CLAIMS 1-20 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 May 04, 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.
Claim Rejection - 35 USC § 112, (New Ground)
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 m
For example, with respect to claim 13, the phrase "no tachycardia is observed in the
patient" 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 patients in need of hair loss treatment,
the minoxidil 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
claim 1, and is therefore indefinite. The same rationale can be applied to the supposed limitations
of claims 12-20 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.
Claim Rejection - 35 USC § 103
The rejection of claims 1-20 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) in view of Reynolds et al., as set forth in the previous Office action dated February 04, 2026 has been overcome by at least Applicant’s amendment to claim 1 and is thus hereby withdrawn.
Applicant's claim 1 now requires "wherein the dosage form comprising the release modifier provides a Cmax of about 20 ng/ml or less” 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 host of the prior
art is not the same as the host of the present claims, i.e., a human being experiencing lichen planopilaris, thus making the presently claimed Cmax characteristic merely a possible characteristic.
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 parameter of a dosage
form containing a release modifier to any such parameter occurring in a particular host as defined by present claim 1.
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).19/094,716; 19/253,703; 19/253,708; 19/255,878; 19/215,242, (claims 1-21); 19/230,054, (claims 1-21); 19/230,047, (claims 1-21); 19/258,817; 19/260,035; 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, 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 at least claim 1 and requests 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 language to claim 1, have not been specifically
addressed by Applicant. Also, pharmacokinetic parameters were previously addressed by the Examiner thus, Applicant's argument is non-persuasive.
This is 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 the claims of U.S. Patent 12,491,184, (cited by the Examiner), each of record, for the reasons of record as set forth in the previous Office action, 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 at least claim 1 and requests 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 language to claim 1, have not been specifically
addressed by Applicant. Also, pharmacokinetic parameters were previously addressed by the Examiner thus, Applicant's argument is non-persuasive.
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
July 29, 2026
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