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 .
Claim status
Claims 1-20 filed 11/21/2024 are pending in the application and are hereby examined on the merits.
Claim Objections
Claim 19 is objected to because of the following informalities: the dash sign before “based” should be removed. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 1, 3- 9, 11, 14-16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakamura JP 2008079505 A1 (cited in the IDS filed 11/21/2024, English translation relied upon for reference, hereinafter referred to as Nakamura).
Regarding claims 1, 3- 9, 11, 14-15 and 18, Nakamura teaches an emulsion comprising 1-6% a surfactant system comprising a polyglycerol ester of fatty acids (PGE) (Abstract and 0009, e.g., a mixture of decaglycerol oleate and decaglycerol stearate at a weight ratio of 2:1 to 1:2 thus reading on claim 1 limitation that the emulsion is free of a polyoxyethylene sorbitan fatty acid ester, and claim 3 limitation that the surfactant system consists of PGE), 1-10% a non-polar phase comprising a flavor oil (e.g., lemon/lime/orange/grapefruit essential oils, flower essential oils, plant essential oils, etc. 0020; 0046), a polar phase that comprises water and a polar non-aqueous solvent (e.g., polyhydric alcohol such as glycerol) wherein water accounts for 10-20% of the emulsion and the polyhydric alcohol accounts for 64-88% of the emulsion (0028-0029). Further, Nakamura teaches that the average emulsion particle size is 200 nm (e.g., 0.2 µm, 0029) or less thus reading on the limitation about nanoemulsion. Decaglycerol oleate is decaglycerol monooleate. Further, both decaglycerol oleate and decaglycerol stearate are known to have an HLB value of ~12.
Further, Nakamura teaches an alcoholic beverage comprising the emulsion (0034; 0048). For example, a syrup that contains vodka, 15.2 g citric acid and 4.4 g sodium citrate per 1000 ml of syrup (0048), which is necessarily acidic.
Regarding claim 16, Nakamura teaches a beverage which is a syrup that contains vodka, 15.2 g citric acid and 4.4 g sodium citrate per 1000 ml of syrup (0048). Such a beverage has a pH of ~2.5 (calculation: pKa1 of citric acid is 3.13, MW of citric acid is 192 g/mol, and MW of sodium citrate is 258 g/mol, thus the mole of citric acid 15.2 g/192 g/mol = 0.0791 mol and the mole of sodium citrate is 4.4 g/ 258 g/mol =0.0171 mol; then, pH = pKa1 + log (conjugate base/acid) = 3.13 + log (0.0171/0.0791) = ~2.5).
Claims 1, 3-9, 11, 14-16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gledovic “Polyglycerol Ester-Based Low Energy Nanoemulsions with Red Raspberry Seed Oil and Fruit Extracts: Formulation Development toward Effective In Vitro/In Vivo Bioperformance”, Nanomaterials 2021, 11, 217, pages 1-22 (cited in the IDS filed 11/21/2024, hereinafter referred to as Gledovic).
Regarding claims 1-4, 6-13, 17 and 19-20, Gledovic teaches a nanoemulsion comprising a surfactant system comprising a PGE (page 3, 2.1, e.g., a mixture of polyglyceryl-4 laurate, polyglyceryl-6 caprylate, polyglyceryl-3 cocoate, polyglyceryl-4 caprate, and polyglyceryl-6 ricinoleate, thus reading on claim 1 limitation that the emulsion is free of a polyoxyethylene sorbitan fatty acid ester, and claim 3 limitation that the surfactant system consists of a PGE), a non-polar phase comprising ethylhexyl pelargonate and a flavor oil (e.g., red raspberry seed oil; page 3, 2.1), a polar phase that comprises water and a polar non-aqueous solvent (e.g., glycerin, which is glycerol, see page 8, 3.1.2) (Abstract; page 3, 2.1 and 2.2.1). Gledovic teaches that the nanoemulsion comprises 10% PGE (page 8, 3.1.2), 2% red raspberry seed oil (page 8, 3.1.2), 80% water phase 30% of which is glycerin (page 8, 3.1.2, thus the amount of glycerin by weight of the nanoemulsion is 80% x 30% = 24%. Gledovic teaches that Z-average value is 50-70 nm (Abstract; Table 2). A laurate has 12 carbon and a ricinoleate has 18 carbon thus reading on claim 4. Further, each of polyglyceryl-4 laurate, polyglyceryl-6 caprylate, polyglyceryl-3 cocoate, polyglyceryl-4 caprate, and polyglyceryl-6 ricinoleate is known to have an HLB value that is less than 16. Further, the ratio of glycerol to polyglycerol ester of fatty acid is 24%/10% =2.4 thus reading on claims 13 and 20.
Claims 1, 3-7, 9-10 and 14-16, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chanamai US Patent Application Publication No. 2007/0087104 A1 (hereinafter referred to as Chanamai).
Regarding claims 1, 3, 6, 9 and 14-16, Chanamai teaches a nanoemulsion (Abstract; 0004) comprising a surfactant system comprising a PGE (0049; 0025-0029, an emulsifier system comprising an low HLB surfactant the HLB value of which is 1-5, a medium HLB surfactant the HLB value of which is 6-8, and a high HLB surfactant the HLB value of which is 9-17), a non-polar phase comprising a flavor oil (for example, lemon oil, 0048; 0065), a polar phase that comprises water (0027) (0025-0029; 0049; 0050). Chanamai further teaches a beverage comprising the nanoemulsion (0025), for example, a beverage that comprises 1% citric acid (Example 9), which necessarily has a pH that is less than 4.
Further, Chanamai includes the embodiment teaching that each of the low, medium and high HLB surfactants is a PGE (0049), thus reading on the claim 1 limitation that the nanoemulsion is free of a polyoxyethylene sorbitan fatty acid ester, and claim 3 limitation that the surfactant system consists of a PGE.
Regarding claims 4-5, Chanamai teaches decaglycerol decaoleate, decaglycerol hexaoleate, triglycerol monooleate, polyglycerol-6 laurate, triglyceryl monostearate, decaglycerol !auric acid esters, decaglycerol oleic acid esters, etc. (0049; 0061).
Regarding claim 7, Chanamai teaches that the amount of high HLB surfactant is 12-18% by weight of the nanoemulsion, and high HLB surfactant can be polyglycerol-6 laurate, decaglycerol lauric acid esters, decaglycerol oleic acid esters, etc. (0049).
Regarding claim 10, Chanamai teaches that the nanoemulsion comprises 70-85% aqueous phase, which comprises water and water-soluble ingredients such as colorant, flavors, vitamins, salts or antioxidants (0050; 0042). For example, Examples 1-3 of Chanamai teaches a water content of 79%, 77% and 71%. Further, judging from Example 1 to Example 3 of Chanamai, the water-soluble ingredients do not account for a large proportion of the water phase, therefore, claim 10 is met by Chanamai.
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.
Claims 2, 10, 12, 13, 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura as applied to claims 1, 7 and 11 above.
Regarding claim 2, Nakamura teaches that the average emulsion particle size is 200 nm (e.g., 0.2 µm, 0029) or less. Given that Z-average value measures the mean droplet size, it logically follows that the Z-average value of the particles of Nakamura encompasses the range as recited in claim 2. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Regarding claim 10, Nakamura as recited above teaches that the emulsion comprises 10-20% water (0029), which overlaps with the range as recited in claim 10. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Regarding claim 12, Nakamura as recited above teaches that the emulsion comprises 64-88% a polyhydric alcohol such as glycerol (0028-0029). Such an amount overlaps with the range as recited in claim 12. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Regarding claims 13 and 20, Nakamura as recited above teaches that that the emulsion comprises 64-88% a polyhydric alcohol such as glycerol (0028-0029), and 1-6% a mixture of decaglycerol oleate and decaglycerol stearate at a weight ratio of 2:1 to 1:2 (Abstract, 0029; 0009), thus the ratio of the former to the latter is 88/1- 64/6 which is 88-10.67. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Further the lower bound of the ratio 10.67 as disclosed by Nakamura is very close to the upper bound 10:1 as recited in claim 20 that one skilled in the art would have expected them to have the same properties, given that both claimed invention and prior art are directed to a nanoemulsion that comprises polyglycerol ester of fatty acid and glycerol. It has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (MPEP 2144.05).
Regarding claim 17, Nakamura as recited above teaches that that the emulsion comprises 1-6% a mixture of decaglycerol oleate and decaglycerol stearate (abstract, 0029). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Claims 2, 8 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Chanamai as applied to claims 1 and 7 above.
Regarding claim 2, Given that Z-average value measures the mean droplet size, and that Chanamai teaches that the oil phase has a particle size mean diameter of 1-200 nm (0050), it logically follows that the Z-average value of the oil particles of Chanamai encompasses the range as recited in claim 2. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Regarding claims 8 and 18, Chanamai teaches that the nanoemulsion comprises 1-15% oil phase, and that the oil phase includes oil, water-insoluble components and low HLB surfactant (0050). Additionally, Chanamai teaches that the nanoemulsion comprises 0.7-1% low HLB surfactant (0049), and that a flavor oil alone (for example, lemon oil) comprises the water insoluble component (0048; 0065). As such, Chanamai teaches a flavor oil content that overlaps with the range as recited in claims 8 and 18. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Regarding claim 17, Chanamai teaches that the amount of high HLB surfactant is 12-18% by weight of the nanoemulsion, and high HLB surfactant can be polyglycerol-6 laurate, decaglycerol lauric acid esters, decaglycerol oleic acid esters, etc. (0049). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Conclusion
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/CHANGQING LI/Primary Examiner, Art Unit 1791
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