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
The preliminary amendment filed 02/08/2024 is entered. Claims 2-12, 14-19, 25, 29, 35, and 37-60 are cancelled. Claims 1, 13, 20-24, 26-28, 30-34, 36, and 61 are pending and under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The instant application is a 371 of PCT application PCT/US2022/070009, which claims benefit of provisional application 63/134093. The effective filing date of the instant application is 01/05/2021, which is the filing date of the provisional application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 7/18/2024 and 01/09/2025 are 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
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 file size is written in kilobytes. The 37 CFR 1.823(b)(1) requirements require the size of the ASCII text file in 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.
Specification
The disclosure is objected to because of the following informalities:
In Table 2, in the sequence for SEQ ID NO: 6 for the scFv clone 15, the same sequence of amino acids, comprising of the claimed paired heavy and light chain CDRs for clone 15, has been written twice, which does not correspond to the length of DNA sequences in Table 1 corresponding to this amino acid sequence. This sequence is also in the sequence listing for SEQ ID NO: 6.
Color features are used to describe figures, such as Figure 4B (page 8). Color features are not resolvable in the grayscale drawings; thus, descriptions requiring color for understanding prevent clear understanding of the figures.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1, 13, 20-24, 26-28, 30-34, 36, and 61 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.
Claims 1, 13, 26, 36, and 61 are directed towards sequences by reference to Tables 3 and 4. Claims must distinctly claim the SEQ ID NO of each CDR and the distinct combination of these CDR in the claims. Claims 20-24 depend on claim 13 and fail to resolve the indefiniteness of their parent claim. Claims 27-28 and 30-34 depend on claim 26 and fail to resolve the indefiniteness of their parent claim.
Furthermore, claim 27 and 28 are directed towards sequences by reference to Table 1. Claims 30 and 31 are directed towards sequences by reference to Table 2. Claims must distinctly claim the SEQ ID NO of each sequence in the claims.
Regarding claims 21, 24, and 34, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 21, 24, and 34, the use of parentheses around limitations renders the claim indefinite because it is unclear whether the limitations within the parentheses are part of the claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO2008025964A2, filed 08/28/2007, published 03/06/2008; hereafter referred to as Barraclough et al.
Barraclough et al teaches an anti-AGR2 antibody, the hybridoma cell encoding this antibody, and methods for its use for prognosis, diagnosis, and treatment of cancer (Abstract and Claims).
Barraclough et al does not explicitly teach the anti-AGR2 antibody in a bispecific, or specifically a T cell bispecific, or as a chimeric antigen receptor. Barraclough et al does not explicitly teach the exact CDR sequence as the instant disclosure.
US10669337B2, effectively filed 07/25/2014, hereafter referred to as Irving et al.
Irving et al teaches the anti-AGR2 antibody in a T cell bispecific antibody (Table 1 and Claim 6). Irving et al does not explicitly teach the exact CDR sequence as the instant disclosure.
No claims are allowed.
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/B.C./Examiner, Art Unit 1645
January 30, 2026
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645