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 09/12/2025 is acknowledged.
Claims 57-64 are pending.
3. Claim 63 is objected to under 37 CFR 1.75 as being a duplicate of claim 62. When two claims in an application are duplicates (or else are so close in content that they both cover the same thing, despite a slight difference in wording), it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k).
It appears that claim 63 may contain a typographical error, wherein “LCVR” rather than “HCVR” was intended. The former interpretation is provisionally assumed for the purposes of the present office action. Appropriate correction or clarification is required.
4. 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.
5. Claims 57-64 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) Claim 57 is indefinite as being in improper Markush format, in the recitation “no more than one of the LCDR1 sequence or LCDR3 sequence.” The Office recommends the use of the phrase "selected from the group consisting of ..." with the use of the conjunction "and" rather than "or" in listing the species. See MPEP 803.02.
(ii) Claims 58-64 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.
6. 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.
7. Claims 57-64 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patents No. 10358495 (cited on IDS) and 11692032.
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 US ‘495 and US ‘032, which recite the same anti-LAG3 antibody as instantly claimed.
The present application was filed as a continuation of USSN 16433263 (issued as US ‘032), which was filed as a continuation of USSN 15289032 (issued as US ‘495).
Claim 1 of US ‘495 recites an anti-LAG3 antibody comprising three heavy chain CDRs contained within HCVR amino acid sequence of SEQ ID NO: 418 and three light chain CDRs contained within LCVR amino acid sequence of SEQ ID NO: 426.
Claims 15-20 of US ‘032 recite polynucleotides of SEQ ID NOS: 417 and 425, encoding an HCVR and an LCVR, respectively, of an anti-LAG3 antibody; SEQ ID NOS: 417 and 425 encode instant SEQ ID NOS: 418 and 426, respectively, as evidenced by the Sequence Listing and Tables 1 and 2 of the specification.
8. Claims 57-64 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patents No. 10905784, 11511001, and 12230364 (all cited on IDS).
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-listed patents, which recite the same anti-LAG3 antibody as instantly claimed.
Specifically, US ‘784 (claim 1) and US ‘001 (claim 1) recite an anti-LAG3 antibody comprising three heavy chain CDRs contained within HCVR amino acid sequence of SEQ ID NO: 418 and three light chain CDRs contained within LCVR amino acid sequence of SEQ ID NO: 426. SEQ ID NOS: 418 and 426 of US ‘784 and US ‘001 are identical to instant SEQ ID NOS: 418 and 426, respectively (see SCORE).
US ‘364 recites an anti-LAG3 antibody comprising an HCVR of SEQ ID NO: 93 and an LCVR of SEQ ID NO: 94 (claims 1, 10 and 39), which are identical to instant SEQ ID NOS: 418 and 426, respectively (see SCORE).
9. Claims 57-64 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of the following copending applications:
USSN 18/049609 US PG Pub. No. 20230270894 (cited on IDS)
USSN 18/444124 US PG Pub. No. 20240299601
USSN 17/611073 US PG Pub. No. 20220249659
USSN 18/930913 US PG Pub. No. 20250179177
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-listed applications, which recite the same anti-LAG3 antibody as instantly claimed.
Specifically, USSN ‘609 (claim 42) and USSN ‘124 (claim 1) recite an anti-LAG3 antibody comprising three heavy chain CDRs contained within HCVR amino acid sequence of SEQ ID NO: 418 and three light chain CDRs contained within LCVR amino acid sequence of SEQ ID NO: 426. SEQ ID NOS: 418 and 426 of USSN ‘609 and USSN ‘124 are identical to instant SEQ ID NOS: 418 and 426, respectively (see SCORE).
USSN ‘073 (claim 35) recites an anti-LAG3 antibody comprising an HCVR of SEQ ID NO: 11 and an LCVR of SEQ ID NO: 12, which are identical to instant SEQ ID NOS: 418 and 426, respectively (see SCORE).
USSN ‘913 (claim 1) recites an anti-LAG3 antibody comprising an HCVR of SEQ ID NO: 1 and an LCVR of SEQ ID NO: 2, which are identical to instant SEQ ID NOS: 418 and 426, respectively (see SCORE).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
10. 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:
USSN US PG Pub. US Patent No.
16/135913 11640848
17/813122 20230051304
18/133288 20230357446
18/661554 20240376229
19/013207 20250218540
11. Conclusion: no claim is allowed.
12. 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.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644