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 .
Application Status
The Amendments and Remarks filed 09 March 2026 are acknowledged and have been entered. Claims 27, 28, 30, 31, 33, and 35 are amended. Claims 1-26, 29, 32, 34, and 37-46 have been cancelled. Claims 47-51 are newly added. Claims 27, 28, 30, 31, 33, 35, 36, and 47-51 are pending and being examined on the merits.
Any objection or rejection not reiterated herein has been overcome by applicants claim amendments.
Priority
This application is a divisional of application 14/981,142 filed 12/28/2015 that claims priority to application 62/133,137 filed 03/13/2015 and application 62/097,375 filed 12/29/2014.
Information Disclosure Statement
The information disclosure statements filed 03/09/2026 have been considered.
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 51 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 51 recites “The method of claim 51”. It is improper for a claim to depend from itself; therefore, this claim is indefinite.
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 27, 28 and 47-51 are rejected under 35 U.S.C. 103 as being unpatentable over Kohn (Kohn et al., Mol. Therapy 2011; 19:432-38) in view of Cooper (WO 2014/186469) and Kaneko (Kaneko et al. Blood, 29 January 2009, Volume 113, Number 5). This is a new rejection necessitated by applicants claim amendments.
Regarding claims 27-28 and 48-49, Kohn teaches that T cells expressing chimeric antigen receptors (“CARs”) have shown great promise in preclinical models and are being moved into clinical testing [page 432, col. 1, 3]. Kohn teaches that the transduction of peripheral blood T lymphocytes CARs confers specific cytotoxic immunoreactivity against cells expressing the target epitope of tumor-associated antigens [pg. 432, col. 3]. Kohn teaches a summary of clinical trials for B cell malignancies, such as B CLL [table 1], in which patients were given T-cells modified to express CARs that target the tumor antigen CD19 present on most B-lineage leukemias and lymphomas (i.e., a cancer) (regarding claims 48 -49) [pg. 432, col. 3]. Kohn teaches that PBMCs that are selectively depleted of CD25+ T regulatory cells can be used for immunotherapy with CARs while preserving the CD4 helper function [pg. 434, col. 3, para 3-pg. 435, col. 1, para 1]. Kohn teaches the use of vectors for introducing CAR into T cells [pg. 434, col. 3, para 2]. Kohn further teaches propagation of T cells for transduction and expansion using anti-CD3 and anti-CD28 produced more T cells with a central memory immunophenotype; the addition of IL-7 and IL-15 to culture medium provides a further augmentation of potency; and bead-bound antibodies to CD3 and CD28 provide activation and costimulation that produces multifunctional T cells with high proliferative potential [pg. 435, col. 3, para 2]. Kohn therefore teaches providing immune effector cells wherein a plurality of the cells comprise a nucleic acid encoding a CAR.
Regarding claims 47 and 51, Kohn teaches bead-bound antibodies to CD3 and CD28 provide activation and costimulation that produces multifunctional T cells with high proliferative potential [pg. 435, col. 3, para 2].
Cooper teaches methods for generating genetically modified CAR-T cells and expressly teaches that the transgenic CAR cells are expanded ex vivo for short periods of time [abstract, 0011, 00121]. Cooper teaches that transgenic CAR cells may be cultured ex vivo for less than 21 days, less than 16 days, less than 13 days, less than 10 days, less than 7 days, less than 5 days, or even less than 3 days, and further teaches that the entire process may be completed in no more than 21, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, or 5 days [0007, 0018, 00121, 00187, Fig. 2D]. Cooper further teaches that the CAR-T cells may be expanded with cytokines including IL-2, IL-7, IL-12, IL-15, and IL-21 [00121].
Kaneko teaches ex vivo culture of genetically modified human T lymphocytes activated through CD3/CD28 stimulation and cultured in the presence of IL-7, IL-15, or a combination of IL-7 and IL-15 [abstract]. Kaneko teaches that culture with IL-7 and IL-15 results in superior expansion, maintenance of central-memory T-cell phenotypes, self-renewal, resistance to activation-induced cell death, and enhanced in vivo persistence relative to conventional culture conditions[pg. 1007, col. 1, para 2; 1009; Fig. 3D ]. Kaneko specifically teaches culturing activated T lymphocytes with IL-7 and IL-15 and demonstrates that such cells exhibit improved proliferative capacity and persistence compared with cells generated under alternative cytokine conditions [pg. 1008, col. 1 – pg. 1009, col. 2; Figs. 1-3; pg. 1014, col. 1, para 2].
Regarding claim 50, Kaneko teaches anti-CD3/CD28 activation followed by culture in IL-15 containing medium [pg. 1007, col. 1, para 3].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the CAR-T manufacturing methods of Kohn by utilizing the short-duration expansion methods taught by Cooper and the IL-7 and/or IL-15 culture conditions taught by Kaneko because both references teach that such conditions improve the expansion, survival, persistence, and functionality of genetically modified T cells. One of ordinary skill would have reasonably expected success because each reference concerns ex vivo manufacture of genetically modified human T lymphocytes for adoptive immunotherapy and utilizes similar activation and expansion methodologies.
Claims 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Kohn (Kohn et al., Mol. Therapy 2011; 19:432-38) in view of Cooper (WO 2014/186469) and Kaneko (Kaneko et al. Blood, 29 January 2009, Volume 113, Number 5) as applied to claim 27 and further in view of Gattinoni (Gattinoni et al. The Journal of clinical investigation 115.6 (2005): 1616-1626) and Klebanoff (Klebanoff et al. Proceedings of the national academy of sciences 102.27 (2005): 9571-9576). This is a new rejection necessitated by applicants claim amendments.
The teachings of Kohn, Cooper, and Kaneko are discussed above as applied to claim 27 and similarly apply to claims 30 and 31.
Kohn, Cooper, and Kaneko do not teach that cells from a 5 day culture are more potent and has higher proliferation.
Gattinoni teaches while the progressive acquisition of terminal effector properties is characterized by pronounced in vitro tumor killing, in vivo T cell activation, proliferation, and survival are progressively impaired [abstract]. Gattinoni teaches that progressive differentiation of T cells to a terminal differentiated effector stage results in a series of phenotypic and functional changes that make them less “fit” to perform these functions [pg. 1622, col. 1, para 1].
Klebanoff teaches that central memory T cells (TCM), which are mounted a heightened in vivo recall response and are superior to effector memory T cells (TEM) for adoptive immunotherapy [pg. 9575, col. 2, para 2-3]. Klebanoff teaches that a marked expansion of adoptively transferred TCM and TEM peaked in 5 days after transfer and the response of TCM was strikingly greater [Fig. 4A and 4B].
It would have been obvious to one of ordinary skill in the art before the effective filing date to expect that expanding the cells for 5 days, versus 9 days, would ensure peak T cell response as well as TCM superior antitumor activity. Thus, in view of Cooper’s teaching that CAR-T cell culture can be 5 days or less and Kaneko’s teaching that IL-7/IL-15 preserves central-memory/self-renewing T cells, one of ordinary skill would have reasonably expected shorter-cultured CAR-T cells to exhibit greater potency and proliferative capacity than longer-cultured cells.
Claims 33 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Kohn (Kohn et al., Mol. Therapy 2011; 19:432-38) in view of Cooper(WO 2014/186469) and Kaneko (Kaneko et al. Blood, 29 January 2009, Volume 113, Number 5) as applied to claim 27 and further in view of Powell (Powell et al., J. Immunother. 2005; 28(4):403-11) as evidenced by Han (Han et al., PLoS ONE, 2011; 6(12)): e28649. doi: 10.1371/journal.pone.0028649). This is a new rejection necessitated by applicants claim amendments.
The teachings of Kohn, Cooper, and Kaneko are discussed above as applied to claim 27 and similarly apply to claim 33.
Kohn, Cooper, and Kaneko do not teach that cells from a population comprising of less than 50% of CD25+ cells.
Powell teaches methods for the large-scale depletion of CD25+ regulatory T cells from patient leukapheresis samples [title, abstract]. Powell teaches that CD4+, CD25+ regulatory T cells possess the ability to suppress antitumor responses [abstract]. Powell teaches the depletion of CD25+ T cells from CD4+ enriched peripheral blood mononuclear cells (PBMCs) using CliniMACS CD25 MicroBeads to which an anti-CD25 antibody has been conjugated [pg. 404, col. 1, para 2-3; pg. 405, col.1, para 2]. The resulting population is inherently a population of immune effector cells (since they were not depleted of CD8+ T cells or NK cells) that can be engineered to express a CAR. Powell teaches that the population of T-regulatory cells contained less than 50% of CD25+ cells [table 1].
Han teaches that CD4+ CD25+ T-regulatory cells express several immune check point inhibitors, including CTLA-4 and PD-1 [Figure 2A]. The claim does not require removing cells from the population which express a check point inhibitor by any particular mechanism, such as negative selection with an anti-CTLA-4 antibody. Accordingly, depletion of CD25+ cells from PBMC, as taught by Powell, would necessarily also remove cells from the population that expressed one or more check point inhibitors.
It would have been obvious to one ordinary skilled in the art before the effective filing date of the claimed invention to modify the methods of Kohn wherein the PBMCs that are modified to express CARs, using a vector as taught by Kohn, are CD25-depleted using Powell’s strategy such that the population of T-regulatory cells contains less than 50% of CD25+ cells as disclosed by Powell for immunotherapy (i.e., a reaction mixture of immune effector cells comprising T-regulatory depleted cells containing less than 50% of CD25+ cells that comprise a nucleic acid molecule). One of ordinary skill would be motivated for the advantage of improved immunotherapy and reduced suppression of antitumor responses.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Kohn (Kohn et al., Mol. Therapy 2011; 19:432-38) in view of Cooper (WO 2014/186469), Kaneko (Kaneko et al. Blood, 29 January 2009, Volume 113, Number 5) and Powell (Powell et al., J. Immunother. 2005; 28(4):403-11) and as evidenced by Han (Han et al., PLoS ONE, 2011; 6(12)): e28649. doi: 10.1371/journal.pone.0028649) as applied to claim 27 and 33, and further in view of Barsov (E.V. Barsov, Immunotherapy 2011; 3(3):407-21). This is a new rejection necessitated by applicants claim amendments.
The teachings of Kohn, Cooper, Kaneko and Powell, and Han are discussed above as applied to claim 27 and 33 and similarly apply to claim 36.
They do not teach wherein the method further comprising contacting the population of immune effector cells with a nucleic acid encoding a telomerase subunit.
Barsov teaches that it was known in the art that ectopic telomerase expression could rescue T cells from senescence [Abstract]. Barsov teaches that primary T cells engineered to express telomerase had substantially expanded replicative lifespans. Barsov notes that such cell are potentially useful for immunotherapy of cancer [Abstract].
It would have been obvious to one ordinary skilled in the art before the effective filing date of the claimed invention to modify the method as taught and suggested by Kohn, Cooper, Kaneko and Powell wherein the expanded T cells are transfected with a telomerase subunit. One of ordinary skill would be motivated to make the modification for the advantage of preparing T cell that expanded replicative lifespans for the use of immunotherapy. While Barsov notes potential concerns, Barsov makes clear that it is desirable to test this approach. Further, the instant method is a method of making a population of cells that includes preparing cells for additional studies prior to any clinical applications. For these reasons, the invention as a whole would have been prima facie obvious to one ordinary skill in the art before the effective filing date of the claimed invention.
Response to Arguments
Applicant's arguments filed 03/09/2026 have been fully considered but they are not persuasive.
Applicant argues that Kohn teaches away from IL-7 and IL-15 due to concerns regarding GVHD. This argument is not persuasive. Neither Kohn nor the cited references criticize, discredit, or otherwise discourage the use of IL-7 or IL-15 during ex vivo expansion of engineered T cells. To the contrary, Cooper expressly identifies IL-7 and IL-15 as cytokines suitable for use during CAR-T cell expansion, and Kaneko specifically teaches that IL-7 and IL-15 improve expansion, persistence, and maintenance of less differentiated T-cell phenotypes. A reference does not teach away merely because it recognizes potential risks associated with a therapeutic modality.
Applicant argues there was no motivation to employ IL-7 and/or IL-15. This argument is unpersuasive. Kaneko expressly teaches that IL-7 and IL-15 improve expansion, persistence, self-renewal, and resistance to activation-induced cell death in genetically modified T cells. Cooper further identifies IL-7 and IL-15 as cytokines useful during CAR-T manufacture. One of ordinary skill would therefore have been motivated to employ the known beneficial cytokines during manufacture of the CAR-T cells of Kohn to improve cell fitness and therapeutic efficacy.
Applicant argues that the specification demonstrates unexpectedly superior potency associated with 5-day expansion. This argument is not persuasive because the evidence is not commensurate in scope with the claims. Claim 27 encompasses: all immune effector cells, all CAR constructs, IL-7 alone, IL-15 alone, and IL-7 plus IL-15. The relied-upon experimental data are limited to particular embodiments and experimental conditions and therefore do not establish unexpected results across the full scope of the claims. Moreover, Kaneko already teaches that IL-7 and IL-15 culture conditions produce enhanced expansion, persistence, and less differentiated T-cell phenotypes, such that improvements in functionality would have been expected from the prior art.
Applicant argues that the prior art does not teach expansion for five days or less. This argument is moot in view of the new rejection set forth above.
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 27, 28, 30, 31, 33, 35, 36, and 47-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. US11896614B2 in view of Kohn (Kohn et al., Mol. Therapy 2011; 19:432-38), Cooper (WO 2014/186469), Kaneko (Kaneko et al. Blood, 29 January 2009, Volume 113, Number 5), Gattinoni (Gattinoni et al. The Journal of clinical investigation 115.6 (2005): 1616-1626), Klebanoff (Klebanoff et al. Proceedings of the national academy of sciences 102.27 (2005): 9571-9576), Powell (Powell et al., J. Immunother. 2005; 28(4):403-11), Barsov (E.V. Barsov, Immunotherapy 2011; 3(3):407-21) and as evidenced by Han (Han et al., PLoS ONE, 2011; 6(12): e28649. doi: 10.1371/journal.pone.0028649).
The patent claims teach all the limitations of the instant claims except where the immune effector cells comprise a population of T regulatory-depleted cells containing less than 50% of CD25+ cells, a nucleic acid encoding a CAR, contacting the population of immune effector cells with an interleukin-15 (IL-15); an interleukin-7 (IL-7); or a combination of IL-15 and IL-7, wherein the population of immune effector cells is expanded for a period of 5 days or contacting the cells with a nucleic acid encoding a telomerase. The teachings of Kohn, Cooper, Kaneko, Gattinoni, Klebanoff, Powell, Barsov, and Han. It would have been obvious before the effective filing date of the claimed invention to modify the methods of the patented claims where the population of T regulatory-depleted cells containing less than 50% of CD25+ cells, a nucleic acid encoding a CAR, contacting the population of immune effector cells with an interleukin-15 (IL-15); an interleukin-7 (IL-7); or a combination of IL-15 and IL-7, wherein the population of immune effector cells is expanded for a period of 5 days or contacting the cells with a nucleic acid encoding a telomerase for the advantage of creating a population of immune effector cells capable of enhancing immunotherapy efforts.
For additional limitations of the instant claims, see the additional teachings of the patented claims. To the extent that there are limitations that are not provided for by the patented claims, the teachings of Kohn, Cooper, Kaneko, Gattinoni, Klebanoff, Powell, Barsov, and Han are discussed above. It would have been obvious to have modified the subject matter of the patented claims to arrive at the subject matter of the instant claims for substantially the same reasons as discussed above in view of the teachings of these references.
Claims 27, 28, 30, 31, 33, 35, 36, and 47-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 36 of U.S. Patent No. US12128069B2 in view of Kohn (Kohn et al., Mol. Therapy 2011; 19:432-38), Cooper (WO 2014/186469), Kaneko (Kaneko et al. Blood, 29 January 2009, Volume 113, Number 5), Gattinoni (Gattinoni et al. The Journal of clinical investigation 115.6 (2005): 1616-1626), Klebanoff (Klebanoff et al. Proceedings of the national academy of sciences 102.27 (2005): 9571-9576), Powell (Powell et al., J. Immunother. 2005; 28(4):403-11), Barsov (E.V. Barsov, Immunotherapy 2011; 3(3):407-21) and as evidenced by Han (Han et al., PLoS ONE, 2011; 6(12): e28649. doi: 10.1371/journal.pone.0028649).
The patent claims teach all the limitations of the instant claims except where the immune effector cells comprise a population of T regulatory-depleted cells containing less than 50% of CD25+ cells, a nucleic acid encoding a CAR, contacting the population of immune effector cells with an interleukin-15 (IL-15); an interleukin-7 (IL-7); or a combination of IL-15 and IL-7, wherein the population of immune effector cells is expanded for a period of 5 days or contacting the cells with a nucleic acid encoding a telomerase. The teachings of Kohn, Cooper, Kaneko, Gattinoni, Klebanoff, Powell, Barsov, and Han. It would have been obvious before the effective filing date of the claimed invention to modify the methods of the patented claims where the population of T regulatory-depleted cells containing less than 50% of CD25+ cells, a nucleic acid encoding a CAR, contacting the population of immune effector cells with an interleukin-15 (IL-15); an interleukin-7 (IL-7); or a combination of IL-15 and IL-7, wherein the population of immune effector cells is expanded for a period of 5 days or contacting the cells with a nucleic acid encoding a telomerase for the advantage of creating a population of immune effector cells capable of enhancing immunotherapy efforts.
For additional limitations of the instant claims, see the additional teachings of the patented claims. To the extent that there are limitations that are not provided for by the patented claims, the teachings of Kohn, Cooper, Kaneko, Gattinoni, Klebanoff, Powell, Barsov, and Han are discussed above. It would have been obvious to have modified the subject matter of the patented claims to arrive at the subject matter of the instant claims for substantially the same reasons as discussed above in view of the teachings of these references.
Claims 27, 28, 30, 31, 33, 35, 36, and 47-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 4, 6, 8, 12, 13, 18, 21, 27, 32, 35, 37, 39-40, 46, 51-52, 55, 57, 59, and 63 of copending Application No. 18/390,604 in view of Kohn (Kohn et al., Mol. Therapy 2011; 19:432-38), Cooper (WO 2014/186469), Kaneko (Kaneko et al. Blood, 29 January 2009, Volume 113, Number 5), Gattinoni (Gattinoni et al. The Journal of clinical investigation 115.6 (2005): 1616-1626), Klebanoff (Klebanoff et al. Proceedings of the national academy of sciences 102.27 (2005): 9571-9576), Powell (Powell et al., J. Immunother. 2005; 28(4):403-11), Barsov (E.V. Barsov, Immunotherapy 2011; 3(3):407-21) and as evidenced by Han (Han et al., PLoS ONE, 2011; 6(12): e28649. doi: 10.1371/journal.pone.0028649).
The claims of the copending application teach all the limitations of the instant claims except where the immune effector cells comprise a population of T regulatory-depleted cells containing less than 50% of CD25+ cells, a nucleic acid encoding a CAR, contacting the population of immune effector cells with an interleukin-15 (IL-15); an interleukin-7 (IL-7); or a combination of IL-15 and IL-7, wherein the population of immune effector cells is expanded for a period of 5 days or contacting the cells with a nucleic acid encoding a telomerase. The teachings of Kohn, Cooper, Kaneko, Gattinoni, Klebanoff, Powell, Barsov, and Han. It would have been obvious before the effective filing date of the claimed invention to modify the methods of the patented claims where the population of T regulatory-depleted cells containing less than 50% of CD25+ cells, a nucleic acid encoding a CAR, contacting the population of immune effector cells with an interleukin-15 (IL-15); an interleukin-7 (IL-7); or a combination of IL-15 and IL-7, wherein the population of immune effector cells is expanded for a period of 5 days or contacting the cells with a nucleic acid encoding a telomerase for the advantage of creating a population of immune effector cells capable of enhancing immunotherapy efforts.
For additional limitations of the instant claims, see the additional teachings of the patented claims. To the extent that there are limitations that are not provided for by the patented claims, the teachings of Kohn, Cooper, Kaneko, Gattinoni, Klebanoff, Powell, Barsov, and Han are discussed above. It would have been obvious to have modified the subject matter of the patented claims to arrive at the subject matter of the instant claims for substantially the same reasons as discussed above in view of the teachings of these references.
This is a provisional nonstatutory double patenting rejection.
Claims 27, 28, 30, 31, 33, 35, 36, and 47-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 18/460,977 in view of Kohn (Kohn et al., Mol. Therapy 2011; 19:432-38), Cooper (WO 2014/186469), Kaneko (Kaneko et al. Blood, 29 January 2009, Volume 113, Number 5), Gattinoni (Gattinoni et al. The Journal of clinical investigation 115.6 (2005): 1616-1626), Klebanoff (Klebanoff et al. Proceedings of the national academy of sciences 102.27 (2005): 9571-9576), Powell (Powell et al., J. Immunother. 2005; 28(4):403-11), Barsov (E.V. Barsov, Immunotherapy 2011; 3(3):407-21) and as evidenced by Han (Han et al., PLoS ONE, 2011; 6(12): e28649. doi: 10.1371/journal.pone.0028649).
The claims of the copending application teach all the limitations of the instant claims except where the immune effector cells comprise a population of T regulatory-depleted cells containing less than 50% of CD25+ cells, a nucleic acid encoding a CAR, contacting the population of immune effector cells with an interleukin-15 (IL-15); an interleukin-7 (IL-7); or a combination of IL-15 and IL-7, wherein the population of immune effector cells is expanded for a period of 5 days or contacting the cells with a nucleic acid encoding a telomerase. The teachings of Kohn, Cooper, Kaneko, Gattinoni, Klebanoff, Powell, Barsov, and Han. It would have been obvious before the effective filing date of the claimed invention to modify the methods of the patented claims where the population of T regulatory-depleted cells containing less than 50% of CD25+ cells, a nucleic acid encoding a CAR, contacting the population of immune effector cells with an interleukin-15 (IL-15); an interleukin-7 (IL-7); or a combination of IL-15 and IL-7, wherein the population of immune effector cells is expanded for a period of 5 days or contacting the cells with a nucleic acid encoding a telomerase for the advantage of creating a population of immune effector cells capable of enhancing immunotherapy efforts.
For additional limitations of the instant claims, see the additional teachings of the patented claims. To the extent that there are limitations that are not provided for by the patented claims, the teachings of Kohn, Cooper, Kaneko, Gattinoni, Klebanoff, Powell, Barsov, and Han are discussed above. It would have been obvious to have modified the subject matter of the patented claims to arrive at the subject matter of the instant claims for substantially the same reasons as discussed above in view of the teachings of these references.
This is a provisional nonstatutory double patenting rejection.
Claims 27, 28, 30, 31, 33, 35, 36, and 47-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 56-58 of copending Application No. 18/055,950 in view of Kohn (Kohn et al., Mol. Therapy 2011; 19:432-38), Cooper (WO 2014/186469), Kaneko (Kaneko et al. Blood, 29 January 2009, Volume 113, Number 5), Gattinoni (Gattinoni et al. The Journal of clinical investigation 115.6 (2005): 1616-1626), Klebanoff (Klebanoff et al. Proceedings of the national academy of sciences 102.27 (2005): 9571-9576), Powell (Powell et al., J. Immunother. 2005; 28(4):403-11), Barsov (E.V. Barsov, Immunotherapy 2011; 3(3):407-21) and as evidenced by Han (Han et al., PLoS ONE, 2011; 6(12): e28649. doi: 10.1371/journal.pone.0028649).
The claims of the copending application teach all the limitations of the instant claims except where the immune effector cells comprise a population of T regulatory-depleted cells containing less than 50% of CD25+ cells, a nucleic acid encoding a CAR, contacting the population of immune effector cells with an interleukin-15 (IL-15); an interleukin-7 (IL-7); or a combination of IL-15 and IL-7, wherein the population of immune effector cells is expanded for a period of 5 days or contacting the cells with a nucleic acid encoding a telomerase. The teachings of Kohn, Cooper, Kaneko, Gattinoni, Klebanoff, Powell, Barsov, and Han. It would have been obvious before the effective filing date of the claimed invention to modify the methods of the patented claims where the population of T regulatory-depleted cells containing less than 50% of CD25+ cells, a nucleic acid encoding a CAR, contacting the population of immune effector cells with an interleukin-15 (IL-15); an interleukin-7 (IL-7); or a combination of IL-15 and IL-7, wherein the population of immune effector cells is expanded for a period of 5 days or contacting the cells with a nucleic acid encoding a telomerase for the advantage of creating a population of immune effector cells capable of enhancing immunotherapy efforts.
For additional limitations of the instant claims, see the additional teachings of the patented claims. To the extent that there are limitations that are not provided for by the patented claims, the teachings of Kohn, Cooper, Kaneko, Gattinoni, Klebanoff, Powell, Barsov, and Han are discussed above. It would have been obvious to have modified the subject matter of the patented claims to arrive at the subject matter of the instant claims for substantially the same reasons as discussed above in view of the teachings of these references.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s arguments, see pgs. 13-16, filed 03/09/2026, with respect to claims 1, 3-5, 9, 11-14, 17-19, 27-31, 33, 35-37, and 40 have been fully considered and are persuasive. The rejection has been withdrawn.
Regarding all other rejections for double patenting, Applicant requests that the Examiner hold these rejections in abeyance until the rejections outstanding in the instant application are overcome. However, the Examiner lacks the authority to hold rejections in abeyance, and thus the rejections of record are simply maintained.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 TIFFANY N GROOMS whose telephone number is (571)272-3771. The examiner can normally be reached M-F 830-530.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at 571-272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIFFANY NICOLE GROOMS/Examiner, Art Unit 1637
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