CLAIMS 1-21 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 and July 15, 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 1-21 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).
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 4.5 mg.”, (see at least the abstract, [0013], [0012]-[0014], (claims 10 and 16) as well as “about 5 mg minoxidil”, ([0039]). 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”, ([0047]), etc., [0046]-[0047].
The differences between the above and the claimed subject matter lie in that Sinha fails to teach (a) the pharmacokinetic parameters of present claims; (b) a dosage frequency of once or twice daily; (c) the types of hair loss as in present claims; and (d) the lack of symptomology as presently claimed.
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) the reference teaches the presently claimed dosage amounts and dosage unit physical form and formulation, thus it must be true that the intrinsic pharmacokinetic parameters as well as (d) non-symptomology associated with the administration of such a dosage unit would have been present in the prior art invention whether reported or not or else recognized by one of ordinary skill in the art.
Regarding (b), in the absence of evidence to the contrary, the determination of the optimum active ingredient dosage frequency to employ for a given patient would have been a matter well within the purview of the skilled artisan based upon the known pharmacological characteristics of the active agent and the patient’s responsiveness to a given treatment protocol. Also, he 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.
Finally, regarding (c), Sinha expressly teaches “[o]ral minoxidil is mainly used for male and female pattern hair loss. However, there can benefit with other types of hair loss too including telogen effluvium, traction alopecia and loose anagen syndrome”, ([0022]), and such 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, including those presently claimed.
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 1-21 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); 19/258,817; 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 method of treating hair loss of the co-pending claim sets are essentially species of the presently claimed method of treating hair loss through the oral administration of the claim defined minoxidil dosage form. The blood concentration ranges, other phasdfrmacokinetic parameters and symptomology or lack thereof of the patented claims would also be within the scope of the presently claimed subject matter as the patient population is either a population having or not having the symptoms as present in the patented claims. Finally, the presently claimed dosage amount of “about 4.5 mg” of minoxidil is either expressly set forth in the co-pending claims or else with a range of dosage amounts also set forth therein.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Non-Provisional
Claims 1-21 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 method of treating hair loss of the patented or soon to be patented claims are essentially species of the presently claimed method of treating hair loss through the oral administration of the claim defined minoxidil dosage form. The blood concentration ranges, other pharmacokinetic parameters and symptomology or lack thereof of the patented claims would also be within the scope of the presently claimed subject matter as the patient population is either a population having or not having the symptoms as present in the patented 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
January 15, 2025