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 preliminary amendment filed on 02/20/2024 is acknowledged.
Claims 19-32 are pending.
3. Claim 25 is objected to because the VH SEQ ID Number in subclause (i) is missing. Appropriate correction is required.
4. 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.
5. Claims 19-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11773167.
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 ‘167 patent.
The present application was filed as a continuation of USSN 17/870479 issued as US ‘167 patent.
US ‘167 recites anti-PD-L1 antibodies comprising the same CDRs (claim 1), the same variable regions (claim 2) and the same heavy and light chains (claim 3) as the anti-PD-L1 antibody recited in instant claims. US ‘167 further recites in claim 4 fusions of IL-10 with the heavy chain of the anti-PD-L1 antibodies, in particular via the same linkers as recited in instant claim 24. Accordingly, instant claims 19-29 are anticipated by claims 1-4 of US ‘167.
Claims 30 and 31 are included in the rejection, because polynucleotides encoding a protein and cells comprising the polynucleotide are inherent in recombinantly produced proteins.
Claim 32 is included, because at present cancer treatment is the only clinical application of anti-PD-L1 antibodies, and as such would be at once envisaged by those skilled in the art in view of US ‘167 claims.
6. Claims 19-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending applications USSN 18/519188 (published as US 20240190934), USSN 18/698803 (US 20240408177), and USSN 18/700015 (US 20240336667).
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 each of the above reference applications, which recite anti-PD-L1- IL-10 fusions within the scope of instant claims.
Specifically, USSN ‘188 recites anti-PD-L1- IL-10 fusions wherein IL-10 is 80% identical to SEQ ID NO: 2, heavy chain is 80% identical to SEQ ID NO: 26 and light chain is 80% identical to SEQ ID NO: 27 (claims 1, 2, 10, 16 and 17). USSN ‘188 SEQ ID NOS: 2, 26 and 27 are identical to instant SEQ ID NOS: 73, 126 and 142, respectively (see SCORE).
USSN ‘803 recites an IL-10 fusion protein having comprising two chains at least 80% identical to SEQ ID NO: 25 and SEQ ID NO: 26 (claims 1, 8 and 13). USSN ‘803 SEQ ID NO: 25 is a fusion of IL-10 to anti-PD-L1 antibody heavy chain identical to instant SEQ ID NO: 161, and USSN ‘803 SEQ ID NO: 26 is identical to instant SEQ ID NO: 142 (see SCORE).
USSN ‘015 recites anti-PD-L1-IL-10 fusions wherein IL-10 comprises SEQ ID NO: 73 (identical to instant SEQ ID NO: 73 – see SCORE) (claims 1 and 21), and anti-PD-L1 antibody comprises a heavy chain of SEQ ID NO: 157 or 158 (identical to instant SEQ ID NOS: 158 and 159, respectively) and light chains of SEQ ID NO: 135 or 137 (identical to instant SEQ ID NOS: 136 and 138, respectively) (claims 26, 29, 31 and 33).
Claims 30-32 are included in the rejection for the same reasons as articulated in section 5 above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
7. Conclusion: no claim is allowed.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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