CLAIMS 1-20 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 May 18, 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.
Claim Objection
Newly added claim 20 is objected to as depending from a rejected claim, but is otherwise in condition for allowance, i.e., Sinha requires multiple active agents to be present in the dosage form or else administered to the patient.
Claim Rejection - 35 USC § 103
Claims 1-19 remain 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 set forth in the previous Office action dated February 06, 2026 and applied to claims 1-19, 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 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 contend that the
combination of Sinha and Reynolds does not teach or suggest at least "wherein the dosage form exhibits a dissolution profile wherein about 25% dissolves in a neutral pH solution in about 1.75 to about 2.25 hours, and wherein about 50% dissolves in about 3.5 to about 7 hours, and wherein the dosage form provides a Cmax of about 0.25 ng/ml to about 20 ng/ml." as required by claim 1.
The Examiner agrees that the specific pharmacokinetic parameters as now present claim 1 and pointed out by Applicant is not taught or suggested in the prior art. However, such does not diminish the propriety of the present rejection because absent evidence to the contrary, the Examiner believes such characteristics to be necessarily present, i.e., inherent, in the prior art method of improving hair growth without cardiac effect in a human being who is seeking to improve hair growth which meets each and every tangible limitation set forth for the dosage form in present claim 1, i.e., dosage form, dosage amount, presence of the newly required "release modifier", oral administration and the improving hair growth without cardiac effect in a human being who is seeking to improve hair growth. It must necessarily follow that, whether taught or recognized in the prior art or not, the same pharmacokinetic characteristics as recited in present in current claim 1 would also be present in the prior art.
As per MPEP 2112 (III), "Where applicant claims a composition in terms
of a function, property or characteristic and the composition of the prior art is the same as that of
the claim but the function is not explicitly disclosed by the reference, the examiner may make a
rejection under both 35 USC 102 and 103".
Applicant has also argued that Reynolds not only doesn’t teach minoxidil, they also fail to teach the presently claimed pharmacokinetic parameter as discussed above.
In response thereto, the Examiner points out that Reynolds remains properly relied upon for the reasons relied upon in the previous Office action. Reynolds was not relied upon because it specifically taught minoxidil. Also, Reynolds was not relied upon for their teaching ANY pharmacokinetic parameter as present in the previous claim set and yet, remains properly relied upon for the undisputed reasons relied upon in previous Office action.
Further, Applicant has argued that there is a wide variability allowed by both Sinha and Reynolds in polymer level, molecular weight, drug level, solubility, type of excipient and tablet shape and size and neither reference teaches how to control these variables to achieve the pharmacokinetic parameters of the present claims.
In response, it is the requirement of the present claims which must be focused on and not the teachings of the reference which do not touch on these requirements. It remains, as posited above by the Examiner, that a method including a minoxidil dosage form is taught by Sinha which meets each and every tangible element recited in the present claims. Thus, the non-recited pharmacokinetic parameters, as well as the undetected cardiac effects, remain to be seen as inherent characteristic of the claimed method and dosage form employed therein. Nothing in Applicant’s remarks persuades the Examiner that such is not the case here.
For the above reasons, the claims are deemed to remain properly rejected.
Double Patenting
Provisional
Claims 1-20 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; 19/215,242, (claims 1-21); 19/230,054, (claims 1-21); 19/230,047, (claims 1-21); 19/260,035; 19/267,447; 19/267,464; 19/308,124; 19/315,454, (claims 1-19); 19/328,077, (claims 1-19); or 19/329,494, (claims 1-19), each of record, for the reasons of record as set forth in the previous Office action dated May 18, 2026 as applied to claims 1-19, which reasons are here incorporated by reference as well as the fact that, as required by newly added claim 20, the copending claims allow for minoxidil as the single active agent.
Applicant's remarks have been carefully considered, but fail to persuade the Examiner of
error in his determination of provisional double-patenting.
In particular, Applicant has merely referenced the amendments to at least claims 1 and 4 and requests reconsideration, (page 8 of Applicant's remarks). This does not persuade the Examiner of error in his determination because the supposed errors in the Examiner's determination, even with the newly added claim language, have not been specifically addressed by Applicant. Also, because previous claim 4 already required a release modifier and pharmacokinetic parameters in general were previously addressed by the Examiner, Applicant’s argument is non-persuasive.
This remains a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Non-Provisional
Claims 1-20 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 dated May 18, 2026 as applied to claims 1-19, which reasons are here incorporated by reference, as well as the fact that, as required by newly added claim 20, the patented claims allow for minoxidil as the single active agent.
Applicant's remarks have been carefully considered, but fail to persuade the Examiner of
error in his determination of provisional double-patenting.
In particular, Applicant has merely referenced the amendments to at least claims 1 and 4 and requests reconsideration, (page 8 of Applicant's remarks). This does not persuade the Examiner of error in his determination because the supposed errors in the Examiner's determination, even with the newly added claim language, have not been specifically addressed by Applicant. Also, because previous claim 4 already required a release modifier and pharmacokinetic parameters in general were previously addressed by the Examiner, Applicant’s argument is non-persuasive.
Accordingly, the claims are deemed properly rejected and none are currently in condition for allowance.
Applicant's amendment necessitated the new grounds of rejection presented in this Office action, i.e., grouping of claims and reasons supporting the rejections. 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.
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/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629
August 11, 2026
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