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 Information Disclosure Statement, amendment and remarks filed May 22, 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 application papers have been amended as directed.
In light of the amendment to claim 1, it cannot be held that the newly added dissolution profile is inherent in the prior art dosage form because the Sinha fails to teach a host experiencing lichen planopilaris and thus the method would have been practiced in a possible host, not a host necessarily in Sinha. Inherency requires that the result be a necessary property and not merely a possible one. Also, nothing in the prior art relied upon teaches or suggests the presently claimed dissolution characteristics as in present claim 1.
Accordingly, for the above reasons, the rejection of the claims under 35 U.S.C. 103 as set forth in the previous Office action is withdrawn.
Claim Rejection - 35 USC § 112
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 13-18 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 13-18 recites a physiological result which follows 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 13, the phrase “oral administration of the dosage form 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 either the patient population of female human diagnosed with female pattern hair loss, the dosage form, or 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.
Paragraphs 0151 and 0152 of the Specification state:
“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”.
Paragraph 0466 of the Specification demonstrates a clinical trial using 5 mg that 1 patient developed tachycardia, which appears contrary to claim 13’s intended result of the functional descriptive claim language.
Taken as a whole, it is still not clear how the disputed limitation of claim 13 further limits claim1, and is therefore indefinite.
The same rationale can be applied to the supposed limitations of claims 14-18 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.
Accordingly, the claims are deemed properly rejected.
Double Patenting
Provisional
Claims 1-21 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; 19/230,007, (claims 1-21);
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 dated February 22, 2026, as applied to claims 1-20.
Applicant’s remarks have been carefully considered, but fail to persuade the Examiner of error in his determination of double patenting. In particular, the previous Office action considered the pharmacokinetic and other physical characteristics of the dosage form in the present claims, thus merely referencing the instantly filed amendment fails to provide an adequate reason for holding that the present rejection is in error.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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. 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 on 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
September 03, 2026
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