DETAILED ACTION
Applicants claim amendments filed 4/1/2024 are acknowledged and entered into the record.
Accordingly, Claims 1-2, 7-9, 11-12, 14-15, 17, 19-20, 22, 32-36, 38 and 39 are pending and will be examined on the merits.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 7-9, 11-12, 14-15, 17, 32-36, 38 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khandekar et al. (WO2019053612, cited on IDS filed 4/1/2024) as evidenced by Matyskiela et al. (J Med Chem, 2018, Jan 25;61(2):535-542).
The claims are drawn to a combination comprising the anti-BCMA antibody belantamab mafodotin conjugated to MMAE or MMAF and a cereblon E3 ligase modulator and a method of treating multiple myeloma comprising administering said combination.
Khandekar et al. teach a combination of an anti-BCMA antibody and an immunodulatory imide drug for treating cancer. Khandekar et al. teach the anti-BCMA antibody having the same instantly claimed CDRs having SEQ ID NOs 1-6 and VH/VL regions comprising SEQ ID NOS: 7&8. Khandekar et al. further teach wherein the anti-BCMA antibody is conjugated to a cytotoxin such as either MMAE or MMAF. Khandekar et al. disclose wherein the anti-BCMA antibody is administering at 1.9 mg/kg, 2.5 mg/kg, or 3.4 mg/kg. Khandekar et al. teach the immunodulatory imide drug is pomalidomide or lenalidomide both of which are cereblon E3 ligase modulators which degrade Ikaros protein or Aiolos protein as evidenced by Matyskiela et al. Khandekar et al. teach the patient population having multiple myeloma and may include relapsed and/or refractory patients. Khandekar et al. teach each and every limitation of the instant claims.
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.
Claim(s) 1-2, 7-9, 11-12, 14-15, 17, 19-20, 22, 32-36, 38 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Khandekar et al. in view of Hasskarl et al. (WO2020097403, cited on IDS filed 4/1/2024) and Hansen et al. (J. Med. Chem; 19 March 2020, cited on IDS filed 4/1/2024).
The teachings of Khandekar et al. are cited in the 102(a)(1) rejection set forth above. Khandekar et al. does not teach combination of the anti-BCMA antibody with the cereblon E3 ligase modulators iberdomide or mesigdomide. This deficiency is made up for by Hasskarl et al. and Hansen et al.
Hasskarl et al. teach combination of an anti-BCMA binding protein and an immunomodulatory agent interacting with cereblon such as iberdomide, avadomide, lenalidomide or pomalidomide. Hasskarl et al. teach said combinations can be used in methods of treating multiple myeloma.
Hansen et al. teach treatment of patients with relapsed or refractory multiple myeloma using novel cereblon E3 ligase modulators such as mezigdomide (CC-92480). Hansen et al. disclose unlike previously identified compounds such as lenalidomide and pomalidomide, which require higher concentrations and longer times to degrade protein substrates, CC92480, has a unique and rapid degradation profile.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use other cereblon E3 ligase modulators in combination with an anti-BCMA antibody for the treatment of relapsed/refractory multiple myeloma (RRMM) based on the teachings of Khandekar et al., Hasskarl et al. and Hansen et al. One of ordinary skill in the art would have been motivated to use the agents in combination in a method of treatment in view of the clinical data presented in the prior art. Each of these agents had been taught by the prior art to be effective against multiple myeloma, thus the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two modes of treatment, each of which is taught by the prior art to be useful for the same purpose in order to make a protocol that is to be used for the very same purpose since the idea of combining them flows logically from their having been individually taught in the prior art. Applying the same logic to the instant claims, given the teaching of Hasskarl et al. and Hansen et al. of using iberdomide or mezigdomide in the treatment of RRMM, it would have been obvious to combine these agents with an anti-BCMA antibody such as belantamab mafodotin conjugated to MMAE or MMAF in the treatment of multiple myeloma as taught by Khandekar et al., because the idea of doing so would have logically followed from their having been individually taught in the prior art to be useful as agents for the same purpose.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 7-9, 11-12, 14-15, 17, 32-36, 38 and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-8, 13-16, 21-22, 28-34 of copending Application No. 18/730,820 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and those of copending application 18/730,820 are both drawn to combination therapy comprising an anti-BCMA antibody (belantamab mafodotin) and a cereblon E3 ligase modulator (lenalidomide) and methods of treating multiple myeloma patients.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-2, 7-9, 11-12, 14-15, 17, 19-20, 22, 32-36, 38 and 39 are rejected.
No Claim is allowed.
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/Meera Natarajan/Primary Examiner, Art Unit 1643
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