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 .
Election/Restrictions
Applicant’s election without traverse of the invention of group I, claims 1-14 in the reply filed on 12/12/2025 is acknowledged.
Claims 17-18, 20-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/12/2025.
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, 4, 6-8, 13, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nikolakis et al., American Journal of Clinical Dermatology (2019) 20:503-513 in view of Vogelzang et al., J Clin Oncol 38, e17578-e17578(2020).
Nikolakis et al. teaches the use of anti-androgen agents for treating hidradenitis suppurativa (HS) (see the abstract). Nikolakis et al. teaches cyproterone acetate, spironolactone, finasteride being effective as well as metformin, possibly due to its anti-androgenic effect (See page 506-511, section 3.1, 3.2, 3.3, and 3.4).
Nikolakis et al. does not expressly teach proxalutamide, in the herein claimed dosage, in the method of treating HS.
Vogelzang et al. teaches proxalutamide as an androgenic receptor antagonist., in a dosage of 400mg as safe in treating mCRPC (see the abstract).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ proxalutamide, in the herein claimed dosage, in a metho of treating HS.
One of ordinary skill in the art would have been motivated to employ proxalutamide, in the herein claimed dosage, in a metho of treating HS. It is well-known that anti-androgen agents as effective to treat HS. Therefore, employing any known anti-androgen agents, including proxalutamide, would be reasonably expected to be effective. Furthermore, employing 400mg of proxalutamide, which is a safe dosage to the patient would be reasonably expected to be useful in treating HS. The amount present in the pharmaceutical composition, although not explicitly disclosed, would be optimized under routine experimentation as being within the purview of the skilled artisan.
Allowable Subject Matter
Claims 3, 5, 9-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627
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