DETAILED ACTION Notice of 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. Status of Application Claims 1-12 are pending and subject to examination on the merits. Priority The instant application is a 371 of PCT/ JP2022 / 013700 filed 23 March 2022 which claims benefit of foreign priority document JP 2021-065373 filed 07 April 2023 is acknowledged. Said document has been received. Information Disclosure Statement The information disclosure statements (IDS) submitted on 03 January 2024, 24 March 2025 and 30 September 2025 have been considered by the examiner. See initialed and signed PTO/SB/08’s. Compliance with Sequence Rules The Specification/Drawings are objected to for lack of sequence compliance. The sequence listing, filed in computer readable form (.txt) on 05 October 2023 , has been received and entered. This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 C.F.R. § 1.821(a)(1) and (a)(2). However, this application fails to fully comply with the requirements of 37 C.F.R. § 1.821 through 1.825. The following Figure contain s sequences that contain four or more specifically defined amino acids or ten or more specifically defined nucleotides without any corresponding SEQ ID NO: and/or no reference to any SEQ ID NO: in the Brief Description of the Drawings. Figure 4 comprises three amino acid sequences in an alignment, each of the sequences require s a sequence identifier . * If the noted sequences are in the sequence listing as filed, Applicants must amend the specification to identify the sequences appropriately by SEQ ID NO: , which as noted can be in the Brief Description of the Drawings . If the noted sequences are not in the sequence listing as filed, Applicants must provide (1) an updated copy of the sequence listing containing the requisite sequences in computer readable form (.txt), (2) an amendment directing its entry into the specification, (3) a statement that no new matter has been added and (4) an amendment to the specification to identify the identified sequences by SEQ ID NO:, which can be in the Brief Description of the Drawings section of the specification (For Figures only) and (5) an incorporation by reference to an electronic sequence listing statement with the new date of creation, sequence file name and size. – See also MPEP 2422. Claim Objections Claim 1 is objected to because of the following informalities: the claim can be improved with respect to form and grammar by deleting “being indicated in” and substituting therefor “comprising”. Claim 1 is objected to because of the following informalities: the claim can be improved with respect to form and grammar by deleting “being indicated in” and substituting therefor “comprising” Appropriate correction is required. Claim Rejections - 35 USC § 112(b) 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. Claims 1-12 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim 1 (1), (2) and (3); claim 3 , claim 4 (1), (2) and (3); claim 10 (1), (2) and (3) render all of the claims (e.g. these claims and the claims which depend therefrom) for being indefinite in the recitation of the phrase “ an amino acid sequence set forth in SEQ ID NO: 1 ”. It is unclear whether the breadth of the claims is intended to encompass the full length sequence or fragments of said sequence. Accordingly, the metes and bounds of the phrase cannot be ascertained from the claims. Replacement of “an” with “the” in each of parts 1-3 of claims 1, 4 and 10 would overcome this rejection. In addition, regarding claim 3, the second and third “an” should be substituted by “the”. Dependent claims 2, 5-9 and 11-12 are included in this rejection as they do not remedy the noted deficiencies. Claim 12 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim 12 recites the limitation "observing fluorescence originating from the polypeptide or the fusion polypeptide " in reference to claim 1. There is insufficient antecedent basis for this limitation in the claim because claim 1 does not recite a fusion polypeptide. The rejection can be overcome by making claim 12 dependent on claims 1 and 9 and/or 10. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1-2 and 4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a natural phenomenon) without additional elements that integrate the judicial exception into a practical application. An analysis with respect to the claims as a whole reveals that they do not include additional elements that integrate the judicial exception into a practical application. See MPEP 2106 . Analysis of subject-matter eligibility under 35 U.S.C. § 101 requires consideration of the following steps: Step (1) whether the claim is directed to one of the four categories recited in §101 (process, machine, manufacture or composition of matter); Step (Revised 2A - Prong 1) do the claims recite an abstract idea (mathematical concepts, mental processes or method of organizing human activity), law of nature or natural phenomenon; Step (Revised 2A - Prong 2) do the claims recite additional elements that integrate the judicial exception into a practical application; and Step (2B) whether the claim as a whole recites something that amounts to significantly more than the judicial exception. (See 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG)). Step 1 : Yes; the claims are directed to a composition of matter. Step 2A – Prong 1: Yes, the claims recite a natural phenomenon, namely, a naturally occurring product/protein. Step 2A – Prong 2: No, the claims do not recite any additional elements that integrate the judicial exception into a practical application because the claims are merely drawn to what already exists in nature. The claims encompass polypeptides (and nucleic acids encoding said polypeptides) having at least 85% identity to SEQ ID NO: 1; or polypeptide having 1 to 32 insertions, deletions, substitutions in SEQ ID NO: 1, wherein said sequence has at least 85% identity to SEQ ID NO: 1; and a polypeptide comprising SEQ ID NO: 1, or as interpreted above, those having multiple fragments thereof . It is noted, SEQ ID NO: 1 (referenced as StayGold , which is polypeptide CU17S with a V186A substitution), wherein this polypeptide is a variant of naturally occurring SEQ ID NO: 4 (referenced as CU17S) in the specification. CU17S is a naturally occurring fluorescent polypeptide isomer isolated from Cytaeis uchidae – See Example 1 and Hirano et al. (Nature Biotechnology, 2022 – cited IDS 03/24/2025 ), which is Applicant’s own post-filing art, See Results and Materials and Methods. Thus, for instance, any polypeptide having one amino acid change, which is inclusive of the reverting Ala 186 back to the naturally occurring Val, thus, reads on the naturally occurring protein and polynucleotides encoding. This is inclusive of part (3) of both claims 1 and 4 because reciting polypeptides having at least 85% identity to SEQ ID NO: 1, include those, for instance having 216/217 and those having 99.5% identity to SEQ ID NO: 1, and again reverting the Ala at position 186 back to the naturally occurring Val. Step 2B: As noted in answering that of 2A – Prong 2 above, there is nothing in the claims which amounts to significantly more in terms of structure and/or function and the claims read on naturally occurring enzymes. Thus, the claims are drawn to a judicial exception, namely, a naturally occurring product. This rejection can be overcome by inserting , for example, a wherein clause at the end of parts (2) and (3), reciting something like: “ and wherein amino acid 168 is an alanine and which is not permitted to be substituted . ” ( Thus also making the presence of claim 3 redundant). Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SUZANNE M NOAKES whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-2924 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F (7-4) . 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 Manjunath Rao can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-0939 . 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. /SUZANNE M NOAKES/ Primary Examiner, Art Unit 1656 02 March 2026