DETAILED ACTION
Applicants claim amendments filed 7/17/2024 are acknowledged and entered into the record.
Accordingly, Claims 87-112 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 § 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) 87-112 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chyung et al. (AU2020210134, published 7/27/2020) in view of McCampbell (WO2021030766).
The claims are drawn to a combination method of treating spinal muscular atrophy (SMA) comprising administering risdiplam and an antibody that binds to myostatin comprising CDRs having SEQ ID NOs: 1-6 (GYM329).
Chyung et al. teach administering myostatin inhibitors to enhance muscle/motor function and prevent muscle atrophy. Chyung et al. teach the myostatin inhibitor MST-1032 antibody comprising 100% identity to the instantly claimed CDRs. Chyung et al. disclose SEQ ID NOs: 117-122 having 100% identity to instantly claimed SEQ ID NOS: 1-6. Chyung et al. teach methods of treating spinal muscular atrophy (SMA) Type I or II by administering a myostatin inhibitor such as the MST-1032 antibody. Chyung et al. teach combination therapy comprising a myostatin inhibitor and an “SMN corrector” which increases or improves SMN1/2 gene expression. Chyung et al. teach administering the SMN corrector prior or concurrently to the administration of the myostatin inhibitor and varying doses. Chyung et al. does not teach combination treatment with risdiplam, this deficiency is made up for by McCampbell.
McCampbell teach combination therapy for the treatment of spinal muscular atrophy (SMA) Type I or II. McCampbell teach administering a small molecule that increases SMN function, such as risdiplam. McCampbell disclose treatment regimens comprising administering the combinations of treatment prior or subsequently and at varying dosages.
One of ordinary skill in the art would have been motivated to test the combination of myostatin inhibitors, such as the MST-1032 antibody taught by Chyung et al. and the SMN corrector, such as risdiplam as taught by Chyung et al. based on the teachings of both Chyung et al. and McCampbell. 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 combine the anti-myostatin antibody and the small molecule, risdiplam for the treatment of spinal muscular atrophy (SMA). 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 instantly claimed method, given the teaching of the prior art of combining therapies for the treatment of SMA, it would have been obvious to treat SMA patients with both an anti-myostatin antibody and risdiplam, 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.
In regards to the specific dosage amounts and administration times recited in the instant claims, 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). Therefore, it would be obvious to one of ordinary skill in the art, at the time the invention was made, to optimize dosage ranges and times by routine experimentation and anticipate the dosage ranges/times cited in the claims.
Conclusion
Claims 87-112 are rejected.
No Claim is allowed.
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/Meera Natarajan/Primary Examiner, Art Unit 1643
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