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 08/11/2023 is acknowledged.
Claims 9-10, 19-20, 24-32 and 36-48 are pending.
3. The Specification and the Drawings filed on 09/12/2023 are objected to for failing to comply with 37 CFR 1.821(d), because the sequences disclosed in the Drawings are not accompanied by SEQ ID Numbers, either in the Drawings or in the Brief Description of the Drawings (see 37 CFR 1.821-1.825). Applicant must comply with the requirements of the sequence rules (37 CFR 1.821 - 1.825) in response to this Office Action.
4. Claim 27 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, claim 27, and claim 28 dependent thereon, have not been further treated on the merits.
5. It appears that claim 19 may contain a typographical error in the recitation “from the light chain variable region CDR1, and CDR3 sequences of SEQ ID NO: 30,” where it appears that “from the light chain variable region CDR1, CDR2, and CDR3 sequences of SEQ ID NO: 30” may have been intended. The latter interpretation is provisionally assumed for the purposes of the present office action. Appropriate clarification or correction is required.
6. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
7. Claims 10, 19 and 30 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i) Claims 10 and 19 are indefinite in the use of the term “preferably,” because it is unclear whether or not the preferred embodiments constitute claim limitations. Description of examples or preferences is properly set forth in the specification rather than the claims.
(ii) Claim 30 is indefinite in the recitation of a nucleic acid molecule or “functional equivalent” thereof, because it is unknown what function(s) are within the scope of the claim, and what are the criteria to define their “equivalence.” Further, the recitation lacks proper antecedent basis in the base claim.
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.
8. 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.
9. Claims 9-10, 19-20, 24-26, 29-32 and 36-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11667714.
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 ‘714, which recite the same anti-PD-1 antibodies as presently claimed.
Specifically, US ‘714 recites anti-PD-1 antibodies comprising the CDRs of the heavy chain variable region of SEQ ID NO: 38-48 (claim 1), which are identical to instant SEQ ID NOS: 57, 56, 55, 54, 52, 52, 47, 49, 50, 51, and 48, respectively (see SCORE)
US ‘714 further recites (claim 12) that the antibody comprises a light chain variable region amino acid sequence of SEQ ID NO: 6, comprising CDR1 sequence QSISSY (SEQ ID NO:70), CDR2 sequence AAS, and CDR3 sequence QQSYSTPPT (SEQ ID NO:71). The claim contains a typographical error, because SEQ ID NO: 6 is a nucleotide sequence (see the Sequence Listing) rather than an amino acid sequence. SEQ ID NO: 6 encodes the amino acid sequence or SEQ ID NO: 7, which is the light chain variable region of the antibody, and comprises CDR1 sequence QSISSY (SEQ ID NO:70), CDR2 sequence AAS, and CDR3 sequence QQSYSTPPT (SEQ ID NO:71) (see the Sequence Listing). SEQ ID NO: 7 of US ‘714 is identical to instant SEQ ID NO: 30 (see SCORE).
US ‘714 further recites method for treating a cancer or an infection with a pathogen comprising administering to a subject in need thereof a therapeutically effective amount of the anti-PD-1 antibody (claim 16). Accordingly, the claims of US ‘714 recite all of the limitations of the instant claims.
10. Claims 9-10, 19-20, 24-26, 29-32 and 36-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11753470.
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 ‘470, which recite the same anti-PD-1 antibodies as presently claimed.
Specifically, US ‘470 recites anti-PD-1 antibodies comprising the CDRs of the heavy chain variable region of SEQ ID NO: 43-53 (claim 1), which are identical to instant SEQ ID NOS: 47-57, respectively (see SCORE). The antibody comprises a light chain variable region of SEQ ID NO:26 (claim 8), which is identical to instant SEQ ID NO: 30 (see SCORE). US ‘470 further recites a pharmaceutical composition comprising the antibody (claim 10), indicating that the antibody is intended for pharmaceutical use. A person of skill in the art would have at once envisaged a method of treating cancer, because anti-PD-1 antibodies were known to be useful for cancer treatment before the effective filing date of the claimed invention.
11. Claims 9-10, 19-20, 24-26, 29-32 and 36-48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 18/062871, published as US 20240034794.
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 the copending application, which recite the same anti-PD-1 antibodies as presently claimed.
USSN ‘871 is a divisional of USSN 16/628547, issued as US Patent No. 11667714 described in section 9 above.
USSN ‘871 recites a method of enhancing T cell mediated anti-tumor response in vivo by an anti-PD-1 antibody (claims 37, 53 and 59), wherein the anti-PD-1 antibody comprises the CDRs of the heavy chain variable region of SEQ ID NO: 38-48 (claims 61-63), which are identical to instant SEQ ID NOS: 57, 56, 55, 54, 52, 52, 47, 49, 50, 51, and 48, respectively (see SCORE).
The anti-PD-1 antibody further comprises a light chain variable region amino acid sequence of SEQ ID NO: 6, comprising CDR1 sequence QSISSY (SEQ ID NO:70), CDR2 sequence AAS, and CDR3 sequence QQSYSTPPT (SEQ ID NO:71) (claims 67-68), which is the same as instant SEQ ID NO: 30, as explained in section 9 above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
12. Claims 9-10, 19-20, 24-26, 29-32 and 36-48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending applications USSN 18/359660, published as US 20230357407.
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 the copending application, which recite the same anti-PD-1 antibodies as presently claimed.
USSN ‘660 is a divisional of USSN 16/628937, issued as US Patent No. 11753470 described in section 10 above.
Claim 32 of USSN ‘660 recites a method for treating a cancer or an infection with a pathogen comprising administering to a subject in need thereof a therapeutically effective amount of an anti-PD-1 antibody comprising the CDRs of the heavy chain variable region of SEQ ID NO: 43-53, which are identical to instant SEQ ID NOS: 47-57, respectively (see SCORE), and a light chain variable region of SEQ ID NO:26, which is identical to instant SEQ ID NO: 30 (see SCORE).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
13. The following is noted regarding additional potential issues of nonstatutory double patenting: the present application was filed on 04/27/2023 as a Divisional of USSN 16/628939, issued on 08/22/2023 as US Patent No. 11732043, which claims bispecific anti-PD-1/anti-LAG3 antibodies which comprise the same CDRs as the anti-PD-1 antibodies of the instant claims.
During prosecution of USSN ‘939 a Requirement for Restriction/Election was issued (dated 05/02/2022), and subsequently maintained, which set forth the claims directed to bispecific antibodies and the claims directed to monospecific anti-PD-1 antibodies as separate groups.
The third sentence of 35 U.S.C. 121 prohibits the use of a patent issuing on an application in which a requirement for restriction has been made, or on an application filed as a result of such a requirement, as a reference against any divisional application in a nonstatutory double patenting rejection, if the divisional application is filed before the issuance of the patent.
Accordingly, the instant claims are not subject to the grounds of nonstatutory double patenting rejection over the claims of the ‘043 patent.
14. Conclusion: no claim is allowed.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644