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
Priority
This application claims priority to U.S. Provisional Application No. 63/214,021, filed June 23, 2021, that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 07/29/2024 is acknowledged. Claims 45-64 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/22/2023 and 06/26/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
Drawings
The drawing filed on 12/22/2023 are acknowledged and accepted by the Examiner.
Specification
The disclosure is objected to because of the following informalities: The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (page 71). 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. Appropriate correction is required.
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.
Claims 45-64 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Church et al. “Church” (WO2019221992, IDS of record dated 12/22/2023).
The claims are directed to a variant adeno-associated virus (AAV) capsid polypeptide having at least 95% identity to the VP1, VP2, or VP3 sequence of SEQ ID NO: 2, wherein the variant AAV capsid polypeptide comprises:
(a) a glutamine at a position corresponding to N449 as compared to SEQ ID NO: 1;
(b) a serine at a position corresponding to T450 as compared to SEQ ID NO: 1;
(c) a glycine at a position corresponding to P451 as compared to SEQ ID NO: 1;
(d) a glycine at a position corresponding to S452 as compared to SEQ ID NO: 1;
(e) an alanine at a position corresponding to T455 as compared to SEQ ID NO: 1;
(f) an alanine at a position corresponding to T456 as compared to SEQ ID NO: 1;
(g) an aspartic acid at a position corresponding to S458 as compared to SEQ ID NO: 1; and
(h) a glutamine at a position corresponding to R459 as compared to SEQ ID NO: 1.
Regarding claims 45-54 and 56, Church discloses “Described herein are viral vectors with modified tropism. Such vectors provide an improvement in the degree of tissue targeting attainable with such vectors. In particular, viral vectors with capsid polypeptide mutations that modify tropism of the viral particles relative to particles with wild-type capsid polypeptide are described. Through systematic mutation of viral capsid polypeptides, specific amino acid residues and amino acid regions have been identified that when mutated increase or decrease tropism of the virus for certain tissue or cell types. This provides the ability to increase the targeting of a given tissue or cell type by a viral vector, or, conversely, to decrease the targeting of a given tissue or cell type by a viral vector depending upon the site-specific mutation(s) introduced to the capsid polypeptide” (para. [0005]). Church discloses a variant capsid polypeptide comprising a polypeptide that has 100% identity to a VP1, VP2, or VP3 sequence of SEQ ID NO: 2 (abstract - "The technology described herein provides viral capsid polypeptides bearing mutations that alters tissue tropism of a virus comprising the viral capsid polypeptide."; para [0006] - "One aspect of the technology described herein provides a viral capsid polypeptide bearing a mutation relative to SEQ ID NO: 1 (WT AAV2) that alters tissue tropism of a virus comprising the viral capsid polypeptide, wherein the mutation is selected from the mutations in any one of Tables 1- 7."; Note-1, residues 1-137 and 138-202 are the VP1 and VP2 regions of SEQ ID NO: 2, see instant application pg 31; Note-2, SEQ ID NO: 1 of Church exhibits 99.1 % overall identity and 100% local identity from residues 1-448 with SEQ ID NO: 2 of the instant application, see below: Qy=SEQ ID NO: 2, Db= SEQ ID NO: 1 of Church).
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379
617
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224
613
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Church further discloses wherein the polypeptide comprises a variant of SEQ ID NO: 1, wherein the variant capsid polypeptide comprises a mutation that corresponds to a mutation at one or more positions of 35, 36, 37, 38, 39, 42, 51, 61, 70, 449, 450, 451, 452, 455, 456, 458, 459, or any combination thereof, as compared to SEQ ID NO: 1, optionally wherein the mutation comprises an insertion, a deletion, or a substitution (para [0060]-[0061] - "As used herein,'mutation' refers to any change in the amino acid sequence, e.g., a substitution, insertion, or deletion of at least one amino acid .... To denote a deletion of an amino acid,(-) follows the amino acid position, e.g., A35(-) means amino acid 35 (alanine) is deleted from the sequence .... The following provides mutations to the AAV2 capsid polypeptide of SEQ ID NO: 1 that provide tropism altered by the indicated degree for cells of the indicated tissues ... "; Table 1 - "Amino acid alteration ... A35(-), E36(CDGV) ... R37(GV) ... H38K ... N449H ... T450(FS) ... T455(GMS), T456A ... "; Note-1, SEQ ID NO: 1 of Church exhibits 100% identity with SEQ ID NO: 1 of the instant application).
Regarding claims 55 and 57, Church discloses a promoter operably linked to a heterologous transgene (para. [0047]).
Regarding claims 58-61, Church discloses host cells comprising a variant capsid polypeptide and nucleic acid molecule of variant AAVs (para. [0045]).
Regarding claims 62-63, Church discloses method of delivering/producing an AAV particle comprising introducing a nucleic acid molecule to a cell (claims 14-27 of Church).
Regarding claim 64, Church discloses a recombinant AAV capsid comprising the VP1 or VP2 of SEQ ID NO: 2 and a minigene having AAV inverted terminal repeats and a transgene (para. [0047]).
Therefore, the cited prior art anticipates the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 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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/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672
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