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
1. Claims 50-58 are under consideration.
Information Disclosure Statement
2. The information disclosure statements (IDS) were submitted on 2/10/2025; 2/10/2025; 2/102025; 7/14/2025; 2/13/2026; 6/19/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
3. 37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the drawings (Fig. 1) are not identified by sequence identifiers in accordance with 37 CFR 1.831(c). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Amended drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers (i.e., “SEQ ID NO:X” or the like) into the Brief Description of the Drawings, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
4. Claims 51-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-29 of U.S. Patent No. 12116385 in view of Gao et al. (WO 2011133890 A1)(See PTO-892: Notice of References Cited).
See claims 51-58 as submitted 11/5/2024.
Claims 1-8, 10-29 of U.S. Patent No. 12116385 recite a variant adeno-associated virus (AAV) capsid polypeptide having at least 95% sequence identity to SEQ ID NO: 2, wherein the variant AAV capsid polypeptide comprises: (a) an alanine at a position corresponding to W595 as compared to SEQ ID NO: 1 (b) a leucine at a position corresponding to V596 as compared to SEQ ID NO: 1; and (c) a serine at a position corresponding to N598 as compared to SEQ ID NO: 1; further comprising a valine at a position corresponding to Q579 as compared to SEQ ID NO: 1 and optionally a valine at a position corresponding to T593 as compared to SEQ ID NO: 1; further comprising: a valine at a position corresponding to Q579 as compared to SEQ ID NO: 1; an isoleucine at a position corresponding to Q592 as compared to SEQ ID NO: 1; a valine at a position corresponding to T593 as compared to SEQ ID NO: 1; and an alanine at a position corresponding to 1601 as compared to SEQ ID NO: 1; comprising the mutation set of any one of SEQ ID NOs: 2, 14, 16, 18, 19, 21, 23, 24, 31, 34, 37, 38, 62, 98 and 128; comprising the amino acid sequence of any one of SEQ ID NOs: 2, 14, 16, 18, 19, 21, 23, 24, 31, 34, 37, 38, 62, 72, 98 and 128; a recombinant AAV virus particle comprising the variant AAV capsid polypeptide of claim 1; an isolated host cell comprising the variant AAV capsid polypeptide of claim 1.; a recombinant AAV virus particle comprising the variant AAV capsid polypeptide of claim 22; comprising a nucleic acid molecule comprising a promoter operably linked to a heterologous transgene. It is noted that U.S. Patent No. 12116385 teaches particles with increased CNS biodistribution (column 1, line 42).
Claims 1-30 of U.S. Patent No. 12116385 do not recite method of delivering; to CNS cell; glial cell.
Gao et al. teaches: recombinant AAV for targeting transgenes to CNS tissue (abstract); delivering to glial cell (p. 33)(as recited in claim 58); delivering transgene to CNS tissue comprising administering rAAV comprising capsid protein and transgene (p. 5)(as recited in claims 50, 57).
One of ordinary skill in the art would have been motivated to use AAV capsid protein as recited in claims 1-30 of U.S. Patent No. 12116385 with the method as taught by Gao et al. Gao et al. teaches delivering transgene to CNS tissue comprising administering rAAV comprising capsid protein and transgene, and claims 1-30 of U.S. Patent No. 12116385 recite such a capsid protein (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using AAV capsid protein as recited in claims 1-30 of U.S. Patent No. 12116385 with the method as taught by Gao et al. There would have been a reasonable expectation of success given the underlying materials (AAV capsid proteins as taught by Gao et al. and claims 1-30 of U.S. Patent No. 12116385) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
5. Claims 51-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12331081 in view of Gao et al. (WO 2011133890 A1)(cited above).
See claim 51-58 as submitted 11/5/2024.
Claims 1-30 of U.S. Patent No. 12331081 recite a variant adeno-associated virus (AAV) capsid polypeptide having at least 95% sequence identity to SEQ ID NO: 2 and comprising: (a) a leucine at a position corresponding to V596 as compared to SEQ ID NO: 1; (b) a serine at a position corresponding to N598 as compared to SEQ ID NO: 1; and (c) an alanine at a position corresponding to I601 as compared to SEQ ID NO: 1. It is noted that U.S. Patent No. 12331081 teaches particles with increased CNS biodistribution (column 1, line 39).
Claims 1-30 of U.S. Patent No. 12331081 do not recite method of delivering; to CNS cell; glial cell.
See the teachings of Gao et al. above.
One of ordinary skill in the art would have been motivated to use AAV capsid protein as recited in claims 1-30 of U.S. Patent No. 12331081 with the method as taught by Gao et al. Gao et al. teaches delivering transgene to CNS tissue comprising administering rAAV comprising capsid protein and transgene, and claims 1-30 of U.S. Patent No. 12331081 recite such a capsid protein (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using AAV capsid protein as recited in claims 1-30 of U.S. Patent No. 12331081 with the method as taught by Gao et al. There would have been a reasonable expectation of success given the underlying materials (AAV capsid proteins as taught by Gao et al. and claims 1-30 of U.S. Patent No. 12331081) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
6. Claims 51-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12655180 in view of Gao et al. (WO2011133890 A1)(cited above).
See claims 51-58 as submitted 11/5/2024.
Claims 1-24 of U.S. Patent No. 12655180 recite a variant adeno-associated virus (AAV) capsid polypeptide having at least 95% sequence identity to the VP1 polypeptide of SEQ ID NO:2 or a VP2 or VP3 portion thereof and comprising: (a) a valine at a position corresponding to T593 as compared to SEQ ID NO: 1; (b) a leucine at a position corresponding to V596 as compared to SEQ ID NO: 1; and (c) a serine at a position corresponding to N598 as compared to SEQ ID NO: 1; a recombinant AAV comprising: (a) an AAV capsid comprising AAV capsid polypeptides, each having at least 95% sequence identity to SEQ ID NO:2 and comprising: (i) a valine at a position corresponding to T593 as compared to SEQ ID NO: 1; (ii) a leucine at a position corresponding to V596 as compared to SEQ ID NO: 1; and (c) a serine at a position corresponding to N598 as compared to SEQ ID NO: 1; and (b) a minigene having AAV inverted terminal repeats and a transgene comprising a heterologous gene operably linked to regulatory sequences which direct expression of the heterologous gene in a host cell. It is noted that U.S. Patent No. 12655180 teaches particles with increased CNS biodistribution (column 1, line 47).
Claims 1-24 of U.S. Patent No. 12655180 do not recite method of delivering; to CNS cell; glial cell.
See the teachings of Gao et al. above.
One of ordinary skill in the art would have been motivated to use AAV capsid protein as recited in claims 1-24 of U.S. Patent No. 12655180 with the method as taught by Gao et al. Gao et al. teaches delivering transgene to CNS tissue comprising administering rAAV comprising capsid protein and transgene, and claims 1-24 of U.S. Patent No. 12655180 recite such a capsid protein (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using AAV capsid protein as recited in claims 1-24 of U.S. Patent No. 12655180 with the method as taught by Gao et al. There would have been a reasonable expectation of success given the underlying materials (AAV capsid proteins as taught by Gao et al. and claims 1-24 of U.S. Patent No. 12655180) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
7. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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