CLAIMS 1-15 AND 22-27 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 August 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 claims have been amended as directed by Applicant.
Applicant’s amendment cancelling claims 16-21 has overcome the rejection of the claims under 35 USC 112 as set forth in the previous Office action.
Claim Rejection - 35 USC § 103
Claims 1-15 and 22-27 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 set forth in the previous Office action dated May 18, 2026, as applied to claims 1-21, 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.
The requirements of newly added claims 22-27 have already been addressed by the Examiner in at least the Office action dated January 12, 2026 and no further comment is deemed necessary. The same is true for the newly added language “a release modifier” in claim 1 since such language was present in previously presented claim 4.
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 references does not teach or suggest at least "wherein the dosage form comprising the release modifier provides a Cmax of about 20 ng/mL or less” as now required by claim 1.
The Examiner agrees that the specific pharmacokinetic characteristic 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 experiencing hair loss. It must therefore 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.
Here, the claims in the present application do not require any specific formulation
structure that is different from the formulation disclosed in the Sinha patent, hence,
products of identical chemical composition cannot have mutually exclusive properties."
In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical
composition and its properties are inseparable. Id.
Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily or inherently possess
the characteristics of his claimed product. Whether the rejection is based on 'inherency' under 35 U.S.C. § 102, on 'prima facie obviousness' under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. See In re Brown, 459 F.2d 531, 59 CCPA
1036, 173 USPQ 685 (1972).
For the above reasons, the claims are deemed to remain properly rejected.
Double Patenting
Provisional
Claims 1-15 and 21-22 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; 19/303,300; 19/315,441; 19/215,216; 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, as applied to claims 1-21, 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 6 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 had a supposed limitation regarding the release 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.
Non-Provisional
Claims 1-15 and 22-27 remain 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. Application No. 19/094,703, (allowed and soon to be patented), each of record for the reasons of record as set forth in the previous Office action dated January 12, 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 6 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 had a supposed limitation regarding the release 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.
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 16, 2026
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