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 remarks and terminal disclaimers filed October 28, 2025 have been received and entered into the application. Accordingly, the double patenting rejection of claims 1-20 as set forth in the previous Office action has been overcome and is thus withdrawn.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 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 follows the administration of minoxidil. However, such a result does not equate to a further limitation of claim 1 respecting the patient population, minoxidil dosage form, dosage amount or the step of administration 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 "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 claim 1 with respect to either the patient population, 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 fromd
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 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
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 via Prov. Application 63/250,009) 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, 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 8.5 mg.", (see at least the abstract, [0013], [0012]-[0014], (claims 10 and 16). 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; (d)
alopecia areata as the types of hair loss; and (e) the lack of symptomology as in present claims.
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 poly saccharides 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 (e) above, the reference teaches a minoxidil dosage form that meets the
physical requirements of 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, regarding (d), Sinha expressly teaches “[o]ral minoxidil is mainly used for male
and female pattern hair loss. However, there can benefit with other types of hair loss too
including telogen effluvium, traction alopecia and loose anagen syndrome", ([0022]), and such
would have readily suggested to one of ordinary skill in the art the specific types of hair loss
known in the art at the time of the invention, including those presently claimed.
Accordingly, for the above reasons, the claims are deemed properly rejected.
Double Patenting
Provisional
Claims 1-20 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; 19/303,300; 19/324,046; 19/234,212;
19/329,476, (claims 1-19); 19/245,208; 19/215,216, (claims 1-21); 19/315,441; 19/230,007,
(claims 1-21); 19/409,546; 19/414,251 or 19/397,854, in view of Sinha, (cited above).
Although the claims at issue are not identical, they are not patentably distinct from each
other because the co-pending claims in each application are directed to either treating hair loss in general or to specific types of hair loss as is presently claimed or else encompassed by present
claim 1. Also, overlapping or the same percentages of hy droxypropyl methylcellulose appears in
the either the independent or dependent copending claims. The presently claimed dosage amount
of "about 8.5 mg" of minoxidil, dosage frequency, other non-active agents and non-
symptomology resulting from the administration are either recited in or else encompassed by the
copending claims as are the pharmacokinetic parameters required by the present claims.
Also, Sinha expressly teaches “[o]ral minoxidil is mainly used for male
and female pattern hair loss. However, there can benefit with other types of hair loss too
including telogen effluvium, traction alopecia and loose anagen syndrome", ([0022]), and such
would have readily suggested to one of ordinary skill in the art the specific types of hair loss
known in the art at the time of the invention.
This is a provisional nonstatutory double patenting rejection because the patentably
indistinct claims have not in fact been patented.
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
April 27, 2026
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