866 (Regulatory 

Planning and Review): This rulemaking 

has been determined to be not 

significant for purposes of Executive 

Order 12866 (Sept. 30, 1993). 

C. Executive Order 13563 (Improving 

Regulation and Regulatory Review): The 

Office has complied with Executive 

Order 13563 (Jan. 18, 2011). 

Specifically, the Office has, to the extent 

feasible and applicable: (1) Made a 

reasoned determination that the benefits 

justify the costs of the rules; (2) tailored 

the rules to impose the least burden on 

society consistent with obtaining the 

regulatory objectives; (3) selected a 

Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Rules and Regulations 82935 

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. 

D. Executive Order 13771 (Reducing 

Regulation and Controlling Regulatory 

Costs): This rule is not an Executive 

Order 13771 (Jan. 30, 2017) regulatory 

action because it is not significant under 

Executive Order 12866. 

E. Executive Order 13132 

(Federalism): This rulemaking does not 

contain policies with federalism 

implications sufficient to warrant 

preparation of a Federalism Assessment 

under Executive Order 13132 (Aug. 4, 

1999). 

F. Executive Order 13211 (Energy 

Effects): This rulemaking is not a 

significant energy action under 

Executive Order 13211 because it 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). 

G. 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 (Feb. 5, 1996). 

H. 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 (Apr. 21, 1997). 

I. 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 (Mar. 15, 

1988). 

J. Congressional Review Act: Under 

the Congressional Review Act 

provisions of the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (5 U.S.C. 801 et seq.), prior to 

issuing any final rule, the United States 

Patent and Trademark Office will 

submit a report containing the rule and 

other required information to the United 

States Senate, the United States House 

of Representatives, and the Comptroller 

General of the Government 

Accountability Office. The changes in 

this 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). 

K. 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. 

L. 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. 

M. 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. 

N. 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. This 

rulemaking does not involve an 

information collection requirement that 

is subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3549). This rulemaking 

does not add any additional information 

requirements or fees for parties before 

the Board. 

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 displays a currently valid 

OMB control number. 

List of Subjects in 37 CFR Part 42 

Administrative practice and 

procedure, Inventions and patents, 

Lawyers. 

PART 42—TRIAL PRACTICE BEFORE 

THE PATENT TRIAL AND APPEAL 

BOARD 

■ 1. The authority citation for 37 CFR 

part 42 continues to read as follows: 

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

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

112–29, 125 Stat. 284; and Pub. L. 112–274, 

126 Stat. 2456. 

■ 2. Amend § 42.121 by adding 

paragraph (d) to read as follows: 

§ 42.121 Amendment of the patent. 

* * * * * 

(d) Burden of Persuasion. On a motion 

to amend: 

(1) 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), (a)(3), (b)(1), and (b)(2) 

of this section; 

(2) A petitioner bears the burden of 

persuasion to show, by a preponderance 

of the evidence, that any proposed 

substitute claims are unpatentable; and 

(3) Irrespective of paragraphs (d)(1) 

and (2) of this section, the Board may, 

in the interests of justice, exercise its 

discretion to grant or deny a motion to 

amend only for reasons supported by 

readily identifiable and persuasive 

evidence of record. In doing so, the 

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. Where the Board 

exercises its discretion under this 

paragraph, the parties will have an 

opportunity to respond. 

■ 3. Amend § 42.221 by adding 

paragraph (d) to read as follows: 

§ 42.221 Amendment of the patent. 

* * * * * 

(d) Burden of Persuasion. On a motion 

to amend: 

(1) 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 

82936 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Rules and Regulations 

1 33 U.S.C. 1313(a), (c). 

2 33 U.S.C. 1313(c)(4). 

paragraphs (a)(2), (a)(3), (b)(1), and (b)(2) 

of this section; 

(2) A petitioner bears the burden of 

persuasion to show, by a preponderance 

of the evidence, that any proposed 

substitute claims are unpatentable; and 

(3) Irrespective of paragraphs (d)(1) 

and (2) of this section, the Board may, 

in the interests of justice, exercise its 

discretion to grant or deny a motion to 

amend only for reasons supported by 

readily identifiable and persuasive 

evidence of record. In doing so, the 

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. Where the Board 

exercises its discretion under this 

paragraph, the parties will have an 

opportunity to respond. 

Andrei Iancu, 

Under Secretary of Commerce for Intellectual 

Property and Director of the United States 

Patent and Trademark Office. 

[FR Doc. 2020–28159 Filed 12–18–20; 8:45 am] 

BILLING CODE 3510–16–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 131 

[EPA–HQ–OW–2015–0804; FRL–10017–97– 

OW] 

RIN 2040–AG00 

Withdrawal of Certain Federal Water 

Quality Criteria Applicable to Maine 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The United States 

Environmental Protection Agency (EPA 

or Agency) is taking final action to 

amend the Federal regulations to 

withdraw human health criteria (HHC) 

for toxic pollutants applicable to waters 

in the State of Maine. EPA is taking this 

action because Maine adopted, and EPA 

approved, HHC that the Agency 

determined are protective of the 

designated uses for these waters. This 

final rule amends the Federal 

regulations to withdraw certain HHC 

applicable to Maine that the Agency had 

promulgated, as described in the 

September 3, 2020 proposed rule. The 

withdrawal of these certain federally 

promulgated HHC will enable Maine to 

implement its EPA-approved HHC, 

submitted on April 24, 2020, and 

approved on June 23, 2020, as 

applicable criteria for Clean Water Act 

(CWA or the Act) purposes. 

DATES: This final rule is effective 

December 21, 2020. 

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

No. EPA–HQ–OW–2015–0804. All 

documents in the docket are listed on 

the http://www.regulations.gov website. 

Although listed in the index, some 

information is not publicly available, 

e.g., CBI or other information for which 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available electronically through http://

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Brundage, Office of Water, 

Standards and Health Protection 

Division (4305T), Environmental 

Protection Agency, 1200 Pennsylvania 

Avenue NW, Washington, DC 20460; 

telephone number: (202) 566–1265; 

email address: brundage.jennifer@

epa.gov or visit https://www.epa.gov/ 

wqs-tech/federal-water-qualitystandards-applicable-maine. 

SUPPLEMENTARY INFORMATION: This final 

rule is organized as follows: 

I. General Information 

A. Does this action apply to me? 

II. Background 

A. What are the applicable Federal 

statutory and regulatory requirements? 

B. What are the applicable Federal water 

quality criteria that EPA is withdrawing? 

C. Comments on the Proposed Rulemaking 

D. Effective Date of Withdrawal 

III. Statutory and Executive Order Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

B. Executive Order 13771 (Reducing 

Regulations and Controlling Regulatory 

Costs) 

C. Paperwork Reduction Act 

D. Regulatory Flexibility Act 

E. Unfunded Mandates Reform Act 

F. Executive Order 13132 (Federalism) 

G. Executive Order 13175 (Consultation 

and Coordination With Indian Tribal 

Governments) 

H. Executive Order 13045 (Protection of 

Children From Environmental Health 

and Safety Risks) 

I. Executive Order 13211 (Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

J. National Technology Transfer and 

Advancement Act of 1995 

K. Executive Order 12898 (Federal Actions 

To Address Environmental Justice in 

Minority Populations and Low-Income 

Populations) 

L. Congressional Review Act 

I. General Information 

A. Does this action apply to me? 

The State of Maine, as well as entities 

that discharge pollutants to waters of 

the United States under the State of 

Maine’s jurisdiction, such as industrial 

facilities, stormwater and combined 

sewer overflow (CSO) management 

districts, or publicly owned treatment 

works (POTWs), may be interested in 

this final rule because it withdraws 

Federal water quality standards (WQS) 

promulgated by EPA to allow the State 

of Maine’s WQS to become the 

applicable WQS for CWA purposes. 

Entities discharging in Maine’s waters 

and citizens concerned with water 

quality in Maine, including members of 

the federally recognized Indian tribes, 

may be interested in this final rule. If 

you have questions regarding the 

applicability of this action to a 

particular entity, consult the person 

identified in the preceding FOR FURTHER

INFORMATION CONTACT section. 

II. Background 

A. What are the applicable Federal 

statutory and regulatory requirements? 

Consistent with the CWA, EPA’s WQS 

program assigns to states and authorized 

tribes the primary authority for adopting 

WQS.1 After states adopt WQS, they 

must be submitted to EPA for review 

and action in accordance with the CWA. 

The Act authorizes EPA to promulgate 

Federal WQS following EPA’s 

disapproval of state WQS or an 

Administrator’s determination that new 

or revised WQS are ‘‘necessary to meet 

the requirements of the Act.’’ 2

B. What are the applicable Federal 

water quality criteria that EPA is 

withdrawing? 

On December 19, 2016, EPA 

promulgated Federal HHC for 96 toxic 

pollutants for waters in Indian lands in 

Maine based on the Agency’s 2015 

disapproval of corresponding Stateestablished HHC and an Administrator’s 

determination that new or revised WQS 

were necessary to meet the requirements 

of the Act. 81 FR 92466 (December 19, 

2016). EPA also promulgated a phenol 

criterion to protect human health from 

consumption of water plus organisms 

for waters outside of Indian lands in 

Maine after disapproving the State’s 

phenol criterion in 2015 because it 

contained a mathematical error. 

EPA’s 2015 disapproval of the State’s 

HHC for waters in Indian lands was 

based on its decision that they were 

inadequate to protect the sustenance