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 1-10 and Exon VI and SEQ ID NOs 9835, 9875, 9900, 9990, 9998, 10103, 10270, 10302, 10340 and 10376 as species in the reply filed on 2/12/2026 is acknowledged.
Claims 11-14 and 16-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/12/2026.
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 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.
Claim 3 is 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.
Regarding claim 3, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Uccellini et al. (4/7/2020, Cell Reports, Vol. 31, pgs. 1-10).
Regarding claims 1-4, Uccellini et al. teach a method for inactivating alleles of the SARM1 gene in a cell to produce SARM1-deficient mice, comprising introducing to a cell a composition comprising at least one sequence encoding a CRISPR/Cas9 nuclease and a gRNA, which results in a double strand break in alleles of the SARM1 gene and where the gRNA is 17-50 contiguous nucleotides (see Abstract, pg. e3 parag. 1 and Table 1).
While Uccellini does not explicitly teach that a photoreceptor cell, the generation of SARM1-deficient mice in Uccellini deletes SARM1 in all cells of the mouse and thus the SARM1 in photoreceptor cells will also be inactivated.
Regarding claims 5-7, Uccellini teaches that the Sarm1AGS3 allele is a 62 bp deletion (pg. 6 col. 1) which results in an early truncation of the protein (pg. 10 col. 1 parag. 2).
Regarding claim 8, Uccellini teaches that guide sequence targeted a sequence in Exon 1 of the SARM1 gene (pg. e3 first full parag.).
Thus the teachings of Uccellini clearly anticipate the invention of claims 1-8.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1, 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Uccellini et al. (4/7/2020, Cell Reports, Vol. 31, pgs. 1-10) in view of Cheng et al. (2019, Diabetes, Vol. 68, pgs. 2120-2129) and Bowie et al. (WO 2007/098654 A1).
Regarding claim 1, Uccellini et al. teach a method for inactivating alleles of the SARM1 gene in a cell to produce SARM1-deficient mice, comprising introducing to a cell a composition comprising at least one sequence encoding a CRISPR/Cas9 nuclease and a gRNA, which results in a double strand break in alleles of the SARM1 gene and where the gRNA is 17-50 contiguous nucleotides (see Abstract, pg. e3 parag. 1 and Table 1).
Uccellini does not teach:
Regarding Exon 6 of SARM1, Cheng et al. teach that at the time of filing Exon VI of the SARM1 gene can be a target for generating SARM-/- mice (pg. 2121 col. 1 last 4 lines bridge col. 2 lines 1-3).
Regarding SEQ ID NO: 9835, Bowie et al. teach the identification and function of the SARM1 gene (pgs. 1-4) and in particular teaches a nucleic acid sequence set forth in SEQ ID NO: 2, which comprises the nucleic acid sequence set forth in instant SEQ ID NO: 9835.
Thus at the time of filing the ordinary artisan would have found it prima facie obvious to combine the teachings of Uccellini regarding inactivating alleles of the SARM1 gene in a cell to produce SARM1-deficient mice with the teachings of Cheng regarding targeting Exon 6 of SARM1 to generate knockout mice and with the teachings of Bowie regarding specific nucleic acid sequences related to SARM1 to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make such a combination since Cheng teaches that Exon 6 can be targeted for generating SARM1-deficient mice and Uccellini teaching how to generate a guide RNA to target a specific exon of the SARM1 gene.
There would have been a reasonable expectation of success that the guide RNA of SEQ ID NO: 9835 could target Exon 6 of the SARM1 gene since Bowie teaches at the time of filing a nucleic acid sequence comprising SEQ ID NO: 9835 that is part of the SARM1 gene.
Thus the cited art provides the requisite teaching and motivations to make and use the invention as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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/DAVID A MONTANARI/Examiner, Art Unit 1632
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