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 .
Claim Status
Claims 1-295, 299, 305, 308, and 310-312 are canceled.
Claims 315-318 are withdrawn.
Claims 296-298, 300-304, 306-307, 309 and 313-314 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/01/2025 is being considered by the examiner.
Objections Withdrawn
Nucleotide and/or Amino Acid Sequence Disclosures
The objection over Figures 20-21 for containing an amino acid sequence not accompanied by sequence identifier is withdrawn in view of Applicant’s amendments to their legends.
Claim Objections
The objection to claim 313 is withdrawn in view of Applicant’s amendments.
Rejections Withdrawn
Claim Rejections - 35 USC § 112
The rejection of claims 313-314 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in view of Applicant’s amendments.
Rejections Maintained
Claim Rejections - 35 USC § 103
Claim(s) 296-298, 300-304, 306-307 and 313-314 remain rejected under 35 U.S.C. 103 as being unpatentable over Campana (US2013/0266551, published 10/10/2013) in view of Chaudhary (US2022/0204582, priority to 12/02/2016, previously cited), Rosa (US2016/0326232, published 11/10/2016, previously cited), and Odani (US2009/0155277, published 06/18/2009).
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered but are not found persuasive.
First it is noted that the claims have been amended. Most changes are grammatical in nature and have no effect on claim scope. However, one change does affect scope and that is the stipulated N-terminus to C-terminus order of the ectodomain components in all claims. This amendment does not obviate the rejection as the required order would have been obvious to PHOSITA as said order was set forth with reference to the related molecule of Campana in the office action dated 01/19/2024 on page 14. As the modified centyrin of Rosa discussed on record replaces the scFv of Campana in the obvious molecule previously discussed, all structurally features of the amended claims are met by the rejection.
Applicant the presents arguments. The first are old arguments they wish incorporated from past responses. These have already been addressed on record. See the previous actions. They were not and art not found persuasive.
Applicant argues that no methionine is needed at the N-terminus of the centyrin in the obvious molecule since the centyrin is not the first domain of the protein and thus does not need a start codon. However, the examiner did not argue the centyrin needed a start codon but rather the centyrin of Rosa would be envisioned with the methionine above and this functional variant would have been obvious to use in the obvious CAR here. See the office action dated 01/19/2024 on page 16-17.
Taken together, this rejection must clearly stand.
New Objections
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 - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
The size is in KB and not bytes. It must be amended to bytes.
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 incorporation-by-reference paragraph, 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.
Conclusion
Claim 309 is allowed.
THIS ACTION IS MADE FINAL. 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 MICHAEL D ALLEN whose telephone number is (571)270-3497. The examiner can normally be reached Mon-Fri 10-6.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michael Allen/Primary Examiner, Art Unit 1642