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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/07/2024 and 04/08/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claims 1-14 are 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 1: The claim requires a modified Cas6, TniQ or Cas8/5 protein comprising an amino acid change relative to a reference amino acid sequence at various positions. It is however, not clear from the wording of the claim as to what constitutes a reference amino acid sequence. The specification does not effectively convey what constitutes a reference a sequence. Appropriate correction is required.
Claims 2-14 are rejected for their dependency on the rejected claim.
Regarding claim 10: The claim requires improved transposition and increased protospacer adjacent motif (PAM) specificity. The terms “improved or increased” in claim 10 is a relative term which renders the claim indefinite. The term “improved or increased” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Similar rejection applies for claims 13-14.
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 1-14 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.
Regarding claim 1: Claim 1 recites, in pertinent part, one or more modified proteins for use in a CRISPR system, wherein the modified proteins may comprise: (i) a Cas6 protein having an amino acid change relative to a reference sequence at position 113 or 153, wherein optionally the change is F113A or F153A; (ii) a TniQ protein having one or more amino acid changes relative to a reference sequence at positions 384, 387, 283, and 330, wherein optionally the changes are H384A, H387A, N283A, and R330A; or (iii) a Cas8/5 protein having one or more amino acid changes relative to a reference sequence at position 247 or 248, wherein optionally the changes are A247T, A247Q, S248A, and S248N.
The specification, however, does not reasonably convey possession of the full scope of the claimed genus of amino acid changes at the recited positions.
For Cas6, the specification specifically discloses alanine substitution of F113 and F153, stating that “alanine mutation of proximal residues in TniQ (N283, R330, H384, and H387) and Cas6 (F113 and F153)” resulted in partial or full restoration of transposition activity of typical crRNA. Thus, the specification provides express support for the species F113A and F153A. However, claim 1 is not limited to alanine substitution. Rather, the claim encompasses substantially any amino-acid substitution or other amino-acid change at position 113 or 153. The specification does not identify or describe the other amino-acid substitutions encompassed by the claim, nor does it provide a representative number of species sufficient to demonstrate possession of the broader genus of all amino-acid changes at those positions.
Similarly, with respect to TniQ, the specification expressly discloses the specific alanine substitutions N283A, R330A, H384A, and H387A and reports functional results for those particular substitutions. The specification does not, however, describe a broader genus of amino-acid substitutions at positions 283, 330, 384, or 387. Claim 1 encompasses changes other than the specifically disclosed alanine substitutions, without providing corresponding structural, functional, or other identifying characteristics that would reasonably demonstrate possession of the full claimed genus.
Likewise, for Cas8/5, the specification describes specific substitutions A247T, A247Q, S248A, and S248N and discusses their effects on PAM selectivity. The specification does not reasonably describe the full genus of amino-acid changes at positions 247 and 248 encompassed by claim 1. In particular, the disclosure does not establish that the inventors had possession of every possible amino-acid substitution, insertion, deletion, or other amino-acid change at those positions, or otherwise provide a sufficient description of the structural or functional boundaries of the claimed genus.
The fact that the specification identifies the recited positions and provides particular examples of substitutions at those positions does not, by itself, demonstrate possession of the broader genus recited in claim 1.
Accordingly, the specification provides written-description support for at least the specifically disclosed species F113A, F153A, N283A, R330A, H384A, H387A, A247T, A247Q, S248A, and S248N, but does not reasonably demonstrate possession of the broader genus of modified Cas6, TniQ, and Cas8/5 proteins encompassing unspecified amino-acid changes at the recited positions.
Regarding claims 2-4: The claims require combination of two amino acid mutations in Cas6, TniQ and Cas8/5. The specification identified individual mutations including F113A, F153A, R33A, H384A and H387A and particular Cas8/5 substitutions, but does not provide sufficient disclosure demonstrating possession of the full range of two mutation combinations encompassed by claims 2-4. Accordingly, the specification lacks written description support for the subject claims.
Conclusion
Claims 1-14 are free of art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAGAMYA VIJAYARAGHAVAN whose telephone number is (703)756-5934. The examiner can normally be reached 9:00a-5:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher M. Babic can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAGAMYA NMN VIJAYARAGHAVAN/Examiner, Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
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