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 .
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 after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.114 has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 CFR 1.114.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 04/03/2026 has been entered.
Claim status
The examiner acknowledged the amendment made to the claims on 04/03/2026.
Claims 32-33, 35-37, 39, 41-44 and 46-69 are pending in the application. Claims 32-33, 44, 48, 58 and 60 are currently amended. Claims 34, 40 and 45 remain cancelled. Claim 38 is newly cancelled. Claims 67-69 are newly presented. Rest of claims are previously presented.. Claims 32-33, 35-37, 39, 41-44 and 46-69 are hereby examined on the merits.
Examiner Note
Any objections and/or rejections that are made in the previous actions and are not repeated below, are hereby withdrawn.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 32-33, 35-37, 39, 41-44, 46-52, 54, 56 and 68-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30-31, 33-36, 38-41 and 43-65 of copending Application No. 18/254,189 in view of Chaudemanche WO 2019/069111 A1 (cited in the IDS submitted 06/12/2025, hereinafter referred to as Chaudemanche). Regarding claims 32 and 68-69, claims 30 and 58 of ‘189 teaches every step except fermenting and/or acidifying the high-protein ingredient to obtain a plant-based food product. To this end, Chaudemanche teaches a method of preparing a non-dairy fermented food product such as yogurt comprising fermenting a pea protein isolate (0003; 0016; 0020; 0026). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have subjected the high leguminous protein ingredient to fermentation to prepare a non-dairy fermented food product. Regarding claim 33, claim 31 of ‘189 teaches the same leguminous protein raw material. Regarding claim 35, claim 33 of ‘189 teaches that the leguminous plant protein raw material is in powder form. Regarding claim 36, claim 34 of ‘189 teaches that the aqueous protein suspension contains 5-30% leguminous protein. Regarding claim 37, claim 35 of ‘189 teaches that the preparation step and the enzyme treatment step are carried out at temperature of 10-60 °C. Regarding claim 39, claim 36 of ‘189 teaches the preparation step is carried out from 10 min to 4 hours. Regarding claims 41-42 and 63-64, claims 59-61 and 38 of ‘189 teach the antioxidant species and concentration. Regarding claim 43, claim 39 of ‘189 teaches that the separation step is carried out by centrifugation. Regarding claims 44, 47 and 66, claims 41, 44 and 63 of ‘189 teaches the same enzyme species. Regarding claim 46, claim 43 of ‘189 teaches that an enzyme reaction time of 5 min to 2 hours. Regarding claim 48, claim 45 of ‘189 teaches that an enzyme dosage of 0.0001-10% on dry matter basis. Regarding claims 49-50, claims 46-47 of ‘189 teach the heat treatment is carried out at a temperature of 60-135 °C or 135 °C for 2-5 seconds. Regarding claim 51, claim 48 of ‘189 teaches that the membrane filtration is MF, UF NF or RO. Regarding claim 52, claim 49 of ‘189 teaches one or more diafiltration. Regarding claim 54, claim 51 of ‘189 teaches concentration and washing step are carried out to separate a retentate and a permeate. Regarding claim 55, claim 52 teaches the same step. Regarding claim 56 claim 53 of ‘189 teaches a pasteurization step followed by cooling to 25-40 °C. Regarding claim 57, claim 54 of ‘189 teaches drying. Regarding claim 58, claim 55 of ‘189 teaches that the high protein ingredient is an isolate with more than 90% protein. Regarding claim 59, claim 56 of ‘189 in view of Chaudemanche teaches a plant-based food product. Regarding claims 60-62, claim 57 of ‘189 in view of Chaudemanche teaches the same plant-based product. Regarding claim 65, claim 62 of ‘189 teaches decanter centrifuge.
This is a provisional nonstatutory double patenting rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 60-62 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 60 recites that the high protein ingredient has a white color. The examiner does not find support for such a limitation in the disclosure as originally filed. Claims 61-62 depend from claim 60 and therefore necessarily incorporate the written description deficiency therein.
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 60-62 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 60 recite that the high protein ingredient has no perceived bitterness. The limitation renders the claim indefinite because absent a recitation of the subject that tests the bitterness, one would not know the metes and bounds of the limitation. Is a machine used to measure bitterness, or is it a human subject? Note that the perception of bitterness in humans varies among individuals. Claims 61-62 are rejected because they depend from claim 60. Appropriate correction is required.
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.
Claims 32-33, 35-37, 39, 41-44, 46-66 and 68-69 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang US Patent Application Publication No. 2022/0015387 A1 (hereinafter referred to as Zhang) in view of Foster US Patent Application Publication No. 2019/0216126 A1 (cited in the IDS submitted 05/24/2023, hereinafter referred to as Foster) and Prevost US Patent Application Publication 2002/0090418 A1 (hereinafter referred to as Prevost), Segall US Patent Application Publication No. 2011/0274797 A1 (cited in the IDS submitted 05/24/2023, hereinafter referred to as Segall) and Chaudemanche WO 2019/069111 A1 (cited in the IDS submitted 06/12/2025, hereinafter referred to as Chaudemanche).
Regarding claims 32-33, 35, 44, 47, 51, 59, 66 and 68-69, Zhang teaches a process for producing a high protein ingredient having a protein content greater than about 70 wt% protein/dry matter (e.g., a protein base composition that comprises 60-90% protein or narrowly 75-85% protein by dry weight, wherein the protein content is expressed as Kjeldahl Nitrogen x 6.25; 0070; 0015), wherein the process comprises the steps of preparing a plant protein suspension (0039) by mixing leguminous plant protein raw material (e.g., pea, lentils, beans, lupin, peanuts, etc. 0028), at least one antioxidant, and water to obtain an aqueous protein suspension (0027; 0029; 0044); separating insoluble solids from the aqueous protein suspension to obtain a clarified aqueous protein suspension and an insoluble fraction (0058); subjecting the clarified aqueous protein suspension to heat treatment at a temperature of 127-148 °C (e.g., 260-300 F, 0027; 0059) to obtain a heat-treated aqueous protein suspension, and concentrating the heat-treated aqueous protein suspension using membrane filtration such as ultrafiltration to obtain a high protein ingredient as a retentate (0063-0064). Further, Zhang teaches that the leguminous plant protein raw material is air classified protein concentrate (0038; 0035), and that the leguminous plant protein raw material is in powder form (e.g., ground or flour, 0033).
Further, Zhang teaches that the pH of the aqueous composition comprising antioxidant is 6-8 or narrowly 6.5-7.5 (0057), which encompasses the pH range of 6-7 as recited in claim 32. 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).
Zhang is silent regarding treating the clarified aqueous protein suspension with at least one enzyme having tannase activity capable of modifying polyphenols originating from the leguminous plant raw material to obtain an enzyme-treated aqueous protein suspension.
Foster in the same field of endeavor teaches a method of making a plant (e.g., yellow pea, lentils, beans, and other legumes, Fig.1; 0059) protein composition comprising subjecting a plant material such as yellow pea flour to form a suspension (e.g. slurry) (0038-0039); conducting an alkaline proteolytic extraction on the aqueous slurry (0015), removing water insoluble components from the aqueous slurry to provide a clarified fraction (0015); performing an amylase and glucoamylase carbohydrate reactions on the clarified fraction to obtain a protein-rich, carbohydrate converted liquor (0015; 0047); and concentrating the liquor by ultrafiltration to separate protein from lower molecular weight materials (0015). Further, Foster teaches that subjecting the clarified fraction to amylase and glucoamylase treatment will convert carbohydrates (e.g., starch, maltodextrin, dextrin, maltose, fiber, etc.) present in the yellow pea into smaller sized carbohydrates which could pass through into the permeate in the downstream ultrafiltration step (0047).
Prevost in the same field of endeavor teaches a method of preparing a soy protein concentrate/isolate, comprising the step of mixing soy meal with water to form a slurry (0022); treating the slurry with an enzyme to remove trypsin inhibitor (0024; 0017); treating the slurry with carbohydrase enzyme complex (for example, Viscozyme L) to convert the long-chained oligosaccharide into lower molecular weight monosaccharide (0029-0031); and subjecting the enzyme-treated slurry to ultrafiltration, wherein the low molecular weight carbohydrate is in the permeate fraction (0035).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Zhang by subjecting the clarified aqueous protein suspension of Zhang to amylase and glucoamylase treatment and/or carbohydrase treatment as disclosed by Foster and Prevost so as to convert long or large carbohydrates to small carbohydrates or monosaccharides. Dong so would have removed the carbohydrates in the ultrafiltration step and results in a purer protein composition.
Amylase and glucoamylase as disclosed by Foster belong to carbohydrase enzyme. Viscozyme L comprises carbohydrase, cellulase, beta-glucanase, hemicellulose, and xylanase (0031 of Prevost). Further, Example 1 of the instant specification evidences that Viscozyme L has tannase activity, which necessarily modifies a polyphenol such as tannin.
Where Zhang as modified by Foster and Prevost teaches treating the clarified aqueous protein suspension with the same type of enzymes including those with tannase activity, it logically follows that the resulting enzyme-treated protein suspension has reduced bitterness. See In re Best.
Regarding the pH of the enzymatic reaction, Foster teaches that the amylase and glucoamylase reaction pH is 5-6 (0018). Prevost teaches that the protein slurry has a pH of 3-10 (0023), and the carbohydrase enzyme reaction pH is 4-6.5 (0029). Therefore, it would have been obvious to adjust the pH of the enzymatic reaction to 5-6 or 4-6.5 because those are the pHs that are known to be suitable for the enzyme to cleave a substrate. The pH of 5-6 or 4-6.5 overlaps the pH range of 6-7 as recited in claim 32. 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).
Zhang teaches that an antioxidant such as ascorbic acid (e.g., vitamin C), vitamin E, zingerone, thymol, BHT, or combination thereof (0047) can be used in the aqueous slurry of a leguminous protein (e.g., lentils, and peas), and the amount of antioxidant is 0.01-1 wt% antioxidant by weight of the suspension, for example, 0.01-0.1% vitamin C (0053; 0056). Zhang is silent regarding a sulfite salt or a sulfate salt.
In the same field of endeavor, Segall discloses the preparation of pulse (lentils, chickpeas, pea and beans) protein products by extraction of a protein source in an aqueous solution, followed by clarification (e.g., using a decanter centrifuge), and ultrafiltration/diafiltration (0005-0016, 0024-0030, 0038-0042), wherein an antioxidant such as sodium sulfite or Vitamin C (e.g., ascorbic acid) can be added to the aqueous solution at a concentration of 0.01-1% (0028).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Zhang by combining sodium sulfite with vitamin C with reasonable expectation of success, because "it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). MPEP 2144.06. In the instant case, prior art has established both vitamin C and sodium sulfite are suitable antioxidants in the process of extracting a leguminous protein by water, thus one of the ordinary skill in the art would have been motivated to combine the two.
Zhang teaches that the protein base composition can be a pea protein isolate (0070; 0029), and can be used to make a plant-based dairy analogues or dairy substitute such as yogurt or cheese (0082; 0090), which necessarily incorporates a fermenting step.
Further, Chaudemanche teaches that a plant-based dairy analogues or dairy substitute (e.g., a non-dairy fermented food product, abstract) can be made by fermenting a pea protein isolate with a LAB culture (0005; 0016; 0020; 0026).
Both Zhang and Chaudemanche are directed to plant-based dairy analogues/substitutes. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Zhang by subjecting the pea protein isolate of Zhang to a fermentation step by LAB culture to make a non-dairy fermented food or yogurt with reasonable expectation of success, for the reason that prior art has established that pea protein isolate can be used to make plant-based yogurt through fermenting.
Regarding claim 36, Zhang teaches that the leguminous protein raw material is combined with water in an amount of 1:1 to 1:100 w/w ratio plant source to water (0040), thus reasonably encompasses the protein concentration range as recited in the claim (for example, pea flour is known to contain ~20% protein, thus dispersing 1 gram of pea flour in 3 gram water will result in a suspension or slurry that contains, 0.2/ 4 = 5%). Further, Foster teaches dehulled pea contains ~50-60% protein (0038), and the aqueous slurry contains 5-12% pea particle (0017), thus the concentration of pea protein in the slurry is 2.5-7%. Further, Prevost teaches that the soy meal is mixed with water to form a slurry that has 10-30% soy meal (0022), thus assuming the soy meal contains ~40% protein, then the aqueous slurry contains 4%- 12% soy protein.
Regarding claim 37, Zhang teaches that the extraction step is carried out at a temperature of not more 38 °C (e.g., 100 F), preferably not more than 30 °C (e.g., 85 F) (0043). 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). Prevost teaches that the temperature for the soy meal to react with Viscozyme L is 50-60 °C (0029; 0031). Foster teaches that the clarified extract is reacted with amylase and glucoamylase at a temperature that is optimal for the enzyme to reduce the size of the carbohydrate fractions (0047). Therefore, it would have been obvious to one of ordinary skill in the art to carry out the enzymatic reaction at optimal temperature to ensure the performance of the enzyme.
Regarding claim 39, Zhang teaches mixing leguminous plant protein raw material, at least one antioxidant, and water to obtain an aqueous protein suspension but is silent regarding the duration of mixing. However, given that the purpose of the mixing is to extracting protein into water (0007; 0042), one of ordinary skill in the art would have been motivated to manipulate the time of extraction to ensure the efficient solubilization of the protein fraction from the leguminous plant raw material.
Regarding claims 41-42 and 63-64, Zhang teaches that the amount of antioxidant is 0.01-1 wt% antioxidant by weight of the suspension, for example, 0.01-0.1% vitamin C (0053; 0056). Segall teaches that the concentration in the antioxidant (e.g., sodium sulfite or vitamin C) in the aqueous solution at a concentration of 0.01-1% (0028). Further, in the case that the suspension contains both sodium sulfite and vitamin C, one of ordinary skill in the art would have been motivated to manipulate the amount of individual antioxidant for effective oxidation stability, provided that the total amount of the antioxidant in the suspension is within the range of 0.01-1 wt% as required by prior art.
Regarding claim 43, Zhang teaches removing insoluble solids by filtering, decentering and centrifugation (0058); and Foster teaches physical separation techniques including centrifugation, decanting, filtration, a hydro cyclone, a setting tank, a screening device or a combination thereof can be used to separate water insoluble materials from the protein-rich fraction (0046).
Regarding claim 46, Foster teaches incubating the amylase and glucoamylase with the clarified suspension for 2 hours (0065), and Prevost teaches incubating the slurry with carbohydrase enzyme for 1-5 hours (0032). On the other hand, the duration of an enzyme reaction is the general condition known by one of ordinary skill in the art to affect the composition of the product. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have varied the reaction time through routine experimentation so as to ensure that the long or large carbohydrates largely convert to smaller carbohydrates. As such, the time range as recited in the claim is merely an obvious variant of the prior art.
Regarding claim 48, Zhang in view of Foster and Prevost teaches an enzyme but is silent regarding the dosage of the enzyme by the dry weight of leguminous protein raw materials. However, the dosage of an enzyme in an enzyme reaction is the general condition known by one of ordinary skill in the art to affect the reaction time and/or the composition of the product. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have varied the enzyme dosage through routine experimentation so as to ensure that the long or large carbohydrates have largely converted to smaller carbohydrates in a given time. As such, the time range as recited in the claim is merely an obvious variant of the prior art.
Regarding claims 49-50, Zhang teaches subjecting the clarified aqueous protein suspension to heat treatment at a temperature of 127-148 °C for 1 second-5 min (or narrowly 1 second- 1 min, or 1-20 seconds (e.g., 260-300 F, 0027; 0059) to obtain a heat-treated aqueous protein suspension. 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 claims 52 and 54, Zhang teaches ultrafiltration step which necessarily results in a retentate that comprises protein, and a permeate that comprises small molecules. Zhang is silent regarding a washing step to separate a retentate and permeate. Foster teaches that the combination of ultrafiltration and diafiltrating can be used to separate the lower molecular weight components from a retentate comprising protein, wherein the retentate can be washed with water in the diafiltration step using the ultrafiltration membrane (0050; 0066). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Zhang by combining UF with DF with reasonable expectation of success, for the reason that such a combination is known in the art of concentrating protein composition to obtain a retentate with high protein concentration.
Regarding claim 53, Zhang teaches protein base composition can be dried or spray-dried to provide a protein concentrate or isolate in powder form (0068; 070; 0074; 0001), the process of which necessarily includes a process of evaporation.
Regarding claims 55-57, Zhang as modified by Foster and Prevost teaches UF/DF of the plant protein (e.g., pea, lentils, beans and peanuts, 0028) solution and further teaching spray drying the protein solution to provide a protein concentrate or isolate (0068; 0070). Additionally, Prevost teaches that the retentate can be pasteurized and dried to form a protein concentration or isolate (0036). Cited arts are silent regarding the pasteurization condition as recited in claim 55, or the cooling and the conditions thereof as recited in claim 56.
In the same field of endeavor, Segall discloses a method of preparing pulse (lentils, chickpeas, pea and beans; 0020) protein products by extraction of a protein source in an aqueous solution, followed by clarification (e.g., using a decanter centrifuge), ultrafiltration/diafiltration (e.g., UF/DF) (0005-0016, 0024-0030, 0038-0042), a pasteurizing step, a cooling step and a drying step (0055), in which the UF/DF solution is pasteurized at a temperature of 55-70 °C for 30 seconds to 60 min, followed by cooled to 25-40 °C before it is dried (0055).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Zhang by subjecting the concentrated protein solution to a pasteurization step as disclosed by Segall to eliminate harmful pathogen, followed by a cooling step such that the protein solution is ready for being dried.
Regarding claim 58, Zhang teaches that the protein based composition is an isolate with protein content of 60-90% protein by dry weight (0070); further, Zhang as modified by Foster or Prevost results in the removal of long chain or large carbohydrate from the leguminous protein raw material, therefore, it logically follows that the maximum protein content upon membrane filtration (e.g., UF) could be higher than 90%
Regarding claims 60-62, Zhang as modified by Foster, Prevost, Segall and Chaudemanche teaches a leguminous plant-based high protein ingredient in connection with claims 32 and 58. Further Zhang alone or Zhang in view of Chaudemanche teaches a plant-based yogurt. Additionally, Chaudemanche teaches that the yogurt comprises live and active LAB (0016; 0046).
On the limitation that the high protein ingredient has white odor and no perceived bitterness: since Zhang as modified by Foster, Prevost, Segall and Chaudemanche as recited above teaches a method of preparing a leguminous plant-based high protein ingredient which is the same as the claimed invention, it logically follows that the leguminous plant-based high protein ingredient as disclosed by prior art has neutral color and no perceived bitterness. See MPEP 2112.01 I, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Regarding claim 65, Zhang teaches removing insoluble solids by filtering, decentering and centrifugation (0058); and Foster teaches physical separation techniques including centrifugation, decanting, filtration, a hydro cyclone, a setting tank, a screening device or a combination thereof can be used to separate water insoluble materials from the protein-rich fraction (0046). Further, Segall teaches that the aqueous phase resulting from the extraction step may be separated from the residual pulse protein source by employing a decanter centrifuge, followed by disc centrifugation and filtration to remove residual pulse protein source material (0029). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Zhang by applying decanter centrifuge before centrifugation or filtration with reasonable expectation of success, for the reason that prior art has established that such an approach is able to separate insoluble solids from the aqueous protein solution in the process of extracting a leguminous protein by water.
Claims 32 and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang US Patent Application Publication No. 2022/0015387 A1 (hereinafter referred to as Zhang) in view of Foster US Patent Application Publication No. 2019/0216126 A1 (cited in the IDS submitted 05/24/2023, hereinafter referred to as Foster) and Prevost US Patent Application Publication 2002/0090418 A1 (hereinafter referred to as Prevost), Segall US Patent Application Publication No. 2011/0274797 A1 (cited in the IDS submitted 05/24/2023, hereinafter referred to as Segall) and McMindes US Patent Application Publication No. 2007/0269567 A1 (hereinafter referred to as McMindes).
Regarding claims 32 and 67, Zhang teaches a process for producing a high protein ingredient having a protein content greater than about 70 wt% protein/dry matter (e.g., a protein base composition that comprises 60-90% protein or 75-85% protein by dry weight, wherein the protein content is expressed as Kjeldahl Nitrogen x 6.25; 0070; 0015), wherein the process comprises the steps of preparing a plant protein suspension (0039) by mixing leguminous plant protein raw material (e.g., pea, lentils, beans, lupin, peanuts, etc., 0028), at least one antioxidant, and water to obtain an aqueous protein suspension (0027; 0029; 0044); separating insoluble solids from the aqueous protein suspension to obtain a clarified aqueous protein suspension and an insoluble fraction (0058); subjecting the clarified aqueous protein suspension to heat treatment at a temperature of 127-148 °C (e.g., 260-300 F, 0027; 0059) to obtain a heat-treated aqueous protein suspension, and concentrating the heat-treated aqueous protein suspension using membrane filtration such as ultrafiltration to obtain a high protein ingredient as a retentate (0063-0064). Further, Zhang teaches that the leguminous plant protein raw material is air classified protein concentrate (0038; 0035), and that the leguminous plant protein raw material is powder form (e.g., ground or flour, 0033).
Further, Zhang teaches that the pH of the aqueous composition comprising antioxidant is 6-8 (0057), which encompasses the pH range of 6-7 as recited in claim 32. 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).
Zhang is silent regarding treating the clarified aqueous protein suspension with at least one enzyme having tannase activity capable of modifying polyphenols originating from leguminous plant raw material to obtain an enzyme-treated aqueous protein suspension.
Foster in the same field of endeavor teaches a method of making a plant (e.g., yellow pea, lentils, beans, and other legumes, Fig.1; 0059) protein composition comprising subjecting a plant material such as yellow pea flour to form a suspension (e.g. slurry) (0038-0039); conducting an alkaline proteolytic extraction on the aqueous slurry (0015), removing water insoluble components from the aqueous slurry to provide a clarified fraction (0015); performing an amylase and glucoamylase carbohydrate reactions on the clarified fraction to obtain a protein-rich, carbohydrate converted liquor (0015; 0047); and concentrating the liquor by ultrafiltration to separate protein from lower molecular weight materials (0015). Further, Foster teaches that subjecting the clarified fraction to amylase and glucoamylase treatment will convert carbohydrates (e.g., starch, maltodextrin, dextrin, maltose, fiber, etc.) present in the yellow pea into smaller sized carbohydrates which could pass through into the permeate in the downstream ultrafiltration step (0047).
Prevost in the same field of endeavor teaches a method of preparing a soy protein concentrate/isolate, comprising the step of mixing soy meal with water to form a slurry (0022); treating the slurry with an enzyme to remove trypsin inhibitor (0024; 0017); treating the slurry with carbohydrase enzyme complex (for example, Viscozyme L) to convert the long-chained oligosaccharide into lower molecular weight monosaccharide (0029-0031); and subjecting the enzyme-treated slurry to ultrafiltration, wherein the low molecular weight carbohydrate is in the permeate fraction (0035).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Zhang by subjecting the clarified aqueous protein suspension of Zhang to amylase and glucoamylase treatment and/or carbohydrase treatment as disclosed by Foster and Prevost so as to convert long or large carbohydrates to small carbohydrates or monosaccharides. Dong so would have removed the carbohydrates in the ultrafiltration step and results in a purer protein composition.
Amylase and glucoamylase as disclosed by Foster belong to carbohydrase enzyme. Viscozyme L comprises carbohydrase, cellulase, beta-glucanase, hemicellulose, and xylanase (0031 of Prevost). Further, Example 1 of the instant specification evidences that Viscozyme L has tannase activity, which necessarily modifies a polyphenol such as tannin.
Where Zhang as modified by Foster and Prevost teaches treating the clarified aqueous protein suspension with the same type of enzymes including those with tannase activity, it logically follows that the resulting enzyme-treated protein suspension has reduced bitterness. See In re Best.
Regarding the pH of the enzymatic reaction, Foster teaches that the amylase and glucoamylase reaction pH is 5-6 (0018). Prevost teaches that the protein slurry has a pH of 3-10 (0023), and the carbohydrase enzyme reaction pH is 4-6.5 (0029). Therefore, it would have been obvious to adjust the pH of the enzymatic reaction to 5-6 or 4-6.5 because those are the pHs that are known to be suitable for the enzyme to cleave a substrate. The pH of 5-6 or 4-6.5 overlaps the pH range of 6-7 as recited in claim 32. 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).
Zhang teaches that an antioxidant such as ascorbic acid (e.g., vitamin C), vitamin E, zingerone, thymol, BHT, or combination thereof (0047) can be used in the aqueous slurry of a leguminous protein (e.g., lentils, and peas), and the amount of antioxidant is 0.01-1 wt% antioxidant by weight of the suspension, for example, 0.01-0.1% vitamin C (0053; 0056). Zhang is silent regarding a sulfite salt or a sulfate salt.
In the same field of endeavor, Segall discloses the preparation of pulse (lentils, chickpeas, pea and beans) protein products by extraction of a protein source in an aqueous solution, followed by clarification (e.g., using a decanter centrifuge), and ultrafiltration/diafiltration (0005-0016, 0024-0030, 0038-0042), wherein an antioxidant such as sodium sulfite or Vitamin C (e.g., ascorbic acid) can be added to the aqueous solution at a concentration of 0.01-1% (0028).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Zhang by combining sodium sulfite with vitamin C with reasonable expectation of success, because "it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). MPEP 2144.06. In the instant case, prior art has established both vitamin C and sodium sulfite are suitable antioxidants in the process of extracting a leguminous protein by water, thus one of the ordinary skill in the art would have been motivated to combine the two.
Zhang teaches that the protein base composition contains 60-90% protein which qualifies as plant (e.g., pea, lentils, beans, lupin and peanuts, etc.) protein concentrate or isolate (0070; 0028-0029), and can be used to make a protein enriched food and beverage products selected from frozen dessert, sport drinks, juice, smoothies, snack food, bakery product, nutritional RTM powder product, sport/nutritional bar, nutritional tea, nutritional coffee, meats, nut-based butter, milk, cream, milk powder, yogurt, cheese, coffee creamer, etc. etc.(0082; 0089-0090). Further, Segall discloses the pulse (lentils, chickpeas, pea and beans) protein products obtained by extraction of a protein source in an aqueous solution, followed by clarification and ultrafiltration/diafiltration (0005-0016, 0024-0030, 0038-0042) is a pulse protein isolate which can be used to make a plant-based meat analogue (0019).
Zhang or Segall does not explicitly teach fermenting the protein base composition or the pulse protein isolate and obtaining a meat analogue.
McMindes teaches a method of making a plant based meat analogue (e.g., restructured meat) that comprises a plant protein such as isolate of legumes, pea, lupin, etc., wherein the process comprising the step of fermenting or acidifying the meat analogue (0024; 0076; 0092; 0114; claims 1 and 10).
Both Zhang and McMindes are directed to plant isolates derived from pea, lupin and legume. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Zhang by subjecting the protein base composition of Zhang to the process of McMindes to make a plant-based meat analogue with reasonable expectation of success, for the reason that prior art has established that the aforementioned protein can be used to make plant-based analogue which comprises a fermentation or acidification step of the plant protein.
Response to Arguments
Applicant's arguments filed 04/03/2026 have been fully considered but they are not persuasive.
Applicant argues on pages 8-9 of the Remarks that neither Zhang nor Segall teach the feature of mixing the protein suspension with the combination of a sulfite and ascorbic acid at the pH of 6-7.
The argument is considered but found not persuasive because although prior art teaches using sulfite or ascorbic but not both together, "it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). MPEP 2144.06. Note that Segall teaches that both sulfite and ascorbic acid serve to inhibit oxidation of any phenolic in the protein solution (0028), thus it is obvious to combine the two to form an antioxidant system.
Further, Zhang teaches a pH 6-8 or narrowly 6.5-7.5 which encompasses the pH as recited in the claim. As such, Zhang as modified by Segall renders obvious the limitation about mixing the protein concentrate with the combination of a sulfite and ascorbic acid at the pH of 6-7.
Applicant argues on page 9 para. 1 of the Remarks that the cited arts provide no motivation to utilize the specific combination of the antioxidants to achieve the result of inhibiting distinct enzymatic pathways.
The argument is considered. However, rationale different from applicant’s is permissible. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). See MPEP 2144 IV. In the instant case, the motivation to combine the two antioxidants is in In re Kerkhoven, which instructs that "it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.
On the other hand, prima facie obviousness is not rebutted by merely recognizing additional advantages or latent properties present but not recognized in the prior art. "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In the instant case, where Zhang as modified teaches mixing a sulfite and ascorbic acid in the leguminous protein suspension, the benefit of inhibiting distinct enzymatic pathways is within the teaching of the prior art.
On page 9 of the Remarks, applicant cites some literatures and argues that since the two types of antioxidants address fundamentally different mechanisms, there is no teaching in the cited art that two antioxidants operating by different mechanisms would be needed to control this pathway.
The argument is considered but found unpersuasive because first, rationale different from applicant’s is permissible (see above). Second, in combining two antioxidants to form a new composition, there is no requirement that the two antioxidants need to work under the same mechanisms, rather, Segall teaches that both sulfite and ascorbic acid serve to inhibit oxidation of any phenolic in the protein solution (0028), suggesting that combining them in one composition is reasonable (In re Kerkhoven instructs that "it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose). Further. None of the literatures as cited by the applicant discourages the combined use of sulfite and ascorbic acid. To this end, applicant’s attention is drawn to para. [0047] of Zhang which teaches that “the antioxidant composition is vitamin E compositions, Vitamin C compositions, catechin, genistein, and 1,3,5-trihydroxybenzene, small quantities of ascorbic acid, tannic acid, gallic acid, synthetic antioxidants such as butylated hydroxyanisol (BHA) and butylated hydroxytoluene (BHT), emerging antioxidants such as thymol, carvacrol, 6-gingerol, hydroxytyrosol and zingerone as well as vegetal antioxidant extracts ( e.g. beta carotene, rosemary and mauqi berry), or combinations thereof”. So based on applicant’s reasoning, all those antioxidants can be used together in Zhang’s protein suspension is because they operated under the same mechanism? Such a reasoning is self-defeating.
Applicant argues on page 10 of the Remarks that a person of ordinary skill in the art would avoid sulfite based antioxidant in protein food application due to the off-flavor issue. Applicant goes on to argue that sulfite is provided in step a) because the subsequent membrane filtration will remove the sulfite but the cited arts suggested this integrated approach.
That person would not, because Segall says it is suitable to use 0.01-1% sulfite type antioxidant in a protein composition (see 0028 of Segall). Further, it is noted that Zhang teaches the same membrane treatment as the claimed invention thus modified Zhang will also remove the sulfite. It is further noted that Segall reference which uses sulfite antioxidant also includes a downstream membrane treatment (e.g., UF of DF), which is the same as the claimed invention, suggesting that applicant is not the first to use a sulfite-based antioxidant in a protein suspension followed by downstream membrane treatment which removes sulfite.
On the other hand, the examiner notes that applicant has not shown any new result associated with the combination of the two antioxidants.
Applicant argues on pages 10-11 of the Remarks that cited arts fail to tach functional tannase treatment to modify polyphenol. In particular, applicant argues that cited arts lack any teaching of the functional feature of treating the aqueous protein suspension with an enzyme having tannase activity to modify polyphenol….”to obtain an enzyme-treated aqueous protein suspension with reduced bitterness”. Applicant goes on to assert that starch is not degraded in the present process. Applicant thus concludes that the purpose of enzymatic treatment in the present claims is fundamentally different from that of Foster and Prevost.
The arguments are considered but found unpersuasive. Applicant is basically saying that although the claimed invention uses the same enzyme (e.g., Viscozyme L) the protein suspension as the prior art, it is for a different purpose. However, rationale different from applicant’s is permissible. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). See MPEP 2144 IV.
On the other hand, prima facie obviousness is not rebutted by merely recognizing additional advantages or latent properties present but not recognized in the prior art. "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In the instant case, where Zhang as modified by Prevost teaches treating the protein suspension with an enzyme having tannase activity to modify polyphenol, the benefit of reducing bitterness is within the teaching of the prior art.
As for applicant’s assertion that starch is not degraded in the present process, attention of the applicant is drawn to instant claims 47 and 66, which recites that an carbohydrase enzyme such as amylase and glucoamylase are also added to the protein suspension. Those enzymes will degrade starch present in the protein suspension.
Applicant argues on page 11 of the Remarks that none of the references of record provides a teaching to conduct tannase-mediated polyphenol modification at a pH of 6-7 on clarified leguminous protein suspension for the purpose of maintaining the solubility of the protein while also enabling modification of the polyphenol.
The argument is considered but found unpersuasive because Foster teaches that the amylase and glucoamylase reaction pH is 5-6 (0018). Prevost teaches that the protein slurry has a pH of 3-10 (0023), and the carbohydrase enzyme reaction pH is 4-6.5 (0029). As such, prior art teaches a pH range that overlaps with the range as recited in the claim thus prima facie case of obviousness exists. Further, absent an evidence of showing, applicant’s assertion that a pH of 6-7 is superior in maintaining the solubility of the protein while also enabling modification of the polyphenol is merely conclusive remarks. See MPEP 716.01(c) II. Attorney arguments cannot take the place of evidence. MPEP 2145 I. Argument does not replace evidence where evidence is necessary.
Applicant argues on page 12 of the Remarks that Chaudemanche is silent regarding preparing protein suspension that comprises the antioxidants, or enzymatic treatment.
The arguments are considered but found piecemeal. Chaudemanche is cited to teach the step fermentation to make a yogurt analogue, and when combined with Zhang, Foster and Prevost, teaches rest of the limitations in claim 32.
Applicant argues on page 12 of the Remarks that the pea protein isolate of Chaudemanche cannot render obvious the high protein ingredient as recited in claim 60 since it lacks the aforementioned steps.
The argument is considered but found unpersuasive because the pea protein isolate of Chaudemanche is not relied upon to render obvious claim 60, rather, the pea protein isolate of Zhang in view of Foster, Prevost and Chaudemanche is. Given that cited arts in combination arrive at the process of claim 32, the high protein ingredient of claim 6 is met by prior art.
Applicant argues on page 13 of the Remarks that the synergistic interaction of the featured recited in step a) and c ) produces results not predictable from the cited arts.
Applicant is again asserting unexpected result. See para. 61 of the office action issued 11/07/2025 for examiner’s stance. Further, a synergies effect needs to be demonstrated by experiment and comparison, not merely by attorney’s argument. See MPEP 716.01(c) II. Attorney arguments cannot take the place of evidence. MPEP 2145 I. Argument does not replace evidence where evidence is necessary.
Conclusion
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/CHANGQING LI/Primary Examiner, Art Unit 1791
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