CLAIMS 1-19 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 April 16, 2026 have been received and entered into the application. Accordingly, the application papers have been amended as directed by Applicant. Also, as reflected by the attached, completed copies of form PTO/SB/08, the cited references have been considered by the Examiner.
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 January 16, 2026, which reasons are here incorporated by reference.
Applicant’s arguments and remarks have been given careful consideration, 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 continues, the
combination of Sinha and Reynolds does not teach or suggest at least "wherein orally administering the dosage form provides a Cmax that is devoid of unacceptable cardiac effects"
administration" as required by claim 1.
The Examiner agrees that the specific pharmacokinetic parameter, i.e., Cmax, as in present claim 1 are 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 dosage form which meets each and every tangible limitation set forth for the dosage form in present claim 1. In particular, the dosage form of Sinha may be sustained release, oral and contain about 8.5 mg of minoxidil. Also, each and every tangible method limitation present in claim 1 is clearly taught by Sinha, i.e., the dosage form is orally administered to a human patient who is seeking to improve hair growth. It must therefor necessarily follow that whether taught or recognized in the prior art or not, the same release characteristics 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 as taught by Reynolds, there are numerous variables which can affect a drug's release from HPMC, e.g., polymer level, molecular weight and solubility.
However, given that the Sinha discloses an identical dosage form and method steps, it is
immaterial that the release of a drug from HPMC, (not required in claim 1, but only present claim 4) can be varied as argued.
Finally, Applicant has argued that the release characteristics of claim 1 are not inherent in
the prior art because they have shown that drug release rates cannot in fact necessarily be
associated with only dosage amounts and dosage form.
This argument is not persuasive because dosage form and a dosage amount are the only
two tangible requirements for the dosage form present in claim 1. While not expressly required
by Applicant's claim 1, it is noted that not only does Sinha teach a dosage form and dosage
amount, but also that the dosage form may be sustained release in nature and may contain
various excipient materials, including a release aid at paragraph [0047]. Applicant's argument
fails to take this teaching into consideration and thus does not persuade the Examiner of error in
his determination.
For the above reasons, the claims are deemed to remain properly rejected.
Double Patenting
Provisional
Claims 1-19 remain 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; 19/215,216, (claims 1-21); 19/245,208; 19/303,300; 19/315,441; 19/230,007, (claims 1-21); 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 dated January 16, 2026, 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.
In particular, Applicant has merely referenced the amendments to claim 1 and asks for
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. The previous
claim set had a supposed limitation regarding pharmacokinetic properties of the dosage form, e.g., claims 5-6. The newly added language is similarly directed to such characteristics, i.e., a Cmax devoid of unacceptable cardiac effects.
This remains a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
For the above reasons, the claims are deemed to remain properly rejected.
Non-Provisional
Claims 1-19 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 12,268,688, already of record, for the reasons of record as set forth in the previous Office action dated January 16, 2026, 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.
In particular, Applicant has merely referenced the amendments to claim 1 and asks for
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. The previous
claim set had a supposed limitation regarding pharmacokinetic properties of the dosage form, e.g., claims 5-6. The newly added language is similarly directed to such characteristics, i.e., a Cmax devoid of unacceptable cardiac effects.
Accordingly, the claims are deemed properly rejected and none are currently in condition for allowance.
Applicant's amendment necessitated the new grounds of rejection, (i.e., remarks by the Examiner newly added to address Applicant’s positions regarding newly added language), 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.
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/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629
June 25, 2026
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