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 and remarks filed on 04/06/2026 are acknowledged.
Claims 154, 156, 158, 170 and 172 are pending.
All presently pending claims read on the elected invention.
3. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
4. Claims 154, 156, 158, 170 and 172 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11858996 (of record).
Applicant has not substantively addressed the grounds of rejection presented in section 16 of the previous office action, which are therefore maintained, and incorporated by reference herein as if reiterated in full.
5. Claims 154, 156, 158, 170 and 172 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of the following copending applications (all of record):
USSN 18/510228 (PG Pub. No. 20240190964),
USSN 17/747886 (PG Pub. No. 20220396623),
USSN 18/174925 (PG Pub. No. 20230348601), and
USSN 16/471161 (PG Pub. No. 20200190191).
Applicant has not substantively addressed the grounds of rejection presented in section 19 of the previous office action, which are therefore maintained, and incorporated by reference herein as if reiterated in full.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
6. Claims 154, 156, 158, 170 and 172 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of the following copending applications, filed and/or published subsequent to the mailing of the previous office action:
USSN 19/299821 (PG Pub. No. 20260070979) and
USSN 19/282256 (PG Pub. No. 20260049143)
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by or obvious over the claims of each of the above copending applications.
Specifically, USSN ‘821 recites methods of treating cancer comprising administering an antibody comprising an antigen-binding site of anti-ICOS antibody STIM003 (claims 1, 24, 40 and 41).
USSN ‘256 recites methods of treating cancer comprising administering an anti-ICOS antibody comprising VH or SEQ ID NO: 408 and VL of SEQ ID NO: 415 (claims 1, 3 and 7).
STIM003 comprises a heavy chain of instant SEQ ID NOS: 410 (which comprises a VH or SEQ ID NO: 408) and a light chain of instant 417 (which comprises a VL or SEQ ID NO: 415), as disclosed e.g. in the present specification at [0147]. The constant regions of the heavy and light chains within SEQ ID NOS: 410 and 417 are well known in the art, and as such would be at once envisaged by, or obvious to, a person of ordinary skill in the art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
7. The following US Patents and/or copending US applications share a coinventor and/or an assignee with the present application, and disclose and/or claim subject matter similar to that of the present claims, but do not contain patented or currently pending claims which would anticipate or make obvious the presently claimed invention:
USSN 18/866299 (PG Pub. No. 20250340641), and
US Patent No. 12404330.
8. Conclusion: no claim is allowed.
9. 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.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 8:30 AM – 5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel Kolker can be reached at 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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