DETAILED ACTION
Applicants claim amendments filed 1/19/2024 is acknowledged and entered into the record.
Accordingly, Claims 1-16 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 § 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.
Claim(s) 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by June et al. (PgPub 2019/0367610, cited on IDS filed 1/19/2024).
The claims are drawn to a chimeric antigen receptor (CAR) comprising an extracellular domain (extracellular binding domain) comprising an antigen-binding domain; a transmembrane domain; and as an intracellular signaling domain comprising an intracellular domain of the receptor comprising a death domain. The claims are further drawn to a polynucleotide comprising a base sequence encoding said CAR, an expression vector comprising said polynucleotide and an immune cell expressing said CAR and a second CAR targeting an antigen expressed in a cancer cell and a method of treatment comprising administering said immune cell to a subject in need thereof.
June et al. teach chimeric antigen receptors (CAR) comprising an extracellular domain, a transmembrane domain and an intracellular domain, also referred to as a cytoplasmic domain. June et al. disclose the extracellular domain includes a CD8a hinge domain and a spacer domain (see paragraphs [0093], [0094, [0096]) and the transmembrane domain is derived from the α, β, or ζ chain of a T-cell receptor, CD28, CD3 epsilon, or CD45 (see paragraph [0107]). June et al. teach the extracellular domain contains an antigen targeting domain targeting tumor-associated antigens (TAA) which is not unique to a tumor cell and instead is also expressed on a normal cell (see paragraph [0101]). June et al. disclose several target antigens, however the preferred antigen binding domain portion of the CAR targets include EGFRvIII (see paragraph [0102]). June et al. teach the cytoplasmic domain of the CAR comprises a death domain of receptors such as TNFR1, p75NTR, DR3, DR4/TrailR1, DR5/TrailR2, and DR6 (see paragraph [0122]-[0126]). June et. disclose a single chain variable fragment (scFv) as the antigen binding domain (see paragraphs [0028] and [0117]). June et al. further disclose the feature wherein the T-cell expresses a plurality of CARs, and the plurality of CARs comprise an extracellular domain comprising antigen-binding domains that bind to different types of antigens (such as HER2), a transmembrane domain, and a cytoplasmic domain (see paragraphs [0019], [0096], [0105], [0117]). June et al. discloses a dual CAR where a T-cell is genetically modified to express an inhibitory CAR and a therapeutic tumor directed CAR and methods of treatment comprising administering the CAR to a subject in need thereof, (see paragraphs [0018] and [0039]). June et al. teach each and every limitation of the instant claims.
Conclusion
Claims 1-16 are rejected.
No Claim is allowed.
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/Meera Natarajan/Primary Examiner, Art Unit 1643
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