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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 4/6/2026 is acknowledged.
Accordingly, claims 23, 24, 26-31, 33, 35, 37,41 43-46 are withdrawn from consideration for being directed to non-elected subject matter. Claims 9-11 and 13 are currently under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/30/2022 has been considered by the examiner.
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 9-11 and 13 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.
Regarding claim 9, the term “derivative” recited in the context of the claim renders the claim indefinite because it is unclear what derivation product would meet the limitation of a CD28 or 4-1BBL polypeptide antibody derivative because the nature and number of derivative process is unclear. The specification does not set forth a definition for the structure and/or function of such “derivative.” As such, the metes and bounds of the claim cannot be established.
Claims 10, 11 and 13 are rejected for same reason because they depend on claim 9 and does not remedy such deficiency.
Regarding claim 11, the term “targeting moiety” on line 3 renders the claim indefinite because it is unclear whether it is referring to targeting domain that targets a portion of a myc epitope, the CD28 or 4-1BBL polypeptide antibody, or a different targeting moiety not recited in claim 9.
Claim Rejections - 35 USC § 103
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.
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.
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.
Claim(s) 9-11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kershaw (US 11,866,504), in view of de Ines (Cancer Gene Therapy, 2000, Vol.7, No.9, pages 1257-1262).
Kershaw teaches a bispecific polypeptide comprising a first binding domain and a second binding domain, wherein the first binding domain that binds an antigen expressed on an antigen presenting cell (APC), and the second binding domain is an antibody or fragment thereof that binds to an antigen on an immune cell that expresses a chimeric antigen receptor (CAR) (2nd col., lines 54-62). Kershaw teaches the bispecific polypeptide is a tandem single chain variable fragment antibody having a first scFv and a second scFv (col., 62-64). Kershaw teaches the antigen can be a tag of a CAR or a region of CAR that is not a tag (col.10, lines 46-53). Kershaw gives examples of the tags presents on CARs including Myc-tag (col.10, line 38-39). Kershaw teaches the second binding domain may also bind to an antigen on an immune cell that expresses a CAR including CD28 (col.43, lines 22-32).
However, Kershaw does not teach a fusion polypeptide that comprises both antibody to myc and CD28 or 4-1BBL.
De Ines teaches expressing a cell surface anti-c-myc single chain antibody binds to anti-CD28 scFv, and specifically activates T cell (abstract). De Ines teaches the activation of T cells during an immune response requires two stimulatory signals, a primary signal provided by TCR/CD3 complex and a second signal provided by costimulatory molecules such as CD28 (page 1257, 1st col., 1st paragraph). de Ines teaches anti-c-myc transfected cells loaded with anti-CD28 scFv in combination with anti-CD3 scFv-transfected cells stimulated T cell proliferation and induced tumor lysis in a synergistic manner, and this approach provides a general tool for the easy and effective ex vivo genetic improvement of cellular tumor vaccines with any c-myc-tagged protein for the treatment of human neoplasia (page 1257, 2nd col., 2nd paragraph).
It would have been obvious to an ordinary skilled in the art that the fusion polypeptide antibody taught by Kershaw would benefit from the addition of an anti-CD28 or anti 4-1BBL antibody because the T cell activation requires co-stimulatory signal that may be provided with anti-CD28 scFv as taught by de Ines. Since Kershaw teaches the bispecific polypeptide is used to bind an antigen on APC and an antigen on the CAR expressed by immune cell in vivo to stimulate activation and expansion of the immune cell for the treatment of cancer, the ordinary skilled in the art would be motivated to include an additional anti-CD28 or anti 4-1BBL scFv to activate and expand the CAR-T cell. The ordinary skilled in the art would have reasonable expectation of success to make a fusion polypeptide that comprises anti-myc scFv and anti-CD28 or anti 4-1BBL scFv following combined teaching from Kershaw and de Ines. Therefore, the claimed invention of claim 9 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Regarding claim 10, Kershaw teaches the bispecific fusion polypeptide and pharmaceutically acceptable excipient/carrier (col.22, lines 62-67).
Regarding claim 11, Kershaw teaches formulating the CAR expressing immune cell and the bispecific fusion polypeptide in the same composition (col.24, line 49-53).
Regarding claim 13, Kershaw teaches said composition is used for treatment of cancer (col.24, line 39-48).
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CELINE X QIAN whose telephone number is (571)272-0777. The examiner can normally be reached M-F (8-4:00).
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/CELINE X QIAN/ Primary Examiner, Art Unit 1637
