CLAIMS 1-11 AND 21-29 ARE PRESENTED FOR EXAMINATION
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 .
Applicant’s amendment, remarks and Information Disclosure Statements filed September 16, 2026 and September 28, 2026 have been received and entered into the application. As reflected by the attached, completed copies of form PTO/SB/08, the cited references have been considered by the Examiner. Also, the application papers have been amended as directed.
Claim Rejection - 35 USC § 112, (Overcome)
The rejection of the claims under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ),
second paragraph, as set forth in the previous Office action has been overcome and is withdrawn
because the rejected claims have been canceled.
Claim Rejection - 35 USC § 103, (Overcome)
The rejection of claims 1-20 under 35 U.S.C. 103 as being unpatentable over Sinha, (U.S.
2024/0474594) in view of Reynolds et al. and Jordan et al., as set forth in the previous Office
action has been overcome and is withdrawn for the following reasons.
Applicant's claim 1 now requires that the dosage form “comprises about 65% to about 85% of hydroxypropyl methylcellulose by weight of the dosage form” and "provides modified release of minoxidil or the pharmaceutically acceptable salt thereof, wherein the dosage form provides a Cmax of minoxidil that is about 0.25 ng/ml to about 20 ng/ml". The Cmax values cannot be said to be inherent in the teachings of the prior art or to have been obvious from the teachings in the prior art. In particular, the requirement cannot be said to be inherent because Sinha does not teach a dosage form comprising hydroxypropyl methylcellulose and thus, the claimed Cmax values cannot be said to be inherent. While a dosage form comprising the methylcellulose ingredient could have been obvious, it is well settled that for inherency to be
present, the inherent result must be a necessity and not merely a possibility. Also, there is no
teaching in the references correlating any pharmacokinetic parameter of a dosage form to the
particular methylcellulose ingredient which could have been employed in the dosage form of Sinha.
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 (
Provisional
Claims 1-11 and 21-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20, (unless otherwise specified), of copending Application Nos. (reference applications): 19/094,716; 19/253,703; 19/253,708; 19/255,878; 19/230,047, (claims 1-21); 19/230,054, (claims 1-21); 19/258,817; 19/260,035; 19/267,447; 19/267,464; 19/308,124; 19/315,454, (claims 1-19); 19/328,077, (claims 1-19); 19/402,798; or 19/329,494, (claims 1-19), each of record, for the reasons of record as set forth in the previous Office action as applied to claims 1-20, which reasons are here incorporated by reference.
Applicant’s remarks have been carefully considered, but fail to persuade the Examiner of error in his determination because the subject matter added by amendment to present claim 1 has been addressed in the previous Office action and as such, the rejection is deemed to remain proper.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Non-Provisional
Claims 1-11 and 21-29 are rejected on the ground of nonstatutory double patenting as being
unpatentable over claims 1-28 of U.S. Patent No. 12,268,688, (cited by Applicant) or (b) claims
1-20 of U.S. Patent No. 12,491,184, each of record, for the reasons of record as set forth in the previous Office action as applied to claims 1-20, which reasons are here incorporated by reference.
Applicant’s remarks have been carefully considered, but fail to persuade the Examiner of error in his determination because the subject matter added by amendment to present claim 1 has been addressed in the previous Office action and as such, the rejection is deemed to remain proper.
Accordingly, the claims are deemed properly rejected and none are currently in condition for allowance.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYMOND J HENLEY III whose telephone number is (571)272-0575. The examiner can normally be reached M-F 6-2:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629
October 12, 2026
