Terminal Disclaimer Practice To Obviate Nonstatutory Double Patenting

Published date10 May 2024
Record Number2024-10166
Citation89 FR 40439
CourtPatent And Trademark Office
SectionProposed rules
Federal Register, Volume 89 Issue 92 (Friday, May 10, 2024)
[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.
                -----------------------------------------------------------------------
                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
                

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