DETAILED ACTION
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, presently claims 1-5, 7, 8, 11, and 15, in the reply filed on 5/28/2026 is acknowledged.
Claims 19-22, 24, 28, 29, and 31-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/28/2026.
Claims 1-5, 7, 8, 11, and 15 are under consideration on the merits.
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 pre-AIA 35 U.S.C. 112, 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.
Claim 8 is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 8 recites the limitation “the cells of T cell lineage”, but there is insufficient antecedent basis for this limitation in the claim. Claim 8 depends from claim 1 and claim 1 does not recite any “cells of T cell lineage”. Correction is required.
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, 8, 11, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Minagawa et al. (Cell Stem Cell (2018), 23, 850-858 and appended Supplemental Information; Reference U) evidenced by Yoshikawa et al. (Cancer Science (2011), 102: 918-925; Reference V).
Minagawa teaches a method of generating genetically modified induced pluripotent stem cells (iPSCs), the method comprising culturing iPSCs and then deleting RAG2 and wherein RAG2 is required for V(D)J recombination (page 852, the paragraph starting "The additional rearrangement of the TCRα.." which ends on page 853, and Figure 2; e3, 1st paragraph under “Method Details”), anticipating claim 1, the embodiment of RAG2 for claim 3, and the embodiment of induced pluripotent stem cells for claim 5. Minagawa teaches further differentiating the RAG2-/- iPSCs into double positive CD4+CD8+T cells (DP) and isolating the T-lineage cells (page 852, the paragraph starting "The additional rearrangement of the TCRα.." which ends on page 853, and Figure 2; e3, subheading “T cell differentiation from iPSCs), anticipating claim 2 and the embodiment of double positive CD4+CD8+T cells for claim 8. Minagawa teaches that the iPSCs were generated from GPC3 peptide-specific CTL clones were obtained from peripheral blood mononuclear cells (PBMCs) of GPC3 peptide-vaccinated human hepatocellular carcinoma patients as evidenced by Yoshikawa (Minagawa: page 851, 1st paragraph under results under the “Result” and being the “RAG2-/- GPC3 T-iPSC-derived DP cells” as cited above; e3, 1st paragraph under “Method Details”. Yoshikawa: see the Abstract and the subheading “Patients” on page 918), anticipating claim 7.
In a separate embodiment, Minagawa teaches culturing and transducing HLA haplotype homologous human iPSCs with FFI-01 with two types of TCRαβ genes: 1) HLA-A*24:02 restricted GPC3298–306 peptide-specific TCR (TRAV5:01 J3:01 TRBV 5-1 TRBJ2-7 TRBD 2-1) and 2) and Wilmus Tumor 1 (WT1)235–243 peptide-specific TCR (TRAV20 TRAJ 33 TRBV5-1 TRBJ2-1) (wherein said iPSCs differentiate into CD8+ T cells (page 854, the paragraph spanning both column and Fig. 3bfor a FACS plot; e3, subheading “T cell differentiation from iPSCs), and wherein RAG2 and RAG1 mRNA expression is completely eliminated (page 851, right column, sentence starting “To determine the frequency and impact…” through the end of the paragraph on page 852; Fig. S1g and S1h and legend, noting “FFI01” for the TCR-transduced iPSCs), anticipating claims 1-3, 5, 7, the embodiment of CD8+ single positive cells for claim 1, the embodiment of a nucleic acid encoding for a TCR and a TCRβ of claim 11, and the embodiment of conferring antigen specificity to GPC3 and WT1 for claim 15.
Claims 1, 2, 4 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Benjelloun et al. (Molecular Therapy (2008), 16(8): 1490-1499; Reference W).
Benjelloun teaches a method of generating hematopoietic stem cells (HSCs) unable to undergo TCR gene rearrangements, the method comprising 1) isolating and culturing Sca1+ cells from the bone marrow (i.e. HSCs) of mice carrying a double genetic knockout of Artemis (Art-/-) (page 1497, subheading “Isolation, transduction, and transplantation of HSCs.”), anticipating claims 1 and 4. Benjelloun teaches injecting mock-transduced the Art-/-Sca1+ cells into mice (i.e. Art-NT) and isolating CD4+CD8+ T cells by FACS (Fig. 1 and the paragraph spanning both columns on page 1491), anticipating claims 2 and 8.
Claims 1, 3, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mehravar et al. (Iranian J Biotech (2019), 17(1), e2205, 9 pages; provided in the IDS 9/11/2025).
Mehravar teaches a method of generating embryonic stem cells unable to undergo TCR gene rearrangements, the method comprising 1) isolating and culturing mouse embryonic stem cells, 2) transfecting said mouse embryonic stem cells with sgRNA specific for RAG1 and a vector encoding for Cas9 (page 47, subheadings 3.3 and 3.4) such as to induce different deletions within the endogenous RAG1 gene (Fig. 3 and subheading 4.2), anticipating claims 1, 3, and 5.
Conclusion
No claims are allowed. No claims are free of the art.
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/Sean C. Barron/
Primary Examiner, Art Unit 1653
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