DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the specification and claims as well as applicant arguments/remarks, filed 10/08/2025, is acknowledged. Amendments to the specification have been entered.
Claims 1-3, 5-19 are pending in this action. Claim 4 has been cancelled. Claims 1, 5-6, 15 have been amended. Claims 1-3, 5-19 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Priority
This application is a continuation of PCT/US2025/026067, filed Apryl 23, 2025, which claims benefit of provisional U.S. Application No. 63/638,348, Apryl 24, 2024.
Specification
The lengthy specification (180 pages, exclusive of claims) has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01. The amended specification, filed 10/08/2025, is further objected to because of the following informalities:
The data provided in the specification are unclear, given that the data are shown without units of measurements, e.g., “50%” (e.g., Para. 0003, 0093, 0094, 0097, 0097). Is it wt%, mol%, etc.? Appropriate correction is required.
The use of the trademarks/trade names/product names, e.g., OPADRY (e.g., Para. 00133, 00199, 00247) has been noted in this application. Although the use of trademarks/trade/product names is permissible in patent applications, the proprietary nature of the trademarks/trade names/product names should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. The use of language such as “the product X (a descriptive name) commonly known as Y (trademark)” is not permissible since such language does not bring out the fact that the latter is a trademark. Language such as “the product X (a descriptive name) sold under the trademark Y” is permissible. MPEP §608.01(v). Further, it is noted that the trademarks/trade names are used to identify a source of goods, and not the goods themselves. The formula or characteristics of the product may change from time to time and yet it may continue to be sold under the same trademark/trade name. Thus, a trademark/trade name does not identify or describe the goods associated with the trademark/trade name/product names. Appropriate correction is required.
The specification comprises product names, e.g., “HPMC K200M”, “HPMC K4M” (e.g., Para. 0077-0080, 0086, 00148, 00214, 00402, 00467, 00557), “poloxamer 188” (Para. 00130, 00196, 00244) without proper definition of the chemical compounds to be used in the disclosed compositions. In the present case, no definitions for recited indexes, i.e., “K200M”, “K4M”, “188”, are provided. Appropriate correction is required.
Claim Objections
Claims 1, 5, 15 are objected to because of the following informalities:
Claim 1 comprises the typographic error “and about 56% (wt/wt) to about 80% (w/w)” that needs to be corrected to “and from about 56% (wt/wt) to about 80% (w/w)”. Similar is applied to other constituents recited in claim 1, as well as to claim 5.
Claim 1 recites the limitation “98 % of the daily dose” that needs to be corrected to “98 % of the daily dose of minoxidil” or clarified.
In claim 15 the term “hydroxypropylmethylcellulose” should be corrected to “hydroxypropyl methylcellulose” (see claims 1, 6).
Claim 15 comprises the typographic error “an acrylic copolymers” that needs to be corrected to “an acrylic copolymer” or clarified.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-3, 5-19 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 pre-AIA the applicant regards as the invention.
Newly amended claim 1 recites the amount limitation “releases in vivo about 50 % to about 98 % of the daily dose” that is unclear and indefinite. In the present case, the recited relative amounts are not clearly delineated (e.g., mol%, wt%, etc.), and one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. This limitation was interpreted as best understood as “releases in vivo from about 50 wt% to about 98 wt% of the daily dose of minoxidil”. Clarification is required.
Claim 6 (dependent on claim 1) recites the limitation “the dosage form further comprises hydroxypropyl methylcellulose”. In the present case, it is noted that newly amended independent claim 1 discloses a dosage from comprising hydroxypropyl methylcellulose. Therefore, it is unclear how claim 6 narrows the scope of the claim upon which it depends. Clarification is required.
Newly amended claim 15 recites the limitation “enteric coating comprising cellulose acetate phthalate, hydroxypropylmethylethylcellulose succinate, hydroxypropylmethylcellulose phthalate, polyvinyl acetate phthalate, methacrylic acid- methyl methacrylate copolymer, polyvinyl alcohol, methacrylic acid-ethyl acrylate copolymer, …” that is not reasonably clear. Does this limitation disclose an enteric coating as a mixture of recited compounds (i.e., comprising), or at least one of them? Clarification is required.
Claims 2-3, 5, 7-14, 16-19 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
Claim Rejections - 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 1-3, 5-19 are rejected under 35 U.S.C. 103 as being unpatentable over Barman et al., US 2019/0381296 (cited in IDS; hereinafter referred to as Barman), in view of Sinclair, US 2019/0269684 (cited in IDS).
Barman teaches methods for treating baldness and promoting hair growth, e.g., female pattern hair loss, alopecia areata, central centrifugal cicatricial alopecia, lichen planopilaris, hair loss caused by hereditary disease, or by telogen effluvium, or by traction (Title; Abstract; Para. 0178-0180, 0723-0724 as applied to claims 1, 7-14).
Barman teaches that said method includes orally administering to a patient in need thereof a composition comprising a hair growth promoting agent, e.g., minoxidil (Para. 0124, 0346, 0361-0362, 0369 as applied to claim 1), wherein said compositions/dosage can be in a modified release form (Para. 0365-0369, 0529, 0534), may include hydroxypropyl methylcellulose (Para. 0538, 0544 as applied to claims 1, 6); and provides concentration of hair growth-promoting agent in plasma or serum of from 0.1 nM to 100 µM in 8 hrs after administering (Para. 0370 as applied to claim 5), and wherein said compositions/dosages may include coating, e.g., with enteric polymers such as hydroxypropyl methylcellulose phthalate (here as HPMCP); cellulose acetate phthalate, polyvinyl alcohol (incorporated by reference to US 5, 698,220, US 5,612,059; Para. 0534, 0545, 0548, 0550, 0553, 0558 as applied to claim 15). Barman teaches that said compositions can be administered once daily, or twice daily (Para. 0664, 0665 as applied to claims 2, 3).
Barman does not specifically disclose the amount of minoxidil to be included into the oral compositions (claim 1).
Sinclair teaches methods of promoting hair growth and treatment of hair loss (Title; Abstract; Para. 0030) by administration of a dose of minoxidil absorbed by the oral mucosa or nasal mucosa, e.g., minoxidil compositions in a form of strip, pellet, granule, tablet, capsule, etc., wherein said compositions can be in sustained release form (Claim 29; Para, 0008-0010, 0017, 0082-0085, 0089). To this point, Sinclair teaches the use of said compositions comprising 05-3 mg of minoxidil (Claim 31; Para. 0014, 0032, 0034, 0038), wherein said compositions results in a minoxidil blood concentration of 0.25-10 ng/ml (Claim 30; Para. 0013, 0091), and can be administered once daily, or twice daily (Claim 33; Para. 0016). Sinclair also teaches that said compositions may include hydroxypropyl methylcellulose, e.g., as a film forming agent (Para.0110).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to control concentrations of minoxidil in oral compositions/dosage forms for treating hair loss as taught by Barman and Sinclair, because the cited prior art teaches that effective compositions suitable for oral administering should provide specific minoxidil blood concentration. Further, it is noted that differences in experimental parameters such as concentration of compounds in a formulation/composition will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations comprising the same components. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Regarding the properties of the disclosed dosage form (claims 1, 16-19), it is noted that the cited prior art teaches compositions that are substantially the same as the compositions recited by the instant claims, i.e., comprise components as instantly claimed. Therefore, it is expected that since the prior art is comprised of the same components, the same beneficial properties and effects would also be provided.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2, 5-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 13 of U.S. Patent No. 12,268,688.
Although the conflicting claims are not identical, they are not patentably distinct from each other, because the prior patent also claims: A method of treating hair loss, comprising orally administering to a subject in need thereof a pharmaceutical formulation comprising 3.5-20 mg of minoxidil or a pharmaceutically acceptable salt thereof; wherein the modified release pharmaceutical formulation provides a blood level of the minoxidil or a pharmaceutically acceptable salt thereof in the range of from 1 ng/ml to 20 ng/ml, wherein said compositions are administered at least once daily. Further, cited prior patent also teaches that said formulations (i) may include hydroxypropyl methylcellulose, e.g., HPMC K200M, in an amount from 0% to about 80% (w/w) of the total formulation; (ii) further comprise a top coat that include cellulose acetate phthalate, hydroxypropylmethylethylcellulose succinate, hydroxypropyl methylcellulose phthalate, polyvinyl alcohol, polyvinyl acetate phthalate, and methacrylic acid-methyl methacrylate copolymer; and (iii) result in substantially no adverse effects such as tachycardia, hypotension, ventricular contractions, tachyarrhythmias. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said prior patent.
Claims 1-3, 5-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over (1) claims 1-3, 17-20 of copending Application No. 19/094,703; (2) claims 1-19 of copending Application No. 19/218,211; (3) claims 1-3, 5-19 of copending Application No. 19/221,432; (4) claims 1-19 of copending Application No. 19/222,947; (5) claims 1-5, 11-18 of copending Application No. 19/235,535; (6) claims 1-5, 11-18 of copending Application No. 19/236,933; (7) claims 1-5, 11-18 of copending Application No. 19/245,208; (8) claims 1-5, 11-18 of copending Application No. 19/250,029; (9) claims 1-5, 11-18 of copending Application No. 19/253,708; (10) claims 1-5, 11-18 of copending Application No. 19/253,703; (11) claims 1-5, 11-18 of copending Application No. 19/255,878; (12) claims 1-5, 11-18 of copending Application No. 19/258,817; (13) claims 1-5, 11-18 of copending Application No. 19/260,035.
Although the conflicting claims are not identical, they are not patentably distinct from each other, because the subject matter claimed in the instant application is fully disclosed in the referenced copending applications and would be covered by any patent granted on that copending applications, since the referenced copending applications and the instant application are claiming common subject matter, as follows: A method of treating hair loss, the method comprising orally administering to a subject in need thereof once daily or twice daily a pharmaceutical formulation comprising minoxidil or a pharmaceutically acceptable salt thereof; a release modifier/hydroxypropyl methylcellulose, and an enteric coating, and wherein said formulation provides a blood level of the minoxidil or a pharmaceutically acceptable salt thereof in the range of from 1 ng/ml to 20 ng/ml; and result in substantially no adverse effects such as tachycardia, hypotension, ventricular contractions, tachyarrhythmias. Further, the referenced copending applications also teach that said formulations may include 0.125-100 mg of minoxidil, and 20-95 wt% of hydroxypropyl methylcellulose as a release modifier. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said copending applications. This is a provisional obviousness-type double patenting rejection, because the conflicting claims have not in fact been patented.
Response to Arguments
Applicant's arguments, filed 12/03/2019, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments and rejections have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments. Additional examiner’s comments are set forth next.
In response to applicant’s argument that the cited prior art does not disclose the amounts of minoxidil to be used in the method for treating hair loss, it is noted that (i) Barman teaches the use of compositions suitable for orally administering once daily or twice daily and comprising minoxidil, wherein said compositions provide concentration of minoxidil in plasma or serum of from 0.1 nM to 100 µM in 8 hrs after administering; and (ii) Sinclair teaches the use of compositions comprising 05-3 mg of minoxidil, wherein said compositions results in a minoxidil blood concentration of 0.25-10 ng/ml, and can be administered once daily, or twice daily. Therefore, the prior art teaches formulations comprising the same components. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Applicant is advised to clarify the claim language, the structure of the claimed compositions to be used in the claimed method, and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in conditions for allowance.
Conclusion
No claim is allowed at this time.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615