CTNF 17/956,078 CTNF 80847 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. DETAILED ACTION Election Restrictions 08-25 AIA 1. Applicant's election with traverse of Group III and species (Cas12; E7; cytokeratin 17; LAMP/RT-LAMP) in the reply filed on 11/18/2025 is acknowledged. The traversal is on the ground(s) that : the embodiments are directed to closely related subject matter, such that any prior art searches for the groups or species would substantially overlap; examination would not impose an undue burden . This is not found persuasive because : as indicated in the Restriction Action issued 6/18/2025, the Groups of inventions are independent or distinct for the reasons as indicated, and further there would be a serious search and/or examination burden if restriction were not required because: the inventions require a different field of search (searching different subclasses or electronic resources, or employing different search strategies of search queries); the inventions have acquired a separate status in the art due to their recognized divergent subject matter. Further, as to species, the species are independent or distinct because: (endonuclease; target; sequence) in the instant case, the products are separate products having distinct functions, distinct structures, and distinct physical, chemical and functional properties requiring separate searches of the prior art; (method of amplification) in the instant case, the different methods of amplification use patentably distinct steps, products and have patentably distinct effects. In addition, these species are not obvious variants of each other based on the current record; There is a search and/or examination burden for the patentably distinct species because at least the following reason(s) apply: the inventions require a different field of search (searching different subclasses or electronic resources, or employing different search strategies of search queries); the inventions have acquired a separate status in the art due to their recognized divergent subject matter . The requirement is still deemed proper and is therefore made FINAL. 08-05 AIA Claim s 1-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Invention , there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/18/2025 . Claims 13-20 are under consideration . Information Disclosure Statement 2. It is noted that applicant has not filed an information disclosure statement under § 1.97(c). Applicant is reminded of 37 CFR § 1.56, which details Applicant’s duty to disclose all information known to be material to patentability. Claim Objections 07-29-01 AIA 3. Claim 20 is objected to because of the following informalities: For improved clarity, claim 20 should recite “(LAMP or RT-LAMP)” . Appropriate correction is required. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-21-aia AIA 4. Claim s 13, 17, 18, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Doudna et al. (U.S. Patent No. 10253365)(See PTO-892: Notice of References Cited) . See claims 13, 17, 18, 20 as submitted 11/18/2025. Doudna et al. teaches: detecting target DNA in sample including: contacting sample with CRISPR/Cas effector protein (Cas12 (column 20, line 4)(as recited in claim 18)); endonuclease (as recited in claims 13, 17)), guide RNA, detector DNA; measuring signal produced by cleavage by the CRISPR/Cas effector protein (as recited in claim 13); wherein detector DNA includes fluorescence-emitting dye pair; in some cases targeting viral DNA (column 2, lines 5-23); including wherein target DNAs include HPV (column 15, line 30); high risk strains of HPV (column 55, line 3)(as recited in claim 13). Doudna et al. teaches wherein: sample includes cell lysate (column 16, line 8); including from a patient for the purpose of diagnosis (column 16, line 21)(as recited in claim 13); wherein sample is cell from cervical swab (column 18, line 44)(as recited in claim 13); sample comprising DNAs obtained from such cells (cell lysate (column 17, line 10)); use of kits (column 29, line 62; column 56, line 36))(interpreted as substrate as recited in claim 13); amplifying nucleic acid (column 20, line 53)(as recited in claim 13); using LAMP (column 23, line 38)(as recited in claim 20); including wherein sample is contacted with amplification components at the same time as effector protein; wherein effector protein is inactive and activated once nucleic acids have been amplified (column 22, line 64-column 23, line 2)(as recited in claim 13); detectable signal produced when ssDNA is cleaved (column 20, line 5)(as recited in claim 13). Thus, the method as instantly claimed is obvious in view of the teachings or suggestions of Doudna et al. One of ordinary skill in the art would have been motivated and had a reasonable expectation of success in arriving at the instantly claimed invention including lysing, capturing, amplifying, cleaving and detecting as recited in claim 13 in view of Doudna et al. Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention . 07-22-aia AIA 5. Claim s 14, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Doudna et al . as applied to claim s 13, 17, 18, 20 above, and further in view of Zhang et al. (US20210292721)(See PTO-892: Notice of References Cited) . See claim 14, 15 as submitted 11/18/2025. See the teachings of Doudna et al. above. It is noted Doudna et al. teaches target DNA to which the guide RNA hybridizes (column 10, line 25); targeting viral DNAs from HPV (column 15, line 30); using Cas12a as diagnostic to distinguish viral serotypes such as HPV (column 54, line 63). Doudna et al. does not teach target HPV oncogene E7. Zhang et al. teaches: compositions comprising Cas12b and guide molecule; method of using for diagnosing diseases (abstract); methods and compositions related to CRISPR-Cas systems [0004]; detection of nucleic acids [0006]; wherein HPV E7 may be targeted in cervical cancer [0625]. One of ordinary skill in the art would have been motivated to target E7 as taught by hang et al. with the method as taught by Doudna et al. Doudna et al. teaches targeting DNA from HPV using Cas proteins for detection, and Zhang et al., which also teaches targeting DNA from HPV using Cas proteins, teaches E7 as such a target (See MPEP 2144.06: Substituting equivalents known for the same purpose). One of ordinary skill in the art would have had a reasonable expectation of success for targeting E7 as taught by Zhang et al. with the method as taught by Doudna et al. There would have been a reasonable expectation of success given the underlying materials and methods (detecting nucleic acids as taught by Zhang et al. and Doudna et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art. Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention . 07-22-aia AIA 6. Claim s 14, 16 is rejected under 35 U.S.C. 103 as being unpatentable over Doudna et al . as applied to claim s 13, 17, 18, 20 above, and further in view of Hobbs et al. (“Loss of Keratin 17 induces tissue-specific cytokine polarization and cellular differentiation in HPV16-driven cervical tumorigenesis in vivo,” Oncogene 1-10 (2016)))(See PTO-892: Notice of References Cited) . See claims 14, 16 as submitted 11/18/2025. See the teachings of Doudna et al. above. Doudna et al. does not teach hrHPV marker sequence cytokeratin (K17). Hobbs et al. teaches: wherein cervical cancer is thought to be initiated by infection of cervical epithelia with high risk strains of HPV, type 16 or 18 (p. 1); wherein K17 (gene KRT17; protein K17) has emerged as a powerful diagnostic and prognostic biomarker with preferential expression in more advanced HSIL and SCC cervical lesions (p. 1); One of ordinary skill in the art would have been motivated to target K17 as taught by Hobbs et al. with the method as taught by Doudna et al. Doudna et al. teaches targeting DNA for detecting HPV including in cervical cell samples, and Hobbs et al. teaches gene of K17 as a powerful diagnostic biomarker in advanced cervical lesions (See MPEP 2144.06: Substituting equivalents known for the same purpose). One of ordinary skill in the art would have had a reasonable expectation of success for target K17 as taught by Hobbs et al. with the method as taught by Doudna et al. There would have been a reasonable expectation of success given the underlying materials and methods (detection of HPV as taught by Hobbs et al. and Doudna et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art. Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention . 07-22-aia AIA 7. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Doudna et al . as applied to claim s 13, 17, 18, 20 above, and further in view of Okano et al. (US20220090174)(See PTO-892: Notice of References Cited) . See claim 19 as submitted 11/18/2025. See the teachings of Doudna et al. above. Doudna et al. does not teach: modified magnetic bead of a test cartridge. Okano et al. teaches: detection methods for target nucleic acid (abstract); using CRISPR-Cas system to recognize and bind to sequences of target nucleic acid [0004]; including use of magnetic beads as substrate [0076]. One of ordinary skill in the art would have been motivated to use substrate as taught by Okano et al. with the method as taught by Doudna et al. Doudna et al. teaches use of kits and CRISPR/Cas for detection of nucleic acids, and Okano et al., which also teaches kits for detection of nucleic acids and CRISPR/Cas for detection of nucleic acids, teaches magnetic beads as such a substrate for use (See MPEP 2144.06: Substituting equivalents known for the same purpose). One of ordinary skill in the art would have had a reasonable expectation of success for using substrate as taught by Okano et al. with the method as taught by Doudna et al. There would have been a reasonable expectation of success given the underlying materials and methods (detection of nucleic acids as taught by Doudna et al. and Okano et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art. Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. Conclusion 8. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00. 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, Thomas Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672 Application/Control Number: 17/956,078 Page 2 Art Unit: 1672 Application/Control Number: 17/956,078 Page 3 Art Unit: 1672 Application/Control Number: 17/956,078 Page 4 Art Unit: 1672 Application/Control Number: 17/956,078 Page 5 Art Unit: 1672 Application/Control Number: 17/956,078 Page 6 Art Unit: 1672 Application/Control Number: 17/956,078 Page 7 Art Unit: 1672 Application/Control Number: 17/956,078 Page 8 Art Unit: 1672