[Federal Register Volume 85, Number 250 (Wednesday, December 30, 2020)]
[Proposed Rules]
[Pages 86518-86525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27676]


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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.

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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[supreg] portable document format or 
Microsoft Word[supreg] 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 [email protected]; or Robert Clarke, Editor, Manual of Patent Examining 
Procedure, Office of the Deputy Commissioner for Patent Examination 
Policy, by email at [email protected].

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

[[Page 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 non-commonly 
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

[[Page 86520]]

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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  1.321(a) to new 
proposed Sec.  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 Sec.  
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 
Sec.  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

[[Page 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 Sec.  1.321(b)(1); in 
applications filed on or after September 16, 2012, are set forth in 
proposed Sec.  1.321(b)(2); and in applications filed before September 
16, 2012, are set forth in proposed Sec.  1.321(b)(3). This proposal 
eliminates the need for the public to consult Sec.  1.321(b) in effect 
on September 15, 2012, when filing terminal disclaimers in an 
application filed before September 16, 2012.
    Each proposed Sec.  1.321(b)(1)-(3) includes parallel requirements 
in proposed subparagraphs (i)-(v) for filing a terminal disclaimer.
    Proposed Sec.  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 Sec.  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 Sec.  
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 Sec.  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 Sec.  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 Sec.  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 Sec.  
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 Sec.  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 
Sec.  1.20(d).
    Proposed Sec.  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 Sec.  1.321(c) adds the heading ``Terminal Disclaimer with 
Common Ownership Enforcement Provision to Obviate Nonstatutory Double 
Patenting'' and generally parallels current Sec.  1.321(c). Proposed 
Sec.  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 Sec.  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 Sec.  1.321(c)(1) incorporates the requirements of current 
Sec.  1.321(c)(1) and (c)(2) which set forth the formal requirements 
and signature requirements for terminal disclaimers.
    Proposed Sec.  1.321(c)(2) revises the requirements of current 
Sec.  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 Sec.  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 Sec.  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 Sec.  
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 Sec.  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 Sec.  
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 Sec.  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 Sec.  
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 Sec.  1.321(d)(1)(i) incorporates the requirements of 
current Sec.  1.321(d)(1) and (d)(2) which set forth the formal 
requirements and signature requirements for terminal disclaimers.
    Proposed Sec.  1.321(d)(1)(ii) revises the requirements of current 
Sec.  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

[[Page 86522]]

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 Sec.  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 Sec.  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 Sec.  1.104(c)(4)(ii). 
Accordingly, if the requirements of Sec.  1.104(c)(4)(ii) have already 
been met, there is no need to take further action to meet the 
requirements of proposed Sec.  1.321(d)(2)(i).
    Proposed Sec.  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 Sec.  
1.104(c)(5)(ii). Accordingly, if the requirements of Sec.  
1.104(c)(5)(ii) have already been met, there is no need to take further 
action to meet the requirements of proposed Sec.  1.321(d)(2)(ii).
    Proposed Sec.  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 Sec. Sec.  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)

[[Page 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

0
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.

0
2. In Sec.  1.130, revise paragraphs (a), introductory text of 
paragraph (b), and (c) to read as follows:


Sec.  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

[[Page 86524]]

application or patent, in which case an applicant or a patent owner may 
file a petition for a derivation proceeding pursuant to Sec. Sec.  
42.401 through 42.407 of this chapter.
* * * * *
0
3. Revise Sec.  1.321 to read as follows:


Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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,

[[Page 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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 
Sec. Sec.  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