CLAIMS 1-12, 19 and 21-28 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 Statement filed August 31, 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 claims have been amended as directed by Applicant.
Claim Rejection - 35 USC § 112, (Overcome)
The rejection of claims 13-18 and 20 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second paragraph, as set forth in the previous Office action has been overcome and is withdrawn because the rejected claims have been canceled.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(U.S. 2024/0474594) in view of Reynolds et al., as set forth in the previous Office action has been overcome and is withdrawn for the following reasons.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 comprise "wherein the dosage form comprising the release modifier provides an AUC that is less than the AUC that would result from orally administering 8.5 mg of minoxidil in an immediate release formulation" and such 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 the host of Sinha does not necessarily suffer from alopecia areata thus making the presently claimed AUC characteristic merely a possible characteristic.
It is well settled that for inherency, the 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 type of alopecia suffered by the host.
Double Patenting
Provisional
Claims 1-12, 19 and 21-28 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). 19/094,703; 19/422,011; 19/413,834; 19/242,858; 19/404,931; 19/241,304; 19/230,051; 19/236,933; 19/235,535; 19/250,029; 19/324,046; 19/234,212; 19/329,476, (claims 1-19); 19/245,208; 19/303,300; 19/315,441; 19/215,216; 19/409,546; 19/414,251; or 19/397,854, 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 of provisional double-patenting because the previous claims had supposed limitations regarding the pharmacokinetic characteristics of the dosage form as well as the limitations of the newly added claims.
For the above reasons, the claims are deemed to remain properly rejected.
Non-Provisional
Claims 1-12, 19 and 21-28 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), already of record, for the reasons of record as applied to claims 1-20 as set forth in the previous Office action dated January 12, 2026, 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 of provisional double-patenting.
Applicant’s remarks have been carefully considered, but fail to persuade the Examiner of error in his determination of provisional double-patenting because the previous claims had supposed limitations regarding the pharmacokinetic characteristics of the dosage form as well as the limitations of the newly added claims.
For the above reasons, the claims are deemed to remain properly rejected.
Applicant's amendment necessitated the new grounds of rejection, i.e., grouping of claims, presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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
September 10, 2026
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