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 of the Request for Continued Examination (RCE under 37 CFR 1.114) and the Response and Amendment filed 16 March 2026 is acknowledged.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 34, 42, 71-72, 102-103, 106 and 108-123
Withdrawn claims: None
Previously canceled claims: 1-33, 35-41, 43-70, 73-101, 104-105, and 107
Newly canceled claims: None
Amended claims: None
New claims: None
Claims currently under consideration: 34, 42, 71-72, 102-103, 106 and 108-123
Currently rejected claims: 34, 42, 71-72, 102-103, 106 and 108-123
Allowed claims: None
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 in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 16 March 2026 has been entered.
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 34, 42, 71-72, 103, 106, 108-110, 112, and 114-115 are rejected under 35 U.S.C. 103 as unpatentable over Liu et al. (CN 103766573 A, machine translation of the document cited on the IDS filed on 9 December 2022) in view of Segall et al. (US 2019/0021364 A1) as evidenced by Shahbal et al. (Shahbal, N., Jing, X., Bhandari, B., Dayananda, B., and Prakash, S. (2023). Effect of enzymatic hydrolysis on solubility and surface properties of pea, rice, hemp, and oat proteins: Implication on high protein concentrations. Food Bioscience, 53(102515), 1-10. https://doi.org/10.1016/j.fbio.2023.102515).
Regarding claim 34, Liu teaches a method for producing a protein composition ([0004]), the method comprising:
(a) adding an aqueous solution to a source protein composition to form a solution of solubilized protein – “mixing low temperature defatted soybean meal with alkaline water” ([0005]).
(b) optionally removing solids from the solution of solubilized protein – “extracted soymilk is mixed with an ethanol solution” ([0005]) indicates an implicit step of separating the solids from the solution of solubilized protein obtained in the alkaline extraction, wherein the extracted soymilk is the liquid phase of the extraction.
(c) heating the solution of solubilized protein – “the extraction temperature is 30 °C to 40 °C” ([0006]).
(d) optionally adjusting the pH of the solution of solubilized protein to about 4.0 to about 9.0 – “the extraction pH is 7.2-7.4” ([0005]).
(f) adding an organic solvent to the solution of solubilized protein to form a solid phase and a liquid phase – “the extracted soy milk is mixed with an ethanol solution and stirred for alcohol precipitation” and subsequently centrifuged “to obtain a liquid phase and a solid phase” ([0005]).
(g) separating the solid phase from the liquid phase to form the protein composition – the solution obtained by centrifugation is sent to an evaporation concentration tank to reclaim the ethanol ([0009]), and the solid phase protein curd obtained by centrifugation is washed with water ([0010]), indicating separation of the solid phase from the liquid phase.
(h) optionally washing the protein composition with a wash solvent – “washing with water comprises: mixing the solid phase protein curd obtained by centrifugation with water and centrifuging” ([0010]).
(i) optionally resolubilizing the protein composition – Liu teaches that the solid phase protein milk obtained by centrifugation is subjected to enzymatic hydrolysis with alkaline protease ([0005]). As evidenced by Shahbal, enzymatic hydrolysis of proteins with the alkaline protease Alcalase® greatly increases protein solubility (p. 9, col. 1, ¶ 4). Therefore, Liu teaches resolubilizing the protein composition.
wherein the protein composition comprises at least 50% by dry weight of a plurality of plant proteins – the protein isolate is a spray-dried total alkaline extract from defatted soybean meal ([0004] – [0005]). Liu terms the product of the method a “protein isolate”, which is commonly accepted as comprising at least 90% by dry weight of protein.
It is noted that step (e) is optional and therefore not required.
Liu does not discuss heating the solution of solubilized protein at a temperature of about 85 °C to about 95 °C or that the protein composition comprises less than 0.8% by dry weight of lipids.
However, Segall teaches a method of producing a pulse protein product ([0027]) comprising the steps of forming an aqueous solution of solubilized pulse protein ([0028]), separating the aqueous pulse protein solution from residual pulse protein source ([0028]), heat treating the pulse protein solution ([0031], [0039]), adjusting the pH of the aqueous pulse protein solution to about pH 6 to about 8 ([0036]), concentrating ([0033]), diafiltering ([0034]), and drying the pulse protein solution ([0039]). The heat treatment is carried out at a temperature of about 70 °C to about 160 °C, more preferably about 85 °C to about 95 °C ([0041], [0076], [0100]). Segall teaches, “The heat treatment step serves to modify the functional properties of the protein product, namely lowering the solubility of the protein and increasing the water binding capacity of the material” ([0017]).
Regarding the lipid concentration, Segall teaches that the separated aqueous pulse protein solution may be subjected to a defatting operation, if required, by “any convenient procedure” ([0070]). Segall also teaches that the invention refers mainly to the production and use of pulse protein isolates having a protein content “preferably at least about 100 wt%” ([0044]). Therefore, it is understood that Segall provides a method for producing a pulse protein isolate having a protein content of 100 wt%, meaning that the lipid content is 0 wt%.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Liu with the teachings of Segall to include a heat treatment step at a temperature of about 85 °C to 95 °C. First, Liu teaches that defatted soybean meal is extracted by heating at a temperature from 30 °C to 40 °C, and then the extracted protein is precipitated with ethanol ([0005] – [0006]). Since Segall teaches that heat treating at a temperature from about 85 °C to about 95 °C lowers the solubility of the protein, and Liu seeks to precipitate (i.e., lower the solubility) of the protein, one of ordinary skill in the art would have been motivated to increase the amount of precipitated protein and/or facilitate precipitation of the protein by adding a heat treatment from about 85 °C to about 95 °C as taught by Segall. One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention because Liu teaches the base protein extraction method and Segall teaches heat treating a solubilized protein solution adjusted to about pH 6 to about pH 8 at about 85 °C to about 95 °C.
Regarding the lipid concentration, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of Liu with the teachings of Segall to include a defatting operation to provide a protein isolate without lipids. One of ordinary skill in the art would have been motivated to do so in order to provide a highly pure protein isolate. One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Segall teaches that a defatting operation may be added ([0070]) and that a pulse protein isolate with a protein content of at least about 100 wt% can be obtained ([0044]).
Therefore, claim 34 is rendered obvious.
Regarding claim 42, Liu teaches the method of claim 34, wherein the organic solvent is ethanol – “the extracted soy milk is mixed with an ethanol solution and stirred for alcohol precipitation” and subsequently centrifuged “to obtain a liquid phase and a solid phase” ([0005]).
Therefore, claim 42 is rendered obvious.
Regarding claim 71, Liu and Segall teach the method of claim 34, and as such, a protein composition produced by the method of claim 34.
Liu also teaches that the soy protein isolate is suitable for use in a solid beverage ([0004]), and that soy protein isolates are widely used in various solid and liquid beverages ([0003]).
Liu does not discuss a method for preparing a food product, the method comprising combining a fat and one or more optional flavor precursor compounds with the soy protein isolate.
However, Segall teaches that the pulse protein isolate is useful in dairy analogue or dairy alternative beverages ([0103]), that the dairy analogue or dairy alternative beverages optionally contain fat ([0104]), and may contain added suitable food grade flavorings ([0109]).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of Liu with the teachings of Segall to produce a dairy analogue or dairy alternative beverage by combining fat, flavorings, and the soy protein isolate. One of ordinary skill in the art would have been motivated to do so in order to provide a ready-to-consume product comprising the soy protein isolate. One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Segall teaches dairy analogues or dairy alternative beverages comprising protein isolates, fat, and flavorings.
Therefore, claim 71 is rendered obvious.
Regarding claim 72:
Claim Interpretation:
The phrase, “for reducing perceived protein source flavor in a food product” is a statement of intended use for the method. A statement with regard to intended use is not further limiting insofar as the structure of the invention is concerned. In order to patentably distinguish the claimed invention from the prior art, a claimed intended use must result in a structural difference between the claimed invention and the prior art. See MPEP § 2111.02(II). In the present case there is no difference between the method suggested in the prior art and the claimed method. This clause is therefore not limiting.
It is also noted that the phrase, “thereby reducing perceived protein source flavor in a food product, as compared to a food product having a similar protein content but lacking the protein composition” is a statement expressing the intended result of the method.
A statement with regard to the intended use of an invention is not further limiting insofar as the structure of the invention is concerned. In order to patentably distinguish the claimed invention from the prior art, a claimed intended use must result in a structural difference between the claimed invention and the prior art. See MPEP § 2111.02(II). Additionally, In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). See MPEP § 2111.04(I).
In the present case, the “thereby” clause, similar to a “whereby” clause, expresses the intended result of the method step of combining a fat, one or more flavor precursor compounds, and at least 5% by weight of the protein composition produced by the method of claim 34, that is, a food product with reduced protein source flavor resulting from the presently claimed method compared to a method not using the claimed protein composition. This clause is therefore not given patentable weight.
The claimed method is therefore interpreted as, “A method comprising combining a fat, one or more flavor precursor compounds and a protein composition, wherein the protein composition is produced by the method of claim 34, wherein at least 5% by weight of the protein content of the food product comprises the protein composition.”
Claim Rejection:
Liu and Segall teach the method of claim 34, and as such, a protein composition produced by the method of claim 34.
Liu also teaches that the soy protein isolate is suitable for use in a solid beverage ([0004]), and that soy protein isolates are widely used in various solid and liquid beverages ([0003]). Liu further teaches that the method optimizes the flavor of the product ([0014]).
Liu does not discuss a that the method comprises combining a fat and one or more optional flavor precursor compounds with the soy protein isolate.
However, Segall teaches that the pulse protein isolate is useful in dairy analogue or dairy alternative beverages ([0103]), that the dairy analogue or dairy alternative beverages optionally contain fat ([0104]), and may contain added suitable food grade flavorings ([0109]). Segall further teaches, “The protein component used in the dairy analogue or dairy alternative beverages provided herein is a pulse protein having a clean flavour and a neurtral pH in solution of about 6.0 to about 8.0, such as the pH adjusted pulse protein product of the present invention.” ([0103]), i.e., the entirety of the protein in the dairy analogue or dairy alternative beverage is the protein isolate of the invention.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of Liu with the teachings of Segall to produce a dairy analogue or dairy alternative beverage by combining fat, flavorings, and the soy protein isolate produced by the method as the protein of the analogue/beverage. One of ordinary skill in the art would have been motivated to do so in order to provide a ready-to-consume product comprising the soy protein isolate. One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Segall teaches dairy analogues or dairy alternative beverages comprising protein isolates, fat, and flavorings.
Therefore, claim 72 is rendered obvious.
Regarding claim 103, Liu and Segall teach the method of claim 34 as described above.
The cited prior art does not discuss that the protein composition has an isoflavone content of less than about 125 ppm, a saponin content of less than about 75 ppm, or a phospholipid content of less than about 500 ppm.
However, the method of Liu as modified by Segall described regarding claim 34 uses claimed steps (a)-(d) and (f)-(i) to produce the soy protein isolate. Step (e) is optional. When the method steps recited in the prior art reference are substantially identical to those of the claims, claimed properties of the resulting composition are presumed to be present in the composition of the prior art. The burden of proof shifts to the applicant to provide objective evidence (i.e., test data) to the contrary. See In re Best, 562, F.2d 1252, 1254, 195 USPQ 403, 433 (CCPA 1977). MPEP § 2112.02(I).
Therefore, where Liu and Segall teach the method of claim 34, one can expect that the same properties are present in the resulting soy protein isolate of the prior art, including an isoflavone content of less than about 125 ppm, a saponin content of less than about 75 ppm, or a phospholipid content of less than about 500 ppm as claimed.
Therefore, claim 103 is rendered obvious.
Regarding claim 106, Liu and Segall teach the method of claim 71, as described above, wherein the food product comprises at least 10% by dry weight of the protein composition – The proposed modification of Liu with the teachings of Segall described regarding claim 71 is to include the protein composition produced by the method as the entirety of the protein in the dairy analogue or dairy alternative beverage. Therefore, claim 106 is obvious for the same reasons as described regarding claim 71.
Regarding claim 108, Liu and Segall teach the method of claim 71.
As described regarding claim 71 above, the resulting food product is a dairy analogue or dairy alternative beverage.
Segall further teaches, “The dairy analogue or dairy alternative product is a beverage, which preferably is formulated and prepared to possess organoleptic and/or nutritional properties similar to cow's milk.” ([0056]). Additionally, Segall teaches that said product may include emulsifiers ([0106]). Dry ingredients are blended together with aqueous liquid ingredients ([0112]), and may be homogenized to disperse the fat phase and discourage it from separating from the aqueous phase ([0114]). Therefore, Segall teaches that the food product is a milk replica, wherein the milk replica comprises an emulsion of the fat, water, and the protein composition.
Where it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of Liu with the teachings of Segall to produce a dairy analogue or dairy alternative beverage as described regarding claim 71, it also would have been obvious to produce a milk replica, wherein the milk replica comprises an emulsion of the fat, water, and the protein composition, as taught by Segall, with the same motivation, and with the same expectation of success, as set forth regarding claim 71.
Therefore, claim 108 is rendered obvious.
Regarding claim 109, Liu and Segall teach the method of claim 34.
The cited prior art does not specifically discuss that the protein composition has: (i) a saponin content that is less than 50% of the saponin content of the source protein composition; (ii) an isoflavone content that is less than 50% of the isoflavone content of the source protein composition; (iii) a phospholipid content that is less than 50% of the phospholipid content of the source protein composition; (iv) a lipid content that is less than 50% of the lipid content of the source protein composition; (v) a phenolic acid content that is less than 50% of the phenolic acid content of the source protein composition; and/or (vi) a flavor compounds content that is less than 50% of the flavor compounds content of the source protein composition, wherein the flavor compounds are selected from the group consisting of aldehydes, ketones, esters, alcohols, pyrazines, pyranones, acids, sulfur compounds, terpenes, furans, alkanes, alkenes, and combinations thereof.
However, the method of Liu as modified by Segall described regarding claim 34 uses claimed steps (a)-(d) and (f)-(i) to produce the soy protein isolate. Step (e) is optional. When the method steps recited in the prior art reference are substantially identical to those of the claims, claimed properties of the resulting composition are presumed to be present in the composition of the prior art. The burden of proof shifts to the applicant to provide objective evidence (i.e., test data) to the contrary. See In re Best, 562, F.2d 1252, 1254, 195 USPQ 403, 433 (CCPA 1977). MPEP § 2112.02(I).
Indeed, Figure 11 of the instant specification shows that isoflavones (e.g., total aglycon and total glucoside isoflavones), saponins (e.g., soyasaponin), and phospoholipids (e.g., phosphatidylcholine) of pureSPI are reduced well below 50% of the starting amounts in soy flour. The pureSPI of the instant specification was prepared by the method described in Example 16 (pp. 153-154), which comprises steps that are substantially identical to the method of claim 34. Therefore, where Liu and Segall teach the method of claim 34, one can expect that the same properties are present in the resulting soy protein isolate of the prior art. While Applicant’s data in Figure 11 provide evidence that this is true for elements (i)-(iii) of claim 109, the same can be expected for elements (iv)-(vi). It is also noted that elements (i)-(vi) are alternatives.
Therefore, claim 109 is rendered obvious.
Regarding claim 110, Liu and Segall teach the method of claim 34.
Liu also teaches that the organic solvent is ethanol ([0005]).
Claim 110 is therefore obvious.
Regarding claim 112, Liu and Segall teach the method of claim 34.
Liu also teaches that the wash solvent is an aqueous solution – “washing with water” ([0010]).
Claim 112 is therefore obvious.
Regarding claim 114, Liu and Segall teach the method of claim 34.
Liu also teaches that the source protein composition is at least 90% plants, a part or derivative thereof on a dry weight basis – Liu teaches that the soy protein isolate is produced from defatted soybean meal ([0005]).
Claim 114 is therefore obvious.
Regarding claim 115, Liu and Segall teach the method of claim 34.
Liu teaches that the soy protein isolate is produced from defatted soybean meal ([0005]).
In the broadest sense, defatted soybean meal is a coarse defatted soy flour. Therefore, Liu teaches that the source protein composition is at least 90% a defatted soy flour on a dry weight basis. Additionally, it is well-known in chemistry and physics that a greater surface area to volume ratio leads to greater exposure to solvent. Therefore, it would have been obvious to grind the defatted soybean meal of Liu to a finer flour in order to increase the surface area to volume ratio of the particles to facilitate extraction.
Claim 115 is therefore obvious.
Claim 102, 116-118, 120, and 122-123 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN 103766573 A, machine translation of the document cited on the IDS filed on 9 December 2022) in view of Segall et al. (US 2019/0021364 A1) and Xie et al. (CN 108409827 A, machine translation of the document cited on the IDS filed on 9 December 2022), and as evidenced by Shahbal et al. (Shahbal, N., Jing, X., Bhandari, B., Dayananda, B., and Prakash, S. (2023). Effect of enzymatic hydrolysis on solubility and surface properties of pea, rice, hemp, and oat proteins: Implication on high protein concentrations. Food Bioscience, 53(102515), 1-10. https://doi.org/10.1016/j.fbio.2023.102515).
Regarding claim 102, Liu teaches a method for producing a protein composition ([0004]), the method comprising:
(a) adding an aqueous solution to a source protein composition to form a solution of solubilized protein – “mixing low temperature defatted soybean meal with alkaline water” ([0005]).
(b) removing solids from the solution of solubilized protein – “extracted soymilk is mixed with an ethanol solution” ([0005]) indicates an implicit step of separating the solids from the solution of solubilized protein obtained in the alkaline extraction, wherein the extracted soymilk is the liquid phase of the extraction.
(c) heating the solution of solubilized protein – “the extraction temperature is 30 °C to 40 °C” ([0006]).
(d) adjusting the pH of the solution of solubilized protein to about 4.0 to about 9.0 – “the extraction pH is 7.2-7.4” ([0005]).
(f) adding an organic solvent to the solution of solubilized protein to form a solid phase and a liquid phase – “the extracted soy milk is mixed with an ethanol solution and stirred for alcohol precipitation” and subsequently centrifuged “to obtain a liquid phase and a solid phase” ([0005]).
(g) separating the solid phase from the liquid phase to form the protein composition – the solution obtained by centrifugation is sent to an evaporation concentration tank to reclaim the ethanol ([0009]), and the solid phase protein curd obtained by centrifugation is washed with water ([0010]), indicating separation of the solid phase from the liquid phase.
(h) washing the protein composition with a wash solvent – “washing with water comprises: mixing the solid phase protein curd obtained by centrifugation with water and centrifuging” ([0010]).
(i) resolubilizing the protein composition – Liu teaches that the solid phase protein milk obtained by centrifugation is subjected to enzymatic hydrolysis with alkaline protease ([0005]). As evidenced by Shahbal, enzymatic hydrolysis of proteins with the alkaline protease Alcalase® greatly increases protein solubility (p. 9, col. 1, ¶ 4). Therefore, Liu teaches resolubilizing the protein composition.
wherein the protein composition comprises at least 50% by dry weight of a plurality of plant proteins – the protein isolate is a spray-dried total alkaline extract from defatted soybean meal ([0004] – [0005]). Liu terms the product of the method a “protein isolate”, which is commonly accepted as comprising at least 90% by dry weight of protein.
Liu does not discuss heating the solution of solubilized protein at a temperature of about 85 °C to about 95 °C, (e) cooling the solution of solubilized protein to about 0 °C to about 10 °C, or that the protein composition comprises less than 0.8% by dry weight of lipids.
However, Segall teaches a method of producing a pulse protein product ([0027]) comprising the steps of forming an aqueous solution of solubilized pulse protein ([0028]), separating the aqueous pulse protein solution from residual pulse protein source ([0028]), heat treating the pulse protein solution ([0031], [0039]), adjusting the pH of the aqueous pulse protein solution to about pH 6 to about 8 ([0036]), concentrating ([0033]), diafiltering ([0034]), and drying the pulse protein solution ([0039]). The heat treatment is carried out at a temperature of about 70 °C to about 160 °C, more preferably about 85 °C to about 95 °C ([0041], [0076], [0100]). Segall teaches, “The heat treatment step serves to modify the functional properties of the protein product, namely lowering the solubility of the protein and increasing the water binding capacity of the material” ([0017]).
Regarding the lipid concentration, Segall teaches that the separated aqueous pulse protein solution may be subjected to a defatting operation, if required, by “any convenient procedure” ([0070]). Segall also teaches that the invention refers mainly to the production and use of pulse protein isolates having a protein content “preferably at least about 100 wt%” ([0044]). Therefore, it is understood that Segall provides a method for producing a pulse protein isolate having a protein content of 100 wt%, meaning that the lipid content is 0 wt%.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Liu with the teachings of Segall to include a heat treatment step at a temperature of about 85 °C to 95 °C. First, Liu teaches that defatted soybean meal is extracted by heating at a temperature from 30 °C to 40 °C, and then the extracted protein is precipitated with ethanol ([0005] – [0006]). Since Segall teaches that heat treating at a temperature from about 85 °C to about 95 °C lowers the solubility of the protein, and Liu seeks to precipitate (i.e., lower the solubility) of the protein, one of ordinary skill in the art would have been motivated to increase the amount of precipitated protein and/or facilitate precipitation of the protein by adding a heat treatment from about 85 °C to about 95 °C as taught by Segall. One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention because Liu teaches the base protein extraction method and Segall teaches heat treating a solubilized protein solution adjusted to about pH 6 to about pH 8 at about 85 °C to about 95 °C.
Regarding the lipid concentration, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of Liu with the teachings of Segall to include a defatting operation to provide a protein isolate without lipids. One of ordinary skill in the art would have been motivated to do so in order to provide a highly pure protein isolate. One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Segall teaches that a defatting operation may be added ([0070]) and that a pulse protein isolate with a protein content of at least about 100 wt% can be obtained ([0044]).
Regarding the cooling step, Xie teaches a method of simultaneous extraction of proteins and polysaccharides from algal residue comprising an alkaline extraction with heating at 30 °C and subsequent separation of the precipitate and alkaline extract supernatant ([0024]), adding ethanol to the alkaline extract, then performing solid-liquid separation ([0025]), wherein the proteins are in the supernatant ([0026]) and the polysaccharides are in the precipitate ([0027]). During the separation step, the solution is cooled to 4 °C for 2 hours ([(0025]). The algal residue protein powder has a protein content of 80 to 95% by weight ([0020]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention, to improve the method of Liu as modified by Segall by adding a step of cooling the solution of solubilized protein to 4 °C as taught by Xie, see MPEP § 2143(I)(D). First, Liu teaches the base method for producing a protein isolate comprising an alkaline extraction and ethanol precipitation as described above. Xie teaches a similar method also comprising cooling the solution to 4 °C during the ethanol precipitation step to obtain a supernatant and a precipitate ([0026]). It is well known in chemistry and physics that cooling facilitates precipitation and settling of particles in a suspension. Therefore, one of ordinary skill in the art would have recognized that adding a cooling step, as taught by Xie, during the alcohol precipitation step of the method of Liu would have yielded the predictable results of facilitating the phase separation.
Therefore, claim 102 is rendered obvious.
Regarding claim 116, Liu, Segall, and Xie teach the method of claim 102.
Liu also teaches that the organic solvent is ethanol ([0005]).
Claim 116 is therefore obvious.
Regarding claim 117, Liu, Segall, and Xie teach the method of claim 102.
The cited prior art does not specifically discuss that the protein composition has: (i) a saponin content that is less than 50% of the saponin content of the source protein composition; (ii) an isoflavone content that is less than 50% of the isoflavone content of the source protein composition; (iii) a phospholipid content that is less than 50% of the phospholipid content of the source protein composition; (iv) a lipid content that is less than 50% of the lipid content of the source protein composition; (v) a phenolic acid content that is less than 50% of the phenolic acid content of the source protein composition; and/or (vi) a flavor compounds content that is less than 50% of the flavor compounds content of the source protein composition, wherein the flavor compounds are selected from the group consisting of aldehydes, ketones, esters, alcohols, pyrazines, pyranones, acids, sulfur compounds, terpenes, furans, alkanes, alkenes, and combinations thereof.
However, the method of Liu as modified by Segall and Xie described regarding claim 102 uses claimed steps (a)-(i) to produce the soy protein isolate. When the method steps recited in the prior art reference are substantially identical to those of the claims, claimed properties of the resulting composition are presumed to be present in the composition of the prior art. The burden of proof shifts to the applicant to provide objective evidence (i.e., test data) to the contrary. See In re Best, 562, F.2d 1252, 1254, 195 USPQ 403, 433 (CCPA 1977). MPEP § 2112.02(I).
Indeed, Figure 11 of the instant specification shows that isoflavones (e.g., total aglycon and total glucoside isoflavones), saponins (e.g., soyasaponin), and phospoholipids (e.g., phosphatidylcholine) of pureSPI are reduced well below 50% of the starting amounts in soy flour. The pureSPI of the instant specification was prepared by the method described in Example 16 (pp. 153-154), which comprises steps that are substantially identical to the method of claim 34. Therefore, where Liu, Segall, and Xie teach the method of claim 102, one can expect that the same properties are present in the resulting soy protein isolate of the prior art. While Applicant’s data in Figure 11 provide evidence that this is true for elements (i)-(iii) of claim 117, the same can be expected for elements (iv)-(vi). It is also noted that elements (i)-(vi) are alternatives.
Therefore, claim 117 is rendered obvious.
Regarding claim 118, Liu, Segall, and Xie teach the method of claim 102.
Liu also teaches that the organic solvent is ethanol ([0005]).
Claim 118 is therefore obvious.
Regarding claim 120, Liu, Segall, and Xie teach the method of claim 102.
Liu also teaches that the wash solvent is an aqueous solution – “washing with water” ([0010]).
Claim 112 is therefore obvious.
Regarding claim 122, Liu, Segall, and Xie teach the method of claim 102.
Liu also teaches that the source protein composition is at least 90% plants, a part or derivative thereof on a dry weight basis – Liu teaches that the soy protein isolate is produced from defatted soybean meal ([0005]).
Claim 122 is therefore obvious.
Regarding claim 123, Liu, Segall, and Xie teach the method of claim 102.
Liu teaches that the soy protein isolate is produced from defatted soybean meal ([0005]).
In the broadest sense, defatted soybean meal is a coarse defatted soy flour. Therefore, Liu teaches that the source protein composition is at least 90% a defatted soy flour on a dry weight basis. Additionally, it is well-known in chemistry and physics that a greater surface area to volume ratio leads to greater exposure to solvent. Therefore, it would have been obvious to grind the defatted soybean meal of Liu to a finer flour in order to increase the surface area to volume ratio of the particles to facilitate extraction.
Claim 123 is therefore obvious.
Claims 111, and 113 are rejected under 35 U.S.C. 103 as unpatentable over Liu et al. (CN 103766573 A, machine translation of the document cited on the IDS filed on 9 December 2022) in view of Segall et al. (US 2019/0021364 A1) and Staerk et al. (US 2008/0182002 A1, cited on the IDS filed on 9 December 2022), and as evidenced by Shahbal et al. (Shahbal, N., Jing, X., Bhandari, B., Dayananda, B., and Prakash, S. (2023). Effect of enzymatic hydrolysis on solubility and surface properties of pea, rice, hemp, and oat proteins: Implication on high protein concentrations. Food Bioscience, 53(102515), 1-10. https://doi.org/10.1016/j.fbio.2023.102515).
Regarding claims 111 and 113, Liu and Segall teach the method of claim 34.
The cited prior art does not discuss that the wash solvent is an organic wash solvent (re: claim 111) or that the wash solvent is a mixture of an aqueous solution and an organic wash solvent (re: claim 113).
However, Staerk teaches a process for the production of soy bean isolates having reduced off-flavors (Abstract). Similar to Liu, the method of Staerk comprises conducting an aqueous extraction of defatted soy flake material with an aqueous alkaline wash, which removes a substantial portion of the isoflavones and carbohydrates ([0021]), precipitating the soy protein to separate remaining impurities ([0025]), and hydrolyzing the soy protein isolate ([0027]). Staerk teaches that the extraction, suspension, and precipitation steps can be repeated one or more times to further remove impurities from the soy protein isolate ([0026]).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of Liu as modified by Segall to repeat the precipitation step as taught by Staerk and to further remove impurities from the soy protein isolate. One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Staerk teaches that repeating extraction, suspension, and precipitation steps is a way to further remove impurities from the soy protein isolate. Where Liu teaches alcohol precipitation with 90% ethanol ([0007]), repeating the precipitation step as taught by Staerk is a wash step, rendering the organic solvent a wash solvent. The wash solvent in such a step is an organic wash solvent (ethanol), and 90% ethanol is understood to comprise a mixture of ethanol and water (i.e., a mixture of an aqueous solution and an organic wash solvent) as claimed.
Claims 111 and 113 are therefore rendered obvious.
Claims 119 and 121 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN 103766573 A, machine translation of the document cited on the IDS filed on 9 December 2022) in view of Segall et al. (US 2019/0021364 A1) and Xie et al. (CN 108409827 A, machine translation of the document cited on the IDS filed on 9 December 2022), and Staerk et al. (US 2008/0182002 A1, cited on the IDS filed on 9 December 2022), and as evidenced by Shahbal et al. (Shahbal, N., Jing, X., Bhandari, B., Dayananda, B., and Prakash, S. (2023). Effect of enzymatic hydrolysis on solubility and surface properties of pea, rice, hemp, and oat proteins: Implication on high protein concentrations. Food Bioscience, 53(102515), 1-10. https://doi.org/10.1016/j.fbio.2023.102515).
Regarding claims 119 and 121, Liu, Segall, and Xie teach the method of claim 102.
The cited prior art does not discuss that the wash solvent is an organic wash solvent (re: claim 119) or that the wash solvent is a mixture of an aqueous solution and an organic wash solvent (re: claim 121).
However, Staerk teaches a process for the production of soy bean isolates having reduced off-flavors (Abstract). Similar to Liu, the method of Staerk comprises conducting an aqueous extraction of defatted soy flake material with an aqueous alkaline wash, which removes a substantial portion of the isoflavones and carbohydrates ([0021]), precipitating the soy protein to separate remaining impurities ([0025]), and hydrolyzing the soy protein isolate ([0027]). Staerk teaches that the extraction, suspension, and precipitation steps can be repeated one or more times to further remove impurities from the soy protein isolate ([0026]).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of Liu as modified by Segall and Xie to repeat the precipitation step as taught by Staerk and to further remove impurities from the soy protein isolate. One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Staerk teaches that repeating extraction, suspension, and precipitation steps is a way to further remove impurities from the soy protein isolate. Where Liu teaches alcohol precipitation with 90% ethanol ([0007]), repeating the precipitation step as taught by Staerk is a wash step, rendering the organic solvent a wash solvent. The wash solvent in such a step is an organic wash solvent (ethanol), and 90% ethanol is understood to comprise a mixture of ethanol and water (i.e., a mixture of an aqueous solution and an organic wash solvent) as claimed.
Claims 119 and 121 are therefore rendered obvious.
Response to Arguments
Claim Rejections – 35 U.S.C. § 103: Applicant’s arguments filed on 16 March 2026 have been fully considered, but they are not persuasive.
Applicant first argued that there is no suggestion or motivation in either Liu or Segall themselves or in the knowledge generally available to one of ordinary skill in the art to modify the references to arrive at the present claims (p. 8, last ¶). Applicant argued that Liu does not teach or suggest “heating…at a temperature of about 85 °C to about 95 °C” as required by the present claims, and disagrees that it would have been obvious to modify the method of Liu with the teachings of Segall to include a heat treatment step at a temperature of about 85 °C to about 95 °C (pp. 10-11, bridging ¶). Applicant argued that Segall teaches heat treatment in the claimed range of a pulse protein solution only after an initial acidification to a pH of about 1.5 to about 4.4 (pp. 11-12, bridging ¶). Applicant argued that Segall does not provide any guidance that the methods described therein would be effective when applied to protein samples that have not undergone the initial acidification step, such as Liu’s extraction at pH 7.2-7.4, and Liu provides no guidance that their method would be effective at an acidic pH (p. 12, ¶ 2). Applicant argued that for these reasons, one of ordinary skill in the art would not have been motivated to modify the method of Liu in view of Segall “to include a heat treatment step at a temperature of about 85 °C to 95 °C”, and the office action fails to clearly articulate any reasonable expectation of success in arriving at the claimed invention in doing so (p. 12, ¶ 2 – p. 14, ¶ 2).
Applicant’s arguments have been considered, but they are not persuasive. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Additionally, MPEP § 2123(I) states, “‘The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.’ In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).” In the present case, the intermediate foodstuffs mixture of Harbour meets all limitations of the claimed invention.
Furthermore, Applicant is reminded that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In the present case, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Liu with the teachings of Segall to include a heat treatment step at a temperature of about 85 °C to 95 °C. This modification is only to apply the heat treatment step at a temperature of about 85 °C to 95 °C of Segall to the extraction of Liu, and not to bodily incorporate other steps of the method of Segall, such as an acidification step at a pH of about 1.5 to about 4.4. Liu teaches that defatted soybean meal is extracted by heating at a temperature from 30 °C to 40 °C, and then the extracted protein is precipitated with ethanol ([0005] – [0006]). Since Segall teaches that heat treating at a temperature from about 85 °C to about 95 °C lowers the solubility of the protein ([0017]), and Liu seeks to precipitate (i.e., lower the solubility) of the protein, one of ordinary skill in the art would have been motivated to increase the amount of precipitated protein and/or facilitate precipitation of the protein by adding a heat treatment from about 85 °C to about 95 °C as taught by Segall.
The method of Segall as described in paragraphs [0027] – [0041] does not require any steps between the acidic pH adjustment and the adjustment to about pH 6 to about 8, and the heat treatment step at a temperature of about 85 °C to 95 °C may be conducted after the adjustment to about pH 6 to about 8. The extraction conditions of Liu are at a pH of 7.2-7.4, which is in the adjusted pH range of Segall. Therefore, the expectation is that the effect of the heat treatment of Segall in reducing solubility would be observed in the system of Liu. Applicant provides no evidence to the contrary.
One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention because Liu teaches the base protein extraction method and Segall teaches heat treating a solubilized protein solution adjusted to about pH 6 to about pH 8 at about 85 °C to about 95 °C. This is done prior to the alcohol precipitation of Liu. Therefore, the proposed modification of Liu with the heat treatment of Segall results in the method as claimed.
Applicant further argued that the present application shows for the first time that producing a protein composition by heating the solution of solubilized protein at a temperature of about 85 °C to about 95 °C followed by adding an organic solvent to the solution of solubilized protein to precipitate the protein – according to the claimed methods - improves the final product quality by increasing the protein content and decreasing the fat and carbohydrate contents, and that Liu and Segall alone or in combination do not teach or suggest the method as required by the instant claims (p. 9, ¶ 1 – p. 10, ¶ 2).
Applicant’s argument has been considered, but it is not persuasive. As provided by MPEP § 2145(II), “[m]ere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979)”, and “‘[t]he 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)”. Furthermore, “[e]vidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978).” See MPEP § 716.02(c)(I). “‘Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof.; In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967)”. See MPEP § 716.02(c)(II).
In the present case, Segall teaches, “The heat treatment step serves to modify the functional properties of the protein product, namely lowering the solubility of the protein and increasing the water binding capacity of the material” ([0017]). Therefore, Applicant’s results of increasing the protein content would have been expected, and even if not specifically recited by Segall or Liu, Applicant’s observed effect of decreasing the fat and carbohydrate contents of the final product are latent properties of performing the method. Applicant’s argument and evidence therefore do not render the claimed invention non-obvious.
Applicant further argued that claims 102, 116-118, 120, 122-123 (p. 14, ¶ 3 – p. 15, ¶ 2), claims 111 and 113 (p. 15, ¶ 3 – p. 16, ¶ 2), and claims 119 and 121 (p. 15, ¶¶ 3-5) are non-obvious for the same reasons as detailed regarding the rejection of claims 34, 42, 71-72, 103, 106, 108-110, 112, and 114-115 over Liu and Segall.
In response, Applicant’s arguments are not persuasive for the same reasons described regarding the rejection over Liu and Segall hereinabove.
The rejections of the present claims are therefore maintained.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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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/JAMES P. SHELLHAMMER/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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