CLAIMS 1-5, 7-12 AND 19-27 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 September 11, 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 previously made 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or 35 U.S.C. 112 (pre-AIA ), second paragraph, as set forth in the previous Office action has been overcome and is withdrawn because the rejected claims have been canceled.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 previously made 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 and Jordan et al., as set forth in the previous Office action has been overcome and is withdrawn for the following reasons.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 comprises “and about 65% to about 85% of hydroxypropyl methylcellulose by weight of the dosage form, wherein orally administering the dosage form provides a Cmax of minoxidil that is about 0.25 ng/ml and about 20 ng/ml.” and the now claimed 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 the host of Sinha does not teach a dosage form containing hydroxypropyl methylcellulose” as is now a limitation of claim 1.
While such an ingredient could have been obvious or a possible ingredient, i.e., as a release modifier or filler, 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, such as Cmax, to a particular release modifier or filler, such as hydroxypropyl methylcellulose.
Double Patenting
Provisional
Claims 1-5, 7-12 and 19-27 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 double-patenting because the previous claims had supposed limitations regarding the pharmacokinetic characteristics of the dosage form, the particular release modifier as well as the limitations of the newly added claims directed to a 5-alpha reductase inhibitor.
For the above reasons, the claims are deemed to remain properly rejected.
Non-Provisional
Claims 1-5, 7-12 and 19-27 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, 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 double-patenting because the previous claims had supposed limitations regarding the pharmacokinetic characteristics of the dosage form, the particular release modifier as well as the limitations of the newly added claims directed to a 5-alpha reductase inhibitor.
For the above reasons, the claims are deemed to remain properly rejected.
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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/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629
October 07, 2026
