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 .
Status of the Application
Receipt is acknowledged of the amendment and response filed 11/14/2025. Claims 1,2,5-10,12,16-19,23,25,27,28,35 and 37-39 are pending in the application. Claims 1,12 and 38 were amended, claims 3-4, 11, 13-15,20-22,24,26,29-34,36,were canceled, and new claim 39 was added.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/14/2025 and 11/28/2025 were filed before close of prosecution in the application. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The declaration under 37 CFR 1.132 filed 11/14/2025 is insufficient to overcome the rejection of claims based upon 35 USC 103 as set forth in the last Office action because: the information therein is not commensurate in scope with the claimed invention. Although claims are interpreted in view of the specification, limitations from the specification cannot be imported into the claims.
Firstly, a structured elastic texture in the invention versus the art is considered an obvious modification of the method in the art. Both the adipose tissue replica in Vrljic and the claimed invention are protein-stabilized transglutaminase-linked emulsion gel systems. A spreadable gel for example, can be experimentally optimized to provide a sliceable gel by increasing protein concentration and providing more cross-linkable residues.
The affidavit characterizes the invention as being composed of liquid oils alone. However, this is not commensurate in scope with the claimed invention which is based on plant-based oil, plant-based fat and combinations thereof. A fat is generally interpreted as a semi-solid crystalline material at typical use temperatures.
Regarding ratios of components, optimizing mechanical properties of a structured gel, more specifically, a protein-stabilized cross-linked high internal phase gel, is within the technical capability of one of ordinary skill in the art.
Regarding the non-use of a phosphate buffer, typically phosphate buffer is routinely used to maintain pH during TG crosslinking. The claims do not show any unexpected effects of unbuffered protein solution in making a structured emulsion as claimed.
Response to Arguments
Applicant’s arguments have been considered, and are partially persuasive. In view of claim amendments, the previous rejections under 35 USC 112(b) are withdrawn.
Regarding the affidavit, the comments in the section above are reiterated here.
For these reasons, applicant’s arguments are not persuasive, and the rejection of claims under 35 USC 103 is maintained.
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.
Claims 1,2,5-10,12,16-19,23,25,27,28,35,37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Vrljic et al. (US 2018/0027851 A1) cited in an IDS.
Regarding claim 1, 2, 6, 9,12, 25, 27 and 35, Vrljic discloses an animal fat substitute and its method of making.
For example, Example 7( [0390]-[0391]) discloses a process for preparing an animal fat substitute composition ("Adipose Replica of Beef Fat") comprising forming a mixture of a plant protein solution ("“moong bean 8S protein") in water and 70 v/v% of plant-based oils and fats ("cocoa butter, coconut butter, olive oil and palm oil" in 1:1:1:1 ratio), emulsifying the mixture to form a emulsion by "vortexing" and "sonication", and stabilizing the emulsion by cross-linking with 0.2% w/v transglutaminase or by heating.
Vrljic therefore also discloses an animal fat substitute composition thus produced comprising a plant protein, plant-based oils and fats, and transglutaminase as claimed.
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. 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).
Regarding the limitation of a structured elastic texture in the invention versus the art, this considered an obvious modification of the method in the art. Both the adipose tissue replica in Vrljic and the claimed invention are protein-stabilized transglutaminase-linked emulsion gel systems. A spreadable gel for example, can be experimentally optimized to provide a sliceable gel by increasing protein concentration and providing more cross-linkable residues.
Regarding claims 7 and 8 the plant protein and water are in a ratio of about 1:6 ("140mg/ml) which falls within or overlaps the claimed ranges.
Regarding claims 5, 17 and 18, Vrljic discloses an adipose tissue replica and process as above in Example 8 ([0392]) wherein the protein is purified pea globulin proteins, which is a source of lysine and glutamic acid, meeting the claimed limitations.
Regarding claim 16, Vrljic discloses that the “adipose replica" are “oil in water emulsions" ([0187]), the proteins are therefore in the continuous phase of the emulsion.
Regarding claims 10 and 28 no distinguishing features from conventional packaging of emulsions are provided, as a casing is by definition a package.
Regarding claim 19, the amount of transglutaminase is exemplified (Example 7) as 0.2% w/v which is close to the lower limit, or overlaps the claimed range. The claim recites “an effective amount” which is optimizable by one of ordinary skill in the art.
Regarding claim 23, Vrljic discloses that the animal fat substitute composition (replica) in some embodiments [0212] some or all of the components of the fat replica are suspended in a gel (e.g., proteinaceous gel). In other embodiments, the gel can be a hydrogel, an organogel, or a xerogel. In some embodiments, the gel can be thickened to a desired consistency using an agent based on polysaccharides or proteins, including the claimed listing of alginate, carboxymethylcellulose and starches.
Regarding claims 37 and 38 discloses a food product that is a meat replica comprising the animal fat substitute of claim 1. For example, Example 16 comprises the adipose replica prepared in Example 7 [0412]-[0413]).
Further, attention is invited to In re Levin, 84 USPQ 232 and the cases cited therein, which are considered in point in fact situation of the instant case. At page 234, the Court stated as follows:
This court has taken the position that new recipes or formulas for cooking food which involve the addition or elimination of common ingredients, or for treating them in ways which differ from the former practice, do not amount to invention, merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In all such cases, there is nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected and useful function. In re Benjamin D. White, 17 C.C.P.A. (Patents) 956, 39 F.2d 974, 5 USPQ 267; In re Mason et al., 33 C.C.P.A. (Patents) 1144, 156 F.2d 189, 70 USPQ 221.
No coaction or cooperative relationship between the claimed components which produces a new, unexpected and useful function has been established in the instant case.
Regarding claim 39, Vrljic in Example 7 discloses a process for preparing an animal fat substitute composition ("Adipose Replica of Beef Fat") comprising forming a mixture of a plant protein solution ("“moong bean 8S protein") in water and 70 v/v% of plant-based oils and fats ("cocoa butter, coconut butter, olive oil and palm oil" in 1:1:1:1 ratio), emulsifying the mixture to form a emulsion by "vortexing" and "sonication", and stabilizing the emulsion by cross-linking with 0.2% w/v transglutaminase or by heating. Cooking involves heating. One of ordinary skill in the art would appropriately optimize protein, oil and fat and transglutaminase ratios to obtain a desired texture in the final emulsion. Regarding the non-use of a phosphate buffer, typically phosphate buffer is used to maintain pH during TG crosslinking. The claims do not show any unexpected effects of unbuffered protein solution in making a structured emulsion as claimed. Proteins themselves have buffering action and one of ordinary skill in the art may choose an unbuffered system with a reasonable expectation of success, for a clean label product. This is considered an obvious modification.
Claims 1,2,5-10,12,16-19,23,25,27,28,35,37-39 are therefore prima facie obvious in view of the art.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Subbalakshmi Prakash whose telephone number is (571)270-3685. The examiner can normally be reached Monday-Friday.
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/SUBBALAKSHMI PRAKASH/Primary Examiner, Art Unit 1793