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 .
Status of Application, Amendments and/or Claims
The amendments of 03 March 2026 and 04 March 206 have been entered in full. Claims 34, 36, 38, 39, 43, 44, 46 are amended. Claims 1-33, 37, and 45 are cancelled. Claims 47-60 are added.
It is noted to Applicant that the claim status identifier for claim 36 still indicates that the claim is “previously presented”. The Examiner acknowledges that claim 36 has clearly been amended and that this amended version will be under consideration.
Furthermore, the status of claims 1-20 is missing. The Examiner acknowledges that claims 1-20 were cancelled in the amendment of 14 October 2020. Applicant must include the status of claims 1-20 in the next response.
Claims 34-36, 38-44, and 46-60 are under consideration in the instant application.
Drawings
The replacement drawings were received on 03 March 2026. These drawings are acceptable.
Withdrawn Objections and/or Rejections
1. The objections to the drawings as set forth at pages 4-6 of the previous Office Action of 03 November 2025 are withdrawn in view of the submission of replacement drawings (03 March 2026).
2. The Sequence Listing Requirement deficiency set forth at pages 6-8 of the previous Office Action of 03 November 2025 is withdrawn in part in view of Applicant’s sequence submission and amendment to the instant specification (04 March 2026). Please see remaining sequence issue set forth below.
3. The objections of claims 23, 25, 26, 28, 30, 32, 34-36, and 39-45 as set forth at pages 8-9 of the previous Office Action of 03 November 2025 are withdrawn in view of the amended and cancelled claims (03 March 2026).
4. The rejections of claims 24, 37, 38, and 44-6 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as set forth at pages 9-11 of the previous Office Action (03 November 2025) are withdrawn in view of the amended and cancelled claims (03 March 2026).
5. The rejection of claims 44-46 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph as set forth at pages 11-16 of the previous Office Action of 03 November 2025 are withdrawn in view of the amended claims (03 March 2026).
6. The rejection of claims 21-25, 27, 29, 31, 33, 38, and 43-46 under 35 U.S.C. 102(a)(1) as being anticipated by Jensen, M.C. (WO 2017/027291; published on 16 February 2017) as set forth at pages 16-18 of the previous Office Action of 03 November 2025 is withdrawn in view of the amended and cancelled claims (03 March 2026).
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.
7. 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. Specifically, the incorporation by reference paragraph does not identify the size of the file in bytes. Rather, the paragraph indicates that the file is 158 kilobytes (KB).
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.
7a. The Examiner acknowledges that Applicant submitted a clean/marked up specification in the Response of 04 March 2026 with an amended incorporation-by-reference paragraph. At page 12 of the Response of 04 March 2026, Applicant indicates that the specification has been amended with the incorporation-by-reference-statement for the material in the XML file. First, the incorporation-by-reference paragraph refers to the file size in “kilobytes” or “KB”. However, as discussed in the previous Office Action of 03 November 2025 and reiterated above, the size of the text file must be provided in bytes as required by item 1) a) or 1) b), above. Second, it is noted to Applicant that the instant application was filed before 01 July 2022 and thus, sequence rules based on ST.25 apply (not ST.26).
New Claim Objections
8. Claims 34, 43, 44, and 52-56 are objected to because of the following informalities:
8a. In claim 34, line 3 there is a word missing after the phrase “polynucleotide encodes”. Please note that this issue could be overcome by amending line 3 to recite, for example, “an isolated polynucleotide that encodes”.
8b. In claim 43, lines 8-9, the phrase “the T cells” should be amended to recite “a T cell” for consistency with claim 39 (from which claim 43 depends).
8c. In claim 44, lines 2, 4, and 11, the claim recites both “T cells” and “T cell”. For consistency, one term should be recited. It is suggested to recite the singular “T cell” because claim 39 (which is recited in claim 44, line 11) recites “T cell”.
8d. In claims 52-56, line 1, the phrase “T cells” should be amended to recite “a T cell” for consistency with independent claim 39.
Appropriate correction is required.
Conclusion
Claims 34, 43, 44, and 52-56 are objected.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Lanitis et al. Cancer Immunol Res 1(1): 43-53, 2013 (teach trans-signaling CAR-T cells; specifically, teach the generation of a first generation CAR that targets mesothelin (and that does not comprise an intracellular signaling domain (Figure 1, “M-z”); also teach the generation of a second generation CAR comprising a MOV19 scFv, CD8 hinge, transmembrane, and CD28 co-stimulatory intracellular domain (Figure 1, “F-28”);; lastly, teach co-expression of the M-z and F-28 constructs in T cells (Figures 2B, 2D, 2E, 3B, 4);; However, Lanitis et al. do not teach or render obvious that the second generation CAR comprises an agonistic single-chain antibody of a costimulatory signal molecule)
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 BRIDGET E BUNNER whose telephone number is (571)272-0881. The examiner can normally be reached Monday-Friday 9:00 am-6:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at (571) 272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BEB
Art Unit 1647
21 May 2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
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