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 .
Applicants’ preliminary amendment filed on February 2, 2025 is acknowledged. Claims 1-8, 10-15, 22, 24-27 and 35 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 7, 2025, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-5, 7, 10-15, 24-27 and 35 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Milone et al. (US Patent Application Publication 20140322183).
Regarding Claims 1, 7, 10-15, 24-27 and 35. Milone discloses a nucleic acid molecule encoding an anti-target CAR (chimeric antigen receptor) polypeptide, wherein the encoded anti-target CAR polypeptide comprising an extracellular ligand that binds to a target CAR polypeptide, a transmembrane domain and an intracellular signaling domain comprising a stimulatory domain (see Figure 1, paragraphs [0104-0113], and claims 67-70).
Regarding Claim 11 and 12. Milone discloses a cell and a vector comprising the nucleic acid molecule and a method of making the cell comprising transducing a T cell with the nucleic acid (see claims 106, 144 and 148).
Regarding present claims 11-12, 25 and 26. Milone discloses a cell comprising anti-CAR polypeptide (see columns 15-17).
Regarding present claims 27 and 35. Milone discloses a method comprising: (a) culturing a population of cytotoxic lymphocytes under conditions promoting activation; (b) transfecting the lymphocyte population of (a) with a vector encoding a chimeric antigen receptor (CAR), wherein the CAR is a fusion protein comprising a recognition region, a co-stimulation domain and an activation signaling domain; (c) administering a therapeutically effective number of the transfected lymphocytes of (b) to a subject having cancer; and (d) administering a small conjugate molecule (SCM) comprising a targeted moiety conjugated to a tumor receptor ligand to the subject, wherein the ligand is recognized and bound by a receptor on the surface of a cell of the cancer, and wherein the CAR has binding specificity for the targeted moiety or can be bound by the targeted moiety; thereby treating cancer in a subject (see columns 20-25).
Thus, by this disclosure Milone anticipates the present claims.
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 2, 8, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Milone et al. (US Patent Application Publication 20140322183) in view of Rotolo et al. (Leuk Lymphoma, 2018, p. 2040-2055 in IDS on 2/7/2025).
Milone et al. teaches the claimed invention as discussed above. He does not teach wherein the target CAR polypeptide is CD33 BCMACAR (CD269) polypeptide.
Rotolo et al. teach anti-CAR nucleic acid molecules wherein the target CAR polypeptide is CD33 BCMACAR (CD269) polypeptide (see page 5).
Regarding claims 8 and 22. It would have been prima facie obvious to provide Milone’s anti-CAR nuclei acid comprising Rotolo et al. anti-CAR nucleic acid molecules wherein the target CAR polypeptide is CD33 or BCMACAR (CD269) polypeptide because Rotolo et al. teach that the B-cell maturation antigen (BCMA) together with CD19 are promising cancer target antigens because, in contrast to CD138, CD38 and CD56, which are expressed on healthy and malignant plasma cells, BCMA is expressed primarily on tumor cells (see page 5, Figure 1).
Regarding claims 2-6. It would have been prima facie obvious to provide Milone’s anti-CAR nuclei acid, wherein the ligand comprises a cognate antigen molecule or an anti-idiotypic antibody molecule molecule that binds to the target CAR polypeptide.
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Pertinent references
Jena et al., (PLOS One, 2013, p. 1-12 in IDS on 2/7/2025) discloses a nucleic acid molecule encoding an anti-target CAR (chimeric antigen receptor) polypeptide, wherein the encoded anti-target CAR polypeptide comprising an extracellular ligand that binds to a target CAR polypeptide, a transmembrane domain and an intracellular signaling domain comprising a stimulatory domain, wherein the target polypeptide is a CD19CAR polypeptide and wherein the ligand comprises an anti-idiotypic antibody (see Results and Discussion). Jena discloses a cell and a vector comprising the nucleic acid molecule and a method of making the cell comprising transducing a T cell with the nucleic acid (see Materials and Methods).
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
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