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 .
Application Status
The Amendments and Remarks filed 08 December 2025 are acknowledged and have been entered. Claims 1, 2, 8, and 66 are amended. Claims 4-5, 9-11, 20-21, 23, 25-26, 29, and 31-64 have been cancelled. Claim 67 is newly added. Claims 1-3, 6-8, 12-19, 22, 24, 27-28, 30 and 65-67 are pending and being examined on the merits.
Any objection or rejection not reiterated herein has been overcome by applicant’s claim amendments.
This rejection contains rejections not necessitated by applicant’s claim amendments and is therefore a non-final rejection.
Priority
This application is a 371 PCT of US21/51318 filed 09/21/2021 which claims priority to applications 63/201,821 filed 05/14/2021 and 63/082,275 filed 09/23/2020.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 6-8, 12-19, 22, 24, 27-28, 30 and 66-67 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 66 requires a CRISPR/Cas12d endonuclease molecule that is a dCas12d molecule that comprises a mutation of one or more of residues selected from the group consisting of D775, E971, D1198, C1053, C1056, C1186, and C1191 of SEO ID NO: 1. The claims links the function of an enzymatically inactive protein, “d”Cas13d, to the mutations of D775, E971, D1198, C1053, C1056, C1186, or C1191 of SEO ID NO: 1, thereby functionally limiting the CRISPR/Cas12d endonuclease.
The specification does not adequately describe the a dCas12d with the corresponding mutations. The specification has not provided any working examples that the claimed nuclease would in fact be enzymatically inactive upon mutating the molecule at the cited positions. Furthermore, the prior art is silent to relate any of these mutations to a functionally inactive nuclease.
Accordingly, in view of the limited amount of guidance provided by the specification and in the art, one of ordinary skill in the art would conclude that applicant was not in possession of
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.
(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 65 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Doudna (US 2020/0255858 A1).
Regarding claim 65, Doudna teaches compositions and methods that includes CasY (i.e., Cas12d) or a nucleic acid encoding the CasY protein and a CasY guide that binds to and provides sequence specificity to the CasY protein, a nucleic acid encoding the CasY guide RNA, and/or a modified host cell comprising the CasY guide RNA [abstract]. Doudna teaches that a CasY guide RNA is a single-molecule guide RNA [0161]. Doudna teaches that the CasY compositions can be used to modify target nucleic acid or modulate transcription of a target nucleic acid (i.e., modify the expression of a gene) by introducing vectors comprising the protein and guide RNA into cells where the cell is a eukaryotic cell, human cell or plant cell [0053, 0201, 0248, 0381]. Doudna teaches that in the CasY system, a CRISPR/Cas endonuclease (e.g., a CasY protein) interacts with (binds to) a corresponding guide RNA (e.g., a CasY guide RNA) to form a ribonucleoprotein (RNP) complex that is targeted to a particular site in a target nucleic acid via base pairing between the guide RNA and a target sequence within the target nucleic acid molecule, where the guide RNA includes a nucleotide sequence (a guide sequence) that is complementary to a sequence (the target site) of a target nucleic acid [0048]. Doudna teaches SEQ ID NO: 153 (RNA_396) which comprises a DNA sequence that is 100% identical to the sgRNA of SEQ ID NO: 3 and is a CasY15 trans cleavage RNA component (i.e. gRNA) [Fig. 14].
Response to Arguments
Applicant's arguments filed 08 December 2025 have been fully considered but they are not persuasive. Claim 65 is an independent claim and is not dependent from claim 1. Doudna teaches SEQ ID NO: 3 as claimed as a sgRNA for CasY.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The closest art is Doudna, as discussed above. Although Doudna teaches the use of dCAS12d [0049], Doudna nor the prior art teaches or provides a reasonable rationale to mutate dCAS12 at the claimed positions and use it in a method of modifying the expression of a gene.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIFFANY N GROOMS whose telephone number is (571)272-3771. The examiner can normally be reached M-F 830-530.
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/TIFFANY NICOLE GROOMS/Examiner, Art Unit 1637
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