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
Receipt is acknowledged of the amendment and response filed 11/11/2025. Claims 3-7,9,11-13,16-19 and 21-24 are pending in the application. Claims 21-24 are withdrawn from consideration. Claims 3 and 5 were amended.
Response to Arguments
Applicant’s arguments have been considered, but are not persuasive because the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with the amended claims. The rejection is therefore maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim 3 , 5 and dependent claims are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a base, does not reasonably provide enablement for “baking powder”. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Specifically, although paragraphs [007],[008] and [044] mention “baking powder” and “sodium free baking powder” in Example 1 and Example 2, the examples themselves use strong sodium free base (KOH) and do not use baking powder .
Independent claim 3 recites “A method for extracting organic plant protein comprising: grinding raw plant material; mixing the raw plant material with water to produce a slurry; adding baking powder, wherein said baking powder base does not contain sodium, resulting in a solution with a pH level of about 8; separating the solution into solid and supernatant components; adding an organic acid to lower the supernatant pH to a level of about 5;separating a solid and a liquid portion from the supernatant to produce solid and liquid protein products wherein sodium in the solid protein products is undetectable.”
Independent claim 5 recites “A method for extracting organic plant protein comprising: mixing raw plant material with water to produce a slurry; adding baking powder a base, wherein said baking powder base does not contain sodium, resulting in a solution with a pH level of about 5 to about 9;separating the solution into solid and supernatant components; adding an organic acid to lower the supernatant pH to a level of about 5; precipitating the supernatant into a precipitate; and drying the precipitate to produce a dry protein product,”
The claims therefore encompass embodiments in which:
Baking powder alone is used as the pH-modifying agent
The baking powder produces pH of “about 8” (claim 3) , “about” being undefined, any pH within the broad range 5 to 9,
Protein solubilization sufficient for downstream separation occurs.
Under 35 USC 112(a) the specification must enable a person of ordinary skill in the art to make and use the full scope of the claimed invention without undue experimentation. See In re Wands, 858 F.2d 731 (Fed. Cir. 1988).
Baking powder use level is less than 0.1% wt.% of the mixture
Enablement is not satisfied if the claims encompass inoperative embodiments, or substantial experimentation would be required to determine which embodiments are operable (In re Wright, 999 F.2d 1557; MagSil v Hitachi, 687 F.3d 1377).
The specification must enable the invention commensurate in scope with the claims.
The specification provides working examples using strong alkalis to adjust pH. Although [007], [008] and [044] mention baking powder, neither Example nor Example 2 uses this as a pH adjusting agent.
Baking powder is conventionally a balanced acid-base leavening system , typically comprising a bicarbonate salt, one or more acid salts and a carrier.
Such systems are formulated to generate CO2 and are not designed to provide controlled or sustained alkaline conditions equivalent to strong alkalis exemplified.
The independent claims recite a broad pH range of pH 5 to 9 spanning:
Near -isoelectric conditions (about pH 5) where many legume proteins exhibit minimal solubility, and
Mildly alkaline conditions (about pH 8-9) associated with increased protein solubilization.
The specification provides no guidance regarding the composition of the baking powder, the quantity required, the interaction with slurry buffering capacity, how to reproducibly achieve specific pH values within the claimed range, and whether sufficient protein solubilization occurs at each claimed pH.
Application of Wand’s factors supports lack of enablement:
Breadth of the claims : pH range 5-9 including neutral pH, any baking powder)
Nature of the invention: predictability is moderate to low due to potential buffering effects of the matrix
Amount of direction provided as to type and quantity of baking powder
Lack of working examples with baking powder
Substantial screening is likely required to identify operable formulations and conditions.
The above factors collectively indicate that undue experimentation would be required. The specification therefore does not enable the full scope of the claimed invention.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 3-7,9,11-13,16-19 are rejected under 35 USC 103 as being unpatentable over Luo (CN111217888A) in view of Calmon et al. (WO2020/123585A1).
Regarding claims 3, 5-7,9,11-13,16, 18 and 19, Luo discloses (a method of alkaline extracting rice protein, wherein the preparation method comprises preparing a slurry of rice powder (ground plant material), alkali extraction with a strong base that may be NaOH, or non-sodium base (KOH or LiOH), at a concentration of 0.1 mol/L to 1 mol/L, encompassing a pH of “about 8” as claimed, centrifugal separation of solid and liquid, collecting the liquid supernatant; acid precipitation: adjusting the supernatant, regulating pH to 4~6, which encompasses the claimed range of “about 5” (about is undefined), carrying out acid precipitation, centrifugal separation to obtain the precipitate, followed by washing and drying. Luo further discloses acetic acid as being the acid used in this step [Example 1]. Regarding the use of “baking powder” in pH adjustment, this limitation is not enabled in the specification, as detailed in the current office action.
Calmon et al. similarly discloses adjusting pH of a pea powder slurry to pH 6-9, encompassing the claimed range of “about 8” with KOH, as in the current disclosure, and precipitating protein at pH 4-5 with HCl to obtain low sodium protein with sodium content below 0.6% w/w of dry matter. Calmon points to the health benefits of low sodium protein and further discloses advantages of non-sodium alkali in protein extraction from legume sources.
It would have been obvious to one of ordinary skill in the art to have substituted an organic acid (citric, lactic or acetic acid for example) for HCl to achieve protein precipitation while avoiding chlorides to meet “organic” food labeling requirements or to improve flavor. Furthermore, Luo successfully used acetic acid in protein isolation from plant sources, with a strong alkali, to produce a product with no added chloride as claimed in claim 18. One would therefore use acetic acid in acidic precipitation of plant proteins from an alkaline extract, with a reasonable expectation of success.
Regarding the limitation in claim 3 that sodium is undetectable in the solid product, Calmon discloses sodium contents below 0.6% based on dry matter, and emphasizes exclusion of sodium hydroxide in extracting pea proteins, and using KOH, whereby the product has improved nutritional and functional properties. Luo suggests non-sodium alkali options in a method as claimed. Applicant has not specified the detection limit which would depend on the method of detection, or the criticality of “undetectable” over “very low sodium” .
Applicant has not shown differences in protein functionality and digestibility between a product produced by a method as claimed, as compared to a product produced by a method in Luo in view of Calmon .
Calmon discloses centrifugal separation and drying, to produce a dried and ground legume protein product (Examples 3 and 4).
Regarding claim 4, Calmon discloses pea protein.
Regarding claim 17, Luo discloses a protein content of 85% w/w or more, (working examples) and Calmon discloses a protein content of above 80% w/w (page 4 lines 15-20) encompassing or overlapping the claimed range.
Regarding claim 19, a product in Luo in view of Calmon is expected to meet the claimed requirements as no chloride is added, and any traces of chloride would be naturally present chloride from the raw material.
Claims 3-7,9,11-13,16-19 are therefore prima facie obvious in view of the art.
Conclusion
THIS ACTION IS MADE FINAL. 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 Subbalakshmi Prakash whose telephone number is (571)270-3685. The examiner can normally be reached Monday-Friday.
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/SUBBALAKSHMI PRAKASH/Primary Examiner, Art Unit 1793