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 After-Final Amendment/remarks filed June 30, 2026 have been received and entered into the application. In light thereof, ALL rejections of the claims under 35 USC 103 for obviousness and for double patenting, both provisional and non-provisional, as set forth in the previous Office action dated March 30, 2026, have been overcome and are hereby withdrawn.
Insofar as this Office action contains a new grounds of rejection, the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn. Currently, claims 1-15 stand in condition for allowance. Claims 16-21 are newly rejected as set forth, infra.
Claim Rejection Overcome - 35 USC § 103
The rejection of the claims 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 March 30, 2026 has been overcome by at least Applicant's
amendment to claim 1 and is hereby withdrawn.
Applicant's claim 1 now requires "wherein the dosage form has the property that about 50% of the dosage form dissolves into a neutral pH solution in about 4 hours to about 6 hours." and such cannot be said to be inherent in the teachings of the prior art or to have been obvious from the teachings in the prior art.
In particular, the requirement cannot be said to be inherent because the dosage form of the prior art is not one taught to comprise a specific ingredient required by present claim 1, i.e., “about 65% to about 85% of hydroxypropyl methylcellulose by weight of the dosage form” thus making the presently claimed dosage form merely a possible dosage form Sinha who does teach a general class of auxiliary agents under which hydroxypropyl methylcellulose would fall, (see the previous Office action).
For inherency, though, the result must be a necessity and not merely a possibility. Also, there is no teaching in Sinha or Reynolds correlating any pharmacokinetic or dissolution parameter, to any particular dosage form as defined by present claim 1.
Double Patenting Rejections Overcome
The double patenting rejections, both provisional and non-provisional, are deemed to
have been overcome and are withdrawn because Applicants have filed a Terminal Disclaimer effectively including the copending applications and patents that previously formed a basis for rejection.
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 16
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 17-21 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.
For the above reasons, claims 16-21 are deemed properly rejected.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629 July 16, 2026
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