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 04/26/2024 is acknowledged.
Claims 21-42 are pending.
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 21-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 8735553.
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 the ‘553 patent, which are directed to the same anti-PD-1 antibody as recited in the instant claims.
Specifically, claim 1 of US ‘553 recites an anti-PD-1 antibody comprising CDRs 1-6 of SEQ ID NOS: 11, 32, 13, 34, 15 and 16, respectively, which are listed as the CDRs of antibody 317-4B6. SEQ ID NOS: 11, 13, 15 and 16 are identical to instant SEQ ID NOS: 31, 33, 35 and 36, respectively (see the Sequence Listing). Accordingly, claim 1 of US ‘553 recites an anti-PD-1 antibody comprising the same CDRs as recited in instant claims 21, 26 and 39. Claim 25 of US ‘553 recites an anti-PD-1 antibody comprising VH and VL of SEQ ID NOS: 24 and 26, respectively i.e. the same VH and VL as recited in instant claims 22, 27 and 40. Claim 32 of US ‘553 specifies that the antibody has an IgG4 heavy chain of SEQ ID NO: 88, as recited in instant claims 23-24, 28-29, and 41-42.
Claim 35 of US ‘553 is directed to a method comprising administering the antibody of claim 1 to a person determined to have cancer, i.e. to a method of treating cancer. Instant claims 30-42, which recite treating specific types of cancer, are included in the rejection because it was known to those skilled in the art that anti-PD-1 antibodies are useful for treating a broad variety of cancers.
5. Claims 21-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patents No. 11186637 and 11673951.
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 patents, which recite the same anti-PD-1 antibody as recited in the instant claims.
Specifically, claims 1-2 of US ‘637 and claims 1-3 of US ‘951 recite an anti-PD-1 antibody comprising the same amino acid sequences of all six CDRs, VH and VL as recited in instant claims. Claims 3-4 of US ‘637 and claims 8-9 of US ‘951 specify that the antibody has an IgG4 heavy chain of SEQ ID NO: 88, as recited in instant claims.
Instant claims 26-42, directed to methods of treating cancer, are included in the rejection because it was known to those skilled in the art that anti-PD-1 antibodies are useful for treating a broad variety of cancers.
6. Claims 21-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of the U.S. Patents No. 10864203, 11202782, 11203637, 11534431, 11597768, and 11786529.
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 the above patents, which are directed to methods of treating cancer which comprise administering the same anti-PD-1 antibody as recited in instant claims.
Specifically, the anti-PD-1 antibody is identified by amino acid sequences of the CDRs and/or variable regions (e.g. claims 1-2 of US 10864203; claims 1-3 of US 11202782; claims 1-2 of US 11534431; claims 1-2 of US 11597768; claim 1 of US 11786529) or by laboratory designation 317-4B6 (e.g. claims 23 and 27 of US 11203637), and has an IgG4 heavy chain of SEQ ID NO: 88 (e.g. claims 3-4 of US 10864203; claim 15 of US 11202782; claim 27 of US 11203637; claim 3 of US 11534431; claim 1 of US 11597768; claim 16 of US 11786529).
7. Claims 21-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 16/967840, published as US 20210040213.
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 USSN ‘840, which are directed to a method of treating cancer which comprises administering the same anti-PD-1 antibody as recited in instant claims.
Specifically, the anti-PD-1 antibody is identified by amino acid sequences of the CDRs and variable regions (claims 1 and 4) and has an IgG4 heavy chain of SEQ ID NO: 88 (claim 1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
8. The following US Patents and/or copending applications share a coinventor and/or an assignee with the present application, and disclose the subject matter of the present claims, but do not contain patented or currently pending claims which would anticipate or make obvious the presently claimed invention:
US Patents No. 9217034, 9834606, 9988450, 10519235, 11701357.
USSN 18/322542 (US 20230364096); USSN 18936922 (US 20250059277).
9. Conclusion: no claim is allowed.
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