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 Claims
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1, 4-18, and 20-23
Withdrawn claims: 16-18
Previously canceled claims: 19
Newly canceled claims: 2-3
Amended claims: 1 and 10-11
New claims: 21-23
Claims currently under consideration: 1, 4-15, and 20-23
Currently rejected claims: 1, 4-15, and 20-23
Allowed claims: None
Election/Restrictions
Applicant’s election of Group I, claims 1-15 and 20 and new claims 21-23 in the reply filed on 8 April 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 16-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 1 and 6 is objected to because of the following informalities:
In claim 1, line 2, replace “;” with “:”.
In claim 1, line 4, replace “,” with “;”.
In claim 6, “Brassica” should be italicized to conform to taxonomic convention.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 6-9, 13-15, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Helling et al. (US 2010/0234569 A1, cited on the IDS filed on 8 March 2024) in view of Yue et al. (Yue, Y., Pang, S., Li, N., Tong, L., Wang, L., Fan, B., ... & Liu, L. (2021). Interactions between pea protein isolate and carboxymethylcellulose in neutral and acid aqueous systems. Foods, 10(7), 1560. https://doi.org/10.3390/foods10071560).
Regarding claim 1, Helling discloses a method of protein recovery from a plant by-product, the method comprising the steps of:
isoelectric solubilization of the plant by-product with an alkali solution to provide a first solubilized protein fraction – Helling states, “The subject invention preferably involves the use of canola presscake [i.e., a plant by-product] as a starting material, the use of an aggressive grinding process that results in a measurable reduction in particle size, solubilization of residual oil and protein through an alkaline (pH > 10) aqueous extraction…” ([0040]). Such solubilization at an alkaline pH is an isoelectric solubilization. Helling further discloses that the subject processes can be extended to other oilseeds ([0120]).
separating the first solubilized protein fraction from insolubilized plant matter – Helling further teaches, “…separation of the oil-water emulsion from the aqueous fraction by centrifugation…” ([0040]). The aqueous fraction comprises the solubilized protein, which is separated from the insoluble oil-water emulsion. See also Example 10 ([0142] – [0148]), which demonstrates that the press cake slurry is adjusted to pH 11.5 ([0142]), centrifuged, and the supernatant was filtered through coarse filter paper to separate from plant solids ([0143]). The aqueous solution was then centrifuged, and the solid emulsion layer removed ([0144]).
and flocculation of the first solubilized protein fraction at a pH of between 4.5 and 5.5, to precipitate the protein – Helling teaches the “precipitation of a protein concentrate by adjusting the pH of the aqueous phase to pH < 5” ([0040]). The claimed pH range of between 4.5 and 5.5 overlaps the disclosed pH range of less than 5. In a 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 flocculation, the instant specification on page 9, lines 14-20 provides:
The term "flocculation" when used herein refers to a process by which proteins form or cause to form small clumps or aggregates, by means of the addition of a "flocculating agent". In this process, the proteins come out of suspension to sediment. A "flocculating agent" is an agent that actions this process.
The term "flocculated protein product", or "aggregated protein product" refers to the complex formed by the flocculating agent and proteins (previously solubilised and then placed at their isoelectric pH) stabilised by electrostatic interactions.
Helling does not discuss flocculation as defined by the specification.
However, Yue teaches that in an aqueous mixture of pea protein isolate and carboxymethylcellulose severe phase separations occur at pH between 4.5 and 5.0 and carboxymethylcellulose (CMC) concentrations < 0.4% (p. 5, ¶ 2). Yue teaches that at pH between 4.5 and 5.0, where the pH near to protein’s pI, CMC cannot supply efficient negative charge to repel cationic amino groups on PPI surface, and extensive protein precipitates occurred via charge neutralization and bridging flocculation (p. 5, ¶ 2). Therefore, Yue teaches one of ordinary skill in the art that concentrations of CMC below 0.4% can be added to plant protein solutions at pH 4.5 to 5.0 to promote flocculation of the protein.
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 Helling with the teachings of Yue to add CMC to the canola protein aqueous phase at a pH of 4.5 to 5.0 to promote flocculation. Where Helling teaches precipitation of the protein at a pH < 5 ([0040]), and where Yue teaches that addition of CMC to a plant protein solution at pH 4.5 to 5.0 promotes flocculation of the protein, one of ordinary skill in the art would have been motivated to add CMC to the canola protein solution of Helling to aid in protein flocculation, and thereby separation from the liquid. One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention because Helling teaches the claimed steps of isoelectric solubilization, separation, and precipitating the protein, and Yue teaches that CMC causes plant protein flocculation at a pH range inside the claimed range of 4.5 to 5.5.
Claim 1 is therefore rendered obvious.
Regarding claim 6, Helling teaches that the plant is a Brassica plant – Helling teaches that the method uses canola press cake ([0040]). Canola is also known as Brassica napus.
Claim 6 is therefore rendered obvious.
Regarding claim 7, Helling teaches that the plant by-product is one produced during oil production from the seed, or seeds, of the plant – Helling teaches that the method uses canola press cake ([0040]). Canola press cake is produced during oil production from canola plant seeds ([0039]).
Claim 7 is therefore rendered obvious.
Regarding claim 8, Helling teaches that the plant is a rapeseed plant and the plant by-product is a rapeseed press cake (RPC) – Helling teaches that the method uses canola press cake ([0040]). Canola is also known as rapeseed.
Claim 8 is therefore rendered obvious.
Regarding claim 9, Helling teaches that the precipitated protein is freeze dried and/or milled – Helling teaches precipitation of a protein concentrate and freeze or spray drying ([0040]). In Example 10, Helling teaches, “The protein pellet was suspended in a minimum amount of deionized water, transferred to a flask, frozen, and freeze dried. The recovered powder was designated as the PPC-1 fraction.” ([0146]).
Claim 9 is therefore rendered obvious.
Regarding claim 13, Helling teaches that the isoelectric solubilization step(s) is carried out under agitation – In Example 10, Helling teaches that the slurry is adjusted to pH 11.5 ([0142]), and stirred (i.e., agitated) ([0143]).
Claim 13 is therefore rendered obvious.
Regarding claim 14, Helling teaches that the method further comprises separating the precipitated protein from soluble matter – In Example 10, Helling teaches acidification of the aqueous extract and separation of the precipitate and aqueous supernatant ([0145]). Here, the precipitate is the protein pellet ([0146]).
Claim 14 is therefore rendered obvious.
Regarding claim 15, Helling teaches that the method further comprises separating the precipitated protein from the soluble matter and freeze drying the separated precipitated protein – Helling teaches precipitation of a protein concentrate and freeze or spray drying ([0040]). In Example 10, Helling teaches acidification of the aqueous extract and separation of the precipitate and aqueous supernatant ([0145]). Here, the precipitate is the protein pellet ([0146]). Helling teaches, “The protein pellet was suspended in a minimum amount of deionized water, transferred to a flask, frozen, and freeze dried. The recovered powder was designated as the PPC-1 fraction.” ([0146]).
Claim 15 is therefore rendered obvious.
Regarding claim 21, Helling and Yue teach the method of claim 1.
Helling does not discuss that flocculation of the first solubilized protein fraction comprises adding a flocculating agent to the solubilized protein fraction (re: claim 21), wherein the flocculating agent is selected from the group consisting of: sodium hexametaphosphate, alginate, carboxymethylcellulose (CMC), polyacrylic acid, and tannic acid (re: claim 22), or wherein the flocculating agent is carboxymethylcellulose (re: claim 23).
However, Yue teaches that in an aqueous mixture of pea protein isolate and carboxymethylcellulose severe phase separations occur at pH between 4.5 and 5.0 and CMC concentrations < 0.4% (p. 5, ¶ 2). Yue teaches that at pH between 4.5 and 5.0, where the pH near to protein’s pI, CMC cannot supply efficient negative charge to repel cationic amino groups on PPI surface, and extensive protein precipitates occurred via charge neutralization and bridging flocculation (p. 5, ¶ 2). Therefore, Yue teaches one of ordinary skill in the art that concentrations of CMC below 0.4% can be added to plant protein solutions at pH 4.5 to 5.0 to promote flocculation of the protein.
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 Helling with the teachings of Yue to add CMC to the canola protein aqueous phase at a pH of 4.5 to 5.0 to promote flocculation. Where Helling teaches precipitation of the protein at a pH < 5 ([0040]), and where Yue teaches that addition of CMC to a plant protein solution at pH 4.5 to 5.0 promotes flocculation of the protein, one of ordinary skill in the art would have been motivated to add CMC to the canola protein solution of Helling to aid in protein flocculation, and thereby separation from the liquid. One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention because Helling teaches the method of claim 1 and Yue teaches that CMC causes plant protein flocculation at a pH range inside the claimed range of 4.5 to 5.5.
Claims 21-23 are therefore rendered obvious.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Helling et al. and Yue et al. as applied to claim 1 above, and further in view of Owen (US 3,758,452 A).
Regarding claims 4-5, Helling and Yue teach the method of claim 1.
Helling does not discuss that the isoelectric solubilization is carried out at a temperature from 40°C to 50°C (re: claim 4) or at a temperature of 45°C (re: claim 5). Helling does not discuss a reaction temperature.
However, Owen teaches a rapeseed protein isolate produced by contacting rapeseed press cake with an aqueous saline extraction medium to extract rapeseed protein from the press cake, and isoelectrically precipitating rapeseed proteins from the extraction medium (Abstract). The extraction medium is at alkaline pH, and temperatures of 5°C to 60°C may be used (col. 2, lines 53-62). The claimed range of 40°C to 50°C and the claimed temperature of 45°C lie inside the disclosed range. In a 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).
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 Helling as modified by Yue with the teachings of Owen to conduct the isoelectric solubilization at a temperature range of 5°C to 60°C. One of ordinary skill in the art would have been motivated to consult Owen to determine a suitable temperature at which to carry out the reaction. One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention because Owen teaches that a range of 5°C to 60°C is suitable for alkaline solubilization of rapeseed press cake, and the claimed temperatures lie inside the disclosed range.
Claims 4-5 are therefore rendered obvious.
Claims 10-12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Helling et al. and Yue et al. as applied to claim 1 above, and further in view of Tiwari et al. (US 2018/0199590 A1).
Regarding claim 10, Helling and Yue teach the method of claim 1.
Helling does not discuss that the method comprises a second step of isoelectric solubilization of the unsolubilized plant matter to provide a second solubilized protein fraction and wherein the first and second solubilized protein fractions are then combined prior to flocculation (re: claim 10), wherein the first and second solubilized protein fractions are combined to provide a pH of 4.5 to 5.5 (re: claim 12).
However, in the art of isoelectric solubilization and purification of proteins, Tiwari teaches an improved sequential extraction based on isoelectric solubilization that allows for isolation of a greater proportion of the total protein from mackerel by-products ([0007]). The method comprises sequential isoelectric solubilization of an animal by-product ([0008]). “The first isoelectric solubilization may be carried out in acid solution and the second isoelectric solubilization step carried out in alkali solution, or vice-versa. The first solubilization step provides a precipitate of unsolubilized matter and a supernatant containing a first solubilized protein fraction, and the second solubilization step is carried out on the precipitate from the first step, and solubilizes proteins that are not solubilized in the first step. In this way, a far greater proportion of the high value protein is recovered.” ([0014]). Tiwari further teaches, “the protein from the first and second solubilized protein fractions are recovered by combining the first and second solubilized protein fractions in a proportion to effect precipitation of the protein. Thus, the acid and alkali supernatants are combined in amounts to effect precipitation. In one embodiment, the first and second solubilized protein fractions are combined proportionally to provide a weakly acidic solubilized protein fraction having a pH of 5-6.” ([0019]). Thus, Tiwari teaches a second step of isoelectric solubilization of the unsolubilized plant matter to provide a second solubilized protein fraction, wherein the first and second solubilized protein fractions are then combined, as claimed, to provide a pH of 5-6. The claimed range of 4.5 to 5.5 overlaps the disclosed range of pH 5-6. In a 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).
Therefore, 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 Helling as modified by Yue with the teachings of Tiwari to include a second step of isoelectric solubilization of the unsolubilized plant matter to provide a second solubilized protein fraction and wherein the first and second solubilized protein fractions are then combined prior to flocculation, wherein the first and second solubilized protein fractions are combined to provide a pH of 5-6. One of ordinary skill in the art would have been motivated to apply the teachings of Tiwari to the method of Helling to isolate a greater proportion of proteins from the canola press cake of Helling. One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention because Tiwari teaches sequential isoelectric solubilization of proteins from by-products and combining and precipitating the protein from the two fractions at a pH of 5-6.
Claims 10 and 12 are therefore rendered obvious.
Regarding claims 11 and 20, Helling and Yue teach the method of claim 1.
Helling does not discuss that the method comprises a second step of isoelectric solubilization of the unsolubilized plant matter to provide a second solubilized protein fraction and wherein the first and second solubilized protein fractions are then combined prior to flocculation and wherein the second step of isoelectric solubilization is with an acid solution (re: claim 11), wherein the first and second solubilized protein fractions are combined to provide a pH of 4.5 to 5.5 (re: claim 20).
However, in the art of isoelectric solubilization and purification of proteins, Tiwari teaches an improved sequential extraction based on isoelectric solubilization that allows for isolation of a greater proportion of the total protein from mackerel by-products ([0007]). The method comprises sequential isoelectric solubilization of an animal by-product ([0008]). “The first isoelectric solubilization may be carried out in acid solution and the second isoelectric solubilization step carried out in alkali solution, or vice-versa. The first solubilization step provides a precipitate of unsolubilized matter and a supernatant containing a first solubilized protein fraction, and the second solubilization step is carried out on the precipitate from the first step, and solubilizes proteins that are not solubilized in the first step. In this way, a far greater proportion of the high value protein is recovered.” ([0014]). Tiwari further teaches, “the protein from the first and second solubilized protein fractions are recovered by combining the first and second solubilized protein fractions in a proportion to effect precipitation of the protein. Thus, the acid and alkali supernatants are combined in amounts to effect precipitation. In one embodiment, the first and second solubilized protein fractions are combined proportionally to provide a weakly acidic solubilized protein fraction having a pH of 5-6.” ([0019]). Thus, Tiwari teaches a second step of isoelectric solubilization of the unsolubilized plant matter to provide a second solubilized protein fraction, wherein the first and second solubilized protein fractions are then combined, and wherein the second step of isoelectric solubilization is with an acid solution as claimed, to provide a pH of 5-6. The claimed range of 4.5 to 5.5 overlaps the disclosed range of pH 5-6. In a 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).
Therefore, 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 Helling as modified by Yue with the teachings of Tiwari to include a second step of isoelectric solubilization of the unsolubilized plant matter with an acid solution to provide a second solubilized protein fraction and wherein the first and second solubilized protein fractions are then combined prior to flocculation, wherein the first and second solubilized protein fractions are combined to provide a pH of 5-6. One of ordinary skill in the art would have been motivated to apply the teachings of Tiwari to the method of Helling to isolate a greater proportion of proteins from the canola press cake of Helling. One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention because Tiwari teaches sequential isoelectric solubilization of proteins from by-products and combining and precipitating the protein from the two fractions at a pH of 5-6.
Claims 11 and 20 are therefore rendered obvious.
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.
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Claims 1, 10-13, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 11,324,232 B2 in view of Helling et al. (US 2010/0234569 A1, cited on the IDS filed on 8 March 2024) and Yue et al. (Yue, Y., Pang, S., Li, N., Tong, L., Wang, L., Fan, B., ... & Liu, L. (2021). Interactions between pea protein isolate and carboxymethylcellulose in neutral and acid aqueous systems. Foods, 10(7), 1560. https://doi.org/10.3390/foods10071560).
Regarding claim 1, patent claim 1 teaches a method of protein recovery from a by-product, the method comprising the steps of; isoelectric solubilization of the by-product with an alkali (“acid or alkali”) solution to provide a first solubilized protein fraction, separating the first solubilized protein fraction from unsolubilized by-product matter; and adjusting the pH of the first solubilized protein fraction (via a second solubilized protein fraction) to a pH of between 5-6 to precipitate the protein. The claimed range of 4.5 to 5.5 overlaps the disclosed range of pH 5-6. In a 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).
Patent claim 1 does not teach that the by-product is a plant by-product. Patent claim 1 does not teach flocculation.
However, Helling discloses a method of protein recovery from a plant by-product, the method comprising the steps of:
isoelectric solubilization of the plant by-product with an alkali solution to provide a first solubilized protein fraction – Helling states, “The subject invention preferably involves the use of canola presscake [i.e., a plant by-product] as a starting material, the use of an aggressive grinding process that results in a measurable reduction in particle size, solubilization of residual oil and protein through an alkaline (pH > 10) aqueous extraction…” ([0040]). Such solubilization at an alkaline pH is an isoelectric solubilization. Helling further discloses that the subject processes can be extended to other oilseeds ([0120]).
separating the first solubilized protein fraction from insolubilized plant matter – Helling further teaches, “…separation of the oil-water emulsion from the aqueous fraction by centrifugation…” ([0040]). The aqueous fraction comprises the solubilized protein, which is separated from the insoluble oil-water emulsion. See also Example 10 ([0142] – [0148]), which demonstrates that the press cake slurry is adjusted to pH 11.5 ([0142]), centrifuged, and the supernatant was filtered through coarse filter paper to separate from plant solids ([0143]). The aqueous solution was then centrifuged, and the solid emulsion layer removed ([0144]).
and precipitating of the first solubilized protein fraction at a pH of between 4.5 and 5.5 – Helling teaches the “precipitation of a protein concentrate by adjusting the pH of the aqueous phase to pH < 5” ([0040]). The claimed pH range of between 4.5 and 5.5 overlaps the disclosed pH range of less than 5. In a 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).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the animal by-product of patent claim 1 with the canola press cake (plant by-product) of Helling to recover protein from a plant-by product as claimed, with the motivation of extending the use of the method to additional by-product protein sources. One of ordinary skill in the art would have had a reasonable expectation in doing so because Helling teaches that it was known in the art to perform the same method steps on a plant by-product.
Regarding flocculation, Yue teaches that in an aqueous mixture of pea protein isolate and carboxymethylcellulose severe phase separations occur at pH between 4.5 and 5.0 and carboxymethylcellulose (CMC) concentrations < 0.4% (p. 5, ¶ 2). Yue teaches that at pH between 4.5 and 5.0, where the pH near to protein’s pI, CMC cannot supply efficient negative charge to repel cationic amino groups on PPI surface, and extensive protein precipitates occurred via charge neutralization and bridging flocculation (p. 5, ¶ 2). Therefore, Yue teaches one of ordinary skill in the art that concentrations of CMC below 0.4% can be added to plant protein solutions at pH 4.5 to 5.0 to promote flocculation of the protein.
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 patent claim 1 as modified by Helling with the teachings of Yue to add CMC to the canola protein aqueous phase at a pH of 4.5 to 5.0 to promote flocculation. Where Helling teaches precipitation of the protein at a pH < 5 ([0040]), and where Yue teaches that addition of CMC to a plant protein solution at pH 4.5 to 5.0 promotes flocculation of the protein, one of ordinary skill in the art would have been motivated to add CMC to the canola protein solution of Helling to aid in protein flocculation, and thereby separation from the liquid. One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention because patent claim 1 and Helling teach the claimed steps of isoelectric solubilization of a plant by-product, separation, and precipitating the protein, and Yue teaches that CMC causes plant protein flocculation at a pH range inside the claimed range of 4.5 to 5.5.
Claim 1 is therefore rendered obvious.
Regarding claims 10-12 and 20, patent claim 1 and Helling teach the method of claim 1.
Patent claim 1 also teaches the method comprising a second step of isoelectric solubilization of the unsolubilized by-product matter to provide a second solubilized protein fraction and wherein the first and second solubilized protein fractions are then combined prior to flocculation (re: claim 10) and wherein the second step of isoelectric solubilization is with an acid solution (re: claim 11), wherein the first and second solubilized protein fractions are combined to provide a pH of 4.5 to 5.5 (re: claims 12 and 20). Patent claim 1 teaches isoelectric solubilization of a by-product in one of an acid or alkali solution, separating the first solubilized protein fraction from the unsolubilized by-product, isoelectric solubilization of the unsolubilized by-product matter in another of the acid or alkali solution to provide a second solubilized solution, separating the second solubilized protein fraction from the unsolubilized by-product matter, and combining the first and second solubilized protein fractions in amounts to achieve a pH of 5-6 to effect precipitation of the protein. The claimed range of 4.5 to 5.5 overlaps the disclosed range of pH 5-6. In a 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).
Therefore, claims 10-12 and 20 are obvious for the same reasons and with the same expectation of success as described regarding claim 1.
Regarding claim 13, patent claim 1 and Helling teach the method of claim 1.
Patent claim 5 teaches that the isoelectric solubilisation step(s) is carried out under agitation (“in a stirred reactor”).
Therefore, claim 13 obvious for the same reasons and with the same expectation of success as described regarding claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Trass et al. (US 2011/0177582 A1) teaches acidic, then alkali extraction of defatted meal at 45°C.
Morse (US 2,331,619 A) teaches vegetable protein extraction by alkali or acidic isoelectric solubilization and precipitation.
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/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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