CTNF 16/955,380 CTNF 99950 DETAILED ACTION 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. Information Disclosure Statement 06-52 The information disclosure statement (IDS) submitted on January 29 th , 2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. Response to Amendment The amendment filed April 29 th , 2026 is acknowledged. Regarding the Office Action mailed January 30 th , 2026: The rejection set forth under 35 U.S.C. 112(a) is withdrawn in view of the amendments. 12-256 AIA New grounds of rejection are set forth below, as necessitated by the amendments and rejoinder of previously withdrawn claims . Election/Restrictions 08-45 Claim 1 is allowable. Claims 76, 79, 80, 86, 111, 112, 115, 116, and 119, previously withdrawn from consideration as a result of a restriction requirement, require all the limitations of the allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement related to the above noted claims as set forth in the Office action mailed on April 5 th , 2023, is hereby withdrawn and claims 76, 79, 80, 86, 111, 112, 115, 116, and 119 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler , 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01. The Examiner would like to note for the Applicant that claims 88, 90, 94, 97, 98, and 183 have not been rejoined as they are not drawn to the nucleic acid detection system of claim 1, as is noted for the other identified claims above. Claim Summary Claims 1, 71, and 88 have been amended. Claims 2-3, 4-28, 30-33, 35-38, 41-42, 44-46, 48, 51-53, 55, 57, 59-62, 64, 66, 68, 70, 72-75, 77-78, 81-85, 87, 89, 91-93, 95-96, 99-105, 107-108, 113-114, 117-118, 120-128, 130-140, 169-171, 177, and 181 have been canceled. Claims 182-183 have been added. Claims 1, 3, 29, 34, 39-40, 43, 47, 49-50, 54, 56, 58, 63, 65, 67, 69, 71, 76, 79-80, 86, 88, 90, 94, 97-98, 106, 109-112, 115-116, 119, 129, 141-168, 172-176, 178-180, and 182-183 are pending. Claims 88, 90, 94, 97, 98, and 183 are withdrawn from consideration as being drawn to a non- elected invention/species. Claims 1, 3, 29, 34, 39-40, 43, 47, 49-50, 54, 56, 58, 63, 65, 67, 69, 71, 76, 79-80, 86, 106, 109-112, 115-116, 119, 129, 141-168, 172-176, 178-180, and 182 are under examination and discussed in this Office action. Claim Rejections - 35 USC § 112(b) 07-30-02 AIA 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 3, 29, 34, 39-40, 43, 47, 71, 79, 80, 86, 106, 110, 112, 116, 129, 141-153, 165-168, 172-176 and 178-180 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 3 recites the limitation “further comprising nucleic acid amplification reagents to amplify the target nucleic acid”. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 3 depends, introduces “target nucleic acids” in the preamble of the claim, indicating that multiple target nucleic acids are being analyzed, each by a particular detection unit. Claim 129 is also rejected here for its dependence on claim 3 and not further clarifying the identified issue. Claim 29 recites the limitation "an activated CRISPR Cas protein". There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 29 depends, introduces “Cas protein”, not “CRISPR Cas protein”. Claims 34, 39-40, 43, 141-148, and 172-176 are also rejected here for ultimately depending from claim 29 and not further clarifying the identified issue. Claim 47 recites the limitation “wherein the one or more guide molecules designed to bind to corresponding target nucleic acids comprise a mismatch”. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 47 depends, introduces “one or more guide molecules directing the Cas protein to a target nucleic acid”, not “one or more guide molecules designed to bind to corresponding target nucleic acids”. Claims 149-153 are also rejected here for their dependence on claim 47 and not further clarifying the identified issue. Claim 71 recites the limitation "is designed to bind the corresponding target nucleic acids prior to detection". There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 71 depends, introduces “distinct target nucleic acids”, not “corresponding target nucleic acids”. Claims 165-168 are also rejected here for ultimately depending from claim 71 and not further clarifying the identified issue. Claim 79 recites the limitation “wherein the target nucleic acid” and “the target nucleic acid”. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 79 ultimately depends, introduces “target nucleic acids” in the preamble of the claim, indicating that multiple target nucleic acids are being analyzed, each by a particular detection unit. Claim 80 recites limitations connected by "or wherein" clauses. Because of this, the metes and bounds of the presented limitation lack clarity. It is unclear if the additional wherein clauses serve to define the individual discrete volumes spotted on a substrate, represent options separate from the substrate with spotted individual discrete volumes, or some other meaning. Claim 86 recites the limitation "guide molecules to the corresponding target nucleic acids" twice in the claim. There is insufficient antecedent basis for this limitation in the claim. The method of claim 86 comprises the nucleic acid detection system of claim 1, which first introduces aspects related to guide molecules. However, claim 1 introduces “one or more guide molecules directing the Cas protein to a target nucleic acid”, not guide molecules to corresponding target nucleic acids. Claim 106 recites the limitation "wherein said guide molecule comprises a spacer". There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 106 depends, indicates that there are multiple guide molecules in the system given that the system comprises two or more CRISPR-Cas detection unit, each detection unit comprising one or more guide molecules. Therefore, later reciting “said guide molecule” in claim 106 lacks antecedent basis. Claims 178-180 are also rejected here for their dependence on claim 106 and not further clarifying the identified issue. Claim 110 recites the limitation “the detectable positive signal with a (synthetic) standard signal”. It is unclear from this recitation if the aspect in the paratheses, synthetic, is a required aspect of the standard signal, or an optional aspect of the standard signal. Claim 112 recites limitations connected by "or wherein" clauses. Because of this, the metes and bounds of the presented limitation lack clarity. It is unclear if the additional wherein clauses serve to define the first and second molecules or the lateral flow strip, represent options separate from the first introduced first and second molecules or the lateral flow strip disease state, or some other meaning. Claim 116 recites limitations connected by "or wherein" clauses. Because of this, the metes and bounds of the presented limitation lack clarity. It is unclear if the additional wherein clauses serve to define the first and second molecules or the lateral flow strip, represent options separate from the first introduced first and second molecules or the lateral flow strip disease state, or some other meaning. Claim 116 recites the limitation "wherein the device comprises two CRISPR Cas systems and two detection constructs or four CRISPR Cas systems and four detection constructs". There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 116 ultimately depends, introduces “CRISPR-Cas detection units”, not “CRISPR Cas systems”. Claim 116 contains the trademarks/trade names FAM, Tye665 and Alexa Fluor 488. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph. See Ex parte Simpson , 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe fluorescent dyes and, accordingly, the identification/description is indefinite. Applicant may amend the claims to recite the specific chemical name(s) of the trademarked structure(s) and must include evidence (e.g., a citation from a catalog available at the time of filing) showing that the name(s) correspond(s) to the trademark(s). Allowable Subject Matter Claims 1, 49-50, 54, 56, 58, 63, 65, 67, 69, 76, 109, 111, 115, 119, 129, 154-164, and 182 are allowable over the prior art. Conclusion Claims 3, 29, 34, 39-40, 43, 47, 71, 79, 80, 86, 106, 110, 112, 116, 129, 141-153, 165-168, 172-176 and 178-180 are rejected. Claims 1, 49-50, 54, 56 , 58, 63, 65, 67, 69, 76, 109, 111, 115, 119, 129, 154-164, and 182 are allowable. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Allison E Schloop whose telephone number is (703)756-4597. The examiner can normally be reached Monday-Friday 8:30-5 ET. 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, Anne Gussow can be reached at (571) 272-6047. 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. /ALLISON E SCHLOOP/Examiner, Art Unit 1683 /Robert T. Crow/Primary Examiner, Art Unit 1683 Application/Control Number: 16/955,380 Page 2 Art Unit: 1683 Application/Control Number: 16/955,380 Page 3 Art Unit: 1683 Application/Control Number: 16/955,380 Page 4 Art Unit: 1683 Application/Control Number: 16/955,380 Page 5 Art Unit: 1683 Application/Control Number: 16/955,380 Page 6 Art Unit: 1683 Application/Control Number: 16/955,380 Page 7 Art Unit: 1683 Application/Control Number: 16/955,380 Page 8 Art Unit: 1683 Application/Control Number: 16/955,380 Page 9 Art Unit: 1683
Prosecution Insights