DETAILED ACTION
The present Office Action is responsive to the Amendment received on October 6, 2026.
Preliminary Remark
Claims 13-27 are canceled.
Claims 7-12 and 28-34 remain withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention without traverse.
Claim Objections
Applicant is advised that should claim 2 be found allowable, claim 6 will be objected to under 37 CFR 1.75 as being an identical duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The rejection of claims 1-6 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to particularly point out and distinctly claim the subject matter, made in the Office Action mailed on July 9, 2025 is withdrawn in view of the Amendment received on October 6, 2025.
Rejection – New, Necessitated by Amendment
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 1-6 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. This is a New Matter Rejection.
Issue No. 1:
Independent claim 1 has been amended to add a “spacer” to a riboregulatory construct, resulting in the structure of, from 5’ to 3’, “a docking site, a spacer, a toehold domain, and a loop domain and an output gene sequence encoding a reporter protein”, wherein “docking site, and the toehold domain are complementary to the mutant nucleic acid molecule, and wherein the spacer is not complementary to the mutant nucleic acid molecule.”
The application as filed does not have a riboregulatory construct which comprises a spacer that is located between a docking site and a toehold domain, wherein the spacer is not complementary to a mutant nucleic acid molecule sought to be detected.
While the application as filed allude to a spacer domain that is not complementary to a target DNA molecule, this embodiment is directed to a construct that is being used as a primer in an isothermal amplification reaction.
For example, in section [0009] of the specification discloses the below:
“a method for preferential amplification of a target DNA molecule comprising a SNP mutation. The method can comprise or consist essentially of a target DNA molecule, wherein the SNP-specific remote toehold primer comprises (i) a 5’ docking site complementary to the target DNA molecule, (ii) a spacer domain not complementary to the target DNA molecule, and (iii) a 3’ mutant targeting remote toehold domain complementary to a target DNA molecule in a region comprising a SNP mutation, and whereby the SNP-specific remote toehold primer associates with the target DNA molecule; and (b) extending the mutant target hairpin of the SNP-specific remote toehold primer along the target DNA molecule with a DNA polymerase molecule and monomers to be incorporated into the extended remote toehold, using the target DNA molecule as a template, wherein in the presence of the target DNA molecule comprising the SNP mutation, the mutant targeting remote toehold binds to the DNA template, leaving the 3’ end in position to prime polymerization by the DNA molecule, and wherein in the presence of the target DNA molecule not containing the SNP mutation, the remote toehold does not bind to the DNA template and prevents primer polymerization”
This embodiment is various forms is found replete throughout specification and in figures (see Fig. 3, Fig. 5, for example).
Therefore, the amendment introduces new matter (and its dependent claims 2-6) which must be removed.
Claim Rejections - 35 USC § 103
The rejection of claims 1-6 under 35 U.S.C. 103 as being unpatentable over Green et al. (Cell, 2014, vol. 159, pages 925-939) in view of Byrom et al. (Nucleic Acids Research, 2014, vol. 42, no. 15, e120, pages 1-13) and Toley et al. (Analyst, 2015, vol. 140, pages 7540-7549), made in the Office Action mailed on July 9, 2025 is withdrawn in view of the Amendment received on October 6, 2026.
The structure employed by Green et al. do not comprise a spacer in the presently claimed configuration and there exists no motivation to place such a region into the riboswitch of Green et al.
Double Patenting
The rejection of claims 1-6 on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,125,743 (herein, “the ‘743 patent”) in view of Byrom et al. (Nucleic Acids Research, 2014, vol. 42, no. 15, e120, pages 1-13) and Toley et al. (Analyst, 2015, vol. 140, pages 7540-7549), made in the Office Action mailed on July 9, 2025 is withdrawn in view of the Amendment received on October 6, 2026.
The structure employed by the claims of the ‘743 patent do not comprise a spacer in the presently claimed configuration and there exists no motivation to place such a region into the configuration claimed by the ‘743 patent.
Conclusion
No claims are allowed.
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.
Inquiries
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Young J. Kim whose telephone number is (571) 272-0785. The Examiner can best be reached from 7:30 a.m. to 4:00 p.m (M-F). The Examiner can also be reached via e-mail to Young.Kim@uspto.gov. However, the office cannot guarantee security through the e-mail system nor should official papers be transmitted through this route.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Gary Benzion, can be reached at (571) 272-0782.
Papers related to this application may be submitted to Art Unit 1681 by facsimile transmission. The faxing of such papers must conform with the notice published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 CFR 1.6(d)). NOTE: If applicant does submit a paper by FAX, the original copy should be retained by applicant or applicant’s representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED, so as to avoid the processing of duplicate papers in the Office. All official documents must be sent to the Official Tech Center Fax number: (571) 273-8300. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-1600.
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/YOUNG J KIM/Primary Examiner
Art Unit 1637 January 15, 2026
/YJK/