DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Claims Status
Claims 1-23 are pending and under current examination in this application. Amendments to claims 1, 6, 8, 14, 15, 18, 19, 21 and 22, filed 05 August 2025, are acknowledged and are supported by the originally-filed disclosure.
Information Disclosure Statement
The Information Disclosure Statement (IDS), filed 05 August 2025, has been considered.
Response to Amendment
The following is a response to the Applicant’s Remarks filed with the Amendment dated 05 August 2025. The arguments presented have been fully considered in light of the amendments to the claims.
The new title, "Topical Anesthetic Treatment Solution," is acceptable and therefore, the objection to the title is withdrawn. The Examiner acknowledges the Applicant's agreement that the claims are entitled to a priority date of 01 February 2023. The amendments to claims 8, 14, 19, and 22, specifying "by weight of the total solution," overcome the 35 U.S.C. § 112(b) indefiniteness rejections. Accordingly, these rejections are withdrawn.
Independent claims 1, 6, 18 and 21 have been amended to address the 35 U.S.C. § 102 and § 103 rejections over Tamarkin (US20060193789A1, publication date: 31 August 2006). As such, the rejections are withdrawn. However, new grounds of rejection have been made in further view of Tamarkin and Besonov (US20090130029A1; published 21 May 2009, referred to as “Besonov”) as set forth below. The combination of the prior art provides clear teaching and motivation to suggest the features of the instant claims as obvious.
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 1-6, 8, 9, 11-13, and 15-23 are rejected under 35 U.S.C. § 103 as being unpatentable over Tamarkin (US20060193789A1, publication date: 31 August 2006) in view of Tamarkin and Besonov (US20090130029A1; published 21 May 2009, hereinafter referred to as “Besonov”).
Tamarkin teaches a foamable composition, including about 6-70% by weight of at least one organic carrier (claim 1), wherein the composition is substantially alcohol-free (claim 2) and the organic carrier is selected from the group consisting of a hydrophobic organic carrier, an emollient, a polar solvent, and mixtures thereof (claim 13) and further including the polar solvent dioxolane (claim 14-xii), emollients (claim 14-xi) and essential and plan-derived oils (claim 14- vii and viii) wherein the organic carrier comprises a hydrophobic carrier/emollient and a polar solvent in a ratio of between about 8:1 and 1:4 (claim 15), resulting in an effective w/w% range of dioxolane to that of the total solution as, 0.7-7.9 and 4.8-56, respectively. Further comprising at least one active agent (claim 18), further including a cosmetic active agent (including eucalyptus oil as outlined in paragraph [0110]), antifungal agent or anesthetic (claim 19) and “…vi. antifungal agents selected from the group consisting of an azole, a diazole, a triazole, miconazole, ketoconazole, clotrimazole, econazole, mebendazole, bifonazole, butoconazole, fenticonazole, isoconazole, oxiconazole, sertaconazole, sulconazole, thiabendazole, tiaconazole, fluconazole, itraconazole, ravuconazole and posaconazole; vii. antifungal agents selected from the group consisting of griseofulvin, ciclopirox, amorolfine, terbinafine, Amphotericin B, potassium iodide, flucytosine (5FC) and any combination thereof at a therapeutically effective concentration; … xx. topical anesthetic agents selected from the group consisting of benzocaine, lidocaine, bupivacaine, chlorprocaine, dibucaine, etidocaine, mepivacaine, tetracaine, dyclonine, hexylcaine, procaine, cocaine, ketamine, pramoxine, benzyl alcohol and phenol; …” (claim 20), wherein the composition comprises at least two active agents (claim 21) and wherein each of the at least two active agents exert its therapeutic effect through at different mode of action (claim 22).
Regarding instant claim 8, Tamarkin also teaches, “…the present invention contains a safe an effective concentration of a pharmaceutical or a cosmetic therapeutic agent (collectively termed herein as “active agent”). The active agent is present in an amount to be effective for its intended purpose. The actual amount may vary widely. For example, in some embodiments, only a few weight percent or even a fraction of a weight percent of active agent is sufficient. In other embodiments, e.g., sun screens and insect repellant, the active agent may constitute a significant component of the foamable composition.” (paragraph [0074]), where clotrimazole has been US FDA-approved since 1974 for use at 1% w/w the total composition as indicated for use in the effective treatment of cutaneous fungal infections, thus teaching the limitation of instant claim 8.
Regarding instant claims 18-23, Tamarkin teaches, “For the purpose of the present application, the term “alcohol free” shall mean that the composition contains no more than an incidental amount of an aliphatic alcohol, e.g. less than about 7.5% of any aliphatic alcohol, having one to six carbon atoms in their carbon backbone, or no more than 7.5% of any mixture of such aliphatic alcohols. Alcohols at these low levels are not considered to have a negative effect on skin or mucous membranes. In one or more embodiments, the foamable compositions do not contain any alcohol.” (paragraph [0121]), thus a treatment solution having an alcohol content of below 15 or 14% w/w of the total composition is taught by the prior art.
Thus, Tamarkin teaches the primary limitations of instant claims 1-6, 8, 9, 11-13, and 15-23, however, the disclosure by Tamarkin is focused on emulsion rather than chemical solutions.
Besonov discloses topical compositions comprising a local anesthetic and/or fungicides (e.g., lidocaine, benzocaine, tetracaine, pramoxine, or prilocaine and/or naphthyl thiocarbamate/tolnaftate, miconazole nitrate, or ketoconazole; claim 15) and a carrier fluid and polar solvent selected from a group including dioxolane (claim 2) which is miscible with the oils, oily compounds, triglycerides and alkyl ester of fatty acids carrier fluids specified in claim 2, which may further comprise an emollient and essential oils (e.g., peppermint oil and eucalyptus oil) (claim 2). While Besonov focuses on glycerol ether vehicles (i.e., glyceryl ethers as co-solvents), it teaches providing secondary solvents or carriers or mixtures thereof to facilitate active agent delivery (e.g., dioxolane; ¶[0010]).
Besonov also teaches the use of antifungal agents at an exemplary concentration of 1% (i.e., ciclopirox, clotrimazole, and terbinafine HCL; Table 2, ¶[0395]) and wherein embodiments are substantially alcohol-free, defined as <5% final concentration (¶[0204]). Most notably, Besonov teaches that the composition can be in the form of a single-phase formulation/solution, homogenous suspension (claim 22; ¶[0360]), or alternatively as a stable emulsion (claim 23). This teaching suggests that the choice of formulating such compositions as a chemical solution, homogenous suspension or emulsion is flexible.
Besonov does not explicitly disclose the concentration of solvent, only non-limiting examples such as, “…Metronidazole: Practically insoluble in mineral oil (<0.01%); soluble more than 1% in dimethyl isosorbide; Ketoconazole: Practically insoluble in mineral oil (<0.01%); soluble more than 1% in glycofurol, propylene glycol and dimethyl isosorbide…” (¶[0240]; wherein dimethyl isosorbide, propylene glycol, and “other glycols” are suitable polar solvents listed as acceptable for use along with dioxolane (¶[0059])), however dioxolane 2-4% total solution weight, as in the limitation of instant claim 14, is consistent with the examples in Besonov indicating the use of >1% polar solvent.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date, having the combine teachings of Tamarkin and Besonov, to modify the formulation of Tamarkin to a chemical solution rather than an emulsion, given that Besonov teaches similar compositions known for the same purpose, that maybe be formulated as solutions or alternatively as emulsions. Since the choice of composition mixture phases has been indicated to be flexible by Besonov, there is reasonable expectation of success in making the change.
The skilled artisan would recognize from the solvency properties and aqueous miscibility of dioxolane and the from teachings of Besonov (i.e., “Polar solvents, such as detailed below [including dioxolane], possess high solubilizing capacity and contribute to the skin penetration of an active agent.” (¶[0235]), and “…“penetration enhancer,” [including dioxolane] is an organic solvent, typically soluble in both water and oil.” (¶[0236])) that higher concentrations (i.e., 2-4%) of dioxolane (>1% as exemplified for antifungals practically insoluble in mineral oil in ¶[0240]) could be used to co-dissolve/solubilize active ingredients in a single-phase chemical solution that could be substituted for the co-suspension emulsions taught by Tamarkin to improve thermodynamic stability, predictable performance, and formulation simplicity or to create more consumer desirable (e.g., transparent uniform appearance)/convenient application formats (e.g., offers more compatibility than multiphase systems). The selection of such known alternative mixture phase distributions to that of Tamarkin for similar compositions (as disclosed by Besonov) is a mere optimization expected in the art to improve stability, reduce undesirable alcohol content while retaining solubility and delivery of the active ingredients. A miscible solvent would be an obvious choice. Employing the same non-alcoholic solvent (e.g. dioxolane) for the topical antifungal active agent as the topical anesthetic active agent is an obvious extension.
Further, the prior art disclosures contemplate multiple active ingredients, including topical anesthetics and antifungals, and a skilled artisan would regard it as straightforward to select from and co-formulate well-known topical anesthetics with another active, such as well-known antifungals, in the same vehicle for convenience of formulation, especially when the physicochemical compatibilities permit. The combination of an antifungal agent with a topical anesthetic is considered to be a mere aggregation of known compounds for their known purposes, which does not yield an unexpected result. A person of ordinary skill, treating a condition involving both pain and a fungal infection (e.g., athlete's foot), would have found it obvious to combine a known antifungal agent with a known topical anesthetic formulation to treat both symptoms simultaneously.
Formulations being essentially free of alcohol, below a concentration of 14%, are taught in the prior art and other concentration ranges are within the predictable property-optimization realm in view of the broad disclosure of adjusting component proportions in prior art disclosures. It would have been obvious to one of ordinary skill to reduce or eliminate the alcohol content in the compositions in view of the teaching by Tamarkin that alcohol can cause skin irritation and that non-alcoholic formulations are desirable (¶[0026]). Determining the specific, low levels of alcohol (e.g., 15 wt% or below) would have been a matter of routine experimental optimization for a formulator based on the desired properties of the final product (e.g., to achieve a desired evaporation rate, feel, or solvent property).
The addition of emollients, essential oils (e.g., peppermint or eucalyptus), and additives (e.g., stabilizers, surfactants, excipients) are disclosed in the prior art and are mere conventional modifications that do not render the claim nonobvious.
Claims 6, 7, 10 and 14 are rejected under 35 U.S.C. § 103 as being unpatentable over Tamarkin (US20060193789A1, publication date: 31 August 2006) in view of Tamarkin and Besonov (US20090130029A1; published 21 May 2009, hereinafter referred to as “Besonov”), and in further view of Zhang et al. (US20070190124A1; publication date: 16 August 2007, hereinafter referred to as “Zhang”).
Tamarkin and Besonov teachs all the limitations of the instant claim 6, from which instant claims 7, 10 and 14 depend, as outlined above, however Tamarkin does not explicitly teach the use of naphthyl thiocarbamate antifungal tolnaftate nor use at 1% w/w of the total composition.
Zhang teaches compositions for dermal delivery that including more than one pharmaceutically active agents, a solvent vehicle and solidifying agent carriers (claims 1 and 17), wherein at least one of the drugs is selected from the member group including lidocaine (claim 18) and tolnaftate (claim 19) and wherein the non-volatile solvent system includes at least one member selected from the group consisting of alkyl dioxolanes (claim 13). Further, tolnaftate has been US FDA-approved since 1965 for use at 1% w/w of the total composition, as indicated for use in the effective treatment of cutaneous tinea infections.
Tamarkin discloses a broad, alcohol-free topical formulation that can contain various antifungal agents and Besonov teaches similar formulations in the form of chemical solutions as an alternative to compositions formulated as emulsions. Zhang specifically teaches the use of the antifungal agent tolnaftate, a naphthyl thiocarbamate compound, in dermal delivered [topical or transdermal (see ¶[0019])] compositions (claim 19 and ¶ [0085]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to substitute the naphthyl thiocarbamate antifungal tolnaftate, taught by Zhang at the FDA-approved concentration of 1% w/w of the total composition, for the antifungals, miconazole, ketoconazole, clotrimazole and terbinafine explicitly claimed by Tamarkin with a reasonable expectation of success in using tolnaftate as an alternative because it is known for the same purpose. This is a simple substitution of one known antifungal for another known antifungal in a known type of formulation. A person of ordinary skill in the art, seeking to provide another effective antifungal agent, such as the well-known antifungal tolnaftate as taught by Zhang, within the alcohol-free formulation taught by Tamarkin would be motivated to substitute the antifungals taught by Tamarkin with tolnaftate.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L. SCOTLAND whose telephone number is (571) 272-2979. The examiner can normally be reached M-F 9:00 am to 5:00 pm EST.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615