CLAIMS 1-3, 5-11 AND 21-30 ARE PRESENTED FOR EXAMINATION
Applicant’s amendment, remarks and Information Disclosure Statement filed August 19, 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.
In light of Applicant’s amendments and remarks, the following is the disposition of the pending claims.
Claim Rejection - 35 USC § 112, Overcome
The rejection of claims 12-20 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 because the rejected claims have been cancelled by Applicant
Claim Rejection - 35 USC § 103, Overcome
The rejection of claims 1-20 rejected under 35 U.S.C. 103 as being unpatentable over Sinha in view of Reynolds et al., as set forth in the previous Office action dated May 19, 2026 has been overcome by at least Applicant’s amendment to claim 1 for the following reasons.
Applicant's claim 1 now requires that the dosage form comprise "about 65% to about 85% of hydroxypropyl methylcellulose by weight of the dosage form” and “wherein the dosage form provides a Cmax between about 0.25 ng/mL and about 20 ng/mL.”. It cannot be said that the Cmax values are 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 dosage form of Sinha does not necessarily contain hydroxypropyl methylcellulose thus making the presently claimed Cmax 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 Sinha or Reynolds correlating any pharmacokinetic parameter of a dosage form containing hydroxypropyl methylcellulose to the presence of hydroxypropyl methylcellulose itself.
Provisional Double Patenting
Claims 1-3, 5-11 and 21-30 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). 19/094,716; 19/253,703; 19/253,708; 19/255,878; 19/230,047, (claims 1-21); 19/230,054, (claims 1-21); 19/258,817; 19/260,035; 19/267,447; 19/267,464; 19/308,124; 19/566,606, 19/315,454, (claims 1-19); 19/328,077, (claims 1-19); 19/329,494, (claims 1-19) or 19/402,798, 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 given careful consideration, but fail to persuade the Examiner of error in his determination because newly required “about 5 mg. of minoxidil” would have been within the teachings in the copending claims of “about 4.5mg”. Further, all other requirements of the present claims are either set forth or encompassed by the copending claims.
Non-Provisional
Claims 1-3, 5-11 and 21-30 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) or (b) claims 1-20 of U.S. Patent No. 12,491,184, (cited by the Examiner), 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 given careful consideration, but fail to persuade the Examiner of error in his determination because newly required “about 5 mg. of minoxidil” would have been within the teachings in the patented teachings for the minoxidil dosage amount. Further, all other requirements of the present claims are either set forth or encompassed by the patented claims.
Accordingly, for the above reasons, the claims are deemed properly rejected and none of the claims are currently in condition for allowance.
THIS ACTION IS MADE FINAL. 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
September 01, 2026
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