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 .
Claim Objections
Claim 7 is objected to because of the following informalities: Claim 7 should be amended to recite “the first fluorophore-quencher pair and the second fluorophore-quencher pair are the same”. Appropriate correction is required.
Withdrawn Rejections
The rejection of claims 1-14 and 16 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, has been withdrawn in view of applicant’s amendments to claim 1 to recite that the effector complex comprises a L1Csm effector complex, and the ancillary protein comprises L1Csm6.
The rejection of claims 1, 5, 9-10, 13-14 and 16 under 35 U.S.C. 103 as being unpatentable over You et al. (Cell, 2019, 176(1-2): 239-253; cited by applicant) and Tamulaitis et al. (Molecular Cell, 2014, 56(4):506-517) has been withdrawn in view of applicant’s amendments to claim 1 to recite that the effector complex comprises a L1Csm effector complex, and the ancillary protein comprises L1Csm6.
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, 4-14 and 16 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.
Claim 1 is directed to a method of detection, the method comprising:
providing a sample comprising a virus, wherein the virus comprises a cognate target RNA;
contacting the sample with an effector complex and an ancillary protein,
wherein the effector complex binds to the cognate target RNA, and the binding of the effector complex to the cognate target RNA produces at least one messenger comprising a cyclic oligoadenylate, wherein the at least one messenger activates nonspecific ssRNA cleavage activity in the ancillary protein to produce detectable DNase activity, detectable RNase activity, or a combination thereof; and
analyzing the sample with one or more reporters to detect the detectable DNase activity, detectable RNase activity, or a combination thereof,
wherein the effector complex comprises a L1Csm effector complex, and the ancillary protein comprises L1Csm6.
In the providing step of claim 1, the virus comprises a cognate target RNA. If the virus comprises the target RNA, it is not clear how the target RNA is released from the viral particle such that the effector complex can then bind to the target RNA. The specification teaches a RNA extraction step for each patient sample [A total of fourteen patient samples were obtained and subjected to RNA extraction. The extracted RNA from each patient was split for simultaneously detection with MORIARTY and an FDA approved qPCR procedure, respectively; see specification page 14, lines 17-19].
Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claims.
Response to Arguments
In the reply dated 12/3/2025, applicant argues that “the target RNA is not ‘released from the viral particle’ to bind with the effector complex”. Applicant’s arguments have been fully considered and not found persuasive.
The specification clearly teaches a RNA extraction step for each patient sample [A total of fourteen patient samples were obtained and subjected to RNA extraction. The extracted RNA from each patient was split for simultaneously detection with MORIARTY and an FDA approved qPCR procedure, respectively; see specification page 14, lines 17-19].
Conclusion
No claim is allowed.
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.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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