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 .
Applicant’s amendment of claims 51, 54 in the paper of 1/28/2026, is acknowledged. Applicants' arguments filed on 1/28/2026, have been fully considered and are deemed to be persuasive to overcome some of the rejections previously applied. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. Claims 51-91 are still at issue and are present for examination.
Terminal Disclaimer
The terminal disclaimer filed on 4/5/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 11,739,308 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Election/Restrictions
Applicant's election without traverse of Group I, claims 51-83, drawn to a composition comprising a Cas13b effector protein, in the paper of 12/6/2024, is acknowledged.
Applicant's election without traverse of the following species:
Species Group 1): SEQ ID NO: 32;
Species Group 2): R116A:
Species Group 3): (GGGGS)3-11;
Species Group 4): MS2;
Species Group 5): huADAR and
Species Group 6): HIV Rev NES
in the paper of 12/6/2024, is acknowledged.
Claims 84-90 are withdrawn from further consideration by the examiner, 37CFR 1.142(b), as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 101
The rejection of claims 51-53, 61, 76-78, under 35 USC § 101is withdrawn based upon applicants amendment of the claims and applicants arguments presented in the paper of 8/27/2025.
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 51-83 and 91 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 pre-AIA the applicant regards as the invention.
Newly amended claim 51 (claims 52-83 and 91 dependent from) is indefinite in the newly added recitation “a Cas13b effector protein comprising at least 90% of any one of amino acid sequences of SEQ ID NO: 31-38” in that it is unclear as to what the reference to 90% is to. The literal interpretation is that the Cas13b effector protein comprises at least 90% of any one of amino acid sequences of SEQ ID NO: 31-38. That is the Cas13b effector protein comprises a fragment of at least 90% of any one of amino acid sequences of SEQ ID NO: 31-38 or in the case of currently examined SEQ ID NO:32, the Cas13b effector protein comprises at least 90% of the amino acid sequence of SEQ ID NO:32 or 1120 amino acids X 90%=1008 amino acids of SEQ ID NO:32.
Newly amended claim 51 (claims 52-83 and 91 dependent from) is indefinite in that the recitation “wherein the engineered guide RNA” lacks antecedent basis.
Appropriate comment/amendment is required.
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.
Claim(s) 51-83 and 91 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Newly amended claim(s) 51-83 and 91 are directed to “a Cas13b effector protein comprising at least 90% of any one of amino acid sequences of SEQ ID NO: 31-38” (a fragment of 90% of SEQ ID NO:32) which is not supported by applicants specification at the time of filing and thus considered new matter (see also above rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA )).
Remarks
No claim is allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 RICHARD G HUTSON whose telephone number is (571)272-0930. The examiner can normally be reached on 6-3 EST Mon-Fri.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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rgh
3/30/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652