DETAILED ACTION
Notice of 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 II, claims 14, 17, 29-30; and new claims 134-146 in the reply filed on 30 January 2026 is acknowledged. The requirement is deemed proper and therefore made Final.
Status of Application
Claims 1-14, 17, 29-30, 36-37, 44, 134-146 are pending; Claims 1-13, 36-37 and 44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Thus, claims 14, 17, 29-30 and 134-146 are subject to examination on the merits.
Priority
The instant application is a 371 of PCT/US2021/022200 filed 21 March 2021 which claims benefit of US Provisionals: 63155268; 63110325; 63108847; 63061766; 63000211; 62990946; 62989525; filed 03/01/2021; 11/05/2020; 11/02/2020; 08/05/2020; 03/26/2020; 03/17/2020 and 03/13/2020, respectively.
It is noted, support for the current claims does not appear in the provisional applications until 05 November 2020, 63/108,847. This is relevant with respect to prior art cited below.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07 August 2025, 30 May 2024, 01 September 2023 and 07 September 2022 have been considered by the examiner. See initialed and signed PTO/SB/08’s.
Compliance with Sequence Rules
The sequence listing, filed in computer readable form (.txt) on 07 September 2022, has been received and entered. This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 C.F.R. § 1.821(a)(1) and (a)(2). However, this application fails to fully comply with the requirements of 37 C.F.R. § 1.821 through 1.825.
The following Figure contains sequences that contain four or more specifically defined amino acids or ten or more specifically defined nucleotides without any corresponding SEQ ID NO: and/or no reference to any SEQ ID NO: in the Brief Description of the Drawings.
In Figure 13, there are three sequences, each of which require their own sequence identifiers (Query, Sbjct and the consensus sequence in the middle).
* If the noted sequences are in the sequence listing as filed, Applicants must amend the specification to identify the sequences appropriately by SEQ ID NO:. If the noted sequences are not in the sequence listing as filed, Applicants must provide (1) an updated copy of the sequence listing containing the requisite sequences in computer readable form (.txt), (2) an amendment directing its entry into the specification, (3) a statement that no new matter has been added and (4) an amendment to the specification to identify the identified sequences by SEQ ID NO:, which can be in the Brief Description of the Drawings section of the specification and (5) an updated incorporation by reference statement with the new date of creation, sequence file name and size. – See also MPEP 2422.
Claim Interpretation
The term “PuroR2” as recited in claim 140 is defined in the specification as having/comprising amino acid sequence SEQ ID NO: 1 (See paragraph 0014 and Table A). As such, the recitation that “said SM protein is PuroR2” is interpreted as said SM protein is PuroR2 and comprises SEQ ID NO: 1. The second part of the claim is interpreted as a sequence having at least 60% or more sequence identity to SEQ ID NO: 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 14, 17, 29-30 and 134-134 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Chaudhary et al (WO 2018102795 – cited on IDS).
Chaudhary et al. teach:
Regarding claims 14, 17, 29-30 and 134-139, an expression vector comprising one or two nucleic acids encoding a protein of interest of synthetic immune receptor (SIR) comprising a T-cell constant chain, an optional linker; and one or more non-natural TCR antigen binding domains (See paragraph 0015); wherein when two SIR are linked then a self-cleavable linker is interposed between the two and are selected from T2A, P2A, F2A, E2A, but specifically is P2A (See claim 34, Figure 2), and wherein the protein of interest/SIR is under the control of an EF1alpha promoter variant (See Figure 2) and vector comprises a PuroR variant (puromycin resistance) selectable marker, and wherein P2A self cleaving peptide is 18-22 amino acids in length and can induce ribosomal skipping. Said vectors are transformed into T-cells (See Examples).
Regarding claim 40 and said PuroR2 selectable marker sequence, the PuroR of the vector comprises SEQ ID NOs: 8251, 8257, 8463, 8471, 8268, 8250, 8256, 8253, 8244, 8252, 8253 or 8679; all of which have 64.7% sequence identity to instant SEQ ID NO: 1 (See Supplemental Content, 20260318_121750_us-17-909-971-1.rag file, Results: 15, 16, 23, 26, 28, 29, 30, 32, 33, 35, 36 and 41, respectively; also See Claim 198.
Claim(s) 14, 17, 29-30 and 134-138 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ildefonso et al. (WO 2015/127094 – cited on IDS).
Regarding claims 14, 17, 134-138, Figures 2 and 23A shows a TatNrf2mer-T2A-PuroR lentivirus or AAV expression vector, and thus comprises a protein of interest of TatNrf2 followed by a self-cleavable linker of T2A and then a PuroR selectable marker which is a selectable marker, and wherein the T2A self-cleavable peptide has between 18-22 amino acids in length and can induce ribosomal skipping; wherein said nucleic acid is operably linked to the CMV-chicken beta actin promoter – See also Example 1.
Regarding claims 29 and 30, said expression vector is transformed into HEK293 cells (See Example 1).
Claim(s) are 14, 29, 30, 134-135, 143 and 145-146 rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sun, Z. (US 11129890 – cited herein, with an effectively filed date of 19 May 2020).
Sun teaches:
Regarding claims 14, 29, 30, 134-135, 143 and 145-146, lentiviral expression vector comprising a heterologous nucleotide encoding a protein of interest which is a SARS-COV-2 spike protein (N) or nucleocapsid protein (N), operably linked to a CMV promoter and further comprising an selectable marker chosen from puromycin resistance gene (PuroR) or AmpR antibiotic resistance gene (See Figures 6-12); and cells transformed/transfected with said vector, such as HEK293 cells (See Col. 157, lines 28-42).
Regarding claim 140, said PuroR (N-acetyltransferase which confers resistance to puromycin) is taught as SEQ ID NO: 10 and has 64.7% sequence identity to instant SEQ ID NO: 1. See Supplemental Content, Duplicates of Result 1, 20260318_121750_us-17-909-971-1.rai; and See Col. 18, lines 14-21.
Claim(s) 14, 29-30, 134-135 and 141 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ng, S.K. (Methods in Molecular Biology, 2012, Chapter 11, pp. 161-172 – cited herein).
Ng teaches:
Regarding claims 14, 134, 135 and 141, an expression vector comprising a CMV promoter, a protein of interest (human interferon-gamma, IFNγ) and an unstable selectable marker which is an unstable DHFR marker fused to a destabilization domain of a PEST sequence – See Figure 1.
Regarding claims 29 and 30, said vector is transfected into CHO cells and cultivated – See section 3.1-3.4.
Claim(s) 14, 29-30, 134 and 142-144 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Watakabe et al. (Frontiers in Neural Circuits, 2014 – cited herein) as evidenced by Addgene, AAV-hSynI-rtTAV16 plasmid #102367 – cited herein.
Watakabe et al. teach:
Regarding claims 14, 134, 142-144, a lentivrial expression vector comprising a protein of interest which is a reverse tetracycline transcriptional activator of rtTAv16, an AmpR selectable marker, and an AmpR promoter; this is evidenced by Addgene AAV-hSynI-rtTAV16 plasmid #102367 – See Plasmid map; also see “Plasmid Construction”, p.2.
Regarding claims 29-30, said vector is produced in a cell population, namely HEK293 (See Viral Injection, p. 3).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 19 March 2026