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 amendment, filed 09 February 2023, has been entered in full. Claims 9, 15, 16, 19, 21 and 23 are canceled. Claims 3-8, 10, 14, 17, 18, 20 and 22 are amended.
Applicant’s election of Group I (claims 1-8, 17, 18, 20, 22 and 24) in the reply filed on 26 June 2026, is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 10-14, 25 and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 26 June 2026. Claims 1-8, 17, 18, 20, 22 and 24 are under examination.
Information Disclosure Statement
The information disclosure statement(s) (IDS) (filed 01 July 2025) was received and complies with the provisions of 37 CFR §§1.97, 1.98 and MPEP § 609. It has been placed in the application file and the information referred to therein has been considered as to the merits.
Claim Objections
Claim 8 is objected to because of the following informalities: Claim 8 is missing a period. Appropriate correction is required.
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.
Claims 7, 17, 18, 20 and 22 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.
Claim 7 is indefinite because it recites the acronyms "F6P, G6P, PVP and F16BP", which have not been defined in the claims. Acronyms should be defined upon their first use in a claim. The presence of an undefined acronym renders a claim indefinite.
Claims 17 is indefinite because it is not clear if the instant claim is drawn to a transgenic animal or cells in culture. Amending claim 17 to recite, “An isolated engineered cell..” would be remedial.
Claims 18, 20 and 22 are included in this rejection insofar as they depend from claim 17 and do not resolve the issues discussed above.
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 (i.e., changing from AIA to pre-AIA ) 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, 2, 5-8, 17, 18, 20, 22 and 24 are rejected under 35 U.S.C. 102(a1) and 35 U.S.C. 102(a2) as being anticipated by Chen et al. (US 2016/0152723; published June 2, 2016).
Chen et al. teach CD19 binding molecules, including anti-CD19 antibodies, including antibody fragments such as single-chain fragments, and chimeric receptors including the antibodies, such as chimeric antigen receptors (CARs)(abstract). Chen et al. teach a CAR comprising an extracellular domain comprising a single chain variable fragment (scFv) that binds CD19 (abstract, paras 0003-0006, 0074, 0085, 0194 and 0252). Chen et al. teach that the CAR comprises a cytoplasmic domain comprising a costimulatory domain and a signaling domain. Chen et al. teach the instant domains as CD3zeta domain, FcR gamma, 4-1BB, Cd28 and ICOS (paras 0259-0260)(applies to claims 1, 5 and 6).
Chen et al. teach that also provided are compositions comprising the antibodies, receptors, molecules, and/or cells, including pharmaceutical compositions, e.g., further including pharmaceutically acceptable substances such as carriers (paras 0090, 0341-0343)(applies to claims 1 and 24). Chen et al. teach that the cells include T cells, NK cells and macrophages (para 0277-0281)(applies to claims 17, 18, 20 and 24). Chen et al. teach that the pharmaceutical composition can contain polyvinylpyrrolidone (PVP)(para 0346)(PVP i.e., glycolysis accelerating metabolite; applies to claims 1 and 7). Chen et al. teach that active ingredients may be entrapped in microcapsules, in colloidal drug delivery systems (for example, liposomes, albumin microspheres, microemulsions, nano-particles and nanocapsules) or in macroemulsions (para 0350).
The Examiner notes that instant claims 2 and 8 are product-by-process claims. MPEP 2113 [R-1] Product-by-Process Claims teaches:
PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). >The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979) (holding “interbonded by interfusion” to limit structure of the claimed composite and noting that terms such as “welded,” “intermixed,” “ground in place,” “press fitted,” and “etched” are capable of construction as structural limitations.)
In the instant case, the products recited in the product-by-process claims are the same as the product taught by Chen et al. (applies to claims 2 and 8).
The Examiner notes that instant claim 22 merely recites the intended use of the claimed composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, the prior art CAR structure is the same as the claimed CAR structure and thus is capable of performing the intended use. In addition, Chen et al. teach using the CAR pharmaceuticals for treating tumors, lymphomas and leukemias (0091 and 0374)(applies to claim 22).
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 (i.e., changing from AIA to pre-AIA ) 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-8, 17, 18, 20, 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 2016/0152723; published June 2, 2016) in view of Kadiyala et al. (US 2018/0221503; published August 9, 2018).
Chen et al. teach CD19 binding molecules, including anti-CD19 antibodies, including antibody fragments such as single-chain fragments, and chimeric receptors including the antibodies, such as chimeric antigen receptors (CARs)(abstract). Chen et al. teach a CAR comprising an extracellular domain comprising a single chain variable fragment (scFv) that binds CD19 (abstract, paras 0003-0006, 0074, 0085, 0194 and 0252). Chen et al. teach that the CAR comprises a cytoplasmic domain comprising a costimulatory domain and a signaling domain. Chen et al. teach the instant domains as CD3zeta domain, FcR gamma, 4-1BB, Cd28 and ICOS (paras 0259-0260)(applies to claims 1, 5 and 6). Chen et al. teach that also provided are compositions comprising the antibodies, receptors, molecules, and/or cells, including pharmaceutical compositions, e.g., further including pharmaceutically acceptable substances such as carriers (paras 0090, 0341-0343)(applies to claims 1 and 24). Chen et al. teach that the cells include T cells, NK cells and macrophages (para 0277-0281)(applies to claims 17, 18, 20 and 24). Chen et al. teach that the pharmaceutical composition can contain polyvinylpyrrolidone (PVP)(para 0346)(PVP i.e., glycolysis accelerating metabolite; applies to claims 1 and 7). Chen et al. teach that active ingredients may be entrapped in microcapsules, in colloidal drug delivery systems (for example, liposomes, albumin microspheres, microemulsions, nano-particles and nanocapsules) or in macroemulsions (para 0350).
The Examiner notes that instant claims 2 and 8 are product-by-process claims.
The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In the instant case, the products recited in the product-by-process claims are the same as the product taught by Chen et al. (applies to claims 2 and 8).
The Examiner notes that instant claim 22 merely recites the intended use of the claimed composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the prior art CAR structure is the same as the claimed CAR structure and thus is capable of performing the intended use. In addition, Chen et al. teach using the CAR pharmaceuticals for treating tumors, lymphomas and leukemias (0091 and 0374)(applies to claim 22).
Chen et al. teach a composition comprising a CAR comprising an extracellular domain comprising a scFv that binds CD19, a cytoplasmic domain comprising a costimulatory domain and a signaling domain. Chen et al. teach that the composition can contain polyvinylpyrrolidone (PVP)(i.e., glycolysis accelerating metabolite) and that active ingredients may be entrapped in microcapsules, colloidal drug delivery systems (for example, liposomes, albumin microspheres, microemulsions, nano-particles and nanocapsules) or in macroemulsions (para 0350).
Chen et al. do not teach that the polyvinylpyrrolidone (PVP) is in particle form.
Kadiyala et al. teach conjugates and nanoparticles for targeted immunotherapy. The conjugates and nanoparticles can increase the delivery of immunologic agents such as tumor specific antigens, artificial antigen presenting cells, T cell agents that can activate T cells, antibodies, cytokines and other immune stimulating agents to a targeted tissue (e.g., a metastatic site, or a lymph node), and/or a particular cell type of interest such as tumor cells and a type of immune cells (abstract, paras 0007 and 0056).
Kadiyala et al. teach that in accordance with the present invention, conjugates comprise at least three moieties: a targeting moiety (or ligand), a linker, and an active agent called a payload that is connected to the targeting moiety via the linker ( para 0064). Kadiyala et al. teach that in certain embodiments, a payload may be a T cell receptor (TCR) or a TCR analog (e.g., engineered CAR). Kadiyala et al. teach that the engineered chimeric antigen receptor (CAR) may be composed of an antibody-derived targeting domain (i.e., an extracellular domain derived from tumor-specific antibody, scFv) fused with T-cell signaling domains (paras 0133 and 0137-0140).
Kadiyala et al. teach that the particles of the invention may contain one or more hydrophilic polymers or biodegradable polymers such as polyvinylpyrrolidone (paras 0237, 0238, 0241-0242, 0324)(applies to claims 3 and 4).
It would have been obvious for one of ordinary skill in the art before the effective filling date to modify a composition comprising a CAR comprising an extracellular domain comprising a scFv that binds CD19, a cytoplasmic domain comprising a costimulatory domain and a signaling domain and glycolysis accelerating metabolite polyvinylpyrrolidone (PVP), as taught by Chen et al. by using polyvinylpyrrolidone (PVP) in particle form, as taught by Kadiyala et al.
One of ordinary skill in the art before the effective filing date, would have been motivated to make such modifications and expect success because Kadiyala et al. teach that the particles can improve pharmacokinetics, targeting of tissues and cells, enhance efficacy, specificity and lowers toxicity.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINA M DEBERRY whose telephone number is (571)272-0882. The examiner can normally be reached M-F 9:00-6:30 pm (alt Fri).
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/R.M.D/Examiner, Art Unit 1647 8/5/2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
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