CTNF 18/268,156 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 08-25-02 1. Applicant’s election of Group II and species (option (a); probes PT0111, PT0112; N6 Lamp primer set; F3 primer from N6; trehalose; GuHcl; Type VI Cas (Cas13); spacer specific for N gene of SARS-CoV-2) in the reply filed on 2/12/2026 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without traverse (MPEP § 818.01(a)). 08-06 AIA Claim s 1-5, 7-11, 13, 14, 16, 23, 26, 28, 30, 31, 51, 52, 55, 59 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/12/2026 . Claims 32-38, 41-43, 45, 47, 49, 54, 56, 57 are under consideration . Information Disclosure Statement 2. The information disclosure statements (IDS) were submitted on 6/16/2023; 2/20/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Specification 07-29 AIA 3. The disclosure is objected to because of the following informalities: A. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 7. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. B. It is noted the specification submitted 2/12/2026 indicates “Clean Copy” but then “Marked up Copy” from pages 26-31. C. It is noted that [000232] contains internal editing commentary and appears incomplete. D. The Examples are numbered from Example 11, to Example 12, to Example 11. E. It is noted page 638 refers to Figure 17. However, no such Figure is included as the Figures only go to Figure 10. F. Pages 15, 256, 334, 622, among possibly others, refers to incomplete SEQ ID NOs:. G. Reference is made to Tables 5, 8. No such Tables are included . Appropriate correction is required. Claim Objections 07-29-01 AIA 4. Claim s 34, 36, 37, 45 are objected to because of the following informalities: As to claims 34, 36, 37, claims should recite SEQ ID NO: when referring to nucleotide sequences (See MPEP 2422; 2422.01). As to claim 45, for improved language, the claim should recite “claim 43, further comprising polyethylene” instead of “wherein there is” . Appropriate correction is required. Nucleotide and/or Amino Acid Sequence Disclosures 5. REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES Items 1) and 2) provide general guidance related to requirements for sequence disclosures. 37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted: In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying: the name of the ASCII text file; ii) the date of creation; and iii) the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying: the name of the ASCII text file; the date of creation; and the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended). When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical. Specific deficiencies and the required response to this Office Action are as follows: Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification at Table 1A, 1B, 2A, p. 322-324, 333, 334, Table 3, p. 617, p. 622, p. 684, p. 686 are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Required response – Applicant must provide: A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of: A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version); A copy of the amended specification without markings (clean version); and A statement that the substitute specification contains no new matter. Claim Rejections - 35 USC § 112 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. 07-34-01 6. Claims 34-38, 41 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. See claims 34-38, 41 as submitted 2/12/2026. As to claim 34, the claim recites “the probes”. There is insufficient antecedent basis for this limitation in the claim. Further, the claim recites “Table 9”. It is not clear what is being referred to as Table 9 is not included in the specification. As to claim 35, the claim recites “preferably”. It is not clear if the ensuing language is a limitation or not. As to claim 36, Tables 5, 8 are not included in the specification, thus it is not clear what is being referred to. Further, it is not clear if the elected species are listed in Table 1A or Table 1B, as the elected species are not referred to by PT0111 or PT0112, which are only referred to on page 684 of the specification. As to claim 37, Tables 5, 8 are not included in the specification, thus it is not clear what is being referred to. As to claim 38, the claim recites “complete” and “incomplete”. The terms “complete” and “incomplete” are relative terms which renders the claim indefinite. It is not clear what constitutes “complete” or “incomplete”. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. 07-30-01 AIA 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. 07-31-01 7. Claims 34, 36, 37 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. See claims 34, 36, 37 as submitted 2/12/2026. See also the 35 U.S.C. 112(b) rejection above. Claims 34, 36, 37 recite Tables 5, 8, 9 for which the instant specification does not teach or provide support. Claim Rejections - 35 USC § 102 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15 AIA 8. Claim s 32, 43 are rejected under 35 U.S.C. 102( a)(1)/(a)(2 ) as being anticipated by Johnson et al. (US20200362396)(cited in applicant's IDS submitted 6/16/2023) . See claims 32, 43 as submitted 2/12/2026. Johnson et al. teaches: detection and quantification of nucleic acids (abstract); including reagents for amplifying the target polynucleotide, solution comprising reagents to amplify target nucleic acid (interpreted to read upon extraction-free solution)[0123]; probe is double stranded DNA probe with reporter-quencher pair [0009]; reporter is fluorophore [0016]; one member of the pair is at 5’ end of the first sequence region, other member of pair is at the 3’ end of the sequence region [0009](as recited in claim 32); beads [0065](as recited in claim 43); nucleic acids on beads [0147](as recited in claim 43). Thus, Johnson et al. anticipates the instant claims . 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 9. Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US20200362396)(cited in applicant's IDS submitted 6/16/2023) as applied to claims 32, 43 above . See claim 35 as submitted 2/12/2026. Johnson et al. teaches concentration of reagents (Table 3, 5). Absent unexpected results, the recitation of claim 35 is considered to be those determined by routine optimization to one of ordinary skill in the art in view of Johnson et al. (See MPEP 2144.05: II. ROUTINE OPTIMIZATION: A.Optimization Within Prior Art Conditions or Through Routine Experimentation: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). 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 10. Claim s 33, 45 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al . as applied to claim s 32, 43 above, and further in view of Broughton et al. (WO2020257356)(PTO-892: Notice of References Cited) . See claim 33, 45 as submitted 2/12/2026. See the teachings of Johnson et al. above. It is noted Johnson et al. also teaches LAMP [0059]. Johnson et al. does not teach: wherein the amplification reagents are LAMP reagents comprising F3, B3, FIP, BIP, Loop Forward and Loop Reverse primers; PEG. Broughton et al. teaches: assays and detection of nucleic acids (title); including use of F3, B3 primers, FIP, BIP primers (p. 22); loop forward and backward primers (p. 207); buffers including PEG (p. 274). One of ordinary skill in the art would have been motivated to use reagents as taught by Broughton et al. with the reagents as taught by Johnson et al. Johnson et al. teaches detection of nucleic acids, and Broughton et al. also teaches detection of nucleic acids (See MPEP 2144.06: Art Recognized Equivalence for the Same Purpose: I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)). One of ordinary skill in the art would have had a reasonable expectation of success for using reagents as taught by Broughton et al. with the reagents as taught by Johnson et al. There would have been a reasonable expectation of success given the underlying materials and methods (detection of nucleic acids as taught by Johnson et al. and Broughton 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 11. Claim s 38, 41, 42, 57 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al . as applied to claim s 32, 43 above, and further in view of Tanner et al (U. S. Patent No, 10968493)(See PTO-892: Notice of References Cited) . See claims 38, 41, 42, 57 as submitted 2/12/2026. See the teachings of Johnson et al. above. It is noted Johnson et al. also teaches LAMP [0059]. Johnson et al. does not teach: wherein the composition is lyophilized, optionally wherein the composition is lyophilized as a complete formulation; optionally wherein the composition is lyophilized as an incomplete formulation and additional components are added later in resuspension buffer; comprising trehalose; guanidinium chloride (GuHCl). Tanner et al. teaches: diagnostic test using LAMP (title); wherein mix may be lyophilized (column 3, line 20)(as recited in claim 38); trehalose (Example 5)(as recited in claim 41); wherein GuHcl increases rate of reactions (Example 8)(as recited in claims 42, 57). One of ordinary skill in the art would have been motivated to use reagents as taught by Tanner et al. with the reagents as taught by Johnson et al. Johnson et al. teaches detection of nucleic acids using LAMP, and Tanner et al. also teaches detection of nucleic acids using LAMP (See MPEP 2144.06: Art Recognized Equivalence for the Same Purpose: I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)). One of ordinary skill in the art would have had a reasonable expectation of success for using reagents as taught by Tanner et al. with the reagents as taught by Johnson et al. There would have been a reasonable expectation of success given the underlying materials and methods (detection of nucleic acids as taught by Johnson et al. and Tanner 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. 12. Claims 47, 49, 54, 56 are rejected under 35 U.S.C. 103 as being unpatentable Johnson et al. as applied to claims 32, 43 above, and further in view of Zhang et al. (US20210292824)(See PTO-892; Notice of References Cited). See claims 47, 49, 54, 56, as submitted 2/12/2026. See the teachings of Johnson et al. above. Johnson et al. does not teach: further comprising one or more Cas proteins and at least one guide polynucleotide designed to form a complex with the one or more Cas proteins, optionally wherein the one or more Cas proteins is a Type Il Cas, Type V Cas, Type VI Cas, or a combination thereof; optionally wherein the Cas is a Cas12b; wherein the one or more Cas proteins is thermostable exhibiting nuclease activity at temperature of at least 50 °C; wherein the guide polynucleotide comprises a sequence selected from Aac guide types 1 to 5. Zhang et al. teaches: diagnostics (abstract); detection of nucleic acids [0005]; including amplification reagents including LAMP [0010]; including use of Type VI CRISPR-Cas [0073](as recited in claim 47); Type VI Cas protein is a thermostable case protein with a nuclease activity above at least 50° C [0073](as recited in claim 49); Cas13 [0221]; the Aac guide has 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% sequence similarity to any one of Type 1 to Type 5 guide sequence below [0147](as recited in claim 54); spacer for N gene of SARS-CoV-2 [0011]. One of ordinary skill in the art would have been motivated to use reagents as taught by Zhang et al. with the reagents as taught by Johnson et al. Johnson et al. teaches detection of nucleic acids using LAMP, and Zhang et al. also teaches detection of nucleic acids using LAMP (See MPEP 2144.06: Art Recognized Equivalence for the Same Purpose: I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)). One of ordinary skill in the art would have had a reasonable expectation of success for using reagents as taught by Zhang et al. with the reagents as taught by Johnson et al. There would have been a reasonable expectation of success given the underlying materials and methods (detection of nucleic acids as taught by Johnson et al. and Zhang 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 13. 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. 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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: 18/268,156 Page 2 Art Unit: 1672 Application/Control Number: 18/268,156 Page 3 Art Unit: 1672 Application/Control Number: 18/268,156 Page 4 Art Unit: 1672 Application/Control Number: 18/268,156 Page 5 Art Unit: 1672 Application/Control Number: 18/268,156 Page 6 Art Unit: 1672 Application/Control Number: 18/268,156 Page 7 Art Unit: 1672 Application/Control Number: 18/268,156 Page 8 Art Unit: 1672 Application/Control Number: 18/268,156 Page 9 Art Unit: 1672 Application/Control Number: 18/268,156 Page 10 Art Unit: 1672 Application/Control Number: 18/268,156 Page 11 Art Unit: 1672 Application/Control Number: 18/268,156 Page 12 Art Unit: 1672 Application/Control Number: 18/268,156 Page 13 Art Unit: 1672 Application/Control Number: 18/268,156 Page 14 Art Unit: 1672
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