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
This action is written in response to applicant’s correspondence received on September 18, 2025. Claim(s) 91-93 and 95-110 are currently pending.
Any rejection or objection not reiterated herein has been overcome by amendment.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 91-110 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 91-129 of U.S. Patent No. 10337051. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed invention would have been obvious in further view of Severinov (US 2017 /0321198, priority to April 8, 2016) and Yang (previously cited).
The pending claims similarly teach an acellular in vitro method of detecting a single stranded target RNA in a sample by contacting the sample in vitro with a C2c2 guide RNA, a labeled
detector RNA, and a C2c2 protein that cleaves the labeled detector RNA, and measuring a detectable
signal produced by cleavage of the labeled detector RNA that provides for detection of the single stranded target RNA in the sample, that is substantially identical to the instant claims. In addition,
pending claim 95-97 teaches wherein the C2c2 protein comprises the amino acid sequence of SEQ ID
NO: 2 and/or SEQ ID NO: 3. In Patent # 10337051 claim 124, wherein the single stranded target RNA is from a virus, a parasite, a helminth, a fungus, a protozoan, a bacterium, which anticipates the claims 95-97. To the extent that there is any limitation that is not taught by the patented claims, the teachings of the prior art of Severinov and Yang are discussed above. It would have been obvious to
have modified the method of the patented claims to arrive at the instant claims for substantially
the same reasons as discussed above.
Allowable Subject Matter
Claims 91-93 and 95-110 are free of the prior art and would be allowable upon filing of a terminal disclaimer to overcome the non-statutory double patenting rejections that are reiterated above.
Regarding claim 91, the closest prior art is set forth in the Office Action mailed June 18, 2025. The disclosures of each of the previously cited references of Severinov (US 2017/0321198, priority to April 8, 2016) in view Yang (Yang et al. "Using Molecular Beacons for Sensitive Fluorescence Assays of the Enzymatic Cleavage of Nucleic Acids", from: Methods in Molecular Biology, vol. 335: Fluorescent Energy Transfer Nucleic Acid Probes: Designs and Protocols, Edited by V. V. Didenko (Totowa, NJ, Humana Press Inc., 2006), pages 71-81) contain differences with the claimed invention. The method of Severinov at [1064] is not in a biological sample. The method of Yang involves the use of DNA molecular beacons, rather than a labeled detector RNA molecule. When the sum total of the modifications necessary to the closest prior art of Severinov are considered, one of ordinary skill in the art would not have been sufficiently motivated to have made all of the necessary modifications to have arrived at the particular method of detecting a single stranded target RNA in a biological sample as required by the current claims.
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 HEATHER CALAMITA whose telephone number is (571)272-2876. The examiner can normally be reached Monday through Friday 8 AM to 4:30 PM.
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HEATHER . CALAMITA
Supervisory Patent Examiner
Art Unit 1684
/HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684