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 .
Applicant's response to the previous Office action, dated June 12, 2026, has been received. By way of this submission, Applicant has amended the specification and claims 27, 29 and 32, and cancelled claims 28, 30, and 31.
Claims 27, 29 and 32-46 are pending in the application. Claims 41-45 remain withdrawn from consideration, pursuant to the Restriction Requirement mailed December 3, 2025.
Claims 27, 29, 32-40, and 46 are therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated March 18, 2026.
Specification
The specification was previously objected to due to the presence of embedded hyperlinks and/or other form of browser-executable code.
Applicant's amendment to the specification has addressed this issue, and this objection is hereby withdrawn.
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).
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).
Applicant argues that the structure of the antibody recited in the claims as amended is markedly superior to bispecific antibodies composed of the same antibody CDR sequences but adopting other structural formats in terms of antibody purity, expression yield, thermostability, antigen binding affinity, shows comparable antigen binding affinity and specificity with the parental antibody. Applicant argues that the structure of the antibody recited in claim 27 would not be obvious to a person skilled in the art, given that multiple choices are available in the construction of bispecific antibodies, and Zhu does not teach how to select from known antibodies, nor does Zhu teach using an anti-PD-L1 antibody in the form of scFv and an anti-VEGF antibody in the form of Fab to construct a bispecific antibody. Applicant further argues that the bispecific antibody of the present application has significantly improved anti-tumor efficacy compared to the combination of monospecific anti-PD-L1 antibody (Atezolizumab) and the monospecific anti-VEGF antibody (Bevacizumab, i.e. Avastin).
Applicant's arguments have been considered fully but are not found to be persuasive.
As stated previously, Zheng teaches that the anti-PD-L1 antibody may be in the form of an scFv (para. 0021). Baca teaches that the anti-VEGF antibody may be in the form of a Fab (para. 0017). Zhu 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). The arrangement of the components of the bispecific antibody and the form of each antigen-binding domain are taught by the prior art. This is motivation to select these formats.
Zhu is explicit that an anti-PD-L1 and anti-VEGF bispecific antibody is useful for treating tumors (i.e., cancer) (claim 11). Zhu also teaches that expression levels and stability are known problems in the art of bispecific antibody engineering (para. 0005 and Figure 4, also see para. 0236-0239).
The cited references describe a finite number of identified, predictable potential solutions to the recognized need or problem; for example, the structures of the antibodies described in Zheng and Baca above.
Applicant's experiments described in their Remarks appear to be nothing more than routine optimization for known result effective variables. "[A] person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). MPEP 2143(I)(E).
The "hypothetical 'person having ordinary skill in the art' to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art." Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). MPEP 2141.03(I).
The function of an anti-PD-L1 and anti-VEGF bispecific antibody is clearly taught by Zhu.
Applicant's claimed invention appears to be nothing more than a combination of known components of a bispecific antibody, selected from a finite number of identified, predictable solutions, with each component performing its known, predicted function, and with a reasonable expectation of success. The cited prior art offers guidance as to both the function of each component of the bispecific antibody, as well as how they may be assembled. The routine optimization for known result effective variables such as antibody yield and stability is motivation for a person of ordinary skill in the art to experiment to reach an optimal result. MPEP 2144.05(II). One of ordinary skill could therefore have arrived at the claimed invention through nothing more than routine optimization, selected from a known, finite list of possible combinations.
The above rejections are therefore maintained.
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.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 7:00 to 3:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PETER JOHANSEN/Examiner, Art Unit 1644
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
Prosecution Insights