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/Restriction/Claims
Applicant’s election with traverse of Group I (claims 1-3, 9, 12-14, 17, 19, 21, 23, 26, 33 and 35-36) in the reply filed on 12/17/2025 is acknowledged. The traversal is on the ground(s) that the search for relevant art pertaining to the composition would provide relevant art for the method of using the composition. Applicant asserts that there would not be a serious burden on the Office to search and examine claims 1-3, 9, 12-14, 17, 19, 21, 23-24, 26, 33 and 35-37 in the same application. This is not found persuasive because the search and examination of methods is not coextensive with the search for compositions, since methods have manipulative steps that compositions don't have, and are evaluated differently under certain statutes (i.e. 35 U.S.C. §§ 101 and 112 in particular). Accordingly, there is a search and examination burden to search these inventions in the same application. The requirement is still deemed proper and is therefore made FINAL.
Claims 1-3, 9, 12-14, 17, 19, 21, 23-24, 26, 33 and 35-37 are pending. Claims 24 and 37 are currently withdrawn from further consideration pursuant to 37 CFR 1.142 (b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-3, 9, 12-14, 17, 19, 21, 23, 26, 33 and 35-36 are the subject of the present Official action.
Priority
Applicant’s claim for the benefit of a prior-filed application EP 20192108.7 and PCT/EP2021/073143 filed on 8/21/2020 and 8/20/2021, respectively, under 35 U.S.C 119(e) or under 35 U.S.C 120, 121 or 365(c) is acknowledged.
Accordingly, the effective priority date of the instant application is granted as 8/21/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 5/16/2023 and 10/19/2023 were received. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the examiner.
Claim Objections
Claims 1 is objected to because of the following informalities: the claims contain the acronym BATF3. While acronyms are permissible shorthand in the claims, the first use should include the full recitation followed by the acronym in parentheses. A similar objection is applied to BCL2L11 as first recited in claim 2. Appropriate correction is required.
Claim Rejections - 35 USC § 112b
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 14 and 17 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 pre-AIA the applicant regards as the invention.
Claims 14 and 17 describe the lymphocyte of claim 1 wherein “the BATF3 level” is a BATF3 protein activity level or protein quantity level or BATF3 expression level. However, claim 1 only describes modifying a lymphocyte to overexpress BATF3 with no mention of a BATF3 level. Thus, there is a lack of antecedent basis for the term “the BATF3 level” since claim 1 only describes overexpression of the BATF3 protein. As a result of this indefinite term, one of ordinary skill in the art would not understand which BATF3 level is referenced. A claim is indefinite when it contains words or phrases whose meaning is unclear, see MPEP2173.05(e).
Claim 26 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 pre-AIA the applicant regards as the invention.
Claim 26 describes a lymphocyte which is “preferably” a T cell or an innate lymphoid cell “such as” an ILC1, ILC2, ILC3 or NK cell wherein the lymphocyte is more preferably a T cell “such as” a CD8+ T cell or a CD4+ T cell. A description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim, see MPEP 2173.05(d). As a result, one of ordinary skill in the art would not understand if the listed T cells are the required lymphocyte cells or are merely exemplary in nature.
Claim Interpretation
With respect to the “optionally” language recited in claims 9, 12, 19, 21, 23 and 35, it is emphasized that claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure, see MPEP 2111.04. A similar analysis is applied to “preferably a T cell” and “preferably a BATF3 protein” in claims 26 and 14, respectively.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 13, 14, 17, 19, 21 and 23 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Xiao et al. US 2022/0000921, published 1/6/2022, priority date 9/19/2019 (hereinafter Xiao) as evidenced by Lee et al. "BATF3 is sufficient for the induction of Il9 expression and can compensate for BATF during Th9 cell differentiation." Experimental & molecular medicine 51.11 (2019): 1-12 (hereinafter Lee).
Claim 1: Xiao describes a pharmaceutical composition comprising modified T cells that express a chimeric antigen receptor (CAR) and one or more therapeutic agents which enhance T cell response and efficacy (Xiao, abstract, para 5, 138 and claim 1). Xiao provides specific embodiments wherein the therapeutic agent expressed or secreted is batf3, which is a protein known to be produced by plasmacytoid dendritic cells and is involved in the innate immunity against viral infection (Xiao, para 138). Lee is provided as evidentiary support to show that BATF3 is a well-known transcription factor used for enhancing T cell fitness by promoting memory formation and enhancing T cell fitness. In particular, Lee shows that BATF3 works in conjunction with IRF4 to rewire the transcription landscape of T cells, increasing the expression of key regulators like IL-9 to enhance proliferation and anti-tumor effector functions. (Lee, introduction).
Claims 13, 14, 17, 19, 21 and 23: Xiao describes modifying CAR T cells using viral vectors which integrate exogenous nucleic acids encoding BATF3 into the genome of the T cells (Xiao, para 138, 143, 168, 183, 185).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 9, 12-14, 17, 19, 21, 23, 26, 33 and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Xiao (supra) as evidenced by Lee (supra) in further view of Rouquette-Jazdanian et al. "miR-155 controls lymphoproliferation in LAT mutant mice by restraining T-cell apoptosis via SHIP-1/mTOR and PAK1/FOXO3/BIM pathways." PLoS One 10.6 (2015): e0131823 (hereinafter Jazdanian).
A description of Xiao and Lee can be found above with respect to claims 1, 13, 14, 17, 19, 21 and 23. Neither Xiao nor Lee describes reducing BCL2L11 expression comprising using an expression cassette or an RNAi effector molecule comprising a siRNA or a shRNA.
Claims 2, 3, 9 and 12: Jazdanian describes the retroviral expression of miR155 in mouse CD4+ T cells to reduce expression of FOXO3 which induces transcription of the pro-apoptotic factor BIM/BCL2L11 (Jazdanian, pg 6 and 10). Jazdanian states that BIM levels are essential for the control of immune system homeostasis and determine CD4+ T cell fate by regulating the balance between cell survival and cell death (Jazdanian, pg 10). Thus, downregulating BIM/BCL2L11 would act to enhance the survival, persistence and anti-tumor efficacy of engineered T cells.
It would have been prima facie obvious to one of ordinary skill in the art to reduce BCL2L11 expression using a retroviral expression cassette for expressing an siRNA to downregulate BCL2L11 as described by Jazdanian in the methods for generating an engineered CAR T cell with overexpressed BATF3 as described by Xiao and Lee. It would have been a matter of combining prior art elements according to known methods to yield predictable results since Jazdanian shows the known advantages of reduce expression of FOXO3 which induces transcription of the pro-apoptotic factor BIM/BCL2L11 (Jazdanian, pg 6 and 10). In particular, one of ordinary skill would be motivated to downregulate BCL2L11 given its role in apoptosis mediation in order to achieve enhanced the survival, persistence and anti-tumor efficacy of engineered T cells. One would have a reasonable expectation of success given that Jazdanian presents an established pathway of targeting FOXO3 and consequently BIM/BCL2L11 using miR155 which was found to predictably enhance the anti-tumor efficacy of engineered T cells. Accordingly, in the absence of evidence to the contrary, one of ordinary skill in the art would have considered the claimed invention to have been prima facie obvious to at the time the invention was made.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dr. ALEXANDER NICOL whose telephone number is (571)272-6383. The examiner can normally be reached on M-F 8-5 EST.
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Alexander Nicol
Patent Examiner
Art Unit 1634
/ALEXANDER W NICOL/Examiner, Art Unit 1634