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 .
Restrictions/Elections
Applicant’s election with traverse filed September 13, 2024 is acknowledged. Applicant elected the following invention and species:
Invention: Group I, claims 1, 2, 5, 11, 18, and 29, drawn to a lymphocytic cell composition comprising a fixed ratio of activated CD4+ T cells, activated CD8+ T cells, and activated CD3+ NKT cells.
Species: the invention in which the fixed ratio of activated CD4+ T cells, activated CD8+ T cells, and activated CD3+ NKT cells is such that the composition comprises 20% activated CD4+ T cells, 50% activated CD8+ T cells, and 30% activated CD3+ NKT cells and in which the activated CD4+ T cells, activated CD8+ T cells, and activated CD3+ NKT cells have bene primed ex vivo against PRAME.
As set forth in the previous Office Action, claims 180-183 and 185 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on September 13, 2024, which was addressed in the Non-Final Office Action filed December 30, 2024.
Status of the Claims
Claims 1, 11, 18, 29, 180-183 and 185 are currently pending. Claims 180-183 and 185 are withdrawn from consideration. Claims 1, 11, 18, and 29 are the subject of this Office Action and are under consideration.
Priority
As set forth in the previous Office Action, the effective filing date of the claims is deemed the filing date of the provisional application (i.e., 62/789,489), namely January 7, 2019.
Withdrawn Claim Rejections
Applicant’s arguments, set forth at pages 2 to 6 of the Reply filed 04 February 2026, with respect to the claim rejections under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, all previous rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sommermeyer.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 11, 18, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou1 in view of Slanetz2, Shibolet3, and Sommermeyer4.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding Office Action, section, and/or rejection above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding claim 1, Zhou discloses cancer treatment methods involving activated lymphocytic cell compositions that are capable of targeting multiple cancer antigens (see Zhou entire document, e.g., the abstract, the claims, [0082], [0338]), wherein the composition comprises a fixed ratio of activated CD4+ T-cells, activated CD8+ T-cells, and activated CD3+ NKT-cells (see Zhou, e.g., at para. [0342], [0344], [0347]-[0347], [0476]-[0477]), and more specifically: (1) 10-30% CD3+CD4+ T-cells (see Zhou at para. [0344]; reads on instant claim 1 (i)); (2) 50-80% CD8+ T-cells (see Zhou at para. [0342]; reads on instant claim 1 (ii)) 5; and (3) 20% CD3+ NKT-cells (see Zhou at para. [0347]; reads partially on instant claim 1 (iii)). Zhou further discloses priming the cells with multiple tumor associated antigens and multiple viral associated antigens ex vivo (see Zhou, e.g., at para. [0473]-[0474] and [0476]-[0477]), and that the resulting composition is capable of increasing cytotoxic T cell activity in a human individual against more than one tumor antigen peptides (see Zhou, e.g., at para. [0349]).
Regarding claim 11, the disclosures of Zhou suggest that their methods, referred to as “Multiple Antigen Specific Cell Therapy (MASCT)” (i.e., their method of developing the activated lymphocytic cell composition directed to multiple tumor antigens), are useful in treating a variety of cancers, and can be tailored to a variety of different tumors based on the TAAs expressed by said tumor (see Zhou, e.g., at para. [0082]-[0083]), including the TAAs set forth in instant claim 11 (see Zhou, e.g., at para. [0226]).
Regarding claim 18, Zhou discloses the activated lymphocytic cell composition directed to multiple tumor antigens associated with the solid tumor cancer, hepatocellular carcinoma (see Zhou, e.g., at para. [0226], [0472]- [0476]).
Regarding claim 29, the disclosure of Zhou suggests use of their claimed composition as allogeneic cell therapy (see Zhou, e.g., at para. [0337]).
The prior art of Zhou differs from the instantly claimed invention as follows: Zhou does not expressly disclose the following: wherein the CD4+ T, CD8+ T, and CD3+ NKT cell populations each comprise a fixed ratio of two or more separately primed and expanded cell subpopulations, as required by instant claim 1; and wherein the fixed ratio of CD3+ NKT cells is between 25-35%, as required by claim 1(iii).
Slanetz discloses a “split pool protocol” where the cell population is divided into two or more sub-populations which are each exposed to a peptide mixture derived from a different target antigen, stimulated, and expanded in separate cultures prior to pooling the cells into one composition for final harvest (see Slanetz, e.g., at para. [0131])6. Slanetz further suggests that the method of dividing subpopulations and carrying out the antigen priming, stimulation, and expansion steps in separate cultures facilitates equivalent representation of a variety of antigens responsive cells (see Slanetz, e.g., at para. [0132]).
The teachings of Shibolet suggest that the proportion of CD8+ T, CD3+ NKT, and CD4+ T cells directly impact tumor suppression, and more specifically, tumor suppression is associated with an increase in peripheral NKT cell and CD8+ T-cell number along with a decrease in CD4+ T-cells (see Shibolet, e.g., col. 2 on p. 240).
The teachings of Sommermeyer suggest the enhancement in antitumor activity by administering a defined ratio of CD19 CAR-T cells derived from CD8+ and CD4+ T cell subsets compared to infusion of CAR-T cells derived from either subset alone, or from unselected T cells without regard for subset composition, as well as (see Sommermeyer, e.g., discussion).
Obviousness Analysis: it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the presently claimed invention in view of the prior art because it amounts to no more than: the use of known technique (e.g., the split pool protocol of Slanetz) to improve similar products (i.e., the activated lymphocytic cell composition of Zhou) in the same way; namely facilitating the balanced representation of the resulting cell subpopulations, each having specificity for a single TAA or VATA that is different from the other subpopulations (see MPEP 2143(I)(C), (G)); and combining the prior art elements of Zhou, as the disclosures of Zhou suggest that their methods and compositions can be applied to various cancer types as well as in the context of allogeneic therapy (see MPEP 2143(I)(A)(G)). While the prior art of Zhou does not expressly teach wherein the CD3+ NKT range set forth in instant claim 1(iii) as discussed above, it would have been obvious to a skilled artisan to have optimized these fixed ratios, as the proportion of CD8+ T, CD3+ NKT, and CD4+ T cells is known to directly impact tumor suppression, as taught by Shibolet. Furthermore, administering a defined ratio of engineered CD8+ and CD4+ T cell subsets enhance antitumor effects, as demonstrated by the prior art of Sommermeyer. In other words, the fixed ratio, i.e., proportion of CD8+ T, CD3+ NKT, and CD4+ T cells, is a result-effective variable, where the optimum ratio can be determined via routine optimization7. See MPEP 2144.05(II).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Thus, a skilled artisan could predictably and reasonably produce the composition of the present invention, as the prior art of Zhou, Slanetz, and Shibolet provides support and motivation for doing so, as discussed above.
Accordingly, claims 1, 11, 18, and 29 are rejected.
Claim Rejections - 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.
Copending Application No. 17/049,307 (US20210046119)
Claims 1, 11, 18, and 29 stand/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 90-92, 94-97, and 108-109 of copending Application No. 17/049,307 (reference application) in view of Slanetz (supra).
This is a provisional nonstatutory double patenting rejection. The disclosures of Slanetz are discussed above and incorporated herein.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding Office Action, section, and/or rejection above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Legal Analysis: MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 1, 11, 18, and 29, the reference application explicitly claims an isolated lymphocytic cell composition, comprising: (i) from about 5-25% activated CD4+ T cells, (ii) from about 25-55% activated CD8+ T, and (iii) from about 7.5-35% activated CD3+ NKT cells, wherein the TAAs are selected from WT1, PRAME, surviving, NY-ESO, MAGE-A3, and SSX (see reference claims 90-92, 94-97, 108-109; compare id. with instant claims 1, 11, and 18). While the reference claims do not explicitly recite allogeneic cells, the reference specification indicates allogeneic compositions as an obvious variant8 of the invention (see lines 18-19 on p. 12 of the ref. specification; reads on instant claim 29).
As set forth in the 35 U.S.C. 103 rejection above, Slanetz discloses the “split pool protocol” and the advantages of this method.
Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to use a known technique (e.g., the split pool protocol of Slanetz) to improve similar products (i.e., the composition of the reference claims) in the same way (see, e.g., MPEP § 804(II)(B)(3)(C),(D); see also MPEP § 2143(B)).
Copending Application No. 17/056,714 (US20230002730)
Claims 1, 11, 18, and 29 stand/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 15, 20, 25-27, 68, 71-73, 82-83, and 87-88 of copending Application No. 17/056,714 (reference application) in view of Zhou (supra), Shibolet (supra), and Sommermeyer (supra).
This is a provisional nonstatutory double patenting rejection. The disclosures/teachings of Zhou, Shibolet, and Sommermeyer are discussed above and incorporated herein.
Claim interpretation: The applicable claim interpretation(s), as set forth above, are incorporated herein. Additional claim interpretations are set forth below.
Legal Analysis: The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 1, 11, 18, and 29, the reference application explicitly claims: isolated T cell compositions, comprising two or more T cell subpopulations, each specific for a different tumor associated antigen, wherein each subpopulation is primed and expanded separately from each other ex vivo, wherein the subpopulations are combined in a defined ratio, wherein the antigen is one of those set forth in instant claim 11, and wherein the cells are allogeneic (see reference claims 1-10, 15, 20, 25-27, 68, 71-73, 82-83, and 87-88; compare id. with instant claims 1, 11, 18, and 29). While the reference claims do not explicitly recite the T cell subpopulations, the reference specification indicates CD8+ T, CD4+ T, and CD3+ NKT cells as an obvious variants8 of the T cell subpopulations (see the ref. specification, e.g., at p. 356, p. 359).
As set forth in the 35 U.S.C. 103 rejection above, Zhou discloses the composition of the present invention, along with the particular ratios set forth in instant claim 1(i) and (ii), and the teachings of references Shibolet and Sommermeyer suggests the importance of the proportions and defined ratios of CD8+ T, CD4+ T, and CD3+ NKT cells in cancer, providing support for routine optimization of said proportions as a result-effective variable.
Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to modify the reference claims by incorporating the disclosures of Zhou, as Zhou discloses the activated lymphocytic compositions with fixed ratios and their use for cancer, and Shibolet teaches and suggests the importance of the proportion of CD8+ T, CD4+ T, and CD3+ NKT cells in cancer (see, e.g., MPEP § 804(II)(B)(3)(D); see also MPEP § 2143(B)).
Copending Application No. 17/421,287 (US20220062342)
Claims 1, 11, 18, and 29 stand/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 9, 12, 14, 19, 21, 24, 26-27, 29, 31-32, 40-43, and 45 of copending Application No. 17/421,287 (reference application) in view of Zhou (supra), Shibolet (supra), and Sommermeyer (supra).
This is a provisional nonstatutory double patenting rejection. The disclosures/teachings of Zhou, Shibolet, and Sommermeyer are discussed above and incorporated herein.
Claim interpretation: The applicable claim interpretation(s), as set forth above, are incorporated herein. Additional claim interpretations are set forth below.
Legal Analysis: The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 1, 11, 18, and 29, the reference application explicitly claims: isolated T cell compositions, comprising two or more T cell subpopulations, each specific for a different tumor associated antigen, wherein each subpopulation is primed and expanded separately from each other ex vivo, wherein the antigen is one of those set forth in instant claim 11, and wherein the cells are allogeneic (see reference claims 1-4, 6, 9, 12, 14, 19, 21, 24, 26-27, 29, 31-32, 40-43, and 45; compare id. with instant claims 1, 11, 18, and 29). While the reference claims do not explicitly recite the T cell subpopulations, the reference specification indicates CD8+ T, CD4+ T, and CD3+ NKT cells as an obvious variants8 of the T cell subpopulations (see the ref. specification, e.g., at p. 11).
As set forth in the 35 U.S.C. 103 rejection above, Zhou discloses the composition of the present invention, along with the particular ratios set forth in instant claim 1(i) and (ii), and the teachings of references Shibolet and Sommermeyer suggests the importance of the proportions and defined ratios of CD8+ T, CD4+ T, and CD3+ NKT cells in cancer, providing support for routine optimization of said proportions as a result-effective variable.
Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to modify the reference claims by incorporating the disclosures of Zhou, as Zhou discloses the activated lymphocytic compositions with fixed ratios and their use for cancer, and Shibolet teaches and suggests the importance of the proportion of CD8+ T, CD4+ T, and CD3+ NKT cells in cancer (see, e.g., MPEP § 804(II)(B)(3)(D); see also MPEP § 2143(B)).
Response to Arguments
Applicant's arguments, set forth at pages 2 to 6 of the Reply filed 04 February 2026, have been fully considered.
It is the Examiner’s understanding that Applicant is attempting to rebut a determination of obviousness under MPEP § 2143(I)(A), (B), (C), (D), and/or (G) by alleging that “it would not have been obvious to optimize the percentages of T-cell types within an isolated population of cells as taught by Zhou” (see, e.g., Reply filed 04 February 2026, of p. 3).
In response to applicant's arguments against references individually or less than all references relied upon by the Examiner, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. As stated in the previous Office Action and above, while the prior art of Zhou does not expressly teach wherein the CD3+ NKT range set forth in instant claim 1(iii), it would have been obvious to a skilled artisan to have optimized these fixed ratios. As discussed above, the prior art of Sommermeyer was additionally cited to provide further support that the method of intentionally fixing and controlling the ratio of activated T-cell types ex vivo in order to produce a composition comprising a defined ratio of T-cell types was known in the art prior to the effective filing date of the present invention, and the proportion of CD8+ T, CD3+ NKT, and CD4+ T cells is known to directly impact tumor suppression, as taught by Shibolet. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). It is neither disputed nor dispositive of obviousness that the primary references, taken alone, fail to satisfy the claimed invention, because no rejections over such individual references have been made.
Furthermore, it is the Examiner’s understanding that Applicant is relying upon a different reference that addresses facts and scientific issues that are not all relevant to the instant invention, and were not relied upon by the Examiner (see, e.g., Applicant’s reliance on the reference, “Sender”, to support the argument, “the number of cells in a dose of an isolated lymphocytic cell composition makes up an incredibly small fraction of a patient's total T cell population”, Reply at p.4). However, it is well known in the art of adoptive cell therapy that lymphodepletion prior to cell therapy administration is an essential and widely used practice to ensure expansion and persistence of administered cells9, and thus, the total number of endogenous T cells in a reference human is not relevant. Furthermore, the present claims do not recite a number of cells in a dose of an isolated lymphocytic cell composition, nor the administration of the isolated lymphocytic cell composition.
The prior art set forth by the Examiner is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)), including “all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” (see, e.g., MPEP § 2123(I)), and here the additional information does not detract or erase the disclosures relied upon by the Examiner in the rejection of record. As discussed above, the prior art of Sommermeyer teaches the method of intentionally manipulating the ratio of T-cell types ex vivo prior to administration into a subject and Shibolet teaches that the proportion of CD8+ T, CD3+ NKT, and CD4+ T cells is known to directly impact tumor suppression. These statements are representative of the proportion of these cell subtypes directly impacting tumor suppression post administration into a patient having a tumor, as set forth in the claims, and provides motivation to a skilled artisan for optimizing these fixed ratios, as they are result-effective variables, where the optimum ratio can be determined via routine optimization.
Moreover, the examples of the present application are merely prophetic. If Applicant means to allege the existence of unexpected results, Applicant is directed to MPEP § 716.02, which identifies the evidence required to establish unexpected results.
Conclusion
Claims 1, 11, 18, and 28 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEA S O'BRIEN whose telephone number is (703)756-4793. The examiner can normally be reached Monday - Thursday 9:00 AM to 6:00 PM PT.
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/LEA S O'BRIEN/Examiner, Art Unit 1646
/MARK HALVORSON/Primary Examiner, Art Unit 1646
1 US20180078624A1; cited in the IDS
2 WO2018005712A1; cited in the IDS
3 Shibolet, Oren et al. “NKT and CD8 lymphocytes mediate suppression of hepatocellular carcinoma growth via tumor antigen-pulsed dendritic cells.” International journal of cancer vol. 106,2 (2003): 236-43.
4 Sommermeyer D et al. “Chimeric antigen receptor-modified T cells derived from defined CD8+ and CD4+ subsets confer superior antitumor reactivity in vivo”. Leukemia vol. 30,2 (2015):492-500.
5 Zhou discloses ranges of CD4+ T and CD8+ T cells that overlap with the ranges presently claimed (i.e., compare with claim 1(i) and 1(ii)). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05.
6 The disclosure of Slanetz reads on “primed ex vivo against two or more TAAs or VATAs… separately primed and expanded… has specificity for a TAA or VATA that is different from all other cell subpopulations in the composition” in instant claim 1.
7 It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art."
In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious).
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”
See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
8 Per MPEP § 804(II)(B)(1), “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application”.
9 Lickefett et al. “Lymphodepletion - an essential but undervalued part of the chimeric antigen receptor T-cell therapy cycle”. Front Immunol. 2023 Dec 22;14:1303935.