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 .
Response to Amendment
Claims 1-19 are pending. Claims 4-11 remain withdrawn as being directed to a non-elected invention.
Applicant’s remarks and amendments filed 11/6/2025, in response to the non-final rejection mailed 8/7/2025, are acknowledged and have been fully considered.
Applicant’s amendment to the claims is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Claims 1-3 and 12-19 are pending and have been examined on the merits.
Response to Arguments
Any previous rejection or objection not mentioned herein is withdrawn.
Regarding the rejections of claims 1-3 and 12-19 under 35 U.S.C. § 101 for being drawn to a judicial exception (a natural product), Applicant’s arguments on pages 5-6 have been fully considered but they are not persuasive.
Regarding claims 1-3, Applicant argues that the claimed invention is not directed to a naturally occurring substance, but to a man-made composition presenting markedly different chemical and functional characteristics from any product existing in nature, and that the plant protein isolate of the invention contains less than 5 µg/g of the sum of four specific volatile compounds (hexanal, 2-pentyl-furan, (E)-2,4-heptadienal, 1- octen-3-ol), wherein the protein isolate comprises a protein which is globulin and thus “Such a value for the sum of those four specific volatile compounds cannot be found in native globulins”. This argument is not found persuasive. A plant protein isolate, from pea or fava beans, is a product derived from nature, comprising one or more polypeptides made of amino acids. The claimed composition having less than the specified amount of the volatile compounds encompasses purified natural globulins alone with no contaminants. A composition derived from plants and comprising only natural plant proteins is a product of nature, that is not significantly distinct from the natural, unpurified counterpart. The claims as presented encompass natural, untransformed, pea plant globulin protein, and thus the claims are directed to a natural product. See MPEP § 2106.04(c).II.C.
There is no evidence of a chemical, physical, or structural change to the globulin proteins imparted by the isolation process. The Applicant argues that embodiments of the claimed composition have improved properties, including improved taste and/or organoleptic properties, but (a) these are not recited in the claims, and (b) these are not evidenced as being due to a direct change on the proteins. The specification and the Applicant’s arguments discusses that these sensory changes are due to the absences of volatile substances, which are not proteins (polypeptides comprised of amino acids) and these volatile compounds (mainly comprising organic hydrocarbon compounds) do not comprise part of a pea plant protein isolate.
Applicant further argues that in claims 12-19, the proteins are obtainable by a method comprising a series of chemical and physical transformations, each of which contributes to a composition of matter that does not occur in nature. This argument is not found persuasive because, as discussed previously, the claims are directed to the products, and the recited method steps for isolating the protein products do not require any direct modification of the proteins. 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”. The recited steps amount to means for isolating the natural protein, yet the product itself remains unchanged compared to the unpurified counterpart (i.e. the sequence of the amino acids, the structure, and the functional properties of the constituent polypeptides are unchanged), and thus, the claimed product, does not have markedly different characteristics from the naturally occurring plant protein (prior to isolation). Further, as an illustrative example, the disclosed “Solvent”-isolated plant protein isolate, referred to in Table 1 of the specification, also amounts to a natural product exception, regardless of the isolation method applied.
Isolation 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 and purification methods excludes undesirable molecules. There is no indication in the record that isolation of the pea plant globulin protein in the claimed manner results in a marked difference in structure, function, or other properties as compared to the natural counterpart, and thus, the claims remain rejected as being drawn to a natural product.
Regarding the Applicant’s arguments of improved protein functionality, it is noted that this is not recited in the claims, except for optionally in claim 12 step (f), which only includes a general recitation of “improved protein functionality”. There are no specific functions recited in the claims. Further, if one was to fully consider the “improved protein functionality” of step (f), there is no recited manner for one to determine whether a protein functionality is improved or is not improved. MPEP § 2103 establishes that “Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation”. Therefore, optional limitations, such as step (f) of washing through a shearing pump or a homogenizer “to improve protein functionality” and step (g) of drying the proteins in claim 12, have not been afforded patentable weight.
Regarding claims 1-3, rejected as being anticipated by Gueguen et al. (Journal of the Science of Food and Agriculture, 1984, of record), Applicant's arguments, on pages 6-7, have been fully considered but they are not persuasive. Applicant argues that Gueguen does not disclose the instantly claimed protein isolate as defined in claims 1-3, because “Gueguen relates to isolation and purification of two globulins: vicilin and legumin, from pea flour for characterization (3.1, page 1026)” (see page 6, last paragraph of Applicant’s remarks), and that “Gueguen describes a biochemical purification aimed at structural characterization of native pea globulins... not the production of a food-grade ingredient”. (on page 7, 2nd paragraph).
This argument is unpersuasive, because under the B.R.I. of the claim limitations, the subject matter of claims 1-3 includes purified pea globulins, including the vicilin and legumin disclosed in Gueguen which are described by the Applicant as being purified sufficiently for analytical characterization. As set forth in the previous Office action, such a purified protein would inherently lack all of the undesirable volatile compounds that are negatively claimed in the instant application. Further, MPEP § 2112.01 discusses that "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In the instant case, Gueguen obtains and describes highly purified pea globulins- the same as instantly claimed- which are polypeptides comprised of amino acids, and which do not comprise the volatile hydrocarbon compounds named in the claims. Because such purified pea globulin proteins are encompassed by the claimed subject matter, the globulins of Gueguen anticipate the instant composition.
Under the B.R.I. of the terms, the instant invention does not appear to be distinct from that of a purified plant protein having zero contaminants, for example, the vicilin and legumin of Gueguen or the referenced one “obtained from a reference process using a solvent...”, as discussed by the Applicant on page 7 of the remarks (see also Table 1 of the specification).
In response to applicant's argument that the purification of the globulins in Gueguen is not for the production of a food-grade ingredient, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Regardless, the instant claims do not recite any intended use of the isolated pea plant protein.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the reported protein isolate properties of “distinctly neutral taste...”, sensory score, and organoleptic properties) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant’s arguments, on pages 8-10 of the remarks filed 11/6/2025, with respect to the rejections of claims 12 and 13 as being anticipated and/or obvious over the teachings of Nickel (US 5,034,227, of record), and the rejections of claims 14 and 15 as being obvious over Nickel in view of Gupta (US Pat No. 4,915,972, of record), have been fully considered and are persuasive, as the prior art does not disclose or suggest subjecting the precipitated protein fraction to a controlled heating step at 60-100 °C under simultaneous acidic conditions. The rejections of claims 12-15 under 35 U.S.C. §§ 102 and 103 have been withdrawn.
MAINTAINED REJECTIONS
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 1-3 and 12-19 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 isolate, obtained from pea or fava bean in claim 1, from pea in claim 2, or from any plant in claims 12-19.
The amended claim 1 recites a pea or fava plant protein isolate, i.e. a protein isolated from a plant, wherein “the protein isolate 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 2 recites that the plant comprises a pea plant. Claim 3 further limits the amount of contaminating saponins. The B.R.I. of claims 1-3 encompasses essentially pure isolated pea proteins comprising globulin without any of the recited contaminants.
Claim 12 recites a plant protein isolate, that is 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 13-19. Claims 12-19 have been 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, the claims 1-3 and 12-19 are 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 1-3 each recite a product of nature, namely the naturally occurring globulin proteins found in a pea plant (or a fava plant for claim 1). The B.R.I. of claims 1-3 encompasses essentially pure isolated pea proteins comprising globulin, including naturally occurring globulin proteins without any of the recited contaminants. Claims 12-19 each recite a plant protein isolate, which encompasses naturally occurring plant proteins. Therefore claims 1-3 and 12-19 each recite a judicial exception, a product of nature.
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 1-3, the B.R.I. of the claimed subject matter encompass naturally occurring globulin proteins, and therefore, the closest naturally occurring counterpart would be naturally occurring globulin proteins found in a plant or plant part without any isolation.
For claims 12-19, 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 unisolated 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 isolated plant protein (i.e. pea globulin proteins), with the naturally occurring counterparts include the structure and functional characteristics of the protein(s).
The third step in the MDC analysis requires comparing the characteristics of the claimed
natural product(s) 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).
Therefore, as the instant claims encompass naturally occurring legumin and vicilin (each being globulins), the structural and functional properties of the instant invention are not distinct from the natural counterpart protein(s). The instant disclosure provides no evidence that the claimed proteins have any marked difference in structural or functional properties as compared to the naturally occurring protein counterpart.
Because there is no indication on the record that the claimed plant protein isolates have any marked difference in structural or functional properties compared to their natural counterpart proteins, the claimed consortia is a product of nature exception (claims 1-3 and 12-19: 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 1 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 3 recites that the plant protein isolate contains less than 5mg of total saponins per gram of dry matter.
The additional elements of claims 1-3 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 12-19, 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 method(s) excludes undesirable molecules, such as the negatively-recited volatile compounds.
There are no steps in the claims recited requiring use of or directing application of the plant protein isolate. (Claims 1-3 and 12-19: 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 1-3, there are no positively recited additional elements beyond the isolated plant protein. For claims 12-19, the isolation steps can be considered additional elements.
Claims 1-3 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(s) is significantly distinct from the natural-occurring counterpart(s).
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 1-3.
The claimed isolation process steps recited in claim 12 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), drawn to processes for manufacturing soluble and functional plant proteins, describes numerous isolation methods, many 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)).
Therefore, taking into account the well-recognized and commonly used means for protein isolation in the art, and the nature of the instant claims 12-19 as being drawn to a product obtainable by the recited additional elements (i.e. a product-by-process claim.), these additional elements do not amount to significantly more than the judicial exception.
Regarding dependent claims 13-19, 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. (Claims 1-3 and 12-19: NO).
Therefore, after consideration of the above subject matter eligibility analysis, claims 1-3 and 12-19, are 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.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gueguen et al. (“Large‐scale purification and characterisation of pea globulins.” Journal of the Science of Food and Agriculture 35.9 (1984): 1024-1033).
Gueguen discloses the isolation of pea globulins, comprising the proteins vicilin and legumin, by ion exchange chromatography (Abstract/Summary and Title).
Particularly, Gueguen states that “Vicilin and legumin were purified from pea flour as shown in the flow diagram (Figure 1). The whole protein extract was fractionated by ion exchange chromatography. The separated vicilin and legumin enriched fractions were pooled, concentrated by ultrafiltration and then purified by size exclusion chromatography. The resulting purified globulins fractions were desalted through a column of Trisacryl GF05 and freeze-dried.” (pg. 1026, 3.1. Preparative chromatography, and see Figure 1). The extraction and purification processes described in Figure 1 of Gueguen includes, inter alia, crude protein extraction, ultrafiltration, ion-exchange chromatography, gel filtration (i.e. ACA 34 Ultrogel), and desalting (i.e. Trisacryl GF05) (see the detailed methods on pgs 1025-1026). These known protein isolation techniques, especially the ultrafiltration and ion-exchange chromatography steps will facilitate the removal of non-protein impurities from the protein isolate.
Therefore, Gueguen disclosures an ultrapure plant isolate obtained from pea plants (as in claims 1 and 2), wherein the proteins comprise globulin (e.g. the purified vicilin and legumin fractions) that would be substantially free of the negatively-recited volatile compounds of claim 1 (), and the negatively-recited saponin compounds of claim 3.
The language of the instant claims 1-3 does not exclude a compound having none of the recited contaminating compounds.
Since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Thus, absent evidence to the contrary, claims 1-3 are rejected under 35 U.S.C. § 102 as being anticipated by Gueguen, which discloses substantially pure preparations of globulins from pea plants, having no contaminants, which is encompassed by the B.R.I. of claims 1-3.
Conclusion
Claims 1-3 and 12-19 are rejected.
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.
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/A.T.M./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655