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 July 01, 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.
Applicant’s terminal disclaimer has overcome this double patenting rejection set forth in the previous Office action. A new double patenting rejection appears below based upon newly discovered reference applications.
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 12-20 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.
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 "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 of patients in need of hair loss treatment,
the minoxidil dosage form, or 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 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
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being
unpatentable over claims 1-11 and 21-29 of now allowed U.S. Patent Application No. 19/428,043 or claims 1-11, 17-19 and 21-26 of now allowed U.S. Patent Application No. 19/568,540 OR claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/424,087; claims 1-12 and 21-28 of copending Application No. 19/402,812; claims 1-20 of copending Application No. 19/442,974; claims 1-11 and 21-29 of copending Application No. 19/412,714; claims 1-20 of copending Application No. 19/533,028; claims 1-11, 17-19 and 21-26 of copending Application No. claims 1-20 of copending Application No. 19/540,478; claims 1-11, 17-19 and 21-26 of copending Application No. 19/546,276; claims 1-20 of copending Application No. 19/561,256; or claims 1-11 and 21-29 of copending Application No. 19/572,667, (reference applications).
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 soon-to-be patented or copending 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 soon-to-be patented or copending claims, i.e., enteric coated. The presently claimed carrier ingredient amounts are either broadly provided for in the soon-to-be patented or copending claims or else specified and are encompassed by the present percentages. Finally, the soon-to-be patented or copending claims which are silent as to a cardiac effect, 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629
September 15, 2026
Prosecution Insights