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 .
Claims 1-9, 12 and 15-19 are under consideration
Rejections/Objections Withdrawn
The 35 USC 112(b) rejection of claims 3, 7-8 and 15 has been withdrawn in view of claim amendments.
The 35 USC 112(d) rejection of claim 2 has been withdrawn in view of claim amendments.
The 35 USC 112(a) written description rejection of claims 1-9, 12 and 15 has been withdrawn in view of claim amendments.
The 35 USC 112(a) scope of enablement rejection of claim 15 has been withdrawn in view of claim amendments.
Rejections Maintained/New Rejections Necessitated by Amendment
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.
Claims 1-3, 5-9, 12 and 15-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-15, 19-20 and 27-32 of copending Application No. 18/260,435 (Published as US-20240034801-A1 on 2/1/2024).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are directed to a bispecific antibody comprising a PDL1 binding domain with the same CDR sequences.
Regarding instant claim 1, copending claim 1 is directed to anti-PDL1 antibodies comprising the same set of six distinct CDRs (Copending claim 1). Regarding instant claim 3, copending claim 11 is directed to antibodies comprising immunoglobin G constant regions. Regarding claims 6-7, copending claim 4 is directed to a VH of copending SEQ ID NO: 6 (same as instant SEQ ID NO: 41) and VL sequence of copending SEQ ID NOs: 2 (same as instant SEQ ID NO: 44). Regarding instant claim 2, as evidenced by the instant Specification, instant SEQ ID NO: 41 is a humanized VH sequence (Specification, p 43, table 7, entry 13) and instant SEQ ID NO: 44 is a humanized VL sequence (Specification, p 43, table 7, entry 3), thus making the antibody of the ‘435 application a humanized antibody.
Regarding instant claim 5, the VH and VL sequences of the ‘435 application (copending SEQ ID NOs: 6 and 2, respectively) are reproduced below with the framework regions underlined and with explanations regarding which, if any, of the permissible amino acid substitutions recited in instant claim 5 are made:
VL of ‘435 application (Copending SEQ ID NO: 2)
DIQMTQSPSSLSASVGDRVTITCKASQDVHTAVAWIQQKPGKSPKLLIYSASNRYTGVPSRFSGSGSGTDFTFTISSLQPEDIATYYC QQHYITPLTFGQGTKLEIK
FRL1 = instant SEQ ID NO: 54
FRL2 = instant SEQ ID NO: 55 with 2nd amino acid Y substituted with L
FRL3 = instant SEQ ID NO: 56
FRL4 = instant SEQ ID NO: 57
VH of ‘435 application (Copending SEQ ID NO: 6)
EVQLVQSGAEVKKPGSSVKVSCKASGFNIEDTYIHWVRQAPGQGLEWMGRIDPANANTKYDPKFQGRVTITADTSTNTAYMELSSLRSEDTAVYYCGRGLGAWFAWGQGTLVTVSS
FRH1 = instant SEQ ID NO: 58 with first amino acid Q substituted with E
FRH2 = instant SEQ ID NO: 59
FRH3 = instant SEQ ID NO: 60 with 8th amino acid E substituted with T and 31st amino acid A substituted with G
FRH3 = instant SEQ ID NO: 61
Regarding instant claims 8 and 17, copending claim 10 is directed to scFv and Fab antigen binding fragments. Regarding instant claim 12, copending claim 19 is directed to compositions comprising the antibody of the ‘435 application and a pharmaceutically acceptable carrier. Regarding instant claim 9, copending claim 15 is directed to nucleic acids encoding the antibodies of the ‘435 application. Regarding instant claims 15 and 18-19, copending claims 27-29 are directed to methods of treating gastric cancer, said method comprising administering the antibody of the ‘435 application. Regarding instant claim 16, copending claim 13 is directed to an anti-PDL1 antibody comprising a heavy chain constant region of copending SEQ ID NO: 8 (note: this is an IgG1 constant region).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 4/22/2026 have been fully considered but they are not persuasive.
Applicant argues that the reference application and the instant application are patentably distinct based on the fact that the instant claimed antibody is an anti-PDL1 antibody whereas the antibody of the reference application is an anti-PDL1/anti-4-1BB bispecific antibody. This is not found to be persuasive because the claims subject to this rejection are directed to an antibody or antigen-binding fragment thereof capable of binding PDL1 and possessing specific amino acid sequence(s) at certain antibody loci and the bispecific antibody of the ‘435 application meets all of the required sequence limitations and is capable of binding PDL1. There is no language in the instant claim set that would exclude antibodies that also bind 4-1BB.
Note: The Office notes that, as of the date of this Office Action (6/11/2026), a Notice of Allowance had been issued for the ‘435 Application (on 4/14/2026) but a patent had not yet been issued.
Allowable Subject Matter/Subject Matter Free of Prior Art
Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
A fused CDR search was performed for each of CDR triplets recited in instant claim 1. No 100% match was found for any claimed VH or VL CDR triplet and the next nearest prior art for the CDR triplets of claim 1 is indicated in the table below:
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200
400
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Note that while the next nearest prior art match for the instant claimed VH CDR sequences does correspond to the VH region of an anti-PDL1 antibody, none of next nearest prior art sequences for the VH CDRs are a 100% matches to the instant claimed binding-critical VH CDRs and the next nearest prior art sequence for the VL CDRs did not come from prior art that corresponds to an anti-PDL1 antibody VL region. Given the lack of established structure/function correlation between antibody CDR sequences and an antibody’s ability to bind its antigen articulated in the previous Office Action, it is unlikely that one of skill in the art would start with the prior art VH CDR sequences (which do correspond to an anti-PDL1 antibody), perform the required modifications to arrive at the instant claimed VH CDR sequences and pair the resultant VH region with VL region that does not correspond to an anti-PDL1 antibody and have a reasonable expectation of success forming a functional antibody capable of performing the required function of binding PDL1. As such, an antibody comprising a LCVR having a LCDR 1 of SEQ ID NO: 20, LCDR2 of SEQ ID NO: 21 and an LCDR3 of SEQ ID NO: 22 and HCVR having a having a HCDR 1 of SEQ ID NO: 23, HCDR2 selected from the group consisting of SEQ ID NO: 24, 45, 46 and 47 and an HCDR3 of SEQ ID NO: 25 and capable of performing the required function of binding PDL1 is free of prior art. Regarding claim 4 specifically, the only standing rejection is a provisional NSDP rejection in view of application 18/260,435 and a match for the VH and VL sequences (SEQ ID NOs: 19 and 18, respectively) required by instant claim 4 was not found for this application in the pending patents database.
Conclusion
Claims 1-3, 5-9, 12 and 15-19 are rejected.
Claim 4 is objected to.
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sydney Van Druff whose telephone number is (571)272-2085. The examiner can normally be reached 10 am - 6 pm.
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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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/SYDNEY VAN DRUFF/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
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