DETAILED ACTION
This office action is in response to the Applicant’s filing dated June 22nd, 2026.
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 .
Priority
This application is a 371 of PCT/US2021/029503 filed on April 27th, 2021; and has a PRO 63/016,983 filed on April 28th, 2020.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 22nd, 2026 has been entered.
Status of Claims
Claims 3, 15-17, 22, 24, 30, 35, 38, 40, 44, 71, 82, 84, 94-95, 98, 100, 107 and 117 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed on June 22nd, 2026. Acknowledgement is made of Applicant's cancelation of claims 10 and 118.
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 3, 15-17, 22, 24, 30, 35, 38, 40, 71, 82, 84, 94-95, 98, 100 and 107 are rejected under 35 U.S.C. 103 as being unpatentable over Bjorklund et al (Leukemia, (2019), 34(4), 1197–1201), cited in a previous Office action; in view of Quigley et al (WO 2018/085690 A1, cited in the IDS filed May 16th, 2023); further in view of Works et al (Molecular Cancer Therapeutics, (2019), 18(12), 2246-2257).
Regarding claim 3, Bjorklund teaches the compound Iberdomide shown below:
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Bjorklund teaches that Iberdomide is potent and effective in treating resistant multiple myeloma (MM) cell lines; reporting that Iberdomide shows strong antiproliferative activity and pro-apoptotic activity in multiple myeloma cell lines, including in lenalidomide resistant cell lines (page 1197, left column, second paragraph). Bjorklund further states that Iberdomide’s biochemical potency provides strong preclinical and translational evidence supporting its clinical potential in relapsed refractory multiple myeloma, including in combination with other agents (page 1200, left column, second paragraph).
Bjorklund does not teach a method of treating MM comprising a T cell therapy; wherein the T cell therapy comprises a dose of genetically engineered T cells expressing a chimeric antigen receptor (CAR) that specifically binds to BCMA, and the administration of the immunomodulatory compound is initiated after administration of the T cell therapy; or wherein the MM is R/R MM, prior to the initiation of administration of T-cell therapy and the immunomodulatory compound, the subject has received one or more prior therapies for treating the R/R MM, the one or more prior therapies comprising an immunomodulatory agent.
Quigley teaches that “Chimeric Antigen Receptor (CAR) T-cells are molecules that combine antibody-based specificity for a desired antigen with a T cell receptor-activating intracellular domain to generate a chimeric protein that exhibits a specific anti-cancer immune activity” (page 1, last paragraph). Quigley further teaches Example 3 (pages 29-32) wherein “anti-BCMA02 CAR T cells were administered to patients with relapsed and/or refractory BCMA-positive MM who received at least 3 prior regimens, including a proteasome inhibitor and an immunomodulatory agent or who were double-refractory; 100% of patients received at least 1 prior autologous stem cell transplant” (page 29, last paragraph; page 30, lines 13-14). Quigley further teaches anti-BCMA02 CAR T cells demonstrate clinical efficacy against relapsed and/or refractory multiple myeloma stating, “Anti-BCMA02 CAR T cells showed remarkable efficacy at dose levels above 5.0 x 107 CAR+ T cells, including 2 CRs and ongoing clinical response at 6 months. In contrast to results with other CAR T cell therapies, the efficacy of the anti-BCMA02 CAR T cells was accompanied by unexpectedly mild and manageable CRS (Cytokine Release Syndrome), including in patients with ≥50% bone marrow involvement. These data support the therapeutic efficacy of anti-BCMA02 CAR T cells for relapsed/refractory multiple myeloma” (pages 31, last paragraph; page 32, first paragraph).
Works teaches that the combination of an immunomodulatory drug with anti-BCMA CAR T cell therapy enhances the therapeutic activity of the CAR T cells against multiple myeloma. Specifically, Works teaches that lenalidomide, an immunomodulatory drug used for treating multiple myeloma, enhances anti-BCMA CAR T cell function, including increased cytolytic activity, cytokine production, activation, and long-term functionality relative to anti-BCMA CAR T cells alone (page 2246, Abstract; page 2248, left column, first paragraph). Works further demonstrates that the addition of lenalidomide to anti-BCMA CAR T cells increased cytolytic activity and effector functionality across several measures in multiple myeloma models (page 2248, left column, first paragraph; page 2249, Figure 1). Works reports that in vivo concurrent administration of lenalidomide with anti-BCMA CAR T cells significantly decreased tumor burden and increased survival relative to anti-BCMA CAR T cells alone (page 2251, left column, last paragraph; right column, first paragraph).
“[T]he rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395.
It would have been prima facie obvious to a person of ordinary skill in the art to combine the immunomodulatory compound Iberdomide taught by Bjorklund with the anti-BCMA CAR+ T cell therapy taught by Quigley for the treatment of R/R MM. Bjorklund establishes the efficacy of Iberdomide in Lenalidomide resistant MM; while Quigley demonstrates the efficacy of anti-BCMA CAR+ T cell therapy in R/R MM patients who had previously received at least 3 prior regimens, including at least 1 prior autologous stem cell transplant, a proteasome inhibitor and an immunomodulatory agent or who were double-refractory. Works provides further express motivation for the combination and a reasonable expectation of enhanced therapeutic activity, teaching that an immunomodulatory drug can potentiate anti-BCMA CAR T cell function and demonstrating increased cytolytic activity, cytokine production, CAR T cell functionality, tumor control and survival when an immunomodulatory agent is combined with anti-BCMA CAR T cells. Accordingly, a person of ordinary skill in the art would have reasonably expected that combining the immunomodulatory activity of Iberdomide with anti-BCMA CAR T cell therapy would provide at least additive, and potentially enhanced, antimyeloma efficacy. Thus, a more pronounced therapeutic effect resulting from the claimed combination would have been consistent with, and reasonably expected from, the teaching of the prior art rather than unexpected. The claimed invention represents the predictable use of prior art elements according to their established functions, yielding predictable results.
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Furthermore, it is obvious to vary and/or optimize the result-effective variables of administration timing and dosing regimens of the immunomodulatory compound in relation to the anti-BCMA02 CAR+ T cells according to guidance established by Bjorklund and Quigley in order to balance safety with efficacy. It is noted that "[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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 15-17, Bjorklund, Quigley and Works render the method of claim 3 obvious as described in the above rejection.
Quigley further teaches that anti-BCMA02 CAR+ T cells were administered to patients with relapsed and/or refractory BCMA-positive MM who received at least 3 prior regimens (addressing claim 15), including a proteasome inhibitor and an immunomodulatory agent or who were double-refractory; 100% of patients received at least 1 prior autologous stem cell transplant, 67% received prior daratumumab or CD38 mab (addressing claim 16), 89% received prior lenalidomide and 78% received prior pomalidomide (addressing claim 17) (page 29, last paragraph; page 30, lines 13-14).
Regarding claims 22, 24, 30, 35, 38 and 40, Bjorklund, Quigley and Works render the method of claim 3 obvious as described in the above rejection.
Bjorklund further teaches that, “CAR+ T cell expansion was consistently demonstrated, and is similar to other published CAR T cell trials” (page 31, lines 8-9).
Bjorklund and Quigley do not teach the dosing regimens of the instant claims for the immunomodulatory compound in relation to the anti-BCMA02 CAR+ T cells.
It is obvious to vary and/or optimize the result-effective variables of administration timing and dosing regimens of the immunomodulatory compound in relation to the anti-BCMA02 CAR+ T cells according to guidance established by Bjorklund and Quigley in order to balance safety with efficacy. It is noted that "[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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 71, Bjorklund, Quigley and Works render the method of claim 3 obvious as
described in the above rejection.
Quigley further teaches dose levels of anti-BCMA02 CAR+ T cells of 5.0 x 107, 15.0 x 107 and 45.0 x 107 (page 31, Table 5).
MPEP § 2144.05 states:
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). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
Regarding claims 82, 94-95, 98 and 100, Bjorklund, Quigley and Works render the method of
claim 3 obvious as described in the above rejection.
Quigley further teaches the anti-BCMA CAR+ comprises an anti-BCMA scFv, which a person of ordinary skill in the art would recognize as an antigen binding domain that binds to BCMA (page 27, Table 3, Nucleotides 3188-3934); a CD8α hinge (spacer) and transmembrane domain (page 27, Table 3, Nucleotides 3935-4141); an intracellular signaling region comprising a CD3-ζ chain (page 28, Table 3, Nucleotides 4270-4606); and wherein the intracellular signaling region further comprises a costimulatory signaling domain, wherein the costimulatory signaling domain comprises an intracellular signaling domain of 4-1BB (page 27, Table 3, Nucleotides 4144-4269).
Regarding claim 84, Bjorklund, Quigley and Works render the method of claim 3 obvious as
described in the above rejection.
Quigley further teaches the amino acid sequences of exemplary light chain CDR sequences, SEQ ID NOs: 1-3 (page 7, lines 2-3; page 49); and amino acid sequences of exemplary heavy chain CDR sequences, SEQ ID NOs: 4-6 (page 7, lines 4-5; page 50).
These light and heavy chain CDR sequences, SEQ ID NOs 1-6, of Quigley are an identical 100% sequence identity match for SEQ ID NOs 62-67 of instant claim 84 as seen on page 205 of the specification.
Regarding claim 107, Bjorklund, Quigley and Works render the method of claim 3 obvious as
described in the above rejection.
Quigley further teaches the full polynucleotide sequence that encodes an exemplary anti-BCMA CAR, SEQ ID NO: 10 (page 7, lines 12-13; pages 54-56).
A BLASTp alignment conducted by the Examiner confirmed that Quigley’s SEQ ID NO: 10 is identical to applicant’s SEQ ID NO: 153 of instant claim 107 as seen on page 216 of the specification; 472/472 identities, 100% sequence identity match, no gaps.
Taken together, all this would result in the practice of the methods of instant claims 3, 15-17, 22, 24, 30, 35, 38, 40, 71, 82, 84, 94-95, 98, 100 and 107 with a reasonable expectation of success.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Bjorklund et al (Leukemia, (2019), 34(4), 1197–1201), cited in a previous Office action; in view of Quigley et al (WO 2018/085690 A1, cited in the IDS filed May 16th, 2023); further in view of Works et al (Molecular Cancer Therapeutics, (2019), 18(12), 2246-2257); further in view of Borovinskaya et al (US 2020/0330445 A1), cited in a previous Office action.
Regarding claim 44, Bjorklund, Quigley and Works render the method of claims 3, 15-17, 22, 24, 30, 35, 38, 40, 71, 82, 84, 94-95, 98, 100 and 107 obvious as described in the above rejection.
Bjorklund, Quigley and Works do not teach the particular weight ranges recited in instant claim 44 of the immunomodulatory compound.
Borovinskaya teaches Iberdomide is an immunomodulatory compound used to treat refractory multiple myeloma (page 1, paragraph [0003]; page 2, paragraph [0008]), and discloses a method wherein the immunomodulatory compound is delivered in a dose of 500 mcg per day (page 4, paragraph [0048]; page 5, paragraph [0050]), which is equivalent to 0.5 mg per day, to treat multiple myeloma (page 5, paragraph [0051]).
MPEP § 2144.05 states:
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). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
Taken together, all this would result in the practice of the method of instant claim 44 with a reasonable expectation of success.
Claim 117 is rejected under 35 U.S.C. 103 as being unpatentable over Bjorklund et al (Leukemia, (2019), 34(4), 1197–1201), cited in a previous Office action; in view of Quigley et al (WO 2018/085690 A1, cited in the IDS filed May 16th, 2023); further in view of Works et al (Molecular Cancer Therapeutics, (2019), 18(12), 2246-2257) as applied to claims 3, 15-17, 22, 24, 30, 35, 38, 40, 71, 82, 84, 94-95, 98, 100 and 107 above.
Regarding claim 117, Bjorklund, Quigley and Works render the method of claims 3, 15-17, 22, 24, 30, 35, 38, 40, 71, 82, 84, 94-95, 98, 100 and 107 obvious as described in the above rejection.
It would have been prima facie obvious to one of ordinary skill in the art to optimize the treatment administration order of Iberdomide and Anti-BCMA CAR-T therapy, since Bjorklund and Quigley teach that each of these therapies are individually useful for treating multiple myeloma, and because both dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable treatment administration order would have been well within the practice of routine experimentation by the skilled artisan.
MPEP 2144.04(IV)(C) states:
“Selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results” In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946); “Selection of any order of mixing ingredients is prima facie obvious.” In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930).
As such, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosing regimen, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Taken together, all this would result in the practice of the method of instant claim 117 with a reasonable expectation of success.
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 3, 15-17, 22, 24, 30, 35, 38, 40, 44, 71, 82 and 117 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 11-13, 15-21 and 26-32 of U.S. Patent No. 12,263,190.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the ‘190 Patent are drawn to a method of treating cancer, comprising administering a T cell therapy, wherein the target antigen is BCMA, and Iberdomide to a subject in need thereof; wherein the cancer is multiple myeloma. Thus, the ‘190 Patent claims a very similar method of treatment when compared to the instant claims.
Regarding dosage and treatment regimen, these are result-effective variables, and the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan; and generally considered prima facie obvious. Please see MPEP § 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Response to Arguments
Applicant argues:
Applicant contends the Examiner has provided no motivation to combine Bjorklund and Quigley, or any reasonable expectation of success. Applicant states Bjorklund and Quigley teach individual components, but do not provide a motivation to combine. Applicant further states the citation of Kerkhoven is misplaced because Kerkhoven was based on methods of making detergent compositions.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
As the Applicant has acknowledged, Bjorklund teaches Iberdomide is potent and effective in treating multiple myeloma (MM), while Quigley teaches anti-BMA CAR-T cell therapy to treat MM. Thus, it is well established in the art that both of these therapies are useful in the treatment of MM. Bjorklund further teaches that Iberdomide’s biochemical potency provides strong preclinical and translational evidence supporting its clinical potential in relapsed refractory multiple myeloma, including in combination with other agents. Combination therapy is routinely employed in the treatment of cancer, including multiple myeloma, to improve therapeutic efficacy, address drug resistance, and in some instances take advantage of complimentary mechanisms of action.
MPEP 2144 (I) states:
“The rationale to modify or combine the prior art does not have to be expressly stated
in the prior art; the rationale may be expressly or impliedly contained in the prior art or
it may be reasoned from knowledge generally available to one of ordinary skill in the art,
established scientific principles, or legal precedent established by prior case law. In re
Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21
USPQ2d 1941 (Fed. Cir. 1992); see also In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d
1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining
teachings).”
Furthermore, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Moreover, as discussed in the above rejection, Works provides further express motivation for the combination and a reasonable expectation of enhanced therapeutic activity, teaching that an immunomodulatory drug, such as Iberdomide, can potentiate anti-BCMA CAR T cell function and demonstrates increased cytolytic activity, cytokine production, CAR T cell functionality, tumor control and survival when an immunomodulatory agent is combined with anti-BCMA CAR T cells.
Applicant’s argument that Kerkhoven is inapplicable because it relates to detergent compositions is not persuasive. The case law establishes the concept of combining individual compositions taught by the prior art to be useful for the same purpose, in order to form a third composition for the very same purpose. Given that both Iberdomide and anti-BCMA CAR-T therapy are independently taught to be effective in treating multiple myeloma, one of ordinary skill in the art would have had a reasonable expectation of success.
Applicant argues:
Applicant contends the Examiner relies on Quigley’s disclosure that patients in Example 3 “received at least 3 prior regimens, including a proteasome inhibitor and an immunomodulatory agent” for motivation; and the fact a patient previously received an immunomodulatory agent as a separate, earlier line of therapy is fundamentally different from the active co-administration of an immunomodulatory compound in combination with CAR T therapy.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
It is respectfully pointed out that the independent claim has a claim limitation that requires the subject to have received one or more prior therapies for treating the R/R MM, the one or more prior therapies comprising an immunomodulatory agent.
Motivation to combine is discussed in the above rejections, notably from the Works reference.
Applicant argues:
Applicant contends that an unexpected increase in performance is exhibited by the claimed methods, outweighing any prima facie case of obviousness. Specifically, that working examples wherein Iberdomide is used in combination with Anti-BCMA CAR-T therapy in Example 6 (pages 195-198 in the Specification) as seen in Figures 6B and 7B demonstrates improved survival rates.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
Applicant’s data shows synergy for the combination of Iberdomide and anti-BCMA CAR T cell therapy, however it is not clear that synergy would occur across a broad dose range; and notably, the data presented in Figures 6B and 7B are not commensurate with the dosage range of claim 44. Importantly, the improvement in therapeutic performance is not considered unexpected in view of the prior art. Works teaches that combining an immunomodulatory drug with anti-BCMA CAR T cell therapy enhances the therapeutic activity of the CAR T cells against multiple myeloma. Specifically, Works teaches that lenalidomide, an immunomodulatory drug used for treating multiple myeloma, enhances anti-BCMA CAR T cell function, including increased cytolytic activity, cytokine production, activation, and long-term functionality relative to anti-BCMA CAR T cells alone. Works further reports that concurrent administration significantly decreased tumor burden and increased survival relative to anti-BCMA CAR T cells alone. Accordingly, a person of ordinary skill in the art would have reasonably expected that combining the immunomodulatory activity of Iberdomide with anti-BCMA CAR T cell therapy would provide at least additive, and potentially enhanced, antimyeloma efficacy. Thus, a more pronounced therapeutic effect relied upon by Applicant is consistent with, and reasonably expected from, the teachings of the prior art rather than unexpected. Applicant’s evidence therefore does not outweigh the prima facie case of obviousness.
Conclusion
Claims 3, 15-17, 22, 24, 30, 35, 38, 40, 44, 71, 82, 84, 94-95, 98, 100, 107 and 117 are rejected.
No claim is allowed.
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/C.L.J./Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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