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. Election/Restrictions Applicant’s election without traverse of Group II (claims 10-20) in the reply filed on February 16, 2026 is acknowledged. Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 February 16, 2026. Thus, claims 10-20 are under examination. Information Disclosure Statement The Information Disclosure Statement filed February 29, 2024 has been considered. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Specification The disclosure is objected to because of the following informalities: An error message appears at the last line of paragraph [0080], which should be deleted. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at paragraphs [0067] and [00111] . 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. The use of the terms MONARCH RNA CLEANUP® at paragraph [0065] and ORIGINLAB® at paragraph {0075], which are trade names or marks used in commerce, has been noted in this application. The term s should be accompanied by the generic terminology; furthermore the term s should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term . Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Appropriate correction is required. Claim Objections Claims 13 and 16 are objected to because of the following informalities: At claim 13, line 2, “FAM” should be written out fully, followed by the acronym in parentheses. At claim 16, lines 1-2, the transcription factor names should be written out fully, followed by the acronyms in parentheses. Appropriate correction is required. Claim Rejections - 35 USC § 112 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 10 - 15 and 17-20 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. The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated: To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious" and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood , 107 F.3d at 1572, 41 USPQ2d at 1966; Regents of the University of California v. Eli Lilly & Co. , 43 USPQ2d 1398. Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. , the court stated: A written description of an invention involving a chemical genus, like a description of a chemical species, "requires a precise definition, such as by structure, formula, [or] chemical name," of the claimed subject matter sufficient to distinguish it from other materials. Fiers v. Revel , 984 F.2d at 1171,25 USPQA2d, 1601; In re Smyth , 480 F.2d 1376,1383, 178 USPQ 279,284 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is an unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus...") Regents of the University of California v. Eli Lilly & Co. , 43 USPQ2d 1398. The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is "not a sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. The MPEP does state that, for a generic claim, the genus can be adequately described in the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number of species to adequately describe a broad genus. In Gostelli , the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli , 872 F.2d at 1012, 10 USPQ2d at 1618. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include: (1) Actual reduction to practice, (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. Complete structure, ii. Partial Structure, iii. Physical and/or chemical properties, iv. Functional characteristics when coupled with a known or disclosed structure, and v. Correlation between function and structure), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art. A "representative number of species" means that the species, which are adequately described, are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. This disclosure of only one or a few species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem , 323 F.3d at 966, 63 USPQ2d at 115; Noelle v. Lederman , 355 F.3d, 1343, 1350, 69 USPO2d 1508, 1514 (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). In addition, it has been well known that minor structural differences even among structurally related compounds can result in substantially different biology, expression, and activities. The instant claims require that the biosensor s comprise a plurality of binding proteins . The rejected claims thus comprise a genus of proteins that bind to a substrate comprising an operator sequence . To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of a complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, and any combination thereof. The specification states that “the biosensor further includes a synthetic double-st ra nded DNA (dsDNA) substrate, selected based on a corresponding DNA binding protein for which the target analyte serves as ligand .” See paragraph [0033] . However, it is impossible for one to extrapolate from the generic recitation of broad classes of binding proteins that would be useful in a biosensor . The prior art does not appear to offset the deficiencies of the instant specification. The prior art teaches the determination of over three dozen new structures of binding proteins, such as p53 tumor suppressor and the amino-terminal fragment of E. coli DNA topoisomerase I (Nelson (5 Current Opinion in Genetics and Development 180-189 (1995)) (abstract) . Nelson further disclose helix-turn-helix domain, tethered helix-turn-helix domains and Hin recombinase minor groove finding with arms (pages 180-181). Deplancke et al. (166 Cell 538-554 (2016) disclose that transcription factor DNA binding interactions are considered drivers of phenotypic variation (abstract). Deplancke further discloses that transcription factor DNA binding events are not driven by sequence alterations in the motif of the transcription factor, which implies that the mechanism underlying TF-DNA binding variation and inter-individual phenotypic variation are more complex than anticipated. Thus, the variation in DNA binding factors, and even in transcription factors are complex and are not extrapolatable to other DNA binding factors. The description of the limited sources binding proteins is not sufficient to support the genus of such proteins . Vas-Cath Inc. v. Mahurkar , 19USPQ2d 1111, clearly states "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed.” ( See Vas-Cath at page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is now is claimed." ( See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of B-cell sources, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation or identification. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel , 25USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd. , 18USPQ2d 1016. Therefore, the skilled artisan would have reasonably concluded applicants were not in possession of the claimed invention for claims 10-15 and 17-20. 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 appl icant regards as his invention. Claim s 12 and 14 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. At claim 12, lines 4-6, it is not clear if the substrate, the binding protein, and the gRNA are each provided in separate wells, or if these components are provided in the same well. For the purpose of examination, this is interpreted as the components all being provided in the same well. Claim 14 depends from claim 12, and is therefore included in this rejection. 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 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. Claims 10-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mahas et al. (94 Analytical Biochemistry 4617-4626 (March 10, 2022)) in view of Aman et al. (9 ACS Synthetic Biology 1226-1233 (2020)). Regarding claim 10, Mahas discloses biosensors that can detect various molecules (abstract). Mahas discloses that the biosensor platform is based on allosteric transcription factor-regulated expression of a CRISPR array (abstract). Mahas discloses that the biosensor discloses target sequences (i.e. operator sequences) that comprise protospacer adjacent motif-flanked Cas12a target sequences (abstract and page 4618, column 1, second and third full paragraphs ). Mahas discloses that the Cas12a has collateral single stranded DNAse activity (abstract). Mahas discloses the presence of a ssDNA reporter construct comprising a detectable tag (abstract). Mahas discloses that the biosensor comprises a guide RNA sequence (page 4618, column 1, first paragraph). Regarding claim 11, Mahas discloses that the biosensor can use paper strip readouts and a lateral-flow based readout or a microplate 384-well flat-bottom plate (page 4618, column 2, second full paragraph and paragraph bridging pages 4624 and 4625). Regarding claim 12, Mahas discloses that an ssDNA FAM reporter (page 4618, column 2, second full paragraph). Regarding claim 13, Mahas discloses that the reactions can include a transcription factor, the Cas12a, ssDNA FAM reporter, and the ligand in a microplate 384-well flat-bottom plate (page 4618, column 2, second full paragraph). Regarding claim 14, Mahas discloses that the detectable tag is a fluorophore-quencher pair (abstract). Regarding claim 15, Mahas discloses that the binding sequence can be a transcription factor (abstract). Regarding claim 16, Mahas discloses that the transcription factor can be TetR (abstract and page 4618, column 2, second full paragraph). Regarding claim 17, Mahas discloses that the Cas nuclease is Cas12a (abstract and page 4618, column 1, second full paragraph and column 2, second full paragraph). Regarding claim 19, Mahas discloses that the biosensor components are lyophilized ( abstract, page 4618, paragraph bridging columns 1 and 2, and page 4625, column 1, final full paragraph). Regarding claim 20, Mahas discloses that the reagents can be lyophilized and rehydrated with the sample to be tested, including environmental water samples, and visual fluorescence readouts using a smartphone application and facilitates in-field deployment, which is interpreted as being a kit comprising the biosensor components. In addition, a kit is a collection of things and Mahas discloses all the items in the kit. Mahas does not explicitly disclose that the biosensor has multiple/plural components. Mahas does not disclose the source of the Cas12a. While Mahas does disclose use of FAM as a fluorescent indicator, Mahas does not disclose the use of biotin in the reporter system . Mahas does not explicitly disclose a kit with instructions for use. Regarding claim 10, Aman discloses biosensor using CRISPR/Cas systems (abstract). Aman discloses that Cas12a is amenable to multiplexing and enabling a single diagnostic test to identify multiple targets, which is interpreted as a plurality of systems for detection of nucleic acids (abstract). Aman discloses that collateral activity of Cas12a can be used to degrade a lab e led nucleic acid to produce a fluorescent signal (abstract). Regarding claim 11, Aman discloses use of a lateral flow system (abstract and Figure 1). Regarding claim 13, Aman discloses that the fluorescent system can be biotin and FAM (page 1230, paragraph bridging columns 1 and 2, and column 2, first full paragraph, and Figure 3). Regarding claim 17, Aman discloses that the CRISPR/Cas enzyme is Cas12a (abstract and Figure1). Regarding claim 18, Aman discloses that the Cas12a is LbCas12a, which is obtained from the Lachnospiraceae family (page 1229, column 1, first full paragraph).. Regarding claim 20, Aman d iscloses that diagnostics kit s cab be used for detection of analytes of interest ( paragraph bridging pages 1231 and 1232 ). It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to use Aman’s multiplexing, which would require a plurality of reagents used in Mahas’ diagnostic systems. One of ordinary skill in the art would have been motivated to use Aman’s multiplexing in Maha’s diagnostic system to detect multiple targets using a single assay, as disclosed by Aman. It would have been obvious to one of ordinary skill in the art bef ore the effective filing date of the claimed invention to use Aman’s LbCas12a in the biosensor of Mahas because both Mahas and Aman each use Cas12a in biosensor systems. One of ordinary skill in the art would have been motivated to use Aman’s LbCas12a in the biosensor of Mahas because it is a well known Cas12a. As such, one of ordinary skill in the art would have had a predictable and reasonable expectation of success in using Aman’s LbCas12a in Mahas’ biosensor. It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to use Aman’s biotin-FAM reporter in Mahas’ biosensor that employs FAM because the biotin-FAM reporter system because this allows for a portable, user-friendly, equipment-free lateral flow biosensor system . One of ordinary skill in the art would have been motivated to use Aman’s biotin-FAM reporter system because this enables portability and ease of use of the biosensor system to detect multiple analytes using a single biosensor system. It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention that the biosensor systems of both Mahas and Aman can be supplied in a kit form, which enables a portable and user-friendly biosensor kit that can be used to detect multiple analytes in a single biosensor system, and to include instructions on use of the kit. This provides for one of ordinary skill in the art to have been able to use the kit as required in order to detect the multiple analytes in a sample. Further, [w]here the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai , 367 F.3d 1336, 1339, 70 USPQ2d 1862,1864 (Fed. Cir. 2004). Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Peng et al. (320 Sensors & Actuators: B. Chemical 128164, 1-5 (2020), and cited in the Information Disclosure Statement filed February 29, 2024 ) disclose an aptasensor that is CRISPR-Cas12a-based for the sensitive and selective ATP detection (abstract). Peng et al. disclose that the system uses DNA-induced non-specific single-stranded DNA cutting activity that can be detected using apatamer mediated fluorescence (abstract). Peng et al. disclose that the ssDNA reporter is labeled with FAM and a black hole quencher (Figure 1). Pent et al. disclose that the Cas12a is LbCas12a (page 3, column 1, second full paragraph). Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT NANCY J LEITH whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (313)446-4874 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Thursday 8:00 AM - 6:30 PM . 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 NEIL HAMMELL can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 270-5919 . 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. FILLIN "Examiner Stamp" \* MERGEFORMAT NANCY J. LEITH Primary Examiner Art Unit 1636 /NANCY J LEITH/ Primary Examiner, Art Unit 1636