CLAIMS 1-21 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 24, 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 § 112, (New Grounds)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ),
second paragraph, as being indefinite for failing to particularly point out and distinctly claim the
subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA
35 U.S.C. 112, the applicant), regards as the invention.
Each of claims 16-21 recites a physiological result which either does not follow or
is lessened after the administration of minoxidil as per the method of claim 1. However, such a
result does not equate to a further limitation of the patient population, minoxidil dosage form or
the step of administration as recited in claim 1 and thus the supposed further limited metes and
bounds of the subject matter of these claims as compared to claim 1 would be unclear to one of
ordinary skill in the art.
For example, with respect to claim 16, the phrase "results in no tachycardia" makes
the claim indefinite because one of ordinary skill in the art could not reasonably determine the
metes and bounds of this limitation. Specifically, it is not clear how this limitation in claim 13
further limits claim 1 with respect to either the patient population, the dosage form, the dosage
amount, the method step of administration, or adds some of functional-descriptive limitation to
the claim.
The specification uses the term "tachycardia" on nine specific instances (see paragraphs
0031, 0033, 0034, 0151, 0153, 0369, 0372, 0466, and 0472). However, none of the appearances
of the limitation in claim 13 in the specification explains how a treatment method without
tachycardia is achieved.
"In some embodiments of the method described herein, administering results in
substantially no cardiac effects. In some embodiments, the cardiac effects are selected from
tachycardia, hypotension, premature ventricular contractions, and other tachyarrhythmias.
In some embodiments of the method described herein, administering results in hair
regrowth with substantially no clinically significant hemodynamic changes in blood pressure. In
some embodiments, administering results in hair regrowth with substantially no cardiac effects.
In some embodiments, the daily dose of minoxidil or a pharmaceutically acceptable salt thereof
results in substantially no cardiac effects or hemodynamic effects as compared to administration
of an immediate-release oral minoxidil or a pharmaceutically".
The current Specification demonstrates a clinical trial using 5 mg that 1 patient
developed tachycardia, which appears contrary to claim 16's intended result of the functional
descriptive claim language.
Taken as a whole, it is still not clear how the disputed limitation of claim 16 further limits
claim 1, and is therefore indefinite.
The same rationale can be applied to the supposed limitations of claims 7-21 resulting in
the same conclusion that one of ordinary skill in the art would be unable to reasonably ascertain
the supposed further limiting metes and bounds of the claimed subject matter.
Claim Rejection - 35 USC § 103
Claims 1-21 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 January 27, 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
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 "a Cmax of minoxidil that is about 0.25 ng/ml to about 20 ng/ml,", "a Tmax of minoxidil that is about 30 to about 360 minutes," or "wherein the dosage form releases from about 50% to about 98% of the about 4.5 mg minoxidil or the equivalent amount of the pharmaceutically acceptable salt thereof within about 18 hours after the oral administration," as required by claim 1.
The Examiner agrees that the specific pharmacokinetic parameters and release characteristics 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 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 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.
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 1-21 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).19/094,716; 19/253,703; 19/253,708; 19/255,878; 19/215,242, (claims 1-21); 19/230,054, (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 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 claims 1 and 4 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. Also, because previous claim 4 already required a release modifier, each and every one of presently claimed limitations were previously considered.
This remains a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Non-Provisional
Claims 1-21 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. 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 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 claims 1 and 4 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. Also, because previous claim 4 already required a release modifier, each and every one of presently claimed limitations were previously considered.
Accordingly, the claims are deemed properly rejected and none are currently in condition for allowance.
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.
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/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629 July 02, 2026
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