CLAIMS 1-21 ARE PRESENTED FOR EXAMINATION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, continues to be examined under the first inventor to file provisions of the AIA .
Applicant’s amendment/remarks filed April 27, 2026 have been received and entered into the application.
Currently, claims 1-18 and 21 stand rejected under the 35 USC 103 rejection of record and claims 1-21 stand rejected for the previously set forth provisional double patenting rejection. Claims 13-17 are newly rejected under 35 USC 112, as set forth, infra.
Claim Rejections - 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 13-17 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 13-17 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, 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 16'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 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 1-18 and 21 remain rejected under 35 U.S.C. 103 as being unpatentable over Sinha, (U.S. 2024/0474594) in view of 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 27, 2026, which reasons are here incorporated by reference.
Claims 19-20 are no longer subject to this rejection because after further consideration, it is not seen that either Sinha alone or in combination with Reynolds would have taught that the patient suffered from a cardiac condition or that the patient was currently taking medication for such a condition.
Newly added claim 21 has been included in the present rejection because, for the reasons below, such would be an inherent characteristic of the practice of the method taught by Sinha which is the same method, in terms of all tangible elements of the present claims, i.e., dosage form, dosage amount, presence of a “release modifier”, oral administration and the treatment of telogen effluvium in a patient suffering therefrom.
Applicant's remarks have been carefully considered, but fail to persuade the Examiner of
error in his determination of obviousness.
In particular, Applicants have argued that the presently claimed subject matter would not have been obvious because claim 1 is not prima facie obvious at least because all elements of the claim are not taught or suggested in the prior art. More specifically, Applicant continues, the
combination of Sinha and Reynolds does not teach or suggest at least "wherein orally administering the dosage form comprising the release modifier provides a Cmax of minoxidil or a salt thereof that does not exceed an exposure cap to limit the likelihood and severity of a cardiovascular effect” as required by claim 1 as well as “the exposure cap is a blood level of minoxidil or a salt thereof of about 20 ng/ml” as is required by newly added claim 21.
The Examiner agrees that the specific release cap and/or pharmacokinetic parameters as in present claim 1 and pointed out by Applicant are not taught or suggested in the prior art. However, such does not diminish the propriety of the present rejection because absent evidence to the contrary, the Examiner believes such characteristics to be necessarily present, i.e., inherent, in the prior art method of treating telogen effluvium in a patient suffering therefrom which meets each and every tangible limitation set forth for the dosage form in present claim 1, i.e., dosage form, dosage amount, presence of a “release modifier”, oral administration and the treatment of telogen effluvium in a patient suffering therefrom. In particular, the dosage form of Sinha may be sustained release, oral and contain about 8.5 mg of minoxidil. Also, each
and every tangible method limitation present in claim 1 is clearly taught by Sinha, i.e., the
dosage form is orally administered to a human patient experiencing telogen effluvium, the dosage form, the dosage amount, the presence of a “release modifier” and oral administration. It must therefor necessarily follow that whether taught or recognized in the prior art or not, the same pharmacokinetic characteristics as recited in present in current claim 1 would also be present in the prior art. As per MPEP 2112 (III), "Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 USC 102 and 103".
Applicant has also argued that as taught by Reynolds, there are numerous variables which
can affect a drug's release from HPMC, e.g., polymer level, molecular weight and solubility and there is no reasonable expectation of arriving at a dosage form providing the currently claimed Cmax. However, given that the Sinha discloses an identical dosage form and method steps, it is
immaterial that Sinha teaches alternative dosage forms which may contained varied amounts or individual ingredient. This rejection is not based upon a supposition that the skilled artisan would have had a reasonable exception of arriving at Applicant’s Cmax through routine experimentation. Rather, it is based upon the fact that Sinha teaches the SAME method a in at least present claim 1 in terms of the tangible elements required as specified by the Examiner above. Being the same, the Cmax characteristic must also be present, i.e., inherent, whether highlighted by Sinha or not.
Finally, Applicant has argued that the pharmacokinetic characteristics of claim 1 are not inherent in the prior art because they have shown that drug release rates cannot in fact necessarily be associated with only dosage amounts and dosage form.
This argument is not persuasive because dosage form and a dosage amount are the only
two tangible requirements for the dosage form present in claim 1. While not expressly required
by Applicant's 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]. Applicant's argument
fails to take this teaching into consideration and thus does not persuade the Examiner of error in
his determination.
For the above reasons, the claims are deemed to remain 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; 19/242,858; 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 27, 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 set had at least one supposed limitation regarding the pharmacokinetic 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.
None of the present claims 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 July 16, 2027
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