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 .
DETAILED ACTION
Election/Restrictions
Claims 22-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Election was made without traverse in the reply filed on 02/01/2026.
Applicant’s election without traverse of Group I, claims 1-21 in the reply filed on 02/01/2026 is acknowledged.
Claim Objections
Claims 4, 5, 6, 9, 12, 17, 20 and 21 are objected to because of the following informalities:
Claims 4, 5, 6, 9, 12 and 21 recite “a group consisting of”. It is suggested to change “a” to –the--.
Claim 17 recites “a gel” in line 1. It is suggested to change “a” to –the--.
Claim 17 recites “an edible composition” in line 1. It is suggested to change “a” to –the--.
Appropriate correction is required.
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 1-21 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.
Claim 1 recites a gel comprising an oleogel wherein the oleogel may comprise either a plant-based oil in a liquid state at room temperature and a wax, or a plant-based oil in non-liquid state at room temperature. It is not clear whether a plant-based oil in non-liquid state at room temperature forms an oleogel as the term is generally understood. The instant specification in Example 4 states that “When the bee's wax was added at 0 weight percent of the oleogel (it is not an oleogel, this is only a comparative example)” (emphasis added in italics). Oleogels are commonly understood to include oil and a structurant (oleoregulator, gelators). See for instance “Oleogel-based emulsions: Concepts, structuring agents, and applications in food”, Silva, Food Science, May 2, 2021 which describes oleogels as made by dissolving gelators (waxes, fatty acids, fatty alcohols, etc.) in oil (2.2). As noted in the instant specification and as understood in the art, when no structurant (wax) is present “it is not an oleogel”. Thus, it is not clear if the term “oleogel” as recited in claim 1 is applicable to the “plant-based oil in non-liquid state at room temperature” or if the claim encompasses a gel having a plant-based oil in non-liquid state that is not an oleogel. Claims 2-21 are included herein as dependent upon or otherwise incorporating claim 1.
Claim 1 further requires “an oleogel dispersed within an aqueous gel which is continuous phase”. The term “continuous phase” is not clearly defined in the instant specification and it is not clear if the claim requires the aqueous phase to be continuous or the oleogel, or both phases are continuous. The instant specification states that in some embodiments the bigel of the invention is in the form of a bi-continuous phase [0056, 0061] and that in some embodiments, the bigel is in a form of a continuous bulk material or a continuous matrix [0112]. No clear reference to the aqueous phase being continuous is found in the specification. While the claim does not recite “bigel” per se, the specification appears to indicate that the claim encompasses a bigel based on the presence of an oleogel and aqueous gel (hydrogel). The claim is no clear, in light of the specification, if the claimed continuous phase is limited to the aqueous phase or if a bigel bi-continous phase is intended.
Claim 9 recites “whey protein isolate/concentrate”. The term “isolate/concentrate” is unclear. Does the term indicate a mixture or does the term indicate isolate “or” concentrate?
Clarity is requested. In keeping with the recitations of isolate and concentrate separately with regard to soy protein and pea protein, the term is interpreted as “or”.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4-6, 12 and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2014/043778 (Marangoni) (cited on IDS filed 01/08/2024).
Marangoni discloses an oil in water emulsion useful as a fat substitute. Marangoni discloses that the emulsion is an oil in water emulsion comprising an oil phase having oil and wax, and a continuous aqueous phase comprising water and polysaccharide (abstract, [0027, 0033, 0037]). The emulsion is stabilized by multiple hydrated saturated monoglyceride-cosurfactant (-19: 1 ) bilayers. These bilayers are lamellar liquid crystalline bilayers that begin to form above the melting point of the saturated monoglyceride in oil of about 72°C. Upon cooling, they crystallize, thereby transitioning from a liquid crystalline L-alpha phase into an alpha-gel state, stabilized by the addition of a co-surfactant, thus the oil phase is considered an oleogel as it forms a gelled oil phase. Moreover, Marangoni discloses that increasing the solid content of the oil in water system (emulsion), structuring agents are added to the oil phase to achieve gelling of the oil phase, which is considered an oleogel [0046]. Regarding the “aqueous gel”, Marangoni discloses that the aqueous phase may include additives such as polysaccharides such as about 0.1% to 3% w/w of the total emulsion, preferably about 2% w/w of a 1 : 1 mixture of lambda- carregeenan-guar gum. This amount is similar to the amount added in Example 5 (Table 3) of the instant specification where 0.5wt% of the emulsion is a polysaccharide. Based upon the similarity in the components disclosed by Marangoni, one of ordinary skill would reasonably consider the aqueous phase to form a gel in a manner similar to that disclosed by applicant.
Regarding claim 4, the wax may be rice bran wax, carnauba wax, candelilla wax, sunflower wax, jojoba oil wax, corn oil wax, sugarcane wax, ouricury wax, retamo wax, paraffin wax and polyethylene wax [0023].
Regarding claims 5 and 6, the oil may be vegetable oils, e.g. high-oleic sunflower, high- oleic & high-stearic sunflower oil, high-oleic soybean, high-oleic canola, high-oleic safflower oil, avocado oil and olive oil, and medium and short-chain saturated triglycerides oils such as capryllic-capric triglyceride oils, Neobee oil and coconut oil, soybean oil, canola oil, sunflower oil, safflower oil, corn oil, flaxseed oil, almond oil, peanut oil, pecan oil, cottonseed oil, algal oil, palm oil, palm stearin, palm olein, palm kernel oil, hydrogenated palm kernel oil, hydrogenated palm stearin, fully hydrogenated soybean, canola or cottonseed oils, high stearic sunflower oil, enzymatically and chemically inter-esterified oils, butteroil, cocoa butter, and mixtures thereof. Preferred oils for use in the present product include soybean, canola, sunflower, palm oil and palm olein [0022]. Note that for claim 6, the option of using plant-based oil in non-liquid state at room temperature is not required. Additionally, were this option required, the presence of wax is not precluded.
Regarding claim 12, the polysaccharide may be carrageenan and guar gum [0038].
Regarding claims 17-19, the gel is edible and thus is an edible composition. Claim 18 states that the edible composition is an animal fat substitute. The recitation of an animal fat substitute is considered intended use and does not limit the claimed structure other than being capable of such a use. Here, the gel of Marangoni is capable of being used as an animal fat substitute. Claim 19 requires a flavorant and Marangoni discloses flavorings may be added [0026].
Regarding claims 20 and 21, examples of foods that may incorporate the gel include a croissant and a Danish. Both of these foods appear suitable for vegetarians based upon the ingredients listed.
Claim(s) 1, 5, 6 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2008/081175 (Morley) (cited on IDS filed 04/16/2025).
Morley discloses method for producing a bigel (considered a gel), the method comprising: (a) providing an oleogel comprising at least one oily agent gelled with at least one cellulose polymer; (b) providing an aqueous gel comprising at least one component whose viscosity is pH dependent, such as a carbomer; (c) mixing the oleogel and the aqueous gel together to form a bigel (abstract). Regarding the continuous nature of the aqueous gel, Morley discloses that if two different dyes of different colours are introduced into the oily and aqueous phases, respectively, before forming the bigel, both colours can be observed uniformly dispersed throughout the bigel. Thus, the phases are considered continuous. The oleogel may comprise palm oil (plant-based oil listed in both claims 5 and 6), and the aqueous gel may comprise gelling agents xantham gum and methylcellulose (polysaccharides) (page 7, lines 13-14; page 14, lines 19-24).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2014/043778 (Marangoni).
Regarding claims 2-3, Marangoni discloses an oil in water emulsion wherein the emulsion includes an oil phase which is an admixture of about 30-60% oil by weight, 0.01-15% wax by weight and a surfactant component, a combination of non-ionic and ionic surfactant in a ratio of at least about 10:1 to 30:1; and an aqueous phase comprising about 30-50% by weight of the emulsion (abstract). Marangoni also discloses that additives such as polysaccharides and proteins may be added to the aqueous phase and gives an example of about 2wt% of a 1:1 carageenan-guar gum additive [0027]. A formulation of Marangoni comprises in the oil phase about 45-60% oil by weight, 3-6% by weight non-ionic surfactant, 0.1 - 0.4% by weight ionic surfactant and 0.5-7.5% by weight wax, and about 35-50% by weight water [0029]. The ranges for the oil and water (aqueous phase) fall within the ranges of claim 2. The range of wax overlaps the range of claim 3 and presents a prima facie overlap.
Claim(s) 7, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2014/043778 (Marangoni) in view of US 2020/0268622 (Abbaspourrad).
Marangoni discloses the oil in water emulsion having an oil phase and aqueous phase as discussed above but does not disclose protein in the aqueous gel phase. Abbaspourrad discloses emulsions where whey protein may be added to the aqueous phase. Specifically, Marangoni discloses that whey proteins are prepared and complexed with different polysaccharides at pH 3.5. Formulations based on 75% water phase (containing whey protein and different whey-polysaccharide complexes) and 20% oil phase were manufactured into emulsion gels using a high shear homogenizer [0014]. The whey may be whey protein isolate and may be complexed with polysaccharides [0022]. Regarding the pH, Abbaspourrad discloses a pH of 6 and adjusting to pH 3.5 [0166]. Protein may be provided as the internal structural in an amount of 0.5-2wt% (claim 26). It would have been obvious to one of ordinary skill in the art to utilize protein in the aqueous phase of Marangoni as disclosed by Abbaspourrad as Marangoni discloses that both polysaccharides and proteins may be added, specifically to the aqueous phase, and Abbaspourrad discloses a mechanism to do so and further discloses the types of protein that may be utilized and the pH that avoids astringency of taste.
Regarding claim 9, Marangoni gives examples where the aqueous gel comprises polysaccharide but does not give a specific example where the aqueous gel comprises protein. However, Marangoni specifically lists both proteins and polysaccharides may be added to enhance one or more properties of the product in amounts suitable to achieve the desired effect but without adverse effect on the rheological properties of the product [0027]. One of ordinary skill would have found it obvious to add proteins in addition to polysaccharides as suggested by Marangoni to obtain the known benefits thereof.
Claim(s) 8-11 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2014/043778 (Marangoni) in view of US 2021/0051977 (Vrljic) (cited on IDS filed 01/08/2024).
Regarding claims 8 and 9, Marangoni discloses that proteins may be added to the aqueous gel but does not disclose cross-linking the proteins. Vrljic discloses a fat analog that can be a gelled emulsion and may include protein (isolates [0182, 0183, 0217]) and polysaccharides [0191]. Vrljic discloses that the emulsion of fat droplets in the protein solution can be stabilized by forming the emulsion into a gel by the cross-linking enzyme, e.g., a transglutaminase[ 0183]. the fat replica comprises cross-linking enzymes that catalyze reactions leading to covalent crosslinks between proteins. Cross-linking enzymes can be used to create or stabilize the desired structure and texture of the adipose tissue replica, to mimic the desired texture of an equivalent desired animal fat. In some embodiments, the cross-linking enzymes are isolated and purified from a non-animal source, examples and embodiments of which are described herein. In some embodiments, the fat replica comprises at least 0.0001%, at least 0.001%, at least 0.01%, at least 0.1%, or at least 1% (wt/vol) of a cross-linking enzyme. The cross-linking enzyme can be selected from, for example, transglutaminases, tyrosinases, lipoxygenases, protein disulfide reductases, protein disulfide isomerases, sulfhydryl oxidases, peroxidases, hexose oxidases, lysyl oxidases, and amine oxidases [0184]. It would have been obvious to use proteins as suggested by Marangoni and Vrljic in a fat analog (substitute) and further to stabilize the gel by using a cross-linker to crosslink the proteins which is known to create or stabilize the desired structure and texture of the fat replica.
Regarding claim 10, Vrljic discloses cold set gels are formed by first heat denaturing a protein solution below its minimum gelling concentration (dependent on pH and type of protein, typically <8% (w/v) at pH 6-9 for globular plant proteins such as pea proteins). The protein solution can heated to a temperature above the denaturation temperature of the protein under conditions where it does not precipitate out of solution (e.g., 0-500 mM sodium chloride, pH 6-9) [0161]. The disclosure of a pH of 6-9 overlaps and renders obvious the claimed pH range of 3-8.
Regarding claim 11, Vlrjic discloses formation of protein-polysaccharide coacervates which is considered cross-linking consistent with applicant’s disclosure of cross-linking between protein and polysaccharides (page 6 of instant specification). Vlrjic discloses that these coacervates are used in the development of biomaterials and can be used to bind and hold together the adipose tissue replicas. It would have been obvious to one of ordinary skill to form a coacervate as disclosed by Vlrjic to bind and hold together the fat substitute.
Regarding claim 13, Vrljic discloses that in general, an increase in protein concentration increases fat replica firmness (hardness) and that the amount of lecithin is a moderator of replica firmness and further that addition of polysaccharides to replicas including but not limited to xanthan gum and flax seed paste can increase the firmness of adipose-replica gels [0194-0195]. Vrljic further states that firmness of an adipose tissue replica constructed as stabilized protein-fat emulsion can be modified by varying the concentration of the protein within adiopose tissue replica matrix. For example, a series of adipose tissue replicas formed with varying concentrations of Rubisco with 70-80% v/v sunflower oil, varied in firmness. Adipose tissue replicas with 0% and 0.18% (wt/vol) Rubisco were very soft, whereas replicas formed with 1.6% (wt/vol) Rubisco were soft, and replicas formed with 1.9% (wt/vol) Rubisco were medium in firmness [0211]. Thus, the amounts each of proteins and polysaccharides and stabilization are variables for adjusting the firmness (hardness) of the fat replica and one of ordinary skill in the art would have found it obvious to adjust the firmness of the fat substitute of Marangoni by optimizing these parameters to obtain the desired firmness thereof. Moreover, Vlrjic discloses an adipose replica of beef fat and applicant states that the animal fat-like texture may be presented by the hardness of the gel composition which has a hardness of the claimed range (instant specification, paragraph bridging pages 4-5). Here, Vlrjic discloses forming a fat replica of an animal fat, thus one of ordinary skill would have found it obvious to optimize the parameters discusses above to replicate an animal fat, such as beef fat, in the substitute fat of Marangoni, and provide the necessary texture and firmness (hardness) thereof.
Regarding claim 14, Vrljic discloses that various oils may be used including non-hydrogenated oils [0147]. It would have been obvious to use a non-hydrogenated oil in the composition of Marangoni as Vrljic discloses such oils are useful for making fat substitutes.
Regarding claims 15 and 16, Vrljic discloses that the fat release temperature (melting point) of the adipose replica can be tailored based on the type and amount of fat, the amount of protein, the type and amount of lecithin, the presence of additives, the method of emulsification, and the method of gelling [0197]. Replicas with a greater amount of unsaturated fats have a higher temperature of fat leakage than the same replica made with more saturated fatty acids. Gels made from 75% oils with higher amounts of unsaturated fatty acids, a high protein content (3%), and minimal lecithin content (0.05%), where the mixture was emulsified by a hand-held homogenizer and gelled using the heat-cool method, can be heated to 200° C. with little or no fat release. Gels made from oils with a higher proportion of short-chained saturated fatty acids, high protein content (3%), and minimal lecithin content (0.05%), can be heated to 200° C. with little fat release [0199]. Thus, depending upon the amount of unsaturated fats, protein content and lecithin, the fat release (melting point) of the gels may be adjusted upwards of 200C. It would have been obvious to one of ordinary skill to adjust the melting point of the gel of Marangoni by optimizing the known parameters as suggested by Vrljic to form a fat substitute with the desired melting point.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2018/0310599 discloses in [0282] Table 7, hydrogel agent release system produced by mixing water and agar, heating the mixture to boiling, adding hydrolyzed pea protein isolate (PPI) P870H (World Food Processing) and a taste agent, mixing on low speed, slowly adding coconut oil and canola oil, and chilling the mixture to harden. (36.5% water, 1.4% agar, 2.4% PPI, 12.2% coconut oil, 42.6% canola oil, and 4.9% taste agent) (29.64% water, 0.68% agar, 1.58% hydrolyzed pea protein isolate, 14.03% coconut oil, 47.51% canola oil, and 6.56% taste agent.)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER C MCNEIL whose telephone number is (571)272-1540. The examiner can normally be reached M-F 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at 571-272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JENNIFER C. MCNEIL
Primary Examiner
Art Unit 1793
/Jennifer McNeil/Primary Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793