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 .
Claim Rejections - 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 1-20 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.
Claim 1 recited the limitation “wherein the dosage form has a property that it releases about 32.7% to about 35% of the minoxidil in the dosage form at about 4 hours when placed in an in vitro dissolution test” in lines 3-5. It is not entirely sure if this is an exemplary release rate or a dissolution rate as recited in the depending claims 4 and 20. Secondly, does the dissolution test in claim 1 the same as those recited in claims 4 and 20?
Claim 6 recited the limitation “wherein the dosage form further comprises hydroxypropyl methylcellulose”. Is this the additional rate adjusting polymer to the release rate adjusting matrix polymer recited in claim 1?
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.
Claims 1-5 and 7-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12,268,688 (‘688). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘688 patent discloses a method of treating hair loss, comprising orally administering to a subject in need thereof a modified release pharmaceutical formulation comprising from about 3.5 mg to about 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 of about 1 ng/ml to about 20 ng/ml; a Cmax of about 0.25 ng/ml to about 20 ng/ml; and a Tmax of about 30 to about 360 minutes. Blood level of minoxidil or a pharmaceutically acceptable salt thereof that is maintained for at least about 12 hours is found in claim 10. 8.5 mg of minoxidil dosing is found in claim 11. Oral formulation for administration at once per day, two times per day, or four times per day is found in claim 23. Release modifier is found in claims 2, 15 and 20.
It is noted that the ‘688 patent is silent with respect to the dissolution rates recited in the present claims. However, it is noted that the claims of the ‘688 patent recited all the features that require in the present claims, namely, an oral dosage form comprising 8.5 mg of minoxidil having the same blood level of minoxidil for at least 12 hours and useful for the treatment of hair loss, therefore, the properties are expected to be similar. Here, the claims in the present application do not require any specific formulation structure that is different from the formulation disclosed in the ‘688 patent, hence, products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.
Thus, it would have been obvious to one of ordinary skill in the art at the time the invention was made to obtain the claimed invention given the claims of the ‘688 patent. This is because the ‘688 patent discloses an invention similar to that of the present invention, namely, orally administering 8.5 mg minoxidil for the treatment of hair loss.
Response to Arguments
Applicant's arguments filed 10/30/2025 have been fully considered but they are not persuasive.
Applicant argues that claim 1 has been amended to include the release rate adjusting matrix polymer, and therefore respectfully requested that the rejection be withdrawn.
However, Applicant’s argument is not persuasive because claims 2, 15 and 20 of the’688 patent disclose the inclusion of the release modifier in the oral pharmaceutical composition for the same purpose, namely, for the treatment of hair loss.
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 and 6-19 are rejected under 35 U.S.C. 103 as being unpatentable over Sinha US 20240374594A1.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sinha US 20240374594A1, in view of Rubio et al. US 20070212416 A1.
These 103 rejections have been withdrawn in view of the Amendment filed 10/30/2025.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See 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 SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615