DETAILED ACTION
Background
The amendment dated September 11, 2025 (amendment) amending claims 1, 3 and 5 and canceling claim 2 has been entered. Claims 1 and 4-5 as filed with the amendment have been examined. Claims 2-3 and 6 have been canceled. In view of the amendment, all outstanding claim objections have been withdrawn.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 11, 2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4 and 5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In each of claims 1, 4 and 5, the amount of polyunsaturated fatty acids recited in mass% is indefinite because no basis or denominator is provided for the recited mass % amount. Is the recited amount of the recited polyunsaturated fatty acids based on the total mass of the recited grape juice-containing gummy, based on the total mass of the recited oil and fat composition, or based on the total mass of the recited mixture?
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.
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 US2004/0028622 A1 to Gurin (Gurin) in view of US 20110313055 A1 to Ervin et al (Ervin) and WO 2017150558 A1 to Kato et al (Kato).
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 [0009], Gurin discloses a gummy product comprising (at [0015]) a flavor amplified composition (FAC) that includes (at [0021]-[0022]) up to about 10 wt%, on a total weight basis, of amplified flavor additives as oils or fats (“oil and fat composition”), 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. 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 the range disclosed in Gurin of at least 10 wt% of oils and fats as polyunsaturated fatty acids, wherein the total amount of oils and fats ranges up to 10 wt% of the grape juice-containing gummy. 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. 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 or their mono-, di- or tri-glycerides.
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]; and, further, the Office considers the claimed polyphenol and citric acid finely dispersed in an oil phase containing polyunsaturated fatty acids (claim 1) to include the forming of the FAC of Gurin as disclosed at [0095], [0099] and [0132]. Moreover, the Office considers the claimed preparing a water phase in which a citric acid is dissolved (claims 4 and 5) to include the mixing of citric acid and polyphenols disclosed in Gurin at [0036]-[0038]; and, further, the Office considers each of the claimed preparing an oil phase containing polyunsaturated fatty acids (claims 4 and 5) and the claimed forming an oil and fat composition having a water phase of a dissolved polyphenol and citric acid finely dispersed therein (claim 1) or the claimed finely dispersing a water phase in which citric acid is dispersed in an oil phase containing polyunsaturated fatty acids (claims 4 and 5), to include the forming of the FAC of Gurin as disclosed at [0095] and [0099].
Gurin does not disclose a grape juice-containing gummy as in claim 1 or method of making one as in claims 4 and 5; Gurin does not disclose that its gummy has reduced offensive odors (claims 1, 4 and 5) 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); further, Gurin does not disclose forming an oil and fat composition in which a water phase with a particle diameter of 300 nm or less is finely dispersed (claims 1, 4 and 5); even further, Gurin does not disclose dispersing the oil and fat composition in a melted grape juice-containing gummy composition to form a mixture before forming a grape juice-containing gummy (claims 1, 4 and 5); and, Gurin does not disclose solidifying the mixture to form the gummy (claims 1, 4 and 5).
However, Gurin at [0032] discloses that its gummy contains a fruit juice concentrate. The Office considers the claimed fruit juice to include the fruit juice concentrate of Gurin.
At Abstract, Ervin discloses a healthy gummy comprising edible oils and an antioxidant and methods for making it. Ervin at [0047] discloses a grape juice-containing gummy confection containing an edible oil (“oil and fat composition”) including soybean, sunflower, and canola or rapeseed oil, all comprising polyunsaturated fatty acids, a water phase, grape juice concentrate and tocopherols or polyphenols as additives. At Example 4 and [0108], Ervin discloses heating grape Welch’s fruit snacks gummy compositions to 150 to 160 °F and combining them with soybean and sunflower oil while mixing, wherein the mixture includes water, followed by cooling the composition to 100°F and adding the polyphenol component, and molding (“solidifying the composition’) to form the gummy. The Office considers the claimed grape juice to include a grape juice concentrate as in Ervin and considers the claimed grape juice-containing gummy forming composition to include the grape gummy composition disclosed in Example 4 of Ervin. Further, the Office considers the claimed dispersing an oil and fat composition in a melted grape juice-containing gummy to include the method disclosed Example 4 at [0108] of Ervin.
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.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Ervin for Gurin to use grape juice as its juice in its gummy as in claim 1 or a method of making one using grape juice as in claims 4 and 5; further the ordinary skilled artisan would have found it obvious in view of Ervin for Gurin to disperse its FAC as an 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 Ervin for Gurin to solidify the mixture to form the gummy of claims 1, 4 and 5 as in Example 4 of Ervin. Both references disclose healthy gummy candy products comprising polyunsaturated fatty acids and polyphenols. The ordinary skilled artisan working in Gurin would have desired to make an oil and fat composition as a microemulsion separately as in Gurin at [0015], [0099] and [0132] and then form a gummy as a melt in the manner of Ervin Example 4 to incorporate the emulsion or FAC into a melted gummy containing mixture to thin out the gummy containing mixture for mixing followed by solidifying the mixture as in Example 4 of Ervin to form its gummy. The ordinary skilled artisan would have found the method of Example 4 of Ervin suitable for handing the protected or stabilized polyphenol in Gurin.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Kato for Gurin as modified by Ervin to form a stabilized polyphenol by dispersion of its antioxidants and preservative organic acids 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 claims 1, 4 and 5 and to incorporate the fat or oil composition in a gummy to form or produce a gummy having reduced offensive odors (claims 1, 4 and 5) and thereby to reduce the occurrence of offensive odors in a grape juice-containing gummy (claim 5). Both Gurin and Kato disclose oil and fat compositions containing polyunsaturated fatty acids and a polyphenol dispersed therein 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 and organic acids in a fat or oil phase to form a particle or dispersion having a particle diameter of 300 nm or less as in Kato to make a stable oil and fat composition having improved antioxidant activity as in Kato in the paragraph bridging pages 5 and 6 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 Gurin at [0009], [0015], [0095] and [0132] as modified by Ervin at Example 4 and [0075] and Kato at 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 Gurin as modified by Ervin 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 Gurin at [0009], [0015], [0095] and [0132] as modified by Ervin at Example 4, as evidenced by the next to last paragraph on page 22 of Kato.
Response to Arguments
In view of the amendment dated September 11, 2025, the following rejections are withdrawn as moot:
The rejections of claims 1-2 and 4-5 under 35 U.S.C. 103 as being unpatentable over US 20110313055 A1 to Ervin et al. in view of WO 2017150558 A1 to Kato et al. and US 2005/0244543 A1 to Takaichi et al.
The positions taken in the remarks accompanying the amendment dated September 11, 2025 (Reply) regarding Takaichi 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 at pages 5-6 that none of the cited art discloses dispersing a polyphenol in the water phase of an oil and fat composition which is later dispersed in an oil phase containing polyunsaturated fatty acids, respectfully, Kato at page 4, 5th full paragraph discloses a water phase antioxidant dispersed in an oil and fat composition as a stable, phase protected composition.
The position taken in the Reply at pages 6-7 and Ervin, the rejection does not rely on Ervin to provide a water-in-oil composition dispersed in a gummy composition as a W/O/W composition and does not rely on Ervin in regard to the claimed amount of polyunsaturated fatty acids. Please be advised however that the amount of polyunsaturated fatty acids in a known fat, such as sunflower seed oil is well established and not at issue in this case.
Regarding the position taken in the Reply at page 7 and Kato, respectfully the Office does not rely on Kato to disclose gummies or grape juice.
Regarding the position taken in the Reply at pages 8-11 and the alleged impact of using grape juice, the rejection has found that Ervin at Example 4 does disclose grape juice. Accordingly, a comparison with a satsuma orange gummy does not address the closest gummy product in the art which is that of Example 4 of Ervin.
Regarding the position taken in the Reply at pages 8-11 alleging unexpected results because citric acid and polyphenols are used in the water phase, respectfully, the rejection does not rely on Ervin or Kato for this feature.
Regarding the position taken in the Reply at pages 10-11 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.
Any comparison that alleges unexpected results should address the closest prior art. The Office considers the closest art of record to include any gummy having a microemulsion of a polyphenol and citric acid in an oil and fat composition as in Gurin at [0009], [0015], [0036]-[0038], [0095] and [0132] yet without grape juice or the specific dispersion particle size claimed, or, alternatively, the gummy of Example 4 of Ervin which has all of the recited ingredients except citric acid but does not comprise the implicitly recited W/O/W feature.
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