RESPONSE TO APPLICANT’S AMENDMENT
1. Applicant's amendment, filed 02/03/2026, is acknowledged.
2. Claims 31-50 are pending and under examination.
3. Applicant’s IDS, filed 02/03/2026, is acknowledged.
4. In view of the amendment filed on 02/03/2026, only the following rejection are remained.
5. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
6. Claims 31-50 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-54 of U.S. Patent No.11396550. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `550 patent are directed to methods of treating an autoimmune disease or condition, a systemic inflammatory disease or condition, or transplant rejection in a human subject, comprising administering to the subject an anti-OX40L antibody or antibody fragment that specifically binds to an hOX40L epitope and comprises the claimed CDRs of antibody 02D10. The Claimed/patented SEQ ID NOs are identical. The claims of the `550 patent anticipate the instant claims.
Applicant’s arguments, filed 02/03/2026, have been fully considered, but have not been found convincing.
Applicant will consider filing a Terminal Disclaimer over the `550 patent once the subject claims are otherwise indicated to be in condition for allowance.
The rejection is maintained until the TD is filed over `550 patent.
7. Claims 31-50 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-54 of U.S. Patent No. US 10654935 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `935 patent are directed to methods of treating systemic lupus erythematosus (SLE) in a human subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of an anti-OX40L antibody or antibody fragment that antagonizes specific binding of OX40 to OX40L, wherein the antibody or antibody fragment comprises: the claimed CDRs of antibody 02D10. The Claimed/patented SEQ ID NOs are identical. The claims of the `935 patent anticipate the instant claims.
Applicant’s arguments, filed 02/03/2026, have been fully considered, but have not been found convincing.
Applicant will consider filing a Terminal Disclaimer over the `935 patent once the subject claims are otherwise indicated to be in condition for allowance.
The rejection is maintained until the TD is filed over `953 patent.
8. Claims 31-50 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-25 of U.S. Patent No. US 9139653 B1. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `653 patent are directed to methods of treating or preventing graft versus host disease (GvHD) or transplant rejection in a human in need thereof, the method comprising administering to said human a therapeutically effective amount of an antibody or fragment thereof : the claimed CDRs of antibody 02D10. The Claimed/patented SEQ ID NOs are identical. The claims of the `653 patent anticipate the instant claims.
Applicant’s arguments, filed 02/03/2026 -have been fully considered, but have not been found convincing.
Applicant will consider filing a Terminal Disclaimer over the `535 patent once the subject claims are otherwise indicated to be in condition for allowance.
The rejection is maintained until the TD is filed over `535 patent.
9. Claims 31-50 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. US 9434785 B1. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `785 patent are directed to method of treating or preventing graft versus host disease (GvHD) in a human subject in need thereof, comprising: administering an anti-OX40L antibody or fragment thereof that antagonizes specific binding of OX40 to OX40L to a subject determined to have a ratio of CD45RA+CCR7+CD95+OX40+ T stem cell memory (Tscm) cells to CD45RA+CCR7+CD95− T-naive (Tn) cells greater than 50:50 wherein the antibody or fragment thereof is administered in an amount effective to reduce the ratio of said Tscm cells in said human, wherein a blood sample obtained from the human subject has been subjected to an assay to measure the ratio of CD45RA+CCR7+CD95+OX40+ Tscm:CD45RA+CCR7+CD95− Tn cells in the sample: the claimed CDRs of antibody 02D10 (i.e., SEQ ID NO: 36, 38, 40, 42, 44, 46, 50, 52, 54, 56, 58, 60). The Claimed/patented SEQ ID NOs are identical. The claims of the `785 patent anticipate the instant claims.
Applicant’s arguments, filed 02/03/2026, have been fully considered, but have not been found convincing.
Applicant traverses the rejection on the bases that the purpose of the judicially created, non-statutory double patenting doctrine is to “prevent patentees from obtaining a second patent on a patentable indistinct invention to effectively extend the life of a first patent to that subject matter.” Allergan USA, Inc. V. MSN Lab’ys Priv. Ltd., 111 F.4th 1358, 1369 (Fed. Cir. 2024) (emphasis added by Applicant).
Applicant continue to argue that the '785 patent was filed November 9, 2015 and has a patent term filing date of April 30, 2015. The anticipated expiration date of the '785 patent is April 30, 2035 (20 years from April 30, 2015).
The instant application has a patent term filing date of March 3, 2015. Claims issuing from the subject application will have a base expiration date (i.e., without PTA or PTE) of March 3,2035, which is not after April 30, 2035, the base expiration date of the '785 patent.
Applicant submits that the '785 patent has a patent term filing date and base expiration date later than that of the instant application. Applicant submits that the reference patent is not a proper obviousness-type double patenting (or "ODP") reference, as the instant application (if granted) would not be a second patent of the subject matter of the reference patent, and the Office has not sufficiently established on the record a proper showing that the instant case would effectively extend the life of the reference patent.
Further, in raising a ODP rejection, the burden initially lies with the Office to identify, with specificity, the clear and certain unjustified extension of rights for allowing the examined case to proceed to grant. Applicant respectfully points to the Manual of Patent Examining Procedure (M.P.E.P), which clearly states the requirements of raising a double patenting rejection. "[T]he examiner must determine whether the grant of a second patent would give rise to an unjustified extension of the rights granted in the first patent." M.P.E.P. 804(I)(A)(emphasis added). Applicant submits that, according to the language of the M.P.E.P., the Office must clearly and definitively establish in the record that a claim rejected under the ODP doctrine will extend the rights of a first- issued patent. Applicant submits that this obligation cannot rely simply on the theory that if a patent grants, it might extend the rights of the first patent due to possible patent term adjustment of the later-filed case. Applicant respectfully submits that the Office has not provided any evidence that such an extension of rights will occur if the instant application proceeds to grant.
The Office disagreed with Applicant's argument and contends that there are two separate justifications for double patenting. Office Action, p. 5. The first is "to prevent unjustified timewise extension of the right to exclude" and the "second rationale is to prevent multiple infringement suits by different assignees asserting essentially the same patented invention." Id. at pp. 5-6. The Office argued that "even if there are no extension of patent rights here, as argued by Applicants, the second justification (i.e., harassment by multiple owners) would still be at play." Id.
Applicant disagrees. In a very recent December 2025 PTAB decision in Ex parte NICOLAS BAURIN et al., Case No. 2024-002920, 12-08-2025, the PTAB denied the Examiner's Request for Rehearing regarding the PTAB's November 4, 2024 decision, in which the PTAB found that a later expiring patent did not serve as a proper ODP reference against an earlier expiring patent and reversed the Examiner's numerous ODP rejections. See Exhibit A (Ex parte NICOLAS BAURIN, 12-08-2025). The PTAB clarified that MPEP § 804.02 VI "does not provide for preventing harassment by common owners of patents or patent applications as a basis for obviousness-type double patenting. (Req. 11.) Rather, it states that harassment is one of two reasons 'for insisting upon a terminal disclaimer to overcome a nonstatutory double patenting rejection.' MPEP § 804.02 VI." Id. at p. 16 (emphasis added). The PTAB noted that "[t]o the extent that any of the cases cited by the Examiner made reference to a policy regarding identifying the risk of separate ownership in their decisions, none hold that it is the basis for making a nonstatutory double patenting rejection and requiring a terminal disclaimer to overcome the rejection, much less in a situation where a reference patent is filed later than and expires later than the application to which it is applied against." Id. at p. 18 (emphasis added). Thus, the Office's argument that harassment by multiple owners may be a separate basis for obviousness-type double patenting is incorrect.
The Office further noted that "with respect to Baurin, there is an exception to double patenting rejections in general that was created for the 'first patent ever' for a particular new invention (by which all later applications improving that first invention are judged). This was discussed by the Federal Circuit in the Allergan case and echoed on page 9 of the Board Decision." Office Action, p. 6. The Office argued that Baurin is not applicable to the instant matter because "this case is NOT the 'first ever patent' and thus would not qualify under this reasoning." Id. at p.
7.
Applicant disagrees. In the PTAB's December 2025 decision for Ex parte NICOLASBAURIN et al., the PTAB specified that "[w]e also disagree with the Examiner that the Allergan decision is only applicable to first-issued patents in a patent family. The case law is clear that an ODP analysis seeks to determine whether a reference patent is claiming a patentably indistinct invention from the patent-at-issue and is extending or prolonging a monopoly on the invention claimed in the non-reference patent, irrespective of their position as a first patent ever in a patent family." Ex parte BAURIN, at p. 6 (emphasis added). Thus, the Office's contention that Baurin is not applicable to the instant matter is misplaced.
In view of the above, the '785 patent does not qualify as a nonstatutory double patenting reference over the subject application, because it has a base expiration date later than the instant application. Further, as discussed above, the Office's argument that harassment by multiple owners may be a separate basis for obviousness-type double patenting is unfounded in view of the PTAB's recent decision denying the Examiner's Request for Rehearing in Ex parte NICOLAS BAURIN.
As the Office is aware, "[t]he purpose of the ODP doctrine is to prevent patentees from obtaining a second patent on a patentably indistinct invention to effectively extend the life of a first patent to that subject matter." Allergan USA, Inc. v. MSNLabs. Private LTD., 111 F.4th 1358, 1369 (Fed. Cir. 2024). Thus, a later filed, later expiring patent cannot serve as a proper obviousness-type double patenting reference against an application with an earlier patent term filing date and base expiration date.
This is not persuasive. The Patent Office did not issue a memorandum of police change based on Baurin decision or incorporate Baurin decision the USPTO training materials and MPEP.
The Examiner’s position remains that there are two separate justifications for double patenting. See In re Hubbell, 709 F. 3d 1140 (Fed. Cir. 2013) (“There are two justifications for obviousness-type double patenting. The first is ‘to prevent unjustified timewise extension of the right to exclude granted by a patent no matter how the extension is brought about.’ … The second rationale is to prevent multiple infringement suits by different assignees asserting essentially the same patented invention … this court reaffirmed the multiple assignee harassment rationale and applied it to a situation where, as here, the patents were related to the application only by way of a common inventor … ."). See also MPEP 804(II)(B) (“A rejection based on nonstatutory double patenting is based on a judicially created doctrine grounded in public policy so as to prevent the unjustified or improper timewise extension of the right to exclude granted by a patent … A double patenting rejection also serves public policy interests by preventing the possibility of multiple suits against an accused infringer by different assignees of patents claiming patentably indistinct variations of the same invention. In re Van Ornum, 686 F.2d 937, 944-48, 214 USPQ 761, 767-70 (CCPA 1982).”). See also Appeal 2018-001186 (11/566,721) (“Appellant does not dispute the Examiner’s finding that the claims are, in fact, obvious over one another, but rather contends that because the instant application and US 8,759,311 share a common expiration date, there would be no improper extension. However, ‘there is a second justification for obviousness-type double patenting--harassment by multiple assignees.’ In re Fallaux, 564 F.3d 1313, 1318–19 (Fed. Cir. 2009) … We therefore affirm the obviousness-type double patenting rejection.”). See also Appeal 2020-005019 (15/823,272) (“The purpose of a terminal disclaimer is to eliminate any possibility of the unjustified or improper time-wise extension of the right to exclude granted by a patent issuing from the present application, AND to eliminate any possibility of multiple suits against an accused infringer by different assignees of the patents by tying together the enforcement of any patents issued based on the application. Hubbell, 709 F.3d at 1145.”).
Accordingly, even if there are no an extension of patent rights here, as argued by Applicants, the second justification (i.e., harassment by multiple owners) would still be at play. The owner of the two patents (i.e., Kymab Limited in your case) could sell each patent to a different company (i.e., A and B). As a result, an infringer out there could potentially be sued twice (i.e., harassed) for essentially the same invention (i.e., sued by companies A and B). Thus, the double patenting rejection is still justified here, irrespective whether there is an extension of patent rights or not. Further, a Board decision like Baurin cannot overrule this federal circuit case law (i.e., In re Hubbell, 709 F. 3d 1140 (Fed. Cir. 2013) and MPEP 804(II)(B)).
With respect to Baurin, there is an exception to double patenting rejections in general that was created for the “first patent ever” for a particular new invention (by which all later applications improving that first invention are judged). This was discussed by the Federal Circuit in the Allergan case and echoed on page 9 of the Board Decision:
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As can be seen the “first patent ever” is “not subject to non-statutory double patenting over claims issued in a subsequently filed patent” according to the Allergan court. Now the holding in Allergan was perhaps limited to cases where “the filed patent … shares a priority date with the first patent” but the Board in Baurin expanded this to include applications that “do not share a priority date or even stem from the same family.” So, according to the Board, the “first patent ever” is shielded from double patenting regardless of whether it is in the same family or not (which has yet to be ruled on by CAFC).
However, this case is NOT the “first ever patent” and thus would not qualify under this reasoning. The instant application was filed 8/3/2023 (i.e., filing dates, not effective filing dates). The ‘785 patent was filed November 9, 2015. Accordingly, the instant application was actually filed AFTER the issued patent, not before, and thus cannot possibly be the “first ever patent” filed on this invention. Accordingly, the Board decision is just not applicable.
In addition, there is no “out of order” issuance issues in the instant case (like there was in Baurin). For instance, the Court stated the following:
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Thus, the ‘922 patent (i.e., “the later-filed now issued patent” aka the “out of order” issued patent) in Baurin was considered to be “non-obvious over the instant disclosure [i.e., instant claims and specification]” and thus a true patentable “improvement” invention. This is significant since if the order of issuance (impliedly) had been correct (i.e., no “out of order” issuance) then the ‘922 patent could have issued without a TD (since it was a non-obvious improvement) so why should a TD be required now simply because the order of issuance was reversed. For these reasons the rejection is maintained.
10. Claims 31-50 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. US 9868789 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `789 patent are directed to methods of treating or preventing transplant rejection in a primate subject in need thereof, comprising: administering intravenously to the subject: a) at least one anti-OX40L antibody or fragment thereof that antagonizes specific binding of OX40 to OX40L comprising the claimed CDRs of antibody 02D10. The Claimed/patented SEQ ID NOs are identical (i.e., SEQ ID NO: 36, 38, 40, 42, 44, 46, 50, 52, 54, 56, 58, 60). The claims of the `789 patent anticipate the instant claims.
Applicant’s arguments, filed 02/03/2026, have been fully considered, but have not been found convincing.
Applicant submits that claims issuing from the subject application will have a base expiration date (i.e., without PTA or PTE) of March 3, 2035, which is not after March 3, 2035, the base expiration date of the '789 patent.
Further, as discussed above for the '785 patent and incorporated herein, the Office's argument that harassment by multiple owners may be a separate basis for obviousness-type double patenting is incorrect in view of the PTAB's recent decision denying the Examiner's Request for Rehearing in Exparte NICOLASBAURIN. Moreover, as discussed above for the '785 patent and incorporated herein, the Office's contention that Baurin is not applicable to the instant matter is misplaced.
It remains the Examiner’s position that the NS-ODP rejection is proper because improper timewise extension is only one issue addressed by NSPD. A TD filed in the instant application to overcome a proper NSDP rejection ensures that the patent issuing from the instant application is only enforceable while commonly owned with the `789 patent and also provides notice to the public that the patent issuing from the instant application is tied to the `789 patent. Also, the patent terms should not be speculated by the Examiner because PTA calculations are complex.
Also, the Examiner points to the MPEP chart II-B_AIA regarding NS-ODP on conflicting claims between an application and a patent instructs the Examiner to do a NSODP irrespective of the filing date and/or expiration date.
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With respect to the Office's argument that "patent terms should not be speculated by the Examiner because PTA calculations are complex" (Office Action, p. 9), Applicant notes that in the PTAB's December 2025 decision for Ex parte NICOLAS BAURIN et al., the PTAB clarified that "determining expiration dates is not inconsistent with USPTO guidance in this regard. (Resp. 7.) As Appellant noted MPEP § 1701, which refers to an employee of the USPTO refusing to express any opinion as to the expiration date of any patent, specifically states that the refusal must give way 'to the extent necessary to carry out (A) an examination of anon-reissue patent application where determination of the expiration date of a patent is necessary to conduct examination of the non-reissue patent application.' MPEP § 1707." Ex parte BAURIN, at p. 12 (emphasis added).
With respect to the Office's contention that MPEP chart II-B AIA "instructs the Examiner to do a NSODP irrespective of the filing date and/or expiration date" (Office Action, p. 9), Applicant underscores that the PTAB's December 2025 decision in Ex parte NICOLAS BAURIN et al. stated that, "as to the Examiner's argument regarding effective filing dates versus actual filing dates, we note that our reviewing court in Allergan made clear that both effective filing dates and expiration dates are to be considered in determining whether claims are proper reference patents." Ex parte BAURIN, at p. 3 (emphasis added). Further, "in contrast to the Examiner's suggestion, the Allergan court in looking at what claims were 'first-filed,' did not ignore the effective filing dates in favor of actual filing dates; it took note of both the effective filing dates and the expiration dates to determine if certain claims could serve as reference patents." Id. at p. 5 (emphasis added). Thus, the Office's assertion that an ODP analysis can be conducted irrespective of filing dates and/or expiration dates is unfounded.
This is not found persuasive because Applicant does not point to the MPEP section which incorporate the Ex parte Baurin decision. The Examiner follows the practices, procedures and guidelines of the MPEP which instructs the Examiner to do a NSODP based on “commonly owned” reference patent irrespective of the filing date and/or expiration date. The Examiner’s position remain the same as set forth in the previous Office Action, mailed 10/03/2025.
11. Claims 31-50 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. US 9868790 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `790 patent are directed to methods of treating or preventing graft versus host disease (GvHD) in a human subject in need thereof, comprising administering to the subject a therapeutically or prophylactically effective amount of: a. at least one anti-OX40L antibody or fragment thereof that antagonizes specific binding of OX40 to OX40L comprising the claimed CDRs of antibody 02D10. The Claimed/patented SEQ ID NOs are identical (i.e., SEQ ID NO: 36, 38, 40, 42, 44, 46, 50, 52, 54, 56, 58, 60). The claims of the `790 patent anticipate the instant claims.
Applicant’s arguments, filed 02/03/2026, have been fully considered, but have not been found convincing.
Applicant submits that the `790 patent, filed July 27, 2017, has a patent term filing date of March 3, 2015.
As discussed above, claims issuing from the subject application will have a based expiration date (i.e., without PTA or PTE) of March 3, 2035, which is not after March 3, 2035, the base expiration date of the `790.
Further, as discussed above for the '785 patent and incorporated herein, the Office's argument that harassment by multiple owners may be a separate basis for obviousness-type double patenting is incorrect in view of the PTAB's recent decision denying the Examiner's Request for Rehearing in Ex parte NICOLAS BAURIN. Moreover, as discussed above for the '785 patent and incorporated herein, the Office's contention that Baurin is not applicable to the instant matter is misplaced. In addition, as discussed above for the '789 patent and incorporated herein, the Office's argument that patent terms should not be speculated by the Examiner because PTA calculations are complex is erroneous. Further, as discussed above for the '789 patent and incorporated herein, the Office's assertion that at an ODP analysis can be conducted irrespective of filing dates and/or expiration dates is unfounded.
This is not found persuasive because Applicant does not point to the MPEP section which incorporate the Ex parte Baurin decision. The Examiner follows the practices, procedures and guidelines of the MPEP which instructs the Examiner to do a NSODP based on “commonly owned” reference patent irrespective of the filing date and/or expiration date. The Examiner’s position remains the same as set forth in the previous Office Action, mailed 10/03/2025.
It is the Examiner’s position that the NS-ODP rejection is proper because improper timewise extension is only one issue addressed by NSPD. A TD filed in the instant application to overcome a proper NSDP rejection ensures that the patent issuing from the instant application is only enforceable while commonly owned with the `790 patent and also provides notice to the public that the patent issuing from the instant application is tied to the `790 patent. Also, the patent terms should not be speculated by the Examiner because PTA calculations are complex.
Also, the Examiner points to the MPEP chart II-B_AIA regarding NS-ODP on conflicting claims between an application and a patent instructs the Examiner to do a NSODP irrespective of the filing date and/or expiration date.
12. Claims 31-50 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. US 9512229 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `229 patent are directed to methods of treating or preventing graft versus host disease (GvHD) in a human subject in need thereof, comprising: administering to the subject a) a therapeutically effective, or prophylactically effective, amount of anti-OX40L antibody or fragment thereof that antagonizes specific binding of OX40 to OX40L; comprising the claimed CDRs of antibody 02D10. The Claimed/patented SEQ ID NOs are identical (i.e., SEQ ID NO: 36, 38, 40, 42, 44, 46, 50, 52, 54, 56, 58, 60). The claims of the `229 patent anticipate the instant claims.
Applicant’s arguments, filed 02/03/2026, have been fully considered, but have not been found convincing.
Applicant submits that the '229 patent, filed April 29, 2016, has a patent term filing date of March 3, 2015. The anticipated expiration date of the '229 patent is March 3, 2035, 20 years from March 3, 2015. The '229 patent has filed a Terminal Disclaimer disclaiming any patent term over that of USSN 15/142,538, which has matured into US Patent No. 9,512,229, which has an anticipated expiration date of March 3, 2035. Accordingly, the anticipated expiration date of the '229 patent remains March 3, 2035.
As discussed above, claims issuing from the subject application will have a base expiration date (i.e., without PTA or PTE) of March 3, 2035, which is not after March 3, 2035, the base expiration date of the '229 patent. Further, as discussed above for the '785 patent and incorporated herein, the Office's argument that harassment by multiple owners may be a separate basis for obviousness-type double patenting is incorrect in view of the PTAB's recent decision denying the Examiner's Request for Rehearing in Ex parte NICOLAS BAURIN. Moreover, as discussed above for the '785 patent and incorporated herein, the Office's contention that Baurin is not applicable to the instant matter is misplaced. In addition, as discussed above for the '789 patent and incorporated herein, the Office's argument that patent terms should not be speculated by the Examiner because PTA calculations are complex is erroneous. Further, as discussed above for the '789 patent and incorporated herein, the Office's assertion that at an ODP analysis can be conducted irrespective of filing dates and/or expiration dates is unfounded.
This is not found persuasive because Applicant does not point to the MPEP section which incorporate the Ex parte Baurin decision. The Examiner follows the practices, procedures and guidelines of the MPEP which instructs the Examiner to do a NSODP based on “commonly owned” reference patent irrespective of the filing date and/or expiration date. The Examiner’s position remains the same as set forth in the previous Office Action, mailed 10/03/2025.
It is the Examiner’s position that the NS-ODP rejection is proper because improper timewise extension is only one issue addressed by NSPD. A TD filed in the instant application to overcome a proper NSDP rejection ensures that the patent issuing from the instant application is only enforceable while commonly owned with the `229 patent and also provides notice to the public that the patent issuing from the instant application is tied to the `229 patent. Also, the patent terms should not be speculated by the Examiner because PTA calculations are complex.
Also, the Examiner points to the MPEP chart II-B_AIA regarding NS-ODP on conflicting claims between an application and a patent instructs the Examiner to do a NSODP irrespective of the filing date and/or expiration date.
13. Claims 31-50 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. US 11779604 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `604 patent are directed to methods for increasing the ratio of Treg:Tconv cells in a patient has dermatitis with an anti-OX40L antibody or antibody fragment that specifically binds to human OX40L (hOX40L), comprising: a) selecting a patient with a ratio of Treg:Tconv cells of 2:100 or less, b) administering to the selected patient an anti-OX40L antibody or antibody fragment that specifically binds to human OX40L (hOX40L); comprising the claimed CDRs of antibody 02D10. The Claimed/patented SEQ ID NOs are identical (i.e., SEQ ID NO: 36, 38, 40, 42, 44, 46, 50, 52, 54, 56, 58, 60). The claims of the `604 patent anticipate the instant claims.
Applicant’s arguments, filed 02/03/2026, have been fully considered, but have not been found convincing.
Applicant submits that the '604 patent, was filed November 3, 2017 and has a patent term filing date of November 3, 2017. The anticipated expiration date of the '604 patent is November 3, 2037, 20 years from November 3, 2017.
As discussed above, claims issuing from the subject application will have a base expiration date (i.e., without PTA or PTE) of March 3, 2035, which is not after November 3, 2037, the base expiration date of the '604 patent.
Further, as discussed above for the '785 patent and incorporated herein, the Office's argument that harassment by multiple owners may be a separate basis for obviousness-type double patenting is incorrect in view of the PTAB's recent decision denying the Examiner's Request for Rehearing in Exparte NICOLASBAURIN. Moreover, as discussed above for the '785 patent and incorporated herein, the Office's contention that Baurin is not applicable to the instant matter is misplaced. In addition, as discussed above for the '789 patent and incorporated herein, the Office's argument that patent terms should not be speculated by the Examiner because PTA calculations are complex is erroneous. Further, as discussed above for the '789 patent and incorporated herein, the Office's assertion that at an ODP analysis can be conducted irrespective of filing dates and/or expiration dates is unfounded.
This is not found persuasive because Applicant does not point to the MPEP section which incorporate the Ex parte Baurin decision. The Examiner follows the practices, procedures and guidelines of the MPEP which instructs the Examiner to do a NSODP based on “commonly owned” reference patent irrespective of the filing date and/or expiration date. The Examiner’s position remains the same as set forth in the previous Office Action, mailed 10/03/2025.
It is the Examiner’s position that the NS-ODP rejection is proper because improper timewise extension is only one issue addressed by NSPD. A TD filed in the instant application to overcome a proper NSDP rejection ensures that the patent issuing from the instant application is only enforceable while commonly owned with the `604 patent and also provides notice to the public that the patent issuing from the instant application is tied to the `604 patent. Also, the patent terms should not be speculated by the Examiner because PTA calculations are complex.
Also, the Examiner points to the MPEP chart II-B_AIA regarding NS-ODP on conflicting claims between an application and a patent instructs the Examiner to do a NSODP irrespective of the filing date and/or expiration date.
14. Claims 31-50 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. US 9587030 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `030 patent are directed to method of treating an autoimmune disease or condition, a systemic inflammatory disease or condition, or transplant rejection in a human subject in need thereof, the method comprising administering to the subject a therapeutically effective, or prophylactically effective, amount of an antibody or a fragment thereof that specifically binds to human OX40-ligand (hOX40L) and competes for binding to said hOX40L with the antibody 02D10 which comprises the claimed CDRs of antibody 02D10. The Claimed/patented SEQ ID NOs are identical (i.e., SEQ ID NO: 36, 38, 40, 42, 44, 46, 50, 52, 54, 56, 58, 60). The claims of the `030 patent anticipate the instant claims.
Applicant’s arguments, filed 02/02/2026, have been fully considered, but have not been found convincing.
Applicants submit that they will consider the merits of filing a Terminal Disclaimer over the `030 patent once the subject claims are otherwise indicated to be in condition for allowance.
The rejection is maintained until the TD is filed over `030 patent.
15 Claims 31-50 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 113-127 of copending Application No. 18/459995 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of `995 application are directed to methods for reducing the proportion of Ki-67+ T-cells in a patient has dermatitis with an anti- OX40L antibody or antibody fragment that specifically binds to human OX40L (hOX40L), comprising: a) selecting a patient with a proportion of greater than or equal to 30% Ki-67+ T-cells out of the total number of CD4+ T-cells and/or CD8' T-cells, b) administering to the selected patient an anti-OX40L antibody or antibody fragment that specifically binds to human OX40L (hOX40L) comprising the claimed CDRs of antibody 02D10. The Claimed/patented SEQ ID NOs are identical (i.e., SEQ ID NO: 36, 38, 40, 42, 44, 46, 50, 52, 54, 56, 58, 60). The claims of the `995 application anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s arguments, filed 02/03/2026, have been fully considered, but have not been found convincing.
Applicant submits that the '995 application, filed September 1, 2023, has a patent term filing date of November 3, 2017. The anticipated expiration date of the '995 application is November 3, 2037, 20 years from November 3, 2017.
As discussed above, claims issuing from the subject application will have a baseexpiration date (i.e., without PTA or PTE) of March 3, 2035, which is not after November 3, 2037, the base expiration date of the '995 application.
Further, as discussed above for the '785 patent and incorporated herein, the Office's argument that harassment by multiple owners may be a separate basis for obviousness-type double patenting is incorrect in view of the PTAB's recent decision denying the Examiner's Request for Rehearing in Exparte NICOLASBAURIN. Moreover, as discussed above for the '785 patent and incorporated herein, the Office's contention that Baurin is not applicable to the instant matter is misplaced. In addition, as discussed above for the '789 patent and incorporated herein, the Office's argument that patent terms should not be speculated by the Examiner because PTA calculations are complex is erroneous. Further, as discussed above for the '789 patent and incorporated herein, the Office's assertion that at an ODP analysis can be conducted irrespective of filing dates and/or expiration dates is unfounded.
This is not found persuasive because Applicant does not point to the MPEP section which incorporate the Ex parte Baurin decision. The Examiner follows the practices, procedures and guidelines of the MPEP which instructs the Examiner to do a NSODP based on “commonly owned” reference patent irrespective of the filing date and/or expiration date. The Examiner’s position remains the same as set forth in the previous Office Action, mailed 10/03/2025.
However, this rejection is not the only rejection remains and the rejection will be withdrawn upon identifying allowable subject matter.
16. Claims 31-50 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 15-20, 22-25 of copending Application No. 17725228 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of `228 application are directed to methods of treating an autoimmune disease or condition or a systemic inflammatory disease or condition in a human subject in need thereof, comprising: administering to the subject a) a therapeutically effective, or prophylactically effective, amount of anti-OX40L antibody or fragment thereof that antagonizes specific binding of OX40 to OX40L comprising the claimed CDRs of antibody 02D10. The Claimed/patented SEQ ID NOs are identical (i.e., SEQ ID NO: 36, 38, 40, 42, 44, 46, 50, 52, 54, 56, 58, 60). The claims of the `228 application anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s arguments, filed 02/03/2026, have been fully considered, but have not been found convincing.
Applicant argues that the '228 application, filed April 20, 2022, has a patent term filing date of March 3, 2015. The anticipated expiration date of the '228 application is March 3, 2035, 20 years from March 3, 2015.
As discussed above, claims issuing from the subject application will have a baseexpiration date (i.e., without PTA or PTE) of March 3, 2035, which is not after March 3, 2035, the base expiration date of the '228 application.
Further, as discussed above for the '785 patent and incorporated herein, the Office's argument that harassment by multiple owners may be a separate basis for obviousness-type double patenting is incorrect in view of the PTAB's recent decision denying the Examiner's Request for Rehearing in Exparte NICOLASBAURIN. Moreover, as discussed above for the '785 patent and incorporated herein, the Office's contention that Baurin is not applicable to the instant matter is misplaced. In addition, as discussed above for the '789 patent and incorporated herein, the Office's argument that patent terms should not be speculated by the Examiner because PTA calculations are complex is erroneous. Further, as discussed above for the '789 patent and incorporated herein, the Office's assertion that at an ODP analysis can be conducted irrespective of filing dates and/or expiration dates is unfounded.
This is not found persuasive because Applicant does not point to the MPEP section which incorporate the Ex parte Baurin decision. The Examiner follows the practices, procedures and guidelines of the MPEP which instructs the Examiner to do a NSODP based on “commonly owned” reference patent irrespective of the filing date and/or expiration date. The Examiner’s position remains the same as set forth in the previous Office Action, mailed 10/03/2025.
This rejection is not the only rejection remains and the rejection will be withdrawn upon identifying allowable subject matter.
17. Claims 31-50 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 15-20, 22-25 of copending Application No. 17818397 (now allowed) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of `397 application are directed to methods of treating an autoimmune disease or condition or a systemic inflammatory disease or condition in a human subject in need thereof, comprising: administering to the subject a) a therapeutically effective, or prophylactically effective, amount of anti-OX40L antibody or fragment thereof that antagonizes specific binding of OX40 to OX40L comprising the claimed CDRs of antibody 02D10. The Claimed/patented SEQ ID NOs are identical (i.e., SEQ ID NO: 36, 38, 40, 42, 44, 46, 50, 52, 54, 56, 58, 60). The claims of the `397 application anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s arguments, filed 02/03/2026, have been fully considered, but have not been found convincing.
The '397 application, filed August 9, 2022, has a patent term filing date of August 9, 2022. The anticipated expiration date of the '397 application is August 9, 2042, 20 years from August 9, 2022.
As discussed above, claims issuing from the subject application will have a base expiration date (i.e., without PTA or PTE) of March 3, 2035, which is not after August 9, 2042, the base expiration date of the '397 application.
Further, as discussed above for the '785 patent and incorporated herein, the Office's argument that harassment by multiple owners may be a separate basis for obviousness-type double patenting is incorrect in view of the PTAB's recent decision denying the Examiner's Request for Rehearing in Exparte NICOLASBAURIN. Moreover, as discussed above for the '785 patent and incorporated herein, the Office's contention that Baurin is not applicable to the instant matter is misplaced. In addition, as discussed above for the '789 patent and incorporated herein, the Office's argument that patent terms should not be speculated by the Examiner because PTA calculations are complex is erroneous. Further, as discussed above for the '789 patent and incorporated herein, the Office's assertion that at an ODP
This is not found persuasive because Applicant does not point to the MPEP section which incorporate the Ex parte Baurin decision. The Examiner follows the practices, procedures and guidelines of the MPEP which instructs the Examiner to do a NSODP based on “commonly owned” reference patent irrespective of the filing date and/or expiration date. The Examiner’s position remains the same as set forth in the previous Office Action, mailed 10/03/2025.
17. Claims 31-50 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 14-19, 24-27, 29 of copending Application No. 19030346 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of `346 application are directed to methods of treating a disease selected from inflammatory bowel disease (IBD), Crohn's disease, rheumatoid arthritis, allogenic transplant rejection, graft- versus-host disease (GvHD), ulcerative colitis, systemic lupus erythematosus (SLE), diabetes, uveitis, ankylosing spondylitis, contact hypersensitivity, psoriasis, multiple sclerosis, and atherosclerosis in a human subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of an anti-OX40L antibody or antibody fragment that antagonizes specific binding of OX40 to OX40L comprising the claimed CDRs of antibody 02D10 (see claims 4 for example). The Claimed/patented SEQ ID NOs are identical (i.e., SEQ ID NO: 36, 38, 40, 42, 44, 46, 50, 52, 54, 56, 58, 60). The claims of the `346 application anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s arguments, filed 02/03/2026, have been fully considered, but have not been found convincing.
The '346 application, filed January 17, 2025, has a patent term filing date of March 3, 2015. The anticipated expiration date of the '346 application is March 3, 2035, 20 years from March 3, 2015.
As discussed above, claims issuing from the subject application will have a base expiration date (i.e., without PTA or PTE) of March 3, 2035, which is not after March 3, 2035, the base expiration date of the '346 application.
Further, as discussed above for the '785 patent and incorporated herein, the Office's argument that harassment by multiple owners may be a separate basis for obviousness-type double patenting is incorrect in view of the PTAB's recent decision denying the Examiner's Request for Rehearing in Exparte NICOLASBAURIN. Moreover, as discussed above for the '785 patent and incorporated herein, the Office's contention that Baurin is not applicable to the instant matter is misplaced. In addition, as discussed above for the '789 patent and incorporated herein, the Office's argument that patent terms should not be speculated by the Examiner because PTA calculations are complex is erroneous. Further, as discussed above for the '789 patent and incorporated herein, the Office's assertion that at an ODP
This is not found persuasive because MPEP states:
If both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome.
The Examiner’s position remains the same as set forth in the previous Office Action, mailed 10/03/2025.
18. Claims 31-50 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 8, 9, 11, 13, 17, 18, 20, 21 25, 28, 29, 31, 35-37, 47, 50 and 53 of copending Application No. 18634191 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of `191 application are directed to methods of treating;a disease or condition in a subject selected from the group consisting of an autoimmune disease or condition, an inflammatory disease or condition, a systemic inflammatory disease or condition, and a transplant rejection disease or condition mediated by human OX40L (hOX40L), comprising administering to the subject an effective amount of the aqueous pharmaceutical formulation comprising the claimed CDRs of antibody 02D10, wherein the disease or condition is atopic dermatitis or asthma. The Claimed/patented SEQ ID NOs are identical (i.e., SEQ ID NO: 36, 38, 40, 42, 44, 46, 50, 52, 54, 56, 58, 60, See sequence table pages 108-110). The claims of the `191 application anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s arguments, filed 02/03/2026, have been fully considered, but have not been found convincing.
Applicant submits that the '191 application, filed April 12, 2024, has a patent term filing date of April 12, 2024. The anticipated expiration date of the '191 application is April 12, 2044, 20 years from April 12, 2024.
As discussed above, claims issuing from the subject application will have a base expiration date (i.e., without PTA or PTE) of March 3, 2035, which is not after April 12, 2044, the base expiration date of the '191 application.
Further, as discussed above for the '785 patent and incorporated herein, the Office's argument that harassment by multiple owners may be a separate basis for obviousness-type double patenting is incorrect in view of the PTAB's recent decision denying the Examiner's Request for Rehearing in Ex parte NICOLAS BAURIN. Moreover, as discussed above for the '785 patent and incorporated herein, the Office's contention that Baurin is not applicable to the instant matter is misplaced. In addition, as discussed above for the '789 patent and incorporated herein, the Office's argument that patent terms should not be speculated by the Examiner because PTA calculations are complex is erroneous. Further, as discussed above for the '789 patent and incorporated herein, the Office's assertion that at an ODP.
This is not found persuasive because Applicant does not point to the MPEP section which incorporate the Ex parte Baurin decision. The Examiner follows the practices, procedures and guidelines of the MPEP which instructs the Examiner to do a NSODP based on “commonly owned” reference patent irrespective of the filing date and/or expiration date. The Examiner’s position remains the same as set forth in the previous Office Action, mailed 10/03/2025.
19. Claims 31-50 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 8, 9, 11, 13, 17, 18, 20, 21 25, 28, 29, 31, 35-37, 47, 50 and 53 of copending Application No. 18748458 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of `458 application are directed to method of treating an immune-mediated disease or atopic dermatitis in a subject in need thereof, comprising administering to the subject an anti-0X40 ligand (OX40L) antibody or antigen binding fragment thereof comprising the claimed CDRs of antibody 02D10/ KY1005 / amlitelimab /SAR445229, wherein the disease or condition is atopic dermatitis or asthma. The Claimed/patented SEQ ID NOs are identical (i.e., SEQ ID NO: 36, 38, 40, 42, 44, 46, 50, 52, 54, 56, 58, 60). The claims of the `458 application anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s arguments, filed 02/03/2026, have been fully considered, but have not been found convincing.
Applicant submits that the '458 application, filed June 20, 2024, has a patent term filing date of June 20, 2024. The anticipated expiration date of the '458 application is June 20, 2044, 20 years from June 20, 2024.
As discussed above, claims issuing from the subject application will have a base expiration date (i.e., without PTA or PTE) of March 3, 2035, which is not after June 20, 2044, the base expiration date of the '458 application.
Further, as discussed above for the '785 patent and incorporated herein, the Office's argument that harassment by multiple owners may be a separate basis for obviousness-type double patenting is incorrect in view of the PTAB's recent decision denying the Examiner's Request for Rehearing in Ex parte NICOLAS BAURIN. Moreover, as discussed above for the '785 patent and incorporated herein, the Office's contention that Baurin is not applicable to the instant matter is misplaced. In addition, as discussed above for the '789 patent and incorporated herein, the Office's argument that patent terms should not be speculated by the Examiner because PTA calculations are complex is erroneous. Further, as discussed above for the '789 patent and incorporated herein, the Office's assertion that at an ODP
This is not found persuasive because Applicant does not point to the MPEP section which incorporate the Ex parte Baurin decision. The Examiner follows the practices, procedures and guidelines of the MPEP which instructs the Examiner to do a NSODP based on “commonly owned” reference patent irrespective of the filing date and/or expiration date. The Examiner’s position remains the same as set forth in the previous Office Action, mailed 10/03/2025.
20. No claim is allowed.
21. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
22. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER M HADDAD whose telephone number is (571)272-0845. The examiner can normally be reached on Monday-Friday from7:00AM to 4:30PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached at telephone number 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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March 1, 2026
/MAHER M HADDAD/ Primary Examiner, Art Unit 1641