CLAIMS 1-20 ARE PRESENTED FOR EXAMINATION
Applicant's amendment, remarks and Information Disclosure Statement filed May 20, 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.
Claim Rejection - 35 USC § 103
Claims 1-20 remain rejected under 35 U.S.C. 103 as being unpatentable over Sinha, (U.S. 2024/0474594, (effective 09/29/21 via Prov. Application 63/250,009), each of record for the reasons of record as set forth in the previous Office action dated February 20, 2026, which reasons are here incorporated by reference.
It is noted that in claim 1, Applicant has added that a “release modifier” is present. The Examiner in the previous Office action pointed out that Sinha teaches at [0047] the inclusion of a “release aids” which appears to be substantially equivalent to the claimed “release modifier”.
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 "being, and 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” or a lack of an unacceptable cardiac effect as now required by claim 1.
The Examiner agrees that the specific dissolution characteristics, pharmacokinetic parameters and a lack of unacceptable cardiac effects as in the present claims 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 4.5 mg of minoxidil. Also, each and every tangible limitation present in claim 1 is clearly taught by Sinha, i.e., the dosage form comprising about 4.5mg of minoxidil is orally administered to a human patient seeking to improve hair growth. 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.
Applicant has also argued that the Examiner has not established an expectation of inherency, i.e., basis in fact and/or technical reasoning. The Examiner believes that he has in pointing out that Sinha teaches every one of the claimed tangible elements/features of the dosage form, the patient and the route of administration as required in at least claim 1 so as to place such in the possession of the public, i.e., anticipate these elements/features. It thus must necessarily be so that the resultant pharmacokinetic and/or drug release characteristic would be the same, whether expressly taught by Sinha or not.
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).
Applicant has further argued that there is no reasonable expectation of success that merely modifying formulation variables as generally described in Sinha would result in a dosage form that achieves the presently claimed pharmacokinetic/release characteristics. However, it is not the Examiner’s position that such modifying is taught by Sinha, but rather that each and every tangible element/feature of the dosage form, the patient and the route of administration as required in at least claim 1 is anticipated by Sinha.
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 1-20 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); 19/230,047, (claims 1-21); 19/258,817; 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 applied to claims 1-19 as set forth in the previous Office action dated January 27, 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 Examiner previously addressed inherency or else the pharmacokinetic and other properties in the copending claims. Also, newly added claim 20 is properly rejected here because such is clearly encompassed by the copending claim sets.
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 February 20, 2026, as 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 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 Examiner previously addressed inherency or else the pharmacokinetic and other properties in the patented claims. Also, newly added claim 20 is properly rejected here because such is clearly encompassed by the patented claim sets
Accordingly, the claims are deemed properly rejected and none are currently in condition for allowance.
THIS ACTION IS MADE FINAL. Applicant’s amendment necessitated the new grounds of rejection, i.e., the addition of new claim 20. 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. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629 September 03, 2026
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