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 .
Priority
This Application filed on 11/11/2022 is a 371 of PCT/IL2021/050549 filed on 05/12/2021, which has a PRO 63/024,085 filed on 05/13/2020.
DETAILED ACTION
The Office Action is in response to the Applicant's reply filed January 12, 2026 to the restriction requirement made on July 16, 2025.
Applicant's election of Group II (claims 11-18) and the species election of A. One or more lipophilic bioactive agents: 5-alpha reductase inhibitors B. One or more oil solvents: Fatty acids C. One or more emulsifiers: Sorbitan oleoate D. Solubility enhancer: Alcohols E. Disease or disorder of the hair follicles: Alopecia in the reply filed on 1/12/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The restriction requirement is deemed proper and made FINAL.
Claims 1-10 are withdrawn from further consideration pursuant to 37 C.F.R. 1.142(b), as being drawn to non-elected subject matter. The claims corresponding to the elected subject matter are claims 11-18 and are herein acted on the merits.
Claims 11-18 are herein acted on the merits.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 3/5/25 is in compliance with the provisions of S7 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
The rejections are as below:
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 11-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guterres et al. (US 2015/0238406 A1).
Guterres et al. teaches a topical compositions comprising polymeric nanoparticles comprising finasteride for treating alopecia (hair loss, disease of the hair follicles). (paragraph [0001], examples; in particular examples 1.2 and 1.6; table 2; paragraph [0102]; claims) Example 1.2 discloses in table 2 the preparation of a finasteride nanoemulsion control formulation (NEF25), in which the drug was dissolved in the internal oil phase. The oil phase comprised triglycerides of capric and caprylic acids (oil solvent with melting point below 15°C), sorbitan monostearate (oil-soluble surfactant), acetone (solubility enhancer), and finasteride (lipophilic bioactive agent), and the aqueous phase comprised polysorbate 80 (water-soluble surfactant), and water. In example 1.6, this formulation was used to treat mice in a model of hair loss. The nanoemulsion had an (average) diameter of 276 nm. Paragraph [0102]
With respect to claims 16-18, the method of treatment wherein the amount bioactive agent per unit are present in the hair follicles is higher than in the skin, the concentration of the bioactive agent in the blood is lower than needed for systemic therapeutic effects, and the bioactive agent in the blood is at least 10X lower than the concentration that would be obtained following oral or parenteral administration, is rendered inherent over the teaching of topically treatment of hair follicles at a concentration of 0.25% of finasteride in the formulation, ([0072]), identical to the administration form and concentration of Applicant’s specification.
Conclusion
No claims allowed.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
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