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 December 19, 2025 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 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” 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 respecting either the patient population, the dosage form, the dosage amount 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.
Claim Rejection - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sinha, (U.S. 2024/0474594, (effective 09/29/21), in view of Reynolds et al., "Investigation of the Effect of Tablet Surface Area/Volume on Drug Release from Hydroxypropylmethylcellulose Controlled-Release Matrix Tablets", Drug Development and Industrial Pharmacy, 28(4), 457-466 (2002), (hereinafter “Reynolds”, cited by Applicant) and Jordan et al., (US 6,448,323, cited by the Examiner).
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, (which dosage range is seen to read each dosage amount between 5 and 10 mg and thus read on the presently claimed dosage of “about 9 mg”; 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]).
The differences between the above and the claimed subject matter lie in that Sinha fails to teach (a) hydroxypropyl methylcellulose as being present in the oral dosage form; (b) a dosage frequency of once or twice daily and proportioning of carrier/auxiliary agents, (c) the pharmacokinetic parameters of the present claims; (d) the lack of detection of the claimed cardiac, cardiovascular, i.e., lightheadedness, or hirsutism effects; and (e) polyvinyl alcohol as the coating material.
However, the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains because (a) Sinha explicitly teaches; extended release dosage forms, [0043]; that among the auxiliary agents present, carriers/excipients may be used, (e.g., [0046]); that the compositions he teaches may be produced in accordance with general practice in the pharmaceutical industry, ([0045]); and that large macromolecules such as polysaccharides can be used as carrier compounds for the compositions, ([0049]). One of ordinary skill in the art would have been motivated to employ hydroxypropyl methylcellulose as an extended release carrier in the compositions of Sinha because Reynolds teaches that “hydrophilic polymers, such as hydroxypropyl methylcellulose (HPMC), are commonly used as rate-controlling polymers for controlled drug release from matrix-type dosage forms”. In the absence of evidence to the contrary, the determination of the optimum dosage frequency to employ is considered to have been a routine matter well within the purview of the artisan having ordinary skill. The determination of the dosing of active agents in the pharmaceutical/medical arts is a primary concern when considering an effective therapeutic regimen for a given patient or patient group.
Regarding differences (c) and (d) above, because the reference teaches the presently claimed dosage amounts, it must be true that the pharmacokinetic parameters and lack of detected cardiac effects associated with such amounts after administration would be present in the prior art whether reported or not or else recognized by one of ordinary skill in the art. Sinha is silent with regard to any of the presently claimed hirsutism, cardiac or cardiovascular effects produced because of the minoxidil administration, whether detected or observed by the patient or a second party who is interested in measuring for such effect thus reading on the presently claimed lessening of experiencing or observation of such effects.
Finally, as noted above, Sinha teaches coatings in general for the pharmaceutical dosage forms, such as tablets, and polyvinyl alcohol would have been one choice of various coatings available to one of ordinary skill in the art, (see Jordan at the abstract, for example, where an example of a polyvinyl alcohol-containing film coating for pharmaceutical tablets is disclosed). In the absence of evidence to the contrary, the selection of any particular coating from those known would have been a routine matter in the and well within the scope and spirit of the invention disclosed by Sinha.
Accordingly, for the above reasons, 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.
Provisional
Claims 1-20 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; 19/230,007, (claims 1-21);
19/409,546; 19/414,251; 19/569,918 or 19/397,854.
Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims in each application are directed to either treating hair loss in general or to specific types of hair loss encompassed by the present claims. The presently claimed dosage amount of “about 9 mg” of minoxidil, dosage frequency, other non-active agents and lack of hirsutism, various cardiac effects or various cardiovascular effects resulting from the administration are either recited in or else, where such hirsutism, cardiac or cardiovascular effects is not recited, reads on the presently claimed requirement where no such effects are detected or observed as are the pharmacokinetic parameters required by the present claims.
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.
Although the claims at issue are not identical, they are not patentably distinct from each
other because the minoxidil formulations of the patented are species of the presently claimed dosage form which is orally administered. The carrier ingredient amounts are either broadly provided for in the patented/soon to be patented claims or else specified and are encompassed by the present percentages. The blood concentration ranges and other pharmacokinetic parameters of the patented claims would also be within the scope of the presently claimed subject matter. Finally, where the patented claims are silent as to the various cardiac effects, cardiovascular effects 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
June 16, 2026
Prosecution Insights