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 .
DETAILED ACTION
The office acknowledges Applicants filing of the claims on 11/27/2023. Claims 1-10 are pending and are examined based on the merits herein.
Application Priority
This application filed 11/27/2023 is a National Stage entry of PCT/US2022/ 036018, International Filing Date: 07/01/2022, PCT/US2022/036018 Claims Priority from Provisional Application 63218153 , filed 07/02/2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 11/27/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
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 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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Vander Jagat (IDS: US 2015/0011494 A1) in view of Wehner et al. (IDS: WO 2007/095255).
As to claim 1, Vander Jagat discloses a pharmaceutical composition comprising the curcumin derivative [0052]) suitable for topical application. The topical formulations include the active agent dissolved or suspended in mineral oil [0223], comprising a curcuminoid compound of Formula 1 (formula 3 in table 1 on page 14), in which one carbonyl group exists as enol tautomer diketone shown in figure 36, i.e., the diketone of formula of the instant application; figure 36, [0176], [0204] as an active pharmaceutical ingredient API in a range of from 0.001 percent w/w to 0.2 percent w/w (compositions contains at least about 0.1 wt %of the active agent; paragraph [0222]; and in an oil solvent system, the active agent dissolved or suspended in mineral oil [0223], wherein percent w/w is compared to the overall weight of the pharmaceutical composition.
Vander Jagat does not disclose the amount of oil is at least 8 % w/w.
Wehner discloses oil in an amount of at least 8 % w/w, the compositions are suitable for topical application and comprise 0.1-20 percent by weight of emollient oils imparting a soothing effect to the skin [00130], [00146], [00162].
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the invention, to have modified the composition, as previously disclosed by Vander Jagat, in order to have provided for oil in an amount of at least 8 % w/w as disclosed by Wehner to provide the topical composition with the soothing effect on the skin. Further, provided that Vander Jagat and Wehner both disclose the topical compositions with antioxidant activity (Vander Jagat [0223], [0358]-[0359], Wehner, [00130], [00141], [00146], [00162].
As to claim 2, Vander Jagat and Wehner in combination disclose the pharmaceutical composition of claim 1, and Vander Jagat further discloses that the composition comprises a surfactant system, solutions of the active agent can be prepared in water with a nontoxic surfactant [0221], and fatty acid (formulations comprise hydrogenated fatty carboxylic acids) [0223] and oil solvent system (topical formulations are suspended in mineral oil [0223].
Vander Jagat do not disclose a surfactant system in a range of from 1.6- to 16 % w/w, said surfactant system comprising a non-ionic surfactant and a fatty acid, wherein the of solvent system is in a range of from 8-32 % w/w, said oil solvent system comprising isopropyl myristate, benzyl alcohol, diethylene glycol monoethyl ether, and dimethicone.
Wehner discloses the surfactant system In a range of from 1.6 percent w/w to 16 percent w/w, personal care compositions comprise the surfactant in 5 to 50 wt.% of the composition [0076], [00282], said surfactant system comprising a non-ionic surfactant [0076], [00280] and a fatty acid (emollients include saturated and unsaturated fatty acids obtained by hydrolysis of animal or vegetable fats and oils) [00146], [00152], wherein the oil solvent system is in 8 range of from 6-32 % w/w (the compositions are suitable for topical application and comprise 0.1-20 percent by weight of emollient oils imparting a soothing effect to the skin) [00130], [00146], [00162], said oil solvent system comprising isopropyl myristate (active therapeutic ingredients benefit by addition of isopropyl myristate that acts as both structurant and sensory modifier) [00128], the composition can comprise 0.4 percent of benzyl alcohol; [00557], [00660], humectants include diethylene glycol monoethyl ether [00284] and emollients include dimethicone as a preferred compound [00146], [00159], [00182].
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention, to have modified the composition, as previously disclosed by Vander Jagat, in order to have provided for the surfactant system in a range of from 1.6 to 16 % w/w, said surfactant system comprising non-ionic surfactant and a fatty acid, wherein the oil solvent system is in a range of from 8-32 % w/w, said oil solvent system comprising isopropyl myristate, benzyl alcohol, diethylene glycol monoethyl ether, and dimethicone to provide the topical composition with the soothing effect on the skin.
As to claim 3, Vander Jagat and Wehner, in combination, disclose the pharmaceutical composition of claim 2, and Vander Jagat further discloses polyethylene glycol [0224]. Vander Jagat does not disclose wherein the non-ionic surfactant is polyoxyethylene alkyl ether. However, Wehner discloses wherein the non-ionic surfactant is polyoxyethylene alkyl other (polyoxyethylene lauryl ether, is, the ether of polyoxyethylene and lauryl alcohol), [00370]. It would have been obvious to a person of ordinary skill in the art, at the time of the Invention, to have modified the composition, as previously disclosed by Vander Jagat, by adding the non-ionic surfactant polyoxyethylene alkyl ether, with a reasonable amount of success and to provide the topical composition with the soothing effect on the skin.
As to claim 4, Vander Jagat and Wehner, in combination, disclose the pharmaceutical composition of claim 2. Vander Jagat do not disclose wherein the dimethicone la in an amount less than 3.5 % w/w. Wehner discloses wherein the dimethicone is in an amount less than 3.5 percent w/w (table on page 90 of example 1, the emulsion comprises 1 wt % dimethicone). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to have added dimethicone (1%) in the composition with a reasonable amount of success and arrive at the claimed topical composition.
As to claim 5, Vander Jagat and Wehner, in combination, disclose the pharmaceutical composition of claim 4, and Vander Jagat further discloses wherein the oil solvent system comprises mineral oil and API have a solvent-to-API ratio of more than 82:1 (compositions contain at least about 0.1 wt-percent of the active agent, i.e., the ratio of 99.9 to 0.1; further, 15 uM solution of curcumin analog 3i having MW 396 in DMSO, i.e., the oily substance, was used, 0.006 w/w% solution in DMSO, i.e., the ratio of solvent to the curcumin analog more than 82:1; paragraphs [0176], [8222], [0396]).
As to claim 6, Vander Jagat does not disclose wherein the all solvent system and the dimethicone have a solvent-to-dimethicone ratio of more than 2.3:1. However, Wehner discloses wherein the oil solvent system and the dimethicone have a solvent-to-dimethicone ratio of more than 2.3:1 (in formulation on page 90, phase B of the formulation comprises 2.5 wt % of stearic acid, 0.5 wt % of Cetearyl Alcohol, 2.5 wt % of Lipomulse 165 (S glyceryl Monostearate) and 1 wt % of dimethicone, i.e., where the ratio of solvent system to dimethicone that is also a part of the oil solvent system, as disclosed in the preceding claim 2, is 0.5 to 1 that is more than 2.3 to 1 [00499], [00563]). It would have been obvious to a person of ordinary skill in the art. at the time of the invention, to have modified the composition, as previously disclosed by Vander Jagat, in order to have provided for wherein the oil solvent system and the dimethicone have a solvent-to-dimethicone ratio of more than 2.3:1, as previously disclosed by Wehner.
As to claim 7, Vander Jagat does not disclose wherein the surfactant system is in an amount less than 16 % w/w. However, Wehner discloses wherein the surfactant system is in an amount less than 16 % w/w (personal care compositions comprise the surfactant in 5 to 50 wt. percent of the composition; paragraphs [0076],(00282)]. It would have been obvious to a person of ordinary skill in the art, at the time of the invention to have modified the composition, as previously disclosed by Vander Jagat, in order to have provided for wherein the surfactant system is in an amount loss than 16 % w/w, to arrive at the topical composition with the soothing effect on the skin.
As to claim 8, Vander Jagat do not disclose wherein the fatty acid is in an amount less than 6.5 percent w/w. However, Wehner discloses wherein the fatty acid is in an amount less than 6.5 percent w/w (as shown in the table on page 90 of example 1, the emulsion comprises 2.5 wt % of stearic acid) [00499]. It would have been obvious to a person of ordinary skill in the art at the time of the invention to have modified the composition with the fatty acid in an amount less than 6.5 % w/w, to arrive at the topical composition with a reasonable amount of success.
As to claim 9, Vander Jagat do not disclose wherein the non-ionic surfactant is in an amount of less than 9.5 % w/w. However, Wehner discloses wherein the non-ionic surfactant is in an amount of less than 9.5 % w/w (the composition in example 5 comprises 8 wt % of PEG 7-glycery-cocoate that is the nonionic surfactant polyoxyalkylene glycerin fatty acid ester [00280], [00509]). It would have been obvious to a person of ordinary skill in the art, at the time of the invention, to have modified the composition, with the non-ionic surfactant amount as in the instant claims to arrive at the topical composition with a reasonable amount of success.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Vander Jagat (US 2015/0011494 A1) in view of Wehner et al. (WO 2007/095255) and further in view of Davidson et al. (IDS: US 2021/0186931 A1).
As to 10, Vander Jagat and Wehner in combination, disclose the pharmaceutical composition of claim 2.
The prior art do not teach the amount of the diethylene glycol monoethyl ether is less than 9 % w/w.
Azora teachings are to topical compositions comprising active agents that can include curcumin [0104] and solvents such as diethylene glycol monoethyl ether, isopropyl myristate, glycerol etc. [0011], [0158], [0166] in an amount of 2.5-50 wt% of the solvent.
A person skilled in the art before the effective filing date of the invention would have found it obvious to add the solvent diethylene glycol monoethyl ether (2.5-50%) in a formulation comprising curcuminoid analog compound of instant claims from Azora. A person skilled in the art would have been motivated to do is arrive at the topical composition comprising the active agent and the solvent (specific wt%) with a reasonable amount of success.
Claim(s) 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Alleyne et al. (IDS: US 20150087705 A1) in view of Garti et al. (WO 2020255114).
Alleyne et al. teach curcumin analog compounds of formula I, its composition for topical administration and its use in treating disorders (See [0011-0012]).
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[0060].
Alleyne further teach the formulations for topical administration include ointments, lotions, creams, gels, drops, sprays, liquids etc. [0073]. Alleyne teach the composition in general can include surface active agents [0064].
Alleyne do not teach the oil based surfactant system comprising the curcumin analog of the compound as in instant claim 1.
Garti disclose drug delivery system comprising a soft polymeric film and a plurality of nanodomains embedded within the film (claim 1), wherein the film, comprises a permeation agent selected from: diethylene glycol monoethyl ether (Transcutol®) oleic acid, oleyl alcohol, benzyl alcohol and any combination thereof (claim 32, p 8, lines 16-20); at least one oil selected from isopropyl myristate, benzyl alcohol, castor oil, oleic acid (claim 28, p 8, lines 7-9) and at least one solvent selected from isopropyl myristate and dimethicone (claim 27). The active pharmaceutical agent in the system include a nutraceutical, curcumin, e.g. 0.024% (See p 26, line 5, example C.14). According to some embodiments, the nanodomains comprise about 0.1%-30% w/w of API, about 0.1%-25% w/w of API, or about 2%-20% w/w of API or any other range within the range of 0.5%-30% API (See p 27, lines 3-5). The surfactants in the composition can be non-ionic (p 19, para 4, line 6) and hydrophilic surfactant include polyoxyethylene sorbitan monolaurate, polyoxyethylene sorbitan monopalmitate, polyoxyethylene sorbitan monooleate, polyoxyethylene sorbitan monostearate, a polyoxyethylene ester of saturated or unsaturated castor oil etc. (p 21, last para).
From Garti and Alleyne a person skilled in the art would have found it obvious to arrive at the claimed pharmaceutical composition comprising the curcumin analog compound (0.02%) as in the instant claim 1 and oil solvent system comprising isopropyl myristate, benzyl alcohol, diethylene glycol monoethyl ether and dimethicone and a surfactant system comprising a non-ionic surfactant. As to the amount of the solvent system it is within the skill of an artisan to arrive at the claimed weight percent amounts and it is routine. A person skilled in the art would have been motivated to arrive at the claimed composition with a reasonable expectation of success and to use the same to derive therapeutic benefits. Thus claims 1-2 are addressed. As to claim 3, Garti teach that polyoxyethylene fatty acid esters can be added to the composition. As to claims 4-10, the amounts of the agents in the composition is not explicitly taught by the above prior art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, it would have been obvious to one of ordinary skill in the art to arrive at the claimed amounts by routine experimentation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
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/Umamaheswari Ramachandran/Primary Examiner, Art Unit 1627
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