DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt of the Request for Continued Examination (RCE under 37 CFR 1.114) and the Response and Amendment filed 25 November 2025 is acknowledged.
Applicant has overcome the following by virtue of amendment of the claims: (1) the objection to claim 33 has been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 29, 33-35, and 37-38
Withdrawn claims: None
Previously canceled claims: 1-28, 30-32 and 36
Newly canceled claims: None
Amended claims: 29 and 33
New claims: None
Claims currently under consideration: 29, 33-35, and 37-38
Currently rejected claims: 29, 33-35, and 37-38
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 25 November 2025 has been entered.
Claim Rejections - 35 USC § 101
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 29, 33-35, and 37-38 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (i.e., product of nature) without significantly more.
The claims recite a protein isolate comprising at least 70%, up to and including 100%, of a native rapeseed protein. The broadest reasonable interpretation of the claim, at best, is directed to a purified native rapeseed protein. The naturally occurring counterpart is the native rapeseed protein itself. The present case is analogous to the DNA example described in MPEP § 2106.04(c)(II)(A), which provides, “Although the selected counterpart should be in its natural state, examiners should take care not to confuse the counterpart with other material that may occur naturally with, or adjacent to, the counterpart. For example, assume that applicant claims a nucleic acid having a nucleotide sequence derived from naturally occurring gene B. Although gene B occurs in nature as part of a chromosome, the closest natural counterpart for the claimed nucleic acid is gene B, and not the whole chromosome. See, e.g., Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591-94, 106 USPQ2d 1972, 1979-81 (2013) (comparing isolated BRCA1 genes and BRCA1 cDNA molecules to naturally occurring BRCA1 gene)”.
Since the protein isolate as claimed may be 100% the native rapeseed protein and 0% of the other claimed elements, the product lacks any markedly different characteristics from the naturally occurring counterpart. Markedly different characteristics can be pharmaceutical functions or activities, chemical properties, functional characteristics, or the like. See MPEP § 2106.04(c)(II)(B). Isolation of a natural rapeseed protein without specifically claiming a feature that distinguishes the isolated product from its naturally occurring counterpart is insufficient for subject matter eligibility. This judicial exception is not integrated into a practical application because the claims do not require additional elements beyond the native rapeseed protein. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the specifically claimed components of the composition are all naturally occurring, and none need be present apart from the native rapeseed protein. The claimed features of nitrogen solubility, Emulsion Activity Index, and amino acid composition are properties of the protein, and as claimed do not appear to contribute to a change in form or functionality of the protein isolate that would amount to significantly more than the judicial exception. Thus, the claims do not qualify as eligible subject matter and are rejected under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 29, 33-35, and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Wnukowski et al. (WO 2013/013949 A1, cited on the IDS filed on 9 November 2022) in view of Murray (US Patent No. 5,844,086).
Regarding claim 29, Wnukowski teaches a protein isolate comprising at least 70 wt% of a native rapeseed protein based on dry matter (p. 3, lines 8-18), less than 1 wt% carbohydrates (see below), less than 0.2 wt% phenolic compounds (p. 3, lines 23-28), and no organic solvents or mineral solvents having 6 or more carbon atoms (p. 3, lines 7-8). The water-soluble organic solvent is methanol, ethanol, or acetone, all of which have less than 6 carbon atoms. The protein is isolated from oil seed meal (p. 2, lines 15-20), and as such is isolated from cellular components in which it is stored within rapeseeds.
It is noted that the limitation “wherein the native rapeseed protein is isolated from cellular components in which it is stored within rapeseeds” is a product-by-process limitation. “[E]ven 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. 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). See MPEP § 2113.
Regarding the amount of carbohydrates in the protein isolate, Wnukowski discloses that by using ultrafiltration for diafiltration, most of the soluble carbohydrates (and polyphenolic compounds) can be removed (p. 10, lines 6-9). Although not explicitly disclosed in Wnukowski, as evidenced by the instant specification in a comparative study with the claimed invention, the carbohydrate content of a rapeseed protein isolate produced by the method of Wnukowski is 0.14 wt% dry weight (p. 27, Table 13, Protein Isolate 1). The amount of carbohydrate in a protein isolate produced by the method of Wnukowski is seen as an inherent property resulting from the method. See MPEP § 2112.01(I), which states, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” Therefore, the method of Wnukowski necessarily results in a protein isolate with less than 1% carbohydrates, as claimed.
Wnukowski does not teach that the protein isolate comprises less than 1 wt% of fats, oils, and lipids, based on dry matter.
However, Murray teaches an aqueous extraction method of isolating protein from canola (i.e., rapeseed) meal and reducing the fat content of the isolate via chilling the extract solution and subsequently pumping the fat off of the surface of the proteinaceous solution (col. 5, lines 21-44). The resulting protein isolate has a fat level of 0.93% after spray drying (col. 5, lines 45-55).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to improve the method of Wnukowski by adding steps of chilling and pumping off the fat to produce protein isolate with minimal fat content. In some embodiments, the rapeseed protein isolate of Wnukowski comprises 6-14% dry weight of fat, depending on extraction temperature (pp. 17-19, Tables 3-5, Washed concentrate after EIP and drying). As disclosed by Murray, it was known in the art before the effective filing date of the claimed invention that the presence of fat in a dry protein product can lead to rancidity and other problems, such as poor solubility and caking (col. 1, lines 26-30). Therefore, one of ordinary skill in the art would have been motivated to consult Murry to identify a method of substantially reducing the amount of residual fat in a final protein isolate to improve shelf stability and functional properties of the protein isolate. One of ordinary skill in the art would have had a reasonable expectation of success for doing so because Murray teaches that the final protein isolate obtained by their method contains 0.93% fat after spray drying (col. 5, lines 45-55).
Therefore, claim 29 is rendered obvious.
Regarding claim 33, Wnukowski teaches the protein isolate according to claim 29, further comprising at least 95 wt% of the native rapeseed protein based on dry matter (p. 3, lines 15-18). Claim 33 is therefore rendered obvious.
Regarding claim 34, Wnukowski teaches the protein isolate according to claim 29, further comprising nitrogen solubility (NS) of more than 75% (p. 4, lines 10-12). Claim 34 is therefore rendered obvious.
Regarding claim 35, Wnukowski teaches the protein isolate of claim 29 comprising an emulsion forming capacity expressed as Emulsion Activity Index (EAI) of more than 20 m2/g. Although not explicitly disclosed in Wnukowski, the EAI is seen as an inherent property of the protein isolate disclosed by Wnukowski. As evidenced by the instant specification in a comparative study with the claimed invention, the EAI of a rapeseed protein isolate produced by the method of Wnukowski is 26.60 m2/g (p. 27, Table 13, Protein Isolate 1). See MPEP § 2112.01(I), which states, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” Therefore, the method of Wnukowski necessarily results in a protein isolate with an EAI of more than 20 m2/g, as claimed.
Regarding claim 37, Wnukowski teaches that the main protein component of the native rapeseed protein is a globulin corresponding to the subunit of native cruciferin protein – “The precipitate mainly comprises 2S protein (napins/albumins) and 12S protein (cruciferins/globulins), when originating from rapeseed” (p. 10, lines 27-28). “In case of rapeseed, the protein isolate or protein composition of the invention will preferably have 2S protein and 12S protein present in a ratio of 1:6 to 6:1…” (p. 4, lines 19-21). 12S protein is cruciferin (p. 10, lines 27-28). Therefore, Wnukowski discloses a native rapeseed protein isolate, wherein the main protein component is cruciferin, as claimed.
Regarding claim 38, Wnukowski teaches the protein isolate of claim 37, wherein glutamic acid and glutamine constitute together more than 20% of total amino acid composition of the protein isolate. Although a value for the glutamic acid + glutamine content is not explicitly disclosed by Wnukowski, the amino acid composition is seen as an inherent property of the rapeseed protein isolate. Wnukowski teaches a rapeseed protein isolate comprising mainly cruciferin as described regarding claim 37 above, and as evidenced by the instant specification, the glutamic acid + glutamine content of a rapeseed protein isolate comprising primarily cruciferin is 22.76% (p. 21, Table 5). See MPEP § 2112.01(I), which states, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” Therefore, the method of Wnukowski necessarily results in a protein isolate wherein glutamic acid and glutamine constitute together more than 20% of total amino acid composition of the protein isolate, as claimed.
Response to Arguments
Claim Objections:
Applicant has overcome the objection to the claim 33 by amendment. Accordingly, the objection has been withdrawn.
Claim Rejections – 35 U.S.C. § 101: Applicant’s arguments filed on 25 November 2025 have been fully considered, but they are not persuasive.
Applicant argued that where amended claim 29 clarifies that it concerns a man-made protein isolate of a native rapeseed protein “wherein the native rapeseed protein is isolated from cellular components in which it is stored within rapeseeds”, the man-made product that has been removed from its natural environment by an industrial process is very different from a product that exists in nature (p. 4, ¶¶ 6-7). Applicant asserted that a naturally existing native rapeseed protein occurs in nature inside rapeseeds in a form tightly associated with (sub)cellular structures a spart of a matrix containing bitter phenolic compounds, sugar compounds, and significant amounts of fat (p. 4, ¶ 8). Applicant argued that rapeseed protein in its native form isolated from the cellular matrix and concentrated to at least 70% based on dry matter in a substance containing less than 1 wt% of fats, oils, and lipids, based on dry matter and free of compounds such as hexane does not exist in nature, and therefore, cannot be considered as a product of nature because human industrial intervention was necessary to remove this native rapeseed protein at such high concentrations from the cellular components surrounding it and from the matrix to which this protein was bound and bring to the world in a form of a man-made isolate with less than 1 wt% of fats, oils and lipids, based on dry matter, and less than 1 wt% carbohydrates, less than 0.2 wt% phenolic compounds (and no organic solvents or mineral solvents having 6 or more carbon atoms) (p. 5, ¶ 3).
Applicant’s arguments have been carefully considered, but they are not found to be persuasive because the naturally occurring counterpart of the product of claim 29 is a native rapeseed protein. Applicant’s amendment of claim 29 to specify that “the native rapeseed protein is isolated from cellular components in which it is stored within rapeseeds” does not overcome the rejection because it does not differentiate the claimed product from the naturally occurring counterpart. The broadest reasonable interpretation of the claim is directed to a purified native rapeseed protein as claim 29 provides for an embodiment wherein the protein isolate comprises 100 wt% of a native rapeseed protein and 0 wt% of carbohydrates, phenolic compounds, organic solvents, and fats/oils/lipids. Such a protein does exist in nature, even if surrounded by other molecules and (sub)cellular components. That the protein is native indicates that it is in its naturally occurring form, possessing any native functionality, and since only the native protein is required by the claim, the product does not possess any markedly different characteristics from the naturally occurring counterpart. Markedly different characteristics can be pharmaceutical functions or activities, chemical properties, functional characteristics, or the like. See MPEP § 2106.04(c)(II)(B). Isolation of a natural rapeseed protein without specifically claiming a feature that distinguishes the isolated product from its naturally occurring counterpart is insufficient for subject matter eligibility. Applicant is directed to a similar case presented in MPEP § 2106.04(c)(II)(C)(2), which discusses that in Myriad, the BRCA1 and BRCA2 genes isolated from the rest of the chromosome on which they exist in nature were not markedly different from their naturally occurring counterparts (the BRCA genes), and thus were product of nature exceptions. In the present case, the isolated native rapeseed protein is analogous to the isolated BRCA1 and BRCA2 genes. In both cases, human industrial intervention is necessary to purify the product, yet such intervention does not render the products markedly different from their naturally occurring counterparts.
It is noted that Applicant’s arguments regarding the claimed composition having not been known or derivable from the prior art before the filing date of the instant application (p. 5, ¶ 2) are moot because the fact that something may not exist in the prior art does not make it patentable subject matter under 35 U.S.C. § 101.
For at least these reasons, the rejection of claims 29, 33-35, and 37-38 under 35 U.S.C. § 101 is maintained.
Claim Rejections – 35 U.S.C. § 103: Applicant’s arguments filed on 25 November 2025 have been fully considered, but they are not persuasive.
Applicant first argued that the method of Wnukowski cannot reduce the amount of fat as specified in the isolate according to amended claim 29, and therefore, the claimed isolate is new compared to the isolate according to Wnukowski (p. 6, ¶ 2). Applicant has argued against Wnukowski individually.
Appliant’s argument has been considered, but it is not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The rejection of claim 29 is based on the combination of Wnukowski and Murray. Therefore, arguments against Wnukowski individually cannot be persuasive.
Applicant next argued that modification of Wnukowski to reduce the amount of fat would require the use of hexane, which would denature the isolated protein and result in a protein isolate not having the features described in claim 29 (p. 6, ¶ 3).
Applicant’s argument has been considered, but it is not persuasive. No proposed modification to use hexane to reduce the fat content of the protein isolate of Wnukowski was proposed in the rejection. The rejection modifies the method of Wnukowski with the chilling and fat removal step of Murray to reduce the amount of fat in the native protein isolate.
Applicant further argued that Murray does not repair the deficiencies of Wnukowski because it teaches a completely different methodology without the use of organic solvents of gradually decreasing polarity, which mild change allows to preserve the native properties of the presently claimed isolate. Applicant argued that Murray uses only salt solutions, and no use of ethanol or ethyl acetate is mentioned, nor does Murray suggest removing fats by a gradual exchange of solvents with a decrease in polarity to remove the fat and preserve the native properties of the rapeseed proteins. Applicant argued that Murray merely teaches chilling and filtration and does not provide an efficient solution to remove fats to arrive at the claimed native rapeseed protein isolate (p. 6, ¶¶ 4-5).
Applicant’s argument has been considered, but it is not persuasive. Applicant is reminded that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
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 method steps by which Applicant produces the claimed protein isolate) 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). Claim 29 is directed toward a protein isolate product. Wnukowski in view of Murray teaches the claimed product.
For these reasons, Applicant’s arguments are not found to be persuasive. Accordingly, the rejection of claims 29, 33-35, and 37-38 under 35 U.S.C. § 103 is maintained.
Conclusion
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/JAMES P. SHELLHAMMER/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793