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1.114, and the fee set forth in 37 CFR 1.114 has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 CFR 1.114.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 05/08/2025 and 11/26/2025 has been entered.
Claim status
The examiner acknowledges the amendment made to pending claims on 05/08/2025.
Claims 11-13, 17-20, 30-38, 40-60, and 62-66 are pending in the application. Claims 42 and 46-47 are currently amended. Claims 1-10, 14-16, 21-29, 39, and 61 remain cancelled. Claims 62-66 are withdrawn without traverse in response to the restriction requirement. Rest of claims are previously presented. Claims 11-13, 17-20, 30-38, and 40-60 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Any objections and/or rejections that are made in the previous actions and are not repeated below, are hereby withdrawn.
Claim Objections
Claim 11 is objected to because of the following informalities: “decanting the hemp grain slurry to produce an aqueous native edestin protein isolate mixture, the aqueous native edestin protein isolate mixture comprising a native edestin protein isolate and water, and, a liquid supernatant fraction, the liquid supernatant fraction comprising a soluble albumin and a hemp oil” should read “decanting the hemp grain slurry to produce an aqueous native edestin protein isolate mixture and a liquid supernatant fraction, wherein the aqueous native edestin protein isolate mixture comprising a native edestin protein isolate and water, and wherein the liquid supernatant fraction comprising a soluble albumin and a hemp oil”. Appropriate correction is required.
Claim 43 is objected to because of the following informalities: “decanting the hemp grain slurry to produce a first aqueous native edestin protein isolate mixture, the first aqueous native edestin protein isolate mixture comprising a native edestin protein isolate and water, and, a liquid supernatant fraction, the liquid supernatant fraction comprising a soluble albumin and a hemp oil” should read “decanting the hemp grain slurry to produce a first aqueous native edestin protein isolate mixture and a liquid supernatant fraction, wherein the first aqueous native edestin protein isolate mixture comprising a native edestin protein isolate and water, and wherein the liquid supernatant fraction comprising a soluble albumin and a hemp oil”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: “centrifugal decanting the hemp grain slurry to produce a first aqueous native edestin protein isolate mixture, the first aqueous native edestin protein isolate mixture comprising a native edestin protein isolate and water, and, a liquid supernatant fraction, the liquid supernatant fraction comprising a soluble albumin and a hemp oil” should read “centrifugal decanting the hemp grain slurry to produce a first aqueous native edestin protein isolate mixture and a liquid supernatant fraction, wherein the first aqueous native edestin protein isolate mixture comprising a native edestin protein isolate and water, and wherein the liquid supernatant fraction comprising a soluble albumin and a hemp oil”. Appropriate correction is required.
Claim 52 is objected to because of the following informalities: “decanting the hemp grain slurry to produce an aqueous native edestin protein isolate mixture, the aqueous native edestin protein isolate mixture comprising a native edestin protein isolate and water, and, a liquid supernatant fraction, the liquid supernatant fraction comprising a soluble albumin and a hemp oil” should read “decanting the hemp grain slurry to produce an aqueous native edestin protein isolate mixture and a liquid supernatant fraction, wherein the aqueous native edestin protein isolate mixture comprising a native edestin protein isolate and water, and wherein the liquid supernatant fraction comprising a soluble albumin and a hemp oil”. Appropriate correction is required.
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 17-19, 34-38, 40 and 43-51 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.
Claims 17-18 recite that a temperature of the water added to the hemp grain is below approximately 50 °F or between approximately 32 °F and 38 °F. The examiner does not find the support for those limitations in the disclosure as originally filed. The examiner notes that para. [00155] of the instant specification teaches that the extraction temperature during the milling is between 33°F and 38 °F, and Example 1 recites that hemp grains are mixed with water having a temperature of 34 °F. However, those are not sufficient to support a limitation that a temperature of the water added to the hemp grain is below approximately 50 °F or is between approximately 32 °F and 38 °F.
Claim 19 recites that the water is added to the hemp grain at a ratio of approximately 4 to 1 by weight. The examiner does not find the support for such a limitation in the disclosure as originally filed. The examiner notes that Example 1 teaches a water/hemp grain weight ratio of 5:1. However, nowhere else in the disclosure discusses the ratio of water to hemp grains for the invention as claimed.
Claim 34 recites that the aqueous native edestin protein isolate mixture is heated at a temperature of below approximately 155 °F. The examiner does not find the support for such a limitation. The examiner notes that para. [0082] or [00174], and Example 1 of the instant specification recite that NEPI is heated at a temperature of 145 °F, thus not supporting a heating temperature that is below approximately 155 °F, which is broader than a temperature of 145 °F.
Claim 35 recites that the aqueous native edestin protein isolate mixture is heated at a temperature of approximately 125-155 °F. The examiner does not find the support for such a limitation. The examiner notes that para. [0082] or [00174], and Example 1 of the instant specification recite that NEPI is heated at a temperature of 145 °F, thus not supporting a heating temperature that is below approximately 125-155 °F, which is broader than a temperature range of 125-155 °F. Claims 36-38 and 40 are rejected because they ultimately depend from claim 35.
Claim 37 recites cooling the protein hydrosol to a temperature between approximately 32 °F and 42 °F. The examiner does not find the support for such a limitation in the disclosure as originally filed. The examiner notes that para. [0083] or Example 1 of the instant specification teaches a cooling temperature of 35 °F . Nowhere else in the disclosure discusses the cooling temperature. Claims 38 and 40 are rejected because they ultimately depend from claim 37.
Claim 38 recites storing the protein hydrosol at a temperature between approximately 32 °F and 42 °F. The examiner does not find the support for such a limitation in the disclosure as originally filed. The examiner notes that para. [0082] or [00175] of the instant specification recites storing the native edestin protein isolate after pasteurization but no temperature is specified. Claim 40 is rejected because it depends from claim 38.
Claim 40 recites spray drying the protein hydrosol at a temperature that is below approximately 155 °F. The examiner does not find the support for such a limitation in the disclosure as originally filed. The examiner notes that para. [0082] of the instant specification recites spray drying the native edestin protein isolate after pasteurization at a temperature range of 145-155 °F, however such a range does not support a temperature that is below approximately 155 °F.
Claims 43 and 48 recite that a temperature of the water added to the hemp grain is between approximately 32 °F and 38 °F, that the aqueous native edestin protein isolate mixture is heated at a temperature of approximately 125-155 °F, and that the temperature of spray drying the protein hydrosol is below approximately 155 °F. The examiner does not find the support for those limitations in the disclosure as originally filed. The examiner notes that para. [00155] of the instant specification teaches that the extraction temperature during the milling is between 33°F and 38 °F, and Example 1 recites that hemp grains are mixed with water having a temperature of 34 °F. However, those are not sufficient to support a limitation that a temperature of the water added to the hemp grain is between approximately 32 °F and 38 °F. The examiner notes that para. [0082] or [00174], and Example 1 of the instant specification recite that NEPI is heated at a temperature of 145 °F, thus not supporting a heating temperature that is below approximately 125-155 °F, which is broader than a temperature range of 125-155 °F. The examiner notes that para. [0082] of the instant specification recites spray drying the native edestin protein isolate after pasteurization at a temperature range of 145-155 °F, however such a range does not support a temperature that is below approximately 155 °F. Claims 44-47 and 49-51 are rejected because they depend from a claim that has written description deficiency.
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 11-13, 17-20, 30-36, 41-51, 54-55 and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Crank US Patent Application Publication No. 2007/0207244 A1 (hereinafter referred to as Crank) in view of Mitchell US Patent No. 7,678,403 B2 (hereinafter referred to as Mitchell), Schweizer US Patent Application Publication No. 2014/0037824 A1 (hereinafter referred to as Schweizer) and Trottet US Patent Application Publication No. 2018/0064137 A1 (hereinafter referred to as Trottet).
Regarding claims 11, 30, 34-36 and 41-42, Crank teaches a process comprising selecting a hemp grain that is full fat or partially defatted (0017; 0021; 0062, milled hemp seed); adding water to the hemp grain (0063); aqueous wet milling the hemp grain to produce a hemp grain slurry (0063); removing an insoluble fiber from the hemp grain slurry through centrifugation (0063; the insoluble by-product was separated from the extract, 0023 of Crank teaches that the insoluble by-product comprises insoluble fiber fraction); treating, through centrifugation (e.g., a high g-force continuous discharge, disk like separator, see 0064) the hemp grain slurry to produce a reduced fat extract (0064) and a fat-enriched hemp cream fraction (0064), Further, Crank teaches that reduced fat extract can be optionally treated with acid or filtration to produce specific reduced fat extract (0008-0009; 0033), and can be used to make a food such as a meat analogue (0042), or can be condensed in an evaporator, or can be spray dried to a produce a reduced-fat extract powder (0031;0066). A meat analogue made from hemp protein is interpreted to read on the “hydrogel structured protein food product”.
Note that since the instant disclosure (e.g., claim 61 as filed on 10/26/2022) has made it clear that wet milling a full fat or partially defatted hemp grain will lead to the formation of an albumin composition in the form of an aqueous oil albumin emulsion, and a native edestin protein isolate, then the wet milling full fat or partially defatted hemp grain step and centrifugation step as disclosed by Crank will reasonably result in an aqueous native edestin protein isolate mixture that comprises a native edestin protein isolate and water, and, a supernatant fraction comprising soluble albumin and a hemp oil.
Crank teaches centrifuging the hemp grain slurry to separate the aqueous native edestin protein isolate mixture and the liquid supernatant fraction but does not teach decanting, however, a decanting step would have been obvious because it is what one of ordinary skill in the art would do to separate a supernatant from the lower part as a result centrifugation. Further, Crank mentions that a centrifugal decanter is suitable for separating one phase from another (0023; 0034;0059), and that a decanter is suitable for decanting a supernatant (0082); 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 used the decanting action since it is suitable for separating a supernatant.
Crank teaches using centrifugation to remove insoluble fiber thus being silent regarding sifting to remove the insoluble fiber.
In the same field of endeavor, Mitchell teaches a process of obtaining a plant protein (e.g., rice) by subjecting whole grain rice to a wet milling process followed by using a sieve to remove insoluble fiber (Example 1).
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 Crank by substituting the sifting method for the centrifugation method to remove insoluble fiber with reasonable expectation of success, for the reason that prior art has established that both methods are suitable for removing insoluble fiber obtained through wet milling a plant seed.
Crank in view of Mitchell is silent regarding heating the aqueous native edestin isolate mixture, for example at a temperature that is below 155 °F or between 125 °F and 155 °F or 145-155 °F as recited in claims 34-35 to produce a protein hydrosol.
In the same field of endeavor, Schweizer teaches a method of extracting hemp protein isolate from hemp seed (0025; 0007-0016), wherein the hemp protein isolate can be used to made a meat analogue (0024); further Schweizer teaches that a pasteurization step can be effected on the hemp protein solution, for example, the hemp protein solution is heated to a temperature of 55-70 °C for about 30 seconds to about 60 minutes; the pasteurized hemp protein solution then may be cooled for drying, preferably to a temperature of 25-40 °C (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 Crank by subjecting the aqueous native edestin isolate mixture (e.g., the reduced fat extract) to a pasteurization step followed by cooling as disclosed by Schweizer for the purpose of killing harmful microbes.
The temperature and the duration of pasteurization as disclosed by Schweizer fall within or overlap with those recited in claims 34-36. 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).
Prior art teaches the same heating condition as recited in the claim, which necessarily results in the formation of a protein hydrosol.
Crank in view of Mitchell and Schweizer teaches what is recited above, further, Crank teaches that reduced fat extract can be used to make a meat analogue (0042). Prior art is silent regarding combining the protein hydrosol with an oil to produce a protein-fat hydrosol and heating the protein-fat hydrosol to produce the hydrogel structured protein food product (e.g., a meat analogue).
Trottet teaches a method of obtaining a meat analogue comprising combining a plant protein, water and oil, and extruding the mixture at a temperature of 70-180 °C to form a meat analogue (0008-0012; 0048).
Both Crank and Trottet are directed to meat analogues made from a plant protein. 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 Crank by combining the protein hydrosol with an oil and water and heat-extruding the mixture at a temperature of 70-180 °C to form a meat analogue with reasonable expectation of success, for the reason that such a method is recognized by prior art to be suitable to make a meat analogue. Prior art teaches the same method of combining the protein hydrosol with an oil as in the claim, which necessarily form a protein-fat hydrosol. The temperature of heating overlaps with the range as recited in claim 42. 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).
Therefore, Crank in view of Mitchell, Schweizer and Trottet renders obvious claims 11, 30, 34-36 and 41-42.
Regarding claim 12, the instant disclosure (e.g., claim 61 as filed on 10/26/2022) has made it clear that wet milling a full fat or partially defatted hemp grain will lead to formation of an albumin composition in the form of an aqueous oil albumin emulsion, and a native edestin protein isolate. In the instant case, Crank in view of Mitchell teaches the same method of wet milling the hemp grain as the method recited in claim 11, it thus logically follows that the native edestin protein isolate as disclosed by prior art is substantially free of albumin. See In re Best.
Regarding claim 13, Crank teaches pre-milled hemp seed and does not specify it is hulled (0062), therefore, implicitly Crank teaches a whole hemp grain. Further, Crank appears to teach that dehulling is an optional treatment (0020, the plant material used in the method can be prepared for processing by any suitable means including dehulling). 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 used either whole hemp seed (e.g., hull-on) or dehulled hemp seed as the hemp protein source because prior art has established that either one is suitable.
Regarding claims 17-18, Crank in view of Mitchell, Schweizer and Trottet teaches what is recited above, further, Mitchell teaches adding cold water of 45 °F to a rice seed before wet milling, and keeping the temperature below the protein denaturization temperature during wet milling (Example 1). 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 optimized the temperature of the water that is added to hemp seed and the temperature of water during the wet milling process to avoid the substantial denaturing of the hemp protein. As such, the temperature as recited in claims 17-18 are merely obvious variants of the prior art.
Regarding claim 19, Crank teaches a specific water/ hemp seed ratio of 320:50 in Example 3 (0063) and Crank also teaches that a water/ plant seed ratio of 4:1 to 16: 1 is suitable (0022). Additionally, Mitchell teaches that the purpose of wet milling is to ensure the complete release of the protein, fiber, fat and starch, and that the ratio of water to grain determines the total solids contents (Example 1). 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 amount of water used for milling to ensure the complete release of the aforementioned components, and/or desired solids contents.
Regarding claim 20, Crank teaches a colloid mill thus being silent regarding a rotor stator type mill. However, Mitchell teaches that a rotor stator type of mill could be used to wet mill a grain (Example 1). 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 Crank by using the rotor stator type mill to wet mill the hemp seed, for the reason that prior art has established that a rotor stator type mill is an art recognized mill suitable for wet mill a plant grain.
Regarding claim 31, Crank teaches adding water to the aqueous native edestin protein isolate mixture (0066; reduced fat extract).
Regarding claims 32-33, Crank teaches adding water to the aqueous native edestin protein isolate mixture (0066; reduced fat extract); further Crank teaches that the reduced fat extract or can be condensed in an evaporator, or can be spray dried to a produce a reduced-fat extract powder (0031), which is interpreted to read on the limitation about adjusting the water content of the aqueous native edestin protein isolate mixture. Further, where Crank teaches concentrating the reduced fat extract, it would have been obvious to adjust the condition of concentrating to obtain a concentrate having a desirable total solid content.
Regarding claims 54-55, Crank in view of Mitchell teaches the same steps of wet milling a hemp grain to form a slurry, sifting the slurry to remove insoluble fiber and decanting the slurry to obtain a native edestin protein isolate (e.g., reduced fat extract) as the steps in claim 11, it thus logically follows that the native edestin protein isolate as disclosed by prior art contains the edestin contents as claimed. See In re Best.
Regarding claim 60, Crank in view of Schweizer as recited above teaches heating (e.g., pasteurizing) the reduced fat extract at a temperature of 55-70 °C, which falls within or overlaps with the range as recited in the claim.
Further, Trottet teaches that in obtaining a meat analogue through heat-extruding the mixture of plant protein, oil and water, the moisture content is 40-70%, the amount protein is 15-35%, and the amount of fat is 2-15% (0008-0012).
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 Crank by including the amounts of water, edestin protein and oil in the mixture to make a meat analogue, for the reason that those aforementioned amounts of each ingredients is recognized by the prior art to be suitable.
The amount of water and oil as disclosed by prior art fall within the ranges as recited in the claim. The ratio of protein/fat as recited in the claim overlaps with the range as recited in the claim. 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).
Further, where Schweizer as recited above teaches that it is suitable to pasteurize a hemp protein solution to kill harmful microbes, 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 mixture that comprises hemp protein, water and oil to pasteurization under the conditions disclosed by Schweizer to further kill the harmful microbes developed during prior processing.
Regarding claims 43-44, Crank teaches a process comprising selecting a hemp grain that is full fat or partially defatted (0017; 0021; 0062, milled hemp seed); adding water to the hemp grain (0063); aqueous wet milling the hemp grain to produce a hemp grain slurry (0063); removing an insoluble fiber from the hemp grain slurry through centrifugation (0063; the insoluble by-product was separated from the extract, 0023 of Crank teaches that the insoluble by-product comprises insoluble fiber fraction); treating, through centrifugation (e.g., a high g-force continuous discharge, disk like separator, see 0064) the hemp grain slurry to produce a reduced fat extract (0064) and a fat-enriched hemp cream fraction (0064). Further, Crank teaches that reduced fat extract can be optionally treated with acid or filtration to produce a specific reduced fat extract (0008-0009; 0033), and can be used to make a food such as meat analogue (0042), or can be condensed in an evaporator, or can be spray dried to a produce a reduced-fat extract powder (0031;0066). A meat analogue made from hemp protein is interpreted to read on the “hydrogel structured protein food product”.
Note that since the instant disclosure (e.g., claim 61 as filed on 10/26/2022) has made it clear that wet milling a full fat or partially defatted hemp grain will lead to the formation of an albumin composition in the form of an aqueous oil albumin emulsion, and a native edestin protein isolate, then the wet milling full fat or partially defatted hemp grain step and centrifuge step as disclosed by Crank will reasonably result in an aqueous native edestin protein isolate mixture that comprises a native edestin protein isolate and water, and, a supernatant fraction comprising soluble albumin and a hemp oil.
Crank teaches centrifuging the hemp grain slurry to separate the aqueous native edestin protein isolate mixture and the liquid supernatant fraction but does not teach decanting, however, a decanting step would have been obvious because it is what one of ordinary skill in the art would do to separate a supernatant from the lower part after the action of centrifugation. Further, Crank mentions that centrifugal decanter is suitable for separating one phase from another (0023; 0034;0059), and that a decanter is suitable for decanting a supernatant (0082); 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 used the decanting action since it is suitable for separating a supernatant.
Crank teaches adding water to the hemp grain and wet milling but is silent regarding the temperature of water that is added to the hemp grain, or the temperature of wet milling. Further, Crank teaches using centrifugation to remove insoluble fiber thus being silent regarding sifting.
In the same field of endeavor, Mitchell teaches a process of obtaining a plant protein (e.g., rice) by subjecting whole grain rice to a wet milling process followed by using a sieve to remove insoluble fiber (Example 1). Further, Mitchell teaches adding cold water of 45 °F to wet mill the plant protein, and keeping the temperature below the protein denaturization temperature during milling (Example 1).
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 Crank by substituting the sifting method for the centrifugation method or using an extra sifting method to remove insoluble fiber with reasonable expectation of success, for the reason that prior art has established that both methods are suitable for removing insoluble fiber obtained through wet milling a plant seed.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have optimized the temperature of the water that is added to hemp seed and the temperature of water during the wet milling process to avoid the substantial denaturing of the hemp protein. As such, the temperatures as recited in claim 43 are merely obvious variants of the prior art.
Crank in view of Mitchell is silent regarding heating the aqueous native edestin isolate mixture at a temperature of 125-155 °F to produce a protein hydrosol and holding the protein hydrosol between 145-155 °F for 30 min.
In the same field of endeavor, Schweizer teaches a method of extracting hemp protein isolate from hemp seed (0025; 0007-0016), wherein the hemp protein isolate can be used to made a meat analogue (0024); further Schweizer teaches that a pasteurization step can be effected on the hemp protein solution, for example, the hemp protein solution is heated to a temperature of 55-70 °C for about 30 seconds to about 60 minutes; and the pasteurized hemp protein solution then may be cooled for drying, preferably to a temperature of 25-40 °C (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 Crank by subjecting the aqueous native edestin isolate mixture (e.g., the reduced fat extract) to a pasteurization step before drying under the condition as disclosed by Schweizer for the purpose of killing harmful microbes.
The temperature and the duration of pasteurization as disclosed by Schweizer overlaps with those recited in the claim. 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).
Prior art teaches the same heating condition as recited in the claim, which necessarily results in a protein hydrosol.
Crank teaches spray drying the plant protein to provide a powder (0031; 0066). Further, given that Mitchell advises not denaturing the protein during processing (Example 1 of Mitchell), one of ordinary skill in the art would have been motivated to manipulate the operational temperature during drying so as to avoid a significant denaturation of the protein. As such, the temperature during spray drying as recited in the claim is merely an obvious variant of the prior art.
Crank as recited above teaches a reduced fat extract powder and also teaches that the reduced fat extract can be used to make a meat analogue (0042). Prior art is silent regarding reconstituting the reduced fat extract powder with water and subjecting the solution to heating at a temperature of 125-155 °F to produce a second protein hydrosol. However, where Schweizer as recited above teaches that it is suitable to pasteurize a hemp protein solution to kill harmful microbes, 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 Crank by adding water to the reduced fat extract powder and pasteurizing so as to kill the harmful microbes developed during storage of protein powder.
Crank in view of Mitchell and Schweizer teaches what is recited above, further, Crank teaches that reduced fat extract can be used to make a meat analogue (0042). Prior art is silent regarding combining the protein hydrosol with an oil to produce a protein-fat hydrosol and heating the protein-fat hydrosol to produce the hydrogel structured protein food product (e.g., a meat analogue).
Trottet teaches a method of obtaining a meat analogue comprising combining a plant protein, water and oil, and extruding the mixture at a temperature of 70-180 °C to form a meat analogue (0008-0012; 0048).
Both Crank and Trottet are directed to meat analogues made from a plant protein. 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 Crank by combining the protein hydrosol with an oil and water and heat-extruding the mixture at a temperature of 70-180 °C to form a meat analogue with reasonable expectation of success, for the reason that such a method is recognized by prior art to be suitable to make a meat analogue. Prior art teaches the same method of combining the protein hydrosol with an oil as in the claim, which necessarily form a protein-fat hydrosol. The temperature of heating overlaps with the range as recited in claim 43. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Regarding claim 45, the instant disclosure (e.g., claim 61 as filed 10/26/2022) has made it clear that wet milling a full fat or partially defatted hemp grain will lead to the formation of an albumin composition in the form of an aqueous oil albumin emulsion, and a native edestin protein isolate. In the instant case, Crank in view of Mitchell teaches the same method of wet milling the hemp grain as the method recited in claim 43, it thus logically follows that the native edestin protein isolate as disclosed by prior art is substantially free of albumin. See In re Best.
Regarding claim 46, Crank teaches adding water to the aqueous native edestin protein isolate mixture (0066, the reduced fat extract).
Regarding claim 47, Crank teaches adding water to the aqueous native edestin protein isolate mixture (0066, the reduced fat extract); further Crank teaches that the reduced fat extract or can be condensed in an evaporator, or can be spray dried to a produce a reduced-fat extract powder (0031), which is interpreted to read on the limitation about adjusting the water content.
Regarding claims 48-51, Crank teaches a process comprising selecting a hemp grain that is full fat or partially defatted (0017; 0021; 0062, milled hemp seed); adding water to the hemp grain (0063); aqueous wet milling the hemp grain to produce a hemp grain slurry (0063); removing an insoluble fiber from the hemp grain slurry through centrifugation (0063; the insoluble by-product was separated from the extract, 0023 of Crank teaches that the insoluble by-product comprises insoluble fiber fraction); treating, through centrifugation (e.g., a high g-force continuous discharge, disk like separator, see 0064) the hemp grain slurry to produce a reduced fat extract (0064) and a fat-enriched hemp cream fraction (0064). Further, Crank teaches that reduced fat extract can be optionally treated with acid or filtration to produce a specific reduced fat extract (0008-0009; 0031), and can be used to make a food such as meat analogue (0042), or can be condensed in an evaporator, or can be spray dried to a produce a reduced-fat extract powder (0031;0066). Crank teaches adding water to the reduced fat extract before spray drying (0066). A meat analogue made from hemp protein is interpreted to read on the “hydrogel structured protein food product”.
Note that since the instant disclosure (e.g., claim 61 as filed on 10/26/2022) has made it clear that wet milling a full fat or partially defatted hemp grain will lead to the formation of an albumin composition in the form of an aqueous oil albumin emulsion, and a native edestin protein isolate, then the wet milling full fat or partially defatted hemp grain step and centrifuge step as disclosed by Crank will reasonably result in an aqueous native edestin protein isolate mixture that comprises a native edestin protein isolate and water, and, a supernatant fraction comprising soluble albumin and a hemp oil, and that the native edestin protein isolate as disclosed by prior art is substantially free of albumin. See In re Best.
Crank teaches centrifuging the hemp grain slurry to separate the aqueous native edestin protein isolate mixture and the liquid supernatant fraction but does not teach decanting, however, a decanting step would have been obvious because it is what one of ordinary skill in the art would do to separate a supernatant from the lower part after the action of centrifugation. Further, Crank mentions that centrifugal decanter is suitable for separating one phase from another (0023; 0034;0059), and that a decanter is suitable for decanting a supernatant (0082); 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 used the decanting action since it is suitable for separating a supernatant.
Crank teaches adding water to the hemp grain and wet milling but is silent regarding the temperature of water that is added to the hemp grain, or the temperature of wet milling. Further, Crank teaches using centrifugation to remove insoluble fiber thus being silent regarding sifting.
In the same field of endeavor, Mitchell teaches a process of obtaining a plant protein (e.g., rice) by subjecting whole grain rice to a wet milling process followed by using a sieve to remove insoluble fiber (Example 1). Further, Mitchell teaches adding cold water of 45 °F to wet mill the plant protein, and keeping the temperature below the protein denaturization temperature during milling (Example 1).
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 Crank by substituting the sifting method for the centrifugation method or using an extra sifting method to remove insoluble fiber with reasonable expectation of success, for the reason that prior art has established that both methods are suitable for removing insoluble fiber obtained through wet milling a plant seed.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have optimized the temperature of the water that is added to hemp seed and the temperature of water during the wet milling process to avoid the substantial denaturing of the hemp protein. As such, the temperatures as recited in claim 48 are merely obvious variants of the prior art.
Crank in view of Mitchell is silent regarding heating the aqueous native edestin isolate mixture at a temperature of 125-155 °F to produce a protein hydrosol and holding the protein hydrosol between 145-155 °F for 30 min as recited in claims 48 and 51.
In the same field of endeavor, Schweizer teaches a method of extracting hemp protein isolate from hemp seed (0025; 0007-0016), wherein the hemp protein isolate can be used to made a meat analogue (0024); further Schweizer teaches that a pasteurization step can be effected on the hemp protein solution, for example, the hemp protein solution is heated to a temperature of about 55-70 °C for about 30 seconds to about 60 minutes; and the pasteurized hemp protein solution then may be cooled for drying, preferably to a temperature of 25-40 °C(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 Crank by subjecting the aqueous native edestin isolate mixture (e.g., the reduced fat extract) to a pasteurization step before drying as disclosed by Schweizer for the purpose of killing harmful microbes.
The temperature and the duration of pasteurization as disclosed by Schweizer overlap with those recited in the claims 48 and 51. 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).
Prior art teaches the same heating condition as recited in the claim, which necessarily results in a protein hydrosol.
Crank teaches spray drying the plant protein to provide a powder (0031; 0066). Further, given that Mitchell advises not denaturing the protein during processing (Example 1 of Mitchell), one of ordinary skill in the art would have been motivated to manipulate the operational temperature during drying so as to avoid significant denaturation of the protein. As such, the temperature during spray drying as recited in the claim is merely an obvious variant of the prior art.
Crank as recited above teaches a reduced fat extract powder and also teaches that the reduced fat extract can be used to make a meat analogue (0042). Prior art is silent regarding reconstituting the reduced fat extract powder with water and subjecting the solution to heating at a temperature of 125-155 °F to produce a protein hydrosol. However, where Schweizer as recited above teaches that it is suitable to pasteurize a hemp protein solution to kill harmful microbes, 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 Crank by adding water to the reduced fat extract powder and pasteurizing so as to kill the harmful microbes developed during storage of hemp protein powder.
Crank in view of Mitchell and Schweizer teaches what is recited above, further, Crank teaches that reduced fat extract can be used to make a meat analogue (0042). Prior art is silent regarding combining the protein hydrosol with an oil to produce a protein-fat hydrosol and heating the protein-fat hydrosol to produce the hydrogel structured protein food product (e.g., a meat analogue).
Trottet teaches a method of obtaining a meat analogue comprising combining a plant protein, water and oil, and extruding the mixture at a temperature of 70-180 °C to form a meat analogue (0008-0012; 0048).
Both Crank and Trottet are directed to meat analogues made from a plant protein, 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 Crank by combining the protein hydrosol with an oil and water and heat-extruding the mixture at a temperature of 70-180 °C to form a meat analogue with reasonable expectation of success, for the reason that such a method is recognized by prior art to be suitable to make a meat analogue. Prior art teaches the same method of combining the protein hydrosol with an oil as in the claim, which necessarily form a protein-fat hydrosol. The temperature of heating overlaps with the range as recited in claim 48. 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).
Claim 13 is rejected as being obvious over Crank in view of Mitchell, Schweizer and Trottet as applied to claim 11 above, further in view of Shen, “The impact of hempseed dehulling on chemical composition, structure properties and aromatic profile of hemp protein isolate”, Food Hydrocolloids, 2020, 106, pages 1-9 (hereinafter referred to as Shen).
Regarding claim 13, Crank teaches pre-milled hemp seed and does not explicitly specify whether it is non-hulled (0062).
Shen teaches that hempseed dehulling has no impact on composition and structural properties of the hemp protein extracted therefrom, however, dehulling increases protein recovery yield and results in a protein with an appealing lighter color, but non-hulled hemp protein has better thermal stability (Abstract and Conclusion on page 8) .
As such, prior art has recognized both pro- and con- of hulling or not hulling a hemp seed, and that either non-hulled or dehulled hempseed can be used for hemp protein extraction. Therefore, one of ordinary skill in the art would have been motivated to use either non-hulled or dehulled hemp seed as the hemp protein source depending on respective advantages desired
Claims 37-38 and 40 are rejected as being obvious over Crank in view of Mitchell, Schweizer and Trottet as applied to claims 11 and 35 above, further in view of New England Biolabs “How Should I store my protein after it is purified? Published 2011-11-23 link: https://www.neb.com/faqs/2011/11/23/how-should-i-store-my-protein-after-it-is-purified#:~:text=Most%20proteins%20can%20be%20stored,store%20at%20%2D20%C2%B0C. (hereinafter referred to as Biolab).
Regarding claims 37-38, Crank in view of Mitchell, Schweizer and Trottet teaches pasteurization but is silent regarding cooling the protein hydrosol after pasteurization in a heat exchanger to 32-42 °F or the step of storing the protein hydrosol at 32-42 °F.
Biolab teaches that protein could be stored for at least a few days at 4 ºC without denaturing (whole page).
Both Crank and Biolab are directed to proteins. 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 Crank by cooling and/or storing the protein at 4 ºC to prevent denaturing.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have put the protein in a refrigerator for the reason that a refrigerator is known to be able to provide the above temperature. A refrigerator is interpreted to read on an heat exchanger.
Regarding claim 40, Crank teaches spray drying the plant protein to provide a powder (0031; 0066). Further, given that Mitchell advises not denaturing the protein during processing (Example 1 of Mitchell), one of ordinary skill in the art would have been motivated to manipulate the operational temperature during drying so as to avoid significant denaturation of the protein. As such, the temperature of drying as recited in the claim is merely an obvious variant of the prior art.
Claims 56-59 are rejected as being obvious over Crank in view of Mitchell, Schweizer and Trottet as applied to claim 11 above, and further in view of Ishizuka US Patent No. 4,579,749 (hereinafter referred to as Ishizuka).
Regarding claims 56-59, Crank in view of Mitchell, Schweizer and Trottet teaches using the hemp protein to make a meat analogue by extrusion which includes a retorting (e.g., heating) step. Crank in view of Mitchell, Schweizer and Trottet is silent regarding the hardness and/or chewiness of the meat analogue.
In the same field of endeavor, Ishizuka teaches a method of making a meat analogue from plant (e.g., soy) protein, and further teaches that the hardness and the chewiness of the meat analogue could be modulated through heating the protein at different temperatures for different durations (column 1, line 35-55; column 3, line 30-45).
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 Crank by subjecting the mixture that comprises hemp protein, water and oil to heating at different temperature for different durations such that desired hardness and chewiness are obtained. As such, the hardness and the chewiness as recited in the claims are merely obvious variants of the prior art.
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Crank US Patent Application Publication No. 2007/0207244 A1 (hereinafter referred to as Crank) in view of Schweizer US Patent Application Publication No. 2014/0037824 A1 (hereinafter referred to as Schweizer) and Trottet US Patent Application Publication No. 2018/0064137 A1).
Regarding claim 52, Crank teaches a process comprising selecting a hemp grain that is full fat or partially defatted (0017; 0021; 0062, milled hemp seed); adding water to the hemp grain (0063); aqueous wet milling the hemp grain to produce a hemp grain slurry (0063); removing an insoluble fiber from the hemp grain slurry through centrifugation (0063; the insoluble by-product was separated from the extract, 0023 of Crank teaches that the insoluble by-product comprises insoluble fiber fraction); treating, through centrifugation (e.g., a high g-force continuous discharge, disk like separator, see 0064) the hemp grain slurry to produce a reduced fat extract (0064) and a fat-enriched hemp cream fraction (0064). Further, Crank teaches that reduced fat extract can be optionally treated with acid or filtered to produce specific reduced fat extract (0008-0009; 0031), and can be used to make a food such as meat analogue (0042), or can be condensed in an evaporator, or can be spray dried to a produce a reduced-fat extract powder (0031;0066). A meat analogue made from hemp protein is interpreted to read on the “hydrogel structured protein food product”.
Note that since the instant disclosure (e.g., claim 61 as filed 10/26/2022) has made it clear that wet milling a full fat or partially defatted hemp grain will lead to formation of an albumin composition in the form of an aqueous oil albumin emulsion, and a native edestin protein isolate, then the wet milling full fat or partially defatted hemp grain step and centrifuge step as disclosed by Crank will reasonably result in an aqueous native edestin protein isolate mixture that comprises a native edestin protein isolate and water, and, a supernatant fraction comprising soluble albumin and a hemp oil.
Crank teaches centrifuging the hemp grain slurry to separate the aqueous native edestin protein isolate mixture and the liquid supernatant fraction but does not teach decanting, however, a decanting step would have been obvious because it is what one of ordinary skill in the art would do to separate a supernatant from a lower portion after the action of centrifugation. Further, Crank mentions that centrifugal decanter is suitable for separating one phase from another (0023; 0034;0059), and that a decanter is suitable for decanting a supernatant (0082); 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 used the decanting action since it is suitable for separating a supernatant.
Crank is silent regarding heating the aqueous native edestin isolate mixture to produce a protein hydrosol.
In the same field of endeavor, Schweizer teaches a method of extracting hemp protein isolate from hemp seed (0025; 0007-0016), wherein the hemp protein isolate can be used to made a protein analogue (0024); further Schweizer teaches that a pasteurization step can be effected on the hemp protein solution, for example, the hemp protein solution is heated to a temperature of about 55-70 °C for about 30 seconds to about 60 minutes; and the pasteurized hemp protein solution then may be cooled for drying, preferably to a temperature of about 25-40 °C (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 Crank by subjecting the aqueous native edestin isolate mixture (e.g., the reduced fat extract) to a pasteurization step as disclosed by Schweizer for the purpose of killing harmful microbes.
Prior art teaches the same heating condition as recited in the claim, which necessarily results in a protein hydrosol.
Crank in view of Schweizer teaches what is recited above, further, Crank teaches that reduced fat extract can be used to make a meat analogue (0042). Prior art is silent regarding combining the protein hydrosol with an oil to produce a protein-fat hydrosol and heating the protein-fat hydrosol to produce the hydrogel structured protein food product (e.g., a meat analogue).
Trottet teaches a method of obtaining a meat analogue comprising combining a plant protein, water and oil, and extruding the mixture at a temperature of 70-180 °C to form a meat analogue (0008-0012; 0048).
Both Crank and Trottet are directed to meat analogues made from a plant protein. 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 Crank by combining the protein hydrosol with an oil and water and heat-extruding the mixture at a temperature of 70-180 °C to form a meat analogue with reasonable expectation of success, for the reason that such a method is recognized by prior art to be suitable to make a meat analogue. Prior art teaches the same method of combining the protein hydrosol with an oil as in the claim, which necessarily form a protein-fat hydrosol.
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Crank in view of Schweizer and Trottet as applied to claim 52 above, and further in view of Mitchell US Patent No. 7,678,403 B2 (hereinafter referred to as Mitchell).
Regarding claim 53, Crank teaches using centrifuge to remove insoluble fiber thus being silent regarding using sifting.
In the same field of endeavor, Mitchell teaches a process of obtaining a plant protein (e.g., rice) by subjecting whole grain rice to a wet milling process followed by using a sieve to remove insoluble fiber (Example 1).
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 Crank by substituting the sifting method for the centrifugation method or using an extra sifting method to remove insoluble fiber with reasonable expectation of success, for the reason that prior art has established that both methods are suitable for removing insoluble fiber obtained through wet milling a plant seed.
Response to Declaration
The declaration under 37 CFR 1.132 filed 11/26/2025 is insufficient to overcome the rejection of pending claims based upon the references as set forth in the last Office action.
It is noted that the declaration has demonstrated by evidence that the edestin protein isolate obtained by the method as shown in Fig. 2 of the instant specification produces a meat analogue having superior hardness and textural properties to Crank’s hemp protein composition. However, the examiner notes that the showing especially the method of obtaining the edestin protein isolate as shown on pages 7-8 of the Declaration is not commensurate in scope with the claims. For example:
-where claim 11 or 52 is silent about the temperature of the water used for wet milling or the temperature of wet milling, the showing specifies using cold water and the temperature of milling being less than 50 °F. It appears the temperature of milling is essential in preserving the structure of the edestin protein (see Mitchell Example 1).
-the showing includes extra ingredient calcium chloride and alpha amylase which are not recited in the pending claims 11, 43, 52 and 58. At least calcium chloride is known to aid in the dissolving a plant protein in an aqueous extraction process.
-Where the showing specifies two different sifting steps with different mesh sizes (e.g. 120 mesh then 170 mesh), the claims 11, 43 and 48 only recite a generic sifting step without even specifying the mesh size. And claim 52 merely recites removing the insoluble without mentioning sifting.
-The showing includes the step of adding water to the protein fraction, but the claims 11, 43, 52 and 58 do not .
-the showing specifies the condition of heating (e.g., pasteurization at 140 °F for 10 min), but claims 11 or 52 merely recites heating without reciting the temperature of heating. Further the heating condition in the showing does not really match claims 43 or claim 48.
-Further, where claims 43 and 52 include extra steps of spray drying the protein hydrosol followed by reconstituting with water and reheating before forming a protein-fat hydrosol, the showing is about using wet protein hydrosol directly to make a protein-fat hydrosol.
For the reasons set forth above, the examiner submits that the showing is not commensurate in scope with the instant claims thus the declaration is insufficient to overcome the rejection of pending claims based upon the references as set forth in the last Office action.
The examiner suggests the applicant amend the pending claims such that they are commensurate in scope with the showing.
Response to Arguments
Applicant's arguments filed 05/08/2025 have been fully considered and the examiner’s response is shown below:
The 35 USC 112 rejection of claims 46-47 are withdrawn in view of the amendment made to the claims.
Conclusion
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/CHANGQING LI/Primary Examiner, Art Unit 1791