69578 Federal Register / Vol. 88, No. 193 / Friday, October 6, 2023 / Proposed Rules 

1Under section 18 of the AIA, the transitional 

program for post-grant review of CBM 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, 

remain pending on appeal at the Federal Circuit 

Court of Appeals. 

earnings and profits under section 

1248(d)(1) and (d)(6), except that those 

exclusions will apply with respect to 

the earnings and profits of a foreign 

corporation that are attributable to: 

* * * * * 

(d) * * * 

(5) Basis adjustments under section 

367(b). With respect to stock of a foreign 

corporation that is exchanged in a 

transaction subject to section 367(b), the 

portion of the basis increase provided 

by § 1.367(b)–2(e)(3)(ii) by reason of 

paragraph (c)(3)(ii) of this section is 

made solely for purposes of section 

1411. 

* * * * * 

(i) * * * Paragraph (c)(3) of this 

section, to the extent it references 

regulations issued under section 367(b), 

and paragraph (d)(5) of this section, 

apply to transactions completed on or 

after October 5, 2023 and to any 

transactions treated as completed before 

October 5, 2023 as a result of an entity 

classification election made under 

§ 301.7701–3 of this chapter that is filed 

on or after October 5, 2023. 

Douglas W. O’Donnell, 

Deputy Commissioner for Services and 

Enforcement. 

[FR Doc. 2023–22061 Filed 10–5–23; 8:45 am] 

BILLING CODE 4830–01–P 

DEPARTMENT OF COMMERCE 

Patent and Trademark Office 

37 CFR Part 43 

[Docket No. PTO–P–2023–0012] 

RIN 0651–AD68 

Rules Governing Pre-Issuance Internal 

Circulation and Review of Decisions 

Within the Patent Trial and Appeal 

Board 

AGENCY: United States Patent and 

Trademark Office, Department of 

Commerce. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The United States Patent and 

Trademark Office (‘‘USPTO’’ or 

‘‘Office’’) proposes regulations to govern 

the pre-issuance circulation and review 

of decisions within the Patent Trial and 

Appeal Board (‘‘PTAB’’ or ‘‘Board’’). 

The Office proposes these provisions to 

refine the current interim process in 

light of stakeholder feedback received in 

response to a Request for Comments 

(RFC). This proposed rule promotes the 

efficient delivery of reliable intellectual 

property rights by promoting consistent, 

clear, and open decision-making 

processes at the PTAB. 

DATES: Comments must be received by 

December 5, 2023 to ensure 

consideration. 

ADDRESSES: Comments must be 

submitted through the Federal 

eRulemaking Portal at 

www.regulations.gov. To submit 

comments via the portal, one should 

enter docket number PTO–P–2023–0012 

on the homepage and select ‘‘search.’’ 

The site will provide search results 

listing all documents associated with 

this docket. Commenters can find a 

reference to this notice and select the 

‘‘comment’’ icon, complete the required 

fields, and enter or attach their 

comments. Attachments to electronic 

comments will be accepted in Adobe®

portable document format (PDF) or 

Microsoft Word® format. Because 

comments will be made available for 

public inspection, information that the 

submitter does not desire to make 

public, such as an address or phone 

number, should not be included in the 

comments. 

Visit the Federal eRulemaking Portal 

for additional instructions on providing 

comments via the portal. If electronic 

submission of, or access to, comments is 

not feasible due to a lack of access to a 

computer and/or the internet, please 

contact the USPTO using the contact 

information below for special 

instructions. 

FOR FURTHER INFORMATION CONTACT: 

Melissa A. Haapala, Vice Chief 

Administrative Patent Judge, or Stacy B. 

Margolies, Lead Administrative Patent 

Judge, 571–272–9797. 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

Purpose: This proposed rule would 

codify processes and standards to 

govern the internal pre-issuance 

circulation and review of decisions 

within the PTAB. 

Since May of 2022, the USPTO has 

been using an interim process for PTAB 

decision circulation and internal PTAB 

review to promote consistent, clear, and 

open decision-making processes at the 

USPTO. The processes were put in 

place to support a consistent and clear 

approach to substantive areas of patent 

law and PTAB-specific procedures, 

while maintaining open decisionmaking processes. The USPTO 

subsequently issued an RFC seeking 

public input on these processes. After 

reviewing feedback received from the 

public in response to the RFC, the 

USPTO now seeks to formalize its 

processes for circulation and review of 

decisions within the PTAB through 

notice-and-comment rulemaking. 

This proposed rule provides that the 

USPTO Director, Deputy Director, and 

Commissioners for Patents and 

Trademarks are not involved, directly or 

indirectly, in the decision making of 

panels of the PTAB prior to issuance of 

a decision by the panel. In addition, no 

employee of the Office external to the 

Board, nor any member of PTAB 

management, is involved, directly or 

indirectly, in panel decision-making 

unless a panel member has requested 

their input. The adoption of any 

feedback received by the panel is 

entirely optional and solely within the 

discretion of the panel. 

This proposed rule also sets forth that, 

if the Office establishes procedures 

governing the internal circulation and 

review of decisions prior to issuance to 

one or more designated members of the 

Board, no management judge shall 

participate in any such review, either 

directly or indirectly. The adoption of 

any feedback received pursuant to such 

review is entirely optional and solely 

within the discretion of the panel. 

Finally, this proposed rule provides 

that decisions of the Board are expected 

to comport with applicable statutes, 

regulations, binding case law, and 

written agency or Board policy or 

guidance, and that there is no unwritten 

agency or Board policy or guidance that 

is binding on any panel of the Board. 

Background 

On September 16, 2011, the America 

Invents Act (AIA) was enacted into law 

(Pub. L. 112–29, 125 Stat. 284 (2011)). 

The AIA established the PTAB, which is 

made up of administrative patent judges 

(APJs) and four statutory members, 

namely the USPTO Director, the USPTO 

Deputy Director, the USPTO 

Commissioner for Patents, and the 

USPTO Commissioner for Trademarks. 

35 U.S.C. 6(a). The PTAB hears and 

decides ex parte appeals of adverse 

decisions by examiners in applications 

for patents; appeals of adverse decisions 

by examiners in reexamination 

proceedings; and proceedings under the 

AIA, including inter partes reviews, 

post grant reviews, covered business 

method (CBM) patent reviews,1 and 

derivation proceedings, in panels of at 

least three members. 35 U.S.C. 6(b), (c). 

Under the statute, the Director 

designates the members of each panel. 

35 U.S.C. 6(c). The Director has 

delegated that authority to the Chief 


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Judge of the Board. See PTAB Standard 

Operating Procedure 1 (SOP1), 

Assignment of Judges to Panels, https:// 

www.uspto.gov/sites/default/files/ 

documents/

SOP%201%20R15%20FINAL.pdf. 

Interim Process and CJP 

The Office recognizes that it is 

important that the PTAB maintain a 

consistent and clear approach to 

substantive areas of patent law and 

PTAB-specific procedures, while 

maintaining open decision-making 

processes. Since May 2022, the USPTO 

has been using an interim process for 

PTAB decision circulation and internal 

PTAB review. See ‘‘Interim process for 

PTAB decision circulation and internal 

PTAB review,’’ available at https://

www.uspto.gov/interim-process-ptabdecision-circulation-and-internal-ptabreview. That interim process has now 

been replaced by a new Standard 

Operating Procedure (SOP4), issued 

concurrently with this Notice of 

Proposed Rulemaking. The process set 

forth in SOP4 is substantially similar to 

the interim process, except for the 

change described below to the 

Circulation Judge Pool (CJP) review. 

SOP4 further sets forth additional 

details requested by stakeholders. 

Under the prior interim process, 

certain categories of PTAB decisions 

were required to be circulated to a pool 

of non-management APJs (the 

Circulation Judge Pool, also known as 

CJP) prior to issuance. These decisions 

included all AIA institution decisions; 

AIA final written decisions; AIA 

decisions on rehearing; inter partes 

reexamination appeal decisions; 

designated categories of ex parte appeal, 

ex parte reexamination appeal, and 

reissue appeal decisions; and all Board 

decisions (including AIA and ex parte 

appeal decisions) following a remand 

from the Federal Circuit. Judges could, 

at their option, circulate other types of 

decisions for CJP review. In response to 

stakeholder feedback, under the process 

set forth in SOP4, circulation to CJP is 

now optional. 

The CJP comprises a representative 

group of non-management APJs who 

collectively have technical/scientific 

backgrounds and legal experience 

representative of the PTAB judges as a 

whole. The CJP was modeled after both 

the Federal Circuit’s previous 

circulation to the Senior Technical 

Assistant and the Federal Circuit’s 10- 

day circulation process for precedential 

decisions. See United States Court of 

Appeals for the Federal Circuit, Internal 

Operating Procedures, Redlined Copy, 

18 (Mar. 1, 2022), available at https://

cafc.uscourts.gov/wp-content/uploads/

RulesProceduresAndForms/

InternalOperatingProcedures/IOPsRedline-03012022.pdf (describing the 

previous circulation to the Senior 

Technical Assistant); and United States 

Court of Appeals for the Federal Circuit, 

Internal Operating Procedures, 10.5 

(Mar. 1, 2022), available at https://

cafc.uscourts.gov/wp-content/uploads/

RulesProceduresAndForms/

InternalOperatingProcedures/IOPs03012022.pdf (describing the 10-day 

circulation process for precedential 

decisions). 

The CJP’s role is to provide the panel 

with information regarding potential 

conflicts or inconsistencies with 

relevant authority, including PTAB 

precedential decisions, Director 

guidance memoranda, and other written 

agency or Board policies or guidance. 

The CJP also provides the panel with 

information regarding potential 

inconsistencies with informative or 

routine PTAB decisions and suggestions 

for improved readability and stylistic 

consistency. The panel has the final 

authority and responsibility for the 

content of a decision and determines 

when and how to incorporate feedback 

from the CJP. The APJs are required to 

apply pertinent statutes, binding case 

law, and written policy or guidance 

issued by the Director or the Director’s 

delegate that is applicable to PTAB 

proceedings. All policies or guidance 

applicable to PTAB proceedings that the 

APJs are required to apply are written. 

The CJP may have periodic meetings 

with PTAB Executive Management (i.e., 

PTAB Chief Judge, Deputy Chief Judge, 

Vice Chief Judges, Senior Lead Judges, 

and those acting in any of the foregoing 

positions) to discuss issued panel 

decisions and general areas for potential 

policy clarification. PTAB Executive 

Management may discuss these issues 

or issued decisions that have issued 

with the Director for the purposes of (i) 

considering whether to issue new or 

updated policies or guidance, for 

example, through regulation, 

precedential or informative decisions, 

and/or a Director guidance 

memorandum; and (ii) considering sua 

sponte (on the Director’s own initiative) 

Director Review of a decision. 

Under the interim process, any panel 

member, at their sole discretion, could 

also optionally consult with one or more 

members of PTAB management (i.e., 

PTAB Executive Management and Lead 

Judges) regarding a decision prior to 

issuance. If consulted, PTAB 

management could provide information 

regarding the consistent application of 

USPTO policy, applicable statutes and 

regulations, and binding case law. 

Adoption of any suggestions provided 

by PTAB management based on such 

consultation was optional. Unless 

consulted by a panel member, PTAB 

management did not make suggestions 

to the panel regarding the substance of 

any pre-issuance decision, either 

directly or indirectly through the CJP. 

The interim PTAB decision 

circulation and internal review 

processes promoted decisional 

consistency and open decision-making 

processes by reinforcing that the 

adoption of all CJP and requested PTAB 

management feedback is optional, that 

members of PTAB management did not 

provide feedback on decisions prior to 

issuance unless they are a panel 

member or a panel member requests 

such feedback, and that the PTAB panel 

had the final authority and 

responsibility for the content of a 

decision. Additionally, the processes 

provided a mechanism by which the 

Director could be made aware of 

decisions to consider for sua sponte 

Director Review, and of areas to 

consider for issuing new, or modified, 

USPTO policy to promote the efficient 

delivery of reliable intellectual property 

rights. 

Furthermore, under both the interim 

process and SOP4, all consultations are 

covered by conflict of interest policies. 

If a member of the CJP or management 

has a conflict of interest, they are 

required to notify the other members of 

their respective team and recuse 

themselves from any discussion or 

analysis of that decision. In determining 

whether a conflict of interest exists, the 

USPTO follows the guidance set forth in 

the Standards of Ethical Conduct for 

Employees of the Executive Branch at 5 

CFR part 2635 and will consult with the 

Department of Commerce Ethics Law 

and Programs Office, as necessary, to 

resolve any questions pertaining to 

conflicts of interest. 

Request for Comments 

On July 20, 2022, the USPTO issued 

an RFC on Director Review, 

Precedential Opinion Panel Review, and 

Internal Circulation and Review of 

Patent Trial and Appeal Board 

Decisions (RFC), to obtain public 

feedback on the interim PTAB decision 

circulation and internal review 

processes. See 87 FR 43249–52. The 

USPTO received over 4,300 comments 

from a wide range of stakeholders, 

including individuals, associations, and 

companies, on all aspects of the RFC 

including specific responses to question 

13 (which asked if any changes should 

be made to the interim PTAB decision 

circulation and review process) and 

question 14 (which asked what other 

considerations should be taken into 


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69580 Federal Register / Vol. 88, No. 193 / Friday, October 6, 2023 / Proposed Rules 

account with respect to the interim 

PTAB decision circulation and internal 

review process). 

Several commenters emphasized the 

need for judicial independence and 

review processes that reduce influence 

by USPTO senior management on PTAB 

panels. Other commenters emphasized 

the value of transparency in the PTAB’s 

processes and requested that further 

details on the CJP be made public. One 

representative commenter stated that, 

even when the CJP reviews a decision 

prior to issuance, it should not discuss 

the decision with PTAB management 

until the decision is issued by the panel. 

Another commenter believed that the 

value of the CJP may be outweighed by 

concerns with undue pre-issuance 

influence by the Director and suggested 

abandoning the CJP procedure in favor 

of entrusting the APJs and the Director 

Review process with maintaining 

consistency and quality of PTAB 

decisions. 

Proposed Provisions Governing PreIssuance Internal Circulation and 

Review 

In view of the comments and the 

USPTO’s further experience with AIA 

proceedings, the USPTO undertakes this 

rulemaking to make policy changes to 

the processes and standards that govern 

the internal pre-issuance circulation and 

review of decisions within the PTAB. 

This rulemaking is consistent with 

comments received from stakeholders 

expressing a preference that key policy 

changes be made and formalized 

through rulemaking. This proposed rule 

seeks to promote consistent, clear, and 

open decision-making processes while 

protecting judicial independence and 

increasing transparency of USPTO 

processes. For example, this proposed 

rule would prohibit PTAB management 

review of decisions prior to issuance by 

the panel (absent a request by a panel 

member, at the panel member’s sole 

discretion). The proposed rule also 

provides that, if the Office establishes 

procedures governing the internal 

circulation and review of decisions 

prior to issuance (such as CJP review), 

no management judge shall participate 

directly or indirectly in any such 

review. Adopting the suggestion of 

stakeholders, this proposed rule further 

specifies that the group of reviewing 

non-management judges (e.g., CJP 

members) would be prohibited from 

discussing any reviewed decision with 

PTAB management prior to issuance. 

In response to public feedback 

requesting additional information on the 

processes, the USPTO has provided 

further details regarding the internal 

circulation process and the structure of 

the reviewing body of non-management 

judges (currently embodied by the CJP) 

by issuing a Standard Operating 

Procedure (SOP4) concurrently with the 

publication of this NPRM. The 

processes set forth in the SOP4 replace 

the former interim process for PTAB 

decision circulation described above. 

The Office may consider further 

refinements or modifications to the 

SOP4 in view of the comments received 

from the public in response to this 

NPRM. 

The USPTO proposes to add part 43, 

which provides for new regulations 

governing the pre-issuance circulation 

and review of decisions within the 

PTAB. A section-by-section discussion 

of the new provisions is as follows: 

Section 43.1: Proposed § 43.1 would 

set forth general policy considerations 

for Part 43 and define the scope of the 

rules. 

Section 43.2: Proposed § 43.2 would 

set forth definitions for terms used in 

Part 43. 

The proposed definition of Board 

would refer to the Patent Trial and 

Appeal Board. 

The proposed definition of decision 

would refer to any decision, order, 

opinion, or other written work product 

intended for entry into the record of a 

Board proceeding. 

The proposed definition of Director 

would refer to the Under Secretary of 

Commerce for Intellectual Property and 

Director of the United States Patent and 

Trademark Office or an individual 

serving as Acting Director or performing 

the functions and duties of the Director. 

The proposed definition of Deputy 

Director would refer to the Deputy 

Under Secretary of Commerce for 

Intellectual Property and Deputy 

Director of the United States Patent and 

Trademark Office or an individual 

serving as Acting Deputy Director. 

The proposed definitions of 

Commissioner for Patents and 

Commissioner for Trademarks would be 

the positions defined in 35 U.S.C. 

3(b)(2) or an individual acting in the 

capacity of one of those positions. 

The proposed definition of issuance 

would refer to the entry of a decision 

into the record of a Board proceeding. 

The proposed definition of 

Management Judge would encompass 

the Chief Administrative Patent Judge, 

the Deputy Chief Administrative Patent 

Judge, a Vice Chief Administrative 

Patent Judge, a Senior Lead 

Administrative Patent Judge, and/or a 

Lead Administrative Patent Judge, 

including individuals who serve in 

these positions in an acting capacity. 

The definition is also intended to 

capture any other Administrative Patent 

Judge who, as part of their duties, 

supervises the work of other 

Administrative Patent Judges or is 

responsible for reviewing the 

performance of other Administrative 

Patent Judges. 

The proposed definition of panel 

would refer to the members of the Board 

assigned to a proceeding pursuant to the 

Board’s Standard Operating Procedure 

1. 

The proposed definition of 

proceeding would refer to an appeal or 

contested case under Part 41 or trial 

proceeding under Part 42. 

Section 43.3: Proposed § 43.3 would 

specify that the Director of the USPTO 

and other high-level officers are not 

involved in panel decisions prior to 

their issuance, either directly or 

indirectly. The provision ensures the 

judicial independence of Board panels 

by insulating panel decision-making 

from the policy-setting functions of 

Office leadership. 

Proposed § 43.3(a) would prohibit the 

Director, Deputy Director, 

Commissioner for Patents, and 

Commissioner for Trademarks from 

communicating, directly or indirectly, 

with any member of a panel regarding 

a decision, prior to issuance of that 

decision by the panel. 

Proposed § 43.3(b) would provide that 

paragraph (a) would not apply to any 

proceeding in which the named 

individual is a member of the panel and 

would also specify that when sitting as 

a member of a panel, the individual is 

a coequal member of the panel. 

Proposed § 43.3(c) would clarify that 

nothing in § 43.3 shall prevent the 

Director or their delegate from 

communicating with a panel as to 

resource needs or the procedural status 

of any proceeding. This provision is 

intended to permit Office leadership to 

engage in communications of a purely 

administrative or logistical nature that 

are necessary to ensure the effective and 

efficient administration of the Office. 

Communications with a panel 

attempting to influence or direct the 

outcome or reasoning of any decision 

would not be permitted under this 

provision. 

Proposed § 43.3(d) would specifically 

delegate to the Chief Administrative 

Patent Judge the Director’s power to 

designate and re-designate panels of the 

Board under 35 U.S.C. 6(c). The 

proposed rule would also prohibit the 

Director from directing or otherwise 

influencing the paneling or repaneling 

of any proceeding prior to issuance of 

the panel decision. The proposed rule 

permits the Director to issue generally 

applicable paneling guidance to be 

applied to proceedings before the Board, 


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Federal Register / Vol. 88, No. 193 / Friday, October 6, 2023 / Proposed Rules 69581 

and to direct the repaneling of a 

proceeding according to that generally 

applicable guidance when the Director 

is reviewing or rehearing an issued 

panel decision. 

Section 43.4: Proposed § 43.4 would 

govern involvement by Board 

management or Office employees 

outside the Board in the review and 

circulation of decisions prior to 

issuance. The provision ensures judicial 

independence of Board panels while 

permitting a panel member to request 

management input on issues when 

desired. 

Proposed § 43.4(a) would prohibit any 

Management Judge or employee of the 

Office external to the Board from 

initiating communication, directly or 

through intermediaries, with any 

member of a panel regarding a decision, 

prior to issuance of that decision. 

Proposed § 43.4(b) would provide an 

exception to paragraph (a) in the event 

a member of the panel requests input 

from a Management Judge prior to 

issuance of the decision. The proposed 

rule clarifies that requesting input is 

optional and the decision to request 

input is solely within the discretion of 

an individual panel member. 

Proposed § 43.4(c) would specify that 

it is within the panel’s sole discretion to 

adopt any edits, suggestions, or 

feedback provided by a Management 

Judge in response to a request for input, 

and the panel has the final authority 

and responsibility for the content of a 

decision. 

Proposed § 43.4(d) would provide that 

paragraph (a) would not apply to a 

Management Judge who is a member of 

the panel and would specify that when 

sitting as a member of a panel, a 

Management Judge is a coequal member 

of the panel and exercises no review 

authority over the decision. 

Proposed § 43.4(e) would clarify that 

nothing in § 43.4 shall prevent a 

Management Judge from communicating 

with a panel as to resource needs or the 

procedural status of any proceeding. 

This provision is intended to permit 

Board management to engage in 

communications of a purely 

administrative or logistical nature that 

are necessary to ensure the effective and 

efficient administration of the Board. 

Communications with a panel 

attempting to influence or direct the 

outcome or reasoning of any decision 

would not be permitted under this 

provision. 

Section 43.5: Proposed § 43.5 would 

govern procedures for circulation of 

decisions to, and review of decisions by, 

a designated group of non-Management 

Judges if the Office sets forth procedures 

for such circulation. The provision 

promotes consistent, clear, and open 

decision-making by permitting peer 

review of decisions prior to issuance, 

while respecting the judicial 

independence of panels by providing 

that all feedback from such review is 

optional and at the panel’s sole 

discretion to adopt. 

Proposed § 43.5(a) would provide that 

no Management Judge shall participate 

in any such circulation and review 

procedures. The proposed rule further 

provides that if a decision is circulated 

to non-Management Judges for review 

prior to issuance, the reviewing judges 

will not discuss the substance of the 

circulated decision with a Management 

Judge prior to issuance by the panel, 

except with a Management Judge who is 

a member of the panel. 

Proposed § 43.5(b) would specify that 

any edits, suggestions, or feedback 

provided, following circulation and 

review to a non-Management Judge, are 

optional and in the sole discretion of a 

panel to accept. The proposed rule also 

states that the panel has final authority 

and responsibility for the content of a 

decision and determines whether and 

how to incorporate any feedback 

provided. 

Section 43.6: Proposed § 43.6 would 

provide that all decisions of the Board 

are expected to comport with all 

applicable statutes, regulations, binding 

case law, and written agency policy or 

guidance applicable to Board 

proceedings. This proposed provision 

would also specifically state that there 

is no unwritten agency or Board policy 

or guidance that is binding on any panel 

of the Board. The proposed provision 

would further require that all written 

policy or guidance binding on panels of 

the Board shall be made public. 

Rulemaking Considerations 

A. Administrative Procedure Act: The 

changes proposed by this rulemaking 

involve rules of agency practice and 

procedure, and/or interpretive rules. See 

Perez v. Mortg. Bankers Ass’n, 135 S.Ct 

1199, 1204 (2015) (Interpretive rules 

‘‘advise the public of the agency’s 

construction of the statutes and rules 

which it administers.’’ (citation and 

internal quotation marks omitted)); Nat’l 

Org. of Veterans’ Advocates, Inc. v. 

Sec’y of Veterans Affairs, 260 F.3d 1365, 

1375 (Fed. Cir. 2001) (Rule that clarifies 

interpretation of a statute is 

interpretive.). 

Accordingly, prior notice and 

opportunity for public comment are not 

required pursuant to 5 U.S.C. 553(b) or 

(c) or any other law. See Perez, 135 S. 

Ct. 1199, 1206 (Notice-and-comment 

procedures are required neither when 

an agency ‘‘issue[s] an initial 

interpretive rule’’ nor ‘‘when it amends 

or repeals that interpretive rule.’’); 

Cooper Techs. Co. v. Dudas, 536 F.3d 

1330, 1336–37 (Fed. Cir. 2008) (stating 

that 5 U.S.C. 553, and thus 35 U.S.C. 

2(b)(2)(B), do not require notice and 

comment rulemaking for ‘‘interpretative 

rules, general statements of policy, or 

rules of agency organization, procedure, 

or practice’’) (quoting 5 U.S.C. 

553(b)(3)(A)). 

The Office, nevertheless, is publishing 

this proposed rule for comment to seek 

the benefit of the public’s views on the 

Office’s proposed changes as set forth 

herein. 

B. Regulatory Flexibility Act: For the 

reasons set forth 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 notice of proposed 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 notice of 

proposed rulemaking are to set forth 

expressly the rules governing the 

circulation and review of decisions of 

the Board prior to issuance by a panel. 

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 proposed changes are of 

minimal or no additional burden to 

those practicing before the Board. 

For the foregoing reasons, the 

proposed changes in this notice of 

proposed rulemaking would not have a 

significant economic impact on a 

substantial number of small entities. 

C. Executive Order 12866 (Regulatory 

Planning and Review): This rulemaking 

has been determined to be not 

significant for purposes of Executive 

Order 12866 (Sept. 30, 1993), as 

amended by Executive Order 14094 

(April 6, 2023). 

D. Executive Order 13563 (Improving 

Regulation and Regulatory Review): The 

Office has complied with Executive 

Order 13563 (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 

regulatory approach that maximizes net 

benefits; (4) specified performance 

objectives; (5) identified and assessed 

available alternatives; (6) involved the 


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public in an open exchange of 

information and perspectives among 

experts in relevant disciplines, affected 

stakeholders in the private sector and 

the public as a whole, and provided online access to the rulemaking docket; (7) 

attempted to promote coordination, 

simplification, and harmonization 

across government agencies and 

identified goals designed to promote 

innovation; (8) considered approaches 

that reduce burdens and maintain 

flexibility and freedom of choice for the 

public; and (9) ensured the objectivity of 

scientific and technological information 

and processes. 

E. Executive Order 13132 

(Federalism): This rulemaking 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 13175 (Tribal 

Consultation): This rulemaking will not: 

(1) have substantial direct effects on one 

or more Indian tribes; (2) impose 

substantial direct compliance costs on 

Indian tribal governments; or (3) 

preempt tribal law. Therefore, a tribal 

summary impact statement is not 

required under Executive Order 13175 

(Nov. 6, 2000). 

G. Executive Order 13211 (Energy 

Effects): This rulemaking is not a 

significant energy action under 

Executive Order 13211 because this 

rulemaking is not likely to have a 

significant adverse effect on the supply, 

distribution, or use of energy. Therefore, 

a Statement of Energy Effects is not 

required under Executive Order 13211 

(May 18, 2001). 

H. Executive Order 12988 (Civil 

Justice Reform): This rulemaking meets 

applicable standards to minimize 

litigation, eliminate ambiguity, and 

reduce burden as set forth in sections 

3(a) and 3(b)(2) of Executive Order 

12988 (Feb. 5, 1996). 

I. Executive Order 13045 (Protection 

of Children): This rulemaking does not 

concern an environmental risk to health 

or safety that may disproportionately 

affect children under Executive Order 

13045 (Apr. 21, 1997). 

J. Executive Order 12630 (Taking of 

Private Property): This rulemaking will 

not affect a taking of private property or 

otherwise have taking implications 

under Executive Order 12630 (Mar. 15, 

1988). 

K. Congressional Review Act: Under 

the Congressional Review Act 

provisions of the Small Business 

Regulatory Enforcement Fairness Act of 

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

issuing any final rule, the USPTO will 

submit a report containing the rule and 

other required information to the United 

States Senate, the United States House 

of Representatives, and the Comptroller 

General of the Government 

Accountability Office. The changes in 

this notice of proposed rulemaking are 

not expected to result in an annual 

effect on the economy of 100 million 

dollars 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 foreignbased enterprises in domestic and 

export markets. Therefore, this 

rulemaking is not a ‘‘major rule’’ as 

defined in 5 U.S.C. 804(2). 

L. Unfunded Mandates Reform Act of 

1995: The changes set forth in this 

notice of proposed 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 dollars (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 dollars (as adjusted) or more in 

any one year, and will not significantly 

or uniquely affect small governments. 

Therefore, no actions are necessary 

under the provisions of the Unfunded 

Mandates Reform Act of 1995. See 2 

U.S.C. 1501 et seq. 

M. National Environmental Policy 

Act: This rulemaking will not have any 

effect on the quality of the environment 

and is thus categorically excluded from 

review under the National 

Environmental Policy Act of 1969. See 

42 U.S.C. 4321 et seq. 

N. National Technology Transfer and 

Advancement Act: 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 which involve 

the use of technical standards. 

O. Paperwork Reduction Act: 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 

proposed 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. 

P. E-Government Act Compliance: 

The USPTO is committed to compliance 

with the E-Government Act to promote 

the use of the internet and other 

information technologies, to provide 

increased opportunities for citizen 

access to Government information and 

services, and for other purposes. 

List of Subjects in 37 CFR Part 43 

Administrative practice and 

procedure. 

For the reasons set forth in the 

preamble, the USPTO proposes to 

amend title 37 as follows: 

■ 1. Add part 43 to read as follows: 

PART 43— DECISION CIRCULATION 

AND REVIEW WITHIN THE PATENT 

TRIAL AND APPEAL BOARD 

Sec. 

43.1 Policy. 

43.2 Definitions. 

43.3 No Pre-Issuance Director Involvement 

in Board Decisions. 

43.4 Limited Pre-Issuance Management 

Involvement in Decisions. 

43.5 Review of Decisions by NonManagement Judges. 

43.6 Controlling Legal Authority; No 

Unwritten or Non-Public Binding Policy 

or Guidance. 

Authority: 35 U.S.C. 2(b)(2), 6, 134, 135, 

311, 316, 321, and 326; Pub. L. 112–29, 125 

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

2456. 

§ 43.1 Policy. 

Scope. This Part sets forth procedures 

for the pre-issuance circulation and 

review within the Patent Trial and 

Appeal Board of draft panel decisions 

rendered in proceedings pending under 

Parts 41 and 42 of this chapter and sets 

forth the controlling legal authority, 

policy, and guidance applicable to the 

decisions of the Board. 

§ 43.2 Definitions. 

The following definitions apply to 

this part: 

Board means the Patent Trial and 

Appeal Board. 

Decision means any decision, order, 

opinion, or other written work product 

intended for entry into the record of a 

Board proceeding. 

Director means the Under Secretary of 

Commerce for Intellectual Property and 

Director of the United States Patent and 

Trademark Office, or an individual 

serving as Acting Director or performing 

the functions and duties of the Director. 


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Federal Register / Vol. 88, No. 193 / Friday, October 6, 2023 / Proposed Rules 69583 

Deputy Director means the Deputy 

Under Secretary of Commerce for 

Intellectual Property and Deputy 

Director of the United States Patent and 

Trademark Office, or an individual 

serving as Acting Deputy Director. 

Commissioner for Patents and 

Commissioner for Trademarks mean the 

positions defined in 35 U.S.C. 3(b)(2), or 

an individual acting in the capacity of 

one of those positions. 

Issuance means the entry of a 

decision into the record of a Board 

proceeding. 

Management Judge means the Chief 

Administrative Patent Judge, the Deputy 

Chief Administrative Patent Judge, a 

Vice Chief Administrative Patent Judge, 

a Senior Lead Administrative Patent 

Judge, a Lead Administrative Patent 

Judge, including individuals who serve 

in these positions in an acting capacity, 

or any other Administrative Patent 

Judge who, as part of their duties, 

supervises the work of other 

Administrative Patent Judges or is 

responsible for reviewing the 

performance of other Administrative 

Patent Judges. 

Panel means the members of the 

Board assigned to a proceeding pursuant 

to the Board’s Standard Operating 

Procedure 1. 

Proceeding means an appeal or 

contested case under Part 41, or trial 

proceeding under Part 42. 

§ 43.3 No Pre-Issuance Director 

Involvement in Panel Decisions. 

(a) Prior to issuance of a decision by 

the panel, the Director, Deputy Director, 

Commissioner for Patents, and 

Commissioner for Trademarks shall not 

communicate, directly or through 

intermediaries, with any member of the 

panel regarding the decision. 

(b) The prohibition of paragraph (a) 

shall not apply to any proceeding in 

which the individual is a member of the 

panel. When sitting as a member of a 

panel, the Director or other individual 

listed in paragraph (a) is a coequal 

member of the panel and exercises no 

review authority over the proceeding 

prior to the issuance of the panel’s 

decision on the merits. 

(c) Nothing in this section shall 

prevent the Director or delegate from 

communicating with a panel as to 

resource needs or the procedural status 

of any proceeding pending before the 

Board. 

(d) The Chief Administrative Patent 

Judge or delegates of the Chief 

Administrative Patent Judge shall 

designate panels of the Board on behalf 

of the Director. The Director may issue 

generally applicable paneling guidance 

to be applied to proceedings before the 

Board. The Director shall not direct or 

otherwise influence the paneling or 

repaneling of any specific proceeding 

prior to issuance of the panel decision. 

When reviewing or rehearing an issued 

panel decision, the Director may direct 

the repaneling of the proceeding in a 

manner consistent with PTAB paneling 

guidance, through an Order entered into 

the record. 

§ 43.4 Limited Pre-Issuance Management 

Involvement in Decisions. 

(a) Except as requested pursuant to 

paragraph (b) or permitted under 

paragraph (d) or (e), prior to issuance of 

a decision by the panel, no Management 

Judge or employee of the Office external 

to the Board shall initiate 

communication, directly or through 

intermediaries, with any member of a 

panel regarding a decision. 

(b) Any individual panel member may 

request that one or more Management 

Judges provide input on a decision prior 

to issuance. The choice to request input 

is optional and solely within the 

discretion of an individual panel 

member. 

(c) It is within the sole discretion of 

the panel to adopt any edits, 

suggestions, or feedback provided to the 

panel by a Management Judge as part of 

a review requested under paragraph (b). 

The panel has final authority and 

responsibility for the content of a 

decision and determines whether and 

how to incorporate any feedback 

requested under paragraph (b). 

(d) The prohibition of paragraph (a) 

shall not apply to any Management 

Judge who is a member of the panel. 

When sitting as a member of a panel, a 

Management Judge is a coequal member 

of the panel and exercises no review 

authority over the proceeding prior to 

the issuance of the panel’s decision on 

the merits. 

(e) Nothing in this section shall 

prevent a Management Judge from 

communicating with a panel as to 

resource needs or the procedural status 

of any case pending before the Board. 

§ 43.5 Review of Decisions by NonManagement Judges. 

If the Office establishes procedures 

governing the internal circulation and 

review of decisions prior to issuance to 

one or more designated members of the 

Board: 

(a) No Management Judge shall 

participate directly or indirectly in any 

such review and the reviewing nonManagement judges shall not discuss 

the substance of any circulated decision 

with a Management Judge prior to 

issuance of the decision, except with a 

Management Judge who is a member of 

the panel; and 

(b) Any edits, suggestions, or feedback 

provided to the panel pursuant to such 

circulation and review are optional and 

in the sole discretion of the panel to 

accept. The panel has final authority 

and responsibility for the content of a 

decision and determines whether and 

how to incorporate any feedback 

provided. 

§ 43.6 Controlling Legal Authority; No 

Unwritten or Non-Public Binding Policy or 

Guidance. 

Notwithstanding any other provision 

of this Part, all decisions of the Board 

are expected to comport with all 

applicable statutes, regulations, binding 

case law, and written agency policy and 

guidance applicable to Board 

proceedings. There shall be no 

unwritten agency or Board policy or 

guidance that is binding on any panel of 

the Board. All written policy and 

guidance binding on panels of the Board 

shall be made public. 

Katherine K. Vidal, 

Under Secretary of Commerce for Intellectual 

Property and Director of the United States 

Patent and Trademark Office. 

[FR Doc. 2023–22218 Filed 10–5–23; 8:45 am] 

BILLING CODE 3510–16–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 93 

RIN 0937–AA12 

Public Health Service Policies on 

Research Misconduct 

AGENCY: U.S. Department of Health and 

Human Services (HHS). 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: In this Notice of Proposed 

Rulemaking (NPRM), the Department of 

Health and Human Services (HHS), 

Office of the Secretary, Office of the 

Assistant Secretary for Health (OASH), 

Office of Research Integrity (ORI) 

proposes to revise the Public Health 

Service (PHS) Policies on Research 

Misconduct. The proposed revisions are 

based on the experience ORI and 

institutions have gained with the 

regulation since it was released in 2005. 

This NPRM seeks comment from 

individuals, institutional officials, 

organizations, institutions, research 

funding agencies, and other members of 

the public on the proposed revisions 

and how to improve the clarity of 

substantive and non-substantive. 


lotter on DSK11XQN23PROD with PROPOSALS1