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 .
Claims 1-3 and 9-16 are pending and under examination.
Priority
Acknowledge is made that this application is international stage of international patent application PCT/JP2023/014667, filed on 04/11/2023; which claims priority from Japan Patent Application JP2022064910, filed on 04/11/2022.
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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/14/2024 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 of this title, 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 9-16 are rejected under 35 U.S.C. 103 as being unpatentable over Andreux et al. (US20180243261).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Andreux et al. teaches compositions comprising a medium chain triglyceride and a urolithin. The invention also provides uses and methods associated with, or making use of the compositions, such as a medicament, dietary supplement, functional food or medical food and in the treatment and/or prophylaxis of a muscle-related pathological condition (abstract). The urolithin typically makes up from 0.1 to 80% w/w of the composition of the invention, for example, 0.3-3% w/w of the composition ([0024]). Urolithins are metabolites produced by the action of mammalian, including human, gut microbiota on ellagitannins and ellagic acid. Urolithins includes Urolithin A. B. C. D. E, M-5, M-6, M-7 and isourolithin A, B ([0032-0033]). Preferably, urolithin for use in compositions of the invention is micronized. Micronization enables the urolithin to disperse or dissolve more rapidly. If micronized urolithin is used, then preferably, the urolithin has a D50 size of under 100 μm—that is to say that 50% of the urolithin by mass has a particle diameter size of under 100 μm, for example 1.0 to 10 μm, for example 1.5 to 7.5 μm, for example 2.8 to 5.5 μm ([0035]). Lecithin, when present in compositions of the invention, typically makes up at least 0.5% w/w of the composition of the invention, preferably at least 1% w/w of the composition of the invention. The lecithin preferably makes up 10% w/w or more of the composition. ‘Lecithin’ designates any group of fatty substances occurring in animal and plant tissues including phosphoric acid, choline, fatty acids, glycerol, glycolipids, triglycerides, and phospholipids ([0038-0039]). Liquid compositions may be in the form of a medicine, a dietary supplement, or a beverage, each for oral consumption. Liquid formulations may be solutions, emulsions, slurries or other semi-liquids. Excipients in a liquid composition can, for example, provide a shelf-life, visual appearance, flavour and mouthfeel such that the composition has an acceptable taste, an attractive appearance and good storage stability. At certain levels of dilution, a drink may need to be shaken before the subject drinks it, so as to maintain an even suspension of the active ingredient ([0048]). In some exemplary embodiments, the compositions of the present invention may comprise, in addition to medium-chain triglycerides and urolithin, one or more additional macronutrients, typically fat or carbohydrate, or fat and carbohydrate. Non-limiting examples of suitable carbohydrates or sources thereof for use in the compositions described herein may include maltodextrin, hydrolyzed or modified starch or cornstarch, glucose polymers, corn syrup, corn syrup solids, rice-derived carbohydrates, glucose, fructose, lactose, high fructose corn syrup, tapioca dextrin, isomaltulose, sucromalt, maltitol powder, glycerin, fructooligosaccharides, soy fiber, corn fiber, guar gum, konjac flour, polydextrose, honey, sugar alcohols (e.g., maltitol, erythritol, sorbitol), and combinations thereof ([0055, 0057]). Suitable emulsifiers, stabilisers, colorants, preservatives, gums, setting agents and thickeners are well known in the art of manufacture of emulsions and other semi-liquids. Emulsifiers may include one or more of phosphatidylcholine, lecithin, polysorbates such as polysorbate 60 or polysorbate 80 (Tween-60 and Tween-80), and glycerol monostearate (GMS) ([0060]). Further compositions of the invention may comprise urolithin, medium-chain triglycerides, an emulsifier such as lecithin and/or Tween (polysorbate), and a stabiliser such as GMS. For example, the composition of the invention may contain 25-75% w/w medium-chain triglycerides, 20-50% w/w urolithin, 0.5-50% w/w lecithin, 0.5-5% w/w GMS and 1-10% w/w Tween-60, for example, 60-75% w/w medium-chain triglycerides, 25-40% w/w urolithin, 0.5-5% w/w lecithin, 0.5-3% w/w GMS and 1-5% w/w Tween-60 ([0073]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Andreux et al. is that Andreux et al. do not expressly all ingredients and their range in one embodiment.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce the instant invention.
Regarding claims 9-13, Andreux et al. teaches a liquid composition in the form of emulsion or slurry comprising urolithin at 0.1-80%; polysorbate 60 or polysorbate 80 at 1-10%; Lecithin such as glycerol and macronutrients such as glycerin. The limitation of polyhydric alcohol is met by glycerol (glycerin). When the amount of urolithin is 0.2% and polysorbate 60 or polysorbate 80 (HLB 15 according to applicant’s specification [0047]; meets the limitation of HLB 12 or greater) is 10%, the ratio is 50 parts of emulsifier and 1 part of urolithin.
Andreux et al. is silent about transmittance of 40% or greater, since Andreux et al. teaches particle size of urolithin with 1.0 to 10 μm, and greater transmittance (for example transparent) is desirable or at least visible desirable, one artisan in the art would have been motivated to optimize the emulsion parament such as particle size to achieve transmittance of 40% or greater through routing experimentation. MPEP 2144.05. Especially in the absence of showing criticality of claimed range.
Regarding claims 9-13, Andreux et al. teaches functional food or medical food.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Andreux et al. (US20180243261), as applied for the above 103 rejection for claims 9-16, in view of Chevalier et al. (FR2893505, Google translation).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Andreux et al. teaching has already been discussed in the above 103 rejection and is incorporated herein by reference.
Chevalier et al. teaches an aqueous dispersion of ellagic acid or its salts or its esters comprising a nonionic surfactant chosen from copolymers consisting of polyethylene glycol and polypropylene glycol blocks. The invention also relates to a cosmetic or dermmatological composition comprising such a dispersion aqueous and a cosmetic process for treating the skin, especially for depigmenting the skin (abstract). The preparation of emulsion comprising ellagic acid includes mixing all ingredients and heating at 70-80ºC (page 4, examples 17-18).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Andreux et al. is that Andreux et al. do not expressly teach heating 120ºC for 1 min. This deficiency in Andreux et al. is cured by the teachings of Chevalier et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Andreux et al., as suggested by Chevalier et al., and produce the instant invention.
Andreux et al. teaches a liquid composition in the form of emulsion or slurry comprising urolithin at 0.1-80%; polysorbate 60 or polysorbate 80 at 1-10%; Lecithin such as glycerol and macronutrients such as glycerin. The limitation of polyhydric alcohol is met by glycerol (glycerin). When the amount of urolithin is 0.2% and polysorbate 60 or polysorbate 80 (HLB 15 according to applicant’s specification [0047]; meets the limitation of HLB 12 or greater) is 10%, the ratio is 50 parts of emulsifier and 1 part of urolithin.
Andreux et al. is silent about transmittance of 40% or greater, since Andreux et al. teaches particle size of urolithin with 1.0 to 10 μm, and greater transmittance (for example transparent) is desirable or at least visible desirable, one artisan in the art would have been motivated to optimize the emulsion parament such as particle size to achieve transmittance of 40% or greater through routing experimentation. MPEP 2144.05. Especially in the absence of showing criticality of claimed range.
Regarding claims 1-3, in order to prepare emulsion, it is obvious to mix all ingredients, and Andreux et al. is silent about heating 120ºC for 1 min
One of ordinary skill in the art would have been motivated to heat all ingredients in a solution because this is known process to prepare emulsion comprising poor aqueous soluble active ellagic acid, it is obvious for one of ordinary skill in the art to prepare emulsion comprising urolithin (known poor aqueous soluble active) by heating and produce instant claimed invention with reasonable expectation of success.
Regarding 120ºC for 1 min, it is with skill of one artisan in the art to optimize the temperature and duration to prepare desired emulsion product through routing experimentation. MPEP 2144.05. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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) .
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
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