DETAILED ACTION
Amendments made September 15, 2025 have been entered.
Claims 1-9 and 11-16 are pending.
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 .
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.
Claim Objections
The objections to claims 1-14 have been withdrawn in light of applicant’s amendments made September 15, 2025.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejections of claims 3, 8, 13, and 14 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inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention have been withdrawn in light of applicant’s amendments made September 15, 2025.
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.
Note: The terms “soft” and “chewy” where known terms within the confectionary art and are considered definite.
The rejection of claims 1-9 and 11-14 under 35 U.S.C. 103 as being unpatentable over Yuna et al (WO 2019/208699 A1 machine translation) in view of Nieto (WO 2019/168594) and Igoe et al (Dictionary of Food Ingredients 4th Edition 2001, pages 37 and 110) has been withdrawn in light of applicant’s amendments made September 15, 2025; specifically, the prior art cited does not teach the specific oils amended into claim 1.
Claims 1-9 and 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Yuna et al (WO 2019/208699 A1 machine translation) in view of Nieto (WO 2019/168594) and Igoe et al (Dictionary of Food Ingredients 4th Edition 2001, pages 37 and 110) and Gorden et al (US 6,077,557).
Regarding claims 1-3, 5-9, 11, 12, and 16 Yuna et al (Yuna) teaches a food, preferably, a gummy (page 4 paragraph 1, embodiment 25 and page 6 paragraph 3) comprising: 5-50% thickener including glycerin which is a humectant and non-ionic polyol and sorbitol which is a binder (page 6 paragraph 7); and 0.1-10% of component B which is at least one oligosaccharide, preferably at least one human milk oligosaccharides (HMO), more preferably, wherein the HMO is selected from the group including 2’FL, 3’SL, 6’SL, LNT, and LNFPI (page 3, paragraph 3, embodiments 2, 3, 11, 12, and 16, page 4, paragraph 8, page 5 paragraphs 3 and 4). Yuna also exemplifies the gummy candy as comprising: 4% of the HMO 3’SL, 5% glycerin which is a non-ionic polyol humectant, and 30% liquid glucose which is a binder (page 10, formulations 10 and 12), which encompass the claimed ranges respectively.
Yuna is silent to the formulation as comprising at least one wetting agent as recited in claim 1, wherein the wetting agent is in the range of 0.05-4.0% as recited in claim 7, or selected from a specific group of components including fatty acid derivates as recited in claim 8, preferably selected from a group including polyglycerol esters as recited in claim 16; to the moisture content of the formulation as less than 8% as recited in claim 1; to the gummy as comprising at least one oil selected from the group including coconut, soybean, or cottonseed oils as recited in claim 1, wherein the at least one oil is from 1-10% as recited in claim 9; and to the hardness of the formulation as in the range of 1.2-4.0kg as recited in claim 2.
Regarding the formulation as comprising at least one wetting agent as recited in claim 1, wherein the wetting agent is in the range of 0.05-4.0% as recited in claim 7, or selected from a specific group of components including fatty acid derivatives as recited in claim 8, preferably selected from a group including polyglycerol esters as recited in claim 16, Igoe et al (Igoe) teaches that polyglycerol esters of fatty acid were known food ingredients, typically used from 0.1-1%, in products including confections for the purpose of gloss (page 110). It would have been obvious to one of ordinary skill in the art for the confectionary product of Yuna to comprise 0.1-1% polyglycerol esters of fatty acids, which is at least one wetting agent, to increase the gloss of the confection as taught by Igoe. To use a known ingredient for its known and intended function would have been obvious and well within the purview of one of ordinary skill in the art.
Regarding the moisture content of the formulation as less than 8% as recited in claim 1, and to the hardness of the formulation as in the range of 1.2-4.0kg as recited in claim 2, Nieto teaches of gummy candies comprising oligosaccharides (abstract and paragraphs 6). Nieto teaches that the confection is made with the desired textural properties (paragraph 21). Nieto teaches that the gummies are cured to obtain a pliable, soft chew composition and are cured to obtain a specific water content in the end product, including about 5-40% water or moisture (paragraphs 33, 41, and 44). Nieto shows that the hardness produced ranges from 2.3-9.5 kg (paragraphs 59 and 60 and Table 3). It would have been obvious to one of ordinary skill in the art for the gummy candy of Yuni to have a known moisture content and hardness, including from about 5-40% moisture and about 2.3-9.5kg as taught by Nieto. One would have been further motivated to adjust the moisture content and hardness within the disclosed ranges as Nieto teaches the gummy with the claimed properties has the desired texture, and is soft and chewable.
Regarding the gummy as comprising at least one oil selected from the group including coconut, soybean, or cottonseed oils as recited in claim 1, wherein the at least one oil is from 1-10% as recited in claim 9, Nieto teaches coconut oil was a known ingredient in the gummy food product (title and paragraph 29). Additionally, Gordon et al (Gordon) teaches that in sweetened gelled foods about 0.1-8% fat selected from soybean, coconut, and/or cottonseed oils, can be included to increase the shortness of texture and/or reduce the stickiness to the consumers teeth (abstract and column 9 lines 9-25). Thus, it would have been obvious when for the gummy candy, i.e. gelled and sweetened candy of Yuna to include soybean, coconut, and/or cottonseed oils in order to increase the shortness of texture and/or reduce the stickiness to the consumers teeth as taught by Gordon. To use a known ingredient for its known purpose would have been obvious to one of ordinary skill in the art.
Regarding the candy as soft and chewy as recited in claim 1, as Yuma teaches the candy as a gummy food (page 4 paragraph 1, embodiment 25, page 6 paragraph 3, and page 10, formulations 10 and 12), and gummies were known to be soft and chewy, the candy of Yuna encompasses or at least makes obvious the claimed limitation. The position of the Office is further supported as the prior art teaches of a composition and hardness overlapping that as claimed, and additionally as the terms soft and chewy are relative to a tablet or hard chewable tablet (see instant specification page 1 and arguments filed September 15, 2025, page 1).
Regarding claim 4, although Yuma is not specific to the gummy composition as comprising the humectant, binder, and 5-45% HMO together, as Yuma exemplifies the gummy candy as comprising both the humectant and binder (page 10 Formulations 10 and 12), and specifically teaches the gummy candy contain 0.1-10% of component B which is selected from oligosaccharides, including the HMOs (page 3 embodiments 11, 12, and 16, and page 4 paragraph 1, embodiment 25), the inclusion of 0.1-10% HMOs in a gummy composition containing both a humectant and binder is considered at least obvious over the teachings of the prior art. It is noted that a reference is not limited to its examples and preferred embodiments, but rather must be considered as a whole.
Regarding claims 13 and 14, Yuna teaches that the formulation may contain binders including cellulose and gums which are bulking agents (page 6 paragraph 7 and page 7 paragraph 1); nutraceuticals including active ingredients, such as anti-inflammatories (page 7 paragraph 4) or spermine, spermidine, sialic acid, and lactoferrin (abstract and page 10 Formulations 10 and 12); sugar which is an additional sweetener (page 10 Formulations 10 and 12); and perfume, which is disclosed as flavor oils (lipids) (page 7 paragraph 3 and page 10 Formulations 10 and 12).
Regarding claim 15, it is noted that claim 8, from which claim 15 depends recites, “wherein at least one wetting agent is selected from the group consisting of lecithin, lecithin derivatives, monoglyceride derivatives, fatty acid derivatives, polysorbate 80, and sorbitan monostearate”. As such, the inclusion of a monoglyceride derivative is not required. Claim 15 does not necessarily further limit the invention of claim 8, in that it does not require that the monoglyceride be included in the product composition. Claim 15 simply provides a further selection of the choices within claim 8, thus claim 15 may still be satisfied by a reference meeting one of the other optional limitations recited in claim 8. Since the reference meets at least one of the optional limitations of claim 8 (fatty acid derivatives), the reference encompasses the claim.
Regarding the claimed ranges, the prior art discloses overlapping ranges of the claimed components. It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Yuna et al (WO 2019/208699 A1 machine translation) in view of Nieto (WO 2019/168594) and Igoe et al (Dictionary of Food Ingredients 4th Edition 2001, pages 37 and 110) and Stewart (“Healthy Gummy Bears (4 Ways)” 2018 https://katiestewartwellness.com/2018/10/30/healthy-gummy-bears-4-ways-pomegranate-grape-mango-coconut/, pages 1-6).
Yuna et al (Yuna) teaches a food, preferably, a candy or gummy (page 4 paragraph 1, embodiment 25 and page 6 paragraph 3) comprising: one or more surfactants including polyoxyethylene fatty acid ester which encompasses known humectants (page 6 paragraph 5); fragrances, including at least one oil (page 7 paragraph 3); one or more thickener including sorbitol which is at least one binder (page 6 paragraph 7); and 0.1-10% of component B which is at least one oligosaccharide, preferably at least one human milk oligosaccharides (HMO), more preferably, wherein the HMO is selected from the group including 2’FL, 3’SL, 6’SL, LNT, and LNFPI (page 3, paragraph 3, embodiments 2, 3, 11, 12, and 16, page 4, paragraph 8, and page 5 paragraphs 3 and 4).
Yuna is silent to the formulation as comprising at least one wetting agent; the moisture content of the formulation as less than 8%; and the gummy as comprising an oil selected from the group including coconut oil as recited in claim 1.
Regarding the formulation as comprising at least one wetting agent as recited in claim 1, Igoe et al (Igoe) teaches that polyglycerol esters of fatty acid were known food ingredients, typically used from 0.1-1%, in products including confections for the purpose of gloss (page 110). It would have been obvious to one of ordinary skill in the art for the confectionary product of Yuna to comprise 0.1-1% polyglycerol esters of fatty acids, which is at least one wetting agent, to increase the gloss of the confection as taught by Igoe. To use a known ingredient for its known and intended function would have been obvious and well within the purview of one of ordinary skill in the art.
Regarding the moisture content of the formulation as less than 8% as recited in claim 1, Nieto teaches of gummy candies comprising oligosaccharides (abstract and paragraphs 6). Nieto teaches that the confection is made with the desired textural properties (paragraph 21). Nieto teaches that the gummies are cured to obtain a pliable, soft chew composition and are cured to obtain a specific water content in the end product, including about 5-40% water or moisture (paragraphs 33, 41, and 44). Nieto shows that the hardness produced ranges from 2.3-9.5 kg (paragraphs 59 and 60 and Table 3). It would have been obvious to one of ordinary skill in the art for the gummy candy of Yuni to have a known moisture content and hardness, including from about 5-40% moisture and about 2.3-9.5kg as taught by Nieto. One would have been further motivated to adjust the moisture content and hardness within the disclosed ranges as Nieto teaches the gummy with the claimed properties has the desired texture, and is soft and chewable.
Regarding the gummy as comprising an oil selected from the group including coconut oil as recited in claim 1, Yuna teaches a candy or gummy comprising flavoring oil. Nieto teaches coconut oil was a known ingredient in the gummy food product (title and paragraph 29). Additionally, Stewart teaches that when using essential oils, i.e. flavor oils, in gummies it was known to mix them in a lipid, including coconut oil, to provide for easy dispersion (page 3, first paragraph). Thus, it would have been obvious when using the flavoring oil of Yuna to also include coconut oil in order to easily disperse the flavoring oil into the dispersion. To use a known ingredient for its known purpose would have been obvious to one of ordinary skill in the art.
Regarding the candy as soft and chewy as recited in claim 1, as Yuma teaches the candy as a gummy food, and gummies were known to be soft and chewy, the candy of Yuna encompasses or at least makes obvious the claimed limitation. The position of the Office is further supported as the prior art teaches of a composition overlapping that as claimed additionally as the terms soft and chewy are relative to a tablet or hard chewable tablet (see instant specification page 1 and arguments filed September 15, 2025, page 1).
The prior art discloses overlapping ranges of the claimed components. It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Response to Arguments
Applicant's arguments filed September 15, 2025 over the prior art as applied in the current rejections have been fully considered but they are not persuasive. It is noted that a new rejection has been presented above in light of the amendments; and the arguments directed to the withdrawn rejections are moot. Claims 15 and 16 are newly presented and claims 2-9 and 11-14 were not previously considered in combination with the limitations previously recited in claim 10.
Applicant argues that a soft chew is different from a gelled composition. This argument is not convincing as there is nothing in the claims or the given definition for soft and chew that would exclude a gelled composition. The prior art is considered to encompass a soft chew because: 1) it teaches an overlapping composition, including a moisture content and hardness within the claimed and disclosed ranges; and/or 2) gelled compositions, like gummies were known to have a soft and chewy texture which was softer than hard chewable stables. See for examples OSD “What Makes Gummies Gummy” https://www.osdmachinery.com/blog/what-makes-gummies-gummy, pages 1-2 which shows gummy candies are chewy and soft.
Applicant argues that Yuna discloses a multitude of product types and not every product type would comprise the disclosed ingredients. This argument is not convincing to withdraw the rejection as it is a 103 obviousness rejection and not a 102 anticipatory rejection. To use the disclosed components of the prior art when forming a disclosed product type would have been encompassed or at least obvious to one of ordinary skill in the art.
Applicant argues that Yuna teaches sorbitol as a thickener and not a binder. This argument is not convincing as sorbitol is a claimed and disclosed binder. Thus, by teaching of a composition comprising sorbitol, the composition would contain a bunder as claimed.
Applicant argues that polyoxyethylene fatty acid ester as taught by Yuna is not a polyol, and is taught as a surfactant and not a humectant. First it is noted that claim 1 does not require a polyol, only a humectant. Additionally, it is noted that the instant disclosure states humectants include polyols and their esters (page 5 paragraph 4). As stated in the rejection, Yuna teaches polyoxyethylene fatty acid ester which encompasses known humectants. As evidenced by Igoe et al, page 110, polyoxyethylene fatty acid esters encompass polysorbate 60, and as evidenced by Surtan, pages 1-4 https://surtensurfactants.com/products/polysorbates/polysorbates, polysorbate 60 is a humectant (page 2, Table).
In response to applicant's argument that Nieto does not teach the same composition as claimed or as that of Yuna, the argument is not convincing as the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
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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/KELLY J BEKKER/Primary Patent Examiner, Art Unit 1792