DETAILED ACTION
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 of the Request for Continued Examination (RCE under 37 CFR 1.114), the Response, and Amendment filed 04/07/2026 is acknowledged.
Applicant has overcome the following rejections by virtue of the amendment: (1) the 35 U.S.C. §112(b) rejections of claims 15-16 have been withdrawn; and (2) the 35 U.S.C. §102(a)(1) rejections of claims 13 and 15 over Dhalleine have been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 13-18, 21-22
Withdrawn claims: None
Previously cancelled claims: 19-20
Newly cancelled claims: None
Amended claims: 13-16
New claims: None
Claims currently under consideration: 13-18, 21-22
Currently rejected claims: 13-18, 21-22
Allowed claims: None
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/07/2026 has been entered.
Claim Rejections - 35 USC § 112
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 13-18 and 21-22 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 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.
Claims 13 and 14 recite that the soluble pea protein is obtained without chemical hydrolysis to achieve solubility. However, none of previous versions of the claim, the present specification, and the provisional application discloses obtaining soluble pea protein without chemical hydrolysis. “Any negative limitation or exclusionary proviso must have basis in the original disclosure[…] The mere absence of a positive recitation is not basis for an exclusion. However, a lack of literal basis in the specification for a negative limitation may not be sufficient to establish a prima facie case for lack of descriptive support. Ex parte Parks, 30 USPQ2d 1234, 1236 (Bd. Pat. App. & Inter. 1993). "Rather, as with positive limitations, the disclosure must only 'reasonably convey[] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.' ... While silence will not generally suffice to support a negative claim limitation, there may be circumstances in which it can be established that a skilled artisan would understand a negative limitation to necessarily be present in a disclosure.” MPEP §2173.05(i). While the Applicant exemplifies a method of making a pea protein product embodiment in [0047] of the present specification, the method does not mention chemical hydrolysis (i.e., hydrolysis using a substance other than an enzyme) at all. Furthermore, the present specification does not demonstrate that this method (or any method) produces a pea protein or a food product comprising a pea protein as recited in the present claims. For this reason, the limitation requiring obtaining soluble pea protein without chemical hydrolysis constitutes new matter.
Claims 15-18 and 21-22 are rejected by reason of dependency from claims 13 or 14.
Claim Rejections - 35 USC § 103
Claims 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Lis (US 2016/0295897; previously cited).
Regarding claim 13, Lis teaches a food product comprising a pea protein product [0014], wherein 20-99 dwt.% of the pea protein is soluble at room temperature (corresponding to water at 20° C±2°C) and at a pH of 7.4-7.6 (corresponding to 7.5+/-0.1) [0068]-[0069]. This disclosed 20-99 dwt.% of soluble pea protein overlaps the claimed solubility. It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP §2144.05.I. Since a characteristic of the pea protein is solubility, the pea protein is inherently soluble as presently claimed. Furthermore, the pea protein of Lis is obtained from a pea protein isolate or concentrate [0076]; therefore, it is obtained without requiring enzymatic hydrolysis or chemical hydrolysis to achieve solubility as presently claimed.
Although Lis teaches a pea protein obtained without requiring enzymatic hydrolysis or chemical hydrolysis as presently claimed, it is noted that claim 13 is a product-by-process claim and “even though product-by-process claims are limited by and defined by the process, determination of patentability is based upon the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP §2113.I.
Regarding claim 14, Lis teaches a food product comprising a pea protein product [0014], the pea protein product comprising: at least about 50 wt.% pea protein [0016] and 15-50 wt.% carbohydrate based on the total weight of the product [0018]. These values fall within the claimed concentrations based on dry weight. It also teaches the pea protein to have a molecular weight distribution profile consisting of 1-8 dwt.% proteins of more than 100 kDa; 20-55 dwt.% proteins of more than 15 kDa and of at most 100 kDa; 15-30 dwt.% proteins of more than 5 kDa and of at most 15 kDa; and 25-55 dwt.% proteins of at most 5 kDa [0070]-[0074]. Therefore, Lis teaches that at least 60 dwt.% of the protein has a molecular weight less than about 100 kDa as presently claimed.
Lis also teaches that 20-99 dwt.% of the pea protein is soluble at room temperature (corresponding to water at 20° C±2°C) and at a pH of 7.4-7.6 (corresponding to 7.5+/-0.1) [0068]-[0069]. This disclosed 20-99 dwt.% of soluble pea protein overlaps the claimed solubility. The selection of a value within the overlapping range renders the claim obvious. MPEP §2144.05.I. Since a characteristic of the pea protein is solubility, the pea protein is inherently soluble as presently claimed. Furthermore, the pea protein of Lis is obtained from a pea protein isolate or concentrate [0076]; therefore, it is obtained without requiring enzymatic hydrolysis or chemical hydrolysis to achieve solubility as presently claimed.
Although Lis teaches a pea protein obtained without requiring enzymatic hydrolysis or chemical hydrolysis as presently claimed, it is noted that claim 14 is a product-by-process claim and “even though product-by-process claims are limited by and defined by the process, determination of patentability is based upon the product itself. MPEP §2113.I.
Regarding claim 15, Lis teaches the invention as described above in claim 13, including the food product is a non-dairy product (corresponding to a food product comprising at least 70 wt.% vegetable protein, 15-50 wt.% vegetable fiber, and 15-50 wt.% microalgal flour) [0016], [0018], [0020].
Regarding claim 16, Lis teaches the invention as described above in claim 14, including the food product is a non-dairy product (corresponding to a food product comprising at least 70 wt.% vegetable protein, 15-50 wt.% vegetable fiber, and 15-50 wt.% microalgal flour) [0016], [0018], [0020].
Regarding claim 17, Lis teaches the invention as described above in claim 14, including the pea protein stabilizes the food product [0166]. Although Lis does not disclose that the pea protein stabilizes a food product against at least one of the recited features in food products, Lis teaches the same pea protein as claimed and instantly disclosed. As such, the pea protein of Lis would necessarily have the claimed features in the claimed food products. It is noted that claim 17 is a recitation of an inherent characteristic wherein the pea protein of Lis is capable of comprising the claimed features in the food products. Regarding product claims, when the ingredient recited in the reference is substantially identical to that of the claims, claimed properties are presumed to be inherent. “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art' s function, does not render the old composition patentably new to the discoverer.” MPEP §2112.01.I.
Regarding claim 18, Lis teaches the invention as described above in claim 14, including the pea protein is added to the food product [0166]. Although Lis does not disclose that the pea protein product creates at least one of the recited features in food products, Lis teaches the same pea protein as claimed and instantly disclosed. As such, the pea protein of Lis would necessarily have the claimed features in the claimed food products. It is noted that claim 18 is a recitation of an inherent characteristic wherein the pea protein of Lis is capable of comprising the claimed features in the food products. Regarding product claims, when the ingredient recited in the reference is substantially identical to that of the claims, claimed properties are presumed to be inherent. MPEP §2112.01.I.
Claims 13 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Boursier (US 2011/0311599).
Regarding claim 13, Boursier teaches a food product (corresponding to granulated powder) containing a pea protein [0037]-[0038], [0061], wherein 20-99 wt.% of the pea protein is soluble at room temperature (corresponding to water at 20°C±2) and at pH 7.4-7.6 (corresponding to 7.5+/-0.1) [0073]-[0075], [0078]. This disclosed 20-99 dwt.% of soluble pea protein overlaps the claimed solubility. It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP §2144.05.I. Since a characteristic of the pea protein is solubility, the pea protein is inherently soluble as presently claimed. Furthermore, the pea protein of Boursier may be obtained from a pea protein isolate or concentrate [0086]; therefore, the pea protein may be obtained without requiring enzymatic hydrolysis or chemical hydrolysis to achieve solubility as presently claimed.
Although Boursier teaches a pea protein obtained without requiring enzymatic hydrolysis or chemical hydrolysis as presently claimed, it is noted that claim 13 is a product-by-process claim and “even though product-by-process claims are limited by and defined by the process, determination of patentability is based upon the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP §2113.I.
Regarding claims 21 and 22, Boursier teaches the invention as described above in claim 13, including the food product may be used as a substitute for animal proteins [0207]; and discloses eggs and egg whites as being animal proteins [003], [0008]. Therefore, Boursier renders the food product being a substitute for eggs and eggs whites as recited in present claims 21 and 22 obvious.
Response to Arguments
Claim Rejections – 35 U.S.C. §112(b) of claims 15-16: Applicant amended the claims to fully address the rejections. Therefore, the rejections are withdrawn.
Claim Rejections – 35 U.S.C. §102(a)(1) of claims 13 and 15 over Dhalleine: Applicant’s arguments with respect to claim(s) 13 and 15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections – 35 U.S.C. §103 of claims 13-18 over Lis: Applicant’s amendments and arguments have been fully considered and are not considered to overcome the prior art rejections.
Applicant amended claims 13 and 14 to recite that the pea protein is obtained without enzymatic hydrolysis or chemical hydrolysis. Applicant argued that Lis does not disclose or suggest (A) a pea protein having at least about 90% solubility at room temperature across the full pH range of about 3-10; or (B) a protein obtained without chemical or enzymatic hydrolysis. Applicant argued that the Examiner’s reliance on overlapping ranges does not establish obviousness of the claimed solubility range as the present specification demonstrates that achieving the claimed solubility is not a routine variation, but allows for the claimed soluble pea protein to exhibit substantially improved dispersion and stability in food applications when compared to the dispersion and stability of insoluble proteins. Applicant argued that the present specification also shows that the claimed solubility enables higher solids processing with improved flowability and reduced water requirements so that the claimed solubility range is critical and produces unexpected results which rebut any prima facie case of obvious (Applicant’s Remarks, page 6, 1st paragraph – page 7, 1st paragraph).
However, in response to Applicant’s assertion that Lis does not disclose or suggest (A) a pea protein having at least about 90% solubility at room temperature across the full pH range of about 3-10, under the broadest reasonable interpretation of the present claims, the present claims do not require the pea protein to have the claimed solubility across the entire pH range of about 3-10, especially wherein Applicant has not stated such an interpretation in any previous argument against the prior art. The claims merely require the pea protein to have at least 90% solubility at room temperature at any single or multiple pH values within the range of “about 3-10”. Therefore, Applicant’s argument regarding the absence of such a feature in Lis is unpersuasive.
In response to Applicant’s assertion that Lis does not disclose a protein obtained without chemical or enzymatic hydrolysis, Lis discloses that the pea protein may be a pea protein isolate or concentrate [0076]; and states that in “another embodiment of the present invention”, the pea protein may be a pea protein hydrolysate obtained by enzymatic hydrolysis or chemical hydrolysis [0079]. Therefore, Lis discloses that in some embodiments, the pea protein may be a pea protein isolate or pea protein concentrate that is not hydrolyzed by enzymatic hydrolysis or chemical hydrolysis as recited in amended claims 13 and 14. Therefore, Applicant’s argument regarding the absence of such a feature in Lis is unpersuasive.
In response to Applicant’s assertion that the Examiner’s reliance on overlapping ranges does not establish obviousness of the claimed solubility range as the present specification demonstrates that achieving the claimed solubility is not a routine variation, but allows for the claimed soluble pea protein to exhibit substantially improved dispersion, stability, flowability, and water requirements in food applications when compared to the dispersion, stability, flowability, and water requirements of insoluble proteins, it is noted that the features upon which applicant relies (i.e., the dispersion, stability, flowability, and water requirements of the claimed soluble pea protein) are not recited in the rejected claim(s). 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). Furthermore, the present specification does not: (A) demonstrate (i.e., provide working examples) a pea protein or a food product comprising a pea protein having the solubility features recited in the present claims; (B) demonstrate (i.e., provide working examples) a method of making a pea protein or a food product comprising a pea protein having the solubility features recited in the present claims wherein the pea protein was produced without enzymatic hydrolysis or chemical hydrolysis; or (C) provide a comparison between the dispersion, stability, flowability, and water requirements of the claimed soluble pea protein to the dispersion, stability, flowability, and water requirements of insoluble pea protein. For at least these reasons, Applicant has not demonstrated unexpected results of a pea protein having the claimed solubility and Applicant’s arguments regarding unexpected results are unpersuasive.
Applicant then argued that the Examiner’s reliance on the product-by-process doctrine is misplaced as the doctrine only applies where the prior art discloses a product that is identical or indistinguishable from the claimed product; and the claimed pea protein is structurally and compositionally distinct from prior art hydrolysates. Applicant pointed to the present specification to demonstrate that the claimed protein has a distinct molecular weight distribution and structural form which is not disclosed by the prior art (Applicant’s Remarks, page 7, 2nd paragraph).
However, claim 13 does not recite any structural or compositional feature for the pea protein; and claim 14 merely requires the structure of at least about 60 wt.% of the protein in the food product to have a molecular weight of less than 100 kDa. Hydrolysates may have a molecular weight of less than 100 kDa. Therefore, the present claims do not require any structure or composition that is not achieved by protein hydrolysates. As such, the Examiner’s reliance on the product-by-process doctrine is not misplaced and Applicant’s arguments regarding such are unpersuasive. Furthermore, the prior art is described as disclosing pea proteins that are not obtained by chemical or enzymatic hydrolysates in the rejections of amended claims 13 and 14 above.
Applicant then argued that the Examiner has not articulated sufficient rationale to modify the prior art to arrive at the claimed invention as Lis does not suggest isolating a naturally-occurring soluble protein fraction having the claimed solubility so that the rejection relies on hindsight (Applicant’s Remarks, page 7, 3rd paragraph – page 8, 1st paragraph).
However, it is noted that the features upon which applicant relies (i.e., isolation of naturally-occurring soluble pea proteins) are not recited in the rejected claim(s). 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).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Since the prior art has been shown to render the present claims obvious and Applicant’s arguments have been shown to be unpersuasive, the rejections of claims 13-18 are maintained as written herein.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kelly Kershaw whose telephone number is (571)272-2847. The examiner can normally be reached Monday - Thursday 9:00 am - 4:00 pm.
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/KELLY P KERSHAW/Examiner, Art Unit 1791
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