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 08/06/2026 is acknowledged.
Claims 53-68 are pending.
3. Claim 1 is objected to because of the following informalities:
(a) apparently superfluous “(i)” between “wherein” and “the antibody,” and
(b) apparently omitted conjunction “and” between subclauses (iii) and(v).
Appropriate corrections or clarifications are required.
4. Claim 68 is objected to under 37 CFR 1.75 as being a duplicate of claim 67. 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 68 may have been intended to depend on claim 54, which dependence is provisionally assumed for examination purposes.
5. 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.
6. Claims 53-68 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 53 is indefinite, because the recitation of “ the antibody or antibody fragment” lacks proper antecedent basis in the preceding part of the claim, which recites an agonistic antibody but does not recite a fragment.
(ii) Claims 54-68 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.
7. 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.
8. Claims 53-68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 18911957 (published as US 20250263484), and USSN 18911982 (published as US 20250263485).
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 applications, which contain identical claims, and recite the same agonistic anti-VISTA antibodies as recited in instant claims, i.e. antibody INX904/VSTB103, SEQ ID NOS: 200-208, and antibody INX907/VSTB66, SEQ ID NOS: 500-508 (claims 120-121 and 130-131), and methods of suppressing T cell immunity in a subject with allergic, autoimmune or inflammatory disease comprising administering the antibody (claims 134-135).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
9. Claims 53-68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 17920445 (published as US 20230310634).
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 USSN ‘445, which recite a method of treating allergic, autoimmune or inflammatory condition comprising administering a conjugate of anti-VISTA antibody comprising CDRs or SEQ ID NOS: 200-205 (claims 65 and 88-90).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
10. Claims 53-68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 18271106 (published as US 20250108119).
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 USSN ‘106, which recite anti-VISTA antibodies comprising CDRs or SEQ ID NOS: 200-205, 380-385, 470-475 and 500-505 conjugated to an anti-inflammatory agent (claim 160, subclauses (i), (xi), (xxix), (xxxviii), and (xli)). A person of skill in the art would at once envisage suppression of T cell immunity and treatment of allergic, autoimmune or inflammatory conditions in view of an antibody conjugated to an anti-inflammatory agent.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
11. Claims 53-68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 19665072.
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 USSN ‘072, which are directed to a method of treating an allergic, autoimmune or inflammatory condition comprising administering an agonistic anti-VISTA antibody (claim 1), wherein the antibody comprises CRDs of SEQ ID NOS: 200-205, 380-385, 470-475 or 500-505 (claims 29-30).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
12. Claims 53-68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending applications USSN 18045525 (published as US 20240067719) and USSN 19193032 (published as US 20250346666).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the claims of each of USSN ‘525 and USSN ‘032 in view of Molloy et al. (US 20180079811).
Copending claims of each of the above applications are directed to anti-VISTA antibodies comprising the CDRs and/or VRs of the same amino acid sequence as the presently recited antibodies (claim 53 of USSN ‘525, and claims 120-121 or USSN ‘032). Molloy teaches that these antibodies are VISTA agonists capable of suppressing T cell immunity and can be used in treating allergic, autoimmune or inflammatory conditions (e.g. claims 32-33, 42 and 44). Based on these teachings, the presently claimed method would be obvious to a person of skill in the art in view of the claims of each of USSN ‘525 and USSN ‘032.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
13. The present application was filed on 05/15/2023 as a Divisional of USSN 15488351 issued on 05/16/2023 as US Patent No. 11649283, which claims the same anti-VITA antibodies as used in the presently claimed method.
During prosecution of USSN ‘351 a Requirement for Restriction/Election (dated 05/06/2019) was issued, and subsequently maintained, which set forth the claims directed to antibodies and the claims directed to methods of treatment using the 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 ‘283 patent.
14. The following US Patents 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 claims which would anticipate or make obvious the presently claimed invention: US 11525000, US 11603402, US 11603403, and US 12139532.
15. Conclusion: no claim is allowed.
16. 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 9 AM - 5:30 PM.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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