DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Restriction/Election
Applicant’s election without traverse of Group I, drawn to an anti-VISTA antibody or antigen-binding portion thereof and corresponding to claims 1-16 in the reply filed 12/30/2025 is acknowledged.
Applicant has further elected examination of the following species:
HCDR1 comprising SEQ ID NO: 64;
HCDR2 comprising SEQ ID NO: 65;
HCDR3 comprising SEQ ID NO: 66;
LCDR1 comprising SEQ ID NO: 57;
LCDR2 comprising SEQ ID NO: 67;
LCDR3 comprising SEQ ID NO: 68;
VH comprises SEQ ID NO: 5; and
VL comprises SEQ ID NO: 6.
Claim Status
Claims 1-35 are pending. Claims 17-35 are withdrawn for being directed to non-elected inventions.
Claims 1-16 are under examination.
Improper Markush Rejection
Claims 1-16 are rejected on the basis that they contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of the anti-VISTA antibodies is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: The 29 claimed antibodies include 8 different parental antibodies and antibodies optimized from the 8 parents. The antibody CDRs as listed in Tables 1-29 have a high degree of variability between antibodies of different parents, seen for example in their HDCR3 sequences.
As the claims are directed to antibodies derived from eight different parental antibodies and there is no single structural similarity between all of the antibodies claimed, the Markush grouping is improper.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 3 discloses that the antibody or antigen-binding fragment is human or chimeric. Claim 3 requires the CDR regions of claim 1, which are fully human CDRs (Specification, Pg. 73, Example 1) and thus cannot be chimeric, which entails non-human variable regions.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 8-11, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of copending Application No. 19/507,455 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending application discloses a method comprising administering the antibody (clone name SNS-101) claimed in the instant application.
Regarding instant claims 1-3 and 10-11, pertaining to the anti-VISTA antibody of the instant invention, ‘455 claims 1, 2, 5, 8, and 10 disclose the antibody of the instant invention with identical heavy and light chains as shown below:
Antibody SNS-101
Instant
19/507,455
VH
CDR1 SEQ ID NO: 64
CDR2 SEQ ID NO: 65
CDR3 SEQ ID NO: 66
VH SEQ ID NO: 5
CDR1 SEQ ID NO: 2
CDR2 SEQ ID NO: 3
CDR3 SEQ ID NO: 4
VH SEQ ID NO:1
VL
CDR1 SEQ ID NO: 57
CDR2 SEQ ID NO: 67
CDR3 SEQ ID NO: 68
VL SEQ ID NO: 6
CDR1 SEQ ID NO: 6
CDR2 SEQ ID NO: 7
CDR3 SEQ ID NO: 8
VL SEQ ID NO:5
Regarding instant claims 4-6 and 8-9, pertaining to the immunoglobulin constant region of the instant invention, ‘455 claims 11 and 33 disclose the anti-VISTA antibody comprises a human IgG1 constant region.
Regarding instant claim 16, pertaining to a pharmaceutical composition comprising the antibody and a pharmaceutically acceptable carrier, ‘455 claims 12 and 31 disclose the anti-VISTA antibody in a pharmaceutical composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of copending Application No. 19/507,455 as applied to claims 1-6, 8-11, and 16 above and further in view of Johnston (US12,173,069B2, published 12/24/2024, effectively filed 03/21/2018).
Co-pending application ‘455 does not disclose: (1) the immunoglobulin constant region of the anti-VISTA antibody is immunologically inert (claim 7), (2) the anti-VISTA antibody is bispecific (claims 12-13) or (3) an immunoconjugate comprising the anti-VISTA antibody linked to a therapeutic agent.
These deficiencies are taught by Johnston.
The disclosure of Johnston is directed to antibodies that bind VISTA at acidic pH and their use in cancer treatment (see Abstract).
Regarding instant claim 7, wherein the immunoglobulin constant region is immunologically inert, Johnston teaches the antibody may be modified with an Fc region that has essentially no effector function, defined by reduced binding to FcγR and reduced complement fixation. The exemplary effectorless IgG1 Fc comprises the mutations L234A, L235E, G237A, A330S, and P331S (Pg. 132, Column 123, Lines 29-33).
Regarding instant claims 12-13, wherein the anti-VISTA antibody is bispecific, Johnston claim 26 discloses the antibody is bispecific or multispecific (Pg. 214, Column 288).
Regarding instant claims 14-15, pertaining to an immunoconjugate comprising the anti-VISTA antibody linked to a therapeutic agent, Johnston claim 28 discloses the antibody is an antibody drug conjugate (Pg. 214, Column 288). As an exemplary therapeutic agent, Johnston teaches the anti-VISTA antibody as part of an ADC linked to cytotoxic tubulysin through binding anti-IgG secondary antibody (Pg. 145, Column 149 and Fig. 6).
It would have been prima facie obvious to one having ordinary skill in the art at the time of filing to modify the anti-VISTA antibody of co-pending ‘455 by (1) using an immunologically inert constant region, (2) formulating the anti-VISTA antibody in a bispecific format, and (3) formulating the anti-VISTA antibody in an immunoconjugate linked to a therapeutic agent. One would have been motivated to do so because Johnston teaches the use of anti-VISTA antibodies modified using well-known methodologies proven to improve the therapeutic efficacy and safety of the antibodies. There would be an expectation of success in modifying the anti-VISTA antibody of co-pending ‘455 with the teachings of Johnston because Johnston teaches antibody modifications and formats that were all commonly practiced at the time of filing and applied to many antibodies used in anti-cancer therapy.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROL ANN CHASE whose telephone number is (571)270-0934. The examiner can normally be reached Monday-Friday 9:00am-6:00pm.
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/CAROL ANN CHASE/Examiner, Art Unit 1646
/HONG SANG/Primary Examiner, Art Unit 1646