DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments and Arguments
2. Claims 52-55 are pending.
Claims 56-59 have been cancelled.
Claims 52-55 have been amended.
Claims 52-55 are examined on the merits.
Withdrawn Grounds of Objection
Specification
3. The title of the invention is now descriptive, see Amendments to the Specification submitted November 3, 2025.
Maintained Grounds of Rejection
Claim Rejections - 35 USC § 102
4. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
5. The rejection of claim(s) 52-55 under 35 U.S.C. 102(a)(2) as being anticipated by Abujoub et al, US 2019/0367628 A1 (effectively filed May 30, 2019) is maintained. Claims 56-59 have been cancelled.
Applicant asserts “[claim] 52 has been amended to incorporate the synergistic effect” and states support for this amendment is found at Example 2 of the specification spanning pages 77-79; and Fig. 2A and 2B, see Remarks submitted November 3, 2025, page 4, 4th paragraph (para.).
Applicant concludes arguments, stating “…Abujoub…[does not disclose]…the combination therapy of the BCMA x CD3 bispecific antibody and the PD-1 antibody would have a synergistic effect in treating cancer.”, see last 5 lines on page 4 of the Remarks.
Applicant’s arguments, passages within the specification and Figures have been carefully considered, but found unpersuasive.
The claims read broadly on any and all types of cancer, notwithstanding Abujoub clearly and plainly discloses the claimed invention, see the entire document. Moreover, the disclosed therapeutic agents, which are the same as that claimed would render the same synergistic effects.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)., see MPEP 2112.01.
“Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id., see MPEP 2112.01.
Hence, the rejection is maintained for the reasons of record and set forth herein.
Abujoub discloses a method of treating hematological cancers including multiple myeloma with the administration of a B-cell maturation antigen (BCMA) binding molecule in combination with a PD-1 inhibitor or PD-L1 inhibitor, see page 126, section 0687; and page 153, section 0903-page 154, section 0922. The BCMA binding molecule may be a bispecific binding molecule (BBM) including PF06863135, see page 1, section 0005; and page 5, section 0068. The PD-1 inhibitor may be PF-06801591, which is also art known as anti-PD-1 antibody, sasanlimab.
Moreover, Abujoub discloses a method of treating hematological cancers including MM with a BCMA binding molecule and a gamma secretase inhibitor (GSI), see page 5, sections 0065 and 0070; page 126, section 0687; and page 131, section 0761. The BCMA binding molecule may be a BBM including PF06863135, see page 1, section 0005; and page 5, section 0068. And the GMI is nirogacestat, see page 136, section 0785.
6. The rejection of claim(s) 52 under 35 U.S.C. 102(a)(1) as being anticipated by Daley et al., WO 2018/201051 A1 (published 01 November 2018/ Foreign Patent Documents, IDS reference #2 on sheet 1 submitted August 18, 2023) is maintained. Claim 56 has been cancelled.
Applicant asserts “[claim] 52 has been amended to incorporate the synergistic effect” and states support for this amendment is found at Example 2 of the specification spanning pages 77-79; and Fig. 2A and 2B, see Remarks submitted November 3, 2025, page 4, 4th paragraph (para.).
Applicant concludes arguments, stating “…Daley…[does not disclose]…the combination therapy of the BCMA x CD3 bispecific antibody and the PD-1 antibody would have a synergistic effect in treating cancer.”, see last 5 lines on page 4 of the Remarks.
Applicant’s arguments, passages within the specification and Figures have been carefully considered, but found unpersuasive.
The claims read broadly on any and all types of cancer, notwithstanding Daley clearly and plainly discloses the claimed invention, see the entire document. Moreover, the disclosed therapeutic agents, which are the same as that claimed would render the same synergistic effects.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)., see MPEP 2112.01.
“Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id., see MPEP 2112.01. Hence, the rejection is maintained for the reasons of record and set forth herein.
Daley discloses a method of treating diseases including multiple myeloma (MM) that expresses B-cell maturation antigen (BCMA) with an anti-BCMA bispecific antibody molecule in combination with a PD-1 inhibitor, PF-06801591, see abstract; page 1, lines 34-36; page 3, lines 25-32; page 19, lines 9-30; and the paragraph bridging pages 31 and 32. PF-06801591 is art known as anti-PD-1 antibody, sasanlimab.
Furthermore, Daley discloses a method of treating diseases with expression of BCMA with an anti-BCMA antibody molecule that is bispecific in combination with a gamma secretase inhibitor (GSI), wherein the GSI is nirogacestat, see abstract; page 1, Field…segment and lines 34-36; page 3, lines 25-32; page 6, lines 10-18; page 19, lines 9-30; page 20; page 25, Fig. 9A caption; Gamma…segment beginning on page 39; and page 49, lines 12-16.
The compositions administered for treatment include a BCMA-targeting agent formulated together with a pharmaceutically acceptable carrier, see Pharmaceutical…segment spanning pages 149-153.
Claim Rejections - 35 USC § 103
7. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
8. The rejection of claim(s) 52-55 under 35 U.S.C. 103 as being unpatentable over Daley et al., WO 2018/201051 A1 (published 01 November 2018/ Foreign Patent Documents, IDS reference #2 submitted August 18, 2023), and further in view of ClinicalTrials.gov Identifier: NCT03269136 (first posted August 31, 2017/ IDS reference #7 on sheet 2 submitted August 18, 2023) and Raje et al., (Blood 653, 1869:134 (Supplement_1): 1-3, November 13, 2019/ IDS reference #9 on sheet 3 submitted August 18, 2023) have been maintained. Claims 56-59 have been cancelled.
“Applicant submits that Example 2 of the instant application demonstrated synergistic effect of the combination of the BCMA x CD3 antibody and the PD-1 antibody and such synergistic effect would be unexpected results over the prior art teachings.”, see Remarks submitted November 3, 2025.
Applicant’s arguments, passages within the specification and Figures have been carefully considered, but found unpersuasive.
The arguments are not persuasive because when compared to the closest prior art herein, it is found to be directed to latent properties, not unexpected results. It would not have been unexpected for the claimed
invention to achieve the results achieved by Applicants. The combination of references does teach the claimed invention. The teachings of all these references embody all three tenets of the requirements for establishing a proper case of obviousness. Moreover, the taught therapeutic agents, which are the same as that claimed would render the same synergistic effects.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)., see MPEP 2112.01.
“Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id., see MPEP 2112.01. Hence, the rejection is maintained for the reasons of record and set forth herein.
Daley teaches a method of treating diseases including multiple myeloma (MM) that expresses B-cell maturation antigen (BCMA) with an anti-BCMA bispecific antibody molecule in combination with a PD-1 inhibitor, PF-06801591, see abstract; page 1, lines 34-36; page 3, lines 25-32; page 19, lines 9-30; and the paragraph bridging pages 31 and 32. PF-06801591 is art known as anti-PD-1 antibody, sasanlimab.
Furthermore, Daley teaches a method of treating diseases with expression of BCMA with an anti-BCMA antibody molecule that is bispecific in combination with a gamma secretase inhibitor (GSI), wherein the GSI is nirogacestat, see abstract; page 1, Field…segment and lines 34-36; page 3, lines 25-32; page 6, lines 10-18; page 19, lines 9-30; page 20; page 25, Fig. 9A caption; Gamma…segment beginning on page 39; and page 49, lines 12-16.
The compositions administered for treatment include a BCMA-targeting agent formulated together with a pharmaceutically acceptable carrier, see Pharmaceutical…segment spanning pages 149-153.
Daley does not teach a method of treating cancer, including MM with the combination therapy, an anti-PD-1 antibody and a BCMA bispecific antibody that is PF-06863135.
However, the trial, NCT03269136 teaches the administration of PF-0683135 (PF-3135) as a single agent, as well as in combination with an additional immunomodulatory agent for the treatment of MM, see title on page 1; and Arms…segment spanning pages 3 and 4.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the references to effectively treat the cancer with an established combinatorial regimen of BCMA bispecific agents, specifically PF-06863135 with additional immunotherapeutic agents, see both references in their entirety and Raje.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings in both references and Raje, the bispecific, humanized, monoclonal antibody (mAb), PF-06863135 (PF-3135) is well tolerated at a range of dosages and has been effective in treating different forms of MM, see all references; and in particular, Raje, Title on page 1 and the Results and Conclusions on page 2.
Double Patenting
9. 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.
10. The provisional nonstatutory double patenting of claims 52-55 as being unpatentable over claims 1-43, 47 and 48 of copending Application No. 18/025,879 (March 10, 2023) is maintained. Claims 56-59 have been cancelled.
Applicant argues claims 1-42, 47 and 48 of the copending “…application do not disclose or suggest the combination of a BCMA x CD3 bispecific antibody with a PD-1 antibody.”, see Remarks submitted November 3, 2025, page 5, last paragraph (para.).
Applicant further notes it is their intent to cancel pending claim 43 in response to the first action on the merits mailed November 3, 2025, see Remarks, 2nd to last sentence in last para. on page 5.
Applicant’s points of view, arguments and copending application have been carefully reviewed and considered.
The combination of references teaches the claimed invention.
The combination of these teachings does not differ from Applicant’s claimed invention, nor what is exemplified in Applicants’ teachings noted in Example 2 spanning pages 77-79. Hence, the same results would render the same synergistic effects as espoused by Applicants.
Furthermore, at this point in prosecution, claim 43 in the copending application has not been cancelled. For the reasons of record and herein the rejection is maintained.
Both sets of claims read on treating cancer and in particular, multiple myeloma a combinatorial therapeutic regimen including a BCMA bispecific antibody that is PF-06863135 with a second therapeutic agent including anti-PD-1 antibody, sasanlimab (PF-06801591).
The instant application, 17/924,975 does not teach the different dose amounts, ranges and time points of the BCMA bispecific antibody.
However, one of ordinary skill in the art would have been motivated to administer the therapeutic agents at the cited dosages within in the instant claims to individuals with MM between at the designated dosage ranges and time points cited within the claims with a reasonable expectation of success by teachings well known that dosages of any pharmaceutical composition may be adjusted and optimized. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings in the art.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235(CCPA 1955).
This is a provisional nonstatutory double patenting rejection.
Conclusion
11. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
12. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can generally be reached between 8AM-8PM, Monday through Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
12 November 2025
/Alana Harris Dent/Primary Examiner, Art Unit 1643