The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Application Status
This application is a Non-Provisional patent application filed on 09/04/2025.
Claims 166-171, 173, 175 and 176-177 are currently pending in the instant application.
The preliminary amendment filed on 06/02/2026, amending claims 166, 168, and 170-171, canceling claims 172, and 174, and adding new claims 176-177 is acknowledged.
Election/Restriction
Applicant's election with traverse of species election of a transferase and a hydrolase in the response filed on 06/02/2026 is acknowledged.
Since, amended independent claim 166 requires two species together, and therefore, the species election for a single species is hereby withdrawn, and all the species will be examined.
The requirement is still deemed proper and is therefore made FINAL.
Claims 166-171, 173, 175 and 176-177 are present for examination.
Priority
Acknowledgement is made of applicants claim for priority of US Provisional applications 63/692,708, filed on 09/09/2024, and 63/765,492, filed on 02/28/2025.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 12/22/2025, and 12/23/2025 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are considered by the examiner. The signed copies of 1449s are enclosed herewith.
Drawings
Drawings Fig. 6A and Fig. 6B submitted on 09/04/2025 are not accepted by the Examiner because they are not clearly legible. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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.
A. Written Description
Claims 166-171, 173, 175 and 176-177 are rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claim(s) 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim166 is directed to a pea protein modification composition, comprising: an enzyme blend including at least a transferase, and a hydrolase in a carrier; wherein the composition is configured to treat pea protein under controlled pH and temperature conditions to produce modified pea protein having reduced presence of at least one off-flavor comprising a beany compound compared to untreated pea protein. composition is configured to treat pea protein under The Court of Appeals for the Federal Circuit has held that a “written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” University of California v. Eli Lilly and Co., 1997 U.S. App. LEXIS 18221, at *23, quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993). To fully describe a genus of genetic material, which is a chemical compound, applicants must (1) fully describe at least one species of the claimed genus sufficient to represent said genus whereby a skilled artisan, in view of the prior art, could predict the structure of other species encompassed by the claimed genus and (2) identify the common characteristics of the claimed molecules, e.g., structure, physical and/or chemical characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or a combination of these (paraphrased from Enzo Biochemical).
Thus, Claim 166 is drawn to any pea protein having no structural feature, modification composition, comprising: any or all enzyme blend including at least any transferase derived from any sources having no structural feature, and any hydrolase derived from any sources having no structural feature, in a carrier; wherein the composition is configured to treat any pea protein under controlled pH and temperature conditions to produce modified any pea protein having reduced presence of at least any one off-flavor comprising any beany compound having no structure compared to untreated pea protein., i.e., claims encompasses many pea protein, many transferase and many hydrolase proteins as well as many mutants, variants, and fragments thereof, which can have wide variety of unknown structures, i.e. No Structure-Function correlation, which is required to fulfill the Written Description (WD) requirement.
As discussed in the written description guidelines the Written Description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A representative number of species means that the species, which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Furthermore, the genus of proteins or polypeptides required in the claimed invention is an extremely large structurally and functionally variable genus. While the argument can be made that the recited genus of polypeptides are adequately described by the disclosure of the structures of prior art. However, the art clearly teaches the “Practical Limits of Function Prediction”: Whisstock et al., (2003) highlight the difficulties associated with “Prediction of protein function from protein sequence and structure”; “To reason from sequence and structure to function is to step onto much shakier ground”, closely related proteins can change function, either through divergence to a related function or by recruitment for a very different function, in such cases, assignment of function on the basis of homology, in the absence of direct experimental evidence, will give the wrong answer, it is difficult to state criteria for successful prediction of function, since function is a vague concept. This finding is reinforced in the following scientific teachings for specific proteins in the art that suggest, even highly structurally homologous polypeptides do not necessarily share the same function and many functionally similar proteins will have little or no structural homology to disclosed proteins. For example, proteins having similar structure have different activities (structure does not always correlate to function); Witkowski et al., (1999) teaches that one conservative amino acid substitution transforms a -ketoacyl synthase into a malonyl decarboxylase and completely eliminates -ketoacyl synthase activity. Similarly, the art also teaches that functionally similar molecules have different structures; Kisselev L., (2002) teach that polypeptide release factors in prokaryotes and eukaryotes have same function but different structures.
Furthermore, the genus of polypeptides required in the claimed invention is an extremely large structurally and functionally variable genus. While the argument can be made that the recited genus of polypeptides are adequately described by the disclosure of the structures of prior art, i.e., lipase variant enzymes. However, the art clearly teaches the “Practical Limits of Function Prediction”: Whisstock et al., (2003) highlight the difficulties associated with “Prediction of protein function from protein sequence and structure”; “To reason from sequence and structure to function is to step onto much shakier ground”, closely related proteins can change function, either through divergence to a related function or by recruitment for a very different function, in such cases, assignment of function on the basis of homology, in the absence of direct experimental evidence, will give the wrong answer, it is difficult to state criteria for successful prediction of function, since function is in principle a fuzzy concept. This finding is reinforced in the following scientific teachings for specific proteins in the art that suggest, even highly structurally homologous polypeptides do not necessarily share the same function and many functionally similar proteins will have little or no structural homology to disclosed proteins. For example, proteins having similar structure have different activities (structure does not always correlate to function); Witkowski et al., (1999) teaches that one conservative amino acid substitution transforms a -ketoacyl synthase into a malonyl decarboxylase and completely eliminates -ketoacyl synthase activity. Similarly, the art also teaches that functionally similar molecules have different structures; Kisselev L., (2002) teach that polypeptide release factors in prokaryotes and eukaryotes have same function but different structures.
Claims are drawn to very broadly any pea protein having no structural feature, modification composition, comprising: any or all enzyme blend including at least any transferase derived from any sources having no structural feature, and any hydrolase derived from any sources having no structural feature, in a carrier; wherein the composition is configured to treat any pea protein under controlled pH and temperature conditions to produce modified any pea protein having reduced presence of at least any one off-flavor comprising any beany compound having no structure compared to untreated pea protein., i.e., claims encompasses many pea protein, many transferase and many hydrolase proteins as well as many mutants, variants, and fragments thereof, which can have wide variety of unknown structures, whose structures are not fully described in the specification. No information, beyond the characterization of few pea proteins, few transferase proteins, and few hydrolase proteins has been provided, which would indicate that applicants had possession of the claimed genus. The specification does not contain sufficient disclosure of the structure with function of all the pea proteins, transferase proteins, and hydrolase proteins, within the scope of the claimed genus. The genus of polypeptides claimed is a large variable genus including many mutants, variant and fragments thereof, which can have wide variety of structures. Therefore, many structurally unrelated proteins within the scope of these claims. The specification discloses the structure of only few representative species of the claimed genus, which is insufficient to put one of skill in the art in possession of the attributes and features of all species within the claimed genus. Therefore, one skilled in the art cannot reasonably conclude that applicant had possession of the claimed invention at the time the instant application was filed.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov.
Claim Rejections - 35 USC § 102
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 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 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.
MPEP-2131 Anticipation — Application of 35 U.S.C. 102 [R-08.2017]
A claimed invention may be rejected under 35 U.S.C. 102 when the invention is anticipated (or is "not novel") over a disclosure that is available as prior art. To reject a claim as anticipated by a reference, the disclosure must teach every element required by the claim under its broadest reasonable interpretation. See, e.g., MPEP § 2114, subsections II and IV.
"A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference." Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987). "When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art." Brown v. 3M, 265 F.3d 1349, 1351, 60 USPQ2d 1375, 1376 (Fed. Cir. 2001) Note that, in some circumstances, it is permissible to use multiple references in a 35 U.S.C. 102 rejection. See MPEP § 2131.01.
MPEP-2131.01 Multiple Reference 35 U.S.C. 102 Rejections [R-11.2013]
Normally, only one reference should be used in making a rejection under 35 U.S.C. 102. However, a 35 U.S.C. 102 rejection over multiple references has been held to be proper when the extra references are cited to:
(A) Prove the primary reference contains an "enabled disclosure;"
(B) Explain the meaning of a term used in the primary reference; or
(C) Show that a characteristic not disclosed in the reference is inherent.
Claims 166-171, 173 and 175-177 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention as anticipated by Clark et al. (Use of enzymes to de-flavor pea protein. US 2020/0245640 A1, publication 08/06/2020).
The Broadest Reasonable Interpretation (BRI) of claim 166, which is drawn to any pea protein modification composition, comprising: an enzyme blend including at least any transferase and any hydrolase in a carrier (liquid); wherein the composition is configured to treat a pea protein under controlled pH and temperature conditions to produce modified pea protein having reduced presence of at least one off-flavor comprising a beany compound compared to untreated pea protein.
The Broadest Reasonable Interpretation (BRI) of claim 166, which is drawn to any pea protein modification composition, comprising: an enzyme blend including at least any transferase and any hydrolase in a carrier (liquid); wherein the composition is configured to treat a pea protein under controlled pH and temperature conditions to produce modified pea protein having reduced presence of at least one off-flavor comprising a beany compound compared to untreated pea protein.
Regarding claims 166-167, 168, 169-171, 173 and 175-177, Clark et al. teach a method for producing a pea plant protein product comprising treating the plant protein with at least one an exogenous enzyme comprising an oxidoreductase and/or a hydrolase, wherein the treated plant protein product has reduced undesirable flavors and reduced undesirable aromas compared to an untreated plant protein product, wherein the oxidoreductase or the hydrolase is selected from the group consisting of esterase, nuclease, phosphodiesterase, lipase, phosphatase, glycosylase, glycoside hydrolase, protease, peptidase, mannosyl-transferase 2, a glycosyltransferase, which transfer mannose to an acceptor molecule, beta-glucosidase A, glucan 1,3-beta-glucosidase, and combinations thereof, wherein the exogenous enzyme is an oxidoreductase, wherein the oxidoreductase is a laccase, at pH 5.5-7.5 at 30 to 50oC for 10 minutes to 2 hours, wherein the method further comprising adding the exogenous enzyme to a solution (carrier) or suspension of plant protein, wherein the plant protein comprises plant protein isolate or plant protein concentrate, and adding the exogenous enzyme to a solution (carrier) or suspension of plant protein containing at least 50% (weight/weight) plant protein on a dry weight basis, wherein at least one the exogenous enzyme is added in an amount sufficient to increase the viscosity of a solution or suspension of the plant protein or increase the water holding capacity and/or water binding of a solution or suspension of the plant protein, wherein the method further comprising heating the treated plant protein to a temperature and for a time sufficient to inactivate the exogenous enzyme, wherein the plant protein comprises pea protein, rice protein, or combinations thereof, wherein the plant source comprises pea, wherein the method further comprises the step of drying the plant protein product, wherein the reduced undesirable flavor is a pea flavor or a bitterness flavor, wherein the reduced undesirable aroma is a beany aroma, and further comprising preparing a food product with the treated plant protein (see, abstract, para 14, 16, 31, claims 1-15).
Claim 168 is included in this rejection because Clark et al. indeed teach using peptidase inherently an amino peptidase, and further teach an enzyme which breaks Sulfur-Sulfur bond inherently a sulfo lyase (see, para 16).
Since, pea protein contains off flavor, bitter flavor or a beany flavor, the pea protein inherently comprises an 20% less off-flavor compound, bitter favor compound as well as astringent compound (for claims 175-177).
Because the composition comprising pea protein of the claimed invention and that of composition comprising pea protein of the reference is one and the same, Examiner takes the position that the limitations of claims 175, 176, 177 inherently associated with the pea protein composition of Clark et al. Since the Office does not have the facilities for examining and comparing applicants' pea protein for reducing recited off-flavor or chemicals by the prior art, the burden is on the 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 et al., 205 USPQ 594.
Therefore, Clark et al. anticipate claims 166-171, 173 and 175-177 of the instant application as written.
Conclusion
Status of the claims:
Claims 166-171, 173 and 175-177 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IQBAL H CHOWDHURY whose telephone number is (571)272-8137. The examiner can normally be reached on M-F, at 9:00-5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Iqbal H. Chowdhury, Primary Patent Examiner
Art Unit 1656 (Recombinant Enzymes and Protein Crystallography)
US Patent and Trademark Office (USPTO)
Ph. (571)-272-8137 and Fax (571)-273-8137
/IQBAL H CHOWDHURY/
Primary Examiner, Art Unit 1656
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