DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment filed December 9, 2025 has been entered. Claims 1-20 are pending.
The previous rejection of claims 2 and 4 under 35 U.S.C. 112 (b) has been withdrawn in light of Applicant’s amendment and remarks filed December 9, 2025.
Claim Rejections - 35 USC § 103
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.
Claims 1-4, 6-14, 16-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 4,084,017) in view of Olatunde et al. (WO 2021/119614) as evidenced by Norton et al. (“Leucine content of dietary proteins is a determinant of postprandial skeletal muscle protein synthesis in adult rats”, Nutrition & Metabolism, 9:67, (2012), pp. 1-9).
Regarding claims 1-4, 6, 10 and 20, Kim et al. disclose a fibrous protein material and method of making wherein the method comprises the steps of: (a) mixing water and soy protein isolate (i.e., vegetable protein) to form an aqueous protein mixture wherein at least a portion of the protein is dissolved in the water and the solids content does not exceed about 35% of the mixture on a weight basis; and (b) freezing the aqueous protein mixture at a temperature of -76°C to provide a well-defined, well-ordered fibrous structure (i.e., fibrous or laminated textured and frozen food product -C3/L3-C6/L28, C11/L1-C13/L7/Example I, II and IV).
While Kim et al. disclose freezing the aqueous protein mixture at a temperature of -76°C, the reference is silent with respect to time. However, given Kim et al. disclose freezing to form a well-defined, well-ordered fibrous structure, the person of ordinary skill in the art would have been motivated to adjust, in routine processing, the freezing time at -76°C to obtain the desired structure.
Kim et al. is silent with respect to enzymatically treating the aqueous protein mixture prior to freezing.
Olatunde et al. teach a method of producing textured plant protein products that can be used in vegan meat substitutes (Abstract) wherein the method comprises the steps of: (a) obtaining a plant protein composition; (b) mixing transglutaminase with the plant protein composition; (c) adding water to the mixture at a temperature of about 55°C for about 2 minutes to form a composition of crosslinked protein; and (c) forming the crosslinked protein composition into a cake and resting the cake at room temperature for a time of up to 60 minutes (obtaining an enzymatically treated protein solution ([0009],[0023]).
Kim et al. and Olatunde et al. are combinable because they are concerned with the same field of endeavor, namely producing textured plant protein products. It would have been obvious to one of ordinary skill in the art at the time of the invention to have, prior to freezing, treated the aqueous protein solution of Kim et al. with transglutaminase to crosslink the protein and produce, after freezing, a stronger fibrous structure.
Kim et al. disclose any edible protein, or combination of proteins can be employed in the process providing that the sole protein or, in the case of combination, at least one of the proteins is soluble or partially soluble (i.e., at least 20% of the proteins would be soluble in the aqueous solution -C3/L3-8). Kim et al. disclose that in general, proteins having excellent solubility provide excellent, distinct fibrous structure (C3/L8-10).
Given the combination of Kim et al. and Olatunde et al. disclose a process of making a fibrous protein material substantially similar to that of claim 6, inherently the product would exhibit the claimed physical and dimensional properties.
Regarding claim 7, modified Kim et al. disclose all of the claim limitations as set forth above. Kim et al. disclose a fibrous protein material wherein the sole protein in the material is soy protein isolate (C12/L28-35/Example IV). No other proteins are identified in Example IV of Kim et al.
Regarding claim 8, modified Kim et al. disclose all of the claim limitations as set forth above. Kim et al. disclose the freezing step is directional (where the cooling is substantially unidirectional-C6/L5-28).
Regarding claim 9, modified Kim et al. disclose all of the claim limitations as set forth above. Kim et al. disclose in Example IV a protein solution comprising 10% by weight soy protein isolate. As evidenced by Norton et al., soy protein isolate comprises 6.3 % by weight lysine (p. 3/Table 3). Therefore, soy protein isolate has a lysine score of about 122 (6.3/5.18 x 100 – see p. 22/L 29-35 of the present specification).
Kim et al. disclose any edible protein, or combination of proteins can be employed in the process providing that the sole protein or, in the case of combination, at least one of the proteins is soluble or partially soluble (i.e., at least 20% of the proteins would be soluble in the aqueous solution -C3/L3-8). Kim et al. disclose that in general, proteins having excellent solubility provide excellent, distinct fibrous structure (C3/L8-10).
Regarding claims 11 and 14 , modified Kim et al. disclose all of the claim limitations as set forth above. Kim et al. disclose salts (i.e., NaCl or KCl can be added to the protein solution (C3/L23-33).
Regarding claim 12, modified Kim et al. disclose all of the claim limitations as set forth above. Given, Kim et al. disclose mixing soy protein isolate with water to make a solution, it necessarily follows the soy protein would be hydrated to some extent. One of ordinary skill in the art would have been motivated to mix the soy protein isolate and water for a period of time sufficient to fully hydrate the protein.
Regarding claim 13, modified Kim et al. disclose all of the claim limitations as set forth above. Olatunde et al. teach adding transglutaminase to the protein solution in an amount of from about 0.0001% to about 10% by weight ([0009]). In the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art a prima facie case of obviousness exists (MPEP §2144.05 I).
Regarding claim 16, modified Kim et al. disclose all of the claim limitations as set forth above. Kim et al. disclose heat setting the frozen fibrous structure by subjecting the structure to a temperature of greater than 50°C (C6/L44-C7/L8, claim 1). Here a temperature of greater than 50°C includes the claimed temperature range of from 70°C to 250°C. In the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art a prima facie case of obviousness exists (MPEP §2144.05 I).
Regarding claim 17, modified Kim et al. disclose all of the claim limitations as set forth above. Kim et al. disclose freeze-drying the heat set frozen fibrous structure (claim 2).
Regarding claim 18, modified Kim et al. disclose all of the claim limitations as set forth above. Kim et al. disclose placing the soy protein isolate solution in a pan to a depth of about 1 inch and freezing (C12/Example IV). Kim et al. is silent with respect to height and width. However, where the only difference between Kim et al. and the prior art structure is the relative dimensions, since the relative size of the structure would be a matter of choice and intended use, the person of ordinary skill in the art prior to the effective filing date of the present application would have found it obvious to have made the frozen fibrous structure any width and height absent evidence the particular dimensions are significant (MPEP §2144.04 IV.C).
Claim 5 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 4,084,017) in view of Olatunde et al. (WO 2021/119614) as applied to claims 1 and 6, and further in view of Shenouda (US 4,423,083).
Regarding claims 5 and 19, modified Kim et al. disclose all of the claim limitations as set forth above. Kim et al. is silent with respect to a step of coating the fibrous protein material.
Shenouda teaches a method of making a fibrous protein product made by freeze a mixture of protein and alginate to form aligned protein fibers (Abstract). Shenouda teaches the fibrous product can be coated with a batter (i.e., solution of food polymers of vegetable origin) for cooking, baking or frying (C9/L5-7).
Kim et al. and Shenouda are combinable because they are concerned with the same field of endeavor, namely fibrous protein products made by freezing a solution of protein. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have coated the fibrous protein material of Kim et al. with a batter as taught by Shenouda to enhance cooking, baking or frying of the product.
Allowable Subject Matter
Claim 15 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Amendment
The Declaration under 37 CFR 1.132 filed December 9, 2025 is insufficient to overcome the rejection of claims 1-4, 6-14, 16-18 and 20 under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 4,084,017) in view of Olatunde et al. (WO 2021/119614) as set forth in the last Office action.
Declarant argue that it is not possible to combine Kim et al. and Olatunde et al. because Kim et al. does not refer to Olatunde et al. and Olatunde et al. does not refer to Kim et al.
A prima facie case of obviousness does not require that the primary or secondary references refer to one another. Rather Kim et al. and Olatunde et al. are considered in the same field of endeavor, namely producing textured plant protein products. Given Olatunde et al. teach using transglutaminase to crosslink protein, it would have been obvious to one of ordinary skill in the art at the time of the invention to have, prior to freezing, treated the aqueous protein solution of Kim et al. with transglutaminase to crosslink the protein and produce, after freezing, a stronger fibrous structure.
Declarant submits “experiments conducted at Umiami have show that combining these teachings does not lead to Invention”
The results of the experiment are not persuasive. The “recipe” is not a fair comparison with the prior art, Kim et al. The method of Kim et al. does not include Shea butter and NaCl. The recipe appear to be most similar to the present invention (see, for example, Examples 22 and 23). Note, the present method claims do not require the inclusion of a fat or salt. Moreover, the freeze step was conducted at a temperature of -25°C while the freezing method of Kim et al. uses a temperature of -76°C.
The experimental procedure appears to be substantially similar to the present invention. It is not clear how the experiments did not result in a fibrous food product.
Response to Arguments
Applicant's arguments filed December 9, 2025 have been fully considered but they are not persuasive.
Applicant submit “there is no sufficient evidence of record for the required motivation to modify the product and method of Kim by incorporating the teachings of Olatunde.” Applicant reasons that because Kim is directed to the cold texturization of proteins and does not mention enzymatic texturization of proteins and Olatunde et al. Ids directed to the enzymatic texturization of proteins and does not mention cold texturization of proteins.
While Kim et al. “does not suggest further improvement is desired,” Olatunde et al. provides the motivation to strengthen or improve the fibers formed in the process of Kim et al. by cross-linking the proteins prior to freeze texturizing.
Applicant submit the combination of Kim et al. and Olatunde et al. fails to achieve the claimed invention.
Applicant is directed to the Response to Amendment section set forth above.
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.
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ELIZABETH A. GWARTNEY
Primary Examiner
Art Unit 1759
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759