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 1-2, 4-12, 16-19, and 21-22 are currently pending in the application. Claims 3, 10, 13-15, and 20 are cancelled. Claims 18-19 and 21-22 are withdrawn from consideration.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 5, 9, 11, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Helgason et al. (herein referred to as Helgason, US 20140023712 A1) in view of Schlegel et al. (herein referred to as Schlegel, US 20100120713 A1), Ando (JP 6231282 B2), and Sweedman et al. (herein referred to as Sweedman, “Structure and physiochemical properties of octenyl succinic anhydride modified starches: A Review”).
With regard to Claim 1, Helgason teaches an oil-in-water emulsion (abstract). The emulsion comprises a plurality of oil droplets as an oil phase ([0014]), an aqueous phase ([0108] Helgason reads such that the modified starch is dissolved in water thus creating an aqueous phase), an emulsifier ([0091]), and a functional ingredient system ([0055], [0096]). Helgason teaches the oil phase is present at a level of 1-30% ([0100], Claim 12), the emulsifier system is present at a level of 0.7%-70%, preferably 1-60%, more preferably 10-50%, especially 20-40% ([0095]).
Helgason teaches in one embodiment 95% of the oil droplets are between 0 and 200nm. See MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions and MPEP 2144.04I(IV)(A) Changes in Size/ Proportion.
Helgason teaches utilizing extracts from fruit (such as apples and pears) in the oil-in-water emulsion ([0063]) but is silent to a non-steviol based taste modulator compound being from the group listed.
Ando teaches an oil and fat composition for bakery foods ([0001]). Ando teaches by adding a sugar and/or a sweetener to the oil and fat composition for bakery foods, the bakery foods having an even better sweetness expression can be produced ([0029]). Ando teaches examples of the sweetener include sucralose, stevia, aspartame, thaumatin, saccharin, neotame, acesulfame potassium, licorice, and monk fruit ([0029]). One with ordinary skill in the art would recognize that monk fruit is another name for Luo Han fruit. Ando teaches the total of the content of the saccharide and the content of the sweetener is preferably 1 to 30% by mass in terms of sucrose, taking into consideration the sweetness degree ([0029]). Ando teaches the total fat/oil content in the fat/oil composition for bakery foods of the present invention is preferably 20 to 95% by mass ([0029] Ando reads such that the total fat/oil content is the equivalent to the instant claims emulsion). Therefore, the relationship of the amount of sweetener to the emulsion taught by Ando would be the sweetener presented at a level of 1.05% to about 150% of the emulsion. See MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Therefore, It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Helgason to use monk fruit in the amount taught by Ando as a taste modulator so the product has a better sweetness expression. In addition because Helgason teaches the use of fruit extracts in the emulsion, Ando imparts reasoning for obvious to utilize monk fruit (luo han fruit) because the teaching shows that monk fruit was known to impart a better sweetness when used in an emulsion and published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to select luo han fruit (monk fruit) as a sweetener for an oil-in-water emulsion, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
Helgason teaches the emulsifier system contains an octenyl succinic anhydride (OSA)-modified starch ([0091]).
However, Helgason is silent to the OSA starch having a weight average molecular weight of 3,000 Dalton or less when measured by gel permeation chromatography at a pH of 2.0.
Schlegel teaches an oil-in-water emulsion composition containing beta-carotene for the enrichment, fortification and/or coloration of food beverages, animal feed, cosmetics or pharmaceutical compositions which contain carotenes ([0002], [0093]). Schlegel teaches the compositions comprises a modified starch ([0009]) and preferably an OSA-starch ([0013]). Schlegel teaches the modified starch acts as a multifunctional ingredient ([0146]) and assist in the stabilization of the functional ingredient in the composition ([0095]). Wherein the modified starch is obtained by separating the starch having a molecular weight from 1 kDa to 200 kDa by ultrafiltration ([0042]). It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Helgason in view of Schlegel to incorporate OSA-starch at a molecular weight from 1 kDa to 200 kDa because Schlegel teaches the modified starch acts as a multifunctional ingredient ([0146]) and assist in the stabilization of the functional ingredient in the composition ([0095]). Schlegel imparts reasoning for obviousness because through routine experimentation with the process of filtration, one with ordinary skill in the art would be able to extract OSA-starch with the desired molecular weight. See MPEP 2144.05(II)(A) Optimization Within Prior Art Conditions or Through Routine Experimentation, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results).
However, Schlegel is silent to the molecular weight being measure by gel permeation chromatography at a pH of 2.0.
Sweedman reviews the synthesis procedures, structural characterization methods, and physico-chemical properties , and the influences of the botanical origins and structural parameters of OSA starches on physico-chemical properties (Abstract) Sweedman teaches using size exclusion chromatography (SEC, used interchangeably in the art with GPC) to quantify size distribution (3.3.1. Size exclusion chromatography (SEC)). Sweedman teaches to quantify the size parameters effectively, molecules must be completely dissolved in the effluent and starch may be made soluble in aqueous media by pH changes to the solvent (3.3.1. Size exclusion chromatography (SEC)).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Helgason in view of the combination of Schlegel and Sweedman to use GPC with a modified pH to measure the molecular weight of OSA-starch because Sweedman provides that using GPC to measure the molecular weight of OSA-Starches was known to be successfully used and published at the time of filing. Through routine optimization, it would have been obvious to one of ordinary skill in the art to use a pH of 2.0.
With regard to Claim 2, Helgason teaches in one embodiment 70% of the oil droplets between 0 and 200 nm ([0027]) and in another embodiment, the pre-emulsification is carried out till the oil droplet size) is 200 nm to 20 μm, preferably 250 nm to 10 μm, more preferably 300 nm to 5 μm ([0084]) See MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions and MPEP 2144.04I(IV)(A) Changes in Size/ Proportion “In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.”
With regard to Claim 5, Helgason teaches the emulsifier system further contains maltose ([0055]).
With regard to Claim 9, Helgason teaches the functional system contains a carbohydrate ([0096]).
With regard to Claim 10, Helgason teaches the taste modulator contains a non-steviol-based compound ([0055], Helgason teaches utilizing glucose syrup which is a non-steviol-based compound).
With regard to Claim 11, Helgason teaches utilizing extracts from fruit (such as apples and pears) in the oil-in-water emulsion ([0063]), but is silent to the non-steviol-based compound being Luo Han fruit extract.
Ando teaches an oil and fat composition for bakery foods ([0001]). Ando teaches by adding a sugar and/or a sweetener to the oil and fat composition for bakery foods, the bakery foods having an even better sweetness expression can be produced ([0029]). Ando teaches examples of the sweetener include sucralose, stevia, aspartame, thaumatin, saccharin, neotame, acesulfame potassium, licorice, and monk fruit ([0029]). One with ordinary skill in the art would recognize that monk fruit is another name for Luo Han fruit.
Therefore, Ando imparts reasoning for obviousness because the teaching shows that luo han fruit was known for such a thing to have been successfully achieved and published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to select luo han fruit (monk fruit) as a sweetener for an oil-in-water emulsion, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
With regard to Claim 12, Helgason teaches the carbohydrate is present at a level of 0.001-80% ([0097]) and can be selected from a group consisting of mono-, di- and
Oligosaccharides ([0055]). See MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions.
With regard to Claim 16, Helgason teaches the oil phase is MCT oil (medium-chain triacylglycerol). One with ordinary skill in the art would know MCT oil has a density of 0.93-0.96 g/ml. See MPEP 2112.01(II) “ A chemical composition and its properties are inseparable.”
Claims 4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Helgason (US 20140023712 A1) in view of Schlegel (US 20100120713 A1), Ando (JP 6231282 B2), Sweedman (“Structure and physiochemical properties of octenyl succinic anhydride modified starches: A Review”), Elkwil (“Design of complex emulsion interfaces for sugar reduction application”) and Tesch et al. (herein referred to as Tesch, “Stabilization of emulsions by OSA starches”)
With regard to Claims 4 and 7, Helgason is silent to the emulsifier system further containing a co-emulsifier. Helgason does teach modified starches with a molecular weight distribution of 10,000-2,000,000 g/mol (Claim 7, 1 g/mol = 1 Da).
Elkwil teaches using whey protein or sodium caseinate as a co-emulsifier with OSA-modified starch (Abstract). Elkwil teaches mixed emulsifiers showed a comparative ability to reduce the interfacial tension at the oil/water interface compared with using OSA starch alone (abstract). , Elkwil teaches embodiments which contain 0.4% OSA modified starch and 0.5% (w/w) whey protein (2.2.2. Mixed interface O/W emulsions).Thus, the ratio of Modified starch to co-emulsifier is 4:5. See MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions.
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Helgason in view of Elkwil to use a co-emulsifier with OSA-modified starch to reduce the interfacial tension at the oil/water interface (abstract).
However, the combination of Helgason and Elkwil are silent to the co-emulsifier being a chemically modified starch.
Tesch explores the possibility of producing finely dispersed emulsions by using OSA starches as additive (abstract). OSA starch is made by esterification of starch and anhydrous octenyl succinic acid under alkaline conditions (1. Introduction, Tesch reads on the starch being chemically modified). Tesch teaches measurements of interfacial tension prove that OSA starches are surface active substances, their dynamic surface tension being comparable to that of whey protein (4. Summary and conclusions).
Tesch clearly shows that OSA modified starches function as an emulsifier and are comparable to whey protein when used to make an emulsion. See MPEP 2144.06 discusses combining or substituting equivalents known for the same purpose. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention that to modify the combination of Helgason and Elkwil to use a chemically modified starch as a co-emulsifier because Tesch teaches OSA modified starches are comparable to whey protein and thus could be substituted for the whey protein used as a co-emulsifier taught by Elkwil. Because Helgason already teaches modified starches with a molecular weight distribution of 10,000-2,000,000 g/mol (Claim 7, 1 g/mol = 1 Da) can be successfully used as emulsifiers, it would have been obvious to one with ordinary skill in the art that the chemically modified starch acting as a co-emulsifier could have a with a molecular weight distribution of 10,000-2,000,000 g/mol because Helgason already proved at that molecular weight modified starches are successful emulsifiers.
Lastly, the combination of Helgason, Elkwil, and Tesch are silent to the chemically modified starch having a weight average molecular weight measured by GPC at a pH of from about 2.0 to about 4.5.
Sweedman reviews the synthesis procedures, structural characterization methods, and physico-chemical properties , and the influences of the botanical origins and structural parameters of OSA starches on physico-chemical properties (Abstract) Sweedman teaches using size exclusion chromatography (SEC, used interchangeably in the art with GPC) to quantify size distribution (3.3.1. Size exclusion chromatography (SEC)). Sweedman teaches to quantify the size parameters effectively, molecules must be completely dissolved in the effluent and starch may be made soluble in aqueous media by pH changes to the solvent (3.3.1. Size exclusion chromatography (SEC)).
Therefore, 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 combination of Helgason, Elkwil, and Tesch in view of Sweedman to use GPC with a modified pH to measure the molecular weight of OSA-starch because Sweedman provides that using GPC to measure the molecular weight of OSA-Starches was known to be successfully used and published at the time of filing. Through routine optimization, it would have been obvious to one of ordinary skill in the art to use a pH of 2.0 to about 4.5.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Helgason (US 20140023712 A1) in view of Schlegel (US 20100120713 A1), Ando (JP 6231282 B2), Sweedman (“Structure and physiochemical properties of octenyl succinic anhydride modified starches: A Review”) and Zhang et al. (herein referred to as Zhang, “Mechanistic understanding of the relationships between molecular structure and emulsification properties of octenyl succinic anhydride (OSA) modified starches”)
With regard to Claim 6, Helgason is silent to the OSA-modified starch containing maltose in an amount of from about 15% to about 60%.
Zhang explores the relationship between performance and molecular structure of Octenyl succinic anhydride modified starches (OSA-starches) (abstract). Zhang teaches the emulsifying properties of OSA-starch can be improved by β-amylase hydrolysis); β-amylase specifically cleaves (1/4)-α glycosidic bonds from the non-reducing ends of starch branches, releasing a maltose for each successful hydrolysis (1. Introduction). Zhang teaches a large amount of maltose results in a low viscosity and a large droplet size (4. Conclusion). Zhang suggests that different treatments on OSA-starch can result in various molecular size distributions. This is due to different hydrolysis mechanisms of enzymes and acid, as well as different processing conditions and the origins of the parent starches (3.1.1. Whole Molecular size distribution of OSA-starches).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Helgason in view of Zhang to incorporate OSA-modified starch with maltose to lower the viscosity and increase the droplet size (4. Conclusion). Because the amount of maltose can vary with the methods used to produce the OSA-modified starch, it would have been obvious, through routine experimentation, that through hydrolysis conditions and the desired viscosity and droplet, one with ordinary skill in the art would produce an OSA-modified starch with the claimed maltose concentrations. See MPEP 2144.05(II)(A) see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Helgason (US 20140023712 A1) in view of Schlegel (US 20100120713 A1), Ando (JP 6231282 B2), Sweedman (“Structure and physiochemical properties of octenyl succinic anhydride modified starches: A Review”) and Xu et al. (herein referred to as Xu, “Effect of pH and ionic strength on the emulsifying properties of two Octenyl succinate starches in comparison with gum Arabic”)
With regard to Claim 8, Helgason is silent to the weight ratio between the emulsifier system and the oil phase.
Xu compares octenyl succinate starches and gum Arabic in terms of molecular structure and emulsion properties (abstract). Xu teaches the emulsions were prepared with emulsifier and orange oil at various mass ratios (5:5, 3:7, 1.5:8.5, 1:9, and 0.5:9.5 (2.7.1. Emulsion preparation). See MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions. Xu teaches the ratio of emulsifier to oil directly effects the size of the droplets and the storage ability (3.2.2. Effect of emulsifier-oil ratio and storage time).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Helgason in view of Xu to utilize the emulsifier to oil ratios taught by Xu to develop the desired droplet size and storage capabilities through routine optimization.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Helgason (US 20140023712 A1) in view of Schlegel (US 20100120713 A1), Ando (JP 6231282 B2), Sweedman (“Structure and physiochemical properties of octenyl succinic anhydride modified starches: A Review”) and Griat (US 5863545 A)
With regard to Claim 17, the combination of Helgason, Schlegel, and Sweedman is silent to the pH of the oil-in-water emulsion.
Griat teaches oil-in-water type emulsions with a pH below or equal to 3.5 (abstract). See MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions Griat teaches acidic emulsions may be encountered, in particular, when it is desired to obtain cosmetic and/or pharmaceutical compositions containing acidic active agents, such as, for example, hydroxy acids having exfoliative/moisturizing properties, acidic compositions for which there is currently a strong need (Col 1, lines 57-67).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Helgason, Schlegel, and Sweedman in view of Griat to use an oil-in-water emulsion with a pH below 3.5 to obtain compositions containing acidic active agents (Col 1, lines 57-67).
Response to Arguments
Applicant's arguments filed 26 August 2025 have been fully considered but they are not persuasive.
Applicant argues that glucose syrup is not a flavor modulator, this argument is moot in view of the newly amended claim 1.
The applicant argues that Helgason does not teach nor suggest the inclusion of the claimed taste modulator compounds. This is not found to be persuasive because Helgason is not relied upon to teach the claimed taste modulator compounds. Helgason merely teaches the use of fruit extracts, while Ando teaches the use of monk fruit as a taste modulator ([0029]). One with ordinary skill in the art would recognize that monk fruit is another name for Luo Han fruit. Thus, applicants argument is not found to be persuasive.
Applicant argues that Helgason and the other references do not teach or suggest the inclusion of the claimed “taste modulator compounds being present at a level of 3 wt% or less of the emulsion.” This is not found to be convincing because, Ando teaches the total of the content of the saccharide and the content of the sweetener is preferably 1 to 30% by mass in terms of sucrose, taking into consideration the sweetness degree ([0029]). Ando teaches the total fat/oil content in the fat/oil composition for bakery foods of the present invention is preferably 20 to 95% by mass ([0029] Ando reads such that the total fat/oil content is the equivalent to the instant claims emulsion). Therefore, the relationship of the amount of sweetener to the emulsion taught by Ando would be the sweetener presented at a level of 1.05% to about 150% of the emulsion. See MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).Thus, applicants argument is not found to be persuasive.
Applicant argues that Sweedman teaches away from the claimed pH. This is not found to be persuasive because although the example highlight by applicant on page 12 of their response states a pH of 6, the same example states “Starch may be made soluble in aqueous media by pH changes to the solvent”. Therefore, it would have been obvious through routine optimization to adjust the pH to achieve the desired results. See MPEP 2144.05(II) A which states 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). Thus, applicants argument is not found to be persuasive.
Lastly, applicant argues that the office action fails to reject all the features of claim 11. Applicant argues that the office action fails to cite a reference teaching the feature of “glucosylated steviol glycoside” on the basis that the interpretation of the definition of “taste modulator” was mistaken. This is not found to be persuasive because, as stated above, Ando teaches the non-steviol based compound is Luo Han Fruit, which is cited in the claim. Applicant also argues that Ando does not teaches the taste modulator compounds being present at a level of 3 wt% or less in the emulsion. The examiner would like to note that the limitation in claim 1 is written as “the taste modulator compounds contain a steviol-based compound, a non- steviol-based compound or both”. How the limitation is written it is interpreted as the composition can have either a steviol-based compound or a non-steviol-based compound or both. Thus, because the art teaches the use of Luo Han fruit, a non-steviol-based compound, the limitations of the claim are fully met. Thus, applicants argument is not found to be persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.I.D./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792