DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
1. Claim 1 is the original claim filed 4/14/2022. In the Preliminary Response of 6/22/2022, Claim 1 is canceled and new Claims 2-16 are added. In the Reply of 9/17/2024, no claims are amended. In the Response of 2/26/2025, Claims 2, 8, 11, and 13 are amended and claims 14-15 are canceled. In the Response After Final Action of 7/2/2025, claim 2 is amended. In the Response of 9/26/2025, claims 2, 8, 11 and 13 are amended. In the Response of 1/28/2026, claims 2, 8, 11 and 13 are amended.
Claims 2-13 and 16 are all the claims.
The finality of the Office Action is withdrawn in view of new grounds for rejection.
Priority
2. USAN 17/720,954, filed 04/14/2022, and having 1 RCE-type filing therein, is a Divisional of 16/387,228, filed 04/17/2019, now U.S. Patent # 11459393,
16/387,228 Claims Priority from Provisional Application 62/826,091, filed 03/29/2019,
16/387,228 Claims Priority from Provisional Application 62/658,899, filed 04/17/2018.
Information Disclosure Statement
3. As of 3/24/2026, a total of six (6) IDS are filed: 6/22/2022; 6/22/2022;
6/22/2022; 1/3/2024; 9/17/2024; and 1/28/2026. The corresponding initialed and dated 1449 form is considered and of record.
Withdrawal of Rejection
Claim Rejections - 35 USC § 112(a)
Written Description
4. The rejection of Claims 2-13 and 16 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn.
Generic claims 2, 8, 11 and 13 are amended to direct the method to treating (therapeutic) a subject having a condition or disease where the condition or disease is cancer wherein the cancer/tumor is CD27+ or CD27-expressing and the amount of the anti-CD27 x anti-PD-L1 bispecific antibody is therapeutically effective. Stimulation of T cell activity is achieved vis-à-vis anti-PD-L1 binding and CD27-expressing tumor cell binding vis-à-vis anti-CD27 binding.
New Grounds for Rejection
Double Patenting
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.
5. Claims 2-13 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1(1)(b) and (2)(g), 41, 43-44, 58, 60, 65, 69, 82, 90-91, 93, 95-97, 100, 108, 117-130 of copending Application No. 18/962,161 (reference application US 20250346671). The reference application is not afforded safe harbor protection under 35 USC 121 because it shares no restriction/speciation with the claims of the instant application.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ref claims are drawn to the same anti-CD27 (9H9) x anti-PDL-1 (2BC) bispecific antibody and methods of treatment as those instant claimed methods:
Anti-CD27
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162
946
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Anti-PD-L1
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184
948
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
6. No claims are allowed.
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Julie 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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/LYNN A BRISTOL/Primary Examiner, Art Unit 1643