DETAILED ACTION
Background
Claims 1-22 as filed with the instant application on September 20, 2024 have been examined. No amendments have been filed.
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 .
Information Disclosure Statement
Applicants are advised that references made of record in a parent application are not automatically made of record in a continuation. Although Applicants still have a duty of disclosure under 37 CFR 1.56, none of the references cited in patent application serial no. 17/052,890 or in any IDS filed therein have been made of record in the instant application.
Claim Objections
Claims 1-3 are objected to because of the following informalities:
In claim 1, at the end of step “a.” at line 5 insert a semicolon --;--; at the end of step “a.” at line 5 insert a semicolon --;--; at the end of step “b.” at line 8 insert a semicolon --;--; at the end of step “c.” at line 11 insert a semicolon --;--; at the end of step “d.” at line 16 insert a semicolon --;--; at the end of step “e.” at line 18 insert a semicolon --;--; and, at the end of step “f.” at line 20 insert --; and,--;
In claim 2, at the end of step “a-1.” at line 3 delete the comma [[,]] and insert a semicolon --;--; at the end of step “b-1.” at line 6 delete the comma [[,]] and insert a semicolon --;--; at the end of step “c-1.” at line 9 delete the comma [[,]] and insert a semicolon --;--; at the end of step “d-1.” at line 14 delete the comma [[,]] and insert a semicolon --;---; at the end of step “e-1.” at line 17 delete the comma [[,]] and insert a semicolon --;--; at the end of step “f-1.” at line 18 delete the comma [[,]] and insert --; and,--; and,
In claim 3, at the end of step “a-2.” at line 3 delete the comma [[,]] and insert a semicolon --;--; at the end of step “b-2.” at line 6 delete the comma [[,]] and insert a semicolon --;--; at the end of step “c-2.” at line 9 delete the comma [[,]] and insert a semicolon --;--; at the end of step “d-2.” at line 14 delete the comma [[,]] and insert a semicolon --;---; at the end of step “e-2.” at line 17 delete the comma [[,]] and insert a semicolon --;--; at the end of step “f-1.” at line 18 delete the comma [[,]] and insert --; and,--.
Appropriate correction is required.
Claim 22 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 9. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 2-3, 10-12, 14-16 and 20-21 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.
Regarding instant claims 2 and 3, claim 2 recites a method “comprising… a-1... b-1… c-1… d-1… e-1… f-1” and “g-1” and claim 3 recites a method “comprising… a-2... b-2… c-2… d-2… e-2… f-2” and “g-2”. There is insufficient antecedent basis for each of these limitations in the claims. Do the steps in claims 2 and 3 add further steps to the steps in claim 1, or do they modify the steps a., b., c., d., e., f., and g in step 1?
The Office interprets the steps in claims 2 and 3 as reciting the same steps a., b., c., d., e., f., and g. as in claim 1. Further, the Office would consider claims 2 and 3 definite if each claim were written to recite the steps as a., b., c., d., e., f., and g.
Regarding claims 10-12, 15-16 and 20-21, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention; and, the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if. See MPEP § 2173.05(c). In the present instance, several claims recite a broad range together with a narrower range, as follows:
Claim 10 recites the broad recitation “heating the solution to a temperature in the range of 0.1-60 °C”, and the claim also recites “such as in the range of 5-25 °C such as in the range of 30-60 °C, such as in the range of 40-60 °C, such as in the range of 45-55°C” which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims;
Claim 11 recites the broad recitation “a pH in the range of pH 4.0 to pH 9.0”, and the claim also recites “such as in the range of pH 4.5 to pH 6.5 such as in the range of pH 4.7 to pH 6.0, such as in the range of pH 4.7 to pH 5.8, such as in the range of pH 4.8 to pH 5.7” which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims;
Claim 12 recites the broad recitation “a pH in the range of 0.1 to 5.0”, and the claim also recites “such as a pH in the range of 0.1 to 4.5, such as a pH in the range of 0.5 to 4.5, such as a pH in the range of 0.8 to 4.5, such as a pH in the range of 0.9 to 4.5, such as a pH in the range of 1.0 to 4.5, such as a pH in the range of 1.3 to 4.5, such as a pH in the range of 1.3 to 3.8, such as a pH in the range of 0.1 to 4.0, such as a pH in the range of 0.5 to 4.0, such as a pH in the range of 1.0 to 4.0, such as a pH in the range of 0.5 to 3.5, such as a pH in the range of 1.0 to 3.3” which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims;
Claim 15 recites the broad recitation “pore size in the range of 0.05 micron to 5 micron”, and the claim also recites “such as in the range of 0.05 micron to 3 micron, such as in the range of 0.05 micron to 2 micron, such as in the range of 0.1 to 1.8 micron, such as in the range of 0.2 micron to 2 micron, such as in the range of 0.5 to 1.7 micron” which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims;
Claim 16 recites the broad recitation “pore size in the range of 1.000 D to 1.000.000 D”, and the claim also recites “such as in the range of 5.000 D to 200.000 D, such as in the range of 7.000 D to 150.000 D, such as in the range of 8.000 D to 100.000 D, such as in the range of 5.000 D to 30.000 D, such as in the range of 30.000 D to 1000.000 D. such as in the range of 50.000 D to 1000.000 D, such as in the range of 100.000 D to 1000.000 D, such as in the range of 250.000 D to 1000.000 D” which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims;
Claim 20 recites the broad recitation “pH in the range of 0.1 to 4.0”, and the claim also recites “such as a pH in the range of 1.3 to 3.8, such as a pH in the range of 0.1 to 3.0, such as a pH in range of 0.1 to 2.5, such as a pH in the range of 0.1 to 2.0” which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims; and,
Claim 21 recites the broad recitation “pH in the range of 0.1 to 4.0”, and the claim also recites “such as a pH in the range of 1.3 to 3.8, such as a pH in the range of 0.1 to 3.0, such as a pH in range of 0.1 to 2.5, such as a pH in the range of 0.1 to 2.0” which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 10 at line 3 recites “heating the solution to a temperature of 0.1°C” and to a range of 0.1 to 60 °C, which is indefinite in referring to the claimed aqueous solution which starts as a solution and not as a frozen thing and because the scope of the claim is not clear. Does the heating refer to the change in temperature caused by the heating or to the resulting temperature of the aqueous solution after heating? If the latter, how can one heat an aqueous solution to result in a temperature of 0.1 °C?
The Office interprets the claim as reciting the temperature of the aqueous solution after heating it.
Claim 14, at line 4 recites “carboxymethyl” as an anionic polymer which is indefinite. Carboxymethyl is not a polymer and it is not clear what if any polymer the claim recites.
Claim 20, at line 2 recites “diafiltration at a pH in a range of 0.1 to 4.0” which is indefinite. Does Applicant intend to claim the pH of the diafiltration medium or of the retentate being so treated?
The Office interprets the claim pH to refer to a diafiltration medium.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2 and 4-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2010006621 A to Andersen et al. (Andersen), as evidenced by US2011/0217436 A1 to Klijnstra et al. (Klijnstra).
All claim steps are referred to consistently and without variation as steps a., b., c., d., e., f., and g.
The Office considers diafiltering disclosed in general as necessarily including a solvent or diafiltration medium.
Regarding instant claims 1 and 2, Andersen at page 41, lines 29-34 discloses separating solids and liquids from grated raw potatoes to provide a liquid potato fraction (“a. providing an aqueous solution”), which at page 42, line 10 to page 43 line 29 comprises the one or more potato proteins and soluble fiber, glycoalkaloids, phenolic compounds (“a group of impurities”). At page 42, lines 16-31, Andersen discloses lowering the pH in the aqueous solution of potato proteins and adjusting its pH to form a sedimented protein layer (“c. precipitating the one or more potato proteins to create a suspension of precipitated potato protein in the solution containing impurities”- in claim 1 as “c. precipitating patatin to create a suspension of patatin” – claim 2), wherein the aqueous solution contains glycoalkaloids, protease inhibitors (as disclosed in Klijnstra at [0016]) and the phenols (“a.” and “c.” claim 2).
Regarding the recited claim 1 b. subjecting the aqueous solution to a pretreatment, while the Office considers optional claim limitations the claim itself does not require it.
Further, at page 42, lines 32 to page 43, line 3, Andersen discloses solid-liquid separation of the suspension after precipitation using a plate-and-frame filter (d. “subjecting the suspension to a membrane filtration”) which retains the proteins. Further, the filtration of Andersen passes at least one member of a group of impurities through the membrane as a permeate and retains the one or more precipitated potato proteins as a concentrate in the retentate, including (at page 44, lines 25-27) patatin in the claimed precipitate suspension (claim 2, c, d, and f). And at page 44, lines 21-24 Andersen then discloses diafiltering (e. in claim 1 and 2) the sedimented protein fraction or the retentate with one or more solvents to further remove impurities including the glycoalkaloids and phenols into a permeate. Further, at page 9, lines 7-8, Andersen discloses (f. in claims 1 and 2 ) finally redissolving (or solubilizing as at page 44, line 22) the sedimented or precipitated protein component. In addition, Andersen discloses at page 44, lines 25-27, separating (g. in claims 1 and 2) the group of impurities in said permeate into at least two individual fractions by cation-exchange chromatography.
Still further, Anderson discloses at page 46, lines 18-29 three separate fractions in the permeate comprising glycoalkaloids (claim 2, g), a neutral protein fraction and a basic protein (including a protease inhibitor as in Klijnstra at [0016]) and peptide fraction. The Office considers the aqueous solution of Andersen and the method of Andersen and the claimed aqueous solution and method to be substantially the same thing. Accordingly, absent a clear showing as to how the filtering, diafiltering and separating in Andersen differ from those steps as claimed, the Office considers the filtering of a low pH precipitated potato protein aqueous suspension disclosed in Andersen at page 42, line 10 to page 43 line 29 and at page 44, lines 21-24 to allow protease inhibitors to pass the membrane to include passing protease inhibitors as in claim 2, d. and e. as a permeate; and, further considers the method of separating a filtrate by chromatography as disclosed in Andersen at page 45, line 27 to page 46, line 5 as separating protease inhibitors and proteins from the glycoalkaloids into two fractions as in claim 2, g. See MPEP 2112.01.I.
Regarding instant claim 4, Andersen discloses adding a chelating agent at page 41, lines 9-12 (“pretreatment of the aqueous solution to clarify and remove suspended non-soluble matter, as in step b).
Regarding instant claim 5, Andersen at page 44, line 22 discloses re-solubilizing precipitated potato protein as in step f.
Regarding instant claim 6, Andersen discloses separating impurities in the permeate into individual fractions as in step g at page 44, lines 25-27.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3, 7-9, 15-17, 19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over WO2010006621 A to Andersen et al. (Andersen), as evidenced by US2011/0217436 A1 to Klijnstra et al. (Klijnstra) as applied to claim 1 above, and further in view of US 2013/0281669 A1 to Guiseppin et al. (Guiseppin).
As applied to claim 1, Andersen at page 41, lines 29-34, at page 42, line 10 to page 43, line 29 and at page 44, lines 21-24 discloses a method of pretreating a potato juice as an aqueous solution of potato proteins and a group of impurities, precipitating the potato proteins to form a suspension of precipitated potato proteins and a solution of impurities, membrane filtering the suspension to give a potato protein retentate and a permeate, diafiltering the retentate to purify it, resolubilizing the protein and separating the permeate into individual fractions.
Regarding instant claim 3, the Office considers claim 3 to comprise the same steps as claim 1, with the following further features:
At page 42, lines 10-13, Andersen discloses the claimed aqueous solution of glycoalkaloids, patatin (page 42, line 27) phenolic compounds and protease inhibitors as other proteins in a liquid potato fraction which is the same as the claimed aqueous solution, as in step a. See MPEP 2112.01.I. Andersen discloses patatin at page 44, lines 25-27, which is the claimed precipitated patatin in steps c and f, and also comprises the patatin in the claimed retentate in steps d and e. And the permeate of Anderson includes the claimed phenols and glycoalkaloids in steps d and e.
Further regarding instant claim 3, the Office considers optional claim limitations as the “optionally separating the patatin and the protease inhibitor fraction”, as in step g but the claim does not require them.
Regarding instant claims 3, Andersen does not disclose membrane filtration as in step d wherein the precipitated patatin and the soluble protease inhibitors are concentrated in the retentate.
Guiseppin at [0040] discloses a method of concentrating native potato proteins with a very low glycoalkaloid content by ultrafiltration of a potato fruit juice via a membrane than is a spiral wound or hollow fibre (“tubular”) membrane at a molecular cut-off of 2 to 20 kDa or 5 to 30 kDa, wherein the juice has been pretreated by flocculation and absorption chromatography (see [0026]-[0028]). The methods keep both patatin and protease inhibitors in the retentate. Further, Guiseppin discloses ultrafiltration membranes including spiral wound, hollow fiber and tubular
As of the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Guiseppin for Andersen to use an ultrafiltration membrane in a crossflow membrane filtration of a liquid potato fraction and thereby concentrate patatin and protease inhibitors in the retentate. Andersen and Guiseppin both want to isolate potato proteins in a simple fashion from potato fruit juice; and the ordinary skilled artisan reading Andersen would desire to use a one step removal of glycoalkaloids from both patatin and other proteins as provided in Guiseppin.
Regarding instant claims 7-9 and 22, Andersen discloses at page 13, line 11-13 adding phosphoric acid in a potato juice pretreatment. The Office considers phosphoric acid to include phosphate ions. Andersen does not disclose adding a flocculant in step b as in claim 7, does not disclose addition of calcium or magnesium ions to the aqueous solution in step b as in claim 8, and does not disclose the addition of phosphate ions calcium or magnesium ions to the aqueous solution in step b as in claims 9 and 22.
Guiseppin at [0026] discloses subjecting potato fruit juice to flocculating or clarifying at a pH of 7 to 9 by adding (at [0031]) calcium ions into the aqueous solution to remove negatively charged polymers, pectins, glycoalkaloids and microorganisms from the potato fruit juice.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Guiseppin for Andersen to flocculate its liquid potato fraction using calcium ions as in claims 8 and 9 prior to adjusting pH down to cause sedimentation of proteins. Both references seek to remove impurities from the same potato fruit juice; and Andersen already includes a pH raising step (page 43, lines 12-14) to aid in dissolving proteins prior to sedimentation which allows one to add calcium ions as in Guiseppin, thereby also effecting a flocculating step at a pH of 7-9 to remove negatively charged polymers, pectins, glycoalkaloids and microorganisms from the potato fruit juice.
Regarding instant claim 15, Andersen at page 23, lines 28-34 discloses a cross-flow membrane filtration method as in step d. The Office considers tangential flow filtration to include cross-flow filtration. Andersen does not disclose a microfiltration membrane pore size. However, the Office considers the claimed pore size of 1000 Da to 1,000,000 Da as in claim 15 to be synonymous with a pore size of from 0.05 to 5 micron.
Guiseppin at Example 1, Table 1, footnote b at [0133] discloses microfiltration membranes with a 0.22 micron pore size to insure solution stability by removing microorganisms from potato fruit juice.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Guiseppin for Andersen to use a 0.22 micron pore size microfiltration membrane in its membrane filtration step d. to remove microbes and smaller impurities from potato fruit juice.
Regarding instant claim 16, Andersen as modified by Guiseppin provides ultrafiltration to produce a potato protein retentate using, respectively, a 30 kDa, a 10kDa and a 10 kDa membrane (claim 16). See methods 9, 10 and 11 of Guiseppin at [0128], [0130] and [0132]. See MPEP 2144.05.I.
Regarding instant claims 17 and 19, Andersen does not disclose its tangential flow filtration via a hollow fiber, tubular or spinning disk membrane a in claim 17 or via a spiral wound polymeric filtration membrane. However, Guiseppin at [0040] discloses ultrafiltration of a potato fruit juice via a membrane than is a spiral wound or hollow fibre (“tubular”) membrane to remove glycoalkaloids.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Guiseppin for Andersen to use an ultrafiltration membrane having any known structure including spiral wound polymer and tubular membranes as claimed in its ultrafiltration method, especially as both references disclose the desirability of ultrafiltration to recover potato proteins.
Claims 10-12 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over WO2010006621 A to Andersen et al. (Andersen), as evidenced by US2011/0217436 A1 to Klijnstra et al. (Klijnstra) as applied to claim 1, above.
As applied to claim 1, Andersen at page 41, lines 29-34, at page 42, line 10 to page 43, line 29 and at page 44, lines 21-24 discloses a method of pretreating a potato juice as an aqueous solution of potato proteins and a group of impurities, precipitating the potato proteins to form a suspension of precipitated potato proteins and a solution of impurities, membrane filtering the suspension to give a potato protein retentate and a permeate, diafiltering the retentate to purify it, resolubilizing the protein and separating the permeate into individual fractions.
Regarding instant claim 10, Andersen at page 23, lines 4-16 discloses keeping or adjusting the temperature of its aqueous solution prior to precipitation and during any pretreatment to from 2 °C to ambient temperature. The Office interprets the recited “heating to solution to a temperature of 0.1 to 60 °C” to include any temperature adjustment necessary to result in an aqueous solution having a temperature of from 0.1 to 60 °C.
Regarding instant claim 11, Andersen discloses at page 41, line 9-12 in a pretreatment using a chelating agent a pH of from 2.0 to 4.5, as in step b, which the claimed range of pH of 4.0 to 9.0 overlaps. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", the Office considers that a prima facie case of obviousness exists. See MPEP 2144.05.I. The ordinary skilled artisan in Andersen would have found it obvious to add a chelating agent at the claimed pH because Andersen discloses that adding a chelating agent at the claimed pH produces a desirable starting aqueous solution.
Regarding instant claim 12, the Andersen disclosed pretreatment pH adjustment down to 2.0 to 4.5 results in precipitation in the form of sedimentation, as in step c.
Regarding instant claim 21, Andersen at page 43, lines 12-14 discloses sedimenting or precipitating potato protein at a pH of about 2.0 to 5.2 for filtration, which the claimed pH of 0.1 to 4.0 for the membrane filtration in claim 21 overlaps. See MPEP 2144.05.I. The ordinary skilled artisan in Andersen would have found it obvious to perform its membrane filtration at the claimed pH because Andersen discloses that filtering at the claimed pH produces a desirable retentate and filtrate.
Claim 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over WO2010006621 A to Andersen et al. (Andersen), as evidenced by US2011/0217436 A1 to Klijnstra et al. (Klijnstra) as applied to claim 1 above, and further in view of WO 2016/036243 A1, to Guiseppin et al. (Guiseppin ‘243), of record.
As applied to claim 1, Andersen at page 41, lines 29-34, at page 42, line 10 to page 43, line 29 and at page 44, lines 21-24 discloses a method of pretreating a potato juice as an aqueous solution of potato proteins and a group of impurities, precipitating the potato proteins to form a suspension of precipitated potato proteins and a solution of impurities, and membrane filtering the suspension to give a potato protein retentate and a permeate.
Andersen does not disclose precipitation in step c by addition of an anionic polymer as in claim 13, and does not disclose that the anionic polymer is an edible polymer chosen from the group of alginate, carrageenan, carboxymethyl cellulose, carboxymethyl starch, carboxymethyl and dextran as in claim 14.
Guiseppin ‘243 at Abstract discloses flocculation of potato juice using carrageenan as a flocculant with a cationic coagulant. At page 2, lines 13-15, flocculation removes insoluble particles to clarify potato juice. At page 7, lines 8-14, the potato juice can be subject to pH adjustment prior to flocculation.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Guiseppin ‘243 for Andersen to use a carrageenan of claim 14 as an anionic polymer flocculant of claim 13 to clarify its liquid potato fraction, which is the same as potato juice in Guiseppin ‘243. Both references seek to remove impurities from the same potato fruit juice; and Andersen includes a pH raising step (page 43, lines 12-14) to aid in dissolving proteins prior to sedimentation, thereby enabling a flocculating step at a pH of 7-9 compatible with carrageenan as an anionic (deprotonated) species. The ordinary skilled artisan in Andersen would desire to perform flocculation with the anionic polymer of Guiseppin ‘243 would help to remove negatively charged polymers, pectins, glycoalkaloids and microorganisms from its potato fruit juice.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over WO2010006621 A to Andersen et al. (Andersen), as evidenced by US2011/0217436 A1 to Klijnstra et al. (Klijnstra) as applied to claim 1 above, and further in view of Zwijnenberg, H. et al, "Native protein recovery from potato fruit juice by ultrafiltration", Desalination, Vol. 144(1-3), p. 331-334, XP004386240, (September 2002) (Zwijnenberg).
As applied to claim 1, Andersen at page 41, lines 29-34, at page 42, line 10 to page 43, line 29 and at page 44, lines 21-24 discloses a method of pretreating a potato juice as an aqueous solution of potato proteins and a group of impurities, precipitating the potato proteins to form a suspension of precipitated potato proteins and a solution of impurities, membrane filtering the suspension to give a potato protein retentate and a permeate.
Regarding instant claims 17 and 19, Andersen does not disclose that the membrane is a hollow fiber, tubular or spinning disk membrane system, in a ceramic membrane system as in claim 17, or in a spiral wound polymeric membrane system as in claim 19. However, Andersen at page 9, lines 28-30 and 34 discloses a cross-flow membrane filtration method as in step d. The Office considers tangential flow filtration to include cross-flow filtration.
Zwijnenberg at p. 332, right hand discloses filtering potato juice with polymeric membranes of a spiral-wound, plate and frame and tubular form to recover proteins.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Zwijnenberg for Andersen to perform its membrane filtration using a spiral-wound polymeric or tubular form membrane system as claimed. Both references disclose crossflow membrane filtration of potato juice to recover proteins therefrom. The ordinary skilled artisan would readily select known architectures for cross-flow filtration membranes as disclosed in Zwijnenberg for use in the method of Andersen for recovering potato proteins.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over WO2010/006621 A to Andersen et al. (Andersen), as evidenced by US2011/0217436 A1 to Klijnstra et al. (Klijnstra) as applied to claim 1 above, in view of US2018/0289036 A1 to Bohlscheid et al. (Bohlscheid).
As applied to claim 1, Andersen at page 41, lines 29-34, at page 42, line 10 to page 43, line 29 and at page 44, lines 21-24 discloses a method of pretreating a potato juice as an aqueous solution of potato proteins and a group of impurities, precipitating the potato proteins to form a suspension of precipitated potato proteins and a solution of impurities, membrane filtering the suspension to give a potato protein retentate and a permeate.
Andersen does not disclose a tangential flow filtration method using a ceramic membrane system
Bohlscheid at Abstract discloses recovering wettable potato protein powders having a low glycoalkaloid content by (at [0053]) ultrafiltration using membranes having a 1 to 800 kDa molecular weight cut-off, wherein the membranes are made of polymers or are ceramic.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Bohlscheid for Andersen to perform its membrane filtration using a ceramic membrane system as claimed. Both references disclose crossflow membrane filtration of potato juice to recover proteins therefrom. The ordinary skilled artisan would readily select known materials for cross-flow filtration membranes as disclosed in Bohlscheid including ceramic membrane systems for use in the method of Andersen for recovering potato proteins.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over WO2010006621 A to Andersen et al. (Andersen), as evidenced by US2011/0217436 A1 to Klijnstra et al. (Klijnstra) as applied to claim 1 above, either taken alone, or taken in view of US6414124 B1 to Ryan et al.
As applied to claim 1, Andersen at page 41, lines 29-34, at page 42, line 10 to page 43, line 29 and at page 44, lines 21-24 discloses a method of pretreating a potato juice as an aqueous solution of potato proteins and a group of impurities, precipitating the potato proteins to form a suspension of precipitated potato proteins and a solution of impurities, membrane filtering the suspension to give a potato protein retentate and a permeate, diafiltering the retentate to purify it, resolubilizing the protein and separating the permeate into individual fractions.
Regarding instant claim 20, Andersen does not disclose a diafiltration medium at a pH of 0.1 to 4.0. However, Andersen at page 44, lines 21-25 discloses diafiltering its sedimented protein fraction; at page 45, lines 20-30, Andersen discloses low pH chromatographic separation of a liquid phase at pH 3.0 to 5.5, which the claimed pH of 0.1 to 4.0 overlaps. And at page 47, lines 8-11, Andersen disclose diafiltration of its protein product from any elution step. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", the Office considers that a prima facie case of obviousness exists. See MPEP 2144.05.I. The ordinary skilled artisan in Andersen would have found it obvious to diafilter its aqueous solution containing potato protein sediment after elution at the claimed pH because Andersen discloses that it is desirable to diafilter to concentrate a potato protein suspension at the claimed pH.
In addition, Ryan at Abstract discloses dialysis (“diafiltration”) recovery of proteinase inhibitors as proteins from potatoes wherein the proteins have been precipitated prior to diafiltration. At Example 2, Ryan discloses diafiltration using a medium having 0.88% (0.019 M) formic acid to precipitate the proteinase inhibitors so they are concentrated by diafiltration. Using a simple pH calculation form x2 = Ka x C, with the Ka for formic acid at 1.8 x 10-4 --for a 0.19 M solution, and solving for x ([H+]) gives X2 = 1.8 x 10-4 x (0.019) or x2 = 3.42 x 10-6, thus X= 0.00185; and pH = -log(x) or -log(.00185) or -(-2.73) or 2.73. Accordingly, the Ryan diafiltration media have a pH at or below 3.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Ryan for Andersen to use a diafiltration medium with a pH of from 0.1 to 4.0 to keep desirable proteins in the retentate and insure efficient diafiltration without separating the patatin and the protease inhibitors. Anderson discloses a low pH retentate of 2.0 to 5.2 (page 43, line 14) and so would desire to use a low pH diafiltration medium that would enable concentration of proteins as sedimented in Andersen.
Conclusion
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/ANDREW E MERRIAM/Examiner, Art Unit 1791
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