CLAIMS 1-5, 7-12, 19, 21 AND 23-31 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 15, 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 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second paragraph, as set forth in the previous Office action has been overcome and is withdrawn because the rejected claims have been canceled.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 1-21 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 and Jordan et al., as set forth in the previous Office action has been overcome and is withdrawn for the following reasons.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 “wherein the minoxidil or a molar equivalent amount of a pharmaceutically acceptable salt thereof is the only active agent administered to the human being” while the primary reference, Sinha, teaches that an additional active ingredient which is a 5-alpha reductase inhibitor is in all instances also administered to the host.
Claim Rejection - 35 USC § 112, (New Ground)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 27 and 31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
These claims ultimately depend from claim 1 which requires that no additional active ingredient is present in the dosage form which is administered to the host while these claims require an active ingredient, i.e., an ingredient which is a 5-alpha reductase inhibitor, to be present in the dosage form.
Double Patenting
Provisional
Claims 1-5, 7-12, 19, 21 and 23-31 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 1-21, 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 previous claim 22 actually should have been rejected in the previous Office action. Clearly, the co-pending claims provide for instances where minoxidil is the only active agent in the dosage form administered to the host.
For the above reasons, the claims are deemed to remain properly rejected.
Non-Provisional
Claims 1-5, 7-12, 19, 21 and 23-31 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 1-21, 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 provisional double-patenting because previous claim 22 actually should have been rejected in the previous Office action. Clearly, the patented claims provide for instances where minoxidil is the only active agent in the dosage form administered to the host.
For the above reasons, the claims are deemed to remain properly rejected.
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
