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 March 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/remarks have overcome the rejection set forth under 35 USC 103 in the previous Office action and, accordingly, that rejection is hereby withdrawn.
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 6 and 13-18 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 6 and 13-18 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 13, 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, the objective of treating androgenetic alopecia or else 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 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 16 further limits
claim 1, and is therefore indefinite.
The same rationale can be applied to the supposed limitations of claims 6 and 14-17 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 1-20 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). 19/094,703; 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 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 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 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.
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.
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/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629
May 19, 2026
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