DETAILED ACTION
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 preliminary amendment filed 11/8/2024, is acknowledged. Claims 29-34 are pending.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 29-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rock et al. (US 2012/0196819) in view of Sinclair (WO 2016/0654426).
Regarding claims 29, Rock et al. “found that administering therapeutic agents via the oral cavity, where the majority is absorbed prior to the gastric mucosa, i.e., under the tongue (sublingual), on the top of the tongue, and/or between the cheek (buccal), to animals, results in rapid onset of activity, more accurate and lowered dosing, an absence or diminishment of side-effects, and greater safety to both the animal and the administrator of the formulation.” Para. [0017]. Rock et al. further teaches that the “formulations may be adapted for humans.” Para. [0011]. Rock et al. terms its invention as “Direct Systemic Introduction” (“DSI”). Para. [0021]. “DSI can provide advantages over traditional oral, intravenous, intramuscular, and subcutaneous routes of administration, in that more of the drug may be available systemically for its desired therapeutic effects.” Para. [0022]. Minoxidil is disclosed as a therapeutic agent. Para. [0028].
Further, “[t]hese fast release formulations may comprise the active therapeutic agent, typically in combination with acceptable excipients such as gelatin, mannitol or another sugar alcohol, together with suitable sweetening agents, such as aspartame, and suitable flavoring agents.” Para. [0013]. Rock et al. also teaches that administration of a DSI formulation may be used to treat hair growth disorders. See para. [0036].
Rock et al. does not teach “a sublingual dosage formulation comprising an active agent consisting of about 0.45 mg minoxidil, wherein minoxidil is not minoxidil sulfate.”
Sinclair discloses methods of treating or preventing hair loss or hair shedding by administration of oral doses of minoxidil. Abstract. In this regard, Sinclair teaches compositions comprise 0.1-0.49 mg of minoxidil (current claim 30).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the invention to combine the teachings of Rock et al. and Sinclair to arrive at the claimed subject matter. “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.” In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983). Here, one of ordinary skill in the art looking to improve the treatment of hair loss and growth of hair with minoxidil would have been motivated by Rock et al.’s teaching of the benefits of DSI to administer a formulation consisting of minoxidil, excipients and taste modifying agents sublingually as taught by Rock et al. and would have looked to Sinclair, which specifically teaches methods of treating excessive hair with minoxidil as a lone drug, to establish a dosing regimen. Further, one of ordinary skill in the art would have had a reasonable expectation of success because Rock et al. teaches that minoxidil as an example of a “therapeutic agent[] that may be utilized in DSI formulations.” Para. [0027].
Regarding the wherein clauses of claims 31-34, they are not considered limitations because they merely express the intended results of a process step positively recited. MPEP 2111.04 (“Claim scope is not limited by claim language that . . . does not limit a claim to a particular structure.”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm.
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/ROBERT S CABRAL/Primary Examiner, Art Unit 1614
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