CLAIMS 1-22 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 April 16, 2026 have been received and entered into the application. Accordingly, the claims have been amended as directed by Applicant. Also, as reflected by the attached, completed copies of form PTO/SB/08, the cited references have been considered by the Examiner.
Claim Objection
Claim 22 is objected to as depending from a rejected base claim, but is otherwise, excepting the double patenting issues addressed herein, in condition for allowance.
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 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 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 either the patient population in need of hair loss treatment, the dosage form, or the method step of administration, or adds some of functional-descriptive limitation to the claim which is not found in claim 1, the claim from which this claim depends.
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 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
Claims 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Sinha, (U.S. 2024/0474594) in view of Baudouin et al., (US 2013/0004444) “Baudouin” and Reynolds et al.,
each of record, for the reasons of record as applied to claims 1-20 as set forth in the previous Office action dated January 16, 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 obviousness.
Applicants have initially argued that the Examiner has not made a prima facie case of obviousness for the presently claimed subject matter because Baudouin allegedly teaches away from a recognition that from their invention involving C7 sugars for the treatment of cicatricial alopecia, one of ordinary skill in the art would have recognized that cicatricial alopecia could also be treated with minoxidil.
In particular, Applicant posits that a “skilled person would especially be
taught away from using minoxidil and towards ‘the use of C7 sugars’ because Baudouin
“found in a surprising manner that the C7 sugars and derivatives of formula (I),
which will be defined below, have, among others, anti-inflammatory activity with
a beneficial effect on the protection of hair follicles and thus on the protection of
the follicle after each growth cycle. These C7 sugars and derivatives are,
surprisingly, endowed with activity favorable to increased hair and nail density”, ([Baudouin at 0021]).
Applicant’s argument fails to persuade the Examiner of error in his determination of obviousness, however, because Baudouin neither explicitly nor implicitly teaches anything about the effectiveness of minoxidil against cicatricial alopecia. The Examiner takes away from the above Applicant’s position that the skill artisan was surprised that C7 sugars were effective for this type of alopecia given what was known previously about the pharmacological properties of C7 sugars against alopecia.
Nothing in Baudouin detracts from the Examiner’s position that given Sinha teaching of “hair loss” or alopecia in general and unlimited, express suggestion that “other types” of alopecia could be treated with their minoxidil invention one skilled in the art would have been motivated to treat cicatricial alopecia because Baudouin establishes that this type of alopecia was known to the skilled artisan and thus would have been considered as within the teachings of Sinha for “other types” of alopecia.
Applicant’s newly added claim 21 reads:
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It is the Examiner’s position that this claim is being properly rejected because neither this claim not claim 1 defines a pharmaceutical dosage form, minoxidil dosage amount or means of administration that is any different that that taught by Sinha. Given that both the prior art and applicants’ claims are directed to the same dosage form, dosage amount and administration means, it must be necessarily the case that same release characteristics detailed in Applicant’s claim 21 must necessarily, i.e., inherently, be present in the prior art whether recognized by Sinha or not.
At page 8 of their remarks, Applicants have argued that the property that ‘he dosage form releases about 50% of the total dose...between about 2 hours to about 8 hours’ is not necessarily present in a minoxidil dosage form based solely on "dosage amounts and ...dosage form" and is thus not inherent. Applicant has shown that pharmacokinetic parameters vary by dosage amount.
This would not diminish the Examiner’s position of inherency because the dosage form and a dosage amount are not the only tangible requirements for the dosage form present in claim 1. While not expressly required by Applicant's claim 1, but nevertheless allowed by claim 1, it is noted that not only does Sinha teach a dosage form and dosage amount, but also that the dosage form may be sustained release in nature and may contain various excipient materials, including a release aid at paragraph [0047]. Applicants’ argument fails to take this teaching into consideration and thus does not persuade the Examiner of error in his determination.
Claims 1-21 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; 19/216,215, (claims 1-21); 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 applied to claims 1-20 as set forth in the previous Office action dated January 16, 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 have not been specifically addressed by Applicant.
Non-Provisional
Claims 1-21 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 (b) claims 1-20 of U.S. Application No. 19/094,703, (allowed and soon to be patented) in view of Baudouin et al., (US 20130004444, “Baudouin”, (2013), cited by the Examiner), each of record for the reasons of record as applied to claims 1-20 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 have not been specifically addressed by Applicant.
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.
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/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629
June 10, 2025
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