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 .
DETAILED ACTION
The amendment filed 12/19/2025 has been entered. Claims 2-18, 20-24, 26, 27, 29-32, and 34-39 are cancelled. Claims 1, 19, 25, 28, 33, and 39-42 are pending. Claims 28, 33, and 39-42 are withdrawn. Claims 1, 19, and 25 are under examination.
Response to Arguments
With respect to the rejection of claims 1 and 25 under 35 USC 112(a) as failing to comply with the written description requirement, Applicant's arguments filed 12/19/2025 have been fully considered but they are not persuasive. Applicant argues that generation of substitution mutations at the recited amino acid positions is well within the capabilities of a person of ordinary skill. However, the specification does not reduce to practice to every possible mutation at the recited residues that generates a functional MAD7 nickase, i.e., the specification does not disclose the entire genus of claimed MAD7 variants with nickase activity, or sufficient representative species within in the genus. The instant claims merely recite R1173A and another substitution relative to SEQ ID NO:1, but does not require any conserved amino acid sequence other than the two substitutions, whereas the species described in the specification appear to require at least the same full-length amino acid sequence as SEQ ID NO:1 except for the specified substitution mutations. Therefore, one of ordinary skill in the art would not recognize that applicant was in possession of the claimed genus of all claimed MAD7 variants.
Claim Rejections - 35 USC § 112(a)
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.
(MAINTAINED REJECTION)
Claims 1, 19 and 25 are 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, 19 and 25 encompass the limitations of: A modified MAD7 enzyme comprising a substitution mutation R1173A relative to SEQ ID NO: 1 and further comprising a substitution mutation at one or more amino acid positions selected from 121, 124, 125, 158, 168, 172, 180, 272, 275, 280, 290, 363, 406, 409, 443, 503, 510, 557, 561, 583, 599, 601, 604, 618, 621, 622, 624, 652, 675, 852, 855, 916, 918, 922, 907, 977, 985, 1022, 1025, 1029, 1114, 1115, 1118, 1157, 1160, 1167, 1241, and 1242 relative to SEQ ID NO: 1, wherein the modified MAD7 enzyme possesses nickase activity.
MPEP 2163.05 II states “the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species. A ‘representative number of species’ means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that ‘only describe[d] one type of structurally similar antibodies’ that ‘are not representative of the full variety or scope of the genus.’). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us].’”
The instant specification only reduces to practice one MAD7 variant comprising a substitution mutation, R173A, (para. [00126]), that has nickase activity. However, the specification does not reduce to practice every possible mutation at the recited residues that generates a functional MAD7 nickase, i.e., the specification does not disclose the entire genus of claimed MAD7 variants with nickase activity.
Bundock et al., (US Pub. No. 2021/0238612 A1), previously cited, teaches one substitution mutation, R1173A, that inactivates the nuclease domain to generate a MAD7-nickase (para. [0071]). Bundock does not disclose any other mutations that generate a MAD7-nickase.
Therefore, neither the instant specification, nor the prior art, discloses a structure-function relationship between nickase activity of MAD7 and the conserved amino acid residues in the enzyme structure. One of ordinary skill in the art cannot reasonably predict what mutations may be made at the recited residues to generate a functional MAD7 nickase. Based on the instant disclosure, those skilled in the art would not conclude that applicant was in possession of all claimed variants.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL EMILY MARTIN whose telephone number is (703)756-1416. The examiner can normally be reached M-Th 8:30-16:00, F 8:30-10:00 EST.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/RACHEL EMILY MARTIN/Examiner, Art Unit 1657