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 Statements filed January 14, 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.
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 17-20 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.
Taking claim 18 as an example, claim 18 is indefinite for reciting the phrase “when the oral dosage is administered to a patient, the patient experiences less tachycardia…” 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 the limitation in claim 18 further limits the dosage form in the kit of claim 1 with respect to either the patient population, the step of administration, the dosage form, the dosage amount or the objective of administration or else adds some type 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 uses or description of the limitation in claim 13 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 18’s intended result of the functional descriptive claim language.
Taken as a whole, it is still not clear how the disputed limitation of claim 18 further limits the dosage form in the kit of claim 1, and is therefore indefinite.
The same rationale can be equally applied to each of claims 17, 19 and 20.
Accordingly, the claims are deemed properly rejected.
Claims Free of the Prior Art
The art closest to the presently claimed invention is Sinha, (U.S. 2024/0474594,
(effective 09/29/21 via Prov. Application 63/250,009).
Sinha teaches a "package', (see at least [0028], line 2; "package" is seen to read on the
claimed term "kit"), comprising an oral dosage comprising "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, ((e.g., each a modified release dosage form) [0043])
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.
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.
Non-Provisional/Provisional
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being
unpatentable over 1-28 of U.S. Patent No. 12,268,688, (cited by Applicant); or claims 1-11 and 21-29 of now allowed U.S. Patent Application Nos. 19/568,540 or 19/428,043; or claims 1-11 and 21-29 of now allowed U.S. Patent Application No. 19/428,098; each in view of Sinha, (U.S. 2024/0474594, and Jordan, (U.S. Patent No. 6,448,323) OR claims 1-20 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent Application Nos. 19/420,555, 19/442,974, 19/533,028, 19/540,478 or 19/561,256 or over claims 1-11 and 21-29 of U.S. Patent Application No. 19/412,714 or over claims 1-11, 17-19 and 21-26 of U.S. Patent Application No. 19/546,276 or claims 1-12 and 21-28 of U.S. Patent Application No. 19/402,812.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims only fail to include a kit means for packaging the dosage form of the methods claimed. It is believed that a mere packaging would have been at least required in the pharmaceutical industry for ensuring the integrity of the dosage forms after manufacture. Also, the written subject matter of the claims not present in the patented claims is not given any patentable weight for the reasons explained above under the rejections under 102 and 103.
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
October 06, 2026
