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 .
Election/Restrictions
Applicant’s election of the species of T7, metal or cation and the election of all four components in claim 1 in the reply filed on 3/30/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-10, 12-18, 20, 29 are pending. Claims 11,19,21-28 have been cancelled.
An action on the merits is set forth below.
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 1-10, 12-18, 20, 29 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.
Claims 1-10, 12-18, 20, 29 are indefinite over the phrase “composition, system or kit” in claim 1. This phrase is unclear as it is not clear, structurally, what the differences between the three types are being attempted by the claims.
Claim 5 is indefinite over the recitation of the parentheses. It is not clear if the claims are attempting to limit the claims to 2’ O-methylation or how the parentheses limit the claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 9-10, 12-18, 20, 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spoonamore et al. (US Patent Application Publication 2019/0195864 June 27, 2019)..
With regard to claim 1, Spoonamore et al teaches compositions comprises an RNA polymerase (para 214), an aTF (paras 84-85), an engineered template (para 85), and fluorophore quencher pairs on a dsDNA (signal gate) (para 100).
With regard to claim 2, Spoonamore et al teaches a method wherein the dsDNA is a single gate molecule that is a fluorophore and quencher pair on different strands (para 100 -108).
With regard to claim 9, Spoonamore et al. teaches all the required structure of claim 1 and as such the RNA would be capable of not forming an intramolecular secondary structure.
With regard to claim 10, Spoonamore et al. teaches a T7 RNA polymerase (para 215).
With regard to claim 12, Spoonamore et al. teaches an aTF that represses (para 107).
With regard to claim 13, Spoonamore teaches a structure of aTF which activates when bound to an operator (para 18-27).
With regard to claims 11-17, the claims are drawn to intended uses of the analyte and aTF, Spoonamore et al. teaches an aTF which would be capable of binding to the operator in the absence of a ligand (para 84).
With regard to claim 18, Spoonamore teaches tetR, arsr, marr class (para 14 and 142).
With regard to claim 20, Spoonamore et al. teaches the analyte is a member of tetracycline (para 130).
With regard to claim 29, Spoonamore et al. teaches contacting the sample with components of the composition and detection signal (para 85-110).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spoonamore et al. (US Patent Application Publication 2019/0195864 June 27, 2019) in view of in view of Canaani et al. (US Patent Application Publication 2019/0300884 October 3,2019).
Spoonamore et al teaches compositions comprises an RNA polymerase (para 214), an aTF (paras 84-85), an engineered template (para 85), and fluorophore quencher pairs on a dsDNA (signal gate) (para 100). Spoonamore et al teaches a method wherein the dsDNA is a single gate molecule that is a fluorophore and quencher pair on different strands (para 100 -108).
However, Spoonamore does not teach the structural positions of the fluorophore and quencher.
With regard to claim 3, Canaani et al. teaches that reporter molecules can be a fluorescently labeled top a quencher on the 5’ of the bottom (para 267-314).
With regard to claim 4, Canaani et al. teaches overhangs (para 325).
With regard to claim 5, Canaani et la. teaches non-natural modifications (para 260).
With regard to claims 6-8, Cananni et al. teaches a nonlabelled/labelled strand and that is longer(para 264-270, 325).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the structure of Spoonamore et al. to use known structural detectors on a dsDNA as taught by Canaani et al. The ordinary artisan would be motivated to modify the structures of labeling techniques using know structural motifs that can be used to detect.
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 1-10, 12-18, 20, 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 12-33 of U.S. Patent No. 12203144. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims encompass a composition, system or kit that comprises RNA polymerase, aTF, engineered transcription template and a dsDNA signal gate molecule.
Claims 1-10, 12-18, 20, 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 4, 6-25 of copending Application No. 18311030 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims encompass a composition, system or kit that comprises RNA polymerase, aTF, engineered transcription template and a dsDNA signal gate molecule.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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, Wu Cheng (Winston) Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
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