86518 Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Proposed Rules 

Issued on November 6, 2020. 

Lance T. Gant, 

Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2020–28823 Filed 12–29–20; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF COMMERCE 

Patent and Trademark Office 

37 CFR Part 1 

[Docket No. PTO–P–2020–0015] 

RIN 0651–AD46 

Disclaimer Practice in Patents and 

Patent 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) proposes to 

amend the rules of practice to expand 

when certain types of patent applicants 

and patentees may, subject to other 

conditions, obtain or enforce a second 

patent for an invention that is similar 

(i.e., patentably indistinct) to a first 

patent. Ordinarily, in examination 

before the USPTO, any application for a 

second patent covering such similar 

invention would be rejected. The 

proposed rule change is limited to the 

situation where owners of the first and 

second patents or patent applications 

are different but have an agreement to 

conduct research together (i.e., a joint 

research agreement). For this limited 

situation, the proposed rule change 

would increase the ability to file a 

document, called a terminal disclaimer, 

that ties the rights of a second patent to 

the first patent. Specifically, a terminal 

disclaimer causes the second patent to 

limit its enforceable patent term to end 

no later than the first patent’s term and 

limits when the second patent can be 

enforced. The proposed rule change 

would expand when a terminal 

disclaimer is permitted to be filed in the 

joint research agreement situation by 

eliminating the requirement that the 

second patent or patent application be 

filed later than the first patent or patent 

application. The USPTO also proposes 

to amend its rules of practice to 

explicitly state existing practices in the 

rules regarding when certain affidavits 

and declarations, as well as terminal 

disclaimers, may be filed. 

DATES: Comments must be received by 

March 22, 2021 to ensure consideration. 

ADDRESSES: For reasons of government 

efficiency, comments must be submitted 

through the Federal eRulemaking Portal 

at https://www.regulations.gov. To 

submit comments via the portal, one 

should enter docket number PTO–P– 

2020–0015 on the homepage and click 

‘‘search.’’ The site will provide search 

results listing all documents associated 

with this docket. Commenters can find 

a reference to this notice and click on 

the ‘‘Comment Now!’’ icon, complete 

the required fields, and enter or attach 

their comments. Attachments to 

electronic comments will be accepted in 

Adobe® portable document format 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 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: 

Susy Tsang-Foster, Senior Legal 

Advisor, Office of Patent Legal 

Administration, Office of the Deputy 

Commissioner for Patent Examination 

Policy, by email at Susy.Tsang-Foster@

uspto.gov; or Robert Clarke, Editor, 

Manual of Patent Examining Procedure, 

Office of the Deputy Commissioner for 

Patent Examination Policy, by email at 

Robert.Clarke@uspto.gov. 

SUPPLEMENTARY INFORMATION: Patent 

applications and patents are subject to 

the doctrine of nonstatutory double 

patenting to prevent both the unjust 

timewise extension of the right to 

exclude and multiple infringement suits 

by different parties. These situations 

may arise from the granting of multiple 

patents with patentably indistinct 

claims where the patents have a 

common owner, applicant, or inventor 

or where the patents are not commonly 

owned but are subject to a joint research 

agreement. Double patenting analysis is 

not limited to situations in which the 

reference patents or applications, whose 

claims form the basis for the 

nonstatutory double patenting rejection, 

are prior art as defined in 35 U.S.C. 102. 

The reference may have an effectively 

filed date that is before, the same as, or 

after the effective filing date of a 

claimed invention in an application 

under examination or patent under 

reexamination (i.e., the subject patent 

application or patent). Thus, the 

reference need not be ‘‘prior art’’ to the 

claimed invention in the subject 

application or patent for its claims to be 

relied upon in a nonstatutory double 

patenting rejection. For more 

information on the nonstatutory double 

patenting doctrine, see section 804 of 

the Manual of Patent Examining 

Procedure (Ninth Edition, Revision 

10.2019, June 2020). 

I. Background: A. Joint Research 

Agreements: The Cooperative Research 

and Technology Enhancement Act of 

2004 (CREATE Act), Public Law 108– 

453, 118 Stat. 3596, was passed to 

promote cooperative research between 

universities, the public sector, and 

private enterprises. The CREATE Act 

amended 35 U.S.C. 103(c), effective on 

December 10, 2004, to provide that 

subject matter developed by another 

person and a claimed invention shall be 

treated as owned by the same person or 

subject to an obligation of assignment to 

the same person for purposes of 

excluding prior art usable in 

obviousness rejections if three 

conditions are met: (1) The claimed 

invention was made by or on behalf of 

parties to a joint research agreement that 

was in effect on or before the date the 

claimed invention was made; (2) the 

claimed invention was made as a result 

of activities undertaken within the 

scope of the joint research agreement; 

and (3) the application for patent for the 

claimed invention discloses or is 

amended to disclose the names of the 

parties to the joint research agreement. 

The legislative history recognized that 

the CREATE Act would result in two or 

more patents being issued to patentably 

indistinct inventions, and called upon 

the nonstatutory double patenting 

doctrine to protect the public from 

multiple enforcement actions based on 

patents issued due to the passage of the 

CREATE Act. See H.R. Rep. No. 108– 

425, at 6 (2003) (stating that a terminal 

disclaimer is required ‘‘when double 

patenting is determined to exist for two 

or more claimed inventions’’ for any 

application for which the applicant 

takes advantage of the ‘‘safe harbor’’ 

provision in [pre-AIA] 35 U.S.C. 103(c) 

as amended by the CREATE Act). 

Consistent with the legislative history, 

the nonstatutory double patenting 

doctrine was expanded to include 

rejections based on patents or patent 

applications that were disqualified as 

prior art under pre-AIA 35 U.S.C. 

103(c). 

A prior art exception, similar to the 

prior art exclusion in the CREATE Act, 

was enacted in 35 U.S.C. 102(b)(2)(C) 

and 102(c) by the Leahy-Smith America 

Invents Act, Public Law 112–29, 125 

Stat. 284 (2011). Consistent with this 

prior art exception, the nonstatutory 

double patenting doctrine was further 

Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Proposed Rules 86519 

revised to include rejections based on 

patents or patent applications that were 

excepted as prior art under 35 U.S.C. 

102(b)(2)(C) and 102(c). 

B. Current Practice: A nonstatutory 

double patenting rejection may be 

obviated, in most circumstances, by 

filing a terminal disclaimer. Under 

current USPTO regulations, two types of 

terminal disclaimers may be used to 

obviate nonstatutory double patenting 

rejections. The first type is filed 

pursuant to 37 CFR 1.321(c) and must 

include a provision that the subject 

patent or any patent issuing from the 

subject patent application shall be 

enforceable only for and during the time 

period that the subject patent or any 

patent issuing from the subject patent 

application is commonly owned with 

the reference that is the basis of the 

nonstatutory double patenting rejection. 

The second type is filed pursuant to 37 

CFR 1.321(d) and must include a 

provision that the subject patent or any 

patent issuing from the subject patent 

application shall be enforceable only for 

and during such period that the subject 

patent or any patent issuing from the 

subject patent application and the 

reference are not separately enforced. 

The second type obviates nonstatutory 

double patenting based on a noncommonly owned reference that is 

disqualified or excepted as prior art as 

a result of activities undertaken within 

the scope of a joint research agreement. 

Currently, 37 CFR 1.321(d) limits the 

ability of parties to a joint research 

agreement to file a terminal disclaimer 

to overcome a nonstatutory double 

patenting rejection to instances where 

the reference application or patent had 

previously been applied as prior art or 

was available as prior art against the 

subject application or patent and the 

reference application publication or 

patent had been excepted or 

disqualified respectively as prior art 

under 37 CFR 1.104(c)(4)(ii) or (c)(5)(ii). 

See Changes To Implement the 

Cooperative Research and Technology 

Enhancement Act of 2004, 70 FR 54259, 

54262 (Sept. 14, 2005). 37 CFR 1.321(d) 

does not provide for the filing of such 

a terminal disclaimer where the 

reference is not prior art under 35 U.S.C. 

102(a)(2) or pre-AIA 35 U.S.C. 102(e) 

and therefore cannot be excepted or 

disqualified as prior art as set forth in 

37 CFR 1.104(c)(4)(ii) or (c)(5)(ii). For 

example, a reference is not prior art 

where the effective filing date of the 

claimed invention in the subject 

application or patent is the same as or 

before the effectively filed date of the 

reference. Because of this limitation, the 

USPTO has granted a number of 

petitions requesting a waiver of the 

prior art requirement in 37 CFR 

1.321(d). Another example where the 

reference is not prior art under 35 U.S.C. 

102(a)(2) or pre-AIA 35 U.S.C. 102(e) is 

where the inventive entities are the 

same for the reference and the subject 

application or patent. 

C. Recent Judicial Change: In 2014, 

the U.S. Court of Appeals for the 

Federal Circuit clarified for patents 

subject to the 20-year patent term that 

a first patent that expires before a 

second patent to a common owner or 

inventor may be used as a reference in 

a nonstatutory double patenting 

rejection, regardless of whether the first 

patent is prior art to the second patent. 

See Gilead Sciences, Inc. v. Natco 

Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 

2014). Following Gilead, applicants that 

received a nonstatutory double 

patenting rejection based on an 

application or a patent under a joint 

research agreement that was not earlier 

filed than the application under 

examination have filed petitions under 

37 CFR 1.183 seeking waiver of the 

requirement in current 37 CFR 1.321(d) 

that the reference in a terminal 

disclaimer be prior art in order to file a 

terminal disclaimer under 37 CFR 

1.321(d). In the last two years, the 

USPTO has received petitions under 37 

CFR 1.183 to waive such requirement of 

37 CFR 1.321(d) in 26 applications. In 

22 of the 26 applications the petitions 

have been granted. In four of the 26 

applications, the petitions were 

dismissed either because the terminal 

disclaimer or the petition failed to 

comply with the requirements of 37 CFR 

1.321(d) or 37 CFR 1.183. Each of these 

dismissals and the impact of the 

proposed rule is discussed in more 

detail below. The proposed rule would 

not have the same impact on these four 

applications because the facts for each 

application are different. On the whole, 

in view of the routine granting of 

petitions to waive the prior art 

requirement in the current regulations 

over the last two years, the Office has 

determined that this proposed rule 

would be beneficial to avoid the 

unnecessary costs and delays incurred 

by users with the current petition 

process. 

In two applications the petitions were 

dismissed because the offered terminal 

disclaimers failed to comply with all of 

the other requirements of 37 CFR 

1.321(d). If these had been filed under 

the proposed rule, there would be no 

change as to the initial disapproval of 

these terminal disclaimers as the other 

requirements of 37 CFR 1.321(d) still 

must be met. The only change in this 

scenario under the proposed rules 

would be that a petition would not have 

been required—a proper terminal 

disclaimer will be accepted without the 

need for a petition. Moving forward in 

these applications, a proper terminal 

disclaimer would be accepted in any 

renewed petition (or depending on the 

timing, without a renewed petition if it 

occurs under the proposed rules). In one 

of the applications, for example, a 

renewed petition has been filed and if 

the revised terminal disclaimer is 

determined to be proper, the renewed 

petition will be granted. No action has 

been taken in the other application to 

rectify the errors in the terminal 

disclaimer. 

In the other two applications where 

petitions were dismissed, the dismissals 

were the result of petitioners’ failure to 

set forth an extraordinary situation 

within the meaning of 37 CFR 1.183 that 

would warrant waiver of the prior art 

requirement in 37 CFR 1.321(d). In both 

applications, the petitions failed to state 

the existence of any extraordinary 

situation as required by the language of 

37 CFR 1.183. Under the proposed rule, 

should another applicant in a similar 

situation file a terminal disclaimer that 

complies with all of the requirements of 

proposed 37 CFR 1.321(d), the 

disclaimer would be accepted without 

the need for a grantable petition under 

37 CFR 1.183. Moving forward in these 

applications, if a renewed petition 

provides the proper showing, the 

request to waive the prior art 

requirement in the rule will be granted 

and concurrently filed terminal 

disclaimers that comply with all of the 

other requirements in 37 CFR 1.321(d) 

will be accepted. In one of the 

applications, a renewed petition has 

been filed. 

II. Proposed Changes: A. Changes to 

Current Practice: The USPTO proposes 

to revise 37 CFR 1.321(d) to permit a 

terminal disclaimer filed by a party to 

a joint research agreement to obviate 

nonstatutory double patenting even 

where the patent application or patent 

referenced in the terminal disclaimer is 

not prior art under 35 U.S.C. 102 with 

respect to the subject application or 

patent in which the disclaimer is filed. 

This change would accommodate the 

two non-prior art circumstances 

discussed above in which a reference 

would not qualify as prior art under 35 

U.S.C. 102(a)(2) or pre-AIA 35 U.S.C. 

102(e). This change, permitting a party 

to a joint research agreement to file a 

terminal disclaimer even where the 

reference is not prior art, is consistent 

with the purpose of the CREATE Act as 

stated in its legislative history. Note that 

this change does not obviate the 

requirement in pre-AIA 35 U.S.C. 103(c) 

or in 35 U.S.C. 102(c) that the claimed 

86520 Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Proposed Rules 

invention of the application or patent in 

which the terminal disclaimer is filed 

was made as a result of activities 

undertaken within the scope of the joint 

research agreement. 

The USPTO is further proposing to 

revise 37 CFR 1.321 such that it will no 

longer be applicable to an owner of a 

sectional interest in a patent. A 

sectional interest allows for the exercise 

of the exclusive patent rights in a 

specified part or portion of the United 

States. See Potter v. Holland, 4 Blatchf. 

206, 19 F. Cas.1154, 1159 (1858) 

(discussing disclaimers by an owner of 

a sectional interest in a patent). While 

35 U.S.C. 253 permits a disclaimer by an 

owner of a sectional interest, the 

assignment of a sectional interest is 

exceedingly rare; thus, to simplify the 

rule, the USPTO is proposing that a 

disclaimer by an owner of a sectional 

interest not be encompassed by 37 CFR 

1.321. The USPTO proposes to address 

disclaimers by owners of a sectional 

interest via a petition under 37 CFR 

1.182. The petition must clearly explain 

the extent of the disclaimant’s interest 

in the patent and identify the complete 

claim(s) or term of a patent being 

disclaimed. This change will assist in 

preventing avoidable costs and delays to 

users due to the improper filing of 

terminal disclaimers by a partial owner 

of an application or patent as an alleged 

sectional interest owner. 

B. Changes Consistent with Current 

Practice: (1) When a Disclaimer May Be 

Filed: The USPTO proposes to revise 37 

CFR 1.321 to explicitly provide that a 

terminal disclaimer may be filed to 

obviate a potential nonstatutory double 

patenting rejection or concern. Such 

disclaimer may be filed during the 

pendency of the application or after 

patent grant. The current practice of the 

USPTO is to accept terminal disclaimers 

that would overcome a potential 

nonstatutory double patenting rejection. 

Such preemptive terminal disclaimers 

avoid delays in examination resulting 

from the imposition of nonstatutory 

double patenting rejections. By revising 

the rule to be consistent with the 

current practice of accepting terminal 

disclaimers even when a nonstatutory 

double patenting rejection has not been 

made, the proposed change makes clear 

that patent applicants may file such 

disclaimers to avoid delays in 

examination. 

A motion authorizing filing of a 

disclaimer must be granted before a 

disclaimer may be filed in an 

application or a patent involved in an 

interference under part 41 or 

administrative proceeding under part 42 

before the Patent Trial and Appeal 

Board (Board). Also, where a terminal 

disclaimer is filed to overcome a 

nonstatutory double patenting issue in a 

reexamination proceeding, it should be 

filed in the reexamination proceeding 

and not in the patent file. 

(2) Who May File a Disclaimer: Under 

proposed 37 CFR 1.321, a disclaimer in 

a patent may only be filed by the owner 

or owner(s) of the whole interest in the 

patent. Where more than one owner 

exists, the disclaimer may be filed as 

either a single document by all the 

owners of the whole interest in the 

patent or as several documents 

considered together, wherein each 

document sets forth the extent of 

disclaimant’s ownership interest in the 

patent and the total ownership interest 

accounts for 100% of the ownership 

interest. Similarly, where more than one 

applicant exists, a disclaimer may be 

filed as either a single document by all 

the applicants or as several documents 

considered together, wherein each 

document sets forth the extent of the 

disclaimant’s ownership interest in the 

application and the total ownership 

interest accounts for 100% of the 

ownership interest. An assignee of 

record of an application filed before 

September 16, 2012, may execute a 

terminal disclaimer. In applications 

filed on or after September 16, 2012, an 

assignee of record of an application that 

is also the applicant of that application 

may execute a terminal disclaimer. For 

all applications and patents, regardless 

of the filing date, a patent practitioner 

of record may execute a terminal 

disclaimer. 

Consistent with 35 U.S.C. 253, the 

USPTO proposes to refer to the party 

making the disclaimer in 37 CFR 1.321 

as the ‘‘disclaimant’’ rather than the 

grantee, patentee, applicant, or assignee, 

as currently prescribed. The use of the 

common term to refer to the party 

making the disclaimer avoids confusion 

as to the proper party to file the paper 

regardless of when the terminal 

disclaimer was filed. 

Consistent with the proposed change 

to explicitly permit the preemptive 

filing of a terminal disclaimer before a 

nonstatutory double patenting rejection 

is made, the USPTO is also proposing to 

revise 37 CFR 1.130 in an analogous 

manner. Specifically, in addition to the 

current practice in which an affidavit or 

declaration of attribution or prior public 

disclosure under the AIA is not filed 

until after rejection, the proposed 

change will explicitly permit an 

applicant or patent owner to file this 

type of affidavit or declaration to 

overcome a potential rejection of a claim 

over the reference, as is the current 

practice. If adopted, this proposed 

change to 37 CFR 1.130 would aid in the 

compact prosecution of applications 

and reexamination proceedings by 

encouraging applicants and patent 

owners to preemptively file such an 

affidavit or declaration as they may 

already do under current practice. 

III. Discussion of Specific Rules: The 

following is a discussion of proposed 

amendments to title 37 of the Code of 

Federal Regulations, part 1: 

The USPTO proposes to amend 

§ 1.130 by deleting ‘‘When any claim of 

an application or a patent under 

reexamination is rejected’’ in paragraphs 

(a) and (b). Paragraph (c) is proposed to 

be revised to change the two instances 

of ‘‘the rejection is based upon’’ to ‘‘the 

disclosure sought to be disqualified.’’ 

The USPTO proposes to amend 

§ 1.321 and to revise its title to limit its 

applicability to disclaimers in a patent 

or application by the owner of the 

whole interest. 

The USPTO proposes to amend 

§ 1.321(a) by adding the heading 

‘‘Disclaimer of Any Complete Claim or 

Claims in a Patent’’ and moving the 

provisions concerning the filing of a 

terminal disclaimer in a patent to 

§ 1.321(b)(1). Paragraph (a)(1) is 

proposed to be revised to replace ‘‘an 

attorney or agent of record’’ with ‘‘a 

patent practitioner of record.’’ The 

requirement that the disclaimer include 

a provision that the disclaimer is 

binding upon the disclaimant and its 

successors and assigns has been moved 

from § 1.321(a) to new proposed 

§ 1.321(a)(5). The reference to a patentee 

owning a sectional interest is also 

proposed to be removed from paragraph 

(a). Paragraph (a)(2), which currently 

applies to both a disclaimer of a 

complete claim or claims in a patent 

and a disclaimer of a term in a patent, 

is proposed to be revised to remove the 

sentence ‘‘A disclaimer which is not a 

disclaimer of a complete claim or 

claims, or term will be refused 

recordation.’’ The language ‘‘refused 

recordation’’ in the current paragraph 

(a)(2) will not be included in the 

proposed § 1.321 because a disclaimer 

may be included in the USPTO’s record 

even if the regulatory requirements for 

a disclaimer have not been met. 

However, a disclaimer that does not 

meet the regulatory requirements in 

§ 1.321 is ineffective and is not recorded 

as a disclaimer even if included in the 

application file. Accordingly, proposed 

paragraphs (a) (disclaimer of any 

complete claim or claims in a patent), 

(b)(1) (terminal disclaimer filed by a 

patentee), (b)(2) (terminal disclaimer in 

an application filed on or after 

September 16, 2012), and (b)(3) 

(terminal disclaimer in an application 

filed before September 16, 2012) state 

Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Proposed Rules 86521 

that the disclaimer must meet the 

requirements of proposed paragraphs 

(a)(1)–(5), (b)(1)(i)–(v), (b)(2)(i)–(v), and 

(b)(3)(i)–(v), respectively, to be effective. 

In addition, paragraphs (a)–(d) are 

proposed to be amended to state that 

only compliant disclaimers are recorded 

in the USPTO. Paragraph (a)(3) is 

proposed to be revised to add that the 

disclaimer must be made by the owner 

of the whole interest in the patent and 

to change ‘‘patentee’s ownership 

interest’’ to ‘‘disclaimant’s ownership 

interest.’’ 

Section 1.321(b) is proposed to be 

revised to add the heading ‘‘Disclaimer 

or Dedication to the Public of the Entire 

Term or Any Terminal Part of the Term 

of a Patent or Any Patent to Be Granted 

on an Application.’’ The specific 

requirements for filing a terminal 

disclaimer in a patent are set forth in 

proposed § 1.321(b)(1); in applications 

filed on or after September 16, 2012, are 

set forth in proposed § 1.321(b)(2); and 

in applications filed before September 

16, 2012, are set forth in proposed 

§ 1.321(b)(3). This proposal eliminates 

the need for the public to consult 

§ 1.321(b) in effect on September 15, 

2012, when filing terminal disclaimers 

in an application filed before September 

16, 2012. 

Each proposed § 1.321(b)(1)–(3) 

includes parallel requirements in 

proposed subparagraphs (i)–(v) for filing 

a terminal disclaimer. 

Proposed § 1.321(b)(1)(i) provides that 

a terminal disclaimer filed in a patent 

must be signed by the patentee or a 

patent practitioner of record. Similarly, 

proposed § 1.321(b)(2)(i) provides that a 

terminal disclaimer filed in an 

application filed on or after September 

16, 2012, must be signed by the 

applicant or a patent practitioner of 

record and further specifies that a 

juristic entity who is the applicant may 

sign the terminal disclaimer. Proposed 

§ 1.321(b)(3)(i) provides that a terminal 

disclaimer filed in an application filed 

before September 16, 2012, must be 

signed by the applicant where the 

application has not been assigned, the 

applicant and an assignee of record, 

where each owns an undivided interest 

in the application, the assignee of record 

of the whole interest in the application, 

or a patent practitioner of record. 

Proposed § 1.321(b)(1)(ii) requires that 

the terminal disclaimer identify the 

patent and the term of the patent that is 

being disclaimed and further specifies 

that the terminal disclaimer must 

disclaim the entire term or any terminal 

part of the term of the patent. Similarly 

proposed § 1.321(b)(2)(ii) and (b)(3)(ii) 

require that the terminal disclaimer 

identify the application and the term of 

the patent to be granted that is being 

disclaimed and further specify that the 

terminal disclaimer must disclaim the 

entire term or any terminal part of the 

term of the patent to be granted. 

Proposed § 1.321(b)(1)(iii) requires 

that the terminal disclaimer state the 

present extent of the disclaimant’s 

ownership interest and that the terminal 

disclaimer be made by the patentee 

owning the whole interest in the patent. 

Similarly, proposed § 1.321(b)(2)(iii) 

and (b)(3)(iii) require that the terminal 

disclaimer state the ownership interest 

of the disclaimant in the application 

and that the terminal disclaimer be 

made by the applicant owning the 

whole interest in the application. 

Proposed § 1.321(b)(1)(iv), (b)(2)(iv), 

and (b)(3)(iv) require that the terminal 

disclaimer be accompanied by the fee 

set forth in § 1.20(d). 

Proposed § 1.321(b)(1)(v), (b)(2)(v), 

and (b)(3)(v) require that the terminal 

disclaimer include a provision that the 

disclaimer is binding on the disclaimant 

and its successors and assigns. 

Proposed § 1.321(c) adds the heading 

‘‘Terminal Disclaimer with Common 

Ownership Enforcement Provision to 

Obviate Nonstatutory Double Patenting’’ 

and generally parallels current 

§ 1.321(c). Proposed § 1.321(c) would 

explicitly provide for filing of a terminal 

disclaimer to obviate a potential 

nonstatutory double patenting rejection 

that has not yet been made. As is the 

case today, when a terminal disclaimer 

under proposed § 1.321(c) is filed to 

overcome a nonstatutory double 

patenting rejection in a reexamination 

proceeding, it should be filed in the 

reexamination proceeding and not in 

the patent file. 

Proposed § 1.321(c)(1) incorporates 

the requirements of current § 1.321(c)(1) 

and (c)(2) which set forth the formal 

requirements and signature 

requirements for terminal disclaimers. 

Proposed § 1.321(c)(2) revises the 

requirements of current § 1.321(c)(3) to 

provide that a terminal disclaimer under 

paragraph (c) must include a provision 

that the patent or any patent granted on 

the application for which the disclaimer 

is filed shall be enforceable only for and 

during such period that the patent or 

any patent granted on the application 

for which the disclaimer is filed is 

commonly owned with the reference 

patent or any patent granted on the 

reference application whose claim(s) 

formed or may form the basis for the 

nonstatutory double patenting. 

Proposed § 1.321(d) adds the heading 

‘‘Terminal Disclaimer with a Joint 

Research Agreement Enforcement 

Provision to Obviate Nonstatutory 

Double Patenting.’’ The CREATE Act 

became effective on December 10, 2004, 

and AIA 35 U.S.C. 102(c) continued the 

intent of the CREATE Act. Therefore, 

proposed § 1.321(d) states that a 

terminal disclaimer filed under this 

paragraph is only available for patents 

granted on or after December 10, 2004, 

for reexamination proceedings of 

patents granted on or after December 10, 

2004, and for applications pending on 

or after December 10, 2004. 

Proposed paragraph (d)(1) revises the 

introductory text of § 1.321(d) to permit 

the filing of a terminal disclaimer by a 

party to a joint research agreement even 

if the reference application or patent on 

which the double patenting is based is 

not prior art to the application or patent 

in which the disclaimer is filed. 

Proposed § 1.321(d)(1) does so by 

removing the requirement that the 

reference patent or application was 

disqualified as prior art as set forth in 

either § 1.104(c)(4)(ii) or (c)(5)(ii). 

Specifically, proposed paragraph (d)(1) 

states that, subject to the requirements 

in proposed paragraph (d)(2), which 

establishes the existence of a joint 

research agreement, a terminal 

disclaimer may be filed in a patent, in 

a reexamination proceeding, or in a 

patent application to obviate 

nonstatutory double patenting or 

potential nonstatutory double patenting 

of a claimed invention based on a 

reference patent or application where 

the reference patent or application and 

the claimed invention are not 

commonly owned but are subject to a 

joint research agreement as defined by 

35 U.S.C. 102(c) in effect on March 16, 

2013 or 35 U.S.C. 103(c)(2) in effect on 

March 15, 2013. Proposed § 1.321(d)(1) 

also explicitly provides for the filing of 

a terminal disclaimer to obviate a 

potential nonstatutory double patenting 

rejection that has not yet been made. As 

is the case today, when a terminal 

disclaimer under proposed § 1.321(d)(1) 

is filed to overcome a nonstatutory 

double patenting rejection in a 

reexamination proceeding, it should be 

filed in the reexamination proceeding 

and not in the patent file. 

Proposed § 1.321(d)(1)(i) incorporates 

the requirements of current § 1.321(d)(1) 

and (d)(2) which set forth the formal 

requirements and signature 

requirements for terminal disclaimers. 

Proposed § 1.321(d)(1)(ii) revises the 

requirements of current § 1.321(d)(3) to 

provide that a terminal disclaimer under 

proposed paragraph (d)(1) must include 

a provision waiving the right to 

separately enforce the patent or any 

patent granted on the application for 

which the disclaimer is filed and the 

reference patent or any patent granted 

on the reference application whose 

86522 Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Proposed Rules 

claim(s) formed or may form the basis 

for the nonstatutory double patenting, 

and agreeing that the patent or any 

patent granted on the application for 

which the disclaimer is filed shall be 

enforceable only for and during such 

period that the patent or any patent 

granted on the application for which the 

disclaimer is filed and the reference 

patent or any patent granted on the 

reference application are not separately 

enforced. 

Proposed § 1.321(d)(2) sets forth the 

requirements to establish the existence 

of a joint research agreement in the 

patent, in the reexamination proceeding, 

or in the patent application, as 

applicable, for which the terminal 

disclaimer under proposed paragraph 

(d)(1) is filed. 

Proposed § 1.321(d)(2)(i) sets forth the 

requirements for applications or patents 

subject to 35 U.S.C. 102 in effect on 

March 16, 2013, and parallels the 

requirements of current § 1.104(c)(4)(ii). 

Accordingly, if the requirements of 

§ 1.104(c)(4)(ii) have already been met, 

there is no need to take further action 

to meet the requirements of proposed 

§ 1.321(d)(2)(i). 

Proposed § 1.321(d)(2)(ii) sets forth 

the requirements for applications or 

patents subject to 35 U.S.C. 102, in 

effect prior to March 16, 2013, and 

parallels the requirements of current 

§ 1.104(c)(5)(ii). Accordingly, if the 

requirements of § 1.104(c)(5)(ii) have 

already been met, there is no need to 

take further action to meet the 

requirements of proposed 

§ 1.321(d)(2)(ii). 

Proposed § 1.321(e) provides that a 

disclaimer may not be entered into the 

official file of an application or a patent 

involved in an interference under 

subpart E of 37 CFR part 41 or any 

proceeding under 37 CFR part 42 unless 

a motion requesting to file the 

disclaimer under §§ 41.121(a)(2), 

41.121(a)(3), or 42.20 is granted by the 

Board. If the disclaimer is inadvertently 

entered without the granting of the 

motion, the disclaimer will be 

expunged. The requirement is 

consistent with the current practice that 

limits when a disclaimer may be filed in 

a patent during certain proceedings 

before the Board. 

IV. Rulemaking Requirements A. 

Administrative Procedure Act: The 

changes proposed in this rulemaking 

involve rules of agency procedure and 

interpretation. See Perez v. Mortg. 

Bankers Ass’n, 575 U.S. 92, 97 (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 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 in this proposed rulemaking are 

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

or (c), or any other law. See Perez, 575 

U.S. at 101 (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)(A))). However, the USPTO has 

chosen to seek public comment before 

implementing the rule to benefit from 

the public’s input. 

B. Regulatory Flexibility Act: Under 

the Regulatory Flexibility Act (RFA) (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. 

Except in the extremely rare 

circumstance of the filing of a 

disclaimer by a sectional interest owner, 

this rulemaking does not propose to 

impose any additional requirements or 

fees on applicants. This rulemaking 

eliminates the need for a small number 

of applicants each year to file a petition 

under 37 CFR 1.183 and pay an 

accompanying fee by authorizing the 

filing of a disclaimer by a joint 

researcher even if the reference patent 

or patent application is not prior art. 

This rulemaking does not propose to 

substantively change when an applicant 

may file a submission under 37 CFR 

1.130 or a disclaimer under 37 CFR 

1.321, although a petition under 37 CFR 

1.183 accompanying the disclaimer may 

no longer be required. The changes 

proposed in this rulemaking will not 

have a significant economic impact on 

a substantial number of small entities 

because applicants continue to be 

entitled to file a disclaimer under 37 

CFR 1.321 or submission under 37 CFR 

1.130 if such filings are appropriate 

today. For the foregoing reasons, the 

changes proposed in this notice will not 

have a significant economic impact on 

a substantial number of small entities. 

C. Executive Order 12866 (Regulatory 

Planning and Review): This rulemaking 

has been determined to be not 

significant under Executive Order 12866 

(Sept. 30, 1993). 

D. Executive Order 13563 (Improving 

Regulation and Regulatory Review): The 

USPTO has complied with Executive 

Order 13563. Specifically, the USPTO 

has, to the extent feasible and 

applicable: (1) Made a reasoned 

determination that the benefits justify 

the costs of the rule; (2) tailored the rule 

to impose the least burden on society 

consistent with obtaining the regulatory 

objectives; (3) selected a regulatory 

approach that maximizes net benefits; 

(4) specified performance objectives; (5) 

identified and assessed available 

alternatives; (6) involved the public in 

an open exchange of information and 

perspectives among experts in relevant 

disciplines, affected stakeholders in the 

private sector, and the public as a 

whole, and provided online access to 

the rulemaking docket; (7) attempted to 

promote coordination, simplification, 

and harmonization across government 

agencies and identified goals designed 

to promote innovation; (8) considered 

approaches that reduce burdens and 

maintain flexibility and freedom of 

choice for the public; and (9) ensured 

the objectivity of scientific and 

technological information and 

processes. 

E. Executive Order 13771 (Reducing 

Regulation and Controlling Regulatory 

Costs): This proposed rule is not 

expected to be an Executive Order 

13771 (Jan. 30, 2017) regulatory action 

because this proposed rule is not 

significant under Executive Order 12866 

(Sept. 30, 1993). 

F. 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). 

G. 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) 

Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Proposed Rules 86523 

preempt tribal law. Therefore, a tribal 

summary impact statement is not 

required under Executive Order 13175 

(Nov. 6, 2000). 

H. 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). 

I. 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). 

J. 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). 

K. 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). 

L. 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 final 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 

proposed 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 

expected to result in a ‘‘major rule’’ as 

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

M. Unfunded Mandates Reform Act of 

1995: The changes proposed 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. 

N. 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. 

O. 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. 

P. 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. The rules of practice pertaining 

to terminal disclaimers have been 

reviewed and approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.) under OMB 

control number 0651–0031. 

This rulemaking does not impose any 

additional requirements (including 

information collection requirements) or 

fees for patent applicants or patentees. 

Therefore, the USPTO is not 

resubmitting an information collection 

package to OMB for its review and 

approval because the changes in this 

rulemaking do not affect the information 

collection requirements associated with 

the information collections approved 

under OMB control number 0651–0031 

or any other information collection. 

Notwithstanding any other provision 

of law, no person is required to respond 

to nor shall a 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 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, the USPTO proposes to 

amend part 1 of title 37 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. In § 1.130, revise paragraphs (a), 

introductory text of paragraph (b), and 

(c) to read as follows: 

§ 1.130 Affidavit or declaration of 

attribution or prior public disclosure under 

the Leahy-Smith America Invents Act. 

(a) Affidavit or declaration of 

attribution. The applicant or patent 

owner may submit an appropriate 

affidavit or declaration to disqualify a 

disclosure as prior art by establishing 

that the disclosure was made by the 

inventor or a joint inventor, or the 

subject matter disclosed was obtained 

directly or indirectly from the inventor 

or a joint inventor. 

(b) Affidavit or declaration of prior 

public disclosure. The applicant or 

patent owner may submit an 

appropriate affidavit or declaration to 

disqualify a disclosure as prior art by 

establishing that the subject matter 

disclosed had, before such disclosure 

was made or before such subject matter 

was effectively filed, been publicly 

disclosed by the inventor or a joint 

inventor or another who obtained the 

subject matter disclosed directly or 

indirectly from the inventor or a joint 

inventor. An affidavit or declaration 

under this paragraph must identify the 

subject matter publicly disclosed and 

provide the date such subject matter 

was publicly disclosed by the inventor 

or a joint inventor or another who 

obtained the subject matter disclosed 

directly or indirectly from the inventor 

or a joint inventor. 

* * * * * 

(c) When this section is not available. 

The provisions of this section are not 

available if the disclosure sought to be 

disqualified was made more than one 

year before the effective filing date of 

the claimed invention. The provisions 

of this section may not be available if 

the disclosure sought to be disqualified 

is a U.S. patent or U.S. patent 

application publication of a patented or 

pending application naming another 

inventor, the patent or pending 

application claims an invention that is 

the same or substantially the same as 

the applicant’s or patent owner’s 

claimed invention, and the affidavit or 

declaration contends that an inventor 

named in the U.S. patent or U.S. patent 

application publication derived the 

claimed invention from the inventor or 

a joint inventor named in the 

86524 Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Proposed Rules 

application or patent, in which case an 

applicant or a patent owner may file a 

petition for a derivation proceeding 

pursuant to §§ 42.401 through 42.407 of 

this chapter. 

* * * * * 

■ 3. Revise § 1.321 to read as follows: 

§ 1.321 Disclaimers in a patent or an 

application by owner of the whole interest. 

(a) Disclaimer of any complete claim 

or claims in a patent. A patentee 

owning the whole interest in a patent 

may disclaim any complete claim or 

claims in a patent. A notice of the 

disclaimer is published in the Official 

Gazette and attached to the printed 

copies of the specification. To be 

effective and recorded under this 

paragraph, the disclaimer must: 

(1) Be signed by the patentee or a 

patent practitioner of record; 

(2) Identify the patent and the 

complete claim or claims being 

disclaimed; 

(3) State the present extent of the 

disclaimant’s ownership interest in the 

patent. The disclaimer must be made by 

the owner of the whole interest in the 

patent; 

(4) Be accompanied by the fee set 

forth in § 1.20(d); and 

(5) Include a provision that the 

disclaimer is binding upon the 

disclaimant and its successors and 

assigns. 

(b) Disclaimer or dedication to the 

public of the entire term or any terminal 

part of the term of a patent or any 

patent to be granted on an application— 

(1) Terminal disclaimers or dedications 

filed by a patentee. A patentee owning 

the whole interest in a patent may 

disclaim or dedicate to the public the 

entire term, or any terminal part of the 

term, of the patent granted. A notice of 

the disclaimer is published in the 

Official Gazette and attached to the 

printed copies of the specification. To 

be effective and recorded under this 

paragraph, the terminal disclaimer 

must: 

(i) Be signed by the patentee or a 

patent practitioner of record; 

(ii) Identify the patent and the term of 

the patent that is being disclaimed. The 

terminal disclaimer must disclaim the 

entire term or any terminal part of the 

term of the patent; 

(iii) State the present extent of the 

disclaimant’s ownership interest in the 

patent. The terminal disclaimer must be 

made by the patentee owning the whole 

interest in the patent; 

(iv) Be accompanied by the fee set 

forth in § 1.20(d); and 

(v) Include a provision that the 

disclaimer is binding upon the 

disclaimant and its successors and 

assigns. 

(2) Terminal disclaimers or 

dedications in applications filed under 

35 U.S.C. 111(a), 363, or 385 on or after 

September 16, 2012. An applicant 

owning the whole interest in an 

application may disclaim or dedicate to 

the public the entire term, or any 

terminal part of the term, of a patent to 

be granted. To be effective and recorded 

under this paragraph, the terminal 

disclaimer must: 

(i) Be signed by the applicant or a 

patent practitioner of record. A juristic 

entity who is the applicant may sign the 

terminal disclaimer; 

(ii) Identify the application and the 

term of the patent to be granted that is 

being disclaimed. The terminal 

disclaimer must disclaim the entire term 

or any terminal part of the term of the 

patent to be granted; 

(iii) State the present extent of the 

disclaimant’s ownership interest in the 

application. The terminal disclaimer 

must be made by the applicant owning 

the whole interest in the application; 

(iv) Be accompanied by the fee set 

forth in § 1.20(d); and 

(v) Include a provision that the 

terminal disclaimer is binding upon the 

disclaimant and its successors or 

assigns. 

(3) Terminal disclaimers or 

dedications in applications filed under 

35 U.S.C. 111(a) or 363 before 

September 16, 2012. An applicant and/ 

or assignee of record owning the whole 

interest in an application may disclaim 

or dedicate to the public the entire term, 

or any terminal part of the term, of a 

patent to be granted. To be effective and 

recorded under this paragraph, the 

terminal disclaimer must: 

(i) Be signed: 

(A) By the applicant where the 

application has not been assigned; 

(B) By the applicant and an assignee 

of record where each owns an 

undivided part interest in the 

application; 

(C) By the assignee of record of the 

whole interest in the application; or 

(D) By a patent practitioner of record; 

(ii) Identify the application and the 

term of the patent to be granted that is 

being disclaimed. A terminal disclaimer 

must disclaim the entire term or any 

terminal part of the term of the patent 

to be granted; 

(iii) State the present extent of 

disclaimant’s ownership interest in the 

application. A terminal disclaimer must 

be made by the owner of the whole 

interest in the application; 

(iv) Be accompanied by the fee set 

forth in § 1.20(d); and 

(v) Include a provision that the 

disclaimer is binding upon the 

disclaimant and its successors and 

assigns. 

(c) Terminal disclaimer with common 

ownership enforcement provision to 

obviate nonstatutory double patenting. 

Except as provided for in paragraph (d) 

of this section, a terminal disclaimer 

may be filed in a patent, in a 

reexamination proceeding, or in a patent 

application to obviate nonstatutory 

double patenting or potential 

nonstatutory double patenting of a 

claimed invention based on a reference 

patent or application. To be effective 

and recorded under this paragraph, the 

terminal disclaimer must: 

(1) Comply with the provisions of 

paragraph (b)(1), (2), or (3) of this 

section as applicable; and 

(2) Include a provision that the patent 

or any patent granted on the application 

for which the disclaimer is filed shall be 

enforceable only for and during such 

period that the patent or any patent to 

be granted on the application for which 

the disclaimer is filed is commonly 

owned with the reference patent or any 

patent granted on the reference 

application whose claim(s) formed or 

may form the basis for the nonstatutory 

double patenting. 

(d) Terminal disclaimer with a joint 

research agreement enforcement 

provision to obviate nonstatutory double 

patenting. This paragraph is only 

applicable for patents granted on or after 

December 10, 2004, reexamination 

proceedings of patents granted on or 

after December 10, 2004, and for 

applications pending on or after 

December 10, 2004. 

(1) Subject to paragraph (d)(2) of this 

section, a terminal disclaimer may be 

filed in a patent, in a reexamination 

proceeding, or in a patent application to 

obviate nonstatutory double patenting 

or potential nonstatutory double 

patenting of a claimed invention based 

on a reference patent or application 

where the reference patent or 

application and the claimed invention 

are not commonly owned but are subject 

to a joint research agreement as defined 

by 35 U.S.C. 102(c) in effect on March 

16, 2013 or 35 U.S.C. 103(c)(2) in effect 

on March 15, 2013. To be effective and 

recorded under this paragraph, the 

terminal disclaimer must: 

(i) Comply with the provisions of 

paragraph (b)(1), (2), or (3) of this 

section as appropriate; and 

(ii) Include a provision waiving the 

right to separately enforce the patent or 

any patent granted on the application 

for which the disclaimer is filed and the 

reference patent or any patent granted 

on the reference application whose 

claim(s) formed or may form the basis 

for the nonstatutory double patenting, 

Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Proposed Rules 86525 

and agreeing that the patent or any 

patent granted on the application for 

which the disclaimer is filed shall be 

enforceable only for and during such 

period that the patent or any patent 

granted on the application for which the 

terminal disclaimer is filed and the 

reference patent or any patent granted 

on the reference application are not 

separately enforced. 

(2) A terminal disclaimer may be filed 

under paragraph (d)(1) of this section if 

the requirements of paragraph (d)(2)(i) 

or (ii), as applicable, have been met. 

(i) For applications or patents subject 

to 35 U.S.C. 102 in effect on March 16, 

2013. 

(A) The applicant or patent owner 

provides, or has provided, a statement 

to the effect that the subject matter of 

the reference patent or application was 

developed and the claimed invention 

was made by or on behalf of one or more 

parties to a joint research agreement, 

within the meaning of 35 U.S.C. 100(h) 

and § 1.9(e), that was in effect on or 

before the effective filing date of the 

claimed invention, and the claimed 

invention was made as a result of 

activities undertaken within the scope 

of the joint research agreement; and 

(B) The application for patent, or the 

patent, for the claimed invention 

discloses or is amended to disclose the 

names of the parties to the joint research 

agreement in accordance with § 1.71(g). 

(ii) For applications or patents subject 

to 35 U.S.C. 102 in effect prior to March 

16, 2013. 

(A) The applicant or patent owner 

provides, or has provided, a statement 

to the effect that the subject matter of 

the reference patent or application and 

the claimed invention were made by or 

on behalf of the parties to a joint 

research agreement, within the meaning 

of 35 U.S.C. 100(h) and § 1.9(e), that was 

in effect on or before the date the 

claimed invention was made, and that 

the claimed invention was made as a 

result of activities undertaken within 

the scope of the joint research 

agreement; and 

(B) The application for patent, or the 

patent, for the claimed invention 

discloses or is amended to disclose the 

names of the parties to the joint research 

agreement in accordance with § 1.71(g). 

(e) Submission of a disclaimer during 

an interference under subpart E of part 

41 or a proceeding under part 42. A 

disclaimer of a complete claim or 

claims, or a disclaimer of the entire term 

or terminal part of the term (terminal 

disclaimer) under this section, of a 

patent involved in an interference under 

subpart E of part 41 of this chapter or 

a proceeding under part 42 of this 

chapter may not be entered into the 

official file or considered, or if 

inadvertently entered, will be expunged 

unless a motion requesting to file the 

disclaimer under §§ 41.121(a)(2), 

41.121(a)(3), or 42.20 of this chapter has 

been granted. 

Andrei Iancu, 

Under Secretary of Commerce for Intellectual 

Property and Director of the United States 

Patent and Trademark Office. 

[FR Doc. 2020–27676 Filed 12–29–20; 8:45 am] 

BILLING CODE 3510–16–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–SFUND–1989–0008; FRL–10018– 

19–OLEM] 

Proposed Deletion From the National 

Priorities List 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule; notice of intent. 

SUMMARY: The Environmental Protection 

Agency (EPA) is issuing a Notice of 

Intent to partially delete the North 

Penn—Area 6 site from the National 

Priorities List (NPL) and requests public 

comments on this proposed action. The 

NPL, promulgated pursuant to the 

Comprehensive Environmental 

Response, Compensation, and Liability 

Act (CERCLA) of 1980, as amended, is 

an appendix of the National Oil and 

Hazardous Substances Pollution 

Contingency Plan (NCP). The EPA and 

the Commonwealth of Pennsylvania, 

through its designated state agency, 

have determined that all appropriate 

response actions under CERCLA, other 

than operations and maintenance, 

monitoring and five-year reviews, where 

applicable, have been completed. 

However, this proposed deletion would 

not preclude future actions under 

Superfund. 

DATES: Comments regarding this 

proposed listing must be submitted on 

or before January 29, 2021. 

ADDRESSES: EPA has established a 

docket for this action under the Docket 

Identification number included in Table 

1 in the SUPPLEMENTARY INFORMATION

section of this document. Submit your 

comments, identified by the appropriate 

Docket ID number, by one of the 

following methods: 

• https://www.regulations.gov. 

Follow on-line instructions for 

submitting comments. 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 

http://www2.epa.gov/dockets/ 

commenting-epa-dockets. 

• Email: Table 2 in the 

SUPPLEMENTARY INFORMATION section of 

this document provides an email 

address to submit public comments for 

the proposed deletion action. 

Instructions: Direct your comments to 

the Docket Identification number 

included in Table 1 in the 

SUPPLEMENTARY INFORMATION section of 

this document. EPA’s policy is that all 

comments received will be included in 

the public docket without change and 

may be made available online at https:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through https://

www.regulations.gov or email. The 

https://www.regulations.gov website is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an email comment directly 

to EPA without going through https://

www.regulations.gov, your email 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the internet. If you 

submit an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD–ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of