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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-12) in the reply filed on 3/2/2026 is acknowledged.
The preliminary amendments to the claims filed 3/2/2026 cancels claims to non-elected subject matter and adds claims 30-35. The newly added claims are the subject matter of group I of the restriction and therefore will be considered in this office action.
As such, claims 1, 3, 5-12, and 30-35 are under consideration in this office action.
Sequence Compliance
The nucleic acid/amino acid sequence disclosure contained in this application does not comply with the requirements for such a disclosure as set forth in 37 C.F.R. 1.821 - 1.825.
37 CFR 1.821(d) states: “[w]here the description or claims of a patent application discuss a sequence that is set forth in the “Sequence Listing” in accordance with paragraph (c) of this section, reference must be made to the sequence by use of the sequence identifier, preceded by “SEQ ID NO:” in the text of the description of claims, even if the sequence is also embedded in the text or the description or claims of the patent application.
Claim 3 recites reference sequences NP_057353.1. This is not an accepted form of sequence disclosure as described in 37 C.F.R. 1.821 - 1.825.
Throughout the specification there are sequences disclosed that are not described by SEQ ID NOS that correspond to SEQ ID NOS present in the sequence listing.
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show “c” in the drawing on page 6/40 as described in the specification on page 7, [0031]. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
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.
Claim 3 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.
Claim 3 recites, “the sequence of Reference Sequence (RefSeq) ID NO:NP_057353.1”. This recitation is indefinite because the reference sequence is from a sequence database that updates the sequences over time. Thus the sequence with this RefSeq ID NO is subject to change. As such, the requisite metes and bound of the sequence are not apparent. For purposes of identifying relevant art, any LEF1 sequence disclosure will be deem relevant art.
Claim Objections
Claim 30 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 6. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Allowable Subject Matter
Claims 1, 5-12, and 31-36 are allowed. Claims 3 and 30 are not allowed.
Examiner’s Comment
Chen (Chen et al. J. Immunology (2010) 184:5047-5054) is the closest prior art found. Chen teaches transfection of K562 cells (myelogenous leukemia line) and Jurkat cells (T cell leukemia cell line) with an expression construct encoding LEF-1 (p. 5048, col 2, paragraph 2). Chen does not teach NKT cells as claimed. The ISA of record (dated 8/7/2023) recites Chen as demonstrating lack of novelty. It states it would have been obvious to modify Chen to include NKT cells. That rationale suggested CD1d re-restricted NKT cells…there is little evidence of a relationship between Wnt signaling NKT cells. Accordingly, we looked into two leukemia cell lines, K562 and Jurkat cells, and found that LEF-1 does bind specifically to the CD1D promoter and regulates CD1D gene expression. Selecting a NKT cell as an immune cell for transfection involves only routine skill in the art. The motivation to do so would be to increase LEF1 expression in various immune cells, including NKT cells (See page 3, section 2 of the ISA). Examiner notes this here because similar to the ISA, the present examiner sees Chen as the closest prior art. However, while means of making the NKT cell with the teachings of Chen are routine, a demonstration that expression of LEF-1 in another immune cell demonstrating regulation of CD1D gene expression in that cell does not demonstrate any particular benefit or expressed phenotype by directly overexpressing LEF-1 in a NKT cell. As such, Examiner does not agree that there is motivation to modify Chen to include NKT cells. Thus the claims are free of the prior art.
Berga-Bolanos et al (Molecular Immunology 2015 68:484-489 of record in IDS) is also relevant prior art because it demonstrates an TCF1 and LEF1 pay an essential role in development of NKT cells. However, it does not provide any motivation or rational to introduce an expression cassette encoding LEF1 into NKT cell itself.
Ngai et al (J Immunology 2020 204 (1_Supplement):88.9 of record in IDS), which includes the inventors in the instant application, teach that CD62L+ NKTs express LEF1, whereas CD62L- NKC do not. The abstract concludes these results identify LEF1 as a key transcriptional activator of the central memory-like program in CD62+NKTs and pave the way for targeted pharmacological enhancement of NKT cell-based cancer immunotherapy. However, this teaching does not imply that actual introduction of a expression construct encoding LEF1 into a NTK has any positive implication.
As such, the state of the art does not appear to motive a particular motivation to introduce an expression construct encoding LEF1 into a NTK cell.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/Primary Examiner, Art Unit 1632
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