DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 2/17/2026 has been entered.
Response to Arguments
Applicant's arguments filed 2/17/2026 have been fully considered but they are not persuasive.
Applicants have amended SEQ ID NO: 12 of the Sequence Listing, which previously included an additional 25 amino acids at the C-terminus; these 25 residues have been removed from SEQ ID NO: 12 in the current RCE filing. Applicant’s position is that this is a typographical error, a notion that is supported by additional context within the application, including that other AAV9’s recited in the claim have amino acid sequence lengths similar in size to the now amended SEQ ID NO: 12 and that SEQ ID NO: 13, which encodes SEQ ID NO: 12, produces a protein product equivalent to the newly amended SEQ ID NO: 12.
However, based on the originally filed application, it is not self-evident that the extra 25 amino acids at the C-terminus of SEQ ID NO: 12 is an obvious typographical error, even taking the above described context into consideration. Therefore, this correction to the Sequence Listing is being treated as new matter and has been rejected below.
Claim Status
In the latest claim set filed on 9/9/2025, claims 1, 2, 5-9, 13, 16-18, 20-24 were pending, with claims 16 and 17 withdrawn and claims 3, 4, 10, 11, 14, 15, and 19 cancelled. This claim set was amended in the Notice of Allowance and Examiner’s Amendment from 12/16/2025, wherein claim 9 was amended such that “a rhabdomyolysis” was cancelled and 12 was cancelled, and claims 1, 2, 5-9, 13, 18, 20-24 were allowed. Thus, currently, claims 1, 2, 5-9, 13, 18, 20-24 are pending under examination.
Priority
The instant application is an RCE of the national stage entry of PCT/EP2019/060790, filed 4/26/2019, which claims priority to the foreign application EP18169822.6, filed 4/27/2018. The priority date of 4/27/2018 is acknowledged.
Nucleotide and/or Amino Acid Sequence Disclosures
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 specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, 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.
See Pg 2, line 4 and below
Specification
The amendment filed 2/17/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: SEQ ID NO: 12 of the Sequence Listing, as described above and below.
Applicant is required to cancel the new matter in the reply to this Office Action.
The disclosure is objected to because of the following informalities: Pg 2, line 4 lists an amino acid sequence with 4 or more specifically defined and enumerated residues and therefore requires a SEQ ID NO. See MPEP 2422 and 37 C.F.R. 1.821. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claim 24 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(s) 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.
As stated above, Applicants have amended the Sequence Listing such that SEQ ID NO: 12 recites a truncated version of the amino acid sequence, but it is not self-evident that this is a typographical error and, consequently, is being treated as new matter.
This is a new matter rejection.
Summary of Claims and Allowable Subject Matter
Claims 1, 2, 5-9, 13, 18, 20-23 are allowed.
Claim 24 is rejected.
Claims 16 and 17 are withdrawn.
Claims 3, 4, 10, 11, 14, 15, and 19 are cancelled.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sara E Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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