DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
The claim amendments filed 24 July 2025 have been entered. Claims 22-32 and 34-41 are pending. Claims 1-21 and 33 have been cancelled. The previous claim objections have been withdrawn in view of applicant’s amendments to the claims. The previous 112 rejections not repeated below have been withdrawn in view of applicant’s amendments to the claims. The previous 103 rejections have been modified in view of applicant’s amendments to the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 22-32 and 34-41 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 recites “wherein the reduced-fumonisin corn protein product cake exhibits an established cake drainage rate that is at least 10% greater than a comparative established cake drainage rate of a like control cake formed from the corn protein product at the same pH as the reduced-fumonisin corn protein product, but not treated with the divalent cationic salt comprising calcium chloride, magnesium chloride, or a combination thereof.” Claim 23 recites “wherein the reduced- fumonisin corn protein product cake exhibits and established cake drainage rate that is at least 25% greater than a comparative established cake drainage rate of a like control cake formed from the corn protein product at the same pH as the reduced-fumonisin corn protein product, but not treated with the divalent cationic salt comprising calcium chloride, magnesium chloride, or a combination thereof.” Claim 32 recites “wherein the reduced-fumonisin corn protein product exhibits a drainage rate that is at least 80% of the drainage rate of a like control cake formed from the corn protein product at the same pH as the reduced-fumonisin corn protein product, but not treated with the divalent cationic salt comprising calcium chloride, magnesium chloride, or a combination thereof.”
It is unclear how the established cake drainage rate of claims 22 and 23 or the cake drainage rate of claim 32 is determined. The specification provides some guidance to determine a cake drainage rates [00041] and the established cake drainage rate is disclosed as the secondary drainage of the cake [00042]. However, one of ordinary skill in the art could, based on the information provided, interpret differently how to obtain an “established cake drainage rate” or “drainage rate.” The starting moisture content of the cake and the final moisture content of the cake are not requirements for determining the established cake drainage rate. The starting and final moisture contents of the cake will influence the drainage rate. The disclosed method states that between the first and second filtration steps “any cracks in the cake were sealed by rubbing the surface with a wet fingertip” [0041]. This method of applying a wet fingertip to the sample while it is still in a filter would result in a change in the compaction of the sample and a change in the remaining moisture content depending on how much pressure is applied. The method disclosed would not result in reproducible results. One of ordinary skill in the art could perform the disclosed method of the claims and perform the test of determining the established cake drainage rate and/or drainage rate and obtain results that fall within and outside the claimed range depending on how the test is performed. For the purpose of examination, claims 22, 23 and 32 will be interpreted as if all of the active method steps for reducing fumonisin in a corn protein product of claims 22 and 32 have been performed, then the resulting reduced-fumonisin corn protein product or cake thereof has the claimed established cake drainage rate (claims 22 and 23) or drainage rate (claim 32).
Claims 31 and 41 recite “wherein the divalent cationic salt is added in amounts ranging from about 0.2 to about 1 wt % on a slurry basis.” It is unclear what is meant by “on a slurry basis.” Is the amount of cationic salt added based on the weight of the slurry before the base is added? Or after the base is added to the slurry comprising the corn protein product? Or is the amount of cationic salt added based on the weight of the slurry which comprises base, water, corn protein product and the cationic salt? Example 1 in the specification discloses adding 50 g corn protein product and then 150 g of a combination of water, sodium hydroxide and calcium chloride for a total mass of 200g [0031]. Table 1 (p6) indicates that when 2g of calcium chloride are added to the total mass of 200g of slurry of corn protein product, water, base and cationic salt; then the calcium chloride is present at 1% of the sample. Therefore, for the purpose of examination, 31 and 41 will be interpreted as: about 0.2 to about 1 wt% based on the total weight of the slurry after the base has been added.
Claims 24-30 are rejected here because they depend from claim 22.
Claims 34-40 are rejected here because they depend from claim 32.
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 22-25, 27-32, 34-35 and 37-41 are rejected under 35 U.S.C. 103 as being unpatentable over Romero (WO 2017/081347 A2) in view of Li (US 2020/0236977 A1) as evidenced by Dombrink-Kurtzman (Effect of Nixtamalization (Alkaline Cooking) on Fumonisin-Contaminated Corn for Production of Masa and Tortillas, J. Agric. Food Chem, 2000, 48, 5781-5786).
NOTE: Mielgo Iza (US 2019/0029295 A1) is cited in the rejections as the English language version of Romero (WO 2017/081347 A2). All reference have been provided with the IDS of the instant application.
Regarding claims 22 and 23, Mielgo Iza discloses a method for reducing inorganic and organic contaminants in high protein vegetable matter [0001]. Mielgo Iza discloses the organic contaminants can be mycotoxins including fumonisin B1 [0036] and [0038] and the high protein vegetable matter can come from corn [0035].
Mielgo Iza discloses a procedure which includes mixing the initial vegetable matter with water (a slurry) and bring the pH of the mixture to between 6.5 and 8.5 [0020]. Mielgo Iza discloses an embodiment where the pH is adjusted using NaOH (a base) [0055]. Mielgo Iza’s adjustment to the pH between 6.5 and 8.5 overlaps with the claimed range of a pH of 6.5-7.25. 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.
Mielgo Iza discloses a step of washing and a solid liquid separation [0021] where the separation can be carried out by decanting, precipitation, sedimentation, sieving centrifugation filtration and cyclone, evaporation or drying [0034]. Mielgo Iza’s separation by drying, evaporation, sedimentation, sieving, or centrifugation would result in the formation of a solid mass. Mielgo Iza’s disclosure is considered to meet the claim limitation of removing water from the slurry to form a cake of a reduced fumonisin corn protein product.
Mielgo Iza discloses the method reduces inorganic contaminants including heavy metals [0001].
Mielgo Iza does not disclose adding a divalent cationic salt which comprises calcium chloride, magnesium chloride or combinations thereof.
Li discloses methods for reducing the leaching toxicity of heavy metals contained in food therefore enhancing food safety [0001]. Li discloses providing a stabilizing agent for reducing the leaching toxicity of heavy metals contained in foods. The stabilizing agent comprises an acidity regular and a chloride [0020]. Li discloses the acidity regulator can be calcium hydroxide or potassium hydroxide (bases) [0022] and the chloride is one or more selected from calcium chloride and magnesium chloride [0023]. Li discloses the food can be a fruit or vegetable, including corn [0025]. Li discloses a preferred embodiment where the food has a pH of 6 or higher [0026].
Li discloses soaking the foods with the stabilizing agent and water followed by stirring to obtain a uniform mixture. Li discloses heavy metals will leach out from the food tissue [0060]. Li further discloses the method enhances food safety [0061].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the calcium chloride and/or magnesium chloride used during soaking of food, including corn, of Li with the slurry comprising corn protein product as taught by Mielgo Iza to obtain a method of reducing fumonisin in corn protein product that includes a step of adding a divalent cationic salt comprising calcium chloride and/or magnesium chloride. One of ordinary skill in the art would have been motivated to do so because both Mielgo Iza and Li are both drawn to methods of improving food safety by decreasing heavy metals using methods comprising soaking the food source in a water based solution comprising a base in overlapping pH ranges.
Mielgo Iza does not disclose the quantity of the reduction in fumonisin in the corn protein product.
Dombrink-Kurzman, in the field of nixtamalization for reducing fumonisin contamination, discloses a method of reducing fumonisin in a corn product (p. 5781, Abstract). Dombrink-Kurtzman discloses nixtamalization is an ancient, traditional process of alkaline cooking with lime as the alkaline component (p. 5781, col. 1, 1st para). Dombrink-Kurtzman discloses making a slurry comprising lime, water, and corn (p. 5781, Figure 2, illustrating mixture of corn, water, and lime as first step in process). Dombrink-Kurtzman discloses pH 7, 10, and between 5 and 7 (p. 5784, col. 1, 3rd para). Dombrink-Kurtzman discloses the process “significantly reduced the amount of fumonisin in corn” (p. 5784, col. 2, DISCUSSION). Dombrink-Kurtzman discloses the major amount fumonisin (FB1) that had been present in corn was recovered in the steeping water (p. 5784, col. 1, last para). Dombrink-Kurtzman discloses the untreated raw corn contained 8.79 ppm of fumonisin (FB1, p. 5782, col. 2, “Corn Sample”). Dombrink-Kurtzman discloses the treated corn contained fumonisin (FB1) in amounts of 0.111 ppm (111 ng/g), 0.172 ppm (172 ng/g), 0.322 ppm (322 ng/g), 0.406 ppm (406 ng/g), and 0.327 ppm (327 ng/g) (p. 5784, Table 2, “FB1 (ng/g)”). The reduced amounts of fumonisin (FB1) represent reductions of about 98.7%, 98.0%, 96.3%, 95.4%, 96.3% (calculation formula: Percentage Decrease = [Starting Value−Final Value]/Starting Value×100%).
As evidenced by Dombrink-Kurzman, known methods of treating corn with a basic solution decrease the amount of fumonisin in the sample between 95-98%. One of ordinary skill in the art would have expected the method of Mielgo Iza in view of Li, which also comprises soaking a corn sample in a basic solution, to result in a similar reduction in fumonisin contamination.
Additionally, as to the claim language “having a reduction of fumonisin of at least 70% comparted to the corn protein product”, this is a property of the product produced by the claimed method. Given the combination of prior art teaches the method as claimed, the product is considered to possess the properties as claimed.
Regarding the claim language: wherein the reduced-fumonisin corn protein product cake exhibits an established cake drainage rate that is at least 10% greater than a comparative established cake drainage rate of a like control cake formed from the corn protein product at the same pH as the reduced-fumonisin corn protein product, but not treated with the divalent cationic salt comprising calcium chloride, magnesium chloride, or a combination thereof (claim 22) and wherein the reduced- fumonisin corn protein product cake exhibits and established cake drainage rate that is at least 25% greater than a comparative established cake drainage rate of a like control cake formed from the corn protein product at the same pH as the reduced-fumonisin corn protein product, but not treated with the divalent cationic salt comprising calcium chloride, magnesium chloride, or a combination thereof (claim 23). A wherein clause limits a process claim where the clause gives meaning and purpose to the manipulative steps. A whereby clause in a method is not given weight when it simply expresses the intended result of a process step positively recited. MPEP 211.04 I. Given the combination of prior art teaches the method as claimed, the product is considered to possess the properties as claimed.
Regarding claim 32, Mielgo Iza discloses a method for reducing inorganic and organic contaminants in high protein vegetable matter [0001]. Mielgo Iza discloses the organic contaminants can be mycotoxins including fumonisin B1 [0036] and [0038] and the high protein vegetable matter can come from corn [0035].
Mielgo Iza discloses a procedure which includes mixing the initial vegetable matter with water (a slurry) and bring the pH of the mixture to between 6.5 and 8.5 [0020]. Mielgo Iza discloses an embodiment where the pH is adjusted using NaOH (a base) [0055]. Mielgo Iza’s adjustment to the pH between 6.5 and 8.5 overlaps with the claimed range of a pH of 6.5-7.25. 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.
Mielgo Iza discloses a step of washing and a solid liquid separation [0021] where the separation can be carried out by decanting, precipitation, sedimentation, sieving centrifugation filtration and cyclone, evaporation or drying [0034]. Mielgo Iza’s disclosure is considered to meet the claim limitation of removing water from the slurry to form a reduced fumonisin corn protein product.
Mielgo Iza discloses the method reduces inorganic contaminants including heavy metals [0001].
Mielgo Iza does not disclose adding a divalent cationic salt which comprises calcium chloride, magnesium chloride or combinations thereof.
Li discloses methods for reducing the leaching toxicity of heavy metals contained in food therefore enhancing food safety [0001]. Li discloses providing a stabilizing agent for reducing the leaching toxicity of heavy metals contained in foods. The stabilizing agent comprises an acidity regular and a chloride [0020]. Li discloses the acidity regulator can be calcium hydroxide or potassium hydroxide (bases) [0022] and the chloride is one or more selected from calcium chloride and magnesium chloride [0023]. Li discloses the food can be a fruit or vegetable, including corn [0025]. Li discloses a preferred embodiment where the food has a pH of 6 or higher [0026].
Li discloses soaking the foods with the stabilizing agent and water followed by stirring to obtain a uniform mixture. Li discloses heavy metals will leach out from the food tissue [0060]. Li further discloses the method enhances food safety [0061].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the calcium chloride and/or magnesium chloride used during soaking of food, including corn, of Li with the slurry comprising corn protein product as taught by Mielgo Iza to obtain a method of reducing fumonisin in corn protein product that includes a step of adding a divalent cationic salt comprising calcium chloride and/or magnesium chloride. One of ordinary skill in the art would have been motivated to do so because both Mielgo Iza and Li are both drawn to methods of improving food safety by decreasing heavy metals using methods comprising soaking the food source in a water based solution comprising a base in overlapping pH ranges.
Mielgo Iza does not disclose the quantity of the reduction in fumonisin in the corn protein product.
Dombrink-Kurzman, in the field of nixtamalization for reducing fumonisin contamination, discloses a method of reducing fumonisin in a corn product (p. 5781, Abstract). Dombrink-Kurtzman discloses nixtamalization is an ancient, traditional process of alkaline cooking with lime as the alkaline component (p. 5781, col. 1, 1st para). Dombrink-Kurtzman discloses making a slurry comprising lime, water, and corn (p. 5781, Figure 2, illustrating mixture of corn, water, and lime as first step in process). Dombrink-Kurtzman discloses pH 7, 10, and between 5 and 7 (p. 5784, col. 1, 3rd para). Dombrink-Kurtzman discloses the process “significantly reduced the amount of fumonisin in corn” (p. 5784, col. 2, DISCUSSION). Dombrink-Kurtzman discloses the major amount fumonisin (FB1) that had been present in corn was recovered in the steeping water (p. 5784, col. 1, last para). Dombrink-Kurtzman discloses the untreated raw corn contained 8.79 ppm of fumonisin (FB1, p. 5782, col. 2, “Corn Sample”). Dombrink-Kurtzman discloses the treated corn contained fumonisin (FB1) in amounts of 0.111 ppm (111 ng/g), 0.172 ppm (172 ng/g), 0.322 ppm (322 ng/g), 0.406 ppm (406 ng/g), and 0.327 ppm (327 ng/g) (p. 5784, Table 2, “FB1 (ng/g)”). The reduced amounts of fumonisin (FB1) represent reductions of about 98.7%, 98.0%, 96.3%, 95.4%, 96.3% (calculation formula: Percentage Decrease = [Starting Value−Final Value]/Starting Value×100%).
As evidenced by Dombrink-Kurzman, known methods of treating corn with a basic solution decrease the amount of fumonisin in the sample between 95-98%. One of ordinary skill in the art would have expected the method of Mielgo Iza in view of Li, which also comprises soaking a corn sample in a basic solution, to result in a similar reduction in fumonisin contamination.
Additionally, as to the claim language “having a reduction of fumonisin of at least 70% comparted to the corn protein product”, this is a property of the product produced by the claimed method. Given the combination of prior art teaches the method as claimed, the product is considered to possess the properties as claimed.
Regarding the claim language: wherein the reduced-fumonisin corn protein product exhibits a drainage rate that is at least 80% of the drainage rate of a like control cake formed from the corn protein product at the same pH as the reduced-fumonisin corn protein product, but not treated with the divalent cationic salt comprising calcium chloride, magnesium chloride, or a combination thereof. A wherein clauses limit a process claim where the clause gives meaning and purpose to the manipulative steps. A whereby clause in a method is not given weight when it simply expresses the intended result of a process step positively recited. MPEP 211.04 I. Given the combination of prior art teaches the method as claimed, the product is considered to possess the properties as claimed.
Regarding claims 24, 25, 34 and 35; Mielgo Iza discloses a pH between 6.5 and 8.5 [0020], which encompasses the claim 24, 25, 34 and 35 ranges of 6.5-7 and 6.75-7. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05 I.
Regarding claims 27 and 37, Mielgo Iza discloses the protein may be from corn [0035]. The disclosure of corn protein is considered to meet the claim limitation of corn protein concentrate because corn protein is a concentrated collection of proteins that originated from a corn kernel.
Additionally per MPEP 2144.05 II, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where 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. A change in form, proportions, or degree will not sustain a patent. It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions. As discussed above, Mielgo Iza discloses the protein may be from corn [0035]. As such the concentration of protein in a corn protein represents a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means. As such, it is not such an invention as will sustain a patent.
Regarding claims 28, 29, 30, 38, 39 and 40; Mielgo Iza does not disclose the final amounts of fumonisin.
Dombrink-Kurzman, in the field of nixtamalization for reducing fumonisin contamination, discloses a method of reducing fumonisin in a corn product (p. 5781, Abstract). Dombrink-Kurtzman discloses nixtamalization is an ancient, traditional process of alkaline cooking with lime as the alkaline component (p. 5781, col. 1, 1st para). Dombrink-Kurtzman discloses making a slurry comprising lime, water, and corn (p. 5781, Figure 2, illustrating mixture of corn, water, and lime as first step in process). Dombrink-Kurtzman discloses pH 7, 10, and between 5 and 7 (p. 5784, col. 1, 3rd para). Dombrink-Kurtzman discloses the process “significantly reduced the amount of fumonisin in corn” (p. 5784, col. 2, DISCUSSION). Dombrink-Kurtzman discloses the major amount fumonisin (FB1) that had been present in corn was recovered in the steeping water (p. 5784, col. 1, last para). Dombrink-Kurtzman discloses the untreated raw corn contained 8.79 ppm of fumonisin (FB1, p. 5782, col. 2, “Corn Sample”). Dombrink-Kurtzman discloses the treated corn contained fumonisin (FB1) in amounts of 0.111 ppm (111 ng/g), 0.172 ppm (172 ng/g), 0.322 ppm (322 ng/g), 0.406 ppm (406 ng/g), and 0.327 ppm (327 ng/g) (p. 5784, Table 2, “FB1 (ng/g)”).
As evidenced by Dombrink-Kurzman, known methods of treating corn with a basic solution decrease the amount of fumonisin in the sample to between 0.111-0.406 ppm. One of ordinary skill in the art would have expected the method of Mielgo Iza in view of Li, which also comprises soaking a corn sample in a basic solution, to result in a similar reduction in fumonisin contamination.
Additionally, as to the claim language: wherein the fumonisin is reduced to an amount less than 1.5 ppm, 0.5 ppm or 0.2 ppm; this is a property of the product produced by the claimed method. A wherein clauses limit a process claim where the clause gives meaning and purpose to the manipulative steps. A whereby clause in a method is not given weight when it simply expresses the intended result of a process step positively recited. MPEP 211.04 I. Given the combination of prior art teaches the method as claimed, the product is considered to possess the properties as claimed.
Regarding claims 31 and 41, Mielgo Iza does not disclose the quantity of divalent cationic salt in the slurry.
Li discloses methods for reducing the leaching toxicity of heavy metals contained in food therefore enhancing food safety [0001]. Li discloses providing a stabilizing agent for reducing the leaching toxicity of heavy metals contained in foods. The stabilizing agent comprises an acidity regular and a chloride [0020]. Li discloses the acidity regulator can be calcium hydroxide or potassium hydroxide (bases) [0022] and the chloride is one or more selected from calcium chloride and magnesium chloride [0023]. Li discloses the food can be a fruit or vegetable, including corn [0025]. Li discloses a preferred embodiment where the food has a pH of 6 or higher [0026]. Li discloses the chloride can be included from 0.5-40 wt% [0035], which overlaps with the claimed range of 0.2-1 wt%. 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.
Li discloses soaking the foods with the stabilizing agent and water followed by stirring to obtain a uniform mixture. Li discloses heavy metals will leach out from the food tissue [0060]. Li further discloses the method enhances food safety [0061].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the calcium chloride and/or magnesium chloride used during soaking of food, including corn, of Li with the slurry comprising corn protein product as taught by Mielgo Iza to obtain a method of reducing fumonisin in corn protein product that includes a step of adding a divalent cationic salt comprising calcium chloride and/or magnesium chloride. One of ordinary skill in the art would have been motivated to do so because both Mielgo Iza and Li are both drawn to methods of improving food safety by decreasing heavy metals using methods comprising soaking the food source in a water based solution comprising a base in overlapping pH ranges.
Claims 26 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Romero (WO 2017/081347 A2) in view of Li (US 2020/0236977 A1) as evidenced by Dombrink-Kurtzman (Effect of Nixtamalization (Alkaline Cooking) on Fumonisin-Contaminated Corn for Production of Masa and Tortillas, J. Agric. Food Chem, 2000, 48, 5781-5786) and Armentrout (US 2016/0165932 A1).
Regarding claims 26 and 36, Regarding claim 4: Mielgo Iza discloses the protein may be from corn [0035]. As evidenced by Armentrout corn gluten is another name for corn protein [0057]. As such, the corn protein of Mielgo Iza is considered to meet the claim limitation of “corn gluten material”.
Response to Arguments
Applicant's arguments filed 24 July 2025 have been fully considered. To the extent they apply to the above rejections they are not persuasive.
Applicant argues, with respect to the 112(b) rejection of claims 22, 23 and 33 (now incorporated into claim 32), the process for determining the established cake drainage rate is explained in Example 3 of the specification in enough detail for one or ordinary skill to obtain reproducible results. Remarks p6.
This argument is not persuasive. The specification provides some guidance to determine a cake drainage rates [00041] and the established cake drainage rate is disclosed as the secondary drainage of the cake [00042]. However, one of ordinary skill in the art could, based on the information provided, interpret differently how to obtain an “established cake drainage rate” or “drainage rate.” The starting moisture content of the cake and the final moisture content of the cake are not requirements for determining the established cake drainage rate. Determining the established drainage rate, as defined in the specification, requires subjecting the initial slurry to vacuum filtering once, then adding water to the resulting cake and then subjecting the cake/water combination to a second vacuum filtering step. The starting and final moisture contents of the cake will influence the drainage rate. The disclosed method states that between the first and second filtration steps “any cracks in the cake were sealed by rubbing the surface with a wet fingertip” [0041]. This method of applying a wet fingertip to the sample while it is still in a filter would result in a change in the compaction of the sample and a change in the remaining moisture content depending on how much pressure is applied. The method disclosed would not result in reproducible results, even when an absolute value of drainage is not sought, but rather just a relative ratio of the drainage rates. One of ordinary skill in the art could perform the disclosed method of the claims and perform the test of determining the established cake drainage rate and/or drainage rate and obtain results that fall within and outside the claimed range depending on how the test is performed.
Applicant argues, with respect to the 112(b) rejection of claims 31 and 41, that the definition of “on a slurry basis” is clear and one of ordinary skill would recognize that the amount of salt to be added is based on the total composition of the slurry and not on a dry basis. Remarks p7.
This argument is not persuasive. It is clear that the amount of salt to be added is not based on a dry basis, but rather on the weight of the slurry. The question remains, however, at what point in the method is the weight of the slurry determined? Is the weight of the slurry determined before or after the base has been added to the slurry in the first recited method step?
Applicant argues surprising results when the pH is adjusted in combination with addition of a water soluble divalent cationic salt. Applicant cites paragraphs [0027] and [0050] in the PG Pub. Paragraph [0050] points to Figure 5. Remarks p 8.
This argument is not persuasive. The data presented with respect to surprising results is not commensurate in scope with the claims. Claim 22 and claim 32 recite no quantity of divalent cationic salt. The specification recites between 0.2-1wt% of the slurry in [0027] and 2.56 wt% CaCl2 [0050]. The data presented in Figure 5. And figure 7 present data for CaCl2 and MgCl2 from 0-2.5% (presumably wt %), while claims 22 and 32 recite no limit on the divalent cationic salt and additionally include the combination of CaCl2 and MgCl2.
Additionally, in response to applicant's argument that the cationic salt surprising effects the drainage rate, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant argues Mielgo Iza discloses a multistep procedure with multiple washings and enzymatic hydrolysis. Remarks pp8-9.
This argument is not persuasive. The instant claims are drawn to methods “comprising” the recited steps, which allows for the inclusion of other method steps, including enzymatic hydrolysis.
Applicant argues Mielgo Iza provides no disclosure of adding divalent cationic salt. Li, which is relied upon for the disclosure of divalent cationic salts to treat corn protein, is concerned with removal of heavy metals, which is different than the presently claimed invention. There is no reason to combine the references to reduce fumonisin. Remarks p9.
This argument is not persuasive. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Both Li and Mielgo Iza are drawn to method of removing undesirable components from vegetable protein products. Additionally, Mielgo Iza discloses the method reduces inorganic contaminants including heavy metals [0001] and Li discloses methods for reducing the leaching toxicity of heavy metals contained in food therefore enhancing food safety [0001]. Li discloses providing a stabilizing agent for reducing the leaching toxicity of heavy metals contained in foods. The stabilizing agent comprises an acidity regular and a chloride [0020]. Li discloses the acidity regulator can be calcium hydroxide or potassium hydroxide (bases) [0022] and the chloride is one or more selected from calcium chloride and magnesium chloride [0023]. Li discloses the food can be a fruit or vegetable, including corn [0025]. Li discloses a preferred embodiment where the food has a pH of 6 or higher [0026].
Li discloses soaking the foods with the stabilizing agent and water followed by stirring to obtain a uniform mixture. Li discloses heavy metals will leach out from the food tissue [0060]. Li further discloses the method enhances food safety [0061]. Mielgo Iza and Li both disclose the methods for reducing heavy metals in the food product to enhance food safety.
Applicant argues Dombrink-Kurtzman does not disclose the divalent cationic salt and there would be no reason to combine Mielgo Iza, Li and Dombrink-Kurtzman. Remarks pp9-10.
This argument is not persuasive. Dombrink-Kurtzman is not relied upon to disclose the divalent cationic salts. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, all three prior art references are drawn to methods for reducing contaminants in vegetable protein.
Applicant argues Armentrout does not teach the divalent cationic salt of the claimed method. Remarks p10.
This argument is not persuasive. Armentrout is not relied upon to disclose the divalent cationic salt.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARRIE GLIMM whose telephone number is (571)272-2839. The examiner can normally be reached Monday-Thursday 10:30-6:30 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at 571-272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.L.G./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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