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 RCE and Information Disclosure Statement filed February 04, 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.
The following are new rejections being made on the record.
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 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).
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 would include a range of 4.7 to 10.0, (i.e., the claimed “about 8.5 mg.”, (see at least the abstract, [0013], [0012]-[0014], (claims 10 and 16). 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, release aids, binders 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 present claims 1, 2 and 12-16; (d) the types of hair loss as in present claims 5-10 and (e) the lack of symptomology as in present claims 19-20).
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”. It is further believed that, in the absence of evidence to the contrary, the determination of the optimum HPMC percentage to employ would have been a routine determination of the skilled artisan. This is also true for active ingredient dosage frequency in regards to difference (b) above 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 (e), because the reference teaches the presently 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.
Regarding difference (d), at least present claim 1 encompasses “hair loss” in general and thus would have readily suggested to one of ordinary skill in the art the specific types of hair loss known in the art at the time of the invention.
Accordingly, for the above reasons, the claims are deemed properly rejected.
Double Patenting
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).19/094,716; 19/253,703; 19/253,708; 19/255,878; 19/230,047, (claims 1-21); 19/230,054, (claims 1-21); 19/258,817; 19/260,035; 19/267,447; 19/267,464; 19/308,124; 19/315,454, (claims 1-19); 19/328,077, (claims 1-19); or 19/329,494, (claims 1-19).
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, overlapping or the same percentages of hydroxypropyl methylcellulose appears in the either the independent or dependent copending claims. The presently claimed dosage amount of “about 8.5 mg” of minoxidil, dosage frequency, other non-active agents and symptomology resulting from the administration are either recited in or else encompassed by the copending claims 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.
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
March 12, 2026