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 (claims 1, 2, 6, 11, 12, 16, 21-23, 25, 27 and 107) in the reply filed on 09/01/2026 is acknowledged. Claims 1, 2, 6, 11, 12, 16, 21-23, 25, 27, 49-51, 64, 65, 67, 71, 75 and 107 are pending; claims 49-51, 64, 65, 67, 71 and 75 are withdrawn from prosecution for being drawn to non-elected subject matter. Claims 1, 2, 6, 11, 12, 16, 21-23, 25, 27 and 107 are examined.
Information Disclosure Statement
The information disclosure statements (IDS)s submitted on 12/29/2023 and 06/12/2026 were 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.
Claim 1 is rejected under 35 U.S.C. 102(1) as being anticipated by Cooper et al. (U.S. Pub. No. 20140349402-cited by Applicant).
The reference discloses methods and compositions for immunotherapy employing a modified T cell comprising disrupted T cell receptor and/or HLA and comprising a chimeric antigen receptor. In certain embodiments, the compositions are employed allogeneically as universal reagents for "off-the-shelf treatment of medical conditions such as cancer, autoimmunity, and infection (abstract). Also disclosed is an isolated T-cell population wherein cells of the population comprise an endogenous T-cell receptor coding sequence that is either not expressed or which encodes a nonfunctional T-cell receptor; and a recombinant chimeric antigen receptor comprising an intracellular signaling domain, a transmembrane domain, and an extracellular domain comprising an antigen binding region. In specific embodiments, the T-cell receptor is nonfunctional by virtue of one or more disruptions in the coding sequence of .alpha. chain, .beta. chain, or both. In some embodiments, the endogenous T-cell receptor is knocked out. In specific embodiments, the antigen binding region is an F(ab')2, Fab', Fab, Fv, or scFv and/or the antigen binding region binds a tumor associated antigen, such as CD19, CD20, ROR1, carcinoembryonic antigen, alphafetoprotein, CA-125, MUC-1, epithelial tumor antigen, melanoma-associated antigen, mutated p53, mutated ras, HER2/Neu, ERBB2, HER3, folate binding protein, HIV-1 envelope glycoprotein gp120, HIV-1 envelope glycoprotein gp41, GD2, CD123, CD23, CD30, CD56, c-Met, mesothelin, GD3, HERV-K, IL-11Ralpha, IL-13Ralpha2, kappa chain, or lambda chain, CSPG4 (also known as, high molecular weight melanoma associated antigen), EGFRvIII, and VEGFR2 ([0018]- claims 1-8).
Thus, in the broadest reasonable interpretation , claim 1 is anticipated by the reference cited.
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, 6, 11, 12, 16, 21-23, 25 and 107 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cooper et al. (U.S. Pub. No. 20140349402-cited by Applicant) in view of Gillies et al. (U.S. Pat No. 7,169,904).
The claims are drawn to an immune effector cell, comprising: a chimeric antigen receptor (CAR) targeting GD2, wherein functions of a T cell antigen receptor (TCR) and major histocompatibility complexes (MHCI, MHCII) in the immune effector cell are inhibited in a cell. The CAR comprises a targeting moiety comprising an antibody heavy chain variable region (VH) of SEQ ID NO: 8 and an antibody light chain variable region (VL) of SEQ ID NO: 16. The VH of SEQ ID NO: 8 comprises a HCDR1 set forth in SEQ ID NO: 1, a HCDR2 set forth in SEQ ID NO: 2, and a HCDR3 set forth in SEQ ID NO: 3, as well as an HFR1 as set forth in SEQ ID NO: 4, an HFR2 as set forth in SEQ ID NO: 5, an HFR3 as set forth in SEQ ID NO: 6, and an HFR4 set forth in SEQ ID NO: 7. The VL of SEQ ID NO: 16 comprises a LCDR1 set forth in SEQ ID NO: 9, a LCDR2 set forth in SEQ ID NO: 10, and a LCDR3 set forth in SEQ ID NO: 11, as well as an LFR1 as set forth in SEQ ID NO: 12, an LFR2 as set forth in SEQ ID NO: 13, an LFR3 as set forth in SEQ ID NO: 14, and an LFR4 set forth in SEQ ID NO: 15.
The teachings of Cooper et al. were presented supra and they differ from the instant Application in that the composition of a CAR is different.
Gillies et al. disclosed that a family of antibodies that specifically bind the human cell surface glycosphingolipid GD2. The antibodies comprise modified variable regions, more specially, modified framework regions, which reduce their immunogenicity when administered to a human. The antibodies may be coupled to a therapeutic agent and used in the treatment of cancer(abstract). The antibodies may be a full-length antibody, a Fab or a single-chain variable fragment (scFv) (col. 3, lines 46-55). The SEQ ID NO: 1 of the Patent is identical to SEQ ID NO: 16 of the instant Application and the SEQ ID NO: 2 of the Patent is identical to SEQ ID NO: 8 of the instant Application.
The Patent also claims a pharmaceutical composition comprising the antibodies disclosed (Col. 9, lines 14-28).
It would have been obvious for a person of ordinary skill in the art at the time that the invention was filed to have used the antibody of Gillies et al. in the chimeric antigen receptor of Cooper with a reasonable expectation of success, since Gillies indicated the superior qualities of their anti-GD-2 antibody. Thus, a skilled artisan would have used known methods and reagents to achieve the desired goal.
A person of ordinary skill in the art is always motivated to pursue the known options within her or his technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Cooper et al. (U.S. Pub. No. 20140349402-cited by Applicant) in view of Chaudhary et al. (WO2017172981)
The claim adds the limitation that the targeting moiety comprises an amino acid sequence set forth in SEQ ID NO: 19.
The teachings of Cooper et al. in view of Gillies et al. were presented above. While Gillies et al. mentions the possibility of using an scFv in their invention, they do not mention the SEQ ID NO: of the construct.
Chaudary et al. discloses an anti GD2 antibody (SEQ ID NO: 2458- Table 11) which is 100% identical with a scFv antibody of SEQ ID NO: 19 of the instant Application.
It would have been obvious for a person of ordinary skill in the art at the time that the invention was filed to have used the antibody of Chaudary et al. in the chimeric antigen receptor of Cooper with a reasonable expectation of success. A skilled artisan would have used known methods and reagents to achieve the desired goal.
A person of ordinary skill in the art is always motivated to pursue the known options within her or his technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Conclusion
No claims are allowed.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647
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