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 Information Disclosure Statement filed December 24, 2025 has 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.
Claims Free of the Prior Art
Claim 1 is representative of the presently claimed invention and reads:
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The art closest to the presently claimed invention is Sinha, (U.S. 2024/0474594, (effective 09/29/21 via Prov. Application 63/250,009).
In particular, 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, (see at least the abstract, [0013], [0012] and (claims 10 and 16 of Sinha). Also, a 5-alpha reductase inhibitor such as finasteride may be present as a co-active ingredient, [0034])-([0035]). The dosage form, which may be provided as a tablet, ([0042]), may provide delayed, sustained or enteric release, [0043], and contain one or more diluents, carriers, excipients, fillers, disintegrants, solubilizing agents, dispersing agents, lubricants, binders, release aids, coatings etc.,([0042] and [0046]-[0047]).
Sinha, however fail to teach or suggest that the minoxidil dosage range which at most is about 10 mg can or should be increased to encompass the presently claimed dosage range of from about 15-18 mg of minoxidil. Accordingly, one of ordinary skill in the art would have not found the presently claimed subject matter to be obvious over the teachings of Sinha.
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 12-20 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 12-20 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 "wherein 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 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 12 and 14-20 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application Nos. 19/420,555, 19/561,256, 19/533,028 or 19/412,714, (reference applications). Although the claims at issue are not identical, they are not patentably distinct from each other because in at least claim 1 of reference applications, the same dosage form containing the same dosage amount of minoxidil is administered to the same patient population in the same manner. Thus, it must be necessarily concluded that whether highlighted or not in the claims of the reference applications, the presently claimed absence of observed tachyarrhythmia would be an inherent characteristic of the reference application claimed dosage form upon administration.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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) in view of Sinha, (U.S. 2024/0474594, (effective 09/29/21 via Prov. Application 63/250,009) and Jordan, (U.S. Patent No. 6,448,323), both cited by the Examiner.
Although the claims at issue are not identical, they are not patentably distinct from each
other because the methods of treatment through the oral administration of minoxidil formulations of the patented claims are species of the presently claimed methods which require the formulation to contain either the same ingredients or category of ingredient which is orally administered. The currently claimed dosage amount of minoxidil of from about 15-18 mg is clearly encompassed by the claimed dosage range of from about 3 mg to about 20 mg of minoxidil. Also, Sinha at [0034-35] teaches the desirability of including a 5-alpha reductase inhibitor to a minoxidil dosage form for treating hair loss while Jordan in its entirely teaches an example of polyvinyl alcohol enteric coating for pharmaceutical dosage forms which is generally provided for in the patented claims, i.e., enteric coated. The presently claimed carrier ingredient amounts are either broadly provided for in the patented claims or else specified and are encompassed by the present percentages. Finally, the patented claims which are silent as to a cardiac effect, e.g., the presently claimed lack of observed tachyarrhythmia, cardiovascular effect or hirsutism being caused by the practice of the invention would read on the present claims requiring no such effects occurring in the subject.
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
June 01, 2026
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