Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Proposed Rules 27043 

Protesters are asked to call or email the 

person listed in the FOR FURTHER

INFORMATION CONTACT section to 

coordinate protest activities so that your 

message can be received without 

jeopardizing the safety or security of 

people, places, or vessels. 

V. Public Participation and Request for 

Comments 

We view public participation as 

essential to effective rulemaking, and 

will consider all comments and material 

received during the comment period. 

Your comment can help shape the 

outcome of this rulemaking. If you 

submit a comment, please include the 

docket number for this rulemaking, 

indicate the specific section of this 

document to which each comment 

applies, and provide a reason for each 

suggestion or recommendation. 

Submitting comments. We encourage 

you to submit comments through the 

Federal Decision Making Portal at 

https://www.regulations.gov. To do so, 

go to https://www.regulations.gov, type 

USCG–2022–0340 in the search box and 

click ‘‘Search.’’ Next, look for this 

document in the Search Results column, 

and click on it. Then click on the 

Comment option. If you cannot submit 

your material by using https://

www.regulations.gov, call or email the 

person in the FOR FURTHER INFORMATION

CONTACT section of this proposed rule 

for alternate instructions. 

Viewing material in docket. To view 

documents mentioned in this proposed 

rule as being available in the docket, 

find the docket as described in the 

previous paragraph, and then select 

‘‘Supporting & Related Material’’ in the 

Document Type column. Public 

comments will also be placed in our 

online docket and can be viewed by 

following instructions on the https://

www.regulations.gov. Frequently Asked 

Questions web page. We review all 

comments received, but we will only 

post comments that address the topic of 

the proposed rule. We may choose not 

to post off-topic, inappropriate, or 

duplicate comments that we receive. 

Personal information. We accept 

anonymous comments. Comments we 

post to https://www.regulations.gov will 

include any personal information you 

have provided. For more about privacy 

and submissions to the docket in 

response to this document, see DHS’s 

eRulemaking System of Records notice 

(85 FR 14226, March 11, 2020). 

List of Subjects in 33 CFR Part 100 

Marine safety, Navigation (water), 

Reporting and recordkeeping 

requirements, Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard is proposing 

to amend 33 CFR part 100 as follows: 

PART 100—SAFETY OF LIFE ON 

NAVIGABLE WATERS 

■ 1. The authority citation for part 100 

continues to read as follows: 

Authority: 46 U.S.C. 70041; 33 CFR 

1.05–1. 

■ 2. Add § 100.T08–0340 to read as 

follows: 

§ 100.T08–0340 Tri Louisville, Ohio River, 

Louisville, KY. 

(a) Regulated area. The regulations in 

this section apply to the following area: 

All waters of Ohio River, from mile 

marker 602 to 603 extending the entire 

width of the river. 

(b) Definitions. As used in this 

section— 

Designated representative means a 

Coast Guard Patrol Commander, 

including a Coast Guard coxswain, petty 

officer, or other officer operating a Coast 

Guard vessel and a Federal, State, and 

local officer designated by or assisting 

the Captain of the Port Sector Ohio 

Valley (COTP) in the enforcement of the 

regulations in this section. 

Participant means all persons and 

vessels registered with the event 

sponsor as a participants in the race. 

(c) Regulations. (1) All nonparticipants are prohibited from 

entering, transiting through, anchoring 

in, or remaining within the regulated 

area described in paragraph (a) of this 

section unless authorized by the Captain 

of the Port Ohio Valley or their 

designated representative. 

(2) To seek permission to enter, 

contact the COTP or the COTP’s 

representative by Sector Ohio Valley 

command center at 502–779–5422. 

Those in the regulated area must 

comply with all lawful orders or 

directions given to them by the COTP or 

the designated representative. 

(3) The COTP will provide notice of 

the regulated area through advanced 

notice via broadcast notice to mariners 

and by on-scene designated 

representatives. 

(d) Enforcement period. This section 

will be enforced from 6 a.m. through 10 

a.m. on July 24, 2022. 

Dated: April 29, 2022. 

A.M. Beach, 

Captain, U.S. Coast Guard, Captain of the 

Port Ohio Valley. 

[FR Doc. 2022–09698 Filed 5–5–22; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF COMMERCE 

Patent and Trademark Office 

37 CFR Part 1 

[Docket No. PTO–P–2021–0061] 

RIN 0651–AD59 

Establishing Permanent Electronic 

Filing for Patent Term Extension 

Applications 

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 to amend the Rules of Practice 

in Patent Cases to require that patent 

term extension (PTE) applications, 

interim PTE applications, and any 

related submissions to the USPTO be 

submitted electronically via the USPTO 

patent electronic filing system (EFSWeb or Patent Center). The proposed 

rule changes would reduce the 

administrative burden on PTE 

applicants. They also would further 

advance the USPTO’s information 

technology (IT) strategy to achieve 

complete beginning-to-end electronic 

processing of patent-related 

submissions, thereby improving 

administrative efficiency by facilitating 

electronic file management, optimizing 

workflow processes, and reducing 

processing errors. 

DATES: Comments must be received by 

July 5, 2022 to ensure consideration. 

ADDRESSES: For reasons of Government 

efficiency, comments must be submitted 

through the Federal eRulemaking Portal 

at www.regulations.gov. To submit 

comments via the portal, enter docket 

number PTO–P–2021–0061 on the 

homepage and click ‘‘Search.’’ The site 

will provide a search results page listing 

all documents associated with this 

docket. Find a reference to this 

document and click on the ‘‘Comment 

Now! ’’ icon, complete the required 

fields, and enter or attach your 

comments. Attachments to electronic 

comments will be accepted in Adobe®

portable document format (PDF) or 

Microsoft Word® format. Because 

comments will be made available for 

public inspection, information that the 

submitter does not desire to make 

public, such as an address or phone 

number, should not be included in the 

comments. 

Visit the Federal eRulemaking Portal 

for additional instructions on providing 

comments via the portal. If electronic 

submission of, or access to, comments is 


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27044 Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Proposed Rules 

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: Ali 

Salimi, Senior Legal Advisor, Office of 

Patent Legal Administration, at 571– 

272–0909; or Raul Tamayo, Senior Legal 

Advisor, Office of Patent Legal 

Administration, at 571–272–7728. You 

can also send inquiries to 

patentpractice@uspto.gov. 

SUPPLEMENTARY INFORMATION: PTE under 

35 U.S.C. 156 enables the owners of 

patents that claim certain human drug 

products, medical device products, 

animal drug products, veterinary 

biological products, and food or color 

additive products to restore to the terms 

of those patents some of the time lost 

while awaiting premarket Government 

approval for the products from a 

regulatory agency. See, e.g., section 

2750 of the Manual of Patent Examining 

Procedure (MPEP, Ninth Edition, R– 

10.2019). The USPTO administers 35 

U.S.C. 156 in partnership with the 

relevant regulatory agencies (i.e., the 

Food and Drug Administration (FDA) 

and the United States Department of 

Agriculture (USDA)). As part of its 

administration, the USPTO sends to the 

relevant agency a copy of any initial 

submission for PTE that the USPTO 

receives (i.e., a copy of any PTE 

application under 35 U.S.C. 156(d)(1) 

and 37 CFR 1.740 or any interim PTE 

application under 35 U.S.C. 156(d)(5) 

and 37 CFR 1.790). 

Prior to the COVID–19 pandemic, the 

USPTO prohibited the electronic filing 

of initial submissions for PTE. See 

section B2 of the Legal Framework for 

Patent Electronic System, available at 

www.uspto.gov/patents/apply/filingonline/legal-framework-efs-web, and 

section 502.05(I)(B)(2) of the MPEP. 

Requiring initial PTE submissions, 

which often comprise hundreds of 

pages, to be physically filed in triplicate 

under 37 CFR 1.740(b) was viewed as 

the most effective way to minimize 

processing errors. 

Due to the workplace changes caused 

by the COVID–19 pandemic, the USPTO 

waived its prohibition on the electronic 

filing of initial submissions for PTE and 

the triplicate copy requirements in 37 

CFR 1.740(b) and 1.790(b). See Relief 

Available to Patentees in View of the 

COVID–19 Outbreak for Submission of 

Initial Patent Term Extension 

Applications Filed Pursuant to 35 

U.S.C. 156, 1475 Off. Gaz. Pat. Office 

234 (June 23, 2020). The waiver did not 

impact related follow-on submissions to 

the USPTO, which were already 

permitted to be filed electronically prior 

to the pandemic. 

Through informal feedback received 

during the processing of PTE 

applications, stakeholders have thus far 

communicated unanimous support for 

electronic filing of initial PTE 

submissions. Additionally, the USPTO 

and its partner agencies have 

successfully implemented a system by 

which the USPTO electronically 

transmits a copy of any initial 

submission for PTE to the relevant 

agency. The new system has not caused 

any processing errors. 

Accordingly, the USPTO is proposing 

to change its rules of practice to require 

that PTE applications, interim PTE 

applications, and any related 

submissions to the USPTO be submitted 

electronically via the USPTO patent 

electronic filing system. The proposed 

rule changes are designed to streamline 

the filing of PTE applications and 

related documents and minimize paper 

handling. As has been the case since the 

June 2020 implementation of the 

electronic filing waiver, the proposed 

rule changes will result in PTE 

applications being viewable in USPTO 

patent electronic viewing systems (the 

Patent Application Information 

Retrieval (PAIR) system or Patent 

Center) immediately upon filing. 

Additionally, the changes would permit 

the USPTO to more efficiently allocate 

the personnel and physical space it 

currently deploys for the handling of 

physical copies of PTE submissions. 

If the proposed rule changes are 

adopted, PTE applicants must use the 

correct document description to ensure 

that USPTO personnel are timely 

apprised of electronic submissions. 

‘‘Patent Term Extension Application 

Under 35 U.S.C. 156’’ (Doc Code 

TERM.REQ) is the correct document 

description for a PTE application under 

35 U.S.C. 156(d)(1) and 37 CFR 1.740, 

and ‘‘Interim Patent Term Extension 

Application Under 35 U.S.C. 156(d)(5)’’ 

(Doc Code TERM.REQ.ITM) is the 

correct document description for an 

interim PTE application under 35 U.S.C. 

156(d)(5) and 37 CFR 1.790. The USPTO 

has also created the new document 

descriptions ‘‘Interim Patent Term 

Extension Request Under 35 U.S.C. 

156(e)(2)’’ (Doc Code TERM.REQ.E2) for 

requests for interim extension of the 

patent term under 35 U.S.C. 156(e)(2) 

and 37 CFR 1.760, and ‘‘Disclosure 

Under 37 CFR 1.765 in a Patent Term 

Extension Application’’ (Doc Code 

TERM.DISCL) for disclosures to the 

USPTO under 37 CFR 1.765. PTE 

applicants are reminded that, when 

multiple PTE applications are filed for 

different patents based on the same 

regulatory review period, it is 

incumbent upon the PTE applicants to 

inform the USPTO of the various PTE 

applications, pursuant to 37 CFR 

1.740(a)(13) and 37 CFR 1.765. See also 

section 2761 of the MPEP. 

In addition, the USPTO has created 

the new document description ‘‘Limited 

POA and/or Change of Address for a 

Patent Term Extension Application’’ 

(Doc Code PTE.POA) for limited powers 

of attorney and/or changes of 

correspondence address that are filed 

specifically for PTE applications. 

Although a power of attorney or limited 

power of attorney is not required for a 

practitioner to prosecute a PTE 

application (practitioners may prosecute 

PTE applications by acting in a 

representative capacity pursuant to 37 

CFR 1.34), the USPTO routinely 

receives limited powers of attorney 

specifying that the power is limited to 

prosecution of the PTE application. A 

limited power of attorney filed using the 

document description ‘‘Limited POA 

and/or Change of Address for a Patent 

Term Extension Application’’ (Doc Code 

PTE.POA) will not be processed by the 

Office of Patent Application Processing 

(OPAP) and will not serve to change an 

existing power for the underlying patent 

or establish power for the underlying 

patent. 

As for a change of the correspondence 

address that is filed specifically for a 

PTE application, the USPTO uses the 37 

CFR 1.740(a)(15) address provided in an 

initial PTE or interim PTE application 

strictly for communications regarding 

the PTE application. If a PTE applicant 

subsequently wishes to change the 37 

CFR 1.740(a)(15) address, the document 

description ‘‘Limited POA and/or 

Change of Address for a Patent Term 

Extension Application’’ (Doc Code 

PTE.POA) should be used for the 

submission. A change of address filed 

using the document description 

‘‘Limited POA and/or Change of 

Address for a Patent Term Extension 

Application’’ (Doc Code PTE.POA) will 

not be processed by the OPAP and will 

not serve to change the correspondence 

address for the underlying patent. PTE 

applicants are reminded to separately 

file a change of address with any other 

relevant regulatory agency to timely 

receive copies of correspondence from 

that agency. 

PTE applicants are strongly 

encouraged to confirm that they have 

used the correct document description 

for any PTE submission, especially 

time-sensitive PTE submissions, such as 

interim PTE applications under 35 

U.S.C. 156(d)(5) and 37 CFR 1.790. Use 

of the correct document description may 

be verified by reviewing the EFS 


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Acknowledgement Receipt (Doc Code 

N417) issued for the submission. In 

addition, both the document description 

and code for a submission may be 

verified in the electronic application 

file. If a mistake is identified, PTE 

applicants should contact the Patent 

Electronic Business Center at 866–217– 

9197 or EBC@uspto.gov. 

When electronically filing a PTE or 

interim PTE application, the PTE or 

interim PTE application, including all 

exhibits, attachments, or appendices, 

should be submitted as a single file. If 

the single file comprising the 

application and its exhibits, 

attachments, or appendices exceeds the 

upload limit of the USPTO patent 

electronic filing system, the file may be 

split into smaller files to permit 

uploading, but the number of separate 

files to be uploaded should be 

minimized. Additionally, when splitting 

a file into smaller files, the order of the 

exhibits, attachments, or appendices as 

mentioned in the application should be 

maintained, and a single exhibit, 

attachment, or appendix should not be 

split, if possible. The USPTO has 

created a new document description, 

‘‘Continuation of Patent Term Extension 

Application’’ (Doc Code 

PTE.APPENDIX), to be used for any 

exhibit, attachment, or appendix to a 

PTE or interim PTE application that is 

filed separately from the application. 

Discussion of Specific Rules 

The following is a discussion of the 

proposed amendments to 37 CFR part 1. 

Section 1.740: Section 1.740(a)(15) is 

proposed to be amended to require the 

provision of an email address of the 

person to whom inquiries and 

correspondence related to the PTE 

application are to be directed. The 

USPTO has found that the availability of 

an email address facilitates contact with 

the PTE applicant’s representative. 

Section 1.740(b) is proposed to be 

amended to require that PTE 

applications under § 1.740, and any 

related submissions to the USPTO, be 

submitted using the USPTO patent 

electronic filing system in accordance 

with the USPTO patent electronic filing 

system requirements. Submissions to 

the USPTO related to PTE applications 

under § 1.740 include any related 

follow-on documents that must be 

submitted to the USPTO, such as 

corrections of informalities under 

§ 1.740(c), petitions requesting review of 

incomplete filings or review of an 

accorded filing date under § 1.741(b), 

requests for reconsideration of notices of 

final determination and responses to 

requirements for information under 

§ 1.750, requests for 35 U.S.C. 156(e)(2) 

interim extensions under § 1.760, 

disclosures to the USPTO under § 1.765, 

express withdrawals under § 1.770, and 

replies to requests to identify the holder 

of an approval under § 1.785(d). PTErelated submissions to the FDA or the 

USDA, such as disclosures to the 

Secretary of Health and Human Services 

or the Secretary of Agriculture under 

§ 1.765, should continue to be filed 

directly with the relevant agency. The 

proposed amendment of § 1.740(b) 

would remove the requirement in the 

current § 1.740(b) to file each PTE 

application in triplicate. 

Section 1.741: Section 1.741(a) is 

proposed to be amended to provide that 

the filing date of a PTE application is 

the date on which a complete PTE 

application is either received in the 

USPTO via the USPTO patent electronic 

filing system or filed pursuant to the 

procedure set forth in § 1.8(a)(1)(i)(C) 

and (a)(1)(ii). The provision in the 

current § 1.741(a), which provides that 

the filing date of a PTE application may 

be the date on which a complete 

application is filed pursuant to the 

physical mailing or facsimile 

transmission procedures set forth in 

§§ 1.8(a)(1)(i)(A) or (B) or 1.10, is 

proposed to be removed in view of the 

proposed requirement to file PTE 

applications via the USPTO patent 

electronic filing system. 

Section 1.770: Section 1.770 is 

proposed to be amended to remove the 

requirement to file duplicates of express 

declarations of withdrawal of PTE 

applications. The requirement would no 

longer be needed in view of the 

proposed requirement to file 

submissions related to PTE applications 

via the USPTO patent electronic filing 

system. 

Section 1.790: Section 1.790(a) is 

proposed to be amended to clarify that 

the referenced paragraphs are 

paragraphs of 35 U.S.C. 156(g). 

Additionally, the time periods in the 

current § 1.790(a) for filing initial and 

subsequent applications for interim 

extension are proposed to be moved to 

newly proposed paragraphs (c)(1) and 

(d)(1), respectively, of this section. 

Section 1.790(b) is proposed to be 

amended to require any application for 

interim extension under this section 

(i.e., both initial and subsequent interim 

extension applications) to be filed using 

the USPTO patent electronic filing 

system in accordance with the USPTO 

patent electronic filing system 

requirements. The provisions in the 

current § 1.790(b) regarding a complete 

application for interim extension are 

proposed to be moved to newly 

proposed paragraph (c)(2) of this 

section. 

Section 1.790(c) is proposed to be 

amended to provide the requirements 

for complete initial applications for 

interim extension. Newly proposed 

§ 1.790(c)(1) contains the time period in 

the current § 1.790(a) for filing an initial 

interim extension application. Newly 

proposed § 1.790(c)(2) contains the 

provisions in the current § 1.790(b) 

regarding a complete interim extension 

application. Note that the reference in 

the current § 1.790(b) to § 1.740(a)(16) 

and (17) is proposed to not be included 

in newly proposed § 1.790(c)(2) to 

correct an oversight. Paragraphs (a)(16) 

and (17) were removed from § 1.740 on 

September 8, 2000. Newly proposed 

§ 1.790(c)(3) requires a statement that 

the applicable regulatory review period, 

described in 35 U.S.C. 156(g)(1)(B)(ii), 

(2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or 

(5)(B)(ii), has begun for the product. It 

also requires an identification of the 

application, petition, or notice that 

caused the applicable regulatory review 

period, described in 35 U.S.C. 

156(g)(1)(B)(ii), (2)(B)(ii), (3)(B)(ii), 

(4)(B)(ii), or (5)(B)(ii), to begin. For a 

human drug, antibiotic, or human 

biological product, it would be the 

number associated with the new drug 

application or Product License 

Application submitted for the product. 

For a new animal drug, it would be the 

number associated with the new animal 

drug application submitted for the drug. 

For a veterinary biological product, it 

would be the number associated with 

the application for license submitted 

under the Virus-Serum-Toxin Act for 

the product. For a food or color 

additive, it would be the number 

associated with the petition for product 

approval submitted under the Federal 

Food, Drug, and Cosmetic Act for the 

additive. For a medical device, it would 

be the number associated with the 

premarket approval application or 

notice of completion of a product 

development protocol submitted for the 

device. The USPTO has occasionally 

received applications for interim 

extension under 35 U.S.C. 156(d)(5) and 

§ 1.790 that fail to meet the statutory 

requirement regarding the applicable 

regulatory review period. 

Newly proposed § 1.790(d) contains 

the requirements for subsequent interim 

extension applications. Newly proposed 

§ 1.790(d)(1) contains the time period in 

the current § 1.790(a) for filing each 

subsequent interim extension 

application. Newly proposed 

§ 1.790(d)(2) contains provisions in the 

current § 1.790(c) regarding the content 

of each subsequent interim extension 

application. Newly proposed 

§ 1.790(d)(3) contains the requirement 


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in the current § 1.790(c) that an 

application contain a statement that the 

applicable regulatory review period, 

described in 35 U.S.C. 156(g)(1)(B)(ii), 

(2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or 

(5)(B)(ii), has not been completed. 

Rulemaking Requirements 

A. Administrative Procedure Act: The 

changes proposed in 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 v. Sec’y of 

Veterans Affairs, 260 F.3d 1365, 1375 

(Fed. Cir. 2001) (rule that clarifies the 

interpretation of a statute is 

interpretive); Bachow Commc’ns Inc. v. 

FCC, 237 F.3d 683, 690 (D.C. Cir. 2001) 

(Rules governing an application process 

are procedural under the Administrative 

Procedure Act.); Inova Alexandria Hosp. 

v. Shalala, 244 F.3d 342, 350 (4th Cir. 

2001) (Rules for handling appeals were 

procedural where they did not change 

the substantive standard for reviewing 

claims.). 

Accordingly, prior notice and 

opportunity for public comment for the 

changes proposed in this rulemaking are 

not required pursuant to 5 U.S.C. 553(b) 

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

S. Ct. at 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-andcomment rulemaking for ‘‘interpretative 

rules, general statements of policy, or 

rules of agency organization, procedure, 

or practice’’ (quoting 5 U.S.C. 

553(b)(A))). However, the USPTO has 

chosen to seek public comment before 

implementing this rule to benefit from 

the public’s input. 

B. Regulatory Flexibility Act: Under 

the Regulatory Flexibility Act (5 U.S.C. 

601 et seq.), whenever an agency is 

required by 5 U.S.C. 553 (or any other 

law) to publish a notice of proposed 

rulemaking, the agency must prepare 

and make available for public comment 

an Initial Regulatory Flexibility 

Analysis, unless the agency certifies 

under 5 U.S.C. 605(b) that the proposed 

rule, if implemented, will not have a 

significant economic impact on a 

substantial number of small entities. 5 

U.S.C. 603, 605. For the reasons set forth 

in this document, the Senior Counsel for 

Regulatory and Legislative Affairs, 

Office of General Law, of the USPTO 

has certified to the Chief Counsel for 

Advocacy of the Small Business 

Administration that the proposed rule, 

if implemented, will not have a 

significant economic impact on a 

substantial number of small entities. See 

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

As a threshold matter, PTE under 35 

U.S.C. 156 is only available for patents 

that claim drug products, medical 

devices, food or color additives, or 

methods of using or manufacturing such 

products, devices, or additives. 

Approximately 100 PTE applications are 

filed annually, and they are typically 

filed by non-small entity 

pharmaceutical and medical device 

companies because of the expense 

required to develop and obtain 

marketing approval for such inventions. 

The changes proposed in this rule are 

procedural in nature and are not 

expected to result in significant costs to 

applicants. The current rules of practice 

permit follow-on documents related to 

PTE applications to be filed 

electronically. The USPTO estimates 

that approximately 99% of follow-on 

documents related to PTE applications 

are filed electronically. Accordingly, the 

proposed rule change requiring followon documents related to PTE 

applications to be filed electronically 

should not cause a substantial change in 

practice or result in additional costs to 

applicants. As for the proposed rule 

change requiring PTE applications to be 

filed electronically, although this would 

be a change in practice, stakeholders 

have unanimously communicated 

support for the USPTO’s current waiver 

of the prohibition against electronic 

filing of PTE applications as a result of 

the COVID–19 outbreak, and the 

proposed rule change would not result 

in any additional cost to applicants. 

Thus, this proposed rule change 

requiring PTE applications to be filed 

electronically is not expected to 

negatively impact stakeholders’ PTE 

practice. 

Finally, the USPTO patent electronic 

filing system will allow PTE applicants 

to file PTE documents through their 

standard web browser without 

downloading special software, changing 

their documentation preparation tools, 

or altering their workflow processes. 

PTE applicants may create their 

documents using the tools and 

processes that they already use and then 

convert those documents into standard 

PDF files for submission through the 

USPTO patent electronic filing system. 

For these reasons, the proposed 

changes will not have a significant 

economic impact on a substantial 

number of small entities. 

C. Executive Order 12866 (Regulatory 

Planning and Review): This proposed 

rule has been determined to be not 

significant for purposes of Executive 

Order 12866 (Sept. 30, 1993). 

D. Executive Order 13563 (Improving 

Regulation and Regulatory Review): The 

USPTO has complied with Executive 

Order 13563 (Jan. 18, 2011). 

Specifically, the USPTO has, to the 

extent feasible and applicable: (1) Made 

a reasoned determination that the 

benefits justify the costs of the proposed 

rule; (2) tailored the proposed rule to 

impose the least burden on society 

consistent with obtaining the regulatory 

objectives; (3) selected a regulatory 

approach that maximizes net benefits; 

(4) specified performance objectives; (5) 

identified and assessed available 

alternatives; (6) involved the public in 

an open exchange of information and 

perspectives among experts in relevant 

disciplines, affected stakeholders in the 

private sector, and the public as a 

whole, and provided online access to 

the rulemaking docket; (7) attempted to 

promote coordination, simplification, 

and harmonization across Government 

agencies and identified goals designed 

to promote innovation; (8) considered 

approaches that reduce burdens and 

maintain flexibility and freedom of 

choice for the public; and (9) ensured 

the objectivity of scientific and 

technological information and 

processes. 

E. Executive Order 13132 

(Federalism): This proposed rule 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 proposed rule 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 proposed rule is not a 

significant energy action under 

Executive Order 13211 because the 

proposed rule 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 proposed rule 

meets applicable standards to minimize 


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Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Proposed Rules 27047 

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 proposed rule 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 proposed rule 

will not effect 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. 801–808), prior to issuing 

any final rule, the USPTO will submit 

a report containing any final rule 

resulting from this proposed rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the Government 

Accountability Office. The changes in 

this proposed rule are not expected to 

result in an annual effect on the 

economy of $100 million or more, a 

major increase in costs or prices, or 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or the ability 

of United States-based enterprises to 

compete with foreign-based enterprises 

in domestic and export markets. 

Therefore, this proposed rule is not a 

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

804(2). 

L. Unfunded Mandates Reform Act of 

1995: The proposed changes set forth in 

this rulemaking do not involve a Federal 

intergovernmental mandate that will 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

of $100 million (as adjusted) or more in 

any one year, or a Federal private sector 

mandate that will result in the 

expenditure by the private sector of 

$100 million (as adjusted) or more in 

any one year, and will not significantly 

or uniquely affect small governments. 

Therefore, no actions are necessary 

under the provisions of the Unfunded 

Mandates Reform Act of 1995. See 2 

U.S.C. 1501 et seq. 

M. National Environmental Policy Act 

of 1969: This proposed rule will not 

have any effect on the quality of the 

environment and is thus categorically 

excluded from review under the 

National Environmental Policy Act of 

1969. See 42 U.S.C. 4321 et seq. 

N. National Technology Transfer and 

Advancement Act of 1995: The 

requirements of section 12(d) of the 

National Technology Transfer and 

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

272 note) are not applicable because this 

proposed rule does not contain 

provisions that involve the use of 

technical standards. 

O. Paperwork Reduction Act of 1995: 

The Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.) requires that the 

USPTO consider the impact of 

paperwork and other information 

collection burdens imposed on the 

public. In accordance with section 

3507(d) of the Paperwork Reduction Act 

of 1995, the paperwork and other 

information collection burdens involved 

with this proposed rule have already 

been approved under the Office of 

Management and Budget (OMB) Control 

Number 0651–0020 (Patent Term 

Extension). However, 0651–0020 will be 

updated to reflect a reduction in burden 

(time) due to the removal of the 

requirement to file PTE applications in 

paper in triplicate. The USPTO 

estimates that this information 

collection’s annual burden will decrease 

by a total of approximately 51 burden 

hours. This estimate is based on the 

current OMB-approved burdens 

(response volumes) associated with this 

information collection, which may 

fluctuate over time and may be different 

from any forecasts mentioned in other 

parts of this proposed rule. 

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 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 1 

Administrative practice and 

procedure, Biologics, Courts, Freedom 

of information, Inventions and patents, 

Reporting and recordkeeping 

requirements, Small businesses. 

For the reasons set forth in the 

preamble, the USPTO proposes to 

amend 37 CFR part 1 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. Amend § 1.740 by revising 

paragraphs (a)(15) and (b) to read as 

follows: 

§ 1.740 Formal requirements for 

application for extension of patent term; 

correction of informalities. 

(a) * * * 

(15) The name, address, telephone 

number, and email address of the 

person to whom inquiries and 

correspondence related to the 

application for patent term extension 

are to be directed. 

(b) The application under this section, 

and any related submissions to the 

Office, must be submitted using the 

USPTO patent electronic filing system 

in accordance with the USPTO patent 

electronic filing system requirements. 

* * * * * 

■ 3. Amend § 1.741 by revising 

paragraph (a) introductory text to read 

as follows: 

§ 1.741 Complete application given a filing 

date; petition procedure. 

(a) The filing date of an application 

for extension of a patent term is the date 

on which a complete application is 

either received in the Office via the 

USPTO patent electronic filing system 

or filed pursuant to the procedure set 

forth in § 1.8(a)(1)(i)(C) and (a)(1)(ii). A 

complete application must include: 

* * * * * 

■ 4. Amend § 1.770 by revising the first 

sentence to read as follows: 

§ 1.770 Express withdrawal of application 

for extension of patent term. 

An application for extension of patent 

term may be expressly withdrawn 

before a determination is made pursuant 

to § 1.750 by filing in the Office a 

written declaration of withdrawal 

signed by the owner of record of the 

patent or its agent. * * * 

■ 5. Revise § 1.790 to read as follows: 

§ 1.790 Interim extension of patent term 

under 35 U.S.C. 156(d)(5). 

(a) An owner of record of a patent or 

its agent who reasonably expects that 

the applicable regulatory review period, 

described in 35 U.S.C. 156(g)(1)(B)(ii), 

(2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or 

(5)(B)(ii), that began for a product that 

is the subject of such patent may extend 

beyond the expiration of the patent term 

in effect may submit one or more 

applications for interim extensions for 

periods of up to one year each. In no 

event will the interim extensions 

granted under this section be longer 

than the maximum period of extension 

to which the applicant would be 

entitled under 35 U.S.C. 156(c). 


JSPEARS on DSK121TN23PROD with PROPOSALS1
27048 Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Proposed Rules 

(b) Any application for interim 

extension under this section must be 

filed using the USPTO patent electronic 

filing system in accordance with the 

USPTO patent electronic filing system 

requirements. 

(c) Complete initial applications for 

interim extension under this section 

must: 

(1) Be filed during the period 

beginning 6 months and ending 15 days 

before the patent term is due to expire, 

and include a statement that the initial 

application is being submitted within 

the period and an identification of the 

date of the last day on which the initial 

application could be submitted; 

(2) Include all of the information 

required for a formal application under 

§ 1.740 and a complete application 

under § 1.741, except as follows: 

(i) Paragraphs (a)(1), (2), (4), and (6) 

through (15) of §§ 1.740 and 1.741 shall 

be read in the context of a product 

currently undergoing regulatory review; 

and 

(ii) Paragraphs (a)(3) and (5) of § 1.740 

are not applicable to an application for 

interim extension under this section; 

and 

(3) Include a statement that the 

applicable regulatory review period, 

described in 35 U.S.C. 156(g)(1)(B)(ii), 

(2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or 

(5)(B)(ii), has begun for the product that 

is the subject of the patent, and identify 

the application, petition, or notice that 

caused the applicable regulatory review 

period to begin. 

(d) Each subsequent application for 

interim extension: 

(1) Must be filed during the period 

beginning 60 days before and ending 30 

days before the expiration of the 

preceding interim extension and 

include a statement that it is being 

submitted within the period and an 

identification of the date of the last day 

on which it could be submitted; 

(2) May be limited in content to a 

request for a subsequent interim 

extension along with any materials or 

information required under §§ 1.740 and 

1.741 that are not present in the 

preceding interim extension 

application; and 

(3) Must include a statement that the 

applicable regulatory review period, 

described in 35 U.S.C. 156(g)(1)(B)(ii), 

(2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or 

(5)(B)(ii), has not been completed. 

Katherine K. Vidal, 

Under Secretary of Commerce for Intellectual 

Property and Director of the United States 

Patent and Trademark Office. 

[FR Doc. 2022–09535 Filed 5–5–22; 8:45 am] 

BILLING CODE 3510–16–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R07–OAR–2022–0382; FRL–9767–01– 

R7] 

Air Plan Approval; Missouri; Removal 

of Control of Emissions From Bakery 

Ovens 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing approval of 

a State Implementation Plan (SIP) 

revision submitted by the State of 

Missouri on January 15, 2019 and 

supplemented by letter on July 11, 2019. 

Missouri requests that the EPA remove 

from its SIP a rule related to control of 

emissions from bakery ovens in St. 

Louis City and Jefferson, St. Charles, 

Franklin, and St. Louis Counties. The 

EPA’s proposed approval of this rule 

revision is in accordance with the 

requirements of the Clean Air Act 

(CAA). 

DATES: Comments must be received on 

or before June 6, 2022. 

ADDRESSES: You may send comments, 

identified by Docket ID No. EPA–R07– 

OAR–2022–0382 to https://

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Instructions: All submissions received 

must include the Docket ID No. for this 

rulemaking. Comments received will be 

posted without change to https://

www.regulations.gov/, including any 

personal information provided. For 

detailed instructions on sending 

comments and additional information 

on the rulemaking process, see the 

‘‘Written Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

FOR FURTHER INFORMATION CONTACT: 

William Stone, Environmental 

Protection Agency, Region 7 Office, Air 

Quality Planning Branch, 11201 Renner 

Boulevard, Lenexa, Kansas 66219; 

telephone number: (913) 551–7714; 

email address: stone.william@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document ‘‘we,’’ ‘‘us,’’ 

and ‘‘our’’ refer to the EPA. 

Table of Contents 

I. Written Comments 

II. What is being addressed in this document? 

III. What is the EPA’s analysis of missouri’s 

SIP revision request? 

IV. Have the requirements for approval of a 

SIP revision been met? 

V. What Action is the EPA taking? 

VI. Incorporation by Reference 

VII. Statutory and Executive Order Reviews 

I. Written Comments 

Submit your comments, identified by 

Docket ID No. EPA–R07–OAR–2022– 

0382, at https://www.regulations.gov. 

Once submitted, comments cannot be 

edited or removed from Regulations.gov. 

The EPA may publish any comment 

received to its public docket. Do not 

submit electronically any information 

you consider to be Confidential 

Business Information (CBI) or other 

information whose disclosure is 

restricted by statute. Multimedia 

submissions (audio, video, etc.) must be 

accompanied by a written comment. 

The written comment is considered the 

official comment and should include 

discussion of all points you wish to 

make. The EPA will generally not 

consider comments or comment 

contents located outside of the primary 

submission (i.e. on the web, cloud, or 

other file sharing system). For 

additional submission methods, the full 

EPA public comment policy, 

information about CBI or multimedia 

submissions, and general guidance on 

making effective comments, please visit 

https://www.epa.gov/dockets/ 

commenting-epa-dockets. 

II. What is being addressed in this 

document? 

The EPA is proposing to approve the 

removal of 10 Code of State Regulation 

(CSR) 10–5.440, Control of Emissions 

From Bakery Ovens, from the Missouri 

SIP. 

Section 110(l) of the CAA prohibits 

the EPA from approving a SIP revision 

that interferes with any applicable 

requirement concerning attainment and 

reasonable further progress (RFP), or 

any other applicable requirement of the 

CAA. The State supplemented its SIP 

revision with a July 11, 2019 letter in 

order to address the requirements of 

section 110(l) of the CAA. 

III. What is the EPA’s analysis of 

Missouri’s SIP revision request? 

According to the January 15, 2019, 

letter from the Missouri Department of 

Natural Resources (MoDNR), available 

in the docket for this proposed action, 

Missouri rescinded 10 CSR 10–5.440, 

Control of Emissions from Bakery Ovens 

because the only source subject to the 

rule ceased operations in 2012. The 

state asserts in their submission to the 

Agency that this rule is no longer 

necessary for controlling emissions of 

volatile organic compounds (VOC’s) 

because there are no existing sources 

subject to the rule and new sources 

would be controlled by other rules. 


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