CLAIMS 1-5, 7-9, 16-21 AND 23-29 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 22, 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.
In light of Applicant’s amendment cancelling claim 6, the rejection of claim 6 under 35 USC 112, as set forth in the previous Office action, is withdrawn.
Claim Rejection - 35 USC § 103
Claims 1-5, 7-9, 16-21 and 23-29 are rejected under 35 U.S.C. 103 as being unpatentable over Sinha, (U.S. 2024/0474594) in view of Reynolds et al., each of record, for the reasons of record as applied to claims 1-9, 16, 17 and 21, as set forth in the previous Office action, which reasons are here incorporated by reference.
Newly added claims 23-29 are deemed properly rejected as these limitations have been previously addressed by the Examiner in the preceding Office actions.
Applicant's remarks have been carefully considered, but fail to persuade the Examiner of
error in his determination of obviousness.
In particular, Applicants have argued that the presently claimed subject matter would not
have been obvious because claim 1 is not prima facie obvious at least because all elements of the
claim are not taught or suggested in the prior art. More specifically, Applicant contends that the
combination of Sinha and Reynolds or each alone does not teach or suggest the limitation newly added to claim 1 which reads: "wherein the minoxidil or the pharmaceutically acceptable salt thereof is the only active agent in the dosage form.” because Sinha teaches a 5-alpha reductase inhibitor as an additional active agent.
However, the claim only requires that minoxidil is the only active ingredient in the dosage form. It is agreed that Sinha teaches a 5-alpha reductase inhibitor as an additional active agent, however this does not diminish the propriety of the present rejection. In particular, the present claims recite “comprising” and thus allow for an additional dosage form to be administered while Sinha teaches that the minoxidil may be present in one dosage form the 5-alpha reductase inhibitor in a second dosage form, (see [0028]).
For this reason, the claims are deemed to be properly rejected.
double Patenting
Provisional
Claims 1-5, 7-9, 16-21 and 23-29 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). 19/094,703; 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; 19/215,216, (claims 1-21); 19/315,441; 19/230,007, (claims 1-21); 19/409,546; 19/414,251 or 19/397,854, in view of Sinha, (cited above), each of record, for the reasons of record as set forth in the previous Office action, as applied to claims 1-9 and 16-22, which reasons are here incorporated by reference.
As in the above rejection, the limitations of newly added claims 23-29 have been previously addressed by the Examiner.
Applicant's remarks have been carefully considered, but fail to persuade the Examiner of
error in his determination of obviousness.
With respect to the limitation newly added to claim 1 which reads: "wherein the minoxidil or the pharmaceutically acceptable salt thereof is the only active agent in the dosage form.”, roughly half of the copending claim sets do not recite an additional active agent and those which also recite a 5-alpha reductase inhibitor, do not require it to be present in the same dosage form.
Accordingly, the claims are deemed to be properly rejected.
Non-Provisional
Claims 1-5, 7-9, 16-21 and 23-29 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 in view of Sinha, cited above, , each of record for the reasons of record as set forth in the previous Office action, as applied to claims 1-9 and 16-22, which reasons are here incorporated by reference.
As in the above rejection, the limitations of newly added claims 23-29 have been previously addressed by the Examiner.
Applicant's remarks have been carefully considered, but fail to persuade the Examiner of
error in his determination of obviousness.
With respect to the limitation newly added to claim 1 which reads: "wherein the minoxidil or the pharmaceutically acceptable salt thereof is the only active agent in the dosage form.”, roughly half of the copending claim sets do not recite an additional active agent and those which also recite a 5-alpha reductase inhibitor, do not require it to be present in the same dosage form.
Accordingly, the claims are deemed to be properly rejected.
Applicant's amendment necessitated the new grounds of rejection 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629
September 28, 2026
