DETAILED ACTION
Applicants claim amendments filed 11/27/2026 are acknowledged and entered into the record.
Accordingly, Claims 83-98 are pending and will be examined on the merits.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 85-86, 88-89 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In particular, the claims reference numerous figures. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim, in this case reciting a specific SEQ ID NO depicted in the figures. Incorporation by reference is a necessity doctrine, not for applicant's convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). Appropriate correction is requested.
Claims 88-89 recite “variant thereof”. It is unclear the metes and bounds of the phrase. What specific mutations, substitutions, or deletions encompass a “variant”? Specific mutations with the CDRs regions of an antibody can affect antigen binding.
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.
Claims 83-98 are rejected under 35 U.S.C. 103 as being unpatentable over Xiao et al. (WO/2023/236099) in view of Rashid et al. (WO/2020/180726, cited on IDS filed 1/15/2025) and Desjarlais et al. (WO/2022/040482, cited on IDS filed 1/15/2025).
The claims are drawn to a bispecific antibody which binds to ENPP3 and CD28. The claims are further drawn to specific VH and VL sequences (depicted in the instant figures) for targeting each antigen. The claims are further drawn to a nucleic acid encoding said bispecific antibody, a vector comprising said nucleic acid and a host cell comprising said vector and a method of making said bispecific antibody comprising culturing said host cell.
Xiao et al. teach bispecific antibodies targeting ENPP3 and a T-cell antigen such as CD28 (see paragraph [0012] and Claim 13). Xiao et al. teach bispecific antibodies targeting a tumor antigen and a t-cell antigen can simultaneously bind to a tumor antigen and a T cell antigen causing aggregation and activation of T cells, eventually leading to the killing of tumor cells. Xiao et al. teach nucleic acids, vectors, and host cells used to make the bispecific antibodies targeting ENPP3 and CD28. Xiao et al. does not teach the instantly claimed SEQ ID NOs for VH/VL for either the ENPP3 targeting or CD28 targeting. This deficiency is made up for by Rashid et al. and Desjarlais et al.
Rashid et al. teach bispecific antibodies targeting ENPP3 and the T-cell antigen CD3 having a 1+1 Fab-scFv-Fc format (ex. 2, fig. 15a). Rashid et al. teach 100% identity to the VH/VL sequences for an anti-ENPP3 antibody according to figure 22 of the instant application.
Desjarlais et al. teach bispecific antibodies targeting a tumor associated antigen (TAA) and CD28 in a 1+1 Fab-scFv-Fc format (see ex. 3, fig. 34a). The scFv may be in a VL/VH or VL/VH configuration (see paragraph [0028]). Desjarlais et al. teach 100% identity to the VH/VL sequences for the anti-CD28 antibody according to figure 21 of the instant application.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make a bispecific antibody targeting ENP33 and CD28 as taught by Xiao et al. using the antibody sequences taught by Rashid et al. and Desjarlais et al. One of ordinary skill in the art would have been motivated to do so because Xiao et al. teach bispecific antibodies targeting a tumor antigen, such as ENPP3, and a T-cell antigen, such as CD28, can cause aggregation and activation of T cells, eventually leading to the killing of tumor cells and Rashid et al. and Desjarlais et al. teach anti-ENPP3 and CD28 antibody sequences that were successful in targeting and binding to the antigens. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success to make and use a bispecific antibody targeting ENP33 and CD28 for therapeutic use in the killing of tumor cells.
Conclusion
Claims 83-98 are rejected.
No Claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEERA NATARAJAN whose telephone number is (571)270-3058. The examiner can normally be reached M-F 9AM - 5PM.
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/Meera Natarajan/Primary Examiner, Art Unit 1643
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