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 07, 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 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 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 "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 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 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
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 via Prov. Application 63/250,009), 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/release rates of the present claims; (d) the lack of observation of the claimed cardiac, cardiovascular 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 same presently claimed dosage amounts, dosage form and route of administration, it must be true that the pharmacokinetic parameters/release rates and lack of detected/observed cardiac, cardiovascular or hirsutism effects associated with such amounts, form and route of 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 cardiac, cardiovascular or hirsutism effect produced because of the minoxidil administration, whether observed or otherwise detected by the patient or a second party who is interested in the occurrence of such effect thus reading of the subject matter of claims 1 and 12-20.
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; 19/414,251; 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; 19/215,216, (claims 1-21); 19/245,208; 19/303,300; 19/315,441; 19/230,007, (claims 1-21); 19/409,546; 19/436,869; 19/441,684 19/329,476; 19/546,283, 19/561,075 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 a cardiac effect resulting from the administration are either recited in or else, where such a cardiac effect is not recited, reads on the presently claimed requirement where no such effect is detected as are the pharmacokinetic parameters required by the present claims. Also, because the present dosage form is identical to the dosage form claimed in the reference applications, it must necessarily be so that the presently claimed release characteristics of claim 1 would be inherent in the dosage form of the claims of the reference applications
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).
Although the claims at issue are not identical, they are not patentably distinct from each
other because the minoxidil formulations of the patented claims 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, the patented claims which are silent as to a cardiac effect, cardiovascular effect or hirsutism being caused by the practice of the invention and subsequently observed 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
July 08, 2026
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