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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 13, 2026 has been entered.
Claim 30 was previously withdrawn. Claims 9-11 have been cancelled and claims 31 and 32 are new. Claims 1, 3-8 and 12-29 are pending examination.
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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 18 is 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 claim 18, the recitation “wherein any ultrafiltration step” renders the claim indefinite because claim 1, from which claim 18 depends only recites one ultrafiltration step.
Claims 12 and 18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12, requires “wherein the pretreatment comprises in any order, a step of ultrafiltration and a step of microfiltration.” Claim 1, from which claim 12 depends already requires a step of ultrafiltration and microfiltration.
Claim 18 requires “wherein any ultrafiltration step is performed using a 5-300 kDa membrane.” Claim 1, from which claim 18 depends already requires the ultrafiltration step be performed using a 5-300 kDa membrane.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-8, 12-19, 22-29, 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Zwijnenberg et al. (“Native protein recovery from potato fruit juice by ultrafiltration”, Desalination, 144, (2002), pp. 331-334-cited on IDS filed November 22, 2021) in view of Köessler et al. (WO 03/086102 A2-Clarivate Analytics translation).
Regarding claims 1, 12-15, 18, 24, 27, 28 and 32, Zwijnenberg et al. disclose a method of recovering protein from potato fruit juice comprising the steps of: (a) obtaining potato fruit juice having proteins in their native form; (b) pre-treating the potato fruit juice to remove air and fibers; (c) ultrafiltering the pre-treated potato fruit juice; (d) diafiltering the ultrafiltered and pre-treated potato fruit juice to wash out low molecular substances like amino-acids, phenolic components, glycoalkaloids and potassium and obtain a retentate (i.e., potato protein isolate) ; and (e) spray drying the diafiltered potato fruit juice to obtain a stable and dry potato protein product comprising 80 wt% native potato protein (p. 332/2. Experimental, p. 332-333/3. Results). Zwijnenberg et al. disclose diafiltered potato fruit juice with a conductivity ranging from 1.3-5.8 mS/cm (p. 334/Table 3).
Zwijnenberg et al. disclose the potato fruit juice is a side stream from the potato starch extraction process (i.e., processing at least one tuber to obtain tuber processing water) and contains everything of the potato except the starch and fiber (p. 332/2. Experimental, Table 1).
Given Zwijnenberg et al. disclose a diafiltration step to remove low molecular substance like amino acids, phenolic components, glycoalkaloids and potassium, inherently the would comprise the claimed total amount of glucose, fructose and sucrose, tuber free amino acids, sulfite, glycoalkaloids and heavy metals selected from the group consisting of cadmium, mercury, lead and arsenic.
While Zwijnenberg et al. disclose a diafiltration step, the reference is silent with respect to a salt solution having a conductivity of at least 5 mS/cm and a 3-500 kDa membrane. Given Zwijnenberg et al. disclose a diafiltration step to wash out low molecular substances like amino-acids, phenolic components, glycoalkaloids and potassium, the person of ordinary skill in the art would adjust the conductivity of the diafiltration solution and size of the diafiltration membrane, in routine processing, to remove the undesired low molecular substances while retaining the native potato protein. Note, Zwijnenberg et al. disclose the average molecular weight of the proteins in the potato fruit juice stream is about 50 kD (p. 332/ 2. Experimental).
While Zwijnenberg et al. disclose a pre-treatment step to remove fibers and air, the reference is silent with respect to microfiltration.
Köessler et al. teaches a process of making products from potato juice (Abstract). Köessler et al. teaches the first step of obtain any product is to separate out any fiber or starch residues using microfiltration (Description, claim 1).
Zwijnenberg et al. and Köessler et al. are combinable because they are concerned with the same field of endeavor, namely producing products from potato fruit juice including a pre-treatment step to separate residual fiber from the juice. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have used a microfiltration process, as taught by Köessler et al. to pre-treat the potato fruit juice of Zwijnenberg et al. to remove residual fiber with a reasonable expectation of success.
Regarding claim 3, modified Zwijnenberg et al. disclose all of the claim limitations as set forth above. Given the combination of Zwijnenberg et al. and X teach a process substantially similar to that of the present invention, inherently all of the protein in the potato protein isolate would be in native form.
Regarding claim 4, modified Zwijnenberg et al. disclose all of the claim limitations as set forth above. Zwijnenberg et al. disclose removing glycoalkaloid in the diafiltration step (p.332/ 2. Experimental). Zwijnenberg et al. disclose that traditional products shows a glycoalkaloid content and salt level that is too high for food applications (p. 333/3. Results). Given the combination of Zwijnenberg et al. and X teach a process substantially similar to that of the present invention, including removing glycoalkaloid from the potato fruit juice, inherently potato protein isolate would comprise at most 200 mg/kg glycoalkaloids.
Regarding claim 5, modified Zwijnenberg et al. disclose all of the claim limitations as set forth above. Zwijnenberg et al. disclose removing glycoalkaloids during the diafiltration step (i.e., step c). While Zwijnenberg et al. does not disclose removing glycoalkaloids after diafiltration (i.e., step c), selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results (MPEP §2144.04 IVC).
Regarding claims 6 and 8, modified Zwijnenberg et al. disclose all of the claim limitations as set forth above. Zwijnenberg et al. is silent with respect to steps of obtaining potato fruit juice from potato processing.
Given Zwijnenberg et al. disclose obtaining potato fruit juice from potato starch production, it necessarily follows the potatoes would have been peeled and at least one of pulped, mashed, rasped, ground, pressed or cut in the process.
Regarding claim 7, modified Zwijnenberg et al. disclose all of the claim limitations as set forth above. Zwijnenberg et al. disclose the potato fruit juice is a side stream from the potato starch extraction process (i.e., processing at least one tuber to obtain tuber processing water) and contains everything of the potato except the starch and fiber (i.e., the process includes a step of starch removal/extraction -p. 332/2. Experimental, Table 1).
Regarding claim 16, modified Zwijnenberg et al. disclose all of the claim limitations as set forth above. Zwijnenberg et al. is silent with respect to the pH during diafiltration. However, it would have been obvious to one of ordinary skill in the art to have diafiltered the ultrafiltered potato juice at a pH where the protein was soluble (i.e., at a pH outside the isoelectric point of potato protein - a pH of above 5.5 or below 4.5).
Regarding claim 17 and 25, modified Zwijnenberg et al. disclose all of the claim limitations as set forth above. While Zwijnenberg et al. disclose a pre-treatment step of ultrafiltration followed by diafiltration to obtain a retentate having about 80 wt% protein, the reference is silent with respect to a second ultrafiltration step to further concentrate the diafiltration retentate. However, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to have further purified the diafiltration retentate of Zwijnenberg et al. by duplicating the ultrafiltration step in order to obtain a more concentrated potato protein product.
Regarding claim 19, modified Zwijnenberg et al. disclose all of the claim limitations as set forth above. Zwijnenberg et al. disclose diafiltration to remove amino acids, it necessarily follow the diafiltration permeate would comprise the amino acids.
Regarding claims 22, 23 and 26, modified Zwijnenberg et al. disclose all of the claim limitations as set forth above. Zwijnenberg et al. is silent with respect to adjusting the pH of the potato protein products.
However, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have adjusted the pH of the potato protein product based on the desired use, for example, to use the potato protein product in an acidic beverage, the pH of the protein product would be adjusted to a pH in an acidic range, including higher than 2.5 and lower than 3.5 or to a pH between 5.5 and 7.0, with a reasonable expectation of success.
Regarding claim 29, modified Zwijnenberg et al. disclose all of the claim limitations as set forth above. Zwijnenberg et al. is silent with respect to protein output.
However, mere scaling up of a prior art process capable being scaled up would not establish patentability in a claim to an old process so scaled (MPEP 2144.04 IVA). It would have been obvious to one ordinary skill in the art prior to the effective filing date of the present application to have scaled the process of Zwijnenberg et al. to an output of 5 kg of protein per hour with a reasonable expectation of success.
Regarding claim 31, modified Zwijnenberg et al. disclose all of the claim limitations as set forth above. Zwijnenberg et al. is silent with respect to native protease inhibitor and native patatin. However, given Zwijnenberg et al. disclose potato fruit juice comprising native potato protein, inherently the protein would comprise patatin and protease inhibitor.
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Zwijnenberg et al. (“Native protein recovery from potato fruit juice by ultrafiltration”, Desalination, 144, (2002), pp. 331-334-cited on IDS filed November 22, 2021) in view of Köessler et al. (WO 03/086102 A2-Clarivate Analytics translation) as applied to claim 19, and further in view of Berghout et al. (WO 2017/146568).
Regarding claims 20 and 21, modified Zwijnenberg et al. disclose all of the claim limitations as set forth above. While Zwijnenberg et al. disclose a diafiltration permeate comprising free amino acids, the reference does not disclose concentrating and/or drying the permeate to obtain a free amino acid composition.
Berghout et al. teach a method of obtaining a tuber protein isolate from tuber juice (Abstract, p. 19/L14-18). Berghout et al. also disclose obtaining products comprising tuber free amino acids (p. 3/L11-15). Berghout et al. disclose the tuber free amino acid products are obtained from the treatment to obtain the tuber protein isolate (i.e., permeate – p. 19/L14-18, p. 24/L12-29). Berghout et al. disclose the tuber free amino acid product is made by drying the protein depleted tuber juice (p. 25/L3-7). Berghout et al. disclose that prior to drying, the protein depleted juice may be concentrated by, for example, freeze concentration (p. 25/L19-28).
Zwijnenberg et al. and Berghout et al. are combinable because they are concerned with the same field of endeavor, namely processing to obtain potato protein products from potato fruit juice. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have concentrated and/or dried the diafiltration permeate of Zwijnenberg et al. ,comprising free amino acids, as taught by Berghout et al. to obtain a tuber free amino acid composition.
Response to Arguments
Applicant’s arguments with respect to claims 1-30 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH A GWARTNEY whose telephone number is (571)270-3874. The examiner can normally be reached M-F: 9 a.m. - 5 p.m. EST.
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ELIZABETH A. GWARTNEY
Primary Examiner
Art Unit 1759
/ELIZABETH GWARTNEY/ Primary Examiner, Art Unit 1759