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 reply to the Restriction Requirement, dated May 20, 2026, has been received. By way of this submission, Applicant has amended claims 17, 19, 27-29, and 50-51, cancelled claims 1-4, 7-8, 10-11, 13-15, 26, 43, and 55-56, and introduced new claims 61-67. By way of this submission, Applicant has elected, without traverse, Group IV: claims 17-22, 24, 27-29, 50-51, and 61-67, and a dysfunctional P2X7 receptor as the species of tumor-specific antigen.
Claims 17-22, 24, 27-29, 50-51, and 61-67 are pending in the application and under examination before the Office.
Claim Objections
Claims 17 and 19 are objected to because of the following informalities: the word “signalling” is misspelled. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17, 22, 24, 27-29, 50-51, and 61 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims are drawn to methods of treating a disorder, comprising administering a cell expressing a receptor comprising an antigen-recognition domain and a signaling domain, and a bridging molecule. Applicant's specification at page 99 defines "disorder" as a functional abnormality or disturbance in a subject such as a cancer, an autoimmune disorder, or an infection by virus, bacteria, parasite, or others. However, the examples described in Applicant's specification are limited to treatment of CD19-positive cancers. There is nothing to suggest that the claimed method would be successful in treating every possible disorder, functional abnormality or disturbance.
Pharmaceutical therapies in the absence of in vivo clinical data are unpredictable for the following reasons; (1) the protein may be inactivated before producing an effect, i.e. such as proteolytic degradation, immunological inactivation or due to an inherently short half-life of the protein; (2) the protein may not reach the target area because, i.e. the protein may not be able to cross the mucosa or the protein may be adsorbed by fluids, cells and tissues where the protein has no effect; and (3) other functional properties, known or unknown, may make the protein unsuitable for in vivo therapeutic use, i.e. such as adverse side effects prohibitive to the use of such treatment. See page 1338, footnote 7 of Ex parte Aggarwal, 23 USPQ2d 1334 (PTO Bd. Pat App. & Inter. 1992).
The specification does not adequately teach how to effectively treat the breadth of diseases or reach an appropriate beneficial therapeutic endpoint in by administering the cell. The specification does not teach how to extrapolate data obtained from various in vitro or in vivo observations as well as clinical experience with the claimed method to the development of effective methods of treating the vast quantity of diseases broadly encompassed by the claimed invention.
There is insufficient guidance and direction as well as objective evidence provided for treating the scope of diseases encompassed by the claimed method. In view of the lack of predictability of the art (e.g., treating any possible disorder) to which the invention pertains, undue experimentation would be required to practice the claimed method of treating any disorder with a reasonable expectation of success, absent a specific and detailed description in Applicant's specification of how to effectively use the claimed agent and absent working examples providing evidence which is reasonably predictive that the claimed agent is effective for ameliorating any disease commensurate in scope with the claimed invention.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary, the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
Applicant is invited to incorporate the subject matter of claim 18 is claim 17 to assist in addressing this issue.
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.
Claim Rejections - 35 USC § 103
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 17-22, 24, 27-29, 50-51, and 61-67 are rejected under 35 U.S.C. 103 as being unpatentable over Kaiser (US20190315879A1) in view of Rokhvarguer (Forschungskolloquium, Universitat Tubingen, 24 January 2020, Abstract no. 65, page 91, cited in IDS).
Kaiser teaches a chimeric antigen receptor (CAR), comprising an extracellular linker/label epitope (LLE) binding domain (i.e., antigen-recognition domain) and a signal transduction domain (i.e., a signaling domain), and a target cell binding molecule (i.e., a bridging molecule), comprising an antigen binding moiety that binds specifically to an antigen expressed on a target cell, and a label moiety that is able to be bound by the CAR (para. 0030).
Kaiser further teaches that the antigen bound by the antigen binding moiety is expressed on a cancer cell (para. 0044).
Kaiser further teaches a method of treating a disorder, comprising administering the above CAR and target cell binding molecule (para. 0069).
Kaiser further teaches that the target cell binding molecule acts as a bridge between the CAR-expressing immune cells and the target cells, for the purpose of killing the target cell (para. 0085), which is pertinent to claim 19.
Kaiser further teaches that the disorder is cancer (para. 0071), which is pertinent to claims 18 and 20.
Kaiser further teaches that label moiety bound by the CAR is novel (i.e., not expressed by the target cell) (para. 0013-0015), which is pertinent to claim 21.
Kaiser further teaches that two or more target cell binding molecules may be administered, with each molecule being different (para. 0132), which is pertinent to claims 22 and 62.
Kaiser further teaches cells comprising polynucleotides that encoding the above system (para. 0065), which is pertinent to claim 24.
Kaiser further teaches that the antigen binding moiety of the target cell binding molecule may bind multiple different antigens or epitopes (para. 0086-0087), which is pertinent to claim 27.
Kaiser further teaches that the antigen bound by the antigen binding moiety of the target cell binding molecule may by CD33 (para. 0045), which is pertinent to claims 50-51 and 65-66.
However, Kaiser does not teach a dysfunctional P2X7 receptor.
Rokhvarguer teaches the use of a dysfunctional P2X7 receptor (nfP2X7) as a suitable target for a CAR-T-based system, using an adapter molecule that links T cell activation and target recognition (AdCAR) (first paragraph). According to Applicant's specification at page 92, nfP2X7 has a reduced capacity to bind ATP at the ATP-binding site compared to an ATP-binding capacity of a functional P2X7 receptor. Rokhvarguer therefore inherently teaches the subject matter of claims 29 and 64.
Rokhvarguer further teaches the epitope E200 is associated with ATP activity (second paragraph), which is pertinent to claims 28 and 63.
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Kaiser and Rokhvarguer to arrive at the claimed invention. An ordinary artisan would have been motivated to do so, and have a reasonable expectation of success, since both Kaiser and Rokhvarguer teach the use of adapter molecules for the use in a CAR-based system. Kaiser teaches a method of treating disease by administering a cell bearing a CAR that can bind a suitable antigen, and an adapter molecule that links the antigen-binding domain of the CAR to a tumor-specific antigen on a cancer cell. Rokhvarguer teaches that nfP2X7 is a good target for CAR-based therapies, especially in the context of a CAR and adapter molecule like the one taught by Kaiser. One of ordinary skill could apply the nfP2X7 of Rokhvarguer to the method of Kaiser to arrive at the claimed invention, with each component of the combination performing its known, usual function, to affect a predictable result.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 7:00 to 3:00.
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/PETER JOHANSEN/Examiner, Art Unit 1644
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