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. Claims 1-18 are pending. An action on the merits is set forth below. Claim Objections Claims 1-18 are objected to because of the following informalities: The claims have been amended, however, the amendment is described as “amended herein”. The descriptor should be amended to “Amended”. Claims 2-18 are further objected to as being depended on an objected claim. Appropriate correction is required. 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. Claim s 1-18 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 1-9 are indefinite over the phrase “not with Bst polymerase”. It is not clear if the limitation is intended to limit the kit (e.g. the kit does not comprise Bst) or if the limitation is intending to limit the instructions. Claims 10-1 6 are indefinite over the phrase “optionally a reverse transcriptase and LAMP primers”. This phrase is unclear as the LAMP assay requires primers and transcriptase to function and therefore it is not clear how these components can be option al in the method. In particular LAMP requires reverse transcriptase to convert RNA into cDNA before amplification. Claim 16 is indefinite over indefinite over “as little as”. The metes and bounds are unclear because it is not clear “as little as” requires less than or less than or equal and as such it is not clear the metes and bounds of the claim. Claims 17-18 are indefinite over the phrase “optionally a reverse transcriptase”. This phrase is unclear as the LAMP assay requires transcriptase to function and therefore it is not clear how these components can be optional in the method. In particular LAMP requires reverse transcriptase to convert RNA into cDNA before amplification. Further, claims 17-18 indefinite over “as little as”. The metes and bounds are unclear because it is not clear “as little as” requires less than or less than or equal and as such it is not clear the metes and bounds of 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) 1-2,7-11 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bashikirov et al. (US Patent Application Publication 2019/0360039 November 28, 2019). With regard to claims 1,2, Bashikirov et al. teaches a BSU DNA polymerase (para 149). The limitation that the kit contains instructions, the inclusion of instructions is not considered to provide a patentable limitation on the claims because the instructions merely represent a statement of intended use in the form of instructions in a kit. See In re Ngai, 367 F.3d 1336, 70 U.S.P.Q.2d 1862 (Fed. Cir. 2004) (holding that an inventor could not patent known kits by simply attaching new set of instructions to that product). The limitation of “with instructions for …” is considered printed instructions and does not limit the required structures. The term “kit” does not provide any structural limitations other than the structures recited. Therefore Bashikirov et al. teaches the required structures of the claims. With regard to claim 7, Bashikirov et al. teaches a reverse transcriptase (para 149). With regard to claim 8, Bashikirov et al. teaches LAMP using primers (para 149). With regard to claim 9, Bashikirov et al. teaches that that reagents can be placed on a substrate (e.g. immobilized on a matrix) (para 149). With regard to claim 10 -11 , Bashikirov et al. teaches a method of detecting target DNA comprising combining a sample with a reaction mixture with BSU LF and performing LAM P at 20 to 37 (which is encompassed by the range) and detecting (para 149). With regard to claim 16, Bashikirov et al. teaches a method wherein at least 10 copies is detected (para 149-160). Claim(s) 1, 4-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Doudna et al. (US Patent No. 10253365 April 9, 2019). With regard to claims 1,2, Doudna et al. teaches a BSU DNA polymerase (para 115). The limitation that the kit contains instructions, the inclusion of instructions is not considered to provide a patentable limitation on the claims because the instructions merely represent a statement of intended use in the form of instructions in a kit. See In re Ngai, 367 F.3d 1336, 70 U.S.P.Q.2d 1862 (Fed. Cir. 2004) (holding that an inventor could not patent known kits by simply attaching new set of instructions to that product). The limitation of “with instructions for …” is considered printed instructions and does not limit the required structures. The term “kit” does not provide any structural limitations other than the structures recited. Therefore Doudna et al. teaches the required structures of the claims. With regard to claims 4-6, Doudna et al. teaches the structure of Cas12a (para 105-106). Although Doudna et al. does not teach SEQ ID NO. 10, the structure of the CAS12A protein of Doudna et al. would encompass the sequence. With regard to claim 7, Doudna et al. teaches a reverse transcriptase (para 116). With regard to claim 8, Doudna et al. teaches LAMP using primers (para 116). With regard to claim 9, Doudna et al. teaches that that reagents can be placed on a substrate (e.g. immobilized on a matrix) (para 263). Claim(s) 1,3-9 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Ouellet et al. (WO2020099675 Publication Date 5/22/2020). With regard to claim s 1 ,3 , Ouellet et al. teaches a Klenow DNA polymerase ( p. 25 lines 1-2). The limitation that the kit contains instructions, the inclusion of instructions is not considered to provide a patentable limitation on the claims because the instructions merely represent a statement of intended use in the form of instructions in a kit. See In re Ngai, 367 F.3d 1336, 70 U.S.P.Q.2d 1862 (Fed. Cir. 2004) (holding that an inventor could not patent known kits by simply attaching new set of instructions to that product). The limitation of “with instructions for …” is considered printed instructions and does not limit the required structures. The term “kit” does not provide any structural limitations other than the structures recited. Therefore Ouellet et al. teaches the required structures of the claims. With regard to claims 4-6, Ouellet et al teaches the structure of Cas12a (p. 12 lines 6-10). Although Ouellet et al. does not specificat i on teach SEQ ID NO. 10, the structure of the CAS12A protein of Ouellet et al. would encompass the sequence. With regard to claim 7, Ouellet et al. teaches a reverse transcriptase (p. 6 lines 25-28). With regard to claim 8, Ouellet et al. teaches LAMP using primers (p. 45). With regard to claim 9, Ouellet et al. teaches that that reagents can be placed on a substrate (e.g. immobilized on a matrix) (p. 46 lines 5-20). 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) 4-6,12-15,17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bashikirov et al. (US Patent Application Publication 2019/0360039 November 28, 2019) in view of Doudna et al. (US Patent No. 10253365 April 9, 2019). Bashikirov et al. teaches a BSU DNA polymerase (para 149). The limitation that the kit contains instructions, the inclusion of instructions is not considered to provide a patentable limitation on the claims because the instructions merely represent a statement of intended use in the form of instructions in a kit. See In re Ngai, 367 F.3d 1336, 70 U.S.P.Q.2d 1862 (Fed. Cir. 2004) (holding that an inventor could not patent known kits by simply attaching new set of instructions to that product). The limitation of “with instructions for …” is considered printed instructions and does not limit the required structures. The term “kit” does not provide any structural limitations other than the structures recited. Therefore Bashikirov et al. teaches the required structures of the claims. Bashikirov et al. teaches a method of detecting target DNA comprising combining a sample with a reaction mixture with BSU LF and performing LAMP at 20 to 37 C(which is encompassed by the range) and detecting (para 149). With regard to claim 15, Bashikirov et al. teaches use of controls and reaction temperatures of less than 60C (para 149-152). With regard to claim 17, Bashikirov et al. teaches a method of detecting target DNA comprising combining a sample with a reaction mixture with BSU LF and performing LAMP at 20 to 37 C(which is encompassed by the range) and detecting (para 149). However, Bashikirov et al. does not teach a quencher and fluorophore or a Cas coupled LAMP. With regard to claim 18, Bashikirov et al. teaches a method of detecting target DNA comprising combining a sample with a reaction mixture with BSU LF and performing LAMP at 20 to 37 (which is encompassed by the range) and detecting (para 149). However, Bashikirov et al. does not teach the use of a CAS protein. With regard to claims 4-6, Doudna et al. teaches a BSU DNA polymerase (para 115). The limitation that the kit contains instructions, the inclusion of instructions is not considered to provide a patentable limitation on the claims because the instructions merely represent a statement of intended use in the form of instructions in a kit. See In re Ngai, 367 F.3d 1336, 70 U.S.P.Q.2d 1862 (Fed. Cir. 2004) (holding that an inventor could not patent known kits by simply attaching new set of instructions to that product). The limitation of “with instructions for …” is considered printed instructions and does not limit the required structures. The term “kit” does not provide any structural limitations other than the structures recited. Therefore Doudna et al. teaches the required structures of the claims. Doudna et al. teaches the structure of Cas12a (para 105-106). Although Doudna et al. does not teach SEQ ID NO. 10, the structure of the CAS12A protein of Doudna et al. would encompass the sequence. With regard to claim 12, Doudna et al. teaches methods of using the reaction mixture with a CAS protein (para 105-115). With regard to claims 13-14,17, Doudna et al. teaches methods of using guided Cas protein that binds to the target and FRET (quencher and a fluorophore ) (para 118-121). 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 method of Bashikirov et al. to further include the CAS guide and the FRET detection system of Doudna et al. The ordinary artisan would be motivated to use these structures and methods of detection in order to predictably detect DNA from a sample. As Doudna et al. teaches use of the LAMP method, the components taught by Doudna et al. would be predictable in other methods of LAMP usage including Bashikirov. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT KATHERINE D SALMON whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-3316 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 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, FILLIN "SPE Name?" \* MERGEFORMAT Wu Cheng (Winston) Shen can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 5712723157 . 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. /KATHERINE D SALMON/ Primary Examiner, Art Unit 1682