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 terminal disclaimer and remarks filed October 28, 2025 have been received and entered into the application. Accordingly, the non-provisional double patenting rejection over U.S. Patent No. 12,268,688, as set forth in the previous Office action dated August 11, 2025, has been overcome and is hereby withdrawn.
New rejections of the claims appear below under 35 U.S.C. 112 and 103.
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 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 does not follow 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, minoxidil dosage amount 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, 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 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 6 and 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
Claim Rejection - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sinha, (U.S. 2024/0474594, (effective 09/29/21) in view of Reynolds et al., "Investigation of the Effect of Tablet Surface Area/Volume on Drug Release from Hydroxypropylmethylcellulose Controlled-Release Matrix Tablets", Drug Development and Industrial Pharmacy, 28(4), 457-466 (2002), (hereinafter “Reynolds”, cited by Applicant).
Sinha teaches a method of treating hair loss, comprising orally administering a dosage form to a human patient experiencing hair loss, including traction alopecia, ([0022]), wherein the dosage form comprises “about 5 mg to about 10 mg” of minoxidil, which would include a range of 4.7 to 10.0, (i.e., the claimed “about 4.5 mg.”, (see at least the abstract, [0013], [0012]-[0014], (claims 10 and 16) as well as “about 5 mg”, ([0039]). The dosage form may provide delayed, sustained or enteric release, [0043], and contain one or more diluents, carriers, excipients, fillers, disintegrants, solubilizing agents, dispersing agents, lubricants, binders and release aids, etc., [0046]-[0047].
The differences between the above and the claimed subject matter lie in that Sinha fails to teach (a) hydroxypropyl methylcellulose as being present in the oral dosage form; (b) a dosage frequency of once or twice daily, (c) the pharmacokinetic parameters of present claims; and (d) the lack of symptomology as in present claims or the cardiac condition status of the patients being treated for hair loss, (present claims 19-20).
However, the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains because (a) Sinha explicitly teaches; extended release dosage forms, [0043]; that among the auxiliary agents present, release aids, carriers/excipients may be used, (e.g., [0047]); that the compositions he teaches may be produced in accordance with general practice in the pharmaceutical industry, ([0045]); and that large macromolecules such as polysaccharides can be used as carrier compounds for the compositions, ([0049]).
One of ordinary skill in the art would have been motivated to employ hydroxypropyl methylcellulose as an extended release carrier in the compositions of Sinha because Reynolds teaches that “hydrophilic polymers, such as hydroxypropyl methylcellulose (HPMC), are commonly used as rate-controlling polymers for controlled drug release from matrix-type dosage forms”. It is further believed that, in the absence of evidence to the contrary, the determination of the optimum dosage frequency to employ would have been a matter of concern and well within the skill of the art and the scope of the invention of Sinha. The optimization of the dosing of active agents in the pharmaceutical/medical arts is a primary concern when considering an effective therapeutic regimen for a given patient or patient group.
Regarding (c) and (d) above, the reference teaches a minoxidil dosage form that meets the tangible requirements of the present claims and is thus the same dosage form as in the present claims. Thus, the pharmacokinetic parameters and lack of symptomology occurring after oral administration are deemed characteristics of the dosage form whether disclosed in the prior art or not.
Finally, given the overwhelming prevalence of cardiac conditions in the general population and those being treated for such conditions, the patient population of Sinha, which is silent regarding this metric, would have necessarily included a small species of cardiac condition-suffering patients, i.e., those who were and were not being treated for the condition, thus placing the requirements of present claims 19-20 in the general scope of the invention of Sinha.
Accordingly, for the above reasons, 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).19/094,716; 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; 19/267,447; 19/308,124; 19/315,454, (claims 1-19); 19/328,077, (claims 1-19); or 19/329,494, (claims 1-19), already of record, for the reasons of record as set forth in the previous Office action, which reasons are here incorporated by reference.
This rejection remains proper because it has not been overcome by any persuasive arguments, terminal disclaimer or being the sole remaining issue in the application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Non-Provisional
Claims 1-20 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,491,184, (cited by the Examiner), already 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 do not address this particular patent and the terminal disclaimer filed fails to list this patent as being subject to the provisions set forth therein.
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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/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629
May 21, 2026
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