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
Status of Claims
Claims 41-60 were pending.
Claims 41-45, 47, 49, 50, 52, 54-57, 59, 60 are amended.
Claim 58 is canceled.
Claims 61-66 are new.
Claims 41-57, 59-66 are under consideration.
Drawings & Nucleotide and/or Amino Acid Sequence Disclosures
(previous objection; withdrawn) REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," 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 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) 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") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) 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 of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated 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 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.
Applicant contends: The brief description of the drawings has been amended to recite the SEQ ID NOs of the reference capsids included in Figures 1A-1C..
Office response: Based on the amendment, the objection is withdrawn.
Specification
(previous objection; withdrawn) The abstract of the disclosure is objected to because (1) rather than being a summary of the invention as a whole, it uses incomplete language like “The disclosure is directed in part to” and (2) it fails to mention “adeno-associated virus” which is the basis of the invention; “variant capsid polypeptides” is too vague.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant contends: The abstract has been amended and now recites, inter alia, "adeno-associated virus capsid polypeptides."
Office Response: Based on the amendment to the abstract, the objection is withdrawn.
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 on page 59. 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.
Applicant contends: The specification has been amended to remove any such embedded hyperlinks (see, e.g., page 60 of the Substitute Specification submitted herewith).
Office response: Based on the amendment, the objection is withdrawn.
The use of the term RNAlater® on page 62, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears 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.
Applicant contends: The specification has been amended to include generic terminology to accompany the term RNAlater (see page 62 of the Substitute Specification submitted herewith). Applicant notes that the term "RNAlater" in the specification is accompanied by the appropriate symbol (®).
Office response: Based on the amendments, the objection is withdrawn.
Claim Objections
(previous objection; withdrawn) Claims 50, 52, 54, 56 are objected to because of the following informalities:
Claims 50, 54: Change “the AAV variant capsid” to “the variant AAV capsid” for consistency with claim 41.
Claim 52, 56: Change “the AAV variant capsid” to “the variant AAV capsid” for consistency with claim 47.
Appropriate correction is required.
Applicant contends: Claims 50, 52, 54, and 56 as amended recite, inter alia, "the variant AAV capsid polypeptide." Accordingly, Applicant requests that these objections to the claims be withdrawn.
Office response: Based on the amendments, the objection to claims 50, 52, 54, and 56 is withdrawn.
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.
(previous rejection; claim canceled; rejection moot) Claim 58 is 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 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.
Applicant contends: Without conceding to the objection, and purely to expedite prosecution, claim 58 has been cancelled, rendering the objection moot. Applicant requests that the rejection under 35 U.S.C. § 112(a) be withdrawn.
Office response: Applicant canceled claim 58 and as a result, the rejection is moot.
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 applicant regards as his invention.
(previous rejection; withdrawn for claims 41-60) Claims 41-60 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.
See claims 41-57, 59, 60 as submitted 07/07/2026.
Applicant contends: Solely to expedite prosecution, claims 41-45 have been amended to recite, inter alia, "to the amino acid sequence of SEQ ID NO: 2 or to the VP2 or VP3 portion thereof." Claim 47 has been amended to recite, inter alia, "comprising the amino acid sequence of SEQ ID NO: 2 or the VP2 or VP3 portion thereof." Claim 60 has been amended to recite, inter alia, "comprising the amino acid sequence of SEQ ID NO: 2."
Applicant submits that the meets and bounds of claims 41-45, 47, and 60 are clear. SEQ ID NO:2 corresponds to the amino acid sequence of the VP1 capsid polypeptide of capsid variant "VAR-1" (see the specification at Table 1, pages 22-23). This VP1 sequence comprises a VP2 portion and a VP3 portion, as indicated in Table 1 (where the starting amino acid of VP2 is underlined and the starting amino acid of VP3 is in bold). Accordingly, the recitation of the amino acid sequence of SEQ ID NO:2 and the VP2 and VP3 portion thereof is clear.
Claim 59 is rejected as depending from canceled claim 6. The dependency of claim 59 has been corrected to properly depend from claim 46.
Applicant requests that the rejections under 35 U.S.C. § 112(b) be withdrawn.
Office response: Based on the applicant’s amendments, the rejection of claims 41-57, 60 are withdrawn. Claim 58 was canceled and so the rejection is moot. Claim 59, however, as written does not match the argument supplied by the applicant. See new U.S.C. 112(b) rejection below.
(new rejection as necessitated by amendment) Claim 59 is 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.
See claim 59 as submitted 07/07/2026.
Claim 59: Claim 59(a) recites “introducing a nucleic acid molecule of claim 0 into a cell”. However, a claim 0 does not exist.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
(previous rejection; withdrawn) Claims 54-57 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
See claims 54-57 as submitted 07/07/2026.
Applicant contends: Without conceding in the propriety of the rejection, and solely to expedite prosecution of this application, Applicant has amended claims 54-57 to recite, inter alia, an "isolated host cell". Applicant requests that the rejection under 35 U.S.C. § 101 be withdrawn.
Office response: Based on the amendment, the rejection to claims 54-57 is withdrawn.
Conclusion
Claims 41-57, 60-66 are free of the prior art.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Claire Cornelius whose telephone number is (571)272-0860. The examiner can normally be reached M-F, 0930-1700.
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/C.C./Examiner, Art Unit 1672
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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