CLAIMS 1-15 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 11, 2026 and September 17, 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 by Applicant.
In light of Applicant’s amendment canceling claims 16-21, the rejection of these claims under 35 USC 112, as set forth in the previous Office action, is hereby withdrawn.
Claim Rejection - 35 USC § 103
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Sinha, (U.S. 2024/0474594, (effective 09/29/21), in view of Reynolds et al., "Investigation of the Effect of Tablet Surface Area/Volume on Drug Release from Hydroxypropylmethylcellulose Controlled-Release Matrix Tablets", Drug Development and Industrial Pharmacy, 28(4), 457-466 (2002), (hereinafter “Reynolds”, cited by Applicant), each of record, for the reasons of record as set forth in the Office action dated January 12, 2026, as applied to claims 1-21, which reasons are here incorporated by reference.
This rejection is being reinstated after being withdrawn in the previous Office action because upon further review of Sinha, it is believed that such withdrawal was not proper.
In particular, it is noted that in present claim 1, it reads “wherein the dosage form does not comprise another pharmaceutically active agent”. While Sinha does teach the co-administration of another pharmaceutically active agent, namely a 5-alpha reductase inhibitor, Sinha does not necessarily teach that minoxidil and the 5-alpha reductase inhibitor must be combined in the same dosage form.
For example, at paragraph [0028], Sinha teaches:
“In one aspect, this disclosure provides a pharmaceutical package comprising two pharmaceutical compositions for oral administration to a subject to treat or prevent
hair loss: a pharmaceutical composition for oral administration of a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive
vasodilator, and a pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of a 5-alpha reductase inhibitor, for treating or preventing hair loss in a subject.”, (emphasis added).
Double Patenting
Provisional
Claims 1-15 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; 19/230,007, (claims 1-21); 19/409,546; 19/414,251 or 19/397,854, each of record, for the reasons of record as set forth in the Office action dated January 12, 2026, as applied to claims 1-21, which reasons are here incorporated by reference.
This rejection is being reinstated because upon a review of the copending claims, it is seen that dosage forms including minoxidil as the sole active agent are indeed set forth.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Non-Provisional
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 12,268,688, already of record, for the reasons of record as set forth in the Office action dated January 12, 2026, as applied to claims 1-21, which reasons are here incorporated by reference.
This rejection is being reinstated after being withdrawn in the previous Office action because upon a review of the patented claims, it is seen that dosage forms including minoxidil as the sole active agent present in the dosage form are indeed set forth.
Accordingly, the claims are deemed properly rejected and none are currently in condition for allowance.
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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/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629
October 12, 2026
