DETAILED ACTION
Background
The amendment dated November 20, 2025 (amendment) amending claims 15, 24, 28 and 42-43 and canceling claims 23 and 46 has been entered. Claims 15, 18-19, 21-22, 24-25, 28, 37-38, 42-43, 60 and 68-71 have been examined. In view of the amendments, all outstanding claim objections have been withdrawn. Claims 1-14, 16-17, 20, 23, 26-27, 29-36, 39-41, 44-46, 47-59 and 61-67 have been canceled. In view of the cancelation of claims 23 and 46, all outstanding rejections of those claims has been withdrawn.
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 .
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 42-43 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 42-43, in claim 42 at line 3 and in claim 43, at lines 2 and 3 (two instances) the recited “% (wt./wt.)” is indefinite because it is not clear what comprises the basis or denominator for the recited amount. Is it a weight % based on the weight of the pea protein isolate (PPI), or a weight % based on the weight of a total aqueous composition containing the PPI?
The Office interprets the claimed wt% (wt./wt.) broadly as any of a weight % of the recited neutralizing agent based on the weight of the total solids of PPI and a weight % of the recited neutralizing agent based on the weight of the aqueous mixture comprising the PPI.
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 15, 18-19, 21-22, 24-25, 28, 37-38, 42-43, 60, 68 and 70-71 are rejected under 35 U.S.C. 103 as being unpatentable over CN113768031 A to Shi et al. (Shi), of record, in view of US 2008/0171356 A1 to Nakamura et al. (Nakamura) and US 2022/0030908 A1 to Zhou et al. (Zhou), of record.
Unless otherwise indicated, all % are considered to be weight %s; and weight %s are considered interchangeable with mass %s.
All references to Shi refer to the Espace.net translation, a copy of was provided in an earlier Office action.
The Office interprets the claimed wt% (wt./wt.) broadly as any of a weight % of the recited neutralizing agent based on the weight of the total solids of PPI and a weight % of the recited neutralizing agent based on the weight of the aqueous mixture comprising the PPI.
Regarding instant claims 15, 18, 21-22, 37-38, 60, 68 and 70-71, Shi at Abstract discloses a method of isolating pea protein having a low volatile organic compound content comprising crushing and digesting peas (“extracting pea protein from a pea plant source in an aqueous solution to produce a pea protein solution” - claim 68), centrifugal separation (“separating the pea protein solution from the remaining pea plant solids” by centrifugation - claim 71), acid precipitation (“precipitating protein”), centrifugal separation and neutralization (“neutralizing”). See also Shi at “summary of the Invention at pages 3-4. At page 4, item (4), Shi discloses precipitating pea protein at 4.5 to 4.8 (“precipitating protein to produce an acidic pea protein isolate” (PPI)) , which the precipitating pH of 4.5 in each of claims 18 and 37-38 lies within, and at a temperature of 50-55°C (claim 21), which the claimed 55°C in claim 22 lies within. Further, at page 3, item (2), Shi discloses a method of extracting pea flour in water at 50-55°C (claim 70) to produce an acidic pea protein isolate (claim 60). 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 Shi would have desired to precipitate its pea protein from solution at a pH of 4.5 and at 55°C as claimed because Shi discloses that such conditions are desirable pea protein precipitating conditions. Further, Shi at Abstract neutralizing its acidic PPI to form a PPI followed by sterilizing and spray drying (“drying”) the PPI; and, still further, at page 4, item (6) Shi discloses homogenizing the pea protein isolate.
Further, and regarding instant claims 37-38, at page 4, 3rd to last paragraph Shi discloses neutralizing the acidic PPI to form a PPI by adding NaOH and/or KOH to a pH of from 6.0 to 7.3, within which range lies the pH 6.0-6.2 in claim 15, the pH 6.0 in claim 37 and the pH 6.2 in claim 38. See MPEP 2144.05.I. The ordinary skilled artisan in Shi would have desired to neutralize its acidic PPI to a pH of 6.0 or 6.2 using NaOH because Shi discloses such pH levels as desirable endpoints for NaOH neutralization of an acidic PPI.
Regarding instant claims 15, 37-38 and 42-43, Shi does not disclose a process further comprising washing the PPI, does not disclose neutralizing acidic PPI by (i) adding NaOH, and then (ii) adding Mg(OH)2 to raise the pH to 7.0 as in claims 15, 37 and 38, thereby providing a PPI with reduced sodium as in claim 15. Further, regarding instant claims 42-43, Shi does not disclose adding as much as 0.29 wt% Mg(OH)2 and as much as 0.20 wt% Mg(OH)2, based on the solids weight of PPI or based on the aqueous solution or suspension of PPI. However, at page 5, 3rd full paragraph Shi discloses a beverage comprising its PPI product and at (12) on page 4 discloses a spray dried protein powder or PPI product.
Regarding instant claims 19 and 24-25, Shi does not disclose a precipitating time or performing precipitation for 10 to 60 minutes as in claim 19, does not disclose the washing of the is performed at an acidic pH as in claim 24, or wherein the washing is performed at the precipitating pH as in claim 25.
Nakamura at Abstract discloses a soybean protein having reduced odor and aftertastes as well as excellent dispersion and excellent throat feeling by adding an Mg compound to neutralize a soybean slurry and form a neutralized solution. At [0014]-[0015], Nakamura discloses a method of neutralizing the soybean curd slurry or protein extract with MgO in water or magnesium hydroxide to adjust pH (at [0027]) and give a pH of 6.8-7.8, which the claimed pH of 7.0 lies within. See MPEP 2144.05.I. Further, Nakamura at [0011] discloses adding from 0.03 to 0.36 wt% Mg or (0.03 x 58/34 to 0.36 x 58/34 or) 0.051 wt% to 0.61 wt% expressed as Mg(OH)2, based on the total solids weight of soybean protein, within which range the claimed 0.29 wt% in claim 42 and the claim 0.29 wt% in claim 43 lies. Still further, at Example 1 at [0038]-[0039] and accompanying Table 1, Nakamura discloses adding the magnesium as MgO to form Mg(OH)2 in Example T-5 (Table 1) in the amount of 0.15 wt% as Mg, followed by adding NaOH to complete neutralization and then (at [0039]) sterilizing the product and spray drying it to form a powder. The ordinary skilled artisan in Nakamura would have desired to neutralize its solution to 7.0 as claimed and to add 0.29 wt% or 0.20wt% on PPI or PPI solids as claimed, respectively in claims 42-43 because Nakamura recites that the recited pH and the recited amounts of Mg(OH)2 make a desirable soy protein isolate.
Zhou at Abstract discloses a plant protein isolate having reduced volatile off flavors made by aqueous extracting the plant protein, followed by washing the extracted protein at a pH of from 4 to 5.5, which is the precipitating pH in Shi. At [0023]-[0027], Zhou discloses pea protein extracting at isoelectric pH or, in Example 3 at [0080] a pH of 4.5 while processing for about 15 minutes.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Nakamura for Shi to neutralize its aqueous pea protein mixture using NaOH and then treat its neutralized PPI with Mg(OH)2 in the amount of 0.20 wt% and 0.29 wt% of Mg(OH)2 as claimed in claims 42-43 as in Nakamura and to arrive at a pH of 7.0 as in both Shi and Nakamura prior to homogenizing and sterilizing. Both references disclose methods for providing pulse protein isolate compositions having improved odor, flavor and feel properties for use in food and beverages. The ordinary skilled artisan in Shi would have desired to add a Mg(OH)2 as dissolved MgO as in Nakamura to its solution of a pea protein isolate (PPI) to adjust its pH to 7.0 which is a desired pH level to improve the mouthfeel, flavor and sensorial properties of the resulting PPI for use in food or beverages while increasing the magnesium content of the product. In addition, the claimed neutralizing with NaOH and then Mg(OH)2 represents a change in the order of neutralizing in Nakamura. However, changing any order of performing process steps is prima facie obvious in the absence of new or unexpected results. See MPEP 2144.04.IV.C.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Zhou for Shi to wash its PPI after precipitating it, to precipitate its acidic PPI for from 10 to 60 minutes as in claim 19, to wash its acidic PPI precipitate in an acidic wash water as in claim 24, and to perform washing at the precipitating pH, such as about 4.5 as in claim 25. Both references disclose the acidic precipitation of and then treating a pea protein isolate or acidic PPI to remove non-protein materials from the slurry. The ordinary skilled artisan in Shi would have desired to continue acidic precipitation for a time of 10 to 60 minutes as is desired in Zhou to obtain a desired yield of proteins as solids, and would have desired to remove more of the non-protein materials from its PPI in its precipitating methods as in Zhou by washing the precipitate while keeping it at the pH of precipitating it.
Further regarding instant claims 42 and 43. the Office considers the PPI product of Shi at Summary of Invention on page 3 to page 4 item (8) as modified by Nakamura at Example 1 and Zhou at Abstract and [0023]-[0027] to be substantially the same thing. Accordingly, absent a clear showing as to how the amounts of each of NaOH in Shi as modified by Nakamura and the amounts claimed differ the Office considers the concentration of NaOH at a pH of 6.0 and 6.2 in Shi at page at page 4 item (6) to comprise 0.56 wt% NaOH (for a pH of 6.0) as in claim 42 and 0.67 wt% NaOH (for a pH of 6.2) as in claim 43. See MPEP 2112.01.I.
Regarding instant claim 28, Shi discloses at page 4, (6) neutralization of its PPI by diluting its product by adding a volume of water 1.5X to 2.5X to the volume of the PPI to form a slurry.
Claim 69 is rejected under 35 U.S.C. 103 as being unpatentable over CN113768031 A to Shi et al. (Shi) in view of US 2008/0171356 A1 to Nakamura et al. (Nakamura) and US 2022/0030908 A1 to Zhou et al. (Zhou) as applied to claim 68 above, and further in view of 2023/0292788 A1 to Schwab (Schwab), of record.
As applied to claim 68, Shi at Abstract and page 3 “Summary of the Invention” to page 4, item (6) as modified by Nakamura at [0014]-[0015] and Example 1 at [0038]-[0039] and Table 1 and Zhou at Abstract and [0023]-[0027] discloses extracting protein from a pea protein source in an aqueous solution and separating the pea protein solution from the remaining pea plant solids, precipitating a pea protein from aqueous solution at a pH of 3.5 to 5.5 to form an acidic PPI, washing at the acidic pH, and neutralizing the acidic PPI by adding NaOH to raise the pH to 6.0-6.2 and adding Mg(OH)2 to raise the pH to 7.0 to make a PPI with reduced sodium.
Shi as modified by Nakamura does not disclose extracting performed at a pH of about 7.5 to 10 but discloses extraction in water at page 3, item (2) of Shi. The Office considers the pH of water to be 7.4 as a neutral pH and considers the claimed pH of “about 7.5” to include the pH of water containing any amount of added base.
Schwab at [0179]-[0181] discloses a pH driven process for forming a pea protein isolate comprising extracting an aqueous slurry of acid washed legume flour including (at [0047]) peas at a preferred pH of higher than 7 or of higher than 8 to provide (at [0066]) a pea protein solution (at [0023]) having improved functional properties and (at [0022]) to remove off flavors.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Schwab for Shi as modified by Nakamura to use a pH of about 7.5 to 10 to make its pea protein isolate, such as by adding a small amount of alkali to improve extraction yield. All references disclose aqueous extraction methods for making pea protein isolates for use in food. The ordinary skilled artisan working in Shi as modified by Nakamura would have desired to extract the pea protein at a pH of about 7.5 to 10 as in Schwab to improve the yield of the pea protein isolate thereby made and to help remove or salt out acids added prior or later.
Response to Arguments
In view of the amendment dated November 20, 2025 following rejections have been withdrawn as moot:
The rejections of claims 42-43 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 5. second paragraph, as being indefinite in regard to the recited "% weight to volume";
The rejections of claims 15, 18-19, 1 21-25, 28, 37-38, 46, 60, 68 and 70-71 under 35 U.S.C. 103 as being unpatentable over CN113768031 A to Shi et al. in view of US 2022/0053793 A1 to Schmitt et al;
The rejections of claims 19 and 23-25 under 35 U.S.C. 103 as being unpatentable over CN113768031 A to Shi et al. in view of US 2022/0053793 A1 to Schmitt et al. and US 2022/0030908 A1 to Zhou et al;
The rejections of claims 42-43 under 35 U.S.C. 103 as being unpatentable over CN113768031 A to Shi et al. in view of US 2022/0053793 A1 to Schmitt et al. and US 4279939 to Cho et al.; and,
The rejection of claim 69 under 35 U.S.C. 103 as being unpatentable over CN113768031 A to Shi et al. in view of US 2022/0053793 A1 to Schmitt et al. and 2023/0292788 A1 to Schwab.
The positions taken in the remarks accompanying the amendment dated November 20, 2025 (Reply) at pages 6-9 have been considered but are moot because the new ground of rejection does not rely on Schmitt or Cho as applied in the prior rejections of record for any teaching or matter specifically challenged in the argument, with the following exceptions:
Regarding the positions taken in the remarks accompanying the amendment dated November 20, 2025 (Reply) at pages 5-9, the positions have been fully considered but they are not found persuasive for the following reasons: Regarding the indefiniteness rejections, the Office appreciates Applicants effort to explain the basis for the claimed percent amount of NaOH and Mg(OH)2. The explanation is clear. Nevertheless, the instant specification does not rectify the unclearly recited amount of NaOH and Mg(OH)2 in claims 42-43. Rather, the instant claims recite a weight to weight ratio with specifying the requisite denominator. As such, the scope of the amount claimed cannot be determined. The Office would consider a claim recite an amount of NaOH or Mg(OH)2 as a “weight %, based on the weight of total PPI solids” as definite.
Regarding the position taken in the Reply that Shi does not render obvious claims reciting claim steps “consisting essentially of” the recited process, respectfully the term “consisting essentially of” is not closed ended. Rather, the transitional phrase consisting essentially of only limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) and MPEP 2111.03.III. And nothing in the Reply or on the record suggest that or how any of the disclosed degassing, protease treatment, separation of volatile organic compounds and heat treating in Shi detracts from the recited characteristics of the recited method of making a pea protein isolate having reduced sodium, or any of the recited extracting, precipitating, washing, neutralizing, homogenizing, sterilizing or drying steps.
Regarding the position taken in the Reply at page 8 and the method of adding a volume of water of 1X to 4X to a PPI to form a slurry, Shi discloses this dilution at page 4, item (6).
Regarding the position taken in the Reply regarding Zhou, the Reply relies on its earlier statements. Accordingly, the position merely repeats positions already addressed and is taken as a general allegation of patentability. See 1.111(b).
Conclusion
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/ANDREW E MERRIAM/Examiner, Art Unit 1791