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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 3, 2026 has been entered.
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 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 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 1, 3-6, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Larsson et al. US 2013/0129801 as further evidenced by Sein et al. US 2012/0088830 and Maunsell et al. US 2020/0069569 in view of Maunsell et al. US 2020/0069569 and Tan US 2016/0089320.
Regarding Claim 1, Larsson et al. discloses an emulsion comprising oat oil (‘801, Paragraph [0189]) comprising about 15 wt% polar lipids rich in galactolipids (‘801, Paragraphs [0154]). Sein et al. provides evidence that galactolipids are a type of glycolipid and that galactolipid emulsifiers are known to be derived from an oat oil source (‘830, Paragraph [0061]) for preparing an emulsion (‘830, Paragraph [0067]). Therefore, the disclosure of Larsson et al. of an emulsion comprising oat oil rich in galactolipids reads on the claimed glycolipids as evidenced by Sein et al. that galactolipids are a type of glycolipid (‘830, Paragraph [0061]). The oat oil comprising about 15 wt% polar lipids rich in glycolipids (galactolipids) (’801, Paragraph [0154]) necessarily teaches the combination of ceramides and glycolipids within the oat oil being more than 8 wt%, i.e. more than about 15 wt% polar lipids of galactolipids since there cannot be a negative concentration of ceramides present in the oat oil. Where the claimed concentration of the combination of ceramides and glycolipids in the oat oil of an emulsion encompasses concentrations of the combination of ceramides and glycolipids in the oat oil of an emulsion disclosed by the prior art, a prima facie case of obviousness exists in view of In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP § 2144.05.I.).
Further regarding Claim 1, Larsson et al. discloses the oil being oat or other cereal lipids (‘801, Paragraph [0025]) wherein the dispersion and/or oil is useful as an ingredient for a pharmaceutical formulation or a cosmetic composition or a food composition (‘801, Paragraphs [0093]-[0097]). Maunsell et al. provides evidence that it was known in the art that oat oil contains at least a small proportion of ceramides (‘569, Paragraphs [0007]-[0008]). Therefore, the oat oil disclosed by Larsson et al. necessarily contains ceramides as evidenced by Maunsell et al. However, Larsson et al. is silent regarding the oat oil comprising at least 3 wt% ceramides.
Maunsell et al. discloses an emulsion comprising an oat lipid extract (‘569, Paragraph [0116]) wherein the oat lipid extract comprises at least 20% w/w polar lipids, i.e. at least 20% of the extract is in the form of polar lipids wherein many of the polar lipids known to be present in oats are ceramides and phospholipids (‘569, Paragraph [0015]) wherein the oat lipid extract comprises at least 3% w/w or at least 4% w/w one or more long chain base compounds of ceramides (‘569, Paragraphs [0055]-[0056] and [0061]-[0064]), which encompasses the claimed oat oil concentration range comprising at least 3 wt% ceramides. Maunsell et al. further discloses the proportion of ceramides and phospholipids can be adjusted by the removal of additional, undesirable components such as sugars and starches and further concentrates the desirable compounds of ceramides and phospholipids (‘569, Paragraph [0104]).
Both Larsson et al. and Maunsell et al. are directed towards the same field of endeavor of emulsions comprising oat oil. Both emulsions containing oat oil of Larsson et al. and Maunsell et al. explicitly teaches the emulsion being used is cosmetic/skin care applications. Larsson et al. teaches the dispersion being used for foods, drugs, or cosmetics applications (‘801, Paragraphs [0001] and [0192]) wherein the dispersion is in the form of an oil in water emulsion of polar lipids (‘801, Paragraph [0086]). Sein et al. provides evidence that it was known in the art that emulsions comprising galactolipids have industrial applications in food and pharmaceutical products (‘830, Paragraph [0061]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the emulsion of Larsson et al. and incorporate ceramides in the claimed concentration of the oat oil as taught by Maunsell et al. since where the claimed ceramide concentration within the oat oil ranges overlaps ceramide concentration within the oat oil ranges disclosed by the prior art, a prima facie case of obviousness exists in view of In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP § 2144.05.I.). Furthermore, differences in the concentration of the ceramides within the oat oil will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration of the ceramides within the oat oil is critical. 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.). One of ordinary skill in the art would adjust the concentration of ceramides within the oat oil of Larsson et al. from oat oils known to contain just 1-2% ceramides as disclosed by Maunsell et al. (‘569, Paragraph [0008]) and adjust the ceramide concentration within the oat oil to a higher concentration of ceramides within the oat oil such as the claimed at least 3 wt% of ceramides since a high proportion of polar lipids such as ceramides known to be present in oats have soothing and barrier enhancing properties (‘569, Paragraphs [0104]-[0106]) as disclosed by Maunsell et al. One of ordinary skill in the art would further concentrate the composition with higher levels of ceramides of the oats based upon the desired degree of soothing and barrier properties as suggested by Maunsell et al.
Further regarding Claim 1, Larsson et al. discloses the emulsion comprising emulsifiers (‘801, Paragraphs [0154] and [0189]). Maunsell et al. discloses saponins are type of compounds that can be found within oats (‘569, Paragraph [0005]).
However, Larsson et al. as further evidenced by Sein et al. and Maunsell et al. in view of Maunsell et al. is silent regarding the emulsion comprising at least one saponin that is additional to the oat oil.
Tan discloses a composition used in foods (‘320, Paragraphs [0019] and [0042]) wherein the composition comprises botanically derived natural surfactants and surfactant aids such as saponins to effect emulsification of nutrients and drugs (‘320, Paragraph [0021]) wherein the botanical emulsifiers/surfactants are saponins from quillaja and yucca (‘320, Paragraph [0036]) wherein the saponin is quillaja (‘320, Paragraph [0057]).
Both modified Larsson et al. and Tan are directed towards the same field of endeavor of emulsions comprising an emulsifier. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the emulsion that uses an emulsifier that is in addition to the saponins naturally found in modified Larsson et al. and use an emulsifier of saponins of quilaja as taught by Tan et al. since the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination in view of Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (MPEP § 2144.07). Tan teaches that there was known utility in the emulsion art to utilize a saponin emulsifier in an emulsion.
Further regarding Claim 1, the limitations “optionally at least one polyol and/or a native or modified carbohydrate” and “optionally at least one benefit agent” are optional limitations that are not required to be taught by the prior art. Nevertheless, Maunsell et al. discloses it was known in the emulsion art to make an emulsion comprising a benefit agent (vitamins) (‘569, Paragraphs [0117] and [0138]). Tan also discloses it was known and conventional in the food and beverage art to make an emulsion comprising a benefit agent (oil soluble nutraceuticals of vitamins) (‘320, Paragraph [0002]). Applicant discloses nutraceuticals are types of benefit agents (Specification, Page 19, lines 20-23). Therefore, the nutraceuticals that are conventionally incorporated into emulsions as disclosed by Maunsell et al. and Tan reads on the claimed benefit agent in view of applicant’s disclosure that nutraceuticals are types of benefit agents. Tan also discloses an emulsion suitable for macronutrient delivery applications involving carbohydrate (‘320, Paragraph [0042]). It is noted that the limitation “a native or modified carbohydrate” encompasses any carbohydrate. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the emulsion of Larsson et al. and incorporate at least one benefit agent of nutraceuticals as well as a carbohydrate macronutrient since Tan teaches that it was known in the food and beverage art to mix an emulsion with a benefit agent of a nutraceutical to incorporate vitamins and other bioactives into the emulsion (‘320, Paragraph [0002]) as well as deliver macronutrients of carbohydrates (‘320, Paragraph [0042]).
Regarding Claim 3, Larsson et al. discloses the emulsion being an oil in water emulsion (‘801, Paragraph [0069]). Tan also discloses the emulsion being an oil in water emulsion (‘320, Paragraph [0069]).
Regarding Claim 4, Larsson et al. discloses the emulsion comprising water wherein a water concentration in the added solvent medium slightly above the critical polarity has been observed to give ideal conditions for initiating the precipitation of cubic particles (‘801, Paragraph [0185]) wherein diluting an oil containing polar lipids using an ethanol water solution with a polarity close to the critical polarity dispersions produces dispersions with very small particles (‘801, Paragraph [0246]). Although Larsson et al. does not explicitly teach the emulsion containing water in an amount of 80 wt% or less, differences in the water concentration of the emulsion will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such water concentration of the emulsion is critical. 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.). One of ordinary skill in the art at the time of the invention would adjust the water concentration of the emulsion of Larsson et al. based upon the desired aqueous dispersions with the desired particle sizes.
Regarding Claim 5, Larsson et al. discloses the emulsion comprising very small uniform particles of unilamellar vesicle type of smaller than 100 nm (‘801, Paragraph [0040]), which overlaps the claimed mean droplet diameter of dispersed droplets in the emulsion of from 50 nm to about 20 micrometer. Larsson et al. also discloses broadly colloidal dispersions that are homogeneous aqueous phases containing particles in the size range of 1-1000 nm (‘801, Paragraph [0107]), which also overlaps the claimed mean droplet diameter of dispersed droplets in the emulsion of from 50 nm to about 20 micrometers. Tan also discloses the oil in water emulsion resulting in particle sizes of 100 nm to 300 nm (‘320, Paragraph [0019]), which also overlaps the claimed mean droplet diameter of dispersed droplets in the emulsion of from 50 nm to about 20 micrometers. Tan discloses the particle sizes being less than 600 nm allows small amounts of nutrients in the form of micronutrients to be delivered using oil/fat as a carrier prior to blending with water (‘320, Paragraph [0044]) wherein smaller nanoparticle sizes make more stable emulsions since bigger microparticle sizes tend to clump and causes the particles to break up and return to the two immiscible oil/fat and water layers and using small amounts of nutrients minimizes flavor/taste alteration (‘320, Paragraph [0045]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the mean droplet diameter of dispersed droplets in the emulsion of Larsson et al. to fall within the claimed sizes of from 50 nm to about 20 micrometers since both Larsson et al. and Tan teaches that the claimed dispersed droplet particle sizes are known sizes in the food emulsion art. Where the claimed mean droplet diameter of dispersed droplets in the emulsion overlaps mean droplet diameter of dispersed droplets in the emulsion ranges disclosed by the prior art, a prima facie case of obviousness exists in view of In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP § 2144.05.I.). Furthermore, differences in the mean droplet diameter of dispersed droplets of the emulsion of Larsson et al. will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such mean droplet diameter of dispersed droplets of the emulsion is critical. 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.). One of ordinary skill in the art at the time of the invention would adjust the mean droplet diameter of dispersed droplets in the emulsion of Larsson et al. based upon the desired degree of nutrients to be delivered and since smaller nanoparticle sizes make more stable emulsions as taught by Tan (‘320, Paragraphs [0044]-[0045]).
Regarding Claim 6, the limitations “prepared by a process comprising mixing ingredients of an aqueous phase, mixing ingredients of a lipid phase, dispersing the oat oil and optionally at least one saponin in at least one of the aqueous phase or the lipid phase, and homogenizing the aqueous and lipid phases to form an emulsion” are product by process limitations. Even though product by process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product by process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process in view of In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (MPEP § 2113.I.). It is noted that the limitations “optionally at least one saponin in at least one of the aqueous phase or the lipid phase” are optional limitations that are not required to be taught by the prior art by virtue of the term “optionally.” Nevertheless, Larsson et al. discloses the emulsion being made by mixing ingredients of an aqueous phase (water/ethanol mixture) and mixing ingredients of a lipid phase (oil) (‘801, Paragraph [0151]) and dispersing the oat oil (‘801, Paragraphs [0008] and [0156]) and homogenizing the aqueous and lipid phases to form the emulsion (‘801, Paragraphs [0107] and [0256]).
Regarding Claim 10, Tan discloses the at least one saponin being quillaja saponins (‘320, Paragraph [0057]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the emulsifier of the emulsion of Larsson et al. to be quillaja saponins as taught by Tan since the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination in view of Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (MPEP § 2144.07). Tan teaches that there was known utility in the emulsion art to utilize a quillaja saponin emulsifier in an emulsion.
Regarding Claim 11, Tan discloses the saponin surfactant (‘320, Paragraph [0161]) being present in the emulsion in a minimum amount to attain a stable emulsion (‘320, Paragraphs [0057]-[0058]) wherein the amount of surfactant is 0.5% to 20% of the aqueous solution (‘320, Paragraph [0059]), which falls within the claimed saponin concentration of from 0.05 wt% to 20 wt%.
Larsson et al. discloses the emulsion being stable (‘801, Paragraphs [0149] and [0165]). Both Larsson et al. and Tan are directed towards the same field of endeavor of emulsions comprising an emulsifier. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the emulsion that uses an emulsifier of Larsson et al. and use an emulsifier of saponin surfactants having the claimed saponin concentration as taught by Tan since where the claimed saponin concentration in the emulsion encompasses saponin concentrations in the emulsion disclosed by the prior art, a prima facie case of obviousness exists in view of In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP § 2144.05.I.). Furthermore, differences in the saponin concentration of the emulsion will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such saponin concentration of the emulsion is critical. 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.). One of ordinary skill in the art at the time of the invention would adjust the concentration of saponin surfactants used in the emulsion of Larsson et al. in order to attain a desired stable emulsion having the desired degree of stability (‘320, Paragraph [0058]).
Regarding Claim 12, Larsson et al. discloses the oat oil being polar lipids in an amount of about 15% of the weight of the oat oil (‘801, Paragraph [0154]), which falls within the claimed oat oil polar lipid concentration of at least 10% by weight of the oat oil. Where the claimed polar lipid concentration in the oat oil of an emulsion encompasses polar lipid concentration in the oat oil of an emulsion disclosed by the prior art, a prima facie case of obviousness exists in view of In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP § 2144.05.I.).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Larsson et al. US 2013/0129801 as further evidenced by Sein et al. US 2012/0088830 and Maunsell et al. US 2020/0069569 in view of Maunsell et al. US 2020/0069569 and Tan US 2016/0089320 as applied to claim 1 above in further view of Miret Carceller et al. US 2018/0020689.
Regarding Claim 4, modified Larsson et al. renders obvious the limitations regarding the water concentration of the emulsion obvious as enumerated in the rejections of Claim 4 provided above. However, in the event that it can be shown with objective evidence that the claimed water concentration of the emulsion is critical, Miret Carceller et al. discloses an emulsion comprising from 45 to 60 wt% of water (‘689, Paragraphs [0012] and [0047]) and oat fibers (‘689, Paragraphs [0036]-[0037]) and at least one benefit agent (coloring agent) (‘689, Paragraph [0050]). The disclosure of the emulsion containing 45 to 60 wt% water falls within the claimed water amount of 80 wt% or less.
Both modified Larsson et al. and Miret Carceller et al. are directed towards the same field of endeavor of emulsions comprising oats. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the emulsion of modified Larsson et al. and incorporate water in the claimed amounts as taught by Miret Carceller et al. since where the claimed amounts of water within the emulsion overlaps water amounts within the emulsion ranges disclosed by the prior art, a prima facie case of obviousness exists in view of In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP § 2144.05.I.). Miret Carceller et al. teaches that there was known utility in the food emulsion art to incorporate water in the claimed concentrations within an emulsion.
Response to Arguments
Examiner notes that the previous indefiniteness rejections under 35 USC 112(b) have been withdrawn in view of the amendments.
Applicant's arguments filed July 3, 2026 have been fully considered but they are not persuasive.
Applicant argues on Page 7 of the Remarks that Larsson does not disclose or suggest oat oil comprising 8 wt% or more of ceramides and glycolipids wherein oat oil comprises at least 3 wt% ceramides as required by Claim 1. Applicant continues that Maunsell expressly discloses that known oat oils contain just 1-2% ceramides, which is wholly outside the claimed range. Applicant continues that the range disclosed in Paragraphs [0055]-[0056]) relates to the total amount of long chain base compounds and not to ceramides. Applicant continues that Claim 1 has been amended to specify that the emulsion is an edible food emulsion whereas Maunsell explicitly teaches the emulsion being used in cosmetic/skin care applications.
Examiner argues the primary reference of Larsson et al. already teaches the emulsion comprising galactolipids (‘801, Paragraph [0154]) being used in pharmaceutical and food compositions (‘801, Paragraph [0001]). Maunsell et al. discloses the emulsion comprising an oat lipid extract (‘569, Paragraph [0116]) comprising galactolipids (DGDG) (‘569, Paragraphs [0065]-[0067]). Sein et al. provides evidence that galactolipids have industrial applications in food, cosmetics, and pharmaceutical products (‘830, Paragraph [0061]). Although Maunsell et al. only explicitly discloses the emulsion comprising galactolipids being used in cosmetics applications, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments in view of In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971) (MPEP § 2123.II.). The primary reference of Larsson et al. already teaches the emulsion comprising galactolipids (‘801, Paragraph [0154]) being used in pharmaceutical and food compositions (‘801, Paragraph [0001]). Furthermore, Maunsell et al. discloses the emulsion comprising an oat lipid extract (‘569, Paragraph [0116]) comprising galactolipids (DGDG) (‘569, Paragraphs [0065]-[0067]). Sein et al. provides evidence that galactolipids have industrial applications in food, cosmetics, and pharmaceutical products (‘830, Paragraph [0061]). Therefore, the emulsion containing galactolipids disclose by Maunsell et al. has other utility in food applications as already taught by the primary reference of Larsson et al. and as suggested by the evidentiary reference of Sein et al. Additionally, the prior art combination relies upon the embodiment disclosed by Maunsell et al. to have the claimed concentration of at least 3% ceramides based on the total weight of the oat oil (‘569, Paragraphs [0055]-[0056] and [0060]-[0064]). The disclosure of Maunsell et al. that known oat oils typically contain just 1-2% ceramides (‘569, Paragraph [0008]) is not the embodiment relied upon in the combination of references. With respect to applicant’s argument that that the range disclosed in Paragraphs [0055]-[0056]) of Maunsell relates to the total amount of long chain base compounds and not to ceramides, Maunsell teaches the oat lipid extract comprises one or more long chain base compounds selected from ceramides…the oat lipid extract comprises at least 3% w/w long chain based compounds (‘569, Paragraphs [0055]-[0056]). Maunsell et al. teaches an embodiment of the long chain base compound being ceramides wherein the long chain base compound is in a concentration of at least 3% w/w of the oat lipid extract. Therefore, these arguments are not found persuasive.
Conclusion
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/ERICSON M LACHICA/Examiner, Art Unit 1792
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