DETAILED ACTION
Background
The amendment dated April 27, 2026 (amendment) amending claims 1, 4 and 5 has been entered. Claims 1 and 4-5 as filed with the amendment have been examined. Claims 2-3 and 6 have been canceled.
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 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 (i.e., changing from AIA to pre-AIA ) 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, 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.
Claims 1 and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over US 20110313055 A1 to Ervin et al (Ervin) in view of WO 2017150558 A1 to Kato et al (Kato) and US2004/0028622 A1 to Gurin (Gurin), all of record
All references to Kato refer to the Clarivate machine translation of that reference that was provided in a prior Office action.
Unless otherwise stated, the Office considers all disclosed percents (%) as weight %s (wt%); and, the Office considers mass % and wt% as interchangeable.
The Office interprets the claimed mass% of polyunsaturated fatty acid as a mass%, based on the total mass% of the recited grape juice-containing gummy.
Regarding instant claims 1 and 4-5, at Abstract Ervin discloses a healthy gummy comprising edible oils and an antioxidant and methods for making it. At [0047], Ervin discloses a grape juice-containing gummy confection containing an edible oil (“oil and fat composition”) including soybean, sunflower, and canola or rapeseed oil (all “polyunsaturated fatty acids”), grape juice, a water phase, additives and preservatives like ascorbic acid, tocopherols or polyphenols and (at [0077]) citric acid as a preservative food acid in its gummy composition. Further, at Example 4 and [0108], Ervin discloses a method as in claims 4 and 5 comprising heating grape Welch’s fruit snacks gummy compositions and water to 150 to 160 °F and combining them with soybean and sunflower oil while mixing (“dispersing the oil and fat composition in a melted grape juice-containing gummy to form a mixture”), followed by cooling the composition to 100°F, adding and blending in the polyphenol component and additives such as the citric acid (“preparing a water phase in which a polyphenol is dissolved”) and cooling to form a grape juice-containing gummy, and molding (“solidifying the composition’) to form the gummy. The Office considers all of “preparing a water phase” and “preparing an oil phase containing polyunsaturated fatty acids” to include the method disclosed Example 4 at [0108] of Ervin.
Further, Ervin does not disclose that its gummy has reduced offensive odors as in claim 1 or a method of producing one having reduced offensive odors (claim 4), or a method of reducing the occurrence of offensive odors in a grape juice-containing gummy (claim 5); Ervin does not disclose an example wherein the grape juice-containing gummy is obtained by forming an oil and fat composition in which a water phase with a particle diameter of 300 nm or less and in which both a polyphenol and citric acid are dissolved is finely dispersed in an oil phase containing the polyunsaturated fatty acids as in claim 1; Ervin does not disclose polyunsaturated fatty acids comprising docosahexaenoic acid and eicosapentaenoic acid as in claims 1, 4 and 5 or a gummy or method of making one containing the amount of 0.1 to 1.2 mass% of the polyunsaturated fatty acids, based on the total weight of the grape juice-containing gummy as in claims 1, 4 and 5; and Ervin does not disclose a method of preparing a water phase in which both a polyphenol and citric acid are dissolved in claims 4 and 5; further, Ervin does not disclose forming an oil and fat composition by finely dispersing a water phase with a particle diameter of 300 nm or less in an oil phase containing the polyunsaturated fatty acids as in claims 4 and 5; and, Ervin does not disclose dispersing the oil and fat composition in a melted grape juice-containing gummy composition before forming a grape juice-containing gummy as in claims 4 and 5. However, Ervin at [0092] discloses gummy candy modified with grape or apple extract, catechins and polyphenols. The ordinary skilled artisan in Ervin would have found it obvious to include a polyphenol in its gummy to improve its nutritional value and for its antioxidant effect. In addition, Ervin at [0093] discloses its grape juice-containing gummy containing from about 0 to about 10 wt% of a supplement component.
Kato at page 7, 3rd full paragraph discloses forming a water phase by dissolving a water-soluble antioxidant which (at page 4, 3rd paragraph) is a catechin (“polyphenol”), and, separately (at page 7, 5th full paragraph) preparing an oil phase which contains (at page 3, 6th paragraph) unsaturated fatty acids such as soybean oil and rapeseed oil and several unsaturated bonds (“polyunsaturated fatty acids”), and then (at page 7, 6th paragraph) emulsifying to form a water-in-oil emulsion (“oil and fat composition”), wherein (at page 7, 8th paragraph) the particle diameter of the water phase is 300 nm or less and in which a polyphenol is finely dispersed. Kato at the next to last paragraph on page 22 discloses antioxidant oil and fat compositions that suppress generation of off-flavors such as fishy odors and have strong antioxidant power. In the paragraph bridging pages 5 and 6, Kato discloses that its dispersion particle size insures strong antioxidant activity. Still further, In the paragraph bridging pages 5 and 6, Kato discloses that its dispersion particle size insures strong antioxidant activity. And Kato at the last paragraph on page 6 discloses its oil and fat compositions comprising from 1 to 50 wt% of docosahexaenoic acid and eicosapentaenoic acid or (DHA and EPA).
Gurin at [0009] discloses a gummy product comprising (at [0021]-[0022]) up to about 10 wt%, on a total weight basis, oils or fats, including nut oils and vegetable oils wherein (at [0031]) the oils and fats contain a minimum of 10 wt% of the total weight of the oils as omega-3 and omega-9 polyunsaturated fatty acids. Further, at [0095] Gurin discloses polyphenols in its FACs, wherein the FAC (at [0132]) forms a water-in-oil emulsion in which [at [0036]-[0038]) a water soluble polyphenol is present and is stabilized by citric acid (claims 1, 4 and 5). Still further, at [0099] Gurin discloses the polyphenols in microemulsions or microencapsulated, wherein (at [0045]) an encapsulant includes oils and fats as liposomes. The Office considers the claimed water phase in which a polyphenol and a citric acid is dissolved (claim 1) to include the mixture of citric acid and polyphenols disclosed in Gurin at [0036]-[0038].
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Kato for Ervin to disperse its oil and fat composition in a melted grape juice-containing gummy composition to form a mixture before forming a grape juice-containing gummy as in claims 1, 4 and 5; and, the ordinary skilled artisan would have found it obvious in view of Kato for Ervin to include the claimed amount of 0.1 to 1.2 mass% of polyunsaturated fatty acids DHA and EPA, based on the total weight of the grape juice-containing gummy in its grape juice-containing gummy. Both references disclose healthy antioxidant and fat supplement products comprising polyunsaturated fatty acids and polyphenols. The ordinary skilled artisan working in Ervin would have desired to make an oil and fat composition as a microemulsion separately as in Kato at page 7, 8th paragraph wherein the particle diameter of the water phase is 300 nm or less and in which a polyphenol is finely dispersed and then disperse the Kato oil and fat composition as a supplement in its Gummy as desired in Kato at the next to last paragraph on page 22 wherein its compositions suppress generation of off-flavors such as fishy odors and have strong antioxidant power.
The grape juice-containing gummy of Ervin as modified by Kato comprises from about 0 to about 10 wt% of the Kato oil and fat composition having 1 to 50 wt% of DHA and EPA, or from about 0 to about 5 wt% of the DHA and EPA, which the claimed 0.1 to 1.2 mass% of polyunsaturated fatty acids, based on the total weight of the grape juice-containing gummy lies within. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", the Office considers that a prima facie case of obviousness exists. See MPEP 2144.05.I. The ordinary skilled artisan in Ervin as modified by Kato would have found it obvious to use the claimed amount of DHA and EPA as Ervin as modified by Kato discloses that the claimed amount of the DHA and EPA makes a desirable supplement containing gummy
Further, before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Gurin Ervin as modified by Kato to form a stabilized polyphenol by dispersion of its antioxidants and preservative citric acid acid in fat by forming an oil and fat composition in which a water phase with a particle diameter of 300 nm or less is finely dispersed as in Kato and to incorporate the fat or oil composition in the gummy of Ervin as modified by Kato produce a gummy having reduced offensive odors and thereby to reduce the occurrence of offensive odors in a grape juice-containing gummy as in claim 5. All references disclose oil and fat compositions containing polyunsaturated fatty acids and all references disclose compositions comprising a polyphenol and a preservative. Further, each of Kato and Gurin disclose polyphenols and citric acid dispersed in an oil and fat composition and methods for making them as microemulsions or microcapsules. The ordinary skilled artisan working in Ervin would have desired to finely disperse its water phase containing polyphenols with citric acid in a fat or oil phase as in Gurin to form a stable oil and fat composition having improved antioxidant activity and to improve the release of the polyunsaturated fatty acids contained in the resulting gummy candy.
Claim 1 is a product by process claim reciting forming an oil and fat composition, dispersing the oil and fat composition in a melted grape juice-containing gummy to form a mixture and solidifying the mixture to form the grape juice-containing gummy. It appears that the product of Ervin at Example 4 and [0093] as modified by and Kato at the bottom of page 5 and the bottom of page 6 and Gurin at [0036]-[0038] to be substantially the same thing as the claimed grape juice-containing gummy. The patentability of a product does not depend on its method of production. See MPEP 2113.I. Further, once a product appearing to be substantially identical is found and a prior art rejection is made, the burden shifts to the applicant to show an nonobvious difference over the art. See MPEP 2113.II.
In addition, the grape juice-containing gummy of Ervin as modified by Kato and Gurin is formed by a method that, at the next to last paragraph on page 22 of Kato, reduces offensive odors in a grape juice-containing gummy containing polyunsaturated fatty acids, such as fishy odors. The Office considers the claimed grape juice-containing gummy having reduced offensive odors and the claimed method or reducing the occurrence of offensive odors (claim 5) as including the grape juice-containing gummy of Ervin at Example 4 and [0093] as modified by and Kato at the bottom of page 5 and the bottom of page 6 and Gurin at [0036]-[0038], as evidenced by the next to last paragraph on page 22 of Kato.
Response to Arguments
In view of the amendment dated April 27, 2026, the following rejections are withdrawn as moot:
The rejections of claims 1, 4 and 5 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in regard to the basis or denominator for the amount of polyunsaturated fatty acids recited in mass%; and,
The rejections of claims 1 and 4-5 under 35 U.S.C. 103 as being unpatentable over US2004/0028622 A1 to Gurin in view of US 20110313055 A1 to Ervin et al. and WO 2017150558 A1 to Kato et al.
The positions taken in the remarks accompanying the amendment dated September 11, 2025 (Reply) regarding Gurin and Ervin have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the position taken in the Reply, respectfully the rejection does not rely on Gurin or Ervin to provide the claimed polyunsaturated fatty acids comprising docosahexaenoic acid and eicosapentaenoic acid.
Regarding the position taken in the Reply at page 9 and Kato, respectfully the Office does not rely on Kato to disclose gummies or grape juice.
Regarding the position taken in the Reply and the alleged impact of using grape juice, the rejection has found that Ervin at Example 4 includes grape juice and includes tocopherol as polyphenol as tocopherol, and has all of the recited ingredients except citric acid and the DHA and EPA but does not comprise the implicitly recited W/O/W feature. Any comparison that alleges unexpected results should address the closest prior art. Accordingly, a comparison with a gummy such as Comparative Example 2-3 and Comparative Example 3-2 does not address the closest gummy product in the art which is that of Example 4 of Ervin because it lacks a polyphenol; further a comparison versus Comparative Example 3-3 does not address the closest gummy product in the art which is that of Example 4 of Ervin because it lacks grape juice.
Regarding the position taken in the Reply alleging that the art does not disclose the recited feature of a gummy having reduced offensive odors, the next to last paragraph on page 22 of Kato discloses that a water in oil microdispersion of an antioxidant in fact does reduce or prevent offensive odors from DHA and EPA.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW E MERRIAM whose telephone number is (571)272-0082. The examiner can normally be reached M-H 8:00A-5:30P and alternate Fridays 8:30A-5P.
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/ANDREW E MERRIAM/Examiner, Art Unit 1791
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