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. DETAILED ACTION Election/Restrictions Applicant’s election without traverse of Group II, corresponding to claims 15, 19-23 in the reply filed on 01/07/2026 is acknowledged. Applicant’s election, without traverse, of SEQ ID NO: 20, encoded by the nucleotide of SEQ ID NO: 6 is also acknowledged. Claims 1, 24-27, 30-33, 35-36, 38, 43, 47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 15, 19-23 are under consideration. Priority Provisional application #63/019, 658 is acknowledged and the effective filing date of 05/04/2020 used for examination. Information Disclosure Statement The information disclosure statement (IDS) submitted on 11/02/2022, 11/22,2022, 06/21/2024, and 09/04/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Objections Claims 15, 21, 23 are objected to because of the following informalities: Claim 15 : Spell out the acronym AAV. Claim 21 : Change “and or” to “and/or”. Claim 23 : For consistency with other claims, add a comma after “claim 15” and additional language like “wherein the AAV capsid protein is”. For example, “of claim 15, wherein the capsid protein is covalently linked…”. 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 appl icant regards as his invention. Claim s 20 - 22 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 20 and 22 : Both the AAV8 capsid protein comparative sequence and the corresponding amino acids in other serotypes are not identified. As a result, it is not clear what the position numbers are relative to or what/where position 1, for example, is located . Claim 21: The AAV 8 capsid protein appears to lack antecedent basis. It is unclear which AAV 8 capsid protein is being disclosed. A GenBank identifier will improve clarity. The meaning of “corresponding amino acids in other serotypes” is also unclear; the metes and bounds/limits of the language is not specified. In line 2, it is unclear if “chimeric capsid protein” refers to a “chimeric AAV capsid protein” or any chimeric capsid protein. 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. Claim s 15 and 23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. This judicial exception is not integrated into a practical application and claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. See MPEP § 2106.04 for analysis parameters. The instant claims are drawn to a adeno-associated virus (AAV) capsid protein s with mutations, i.e., composition of matter, which is a statutory category of inventions (Step 1: YES) . Instant clai m 15 recite s AAV capsid protein comprising an amino acid sequence at least 90% identical [to the elected SEQ ID NO: 20] . Instant claim 23 recites AAV capsid protein of claim 15 covalently linked, bound to, or encapsidating a compound selected from the group consisting of a DNA molecule, an RNA molecule, a polypeptide, a carbohydrate, a lipid, and a small organic molecule. Gao et al. (2004) teaches t he “presence of latent AAVs that are widely disseminated throughout human and nonhuman primates and their apparent predisposition to recombine and to cross species barriers raise important issues. This combination of events has the potential to lead to the emergence of new infectious agents with modified virulence” (p. 6387). Gao et al. ( 2004 ) also teaches a full capsid protein with an amino acid sequence that has 96% similarity to instant application SEQ ID NO: 20 (See Result 2, Q6JC59_9VIRU , us-17-997-791-20.align450.rup, 2/17/2026 in supplemental content tab). With respect to claim 23, a naturally occurring AAV capsid protein can also encapsidate nucleic acids, etc. As such, the instant claims recite judicial exceptions (JE) in the form of a law of nature (Step 2A, Prong One: YES) . The instant claims 15 and 23 are drawn only to adeno-associated virus (AAV) capsid protein. As such, the claims are limited to only the JE and do not recite any additional elements that integrate the JE into a practical application (Step 2A, Prong Two: NO) . As discussed above, the instant claims do not recite any additional elements beyond the JE itself. It was well understood, as noted above, that AAVs have a predisposition to recombine and mutations could arise. As such, the instant claims do not recite any additional elements that amount to significantly more than the JE (Step 2B: NO) . Accordingly, the instant claims do not constitute patent eligible subject matter under 35 U.S.C. § 101. Claim Rejections - 35 USC § 102 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. (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. Claim s 15 , 20 , 22- 23 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Gray et al. (Gray)( WO2016081811-A1 ) (See PTO-892 Notice of References Cited) . Regarding claim 15 , Gray teaches recombinant AAV capsid protein, SEQ ID 109 [0097 – chimeric AAV capsid protein] with a 99.4% ident ity to SEQ ID NO: 20 (as recited in claim 15, “at least 90% identical”) (See Result 2, BDA63248, us-17-997-791-20.align450.rag , 2/16/2026, in supplemental content tab). Regarding claim 20 , Gray teaches recombinant AAV capsid protein, SEQ ID 109 with the following amino acid positions : 188L; 200P; 201N; 348E; 360Q; 383N; 725H; and 735P (See Result 2, BDA63248, us-17-997-791-20.align450.rag, 2/16/2026, in supplemental content tab). It is noted that SEQ ID 109 has amino acids in locations that are in common with the some of the listed claim mutations (see above, e.g., d) I188L, etc.) (as recited in claim 20, “comprising one or more of the following mutations”) . Regarding claim 22 , Gray teaches claim 15 and also teaches a K at the 531 position (See Result 2, BDA63248, us-17-997-791-20.align450.rag, 2/16/2026, in supplemental content tab). It is noted that SEQ ID 109 has an amino acid in location that is in common with the resulting mutation E531K. For both claims 20 and 22 , the claimed products appear to be the same as that of the prior art as taught by Gray even if the process by which the claim product and the prior art product were produced may potentially differ. As per MPEP 2113, Product-by-Process Claims [R-01.2024], I. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps : “[E] ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) . In this case, for example, a lysine is finally located at position 188 (like in 20 d) , a proline is finally located at position 200 (like in 20 e) , etc. Regarding claim 23 , Gray teaches reference claim 71 which refers to SEQ ID NO: 109 (The AAV capsid…comprising the amino acid sequences of any of the SEQ ID NOSL 108-128) and claim 72 which recites: The AAV capsid of any one of claims 64-71 covalently linked, bound to, or encapsidating a compound selected from the group consisting of a DNA molecule, an RNA molecule, a polypeptide, a carbohydrate, a lipid, and a small organic molecule. Accordingly, Gray teaches each and every aspect of claim s 15, 20, 22-23 . Claim 21 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bowles et al. (Bowles) (See PTO-892 Notice of References Cited). Bowles teaches a chimeric adeno-associated virus (AAV) capsid variant (designated AAV2.5) “ where four residues were substituted with AAV1 amino acids (Q263A, N705A, V708A, T716N, AAV2 numbering) and one AAV1 amino acid (T265, AAV1 numbering) was inserted into the AAV2 capsid… These mutations are all on the VRs of the virion surface (VR I and VR IX) ” (p. 444, Figure 1). The Q263A substitution is specifically in VR 1. Figure 1 shows correspondence with the VR1 loop of AAV8 (p. 444, Figure 1). Bowles also teaches Figure 3 Neutralizing antibody analysis to AAV2.5 which shows “ AAV2.5 with minimal change of 5 aa has antigenic properties that are distinct from those of the parental viruses suggesting that the engineered AAV2.5 capsid may eliminate the AAV2 or AAV1 antibody recognized epitopes or change virion three-dimension structure and such that it is less likely to be neutralized by the sera of animals pretreated with AAV2 and AAV1 ” (p. 446-447) . Accordingly, Bowles teaches the first embodiment (AAV capsid protein comprising one or more mutations in the variable region 1 (VR1 loop)) of claim 21. Allowable Subject Matter Claim 19 is objected (The AAV capsid protein of claim 15, comprising the amino acid sequence of SEQ ID NO: 20) to as being dependent upon a rejected base claim (e.g., claim 15), but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Conclusion No claims allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Claire Cornelius whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571) 272-0860 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F, 0930-1700 . 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 Thomas J. Visone can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 270-0684 . 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. /C.C./ Examiner, Art Unit 1672 /M FRANCO G SALVOZA/ Primary Examiner, Art Unit 1672