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 05, 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 Grounds)
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 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.
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 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, (Overcome)
The rejection of claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sinha, (U.S. 2024/0474594) in view of Reynolds et al., as set forth in the previous Office action dated February 05, 2026 has been overcome by at least Applicant’s amendments to present claim 1 and is therefore here withdrawn.
Applicant's claim 1 now requires "wherein the dosage form comprises a release modifier, and the release modifier comprises 0% (w/w) K4M hydroxypropyl methylcellulose and about 72% (w/w) to about 88% (w/w) K200M hydroxypropyl methylcellulose” and such is not seen to have been obvious to the Examiner because of the vast number of types of hydroxypropyl methylcellulose from which the skilled artisan would have had to choose from to arrive at K200M and then to have used it only in a percentage of from about 72% to about 88% of the release modifier.
In particular, the above requirement is not believed to have been obvious because a cursory search by the Examiner of the number of different types of HPMC products available to the artisan resulted in a finding that there are tens to low hundreds of distinct HPMC products on the market which differ in such characteristics as viscosity, molecular weight and degree of cellulose substitution.
Reynolds teaches HPMC broadly as a pharmaceutical release aid and specifically teaches HPMC USP Type 2208, (pg. 459, under “Materials”). There is no teaching or suggestion in either Sinha or Reynolds that would have motivated one of ordinary skill in the art to (a) select K200M as the HPMC and then to use it as 72%-88% (w/w) of the release modifier. As referenced above, there was a vast number of HPMC product available. Lacking any direction or else motivation to select a particular type of HPMC, having its own inherent release characteristics and drug compatibility, from the vast number known, no reasonable expectation of success in using K200M as the type of HPMC is seen to exist.
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), 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, the release aid aspect of the claimed invention was addressed in the previous Office action. Further, where the claims of the copending applications do not specify the instantly claimed type of HPMC, the term “release modifier” does and the specification at [0067] where HPMC K200M is specified would have been used as a dictionary for the skilled artisan.
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 (b) claims 1-20 of U.S. Patent No. 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 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, the release aid aspect of the claimed invention was addressed in the previous Office action. Further, where the patented claim sets do not specify the instantly claimed type of HPMC, the term “release modifier” does and the specification at [0067] where HPMC K200M is specified would have been used as a dictionary for the skilled artisan.
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
August 04, 2026
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