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 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 20 July 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 1-4, 7-12, 17, and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Neumüller (EP 3550004 A1) in view of Tang (US 20090286961 A1) and Helling et al. (herein referred to as Helling, US 20100234569 A1)
With regard to Claim 1, Neumüller teaches a process for producing a protein concentrate from oilseed from the plant family Brassicaceae ([0001]-[0003] Neumüller reads such that the invention uses rapeseed (Brassica napus) which is in the family Brassicaceae). Neumüller teaches the process comprises providing a presscake from at least partially dehulled oilseed ([0001]). Neumüller teaches washing said presscake by mixing it with a first alcohol solvent to obtain a washed presscake ([0026]) Neumüller teaches that the pellets of the press cake can be extracted with hexane or another organic solvent in which oil dissolves well such as isopropanol ([0026]). Neumüller teaches eventually separating said washed presscake from said first hydrous-alcohol solvent, to obtain a washed, and eventually separated, presscake ([0044] Neumüller reads such that extracted Collets are drained and dehumidified). Neumüller teaches washing said washed, and eventually separated presscake by mixing it with a last hydrous-alcohol solvent to obtain a protein-containing solid and separating said protein- containing solid from said last hydrous-alcohol solvent to obtain a protein concentrate ([0044]).
However, Neumüller is silent to the solvents alcohol concentration in the first and last wash.
Tang teaches processes for the production of protein concentrates and protein isolates (abstract). Tang teaches the process includes a wash step with an extraction solvent to form an extract and a washed defatted or protein-enriched meal ([0015]). Tang teaches an embodiment where the a defatted or protein-enriched meal is washed at least once with about 5% to about 100%, optionally about 20% to about 90%, or about 40% to about 80% (v/v) ethanol in water, resulting in an ethanol extract and an ethanol washed defatted or protein-enriched meal. Other alcohols, such as methanol or isopropanol, can be utilized for washing the defatted or protein-enriched meal ([0345]). Tang teaches washing the defatted or protein-enriched meal at least twice results in the removal of more impurities from the defatted or protein-enriched meal and therefore increases the protein content in the protein concentrate ([0347]).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Neumüller in view of Tang to use a wash solvent containing about 5% to about 100% to form an extract and a washed defatted or protein-enriched meal. One with ordinary skill in the art would recognize adjusting the ethanol concentration in the first and last wash to achieve the desired amount of impurity removal and result in the desired protein content in the protein concentrate. This is further supported by Neumüller who teaches in the final alcohol stage is a displacement of the alcohol-water mixture against 96% ethanol in order to reduce the energy costs of the subsequent drying ([0044]). See MPEP 2144.05(II)(A) which states, “"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”
In addition, Tang imparts reasoning for obviousness because the teaching shows using isopropanol solvent in the presence of water was known for such a thing to have been successfully achieved and published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to using isopropanol in combination with water because it would have been obvious to one with ordinary skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
With regard to the oil concentration of the presscake, Neumüller teaches the press cake of step a) has an oil content of 18 to 28 percent by weight after being pressed ([0023]) and has not been subjected to a non-polar solvent prior. However, this range is slightly higher than the claimed range.
Helling teaches processes for aqueous milling of press cakes to extract and recover protein fractions ([0037]). Helling teaches using press cakes as the starting material. Wherein the presscakes have not been subject to a solvent or other chemical extracts ([0039]). Helling teaches embodiments wherein the starting presscake material has 10.4% oil (Table 23), 11.2% (Table 27), and 10.3% oil (Table 30). Helling teaches presscakes offer some unique advantages, including: less heat history and degradation of proteins, complete avoidance of organic solvents, and the ability to recover most of the oil as free oil from the presses. By removing the majority of the oil before contacting water, the amount of emulsion made and the quantity of water required should be greatly reduced compared to wet milling of grains ([0050]).
Therefore, it would have been obvious to one with ordinary skill in the art to modify Neumüller to utilize the presscakes as a starting material as described by Helling to greatly reduce the amount of emulsion made and the quantity of water required compared to wet milling of grains.
With regard to Claim 2, Neumüller teaches the oilseed is from the plant family Brassicaceae ([0001]-[0003] Neumüller reads such that the invention uses rapeseed (Brassica napus) which is in the family Brassicaceae).
With regard to Claims 3 and 4, Neumüller teaches the alcohol extraction serves to remove toxins and other anti-nutritional ingredients ([0026]). Neumüller teaches in one embodiment least 10 extraction stages are carried out in countercurrent ([0026]).
It would have been obvious to one with ordinary skill to add addition wash steps before the last wash with the hydrous-alcohol solvent in order to remove the desired amount of toxins and other anti-nutritional ingredients. See MPEP(II)(A) "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In addition, one with ordinary skill in the art would recognize “extraction” means the hydrous-alcohol solvent is inherently separated.
With regard to Claim 7, Neumüller teaches the hydrous-alcohol solvent can be ethanol ([0029]). One with ordinary skill in the art would recognize ethanol is a C1 to C3 aliphatic alcohol.
With regard to Claim 8, Neumüller is silent to the solvents alcohol concentration in the first and final wash.
Tang teaches the process includes a wash step with an extraction solvent to form an extract and a washed defatted or protein-enriched meal ([0015]). Tang teaches an embodiment where the a defatted or protein-enriched meal is washed at least once with about 5% to about 100%, optionally about 20% to about 90%, or about 40% to about 80% (v/v) ethanol in water, resulting in an ethanol extract and an ethanol washed defatted or protein-enriched meal ([0345]). Tang teaches washing the defatted or protein-enriched meal at least twice results in the removal of more impurities from the defatted or protein-enriched meal and therefore increases the protein content in the protein concentrate ([0347]).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Neumüller in view of Tang to use a wash solvent containing about 5% to about 100% to form an extract and a washed defatted or protein-enriched meal. One with ordinary skill in the art would recognize adjusting the ethanol concentration in the first and final wash to achieve the desired amount of impurity removal and result in the desired protein content in the protein concentrate. See MPEP 2144.05(II)(A) which states, “"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”
With regard to Claims 9 and 20, Neumüller is silent to the temperature of the wash steps.
Tang teaches washing the mixture with an extraction solvent at a temperature of about 10℃ to about 90℃. See MPEP 2144.05(I) which states in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Tang teaches an embodiment wherein protein enriched meal 80% ethanol (v/v) in a stainless steel pot under homogeneous agitation using an overhead stirrer at room temperature for 1 hour. After extraction the slurry was centrifuged batch wise at to separate the insoluble protein solids. The protein solids were mixed with 80% ethanol (v/v) under homogeneous agitation at room temperature for 1 hour, which was followed by centrifugation of the protein slurry to separate washed protein solids from the washing sugar extract. Finally, the washed protein solids were extracted for a 3rd time with 80% ethanol (v/v) under homogeneous agitation at room temperature for 1 hour ([0567], [0568]).
Therefore Tang imparts reasoning for obviousness because the teaching shows embodiment in which a washing step, with the claimed hydrous-alcohol solvent, is performed within the claimed temperature range and had been successfully published at the time of filing. Which means it was within the general skill of one with ordinary skill in the art to select the wash temperature taught by Tang because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
With regard to Claim 10, Neumüller teaches the final alcohol stage is a displacement of the alcohol-water mixture against 96% ethanol in order to reduce the energy costs of the subsequent drying. The alcohol is distilled off and reused. ([0044]). Neumüller reads that the hydrous-alcohol solvent is completely removed via the distillation.
With regard to Claim 11, Neumüller teaches cleaning the rapeseed ([0040]).
With regard to Claim 12, Neumüller is silent to the protein concentrate being subjected to at least one sieving step.
Tang teaches a process for the production of a protein isolate from a defatted or protein-enriched meal ([0563]). Tang teaches the defatted meal is typically subjected to a milling step and a screening step to remove fiber and obtain a protein-enriched meal ([0285]).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Neumüller in view of Tang to subject the protein concentrate to a milling and screen (i.e., sieving) step to remove fiber and obtain a protein-enriched meal.
With regard to Claim 17, Neumüller teaches the oilseed is rapeseed (Brassica napus) ([0001]-[0003]).
With regard to Claims 19 and 21, Neumüller teaches the hydrous-alcohol solvent comprises ethanol or isopropanol ([0029], [0026]).
With regard to Claim 22, Neumüller teaches wherein no alkane extraction is carried out ([0029], [0026], [0044])
Claims 6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Neumüller (EP 3550004 A1) in view of Tang (US 20090286961 A1) and Oteza (“Hot Pressing”).
With regard to Claims 6 and 18, Neumüller is silent to the preliminary cooking step, the first pressing, and the second pressing.
Oteza teaches two-stage hot pressing is a method an oilseed processing method. Oteza teaches two-stage hot pressing ensures the highest oil yield of all technologies (“Two-stage hot pressing”). Oteza teaches pre-heating the seeds alters the properties of cell structures, converts proteins and aggregates oil at the cellular level (“Two-stage hot pressing”). The pre-heating taught by Oteza reads on the instant claims cooking step prior to pressing. Oteza teaches the use of a first-stage press and a second stage press (“Description of two-stage hot pressing”). Oteza teaches with increasing temperature the viscosity of the oil decreases significantly. These effects enhance the compressibility of oil (“Two-stage hot pressing”).
It would have been obvious to one with ordinary skill in the art to modify Neumüller in view of Oteza to use a two-stage hot pressing method to ensure the highest removal of oil from the oilseed presscake. Oteza teaches it is advantageous to use a cooking step prior to pressing to alter the properties of cell structures, convert proteins, and aggregate oil at the cellular level. With regard to temperature, it would have been obvious to one with ordinary skill in the art to adjust temperature through routine experimentation to achieved the desired oil viscosity for the removal process. See MPEP 2144.05(II)(A) Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant's arguments filed 20 July 2026 have been fully considered but they are not persuasive.
First, applicant argues that the combination of Neumüller and Tang do not teach the newly added limitations of claim 1, specifically the references do not teach the presscake having an oil content ranging from 5% to 14% dry w/w. This argument is moot due to addition of the reference Helling which teaches using press cakes as the starting material to extract and recover protein fractions wherein the starting presscake material has 10.4% oil (Table 23), 11.2% (Table 27), and 10.3% oil (Table 30). Advantageously Helling teaches utilizing presscakes as a starting material greatly reduce the amount of emulsion made and the quantity of water required compared to wet milling of grains. Therefore, Helling teaches the newly added limitations of claim 1 and further provides ample motivation to be combined with Neumüller. Thus, applicant’s argument is not found to be persuasive.
Next applicant argues Applicant argues that Neumüller does not teach or suggest using a first hydrous-alcohol solvent to obtained a wash presscake. Applicant argues that Neumüller makes no mention of using isopropanol in the presence of water. First, Neumüller states pellets of the press cake can be extracted with hexane or another organic solvent (emphasis added) in which oil dissolves well such as isopropanol (emphasis added, [0026]). Per applicants specification, isopropanol is a particularly preferred hydrous-alcohol solvent (applicant specification page 8). Next, Tang is relied upon to teach the percentage of alcohol in the first-hydrous-alcohol. Neumüller is not relied upon to teach the concentration of alcohol, the reference is merely relied upon to show the use of the first solvent. In this case, Tang teaches a wash solvent containing about 5% to about 100% ethanol in water to form an extract and a washed defatted or protein-enriched meal. This range clearly overlaps with the claimed range. Per MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Tang teaches the wash solvent is alcohol in water and Tang teaches other alcohols, such as methanol or isopropanol, can be utilized for washing the defatted or protein-enriched meal ([0345]). Therefore, Tang clearly teaches isopropanol in the presence of water as a wash solvent. In addition, one with ordinary skill in the art would recognize adjusting the ethanol concentration in the first and last wash to achieve the desired amount of impurity removal and result in the desired protein content in the protein concentrate. In addition, it would have been obvious to one with ordinary skill in the art through routine optimization to determine the desired amount of the first hydrous-alcohol solvent taught by Neumüller. See MPEP 2144.05(II) Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, applicants argument is not found to be persuasive.
Further, applicant submits a declaration, now referred to as the “Dr. Ndiaye declaration”. The Dr. Ndiaye declaration is an opinion based declaration which argues that one with ordinary skill in the art would generally not regard a hydrous alcohol have from 25% to 40% w/w of water as a promising or preferred alternative for efficient degreasing. The Dr. Ndiaye declaration further states that one with ordinary skill in the art would recognize that the introduction of water into an alcohol solvent would significantly impair its performance as a degreasing agent. Further The Dr. Ndiaye declaration continues that a person of ordinary skill in the art would not merely fail to consider hydrous alcohol as an obvious alternative but would recognize it as unsuitable and inefficient choice for degreasing. Frist, the examiner would like to highlight MPEP 716.01(c)(III) which states Although an affidavit or declaration which states only conclusions may have some probative value, such an affidavit or declaration may have little weight when considered in light of all the evidence of record in the application. In re Brandstadter, 484 F.2d 1395, 179 USPQ 286 (CCPA 1973). In this case, The Dr. Ndiaye declaration does not contain factual evidence and only states opinions and conclusions through the opinions of Dr. Ndiaye. The examiner would like to acknowledge MPEP 716.01(c)(III) Although factual evidence is preferable to opinion testimony, such testimony is entitled to consideration and some weight so long as the opinion is not on the ultimate legal conclusion at issue. While an opinion as to a legal conclusion is not entitled to any weight, the underlying basis for the opinion may be persuasive. Further, In assessing the probative value of an expert opinion, the examiner must consider the nature of the matter sought to be established, the strength of any opposing evidence, the interest of the expert in the outcome of the case, and the presence or absence of factual support for the expert’s opinion. Thus, when assessing The Dr. Ndiaye declaration the declaration does not present evidence merely opinion. With regard to the “the interest of the expert in the outcome of the case” the expert in this case is one of the inventors and not a third party expert. With regard to the factual support, as stated above the declaration does not provide factual support and is merely opinion based. Therefore, The Dr. Ndiaye declaration is not found to be persuasive.
Further with regard to the arguments presented in the Dr. Ndiaye declaration Tang teaches a defatted or protein-enriched meal is washed at least once with about 5% to about 100%, optionally about 20% to about 90%, or about 40% to about 80% (v/v) ethanol in water ([0345]). Per applicant’s specification page 8 ethanol is a particularly preferred alcohol solvent. Therefore, Tang teaches the claimed hydrous alcohol and water combination in the claim amount. Therefore, applicant’s argument is not found to be persuasive.
Lastly, applicant argues that the specification discloses unexpected results. Applicant states, “surprisingly found that the step of hexane extraction can be omitted by successive extractions or washes with hydrous alcohol solvents”. The applicant does not further cite any data to corroborate their statement. Per MPEP 716.02(b)(I) The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); The examiner would also like to point out MPEP 716.02(d)(II) which states, “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).” In this case, the applicant’s claim without the appropriate data is not sufficient to show unexpected results. Therefore applicant’s argument is not found to be persuasive.
Conclusion
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/K.I.D./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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