DETAILED ACTION
1. The present application is being examined under the pre-AIA first to invent provisions.
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 01/05/2026 has been entered.
3. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
4. Claims 32-37 are rejected under 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention.
Claim 32 is indefinite, because the first instance of recitation of “the nivolumab” lacks proper antecedent basis in the preceding part of the claim.
Claims 33-37 are indefinite, because they encompass the indefinite limitations of the claim(s) on which they depend.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
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 §§ 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.
6. Claims 18-23, 26-27 and 29-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12479917.
In the office action dated 06/16/2025 (section 10), the present claims were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 17/287838. In the Notice of Allowance dated 10/03/2025 (section 1), the provisional rejection was withdrawn to permit the present application to issue first.
USSN 17/287838 issued as US ‘917 on 11/25/2025. Accordingly, the ground of provisional rejection over USSN 17/287838 are presently reinstated as non-provisional double patenting rejection over US ‘917.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of US ‘917, which recite a method of treating metastatic NSCLC comprising administering to the subject nivolumab in combination with platinum doublet chemotherapy comprising carboplatin and paclitaxel, wherein the nivolumab is administered once every 3 weeks (claims 1-2 and 19-20), wherein at least 1% of tumor cells exhibit membrane PD-L1 expression (claim 4).
A person of skill in the art would have been aware that the standard route of nivolumab administration is by intravenous infusion. Further, a person of skill in the art would have readily understood that if a tumor with at least 1% of tumor cells exhibiting membrane PD-L1 expression is treatable with nivolumab, a tumor with at least 10% of tumor cells exhibiting membrane PD-L1 expression would also be treatable with nivolumab, because it was known that patients with higher PD-L1 expression are more likely to benefit from anti-PD-1 treatment. The limitations of instant claims 20-23 and 26-27 are either routine in the art or inherent in US ‘917 claims.
7. Claims 18-27 and 29-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12528865.
In the office action dated 06/16/2025 (section 10), the present claims were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 17/385636. In the Notice of Allowance dated 10/03/2025 (section 1), the provisional rejection was withdrawn to permit the present application to issue first.
USSN 17/385636 issues as US ‘865 on 01/20/2026. Accordingly, the ground of provisional rejection over USSN 17/385636 are presently reinstated as non-provisional double patenting rejection over US ‘865.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of US ‘865, which recite a method of treating advanced NSCLC comprising administering to the subject nivolumab once every 3 weeks, wherein at least 50% of tumor cells express PD-L1 (claims 1-3), further comprising administering platinum-based doublet chemotherapy comprising carboplatin and paclitaxel (claims 12-14), wherein the treatment is further combined with surgery (claim 11).
8. Claims 18-27 and 29-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending applications USSN 18/778430, published as US 20250011466 (of record), and 19/141978, published as US 20260000757.
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 copending applications, either alone or in view of Korman et al. (US 20090217401) and/or Brahmer et al. (2010; both of record).
USSN ‘430 recites a method of treating NSCLC comprising administering nivolumab once every 3 weeks and platinum-based doublet chemotherapy comprising carboplatin and paclitaxel (claims 1-2, 8, 10 and 13-14). It would have been obvious to one of ordinary skill in the art at the time the invention was made to select patients whose tumor cells exhibited membrane PD- L1 expression, based on Brahmer's teachings that only such patients experienced tumor regressions in response to anti-PD-1 treatment (see p. 3170).
USSN ‘978 recites a method of treating metastatic NSCLC comprising administering nivolumab (claims 185, 188, 191) and platinum doublet chemotherapy comprising carboplatin and paclitaxel (claims 192 and 196-197), wherein tumor cells express PD-L1 (claim 203). Although USSN ‘978 claims do not specifically exemplify administering nivolumab once every 3 weeks, it was within the skill in the art to adjust administration schedule according to the needs of the patient, in particular since such administration schedule was suggested by Korman (e.g. [0451]) for anti-PD-1 antibodies including antibody "5C4," now known as nivolumab.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
9. Claim 28 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all relevant limitations of the base claim and any intervening claims.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644