[Federal Register Volume 89, Number 92 (Friday, May 10, 2024)]
[Proposed Rules]
[Pages 40439-40449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10166]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Part 1

[Docket No. PTO-P-2024-0003]
RIN 0651-AD76


Terminal Disclaimer Practice To Obviate Nonstatutory Double 
Patenting

AGENCY: United States Patent and Trademark Office, Department of 
Commerce.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The USPTO proposes to amend the rules of practice to add a new 
requirement for an acceptable terminal disclaimer that is filed to 
obviate (that is, overcome) nonstatutory double patenting. The proposed 
rule change would require terminal disclaimers filed to obviate 
nonstatutory double patenting to include an agreement by the 
disclaimant that the patent in which the terminal disclaimer is filed, 
or any patent granted on an application in which a terminal disclaimer 
is filed, will be enforceable only if the patent is not tied and has 
never been tied directly or indirectly to a patent by one or more 
terminal disclaimers filed to obviate nonstatutory double patenting in 
which: any claim has been finally held unpatentable or invalid as 
anticipated or obvious by a Federal court in a civil action or by the 
USPTO, and all appeal rights have been exhausted; or a statutory 
disclaimer of a claim is filed after any challenge based on 
anticipation or obviousness to that claim has been made. This action is 
being taken to prevent multiple patents directed to obvious variants of 
an invention from potentially deterring competition and to promote 
innovation and competition by allowing a competitor to avoid 
enforcement of patents tied by one or more terminal disclaimers to 
another patent having a claim finally held unpatentable or invalid over 
prior art.

DATES: Comments must be received by July 9, 2024 to ensure 
consideration.

ADDRESSES: For reasons of government efficiency, comments must be 
submitted through the Federal eRulemaking Portal at 
www.regulations.gov. To submit comments via the portal, one should 
enter docket number PTO-P-2024-0003 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 
proposed rule and click on the ``Comment'' icon, complete the required 
fields, and enter or attach their comments. Attachments to electronic 
comments will be accepted in Adobe[supreg] portable document format 
(PDF) 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 or 
access to comments is not feasible due to a lack of access to a 
computer and/or the internet, please contact the USPTO using the 
contact information below for special instructions.

FOR FURTHER INFORMATION CONTACT: Susy Tsang-Foster, Senior Legal 
Advisor, Office of Patent Legal Administration, at 571-272-7711; or 
Nicholas Hill, Legal Advisor, Office of Patent Legal Administration, at 
571-270-1485.

SUPPLEMENTARY INFORMATION: Under U.S. law, a person is entitled to a 
patent, absent certain exceptions, for an invention that is new and not 
obvious as of the effective filing date of the claimed invention. 
Because a patent owner may file continuing applications and obtain 
follow-on patents with claims that have the same effective filing date 
as those of the original patent, patent owners may pursue multiple 
patents with claims that vary in only minor ways from each other. A 
patent owner may also, under certain circumstances (for example, when 
two applications are filed on the same day), obtain patents that are 
not part of the same patent family for obvious variants of an 
invention. As a result, obviousness-type double patenting (also 
referred to as nonstatutory double patenting) may exist between patents 
and/or applications in the same patent family or in a different patent 
family. Under the doctrine of obviousness-type double patenting, the 
USPTO rejects patentably indistinct claims filed in patent applications 
when these applications and the applications and/or patents whose 
claims form the basis of the nonstatutory double patenting: (1) have 
the same inventive entity, at least one common (joint) inventor, a 
common applicant, and/or a common owner/assignee; or (2) are not 
commonly owned but are owned by parties to a joint research agreement.
    Under current practice, a patent applicant or patent owner (also 
referred to as a patentee) may, in most instances, obviate nonstatutory 
double patenting by filing a terminal disclaimer meeting the 
requirements of 37 CFR 1.321(c) or (d). A terminal disclaimer will 
ensure that the term of the patent with the terminal disclaimer will 
not extend beyond the term of the patent forming the basis of the 
nonstatutory double patenting. To prevent the harassment of an alleged 
infringer by multiple parties, under current 37 CFR 1.321(c) or (d) a 
terminal disclaimer must state that the patent in which the terminal 
disclaimer is filed shall be enforceable only for and during the period 
that the patent is commonly owned, or commonly enforced, with the 
patent which formed the basis for the nonstatutory double patenting.
    Even with the protections currently provided by a terminal 
disclaimer, multiple patents tied by terminal disclaimers that are 
directed to obvious variants of an invention could deter competition 
due to the prohibitive cost of challenging each patent separately in 
litigation or administrative proceedings.
    Currently, a terminal disclaimer filed to obviate nonstatutory 
double patenting over a conflicting patent must include a disclaimer of 
term, if any, extending beyond the term of the conflicting patent and a 
common ownership or common enforcement agreement. Under

[[Page 40440]]

the proposed rule, the USPTO will not issue a patent to a common owner 
or inventor with a claim that conflicts with a claim of a second patent 
unless the terminal disclaimer includes an additional agreement that 
the patent with the terminal disclaimer will not be enforced if any 
claim of the second patent is invalidated by prior art. That means to 
resolve a dispute where there are multiple patents tied by terminal 
disclaimers, competitors could focus on addressing the validity of the 
claims of a single patent. As is the case under current practice, a 
terminal disclaimer under the proposed rule would be unidirectional, 
encumbering only the patent with the terminal disclaimer and not the 
conflicting patent. The reason for this is that a terminal disclaimer 
is signed only by the owner of the patent with the terminal disclaimer, 
and that patent and the conflicting patent might not be commonly owned 
when the terminal disclaimer is filed. See 35 U.S.C. 253 (providing for 
filing of a terminal disclaimer by the owner of the patent in which it 
is filed). The proposed rule is intended to promote competition by 
lowering the cost of challenging groups of patents tied by terminal 
disclaimers, resulting in reduced barriers to market entry and lower 
costs for consumers. The proposed rule furthers the objectives of 
Executive Order 14036 on ``Promoting Competition in the American 
Economy,'' 86 FR 36987 (July 14, 2021).
    As an example of how the proposed rule would lower costs of 
challenging multiple related patents, in a litigation in which a patent 
owner is enforcing a patent along with several other patents that are 
tied by one or more terminal disclaimers to that patent, a competitor 
could seek to have the court narrow any validity disputes to address 
only that patent. Narrowing validity disputes in litigation to only one 
such patent could result in more focused claim construction hearings, 
lower litigation costs, and faster resolution. Similarly, a competitor 
could petition for an inter partes or post-grant review of just a 
single patent to which multiple patents are tied by one or more 
terminal disclaimers with the proposed agreement. The outcome of the 
post-grant challenge to the claims in the selected patent may also 
resolve the enforceability of the multiple patents tied to that 
selected patent. Because only one patent can be challenged per post-
grant petition, the proposed terminal disclaimer rule would lower the 
cost of administrative proceedings by enabling a challenger to seek the 
freedom to operate through the review of only one patent, as opposed to 
seeking the review of a number of patents claiming obvious variants of 
a single invention.

I. Background

A. Request for Comments on Whether Any Changes Need To Be Made to the 
Patent System Regarding Nonstatutory Double Patenting

    In a recent request for comments, the USPTO sought public input on 
whether changes are needed in terminal disclaimer practice to help 
ensure that the U.S. patent system properly and adequately protects 
innovation while not unnecessarily harming competition. See Request for 
Comments on USPTO Initiatives To Ensure the Robustness and Reliability 
of Patent Rights, 87 FR 60130 (October 4, 2022) (``Request for 
Comments''). In the Request for Comments, the USPTO recognized that 
existing practice may not adequately address concerns that multiple 
patents directed to obvious variants of an invention could deter 
competition if the number of patents is prohibitively expensive to 
challenge in post-grant proceedings before the PTAB or in district 
court. To address this issue, the Request for Comments asked whether 
applicants seeking patents on obvious variations to prior claims should 
be required to stipulate that the claims are not patentably distinct 
from the previously considered claims as a condition of filing a 
terminal disclaimer to obviate an obviousness-type double patenting 
rejection. The Request for Comments also recognized that, under current 
practice, patents tied together with a terminal disclaimer after an 
obviousness-type double patenting rejection must be separately 
challenged on validity grounds. The Request for Comments asked whether 
the filing of a terminal disclaimer in these patents should be an 
admission of obviousness and, if so, whether the patents, when their 
validity is challenged after issuance, should stand and fall together.
    The USPTO received comments expressing a range of views on the 
questions posed in the Request for Comments. Some comments supported 
the stipulation requirement and the proposition that the filing of a 
terminal disclaimer should be an admission of obviousness such that 
patents tied by terminal disclaimers should stand and fall together. 
These include comments suggesting that a stipulation could clarify the 
intrinsic record or simplify subsequent litigation. Some comments 
stated that a stipulation or admission could reduce the cost and risk 
of challenging multiple duplicative patents and lower drug prices for 
drugs that are no longer considered innovative. Some comments also 
indicated that a stipulation could create an incentive for applicants 
to address nonstatutory double patenting questions on the merits and 
that this would encourage innovators to create more inventions, 
stimulating investment into innovation.
    Other comments opposed the stipulation requirement and the 
proposition that the filing of a terminal disclaimer should be an 
admission of obviousness such that patents tied by terminal disclaimers 
should stand and fall together. These include comments asserting that 
the decision of whether to file a terminal disclaimer is often driven 
by a desire to expedite prosecution and reduce costs rather than by the 
merits of the nonstatutory double patenting rejection, that a 
stipulation requirement would cause delays and increase burdens on 
applicants, and/or that a stipulation requirement would encourage 
applicants to file a large number of claims in a single application. 
Comments opposed to treating the filing of a terminal disclaimer as an 
admission of obviousness include comments citing SimpleAir, Inc. v. 
Google LLC, 884 F.3d 1160 (Fed. Cir. 2018), or earlier Federal Circuit 
cases, for the proposition that a terminal disclaimer should not be 
considered an admission or give rise to a presumption/estoppel. 
Comments opposing the changes in terminal disclaimer practice discussed 
in the Request for Comments also include comments asserting the 
following: validity is determined on a claim-by-claim basis; claims are 
presumed valid under 35 U.S.C. 282; the fact that prior art invalidates 
a claim in one of two patents tied together by a terminal disclaimer 
does not necessarily mean that the same prior art would invalidate a 
claim in the other patent; and/or these changes raise questions of due 
process and fairness.
    In addition, some comments broadly opposed any changes to terminal 
disclaimer practice. Commenters were concerned that such changes would 
increase the burden on applicants. Some commenters asserted that the 
stipulation requirement described in the Request for Comments would be 
a substantive rule that the USPTO does not have authority to make.
    Upon consideration of the comments, the USPTO has opted not to 
propose a rule requiring a stipulation that the claims are not 
patentably distinct or an agreement by the disclaimant that filing a 
terminal disclaimer is an admission of obviousness. The proposed rule 
does not concern the validity of claims.

[[Page 40441]]

Instead, the proposed rule would require an agreement by the 
disclaimant that the patent with the terminal disclaimer will be 
enforced only under certain conditions. To the extent an applicant 
believes claims are patentably distinct, they may either challenge the 
rejection or move those claims to an application in which a terminal 
disclaimer has not been, and will not be, filed. A rule requiring that 
terminal disclaimers filed to obviate nonstatutory double patenting 
include language placing conditions upon enforcement was previously 
upheld as within the USPTO's rulemaking authority. See In re Van Ornum, 
686 F.2d 937 (CCPA 1982).

B. Current Practice

    Nonstatutory double patenting may be obviated, in most instances, 
by filing a terminal disclaimer. The terminal disclaimer will ensure 
that the term of the patent with the terminal disclaimer will not 
extend beyond the term of the patent forming the basis of the 
nonstatutory double patenting. In addition, the enforcement provision 
of the terminal disclaimer will prevent the harassment of an alleged 
infringer by multiple parties. Under current USPTO regulations, two 
types of terminal disclaimers may be used to obviate nonstatutory 
double patenting. The first type is filed pursuant to 37 CFR 1.321(c) 
and must include a provision that the patent in which the terminal 
disclaimer is filed (that is, the subject patent) or any patent granted 
on the application in which the terminal disclaimer is filed (that is, 
any patent granted on the subject application) shall be enforceable 
only for and during the period that the subject patent or any patent 
granted on the subject application is commonly owned with the reference 
patent or any patent granted on the reference application which formed 
the basis for the nonstatutory double patenting. The second type is 
filed pursuant to 37 CFR 1.321(d) and must include a provision that the 
subject patent or any patent granted on the subject application shall 
be enforceable only for and during such period that the subject patent 
or any patent granted on the subject application and the reference 
patent or any patent granted on the reference application which formed 
the basis for the nonstatutory double patenting are not separately 
enforced. The second type obviates nonstatutory double patenting based 
on a non-commonly owned reference patent or application that is 
excepted or disqualified as prior art as a result of the subject matter 
of the reference patent or application and the claimed invention in the 
subject patent or application being treated as commonly owned on the 
basis of a joint research agreement.
    Currently, claims in patents tied by a terminal disclaimer filed 
under 37 CFR 1.321(c) or (d) to obviate nonstatutory double patenting 
must be separately challenged on validity grounds. See 35 U.S.C. 
282(a); see also SimpleAir, Inc. v. Google LLC, 884 F.3d 1160, 1167-68 
(Fed. Cir. 2018) (``[O]ur cases foreclose the inference that filing a 
terminal disclaimer functions as an admission regarding the 
patentability of the resulting claims.''); Motionless Keyboard Co. v. 
Microsoft Corp., 486 F.3d 1376, 1385 (Fed. Cir. 2007) (``A terminal 
disclaimer simply is not an admission that a later-filed invention is 
obvious.''); Ortho Pharm. Corp. v. Smith, 959 F.2d 936, 941 (Fed. Cir. 
1992) (rejecting the argument that the patent applicant admitted to 
obviousness-type double patenting by filing a terminal disclaimer); 
Quad Envtl. Techs. Corp. v. Union Sanitary Dist., 946 F.2d 870, 874 
(Fed. Cir. 1991) (``[T]he filing of a terminal disclaimer simply serves 
the statutory function of removing the rejection of double patenting, 
and raises neither presumption nor estoppel on the merits of the 
rejection.''). The current state of the law exposes competitors 
attempting to enter the market to potentially high costs because they 
may have to defend against patents to obvious variants of a single 
invention despite the presence of terminal disclaimers.

II. Proposed Changes

A. Changes to Current Practice

    The USPTO proposes to revise the enforcement provisions in 37 CFR 
1.321(c) and (d) to require that a terminal disclaimer filed to obviate 
nonstatutory double patenting include an agreement by the disclaimant 
that the subject patent or any patent granted on the subject 
application shall be enforceable only if the patent is not tied and has 
never been tied directly or indirectly to a patent by one or more 
terminal disclaimers filed to obviate nonstatutory double patenting in 
which: (1) any claim has been finally held unpatentable or invalid 
under 35 U.S.C. 102 or 103 (statutory provisions for anticipation or 
obviousness as referred to in the SUMMARY above) by a Federal court in 
a civil action or by the USPTO, and all appeal rights have been 
exhausted; or (2) a statutory disclaimer of a claim is filed after any 
challenge based on 35 U.S.C. 102 or 103 to that claim has been made. 
The new requirement for a terminal disclaimer in this proposed rule 
differs from the stipulation described in the Request for Comments 
discussed above. See 87 FR at 60134. Specifically, the proposed rule 
does not require an applicant or a patentee to make a statement in the 
terminal disclaimer regarding conflicting claims being patentably 
indistinct. The new requirement has the likely advantages of reducing 
litigation and administrative proceeding costs and increasing 
predictability compared with the stipulation requirement in the Request 
for Comments because a comparison of claims is not necessary to 
determine which claims are subject to a stipulation (or an agreement), 
including claims that are amended during prosecution after the terminal 
disclaimer is filed. The proposed agreement would not affect the 
validity of the claims in the subject patent or any patent granted on 
the subject application because it is a voluntary agreement by the 
patentee that the patent with the terminal disclaimer will be 
enforceable only under certain conditions and does not touch on the 
validity of the claims. The new requirement solves the current problem 
of requiring a competitor to invalidate multiple patents tied by 
terminal disclaimers in order to have the freedom to operate. To the 
extent an applicant believes claims are patentably distinct, they may 
either challenge the rejection or move those claims to an application 
in which a terminal disclaimer has not been, and will not be, filed.
(1) Meaning of Direct and Indirect Tying
a. Direct Tying--By One Terminal Disclaimer
    The subject patent or any patent granted on the subject application 
is tied directly by a terminal disclaimer to another patent when: (1) 
the terminal disclaimer is filed in the subject patent or application; 
and (2) the other patent, or the application that issued as the other 
patent, is the reference patent or application identified in the 
terminal disclaimer. The tying by a terminal disclaimer is 
unidirectional and is effective only for the patent with the terminal 
disclaimer. Therefore, a terminal disclaimer that directly ties a 
subject patent or any patent granted on a subject application to a 
reference patent or any patent granted on a reference application does 
not directly tie the reference patent or any patent granted on the 
reference application to the subject patent or any patent granted on 
the subject application. Direct tying is illustrated by example 1 in 
section (II)(A)(3) below.
    If timely requested, a recorded terminal disclaimer may be 
withdrawn

[[Page 40442]]

before the application in which it is filed issues as a patent, or if a 
terminal disclaimer is filed in a reexamination proceeding, before the 
reexamination certificate issues. See section 1490, subsection VIII of 
the Manual of Patent Examining Procedure (MPEP) (Ninth Edition, 
Revision 07.2022, February 2023). After a patent or reexamination 
certificate issues, a recorded terminal disclaimer will not be 
nullified. Id. For a terminal disclaimer filed in a patent, the 
recorded terminal disclaimer is considered part of the original patent. 
See 35 U.S.C. 253(b) and 37 CFR 1.321(a). By contrast, a terminal 
disclaimer filed in a reexamination proceeding is a proposed amendment 
to the patent that does not take effect until the reexamination 
certificate issues. See MPEP 2288.
    Where a terminal disclaimer is filed in an application, if the 
terminal disclaimer is withdrawn before a patent issues from the 
application, then the patent containing the withdrawn terminal 
disclaimer is not tied and has never been tied to the patent identified 
in the withdrawn terminal disclaimer (or to any patent granted on the 
application identified in the withdrawn terminal disclaimer).
b. Indirect Tying--By Two or More Terminal Disclaimers
    The subject patent or any patent granted on the subject application 
is tied indirectly by two terminal disclaimers to another patent when: 
(1) a terminal disclaimer filed in the subject patent or application 
identifies an intermediate patent/application as the reference patent 
or application; and (2) a terminal disclaimer filed in the intermediate 
patent/application identifies the other patent, or the application that 
issued as the other patent, as the reference patent or application. 
This is illustrated by example 2 in section (II)(A)(3) below.
    As discussed above with respect to direct tying, terminal 
disclaimers may be withdrawn from an application in certain 
circumstances. The following four illustrations show the effect on 
tying of withdrawing a terminal disclaimer from an intermediate 
application where a terminal disclaimer is also filed in a subject 
application.
    (1) Where the terminal disclaimer filed in the intermediate 
application identifies the other patent and is withdrawn before a 
patent is granted on the subject application, the patent granted on the 
subject application was never tied indirectly to the other patent.
    (2) Where the terminal disclaimer filed in the intermediate 
application identifies the other patent and is withdrawn after a patent 
is granted on the subject application, the indirect tying to the other 
patent is undone but the patent granted on the subject application was 
at one point tied indirectly to the other patent.
    (3) Where the terminal disclaimer filed in the intermediate 
application identifies the application that later issues as the other 
patent and is withdrawn before a patent is granted on the subject 
application or before the other patent issues, the patent granted on 
the subject application was never tied indirectly to the other patent.
    (4) Where the terminal disclaimer filed in the intermediate 
application identifies the application that later issues as the other 
patent and is withdrawn after a patent is granted on the subject 
application and after the other patent issues, the indirect tying to 
the other patent is undone but the patent granted on the subject 
application was at one point tied indirectly to the other patent.
    Tying by more than two terminal disclaimers is illustrated by 
example 3 in section (II)(A)(3) below.
(2) Meaning of ``A Claim Has Been Finally Held Unpatentable or 
Invalid''
    The term ``finally held unpatentable'' refers to a final 
determination by the USPTO in a trial established by the Leahy-Smith 
America Invents Act (AIA) (Pub. L. 112-29 (2011)) or a reexamination 
proceeding that one or more claims in a patent are unpatentable after 
all appeals have been concluded or appeal rights exhausted. The term 
``finally held . . . invalid'' relates to a final decision entered in a 
Federal court in a civil action holding one or more claims of a patent 
invalid after all appeals have been concluded or appeal rights 
exhausted. The proposed agreement is independent of the relative timing 
of the terminal disclaimer and the final holding of unpatentability or 
invalidity over prior art. Additionally, the proposed agreement cannot 
be avoided by filing a statutory disclaimer of a claim under 35 U.S.C. 
253(a) after any challenge based on 35 U.S.C. 102 or 103 to that claim 
has been made.
(3) Examples
    The following examples illustrate the meaning of: (1) direct and 
indirect tying in the proposed rule, and (2) the possible consequences 
of the agreement in the proposed rule.
    In the examples, all terminal disclaimers include the agreement in 
the proposed rule and are filed to obviate nonstatutory double 
patenting, unless otherwise noted.
    A single capital letter identifies both an application and any 
patent that issues from that application, with the letter ``A'' in 
parentheses used to identify the application and the letter ``P'' in 
parentheses used to identify the patent. Thus, X(P) is any patent that 
has issued from application X(A).
    An arrow represents a terminal disclaimer filed to obviate 
nonstatutory double patenting. The arrow starts at the subject patent 
or application and points toward the reference patent or application.
    The patents and applications in these examples may be in the same 
patent family or in a different patent family.
    The enumeration of the terminal disclaimers using terms such as 
``first,'' ``second,'' etc. does not refer to when the terminal 
disclaimers are filed but is instead used for identification purposes.
Example 1
    The subject patent or any patent granted on the subject application 
is tied directly to the reference patent or any patent granted on the 
reference application by a terminal disclaimer filed in the subject 
patent or application to obviate nonstatutory double patenting based on 
the reference patent or application.
    Thus, if a terminal disclaimer is filed in X(P) or X(A) identifying 
W(P) or W(A) as a reference patent or application, then X(P) is tied 
directly to W(P). Example 1 may be represented visually as:

W [larr] X

    The tying by a terminal disclaimer is unidirectional. Therefore, in 
this example, W(P) is not tied to X(P) by the terminal disclaimer filed 
in X.
    In this example, X(P) is the subject patent or any patent granted 
on the subject application, and W(P) is the reference patent or any 
patent granted on the reference application. As a result, if a claim of 
W(P) is finally held unpatentable or invalid over prior art, X(P) may 
not be enforced. However, if a claim of X(P) is finally held 
unpatentable or invalid over prior art, W(P) may still be enforced 
because a terminal disclaimer with the agreement in the proposed rule 
was not filed in W identifying X as a reference patent or application.
    If the terminal disclaimer filed in X(A) is withdrawn before X(A) 
issues as a patent, then X(P) may be enforced even if a claim in W(P) 
is finally held unpatentable or invalid over prior art because X(P) was 
never tied to W(P).
    We can further explain example 1 in practical terms. For instance, 
applicant overcomes a nonstatutory double

[[Page 40443]]

patenting rejection in application X(A) based on reference patent W(P) 
by filing a terminal disclaimer with the agreement in the proposed 
rule, thereby obtaining patent X(P). Under the current rule, both 
patents X(P) and W(P) may block competitors and need to be separately 
invalidated or licensed to gain freedom to operate. Under the proposed 
rule, if a claim of patent W(P) is finally held invalid or unpatentable 
over prior art, competitors would avoid the enforcement of patent X(P) 
based on the agreement in the proposed rule in the terminal disclaimer 
in patent X(P). However, if a claim of patent X(P) is finally held 
invalid or unpatentable over prior art, competitors would not be able 
to, solely on this basis, avoid the enforcement of patent W(P) because 
a terminal disclaimer containing the proposed agreement was not filed 
in W identifying X as a reference patent or application.
    Additionally, multiple subject patents or applications may have 
terminal disclaimers identifying the same reference patent or 
application. Under the proposed rule, if a claim of the reference 
patent or any patent granted on the reference application is finally 
held invalid or unpatentable over prior art, competitors would avoid 
the enforcement of these multiple patents based on the proposed 
agreement in the terminal disclaimers filed in these patents.
Example 2
    Extending example 1 (where the terminal disclaimer filed in X 
includes the proposed agreement), if a second terminal disclaimer is 
filed in Y(P) or Y(A) identifying X(P) or X(A) as a reference patent or 
application, then Y(P) is tied indirectly to W(P). This would be the 
case even if X(A) is abandoned or remains pending. Example 2 may be 
represented visually as:

W [larr] X [larr] Y

    Consistent with example 1, Y(P) is tied directly to X(P), and X(P) 
is tied directly to W(P). In this example, X(P) or X(A), as the case 
may be, is an intermediate patent/application because the two terminal 
disclaimers tie Y(P) to W(P).
    In this example, W(P) is not tied to X(P) or Y(P), and X(P) is not 
tied to Y(P).
    In this example, Y(P) is a subject patent or any patent granted on 
a subject application for the terminal disclaimer filed in Y, and W(P) 
is a reference patent or any patent granted on a reference application 
for the terminal disclaimer filed in X. In this example, X is an 
intermediate patent/application that is the reference patent or 
application for the terminal disclaimer filed in Y and the subject 
patent or application for the terminal disclaimer filed in X. As a 
result, if a claim of W(P) is finally held unpatentable or invalid over 
prior art, and the terminal disclaimer in Y(P) contains the proposed 
agreement, Y(P) may not be enforced.
    As in example 1, if a claim of W(P) is finally held unpatentable or 
invalid over prior art, X(P) may not be enforced. Similarly, if a claim 
of X(P) is finally held unpatentable or invalid over prior art, Y(P) 
may not be enforced.
    If the terminal disclaimer filed in X(A) identifying W(P) is 
withdrawn before Y(A) issues as a patent, then Y(P) would still be 
enforceable in the event that a claim in W(P) is finally held 
unpatentable or invalid over prior art because Y(P) was never tied to 
W(P). On the other hand, if the terminal disclaimer filed in X(A) 
identifying W(P) is withdrawn after Y(A) has issued as a patent, then 
Y(P) may not be enforced in the event that a claim in W(P) is finally 
held unpatentable or invalid over prior art because Y(P) was once tied 
to W(P).
    Note that even if the terminal disclaimer filed in X did not 
contain the proposed agreement (because it was filed prior to the 
implementation of this proposed rule), Y(P) is still tied to W(P). In 
this situation, if a claim in W(P) is finally held unpatentable or 
invalid over prior art, X(P) may still be enforced (because the 
terminal disclaimer filed in X does not contain the proposed agreement) 
even though Y(P) may not be enforced.
Example 3
    Indirect tying may also occur through multiple intermediate 
patents/applications. Extending example 2, if a third terminal 
disclaimer is filed in Z(P) or Z(A) identifying Y(P) or Y(A) as a 
reference patent or application, then Z(P) is tied indirectly to W(P). 
This would be the case even if X(A) and/or Y(A) are/is abandoned or 
remain(s) pending. Example 3 may be represented visually as:

W [larr] X [larr] Y [larr] Z

    In this example, all the tying relationships of example 2 remain.
    Also in this example, Z(P) is a subject patent or any patent 
granted on a subject application for the terminal disclaimer filed in 
Z, and W(P) is a reference patent or any patent granted on a reference 
application for the terminal disclaimer filed in X. X(P) or X(A) and 
Y(P) or Y(A), as the case may be, are intermediate patents/applications 
because the three terminal disclaimers tie Z(P) to W(P). As a result, 
if a claim of W(P) is finally held unpatentable or invalid over prior 
art and if the terminal disclaimer filed in Z(A) contains the proposed 
agreement, Z(P) may not be enforced.
    As in example 2, if a claim of W(P) is finally held unpatentable or 
invalid over prior art, Y(P) and X(P) may not be enforced; if a claim 
of X(P) is finally held unpatentable or invalid over prior art, Y(P) 
and Z(P) may not be enforced; and if a claim of Y(P) is finally held 
unpatentable or invalid over prior art, Z(P) may not be enforced.
Example 4
    This example shows three patents tied directly and indirectly by 
terminal disclaimers. In this example, a first terminal disclaimer is 
filed in X(P) or X(A) identifying W(P) or W(A) as a reference patent or 
application, directly tying X(P) to W(P).

W [larr] X

    A second terminal disclaimer is filed in W(P) or W(A) identifying 
X(P) or X(A) as a reference patent or application, directly tying W(P) 
to X(P).

W [lrarr] X

    A third terminal disclaimer is filed in Y(P) or Y(A) identifying 
X(P) or X(A) as a reference patent or application, directly tying Y(P) 
to X(P).

W [lrarr] X [larr] Y

    A fourth terminal disclaimer is filed in X(P) or X(A) identifying 
Y(P) or Y(A) as a reference patent or application, directly tying X(P) 
to Y(P).

W [lrarr] X [lrarr] Y

    A fifth terminal disclaimer is filed in Y(P) or Y(A) identifying 
W(P) or W(A) as a reference patent or application, directly tying Y(P) 
to W(P).

W [larr] Y

    A sixth terminal disclaimer is filed in W(P) or W(A) identifying 
Y(P) or Y(A) as a reference patent or application, directly tying W(P) 
to Y(P).

W [lrarr] Y

    Example 4 may be represented visually as:

W [lrarr] X [lrarr] Y and W [lrarr] Y

    In this example, in addition to W(P), X(P), and Y(P) each being 
directly tied to one another, they each are indirectly tied to one 
another. As a result, if a claim in any one of W(P), X(P), or Y(P) is 
finally held unpatentable or invalid over prior art and if the terminal 
disclaimers filed in W, X, and Y contain the proposed agreement, the 
other two patents may not be enforced.
Example 5
    The following example illustrates two patents that are not 
indirectly tied by

[[Page 40444]]

terminal disclaimers even though each has a terminal disclaimer 
identifying the same reference patent or application, due to the 
unidirectionality of tying by a terminal disclaimer.
    In this example, a first terminal disclaimer is filed in X(P) or 
X(A) identifying Y(P) or Y(A) as a reference patent or application, and 
a second terminal disclaimer is filed in Z(P) or Z(A) identifying Y(P) 
or Y(A) as a reference patent or application. Example 5 may be 
represented visually as:

X [rarr] Y [larr] Z

    In this example, X(P) and Z(P) are both tied directly to Y(P). As a 
result, if a claim in Y(P) is finally held unpatentable or invalid over 
prior art and if the proposed agreement is contained in the terminal 
disclaimers filed in X and Z, X(P) and Z(P) cannot be enforced.
    However, Z(P) is not tied to X(P), X(P) is not tied to Z(P), and 
Y(P) is not tied to either X(P) or Z(P). Thus, if a claim in X(P) or 
Z(P) is finally held unpatentable or invalid over prior art, there is 
no effect on whether the other two patents may be enforced.
(4) Ways To Address Nonstatutory Double Patenting
    To obviate nonstatutory double patenting, patent owners and 
applicants can voluntarily file a terminal disclaimer with the proposed 
agreement. If applicants and patent owners are concerned about the new 
requirement and seek to avoid the consequences of the proposed 
agreement, applicants and patent owners have the option of not filing a 
terminal disclaimer with the proposed agreement. The nonstatutory 
double patenting may be dealt with in a number of ways.
    An applicant facing a nonstatutory double patenting rejection in an 
application has a number of options to avoid filing a terminal 
disclaimer with the proposed agreement such as:
    (1) combining the conflicting claims into a single application,
    (2) canceling or amending any conflicting claims in the application 
or in the other application containing the conflicting claims that 
formed the basis of the nonstatutory double patenting,
    (3) arguing that rejected claims in the application are patentably 
distinct from the claims of the reference patent or application, or
    (4) filing a reissue application of the patent whose claims formed 
the basis of the nonstatutory double patenting in order to add canceled 
conflicting claims from the application into the reissue application, 
provided that the added claims do not introduce new matter into the 
reissue application.
    Alternatively, an applicant may separate the patentably distinct 
claims into another application and file a terminal disclaimer with the 
proposed agreement in the application with the indistinct claims.
    If the applicant amends the claims after the filing of the terminal 
disclaimer such that the claims no longer conflict with the claims in 
the reference patent or application, the applicant may file a petition 
under 37 CFR 1.182 to withdraw the terminal disclaimer prior to the 
issuance of the application to avoid the effect of the proposed 
agreement on patentably distinct claims and any potential loss of 
patent term. As discussed above, after patent grant, a recorded 
terminal disclaimer will not be withdrawn. See MPEP 1490, subsection 
VIII.

B. Changes Consistent With Current Practice

(1) Who May File a Disclaimer
    The proposed rule makes no change to who may file a terminal 
disclaimer. Consistent with 35 U.S.C. 253, the USPTO proposes to refer 
to the party with the ownership interest making the disclaimer in 37 
CFR 1.321 as the ``disclaimant'' rather than the patentee, applicant, 
assignee, or grantee as currently prescribed in the regulations.
(2) Clarify That a Terminal Disclaimer Can Be Filed in a Patent To 
Obviate Nonstatutory Double Patenting
    Current 37 CFR 1.321(c) and (d) state that a terminal disclaimer 
may be filed in an application or in a reexamination proceeding but do 
not explicitly state that the terminal disclaimer to obviate 
nonstatutory double patenting can be filed in a patent not subject to a 
reexamination proceeding. Consistent with the guidance set forth in the 
MPEP, a terminal disclaimer may be filed in a patent under 37 CFR 
1.321(c) or (d) that is not subject to a reexamination proceeding. See 
MPEP 1490, subsection II. Proposed 37 CFR 1.321(c) and (d) are amended 
to explicitly state that a terminal disclaimer may be filed in a patent 
to obviate nonstatutory double patenting.
(3) Changes To Reflect Current Terminology in the MPEP
    Consistent with current usage in the MPEP (see, for example, 
chapters 800 and 1400), the USPTO proposes the following changes in 37 
CFR 1.321: (1) replace ``judicially created double patenting'' with the 
phrase ``nonstatutory double patenting,'' (2) refer to the patent in 
which a terminal disclaimer is filed and the patent subject to a 
reexamination proceeding in which the terminal disclaimer is filed as 
the ``subject patent,'' (3) refer to the application in which a 
terminal disclaimer is filed as the ``subject application,'' and (4) 
refer to the patent or application forming the basis for the 
nonstatutory double patenting as the ``reference patent or 
application.''
(4) Changes To Conform With Current Language in the MPEP
    MPEP 1490, subsection VII, provides examples of acceptable terminal 
disclaimer language to use for terminal disclaimers filed under 37 CFR 
1.321(c) or (d). In a few of the examples, the language states that the 
patentee/applicant agrees to the enforcement provision of current 37 
CFR 1.321(c)(3) or (d)(3). Consistent with this guidance set forth in 
the MPEP, the USPTO proposes to amend 37 CFR 1.321(c)(3) and (d)(3) by 
adding ``agreeing'' in the enforcement provision.

III. Discussion of Proposed Rules

    The following is a discussion of proposed amendments to 37 CFR part 
1:
    The USPTO proposes to amend Sec.  1.321(a) and (b) by replacing 
``grantee'' with ``disclaimant.''
    The USPTO proposes to amend Sec.  1.321(a)(3) by replacing 
``patentee's ownership interest'' with ``the disclaimant's ownership 
interest.''
    The USPTO proposes to amend Sec.  1.321(b)(1) by redesignating 
current Sec.  1.321(b)(1) as Sec.  1.321(b)(1)(i) and adding new 
subparagraph Sec.  1.321(b)(1)(ii) to incorporate the requirements of 
Sec.  1.321(b)(1) in effect on September 15, 2012. This proposal 
eliminates the need for the public to consult Sec.  1.321 in effect on 
September 15, 2012, when filing a terminal disclaimer in an application 
filed before September 16, 2012, and makes the proposed Sec.  1.321 
applicable to all applications, regardless of their filing date. 
``Inventor'' and ``applicant'' are no longer synonymous for 
applications filed on or after September 16, 2012. See MPEP 605 and 
Changes To Implement the Inventor's Oath or Declaration Provisions of 
the Leahy-Smith America Invents Act, 77 FR 48776, 48778-79 (August 14, 
2012) (final rule). The term ``applicant'' in proposed Sec.  
1.321(b)(1)(i) can include an inventor(s), an assignee(s), or others 
with a sufficient proprietary interest, whereas the term ``applicant'' 
in proposed Sec.  1.321(b)(1)(ii) refers to the inventor(s).
    The USPTO proposes to amend Sec.  1.321(b)(3) by replacing 
``applicant's

[[Page 40445]]

ownership interest'' with ``the disclaimant's ownership interest.''
    The USPTO proposes to amend Sec.  1.321(c) by replacing 
``judicially created double patenting'' with ``nonstatutory double 
patenting.''
    Additionally, proposed Sec.  1.321(c) would explicitly provide for 
the filing of a terminal disclaimer in a patent not subject to a 
reexamination proceeding. As is the case today, when a terminal 
disclaimer under proposed Sec.  1.321(c) is filed to obviate 
nonstatutory double patenting in a reexamination proceeding, it should 
be filed in the reexamination proceeding and not in the patent file. 
See 37 CFR 1.321(c) and MPEP 1490, subsection III.A.
    The USPTO proposes to amend Sec.  1.321(c)(3) by adding 
``agreeing,'' which is consistent with current practice (see MPEP 1490, 
subsection VII).
    The USPTO proposes to amend Sec.  1.321(d) to specify that the type 
of double patenting that may be obviated by filing a terminal 
disclaimer is ``nonstatutory double patenting.''
    Additionally, proposed Sec.  1.321(d) would explicitly provide for 
the filing of a terminal disclaimer in a patent not subject to a 
reexamination proceeding. As is the case today, when a terminal 
disclaimer under proposed Sec.  1.321(d) is filed to obviate 
nonstatutory double patenting in a reexamination proceeding, it should 
be filed in the reexamination proceeding and not in the patent file. 
See 37 CFR 1.321(d) and MPEP 1490, subsection III.A.
    The USPTO proposes to amend Sec.  1.321(d)(3) by adding 
``agreeing,'' which is consistent with current practice (see MPEP 1490, 
subsection VII).
    The USPTO proposes to amend Sec.  1.321(c), (c)(3), (d), and (d)(3) 
to identify the patent or application forming the basis for the 
nonstatutory double patenting as the ``reference patent or 
application.''
    The USPTO proposes to amend Sec.  1.321(c)(2), (c)(3), (d)(2), and 
(d)(3) to identify an application in which a terminal disclaimer is 
filed to obviate nonstatutory double patenting as a ``subject 
application'' and a patent in which a terminal disclaimer is filed to 
obviate nonstatutory double patenting as a ``subject patent.'' The term 
``subject patent'' includes both patents that are undergoing a 
reexamination proceeding and patents that are not undergoing a 
reexamination proceeding.
    The USPTO proposes to amend Sec.  1.321(c)(3) and (d)(3) to require 
that a terminal disclaimer filed to obviate nonstatutory double 
patenting include an agreement by the disclaimant that the patent in 
which the terminal disclaimer is filed, or any patent granted on an 
application in which the terminal disclaimer is filed, will be 
enforceable only if the patent is not tied and has never been tied 
directly or indirectly to a patent by one or more terminal disclaimers 
filed to obviate nonstatutory double patenting in which: (1) any claim 
has been finally held unpatentable or invalid under 35 U.S.C. 102 or 
103 in a Federal court in a civil action or at the USPTO, and all 
appeal rights have been exhausted; or (2) a statutory disclaimer of a 
claim is filed after any challenge based on 35 U.S.C. 102 or 103 to 
that claim has been made.

IV. Rulemaking Considerations

A. Administrative Procedure Act

    The changes proposed by this rulemaking involve rules of agency 
practice and procedure, and/or interpretive rules, and do not require 
notice-and-comment rulemaking. See Perez v. Mortg. Bankers Ass'n, 575 
U.S. 92, 97, 101 (2015) (explaining that interpretive rules ``advise 
the public of the agency's construction of the statutes and rules which 
it administers'' and do not require notice and comment when issued or 
amended); 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''); and JEM Broadcasting Co. v. F.C.C., 22 F.3d 
320, 328 (D.C. Cir. 1994) (explaining that rules are not legislative 
because they do not ``foreclose effective opportunity to make one's 
case on the merits'').
    Nevertheless, the USPTO is publishing this proposed rule for 
comment to seek the benefit of the public's views on the Office's 
proposed regulatory changes.

B. Regulatory Flexibility Act (RFA)

    For the following reasons, the Senior Counsel for Regulatory and 
Legislative Affairs of the USPTO has certified to the Chief Counsel for 
Advocacy of the Small Business Administration that this rule will not 
have a significant economic impact on a substantial number of small 
entities. See 5 U.S.C. 605(b).
    The USPTO is proposing to revise the enforcement provisions in 
Sec.  1.321(c) and (d) to require that a terminal disclaimer filed to 
obviate nonstatutory double patenting include an agreement by the 
disclaimant that the subject patent, or any patent granted on the 
subject application, shall be enforceable only if the patent is not 
tied and has never been tied directly or indirectly to a patent by one 
or more terminal disclaimers filed to obviate nonstatutory double 
patenting: (1) in which any claim has been finally held unpatentable or 
invalid under 35 U.S.C. 102 or 103 by a Federal court in a civil action 
or by the USPTO, and all appeal rights have been exhausted; or (2) in 
which a statutory disclaimer of a claim is filed after any challenge 
based on 35 U.S.C. 102 or 103 to that claim has been made. Thus, the 
rulemaking does not propose to substantively change when an applicant 
or patent owner may file a terminal disclaimer under Sec.  1.321.
    The Small Business Administration (SBA) small business size 
standards that are applicable to most analyses conducted to comply with 
the RFA are set forth in 13 CFR 121.201. These regulations generally 
define small businesses as those with fewer than a specified maximum 
number of employees or less than a specified level of annual receipts 
for the entity's industrial sector or North American Industry 
Classification System (NAICS) code. As provided by the RFA, and after 
consulting with the SBA, the USPTO formally adopted an alternate size 
standard for the purpose of conducting an analysis or making a 
certification under the RFA for patent-related regulations. See 
Business Size Standard for Purposes of United States Patent and 
Trademark Office Regulatory Flexibility Analysis for Patent-Related 
Regulations, 71 FR 67109 (Nov. 20, 2006), 1313 Off. Gaz. Pat. Office 60 
(Dec. 12, 2006). The USPTO's alternate small business size standard is 
SBA's previously established size standard that identifies the criteria 
entities must meet to be entitled to pay reduced patent fees. See 13 
CFR 121.802. If patent applicants identify themselves on a patent 
application as qualifying for reduced patent fees, the USPTO captures 
this data in its patent application data repository (formerly the 
Patent Application Monitoring and Locating (PALM) system and now called 
the One Patent Service Gateway (OPSG) system), which tracks information 
on each patent application submitted to the Office.
    Unlike the SBA small business size standards set forth in 13 CFR 
121.201, the size standard for the USPTO is not industry specific. The 
Office's definition of a small business concern for RFA purposes is a 
business or other concern that: (1) meets the SBA's definition of a 
``business concern or concern'' set forth in 13 CFR 121.105; and (2) 
meets the size standards set forth in 13 CFR 121.802 for the purpose of 
paying reduced patent fees, namely, an entity:

[[Page 40446]]

(a) whose number of employees, including affiliates, does not exceed 
500 persons; and (b) which has not assigned, granted, conveyed, or 
licensed (and is under no obligation to do so) any rights in the 
invention to any person who made it and could not be classified as an 
independent inventor, or to any concern that would not qualify as a 
nonprofit organization or a small business concern under this 
definition. See Business Size Standard for Purposes of United States 
Patent and Trademark Office Regulatory Flexibility Analysis for Patent-
Related Regulations, 71 FR at 67112 (Nov. 20, 2006), 1313 Off. Gaz. 
Pat. Office at 63 (Dec. 12, 2006). For purposes of this certification, 
the USPTO defines small entities to include entities who are paying 
small or micro entity fee rates at the USPTO.
    The USPTO estimates that approximately 20% of applicants and patent 
owners (including small entity applicants and patent owners, who 
account for approximately 27% of patent filings) that are considering 
the filing of a terminal disclaimer to obviate nonstatutory double 
patenting will opt not to file a terminal disclaimer containing the 
proposed agreement, at least during an initial period after the 
effective date of the final rule. As mentioned earlier herein, 
applicants and patent owners who choose not to file a terminal 
disclaimer with the proposed agreement have a number of alternatives to 
obviate nonstatutory double patenting. The USPTO estimates that the 
vast majority of applicants and patent owners who choose not to file a 
terminal disclaimer with the proposed agreement will opt to argue and/
or amend claims to obviate nonstatutory double patenting.
    The number of instances in which applicants and patent owners have 
to obviate nonstatutory double patenting is relatively low. The USPTO 
issues roughly 650,000 nonfinal and final Office actions per fiscal 
year, of which 175,500 (or 27%) are issued to small entities. Of the 
175,500 Office actions issued to small entities, approximately 14%, or 
approximately 24,570, contain at least one nonstatutory double 
patenting rejection, and approximately 4%, or approximately 7,020, 
contain only a nonstatutory double patenting rejection(s).
    To estimate the potential impact on small entities from this 
proposed rulemaking, the USPTO refers to the 2023 Report of the 
Economic Survey, published by the Committee on Economics of Legal 
Practice of the American Intellectual Property Law Association, which 
estimates a median cost of $3,500 per Office action response.\1\
---------------------------------------------------------------------------

    \1\ This cost represents the report's median charges for 
services categorized as ``Application amendment/argument, relatively 
complex--biotech/chemical'' and ``Application amendment/argument, 
relatively complex--electrical/computer.''
---------------------------------------------------------------------------

    For purposes of this certification, the USPTO estimates that all of 
the approximately 20% of the small entity applicants and patent owners 
who the USPTO estimates will choose not to file a terminal disclaimer 
with the proposed agreement will opt to argue and/or amend claims to 
obviate the nonstatutory double patenting rejection(s). The USPTO 
therefore estimates that the proposed rulemaking could have a potential 
annual cost to small entities of $17,199,000 (24,570 x 20% x $3,500) 
for responding to an Office action containing at least one nonstatutory 
double patenting rejection by arguing and/or amending claims, rather by 
than filing a terminal disclaimer.
    Furthermore, the USPTO estimates that, on the upper range, 
approximately 50%, or approximately 2,457 (24,570 x 20% x 50%), of the 
responses filed will fail to obviate at least one nonstatutory double 
patenting rejection. These cases may potentially incur the additional 
cost to small entities of $8,599,500 (2,457 x $3,500) to respond to an 
additional Office action. Therefore, the USPTO estimates that the upper 
range of cost that the proposed rulemaking could have on the 
approximately 20% of potentially impacted small entities is $25,798,500 
($17,199,000 + $8,599,500). The estimated cost will therefore not 
affect a substantial number (approximately 20%) of small entities.
    For at least two reasons, the USPTO believes these estimates to 
represent the upper range of the potential impact on small entities. 
First, the preceding estimates do not account for the cost savings, 
including filing fee savings, from not filing a terminal disclaimer. 
The USPTO charges a fee of $170 for filing a terminal disclaimer. Based 
on the estimated 4,914 small entity applicants that opt to not file a 
terminal disclaimer, the USPTO estimates terminal disclaimer filing fee 
savings of $835,380. In addition, the USPTO estimates that it takes an 
estimated 0.25 hours (15 minutes) for applicants and patent owners to 
file a terminal disclaimer. The 2023 Report of the Economic Survey 
estimates an hourly attorney fee of $447. Based on the estimated 4,914 
small entity applicants that opt to not file a terminal disclaimer, the 
USPTO estimates cost savings of $549,140. Therefore, the total cost 
savings for those not filing a terminal disclaimer because of the 
proposed rulemaking is $1,384,520.
    Second, the preceding cost estimates are based on all Office 
actions containing at least one nonstatutory double patenting 
rejection, including Office actions containing at least one other 
rejection that is not a nonstatutory double patenting rejection. As 
stated above, the USPTO estimates that 7,020 Office actions contain 
only a nonstatutory double patenting rejection(s). Thus, in 17,550 
(24,570-7,020) Office actions, small entity applicants and patent 
owners would have to respond to at least one rejection that is not a 
nonstatutory double patenting rejection. It therefore follows that at 
least some portions of the annual costs in the preceding estimates for 
these 17,550 Office actions should be excluded as they would be 
attributed to responding to those other rejection(s).
    Thus, the total upper range of estimated cost to the 24,570 small 
entity applicants and patent owners impacted by this rule would be 
$24,413,980 ($25,798,500-$1,384,520). The USPTO does not have the data 
to determine the distribution of this cost across the 24,570 small 
entity applicants and patent owners that would be impacted by this 
rule. Thus, for purposes of this certification, the USPTO estimates an 
average of less than $1,000 in impact to the 24,570 small entities. 
However, as mentioned above, this estimate is likely to be overstated 
as some of that impact would be attributed to costs related to 
responding to a rejection that is not a nonstatutory double patenting 
rejection.
    For the foregoing reasons, the changes proposed in this rulemaking 
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 (September 30, 1993), as amended by Executive 
Order 14094 (April 6, 2023).

D. Executive Order 13563 (Improving Regulation and Regulatory Review)

    The USPTO has complied with Executive Order 13563 (January 18, 
2011). Specifically, and as discussed above, 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

[[Page 40447]]

objectives; (5) identified and assessed available alternatives; (6) 
involved the public in an open exchange of information and perspectives 
among experts in relevant disciplines, affected stakeholders in the 
private sector, and the public as a whole, and provided online access 
to the rulemaking docket; (7) attempted to promote coordination, 
simplification, and harmonization across government agencies and 
identified goals designed to promote innovation; (8) considered 
approaches that reduce burdens and maintain flexibility and freedom of 
choice for the public; and (9) ensured the objectivity of scientific 
and technological information and processes.

E. Executive Order 13132 (Federalism)

    This rulemaking pertains strictly to Federal agency procedures and 
does not contain policies with federalism implications sufficient to 
warrant the preparation of a Federalism Assessment under Executive 
Order 13132 (August 4, 1999).

F. Executive Order 13175 (Tribal Consultation)

    This rulemaking will not: (1) have substantial direct effects on 
one or more Indian Tribes; (2) impose substantial direct compliance 
costs on Indian Tribal governments; or (3) preempt Tribal law. 
Therefore, a Tribal summary impact statement is not required under 
Executive Order 13175 (November 6, 2000).

G. Executive Order 13211 (Energy Effects)

    This rulemaking is not a significant energy action under Executive 
Order 13211 because this rulemaking is not likely to have a significant 
adverse effect on the supply, distribution, or use of energy. 
Therefore, a Statement of Energy Effects is not required under 
Executive Order 13211 (May 18, 2001).

H. Executive Order 12988 (Civil Justice Reform)

    This rulemaking meets applicable standards to minimize litigation, 
eliminate ambiguity, and reduce burden as set forth in sections 3(a) 
and 3(b)(2) of Executive Order 12988 (February 5, 1996).

I. Executive Order 13045 (Protection of Children)

    This rulemaking does not concern an environmental risk to health or 
safety that may disproportionately affect children under Executive 
Order 13045 (April 21, 1997).

J. Executive Order 12630 (Taking of Private Property)

    This rulemaking will not affect a taking of private property or 
otherwise have taking implications under Executive Order 12630 (March 
15, 1988).

K. Congressional Review Act

    Under the Congressional Review Act provisions of the Small Business 
Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), 
prior to issuing any final rule, the USPTO will submit a report 
containing the 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).

L. 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.

M. 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.

N. National Technology Transfer and Advancement Act of 1995

    The requirements of section 12(d) of the National Technology 
Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) are not 
applicable because this rulemaking does not contain provisions that 
involve the use of technical standards.

O. Paperwork Reduction Act of 1995

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA) 
requires that the USPTO consider the impact of paperwork and other 
information collection burdens imposed on the public. This rulemaking 
involves information collection requirements that are subject to review 
and approval by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act.
    This proposed rulemaking impacts the rules of practice pertaining 
to terminal disclaimers. The general provisions pertaining to terminal 
disclaimers have been reviewed and approved by the OMB under OMB 
control number 0651-0031 and are accounted for under the line item 
Statutory Disclaimers (including terminal disclaimers) as contained in 
0651-0031. In a 60-day notice published January 29, 2024 (89 FR 5500), 
for the renewal of 0651-0031, the USPTO provided estimates for this 
line item and those estimates appear below.
    Under this proposed rulemaking, the USPTO proposes to modify 
terminal disclaimers to include the additional agreement as discussed 
in the preamble. The USPTO estimates that approximately 20% of 
applicants and patent owners that are considering the filing of a 
terminal disclaimer to obviate nonstatutory double patenting will opt 
not to file a terminal disclaimer containing the proposed agreement, at 
least during an initial period after the effective date of the final 
rule. Therefore, the USPTO proposed estimates below take into account 
the anticipated 20% reduction in terminal disclaimer filings.
    The USPTO will be accounting for this impact in a proposed new 
information collection that has been submitted to the OMB. The proposed 
new information collection will reflect an estimated total decrease of 
9,990 respondents, 2,498 burden hours and $1,698,300 in filing fees 
with respect to terminal disclaimers, because some applicants and 
patent owners will choose not to file a terminal disclaimer with the 
proposed agreement. A summary of the change in burden to terminal 
disclaimers follows. The proposed new information collection will be 
available at the OMB's Information Collection Review website 
(www.reginfo.gov/public/do/PRAMain).
    Estimated Data Published in the 60-day Notice for 0651-0031 
(January 29, 2024):

[[Page 40448]]

    Estimated number of annual respondents for statutory disclaimers 
(including terminal disclaimers): 49,950.
    Estimated number of annual responses for statutory disclaimers 
(including terminal disclaimers): 49,950.
    Estimated total annual respondent burden hours for statutory 
disclaimers (including terminal disclaimers): 12,488.
    Estimated total annual respondent hourly cost burden for statutory 
disclaimers (including terminal disclaimers): $5,582,136.
    Estimated total annual respondent non-hourly cost burden for 
statutory disclaimers (including terminal disclaimers): $8,491,500 in 
the form of filing fees.
    Proposed New Information Collection Associated with RIN 0651-AD76:
    OMB control number: 0651-NEW.
    Title of collection: Terminal disclaimers.
    Needs and uses: The changes under proposed Sec.  1.321 on the 
filing of terminal disclaimers would be used by an owner (in whole or 
in part) of a patent or a patent to be granted to agree that the patent 
in which the terminal disclaimer is filed, or any patent granted on an 
application in which a terminal disclaimer is filed, will be 
enforceable only if the patent is not tied and has never been tied 
directly or indirectly to a patent by one or more terminal disclaimers 
filed to obviate nonstatutory double patenting in which: any claim has 
been finally held unpatentable or invalid as anticipated or obvious by 
a Federal court in a civil action or by the USPTO, and all appeal 
rights have been exhausted; or a statutory disclaimer of a claim is 
filed after any challenge based on anticipation or obviousness to that 
claim has been made.
    The changes would be used by the USPTO to ensure it does not issue 
a patent to a common owner or inventor with a claim that conflicts with 
a claim of a second patent, unless the terminal disclaimer includes the 
additional agreement that the patent with the terminal disclaimer will 
not be enforced if any claim of the second patent is invalidated by 
prior art.
    The changes would be used by the public to focus on addressing the 
validity of the claims of a single patent to resolve a dispute where 
there are multiple patents tied by terminal disclaimers.
    Impacted forms in this information collection:

 PTO/AIA/25 (Terminal Disclaimer to Obviate a Provisional 
Double Patenting Rejection Over a Pending ``Reference'' Application)
 PTO/SB/25 (Terminal Disclaimer to Obviate a Provisional Double 
Patenting Rejection over a Pending Second Application)
 PTO/SB/25a (Terminal Disclaimer in a Patent or Proceeding in 
view of an Application)
 PTO/AIA/26 (Terminal Disclaimer to Obviate a Double Patenting 
Rejection Over a ``Prior'' Patent)
 PTO/SB/26 (Terminal Disclaimer to Obviate a Double Patenting 
Rejection over a Prior Patent)
 PTO/SB/26a (Terminal Disclaimer in a Patent or Proceeding in 
view of Another Patent)
 PTO/AIA/63 (Terminal Disclaimer to Accompany Petition under 37 
CFR 1.137 in a Design Application Filed on or after September 16, 2012)
 PTO/SB/63 (Terminal Disclosure to Accompany Petition)

    Type of review: New.
    Affected public: Private Sector.
    Respondent's Obligation: Required to obtain or retain benefits.
    Frequency: On occasion.
    Estimated number of annual respondents for statutory disclaimers 
(including terminal disclaimers): 39,960.
    Estimated number of annual responses for statutory disclaimers 
(including terminal disclaimers): 39,960.
    Estimated total annual respondent burden hours for statutory 
disclaimers (including terminal disclaimers): 9,990.
    Estimated total annual respondent hourly cost burden for statutory 
disclaimers (including terminal disclaimers): $4,465,530.
    Estimated total annual respondent non-hourly cost burden for 
statutory disclaimers (including terminal disclaimers): $6,793,200 in 
the form of filing fees.
    The USPTO is soliciting public comments to:
    (a) evaluate whether the collection of information is necessary for 
the proper performance of the functions of the Agency, including 
whether the information will have practical utility;
    (b) evaluate the accuracy of the Agency's estimate of the burden of 
the proposed collection of information;
    (c) enhance the quality, utility, and clarity of the information to 
be collected; and
    (d) minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting the electronic 
submission of responses.
    Please submit comments on this new collection of information at 
www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review'' or by using the 
search function and entering the title of the collection. Please send a 
copy of your comments to the USPTO using the method described under 
ADDRESSES at the beginning of this document.
    All comments submitted in response to this proposed rulemaking are 
a matter of public record. The USPTO will include or summarize the 
comments received in the request to the OMB to approve the new 
information collection requirements.
    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 PRA unless that collection of information displays a currently 
valid OMB control number.

P. E-Government Act Compliance

    The USPTO is committed to compliance with the E-Government Act to 
promote the use of the internet and other information technologies, to 
provide increased opportunities for citizen access to Government 
information and services, and for other purposes.

List of Subjects in 37 CFR Part 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 
37 CFR part 1 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. Revise Sec.  1.321 to read as follows:


Sec.  1.321   Statutory disclaimers, including terminal disclaimers.

    (a) A patentee owning the whole or any sectional interest in a 
patent may disclaim any complete claim or claims in a patent. In like 
manner any patentee may disclaim or dedicate to the public the entire 
term, or any terminal part of the term, of the patent granted. Such 
disclaimer is binding upon the

[[Page 40449]]

disclaimant and its successors or assigns. A notice of the disclaimer 
is published in the Official Gazette and attached to the printed copies 
of the specification. The disclaimer, to be recorded in the Patent and 
Trademark Office, must:
    (1) Be signed by the patentee, or an attorney or agent of record;
    (2) Identify the patent and complete claim or claims, or term being 
disclaimed. A disclaimer which is not a disclaimer of a complete claim 
or claims, or term will be refused recordation;
    (3) State the present extent of the disclaimant's ownership 
interest in the patent; and
    (4) Be accompanied by the fee set forth in Sec.  1.20(d).
    (b) An applicant may disclaim or dedicate to the public the entire 
term, or any terminal part of the term, of a patent to be granted. Such 
terminal disclaimer is binding upon the disclaimant and its successors 
or assigns. The terminal disclaimer, to be recorded in the Patent and 
Trademark Office, must:
    (1)(i) For patent applications filed under 35 U.S.C. 111(a) or 363 
on or after September 16, 2012, be signed by the applicant or an 
attorney or agent of record; or
    (ii) For patent applications filed under 35 U.S.C. 111(a) or 363 
before September 16, 2012, be signed:
    (A) By the applicant;
    (B) If there is an assignee of record of an undivided part 
interest, by the applicant and such assignee;
    (C) If there is an assignee of record of the entire interest, by 
such assignee; or
    (D) By an attorney or agent of record;
    (2) Specify the portion of the term of the patent being disclaimed;
    (3) State the present extent of the disclaimant's ownership 
interest in the patent to be granted; and
    (4) Be accompanied by the fee set forth in Sec.  1.20(d).
    (c) Except as provided for in paragraph (d) of this section, a 
terminal disclaimer, when filed in a patent, a reexamination 
proceeding, or a patent application to obviate nonstatutory double 
patenting of a claimed invention based on a reference patent or 
application, must:
    (1) Comply with the provisions of paragraphs (b)(2) through (4) of 
this section;
    (2) Be signed in accordance with paragraph (b)(1) of this section 
if filed in a patent application (the subject application) or in 
accordance with paragraph (a)(1) of this section if filed in a patent 
or in a reexamination proceeding (the subject patent); and
    (3) Include a provision agreeing that the subject patent or any 
patent granted on the subject application shall be enforceable:
    (i) Only for and during such period that the subject patent or any 
patent granted on the subject application is commonly owned with the 
reference patent or any patent granted on the reference application; 
and
    (ii) Only if the subject patent or any patent granted on the 
subject application is not tied and has never been tied directly or 
indirectly to a patent by one or more terminal disclaimers filed to 
obviate nonstatutory double patenting in which:
    (A) A claim has been finally held unpatentable or invalid under 35 
U.S.C. 102 or 103 in a Federal court in a civil action or at the USPTO, 
and all appeal rights have been exhausted; or
    (B) A statutory disclaimer of a claim is filed after any challenge 
based on 35 U.S.C. 102 or 103 to that claim has been made.
    (d) A terminal disclaimer, when filed in a patent, a reexamination 
proceeding, or a patent application to obviate nonstatutory double 
patenting of a claimed invention based on a reference patent or 
application that is not commonly owned but was disqualified as prior 
art as set forth in either Sec.  1.104(c)(4)(ii) or (c)(5)(ii) as the 
result of activities undertaken within the scope of a joint research 
agreement, must:
    (1) Comply with the provisions of paragraphs (b)(2) through (4) of 
this section;
    (2) Be signed in accordance with paragraph (b)(1) of this section 
if filed in a patent application (the subject application) or be signed 
in accordance with paragraph (a)(1) of this section if filed in a 
patent or in a reexamination proceeding (the subject patent); and
    (3) Include a provision waiving the right to separately enforce the 
subject patent or any patent granted on the subject application and the 
reference patent or any patent granted on the reference application, 
and agreeing that the subject patent or any patent granted on the 
subject application shall be enforceable:
    (i) Only for and during such period that the subject patent or any 
patent granted on the subject application and the reference patent or 
any patent granted on the reference application are not separately 
enforced; and
    (ii) Only if the subject patent or any patent granted on the 
subject application is not tied and has never been tied directly or 
indirectly to a patent by one or more terminal disclaimers filed to 
obviate nonstatutory double patenting in which:
    (A) A claim has been finally held unpatentable or invalid under 35 
U.S.C. 102 or 103 in a Federal court in a civil action or at the USPTO, 
and all appeal rights have been exhausted; or
    (B) A statutory disclaimer of a claim is filed after any challenge 
based on 35 U.S.C. 102 or 103 to that claim has been made.

Katherine K. Vidal,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2024-10166 Filed 5-9-24; 8:45 am]
BILLING CODE 3510-16-P