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 .
Election/Restrictions
Applicant's reply to the Restriction Requirement, dated January 15, 2026, has been received. By way of this reply, Applicant has elected, with traverse, Group I: claims 27-40 and 46.
Applicant's election with traverse of Group I in the reply filed on January 15, 2026 is acknowledged. The traversal is on the ground(s) that search and examination of all recited species can be made without serious burden. This is not found persuasive for reasons stated in the previous Restriction Requirement, mailed December 3, 2025.
Should Applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, Applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the Examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
The requirement is still deemed proper and is therefore made FINAL.
Claims 41-45 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on January 15, 2026.
Claims 27-40 and 46 are under examination before the Office.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at page 23. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 27-32, 37-40 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu (WO2020200210A1, cited in IDS, paragraph numbers reflect corresponding US publication US20220002418A1), in view of Zheng (WO2017020291A1, cited in IDS) and Baca (US20030190317A1).
Zhu teaches a bispecific antibody, comprising an anti-PD-L1 antibody or element, and an anti-VEGF antibody or element linked to the anti-PD-L1 antibody or element (claim 1 and para. 0009-0010).
Zhu further teaches that the anti-PD-L1 antibody or element may be linked to the initiation terminal (i.e., the N-terminus) of the heavy chain variable region of the anti-VEGF antibody (para. 0017).
Zhu further teaches the use of the linker element GGGGS to connect the two elements (para. 0043), which is pertinent to claims 31-32.
Zhu further teaches nucleic acids and expression vectors encoding the above bispecific antibody, which may be used to transform suitable host cells (para. 0214-0221), which is pertinent to claims 37-39.
Zhu further teaches pharmaceutical compositions comprising the above bispecific antibody and a pharmaceutically acceptable carrier (para. 0231), which is pertinent to claim 40.
Zhu further teaches that bispecific antibodies may comprise an Fc region (para. 0117).
However, Zhu does not teach the claimed complementarity determining regions (CDRs).
Zheng teaches an anti-PD-L1 antibody with heavy and light chains of SEQ ID NOs: 47 and 49, which are identical to Applicant's SEQ ID NO: 13 and 14, and also comprise the CDRs of SEQ ID NOs: 1-6 recited in claim 1 (para. 0016), which is pertinent to claims 27 and 29.
Zheng further teaches kits comprising the above antibody (para. 0026), which is pertinent to claim 46.
Zheng further teaches that the anti-PD-L1 antibody may be in the form of an scFv (para. 0021), which is pertinent to claim 28.
Baca teaches an anti-VEGF antibody with heavy and light chains of SEQ ID NOs: 7 and 8, which are identical to Applicant's SEQ ID NO: 15 and 16, and also comprise the CDRs of SEQ ID NOs: 7-12 recited in claim 1 (claim 11), which is pertinent to claims 27 and 29.
Baca further teaches kits comprising the above antibody (para. 0018), which is pertinent to claim 46.
Baca further teaches that the anti-VEGF antibody may be in the form of an Fab (para. 0017), which is pertinent to claim 28.
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Zhu, Zheng, and Baca to arrive at the claimed invention. The base device of a generic bispecific antibody that binds PD-L1 and VEGF is taught by Zhu. Zhu differs from the current invention by the specific sequences of the antigen-binding regions. These sequences are taught by Zheng and Baca, respectively. One of ordinary skill in the art could have applied the sequences of Zheng and Baca to the bispecific antibody of Zhu by simple substitution, with each component of the combination performing its known, usual function, and the combination would yield nothing more than predictable results.
Claims 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu, Zheng, and Baca as applied to claim 27 above, and further in view of Bardoff (US20190002589A1) and Lu (J Immunol Methods. 2002 Sep 15;267(2):213-26).
The teachings of Zhu, Zheng, and Baca have been discussed supra. However, Zhu, Zheng, and Baca do not teach the claimed arrangement of subunits or human IgG1 Fc that comprises L234A and L235A.
Bardroff teaches the use of a human IgG1 Fc in a bispecific antibody (para. 0016). Bardroff further teaches that it is useful to use a mutant variant of IgG1 Fc which reduces or eliminates the ability of the fusion polypeptide to mediate antibody dependent cellular cytotoxicity (ADCC) and/or to bind to an Fcγ receptor, such as a mutant with L234A and L235A mutations (para. 0142).
Lu teaches a Fab-scFv fusion protein, wherein an scFv is fused to the C-terminus of the first constant domain of a Fab fragment of a second antibody (page 214, right column, first paragraph).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Zhu, Zheng, Baca, Bardroff, and Lu to arrive at the claimed invention. Starting from the base device of Zhu, Zheng, and Baca, Bardoff and Lu teach additional features in the context of a bispecific antibody. Additionally, Zhu further teaches that the anti-PD-L1 antibody or element may be linked to the initiation terminal (i.e., the N-terminus) of the heavy chain variable region of the anti-VEGF antibody (para. 0017). From this teaching of Zhu, the skilled artisan could apply this configuration to the scFv-Fab fusion taught by Lu to arrive at the claimed composition. Each component of the combination would perform its known, usual function, and the combination would yield nothing more than predictable results.
Allowable Subject Matter
Claim 36 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The sequence of SEQ ID NO: 17 has been searched and found free of the art.
Conclusion
No claim is allowed.
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/PETER JOHANSEN/Examiner, Art Unit 1644