DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment, filed 10/02/2025, has been entered.
Claims 1, 4, 6-9, 18, 21, 23-26, 34, 35, 38, 43, 80-89 are pending and currently under examination as they read on a method for inducing an immune response comprising providing CAR T cells and IL2 and IL7 (as the elected species).
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 1, 4, 6-9, 18, 21, 23-26, 34, 35, 38, 43, 80-89 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant’s argument and amendment have been considered but have not been found persuasive to overcome the previous Written Description rejection. The rejection of record can be found in the previous Office Action, mailed 06/03/2025.
Applicant argues that the claims have been amended to recited the CAR components, i.e., transmembrane domain, costimulation domain and activation signaling domain. In response, it is noted that the grounds of the written description rejection are pertaining to the genus of different antigen binding receptors encompassed by the recited CAR. The claims encompass a huge genus of different antigen binding receptors, and different chimeric receptors of different structures and functions as either activating or inhibitory. The claims encompass T cells targeting a genus of different combinations of antigen in each inhibitory or activating receptor. There is no art recognized correlation between the structure of chimeric antigen receptors and function as broadly claimed. Certain chimeric antigen receptors for use in T cells are known that have antibodies or particular specificities or scFV antigen binding domain specific for certain specific antigens, a transmembrane domain, and a signaling chain from CD3 in combination with certain costimulatory signaling domains, such as CD28 (see Cartellier et al., 2010 J Biomed Biotechnol; 2010:956304). However, as taught by Cartiellier, so far no general a priori rules can be defined for the functionally of any given binding moiety in the context of a chimeric antigen receptor and function depends on a multitude of factors (see page 4, in particular). The present claims also broadly encompass chimeric receptors of any structure, such as those including any antigen binding domain. Given the diversity of immunoglobulin sequences, this would encompass an essentially unlimited numbers of different antibody sequences. Given the well-known high level of polymorphism of immunoglobulins / antibodies, the skilled artisan would not have been in possession of the vast repertoire of antibody binding domains encompassed by the claimed invention.
Therefore, the present claims fail to meet the written description requirement as the instant specification does not disclose a representative number of species to support the broad genus of structurally and functionally different chimeric antigen receptors encompassed by the instant claims.
The rejection is maintained as it applies to amended and newly added claims.
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 § 102
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, 6-9, 18, 23-26, 34, 35, 38, 43, 80-89 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Xiao et al. (US Patent 10,918,667 B2; see entire document).
Xiao et al. disclosed a method for inducing an immune response comprising administering a CAR T cell and IL-2 and IL-7 (see, e.g., paragraph bridging columns 19-20). Furthermore, Xiao taught that IL-2 and IL-7 are encoded by RNAs (column 18, lines 7-10) and CAR specific for tumor antigen CLDN6 (column 18, line 36). Xiao also taught the newly added claim limitations of transmembrane domain, costimulation domain and activation signaling domain (see, e.g., columns 13-15). In particular, Xiao taught 4-1BB co-stimulatory domain (column 5, lines 48) and CD3zeta signaling domain (column 45 table 2).
Response to Applicant’s argument
Applicant argues that the independent claims 1 and 18 have been amended to recite the elements of claim 38 which was not subject to anticipation rejection. In response, it is noted that the limitation in claim 38 that was not subject to the anticipation rejection was “the further cytokine…IL7 or IL21, is extended pharmacokinetic (PK) cytokine”. The currently amended claims 1 and 18 do not recite extended PK IL-7 or IL21. Therefore, the rejection of record is still applicable to the present claims as Xiao taught that IL2 and IL7 are encoded by RNA as noted above.
Applicant’s argument has not been found convincing. Therefore, the rejection is maintained.
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.
Claims 1, 4, 6-9, 18, 21, 23-26, 34, 35, 38, 43, 80-89 are rejected under 35 U.S.C. 103 as being unpatentable over Xiao et al. (US Patent 10,918,667 B2) in view of Zhu et al. (Cancer Cell 2015 27:489-501).
Applicant’s argument and amendment have been considered but have not been found persuasive to overcome the previous Written Description rejection. The rejection of record can be found in the previous Office Action, mailed 06/03/2025.
Applicant argues that there is no reason why a POSA would select a combination of IL-2 and IL-7 to arrive at the claimed invention. In response, it is first noted that given the comprising language, the claims are not limiting to IL-2 and IL-7 only. Secondly, the number of cytokines taught by the prior art is not large and it would be well within the skill of one of ordinary skill in the art to test the possible combination without undue experimentation.
In response to Applicant’s argument regarding extended PK and that Zhu was not in the context of cellular therapy, it is noted that given that IL-2 was a well known cytokine for enhancing immune response in any immunotherapy, it would have been obvious to use an extended PK IL-2 as taught by Zhu.
Therefore, the rejection is maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4, 6-9, 18, 21, 23-26, 34, 35, 38, 43, 80-89 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 10-13, 23, 26-32 of copending Application No. 17757195 in view of Xiao et al. (US Patent 10,918,667 B2) and Zhu et al. (Cancer Cell 2015 27:489-501). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the co-pending application disclosed a method of treatment of cancer comprising administering a CAR T cell. Although the claims did not disclose administering IL-2 and IL-7, it would have been obvious in view of Xiao et al. and Zhu et al. as discussed above (see 103). Therefore, the co-pending claims render obvious of the present claims in view of Xiao et al. and Zhu et al.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Given that there are still outstanding rejections, the provisional NSDP rejection is maintained.
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 SHARON X WEN whose telephone number is (571)270-3064. The examiner can normally be reached Mon-Fri 8-5.
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/SHARON X WEN/Primary Examiner, Art Unit 1641