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 .
Information Disclosure Statement
An information disclosure statement was filed on 04/09/2024.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-26 in the reply filed on 03/30/2026 is acknowledged.
Claims 27. 28, 31-33, 37, and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 03/30/2026.
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) 1-4, 12, 13, 14, 17-21 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/290615 (El Glaoui et al), in view of Umesh et al (submitted in the European Search Report in the IDS filed 04/09/2024).
El Glaoui et al teach a pellet comprising an inert core, a drug layer comprising sildosin and a binder (HPMC) ([0037] – [0040] and [0212]), a sealing layer is set out at [0081].and an extended release layer of ethyl cellulose (pages 30-31, Example 1). Antioxidants are set out at [0212], including ascorbic acid. Talc is listed as a anti -tacking agent in [0212]. El Glaoui et al differs in that vinyl polymers are not taught as extended release polymers.
Umesh et al teach that vinyl polymers may be used as extended release polymers (see pages 73-74. Therefore it would be well within the skill of the ordinary practitioner to use a vinyl polymer as an extended release coating on the pellet composition of El Glaoui et al with a reasonable expectation of similar therapeutic result. The instant composition would have been obvious in view of El Glaoui et al which teaches a coated pellet, and further add an extended release coating to those of ordinary skill as taught by Umesh et al at the time of filing.
Conclusion
No claims are allowed.
Claims 5-11, 15=16, 22-23, and 25-26 are objected to as dependent upon a rejected base claim.
It is noted that El Glaoui et al does not teach the inclusion of plasticizers to their coated pellet. Amendment of the rejected claims to include this excipient would place the claims in condition for allowance.
The articles by Kallai-Szabo et al is cited as state of the art in coating pellets.
Correspondence
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz
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