CLAIMS 1-19 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 August 29, 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 § 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 1-19 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 AreaNolume on Drug Release from Hydroxypropylmethylcellulose Controlled-Release Matrix Tablets", Drug Development and Industrial Pharmacy, 28(4), 457-466 (2002), (hereinafter "Reynolds", cited by Applicant).
upSinha teaches a method of treating hair loss by promoting hair growth, 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], (claims 10 and 16), i.e., “about 4.5 mg”. The dosage form 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, etc., [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, (c) the pharmacokinetic parameters of the present claims and (d) the absence of detection of a cardiac effect as in present claims 1 and 7-17).
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".
The determination of the optimum active ingredient dosage frequency as with (b) above to employ would have been a matter well within the skill of the artisan and the scope of the invention described by Sinha; because the optimization 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), because the reference teaches the presentl claimed dosage amounts, it must be true that the pharmacokinetic parameters and non-symptomology 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. Nowhere does Sinha teach cardiac equipment capable of detecting cardiac effects due to the administration of the claimed dosage form and thus there would have been no cardiac effects detected which meets the claimed requirements, (claims 1 and 7-17).
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 1-19 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): 19/094,716; 19/253,703; 19/253,708; 19/255,878; 19/215,242, (claims 1-21); 19/230,054, (claims 1-21); 19/230,047, (claims 1-21); 19/258,817; 19/260,035; 19/267,447; 19/308,124; 19/315,454, (claims 1-19); or 19/329,494, (claims 1-19), in view of Sinha, (cited above).
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 as is presently claimed or else encompassed by present claim 1. Also, hydroxypropyl methylcellulose appears in the either the independent or
dependent copending claims. The presently claimed dosage amount of “about 4.5 mg” of minoxidil, dosage frequency, other non-active agents and non-symptomology resulting from the
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Non-Provisional
Claims 1-19 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) or (b) claims 1-20 of U.S. Patent No. 12,491,184, (cited by the Examiner).
Although the claims at issue are not identical, they are not patentably distinct from each other because the minoxidil formulations of the patented or soon to be patented claims are species of the presently claimed dosage form which is orally administered. The blood concentration ranges and other pharmacokinetic parameters of the patented claims would also be within the scope of the presently claimed subject matter if they are already not expressly set forth in the present claims.
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
February 02, 2026