CLAIMS 1-5, 7-12 AND 19-27 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 July 30, 2026 have been received and entered into the application.
Accordingly, the application papers have been amended as directed and the section 112 amendment set forth in the previous Office action dated April 30, 2026 has been overcome and is hereby withdrawn. 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 1-3, 5, 8-12 and 21-27 are rejected under 35 U.S.C. 103 as being unpatentable over Sinha in view of Reynolds et al. and Jordan et al., each of record, for the reasons of record as set forth in the previous Office action dated April 30, 2026 as applied to claims 1-20, which reasons are here incorporated by reference.
Claims 4, 19 and 20 are not included in this rejection because the requirements therein are not taught in the primary reference and thus, it cannot be said that the pharmacokinetic parameters recited in the claims would be inherent in the prior art formulation or method since the same or a similar formulation or method is not disclosed in Sinha.
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
claims 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 " 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 75% dissolves in about 9 to about 11 hours, and wherein orally administering the dosage form provides a Cmax between about 0.25 ng/mL and about 20 ng/mL” as required by at least claim 1 as amended.
Insofar the remarks already of record and those which follow will apply to newly added claims 21-27, no further remarks here are deemed necessary and are only being mentioned to show consideration of them by the Examiner.
The Examiner agrees that the specific dissolution rate and Cmax as in present claim 1 and pointed out by Applicant 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 method of treating female pattern hair loss in a patient suffering therefrom which meets each and every tangible limitation set forth for the dosage form in present claim 1, i.e., dosage form, dosage amount, oral administration and the treatment of female pattern hair loss in a patient suffering therefrom.
Because the same method and formulation of claim 1 is taught in Sinha, it must therefore 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 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 and
there is no reasonable expectation of arriving at a dosage form providing the currently claimed
Cmax. However, given that the Sinha discloses an identical dosage form and method steps, it is
immaterial that Sinha teaches alternative dosage forms which may contain varied amounts or
individual ingredient. This rejection is not based upon a supposition that the skilled artisan
would have had a reasonable exception of arriving at Applicant's Cmax through routine
experimentation. Rather, it is based upon the fact that Sinha teaches the SAME method a in at
least present claim 1 in terms of the tangible elements required as specified by the Examiner
above. Being the same, the release and Cmax characteristic must also be present, i.e., inherent, whether highlighted by Sinha or not.
Finally, Applicant has argued that the pharmacokinetic characteristics of claim 1 are not
inherent in the prior art because they have shown that Cmax and drug release rates cannot in fact
necessarily be associated with only dosage amounts and dosage form.
This argument is not persuasive because the dosage amount and form are not the only tangible requirements of the claims. The tangible requirements include not only the dosage form and amount, but the host and method step as well. Also, 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 1-5, 7-12 and 19-27 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; 19/253,708; 19/255,878; 19/215,242, (claims 1-21); 19/230,054, (claims 1-21); 19/230,047, (claims 1-21); 19/258,817; 19/260,035; 19/267,447; 19/308,124; 19/315,454, (claims 1-19); 19/328,077, (claims 1-19); or 19/329,494, (claims 1-19), in view of Sinha, (cited above), each of record, for the reasons of reasons of record as set forth in the previous Office action dated April 30, 2026 as applied to claims 1-20, 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 at least one supposed limitation regarding the pharmacokinetic characteristics of
the dosage form. The newly added language is similarly directed to such characteristics.
For the above reasons, the claims are deemed to remain properly rejected.
None of the present 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
August 31, 2026
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