DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2 Applicant's amendment, filed on 05/15/2025, is acknowledged.
3. Claims 1, 8, 12 and 18-30 are pending and under examination.
4. Applicant’s IDS, filed 05/23/2023, 08/12/2024, 05/15/2025, 05/28/25 and 07/15/2025, is acknowledged.
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 1, 8, 12 and 18-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-5, 9, 19-33 of copending Application No. 17604735 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `735 are directed to anti-human Claudin 18.2 comprising the VH of SEQ ID NO: 231 and VL of SEQ I DNO: 261 comprising the claimed CDRs (see sequence alignment below). The `735 applicant also claims a conjugate comprising the antibody attached to a cytotoxic drug (see referenced claims 9, 19-22, 24 and 27-33). The specification of the `735 discloses the coupling (i.e., physically linking) to conjugate the antibody to a detectable substance (see page 31 top ¶). It would have been obvious to one skilled in the art to link the antibody to the cytotoxic.
Alignment of VH of referenced/claimed SEQ ID NO: 231/41 and 65 comprising claims SEQ ID NO: 24-43-44.
Qy 1 GGSISSNYAWN--------------YIYYSGNTNYNPSLKS------------------- 27
||||||||||| ||||||||||||||||
Db 26 GGSISSNYAWNWIRQPPGKGLEWIGYIYYSGNTNYNPSLKSRVTISRDTSKNQFSLKLSS 85
Qy 28 -------------SYYGNSFIY 36
|||||||||
Db 86 VTAADTAVYYCATSYYGNSFIY 107
Alignment of VH of referenced/claimed SEQ ID NO: 261/116 and 65 comprising claims SEQ ID NO: 50-52.
Qy 1 KSSQSLLNSGNQKNYLT---------------WASTRES--------------------- 24
||||||||||||||||| |||||||
Db 24 KSSQSLLNSGNQKNYLTWYQQKPGQPPKLLIYWASTRESGVPDRFSGSGSGTDFTLTISS 83
Qy 25 -----------QNAYSFPWT 33
|||||||||
Db 84 LQAEDVAVYYCQNAYSFPWT 103
The claims of the `735 renders the instant claims obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
7. Claims 1, 8, 12 and 18-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18910550 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `550 are directed to antibody-drug conjugate which has the structure shown in Formula Ab-(L-D)p comprising the anti-human Claudin 18.2 comprising 100% identical VH of SEQ ID NO: 61/61 and VL of SEQ I DNO: 49/66 comprising the claimed CDRs (see sequence alignment below), a linker and a cytotoxic agent.
Alignment of VL referenced/claimed SEQ ID NO: 65 and claims SEQ ID NO: 42-43-44.
Qy 1 GGSISSNYAWN--------------YIYYSGNTNYNPSLKS------------------- 27
||||||||||| ||||||||||||||||
Db 26 GGSISSNYAWNWIRQPPGKGLEWIGYIYYSGNTNYNPSLKSRVTISRDTSKNQFSLKLSS 85
Qy 28 -------------SYYGNSFIY 36
|||||||||
Db 86 VTAADTAVYYCATSYYGNSFIY 107
Alignment of VL referenced/claimed SEQ ID NO: 49/66 and claims SEQ ID NO: 50-51-52.
Qy 1 KSSQSLLNSGNQKNYLT---------------WASTRES--------------------- 24
||||||||||||||||| |||||||
Db 24 KSSQSLLNSGNQKNYLTWYQQKPGQPPKLLIYWASTRESGVPDRFSGSGSGTDFTLTISS 83
Qy 25 -----------QNAYSFPWT 33
|||||||||
Db 84 LQAEDVAVYYCQNAYSFPWT 103
The claims of the `550 application anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
8. Claims 1, 8, 12 and 18-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-7, 9-19, 2426, 28-31 of copending Application No. 18927411 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `411 are directed to method of using antibody-drug conjugate which has the structure shown in Formula Ab-(L-D)p comprising the anti-human Claudin 18.2 comprising 100% identical VH of claimed/referenced SEQ ID NO: 7/65 (41) and VL of claimed/referenced SEQ I DNO: 8/66(49) comprising the claimed CDRs, a linker and a cytotoxic agent.
The claims of the `411 applicant anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
9. No claim is allowed.
10. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Singh et al. Anti-claudin 18.2 antibody as new targeted therapy for advanced gastric cancer. J Hematol Oncol. 2017 May 12;10(1):105.
11. 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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November 10, 2025
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644