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 .
Priority
This application is a 371 of PCT/US2018/051280 filed 09/17/2018. PCT/US2018/051280 has PRO 62/565,464 filed 09/29/2017.
Claim Status
Claims 1-15, 18-21, and 23 are pending. Claims 7, 12-15, 18-21 are withdrawn.
Claims 1-3 are amended. Claims 16-17, and 22 are canceled.
Claims 1-6, 8-11, and 23 are being examined on the merits in this office action.
Claim Rejections - 35 USC § 112 - Withdrawn
The rejection of claims 1-6, 8-11 and 23 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in view of the amendment to claim 1 to delete “no more than 25 amino acids in length.
The rejection of claims 1-6, 8-11 and 23 under 35 U.S.C. 103 as being unpatentable over WO 2016/053339 A1 (hereinafter “the ‘339 publication”, cited and enclosed in the previous office action) in view of Shamalov et al. (Oncoimmunology. 2017; 6(4): e1285990, cited and enclosed in the previous office action), and Fersht et al. (WO 2008017863A2 – hereinafter “Fersht - cited and enclosed in the previous office action) is withdrawn in view of the claim amendments and arguments that the mutated p53 sequence consists of amino acids sequence of SEQ ID Nos. 2-13, 508-512, 520-530, 534, 591, 596-602.
Claim Rejections - 35 USC § 112 - New
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 1-6, 8-11, and 23 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.
Claim 1 recites “…each mutated p53 amino acid sequence of SEQ ID NOs: 2-13, 508-512, 520-530, 534, 591, or 596- 602…”. It is unclear if one or several of the mutants is being co-cultured. Additionally, it is unclear which mutated p53 needs to be presented and which p53 mutant encoded in the MHC. As a result, it is unclear which T-cells are being selected.
Claim 2 has a similar issue reciting “…a pool of peptides comprising a different mutated p53 amino acid sequence”. It is unclear which peptide the mutated p53 amino acid sequence the claim is referencing.
Claim 5 is indefinite since it is unclear if the genes encode any of the sequences in claim 1.
Claim 10 recites several p53 mutants and is also indefinite.
Regarding claims 4 and 23, it is unclear which p53 mutant the claim is referencing.
Applicant can amend claim 1 to recite:
“A method of isolating T cells having antigenic specificity for a mutated p53 amino acid sequence encoded by a cancer-specific p53 missense mutation, the method comprising:
inducing autologous antigen presenting cells (APCs) of a patient with a tumor to present at least two mutated p53 amino acid sequences of any of SEQ ID NOs: 2-13, 508-512, 520-530, 534, 591, or 596- 602;
co-culturing autologous T cells of the patient with the autologous APCs that present the mutated p53 amino acid sequences;
and selecting the autologous T cells that (a) were co-cultured with the autologous APCs that present the mutated p53 amino acid sequences and (b) have antigenic specificity for the mutated p53 amino acid sequences presented in the context of a major histocompatibility complex (MHC) molecule expressed by the patient to provide isolated T cells having antigenic specificity for the mutated p53 amino acid sequences encoded by the cancer- specific p53 missense mutation”.
The dependent claims do not clear up the indefiniteness issue and are also rejected.
Closest prior art
The closest prior art is WO 2016/053339 A1. ‘339 teaches a method of isolating T cells having antigenic specificity for a mutated amino acid sequence encoded by a cancer-specific mutation, the method comprising: identifying one or more genes in the nucleic acid of a cancer cell of a patient, each gene containing a cancer-specific mutation that encodes a mutated amino acid sequence; inducing autologous antigen presenting cells (APCs) of the patient to present the mutated amino acid sequence; co-culturing autologous T cells of the patient with the autologous APCs that present the mutated amino acid sequence; and selecting the autologous T cells that (a) were co-cultured with the autologous APCs that present the mutated amino acid sequence and (b) have antigenic specificity for the mutated amino acid sequence presented in the context of a major histocompatability complex (MHC) molecule expressed by the patient to provide isolated T cells having antigenic specificity for the mutated amino acid sequence encoded by the cancer-specific mutation (claim 1).
‘339 does not teach wherein the mutated amino acid sequence is the mutated p53 amino acid sequence consisting of a sequence of SEQ ID NOs: 2-13, 508-512, 520-530, 534, 591, or 596- 602.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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