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 .
Priority
The instant application is the national stage entry of PCT/KR2022/009433 filed 30 June 2022. Acknowledgement is made of the Applicant’s claim of foreign priority to application KR10-2021-0085581 filed 30 June 2021. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Status of the Claims
Claims 1-13 are pending.
Claims 1-13 are rejected.
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 7-9 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. Claims 7-9 contain many trademarks/trade names such as, BRIJ, LABRAFAC, SPAN, TWEEN, LABRASOL, TRANSCUTOL, and CREMOPHOR. The claims comprise several more trademarks than listed. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe various surfactants and, accordingly, the identification/description is indefinite.
Claim Rejections - 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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2 and 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Goren et al. (US 2020/0214958) in view of Osborne et al. (AAPS PharmSciTech, Vol. 19, No. 8, November 2018, pgs 3512-3533).
Goren teaches a topical formulation comprising minoxidil (5 wt%), glycerol (18 wt%; moisturizer), LABRASOL (5 wt%; surfactant), lecithin (1.25 wt%; emulsifier), water (23 wt%; diluent), and optionally SPAN 20 (1 wt%; diluent) [0334-0335]. More broadly, the therapeutic agent can be included in amounts ranging from 0.1-35% by weight [0104]. Goren further teaches that the invention can be used to treat hair loss by further including a penetration enhancer selected from the group comprising surfactants [0048]. The composition may be formulated as a gel [0138].
Goren does not teach the required weight percentages of the excipients. Goren does not teach a co-surfactant.
Osborne teaches that TRANSCUTOL, with superior solubilization power, unique physicochemical properties, and well-established safety profile, is an ideal penetration/permeation enhancer. Addition of up to 50% TRANSCUTOL to a gel formulation resulted in enhanced skin penetration (pg 3529, ¶2).
It would have been prima facie obvious to prepare the composition of Goren and further include a penetration enhancer for a hair loss treatment. The penetration enhancer is not specifically taught and any species would have been suitable such as TRANSCUTOL, as taught by Osborne. The resulting composition useful for the treatment of hair loss would comprise minoxidil (5%) as a functional ingredient for hair loss, water and/or SPAN 20 as a diluent (23%), LABRASOL (5%) as a surfactant, lecithin (1.25%) as an emulsifier, glycerol (18%) as a moisturizer, and a penetration enhancer selected as TRANSCUTOL (up to 50%). It is noted that although the prior art may teach different uses for said agents, a chemical and its properties cannot be separated. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” 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. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)). The skilled artisan would have found it obvious to include TRANSCUTOL as the penetration enhancer in Goren, based on the teachings of Osborne. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).
That being said and in lieu of objective evidence of unexpected results, the amount of each surfactant can be viewed as a variable which achieves the recognized result of successfully providing emulsifying and skin permeating benefits to the topical gel formulation. The optimum or workable range of surfactants can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of surfactants nonobvious.
Claims 1-2 and 7-13 are accordingly rejected as obvious in view of the prior art.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Goren et al. (US 2020/0214958) in view of Osborne et al. (AAPS PharmSciTech, Vol. 19, No. 8, November 2018, pgs 3512-3533) in view of Yang et al. (US 2021/0138011) in view of Chan et al. (Journal of Pharmaceutical and Biomedical Analysis 125 (2016) 400–407) in view of King et al. (US 2012/0156314).
Goren and Osborne, as applied supra, are herein applied in their entirety for the teachings of a hair loss treatment comprising minoxidil (5%) as a functional ingredient for hair loss, water and/or SPAN 20 as a diluent (23%), LABRASOL (5%) as a surfactant, lecithin (1.25%) as an emulsifier, glycerol (18%) as a moisturizer, and a penetration enhancer selected as TRANSCUTOL (up to 50%).
Goren does not teach wherein the functional ingredient for hair loss is brevilin A, arnicololide D, arnicolide C, and/or microhelenin C.
Yang teaches a composition including Centipeda minima extract for the promotion of growth of hair (abstract). The extract is formed with methanol [0109]. The composition can be used topically [0047].
Chan teaches Centipeda minima, also known as Ebushicao, when extracted with ethanol, comprises various components including, but not limited to, brevelin A, arnicolide D, and arnicolide C (pg 400, ¶2; pg 401, Table 2).
King teaches that the ethanolic extract of Centipeda minima, along with arnicolide D and arnicolide C, the extract further comprises microhelenin C [0034-0037].
It would have been prima facie obvious to prepare the composition of Goren and Osborne comprising minoxidil (5%) as a functional ingredient for hair loss, water and/or SPAN 20 as a diluent (23%), LABRASOL (5%) as a surfactant, lecithin (1.25%) as an emulsifier, glycerol (18%) as a moisturizer, and a penetration enhancer selected as TRANSCUTOL (up to 50%). It would have been further obvious to substitute alternative hair loss therapeutic agents in place of the minoxidil, such as the alcohol extract of Centipeda minima of Yang. Chan and King provide evidence that alcohol extracts of Centipeda minima comprise brevelin A, arnicolide D, arnicolide C, and microhelenin C. Although, the art does not provide percentages of each component in the composition, the amount of each component is considered to be an inherent property of Centipeda minima extract using an alcoholic extract such as ethanol or methanol. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” 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. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)). Here, the prior art is teaching the same solvent extraction as the instant claims (as taught by the instant specification) thus the same composition of the extract as claimed can be assumed.
As such, claims 1-13 are rejected in view of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW S ROSENTHAL/ Primary Examiner, Art Unit 1613
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