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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/5/2026 has been entered.
Response to Amendment
Applicant’s remarks and amendments filed 5/5/2026, in response to the final rejection mailed 2/6/2026, are acknowledged and have been fully considered.
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s amendment to the claims is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Claim Status
Claims 1-3 and 12-19 are canceled by amendment. Claims 20-31 are new.
Claims 4-11 remain withdrawn.
Claims 20-31 are now pending and are examined on the merits.
Claim Interpretation
New claims 20-31 recite the phrase “a plant protein product”, which under the broadest reasonable interpretation (B.R.I.) is being interpreted as a protein obtained from a plant, or a mixture of plant proteins. Claim 20 requires that the protein product comprises a protein which is globulin, but this language does not exclude other proteins from being present in the product.
Claims 23-30 are being interpreted as product-by-process claims. As discussed in MPEP § 2113, such product-by-process claims are not limited to the manipulations of the recited steps, only the resulting structure ("Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)).
Claim Rejections - 35 USC § 112(b)
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.
Claim 27 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.
Claim 27 recites the phrase "in particular" which renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. The claim is indefinite because one cannot determine if “hydrochloric acid, citric acid or sulfuric acid” is meant to further limit the claim or if these are merely exemplary. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 112(a) - New Matter
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 31 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
MPEP § 2163 sets forth the guidelines for examining patent applications for complying with the “Written Description” and new matter requirements. MPEP § 2163.I.B: “the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations that are not supported by the as-filed disclosure violate the written description requirement.”
Claim 31 recites a food product that comprises a plant protein product and at least one additional food ingredient. There is no explicit description or implied support for the subject matter of claim 31, because there is no explicit or implicit recitation of a “food ingredient” in the application as filed.
In the remarks filed on 5/5/2026, Applicant states that support for the claim is found on page 5, lines 10-14. This passage states: “A third aspect of the present invention is its involvement in the use of plant proteins, including isolate or concentrate, preferably leguminous protein isolates, more preferably pea protein isolates of the invention in food applications, feed applications, cosmetic applications and pharmaceutical applications.”
This provides support for using the isolated protein product in a general food application or feed application (presumably for agriculture feed). The sections of the application pointed out by the Applicant amount to merely suggestions or intended usages of the plant protein product. There is no practical description of any food ingredients in accordance with the newly recited subject matter. There is no general support in the application, as filed, for a food product comprising a plant protein product and at least one additional food ingredient.
Food ingredients are not defined in the specification. On page 2, lines 1-3, the specification describes that “it is known practice to use plant proteins to replace all or some of the animal proteins in food products”. However, there is no description for food ingredients in the specification and there is no support the explicitly claimed combination of the plant protein product and additional food ingredients.
Applicant is requested to cancel or amend the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 20-31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
The claims recite a plant protein product, obtained from pea or fava bean in claim 20, from pea in claim 21, or from any plant via the processes recited in claims 23-30. Claim 31 recites the plant protein product and an additional food ingredient, without any limitations to the identity of this food ingredient.
The claim 20 recites a pea or fava plant protein product, which encompasses any proteins isolated from a plant, wherein “said protein product comprises a protein which is globulin” and contains less than 5 µg of the sum of hexanal, 2-pentyl-furan, (E)-2,4, heptadienal and 1-octen-3-ol per gram of dry matter. Claim 20 also recites a functional property of the plant product, that the product has a solubility in water at 20°C and pH 7 of at least 60%. It is found that this is a functional property at a contingent condition, i.e. this property emerges from the physical composition and characteristics of the obtained protein products.
Claim 21 recites that the protein product is obtained from pea. Claim 22 further limits the amount of contaminating saponins in the product.
Claims 20-22 encompass essentially pure isolated pea proteins that include globulins and any other amount of plant proteins without any of the recited contaminants.
Claim 23 recites a plant protein product, obtained by a method comprising the method steps (a)-(e), optionally (f) and (g), as set forth in the claim. The method steps are further limited by the elements recited in the dependent claims 24-30. Claims 23-30 are interpreted as product-by-process claims, as described above. MPEP § 2106.04(c)(I.B.) states that for “a product-by-process claim (e.g., a claim to a cloned farm animal produced by a nuclear transfer cloning method), the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart”.
For determining subject matter eligibility, the following analysis was considered, per MPEP § 2106.
Patent Eligibility Analysis Step 1: Step 1 requires determining whether the claims are
directed to one of the four categories of subject matter recited in 35 U.S.C. 101. In this case, YES, claims 20-31 are each directed to a composition of matter.
Patent Eligibility Analysis Step 2A Prong 1: Step 2A, Prong 1 requires evaluating whether the claims recite a judicial exception (i.e., a law of nature, natural phenomenon, or abstract idea).
Claims 20-31 each recite a product of nature, namely naturally occurring plant protein products including globulin proteins as found in a pea plant (or a fava plant for claim 1). The B.R.I. of claims 20-22 encompasses a mixture of isolated pea proteins which includes globulin, without any of the recited contaminants.
Claims 24-30 each recite a plant protein product, encompassing naturally occurring plant proteins, obtained from natural sources. Even though the claim is a product-by-process, the determination of patent eligibility is based upon the structure of the product. Therefore claims 20-30 each recite a judicial exception, a product of nature.
Claim 31 recites the plant protein product and an additional food ingredient. This includes any foods, including peas or carbohydrates obtained from peas- also natural products.
When a claim recites a natural product limitation, the markedly different characteristics (MDC) analysis is used to determine whether the natural product has markedly different characteristics from its natural counterpart (see MPEP 2106.04(c)).
The first step in the MDC analysis requires selecting the appropriate counterpart.
For claims 20-22 and 31, the B.R.I. of the claimed subject matter encompass naturally occurring globulin proteins but does not exclude other pea plant-derived proteins, and therefore, the closest naturally occurring counterpart would be naturally occurring proteins found in a plant or plant part, without isolation. For claim 31 the food ingredient can include the remains of the peas (i.e. the non-protein parts) or carbohydrates obtained from peas- also natural products.
For claims 24-30, the appropriate naturally occurring counterpart is a naturally occurring protein found in a plant or plant part. In this case, the comparisons for the plant protein isolate will be based on comparing an obtained plant protein (or a mixture of plant proteins) to its un-isolated naturally-occurring counterpart, particularly proteins obtained from pea plants. See MPEP § 2106.04(c)(I.B.) regarding the consideration of product-by-process claims.
The second step in the MDC analysis requires selecting the appropriate characteristics for
analysis. The appropriate characteristics for analysis can be expressed as the natural product’s structure, function, and/or other properties, and are evaluated on a case-by-case basis. In this case, the appropriate characteristics for which to compare the claimed plant protein product (i.e. a mixture including pea globulin proteins), with the naturally occurring counterparts include the structure and functional characteristics of the proteins.
The third step in the MDC analysis requires comparing the characteristics of the claimed
natural products to the naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed product are markedly different.
The claims are drawn to isolated forms of a natural product, however, such isolation does not result in any markedly different change to the proteins themselves and thus the proteins of the instantly claimed protein isolates are the same as those found in nature.
References from the art were consulted as evidence regarding the structure and functions of naturally occurring plant proteins, including globulins from pea plants.
“Koyoro and Powers” (Cereal Chem. 64(2):97-101, on PTO-892) describes preparations of natural pea globulin proteins, particularly legumin and vicilin, that are isolated via steps of milling, extraction, isoelectric precipitation (at an acidic pH), dialysis, and centrifugation (Fig. 1 and pg. 97, right col). Koyoro and Powers quantifies and describes the structural and functional properties of isolated pea plant globulins (Tables 1-3). The authors state that “Legumin and vicilin preparations had different solubility, foaming, and emulsion properties. This suggests that for a particular application, a pea cultivar with a specific protein make-up… might be appropriate as raw material for production of a protein isolate. Alternately, processing conditions could be changed to enrich the isolate for legumin or vicilin.” (pg 101, top left, Conclusion).
Koyoro and Powers also demonstrates that the solubility is variable, based upon the identity and structural composition of the natural protein, however it is evident that this is a natural emergent property of the protein composition (pg. 100, left hand col., “Functional Properties” ). This article discusses that at pH 7, the solubility of the mixed globulin preparation was 86.1 %, whereas the legumin fraction was ~73% and the vicilin fraction was 96.9% soluble (Table II). Koyoro and Powers also teaches that the isolation procedure used therein was expected to yield highly soluble native plant proteins ([g. 100, left col., 4th paragraph).
Shevkani et al. (2019. “Pulse proteins: secondary structure, functionality and applications”. J Food Sci Technol ;56(6):2787-2798. doi:10.1007/s13197-019-03723-8) discusses features and properties of proteins from different pulses, including beans, peas, lentils, cowpeas, chickpeas, and pigeon peas (Abstract). Shevkani teaches that typically, the pulse proteins compositions are comprises of mainly globulins which are soluble in salt solutions and albumins that are mostly soluble in water (see pg. 2788, left col under “Composition”). Shevkani teaches that differences in functional properties such as solubility can be attributed to differences in protein molecular features such as amino acid composition, MW, secondary structure, charge distribution, hydrophobicity, etc., as well as the processing conditions or environmental factors (see pg. 2790 under “Functional Properties”). Shevkani states that the solubility of protein isolates is dependent primarily on the balance of hydrophilic to hydrophobic residues in the structure, and that the pH of medium has significant effect on the solubility (pg. 2790-2791, “Protein solubility”). Figure 2 of Shevkani demonstrates the typical solubility profile of natural pulse extracts, including peas, kidney beans, and cowpeas. Figure 2 demonstrates that these proteins are typically more soluble when the medium is lower or higher than the isoelectric point, which is typically from pH 4-5. At pH 7, each of the protein pulse mixtures shown in Fig. 2 had a solubility of around or greater than 60%.
Lu et al. (2019. “Composition, physicochemical properties of pea protein and its application in functional foods,” Critical Reviews in Food Science and Nutrition, DOI: 10.1080/10408398.2019.1651248) is a review of pea protein isolation and discusses the composition and structural properties of such pea protein preparations (Title, Abstract). Lu discusses that pea protein includes four major classes, including globulin, albumin, prolamin, and glutelin, in which globulin and albumin are major storage proteins in pea seeds. Lu teaches that globulin is typically soluble in salt solutions and can be further classified into legumin and vicilin whereas albumin is soluble in water (Abstract, Table 1). Lu states that “Globulin and albumin are two major types of pea protein and their composition, molecular structure, charge distribution determine PPI physical and chemical properties” (pg. 3, left col, last paragraph). This review establishes that the field is aware of the variation in solubility among naturally-occurring pea proteins, and that these are due to natural properties of the proteins as well as conditions of the environment (i.e. the pH and temperature).
From these references, it is apparent that the claimed solubility limitations are dependent upon properties of the natural proteins, resulting from the composition of the mixture and natural factors such as pH (e.g. the pH of water is typically around 7.0). Thus, this claimed limitation does not transform or change the claimed subject matter in a way that is markedly distinct from the counterparts found in nature. Indeed, the prior art establishes that the higher the pH, the more soluble pea plant proteins are, and demonstrates that albumins are typically more soluble than other components. Thus, the resulting solubility is due to emergent natural properties and not due to any physical changes brought upon by the inventors.
Therefore, as the instant claims encompass naturally occurring globulins such as legumin and vicilin as well as albumins and other pea plant proteins, the structural and functional properties of the instant invention are not distinct from the natural counterpart proteins.
In regards to the product-by-process claims, there are no required claimed steps that would practically change the structure of the proteins such that they are distinct from the natural counterpart. The solubility is determined mainly by the structural components of the proteins (i.e. the amount of hydrophilic vs. hydrophobic residues). Further, this product is defined by its structure and not by the actual process in which it is obtained. If the nature-based product is indistinguishable from the protein as it exists in nature (i.e. a mixture of proteins is naturally found in plants), then the product remains an ineligible product of nature.
For claim 31, the additional food carbohydrates or similar compounds from a pea would also be present in the nature. There would be no distinguishing characteristics, as claimed. A combination of ineligible products does not on its own result in a patent eligible product.
None of the dependent claims require a physical transformation resulting in characteristics that are markedly distinct from the naturally-occurring products.
Neither the instant disclosure nor the previous arguments of record provide additional evidence that the protein product as claimed has any marked difference in structural or functional properties when compared to the naturally occurring protein counterpart.
Because there is no convincing evidence on the record that the claimed plant protein product has any markedly distinct characteristics when compared to a mixture of natural proteins, the claimed product is drawn to a product of nature exception (Step 2A, Prong 1, claims 20-31: YES).
Patent Eligibility Analysis Step 2A Prong 2: Prong Two requires evaluating whether the claims recite additional elements that integrate the judicial exception into a practical application.
Claim 20 recites that the “plant protein isolate” has less than 5µg of the sum of hexanal, 2-pentyl-furan, (E)-2,4, heptadienal and 1-octen-3-ol per gram of dry matter. Claim 22 recites that the plant protein isolate contains less than 5mg of total saponins per gram of dry matter.
The additional elements of claims 20-23 do not integrate the exception into a practical application because, although limiting the composition to exclude those compounds, a substantially pure protein composition having no contaminants and fulfilling these limitations is encompassed by the claim, and the proteins themselves are naturally occurring products. The claim is drawn to merely the isolated natural product, and the natural product is not implemented into any practical application or directed use.
For claims 24-30, the additional recited elements include methods for extraction and isolation of the plant components that do not integrate the natural product into a practical application. Such isolation merely concentrates and/or reallocates the naturally occurring compounds of the plant which are soluble or insoluble when provided with a particular solvent and treatment conditions (i.e. the extraction method used determines chemical solubility and extractability). The extraction process collects and concentrates the desired proteins that are naturally found in the plant to produce an extract, and the selected extraction methods exclude undesirable molecules, such as the negatively-recited volatile compounds.
The claims also all recite a limitation regarding the solubility of the proteins under certain conditions. This amounts to a functional property that arises from the composition (i.e. the amino acid make-up) of the natural proteins. Thus, the solubility has been found to a be a natural variable that is influenced by the constituent proteins present in the mixture, as well as the isoelectric point of the proteins and the charge under any particular pH. This does not amount to an additional element that requires a practical application of the ineligible product.
For claim 31, the inclusion of additional food elements, which encompasses many possible natural products is not a practical application of the claimed natural protein product.
There are no steps in the claims recited requiring use of or directing application of the plant protein isolate. (Step 2A, Prong 2, Claims 20-31: NO).
Patent Eligibility Analysis Step 2B: Step 2B requires evaluating whether the claims recite additional elements that amount to significantly more than the judicial exception. For claims 20-23, there are no positively recited additional elements beyond the isolated plant protein and innate functional properties thereof (i.e. the solubility limitation). For claims 24-30, the isolation steps can be considered additional elements, if they are deemed to have a transformative effect on the natural product that affects the product’s structure.
Claims 20-23 do not recite any additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements regarding general isolation and exclusion of undesirable contaminants, in which the contaminant chemicals cannot themselves be considered “protein”, do not practically limit or affect the intrinsic structural or functional properties of the isolated plant proteins, in such a manner that the claimed protein product (i.e. mixture) is significantly distinct from the natural-occurring counterparts.
Regarding isolating the protein, isolation of proteins from plant sources, including pea plants, represents nothing more than well-understood, routine, and conventional activity when recited at a high level of generality as in claims 20-23. This is extensively reviewed in the prior art, see for example, the cited reference Lu et al. (2019. Critical Reviews in Food Science and Nutrition) as discussed above. For claim 31, the inclusion of additional food elements, which encompasses many possible natural products does not amount to significantly more than the natural protein product as it exists in nature, as additional food ingredients are found there as well (such as carbohydrates in a pea plant).
The claimed isolation process steps recited in claim 24 include milling, mixing, and separation steps (i.e. flocculating, precipitating, suspending, extracting, washing, etc.), which all common techniques in the art. For example, the disclosure suggests that, generally, methods for isolating protein from plants are well-understood, routine, and conventional commercial processes (pgs 1-3) and examples of known isolation methods are provided (Table 1; pg. 14).
As an example only, Dhalleine et al. (US Pat. No. 9,259,017), which is drawn to processes for manufacturing soluble and functional plant proteins, describes numerous isolation methods known to the art (Cols. 2-3), and describes processes including flocculation, i.e. isoelectric precipitation (Col 6), and steps of heating (Col 6-7). Additionally, Lam et al. ("Pea protein isolates: Structure, extraction, and functionality." Food reviews international 34.2 (2018): 126-147, provided on PTO-982) reviews structure–function relationships of pea protein isolates and the impact of extraction techniques used to produce the isolate (Abstract). Lam et al. discusses many known extraction methods and studies to optimize said methods on pgs 130-131.
The judicious selection of isolation methods from among those known in the art does not change the intrinsic properties of the natural protein itself, merely it affects properties of a mixed composition which includes the natural proteins, and the additional elements do not require or impart any transformation of the naturally occurring protein constituents. Please note that modifying the concentration of the product/composition is not sufficient to remove the claimed composition from a judicial exception (see, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 133 S. Ct. 2107, 106 USPQ2d 1972 (2013)).
The recitation of a particular desired solubility fails to amount to significantly more than the judicial exception because this is a purely functional limitation (and a contingent one) that depends upon the natural properties of the obtained proteins, as discussed above.
There is no evidence that the recited steps for isolation practically transforms the protein product, or practically effects the solubility when the product is tested in the required manner. Adjusting pH and determining solubility is also well known to one of skill in the art, and extraction processes typically collect or exclude proteins based upon solubility.
Regarding dependent claims 25-30, because the steps are routine and conventional steps recited at such a degree of generality, the claimed product thereof (a product-by-process) remains non-distinguishing from the above rejected natural materials.
Therefore, taking into account the well-recognized and commonly used means for protein isolation in the art, and the nature of the instant claims 24-30 as being drawn to a product obtained by the recited method (i.e. a product-by-process claim.), these additional elements do not amount to significantly more than the judicial exception. (Step 2B: Claims 20-31: NO).
Therefore, after consideration of the above subject matter eligibility analysis, claims 20-31 are herein rejected under 35 U.S.C. § 101 because the claims, as presented, are directed to the judicial exception of a natural product without significantly more.
Response to Arguments
Applicant's arguments filed 5/5/2026 regarding the patent eligibility of the newly added claims 20-30 have been fully considered but they are not persuasive.
Presented herein are new rejections under 35 U.S.C. § 101 of these newly added claims, however, the arguments set forth previously have been fully considered.
Applicant argues that the claimed products have defined compositions and specific functional properties which distinguish the claimed product from any naturally occurring pea or fava bean protein. This argument is not persuasive, because as described above, the features upon which applicant relies upon, including the exclusion of volatile chemicals which are notably not proteins, and the solubility of the protein mixture are not structural limitations that amount to a markedly distinct characteristic of the claimed protein product, when compared to the naturally occurring counterparts. A product or component claim is defined by its structure. Recitation of negative limitations and functional properties are to be considered but in this case these limitations do not distinguish the claimed product from a naturally occurring mixture of proteins having the suitable solubility (i.e. having a larger amount of albumins which are generally recognized as water soluble).
The claimed protein product encompasses naturally-occurring mixtures of fava or pea plant proteins, namely plant globulins and albumins. These have intrinsic properties in nature, including their solubility, which is determined based upon the relative amounts of hydrophilic and hydrophobic amino acids and their charge. The pH of the solution is a contingent limitation, however it is noted that pH 7 is typical of water, which also occurs in plants in nature. The temperature of 20°C is approximately ambient conditions or room temperature.
Further, the measurement of the solubility of these otherwise natural protein mixtures does not amount to significantly more than the naturally occurring counterpart. Discovery of a new property, which is also a natural phenomenon, does not result in a natural product becoming patent eligible (see MPEP § 2106.04(b) in regards to Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948), Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980)).
There is no physical transformation or artificial treatment claimed here that results in a product that is markedly distinct from the naturally occurring plant proteins. Isolation of a natural product on its own does not amount to more than the ineligible product (see e.g. MPEP § 2106.04(b).I. in regards to isolated natural DNA, of which the instantly claimed natural protein is akin to, Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014)).
Therefore the newly presented claims 20-31 are rejected under 35 U.S.C. § 101.
Conclusion
Claims 4 -11 and 20-31 are pending, of which claims 4-11 remain withdrawn.
Claims 20-31 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW TERRY MOEHLMAN whose telephone number is (571)270-0990. The examiner can normally be reached M-F 9am-5pm EST.
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/A.T.M./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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