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 Response and Amendment after Non-Final Office Action filed 19 July 2026 is acknowledged.
Applicant has overcome the following by virtue of amendment of the claims: (1) the 35 U.S.C. § 101 rejection has been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 29 and 37-38
Withdrawn claims: None
Previously canceled claims: 1-28, 30-32 and 36
Newly canceled claims: 33-35
Amended claims: 29 and 37
New claims: None
Claims currently under consideration: 29 and 37-38
Currently rejected claims: 29 and 37-38
Allowed claims: None
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 29 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schweizer et al. (US 2014/0066597 A1).
Regarding claim 29, Schweizer teaches a canola (i.e., rapeseed) protein isolate having a protein content of at least about 100 wt % (N.times.6.25) on a dry weight basis and having a canola protein profile which is about 40 to about 50 wt % of 2S canola protein, about 50 to about 60 wt % of 7S canola protein and about 1 to about 5 wt % of 12S canola protein (claim 41). The canola protein isolate having preferably at least about 100 wt % protein is substantially undenatured (i.e., native) ([0051]).
As such, where Schweizer teaches a native rapeseed protein isolate that is 100 wt % protein based on dry weight, there would be no carbohydrates, phenolic compounds, organic solvents or mineral solvents having 6 or more carbon atoms, fats, oils, or lipids in the composition. Schweizer therefore meets the claimed limitations of a protein isolate comprising at least 95 wt% of a native rapeseed protein based on dry matter, 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, wherein the protein isolate comprises less than 1 wt% of fats, oils and lipids, based on dry matter.
The limitation “wherein the protein isolate has a nitrogen solubility (NS) of more than 75% and an emulsion forming capacity expressed as an Emulsion Activity Index (EAI) of more than 20 m2/g” is toward properties of the claimed composition. MPEP § 2112.01(I) states, “When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. 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. ‘When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.’ In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).” Therefore, where the native rapeseed protein isolate of Schweizer has the same composition as the claimed native rapeseed protein isolate, the properties of a nitrogen solubility (NS) of more than 75% and an emulsion forming capacity expressed as an Emulsion Activity Index (EAI) of more than 20 m2/g are presumed to be inherent.
Claim 29 is therefore anticipated.
Claim 37 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schweizer et al. (US 2014/0066597 A1) as evidenced by Shi et al. (WO 2017/102535 A1).
Regarding claim 37, Schweizer teaches the protein isolate according to claim 29, wherein a main protein component of the native rapeseed protein is a globulin corresponding to the subunit of native cruciferin protein, said main protein component having an apparent molecular mass of 148 ± 10 kDa and corresponding to a 7S component on the Svedberg scale – Schweizer teaches that the protein isolate comprises about 50 to about 60 wt % of 7S canola protein (claim 41). As evidenced by Shi, “the cruciferin complex is present as a 300 kDa 12S hexamer…and reversibly dissociates into 7S trimeric molecules of 150 kDa when exposed to low ionic strength conditions.” (p. 5, lines 20 – 28).
Regarding the phrase, “as determined by size exclusion chromatography”, absent evidence of criticality regarding the presently claimed means of measuring the protein components, and given that the cited prior art meets the requirements of the protein isolate having a 7S component as a main component, Schweizer meets the requirements of claim 37.
Claim 37 is therefore anticipated.
Claim 38 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schweizer et al. (US 2014/0066597 A1) as evidenced by Shi et al. (WO 2017/102535 A1) as applied to claim 37 above and further evidenced by UniProtKB CRU1 (The UniProt Consortium. (n.d.). CRU1 entry P33525. UniProt Knowledgebase. Retrieved August 26, 2026, from https://www.uniprot.org/uniprotkb/P33525/entry) and UniProtKB Napin-1 (The UniProt Consortium. (n.d.). Napin-1 entry P01091. UniProt Knowledgebase. Retrieved August 26, 2026, from https://www.uniprot.org/uniprotkb/P01091/entry#structure).
Regarding claim 38, Schweizer teaches the protein isolate according to claim 37.
Schweizer also teaches that glutamic acid and glutamine constitute together more than 20% of a total amino acid composition of the protein isolate:
First, Schweizer teaches that the protein isolate comprises 100 wt% canola protein wherein about 40 to about 50 wt % of 2S canola protein, about 50 to about 60 wt % of 7S canola protein and about 1 to about 5 wt % of 12S canola protein. Schweizer further teaches that the 12S globulin is known as cruciferin and the 2S storage protein is known as napin ([0008]). As evidenced by Shi, “the cruciferin complex is present as a 300 kDa 12S hexamer…and reversibly dissociates into 7S trimeric molecules of 150 kDa when exposed to low ionic strength conditions.” (p. 5, lines 20 – 28). As such, it is known that the 12S cruciferin hexamer is made up of 7S cruciferin trimers. As evidenced by UniProtKB CRU1, the cruciferin sequence comprises 79 glutamine (Q) residues, and 21 glutamic acid (E) residues, totaling to 100 of the 509 cruciferin residues (p. 4, Sequence). This equates to glutamic acid and glutamine together constituting 19.6% of the cruciferin residues. As evidenced by UniProtKB Napin-1, napin is a monomer (p. 3, Oligomeric State), and the napin sequence comprises 27 glutamine (Q) residues, and 8 glutamic acid (E) residues, totaling to 35 of the 133 cruciferin residues (p. 4, Sequence). This equates to glutamic acid and glutamine together constituting 26.3% of the napin residues.
The embodiment of Schweizer of a protein isolate comprising 100 wt% canola protein wherein 35 wt % of 2S canola protein, 60 wt % of 7S canola protein and 5 wt % of 12S canola protein represents the embodiment comprising the maximum disclosed amount of crucifierin (having a lower total glutamic acid + glutamine value than napin), and the minimum amount of napin (having the higher glutamic acid + glutamine value) to total to 100 wt % protein. The total glutamic acid + glutamine (E+Q) in this embodiment is calculated and shown in the table below.
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200
400
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Greyscale
The percent E+Q is weighted based on the number of subunits in each of the 2S, 7S, and 12S proteins and the percentage of each the 2S, 7S, and 12S proteins in the protein isolate. For example, 7S cruciferin trimer has 3 subunits and represents 60% of the protein isolate, providing 180 cruciferin subunits per 100 proteins (2S+7S+12S) of the protein isolate. Each cruciferin subunit has 19.6% E+Q, resulting in a total contribution of 14.4% E+Q from 7S cruciferin proteins. Repeating the process for 2S and 12S proteins and adding the resulting weighted E+Q percentages results in 20.6% E+Q in the protein isolate. Therefore, even in the embodiment disclosed by Schweizer with the minimum amount of glutamic acid and glutamine, glutamic acid and glutamine together constitute more than 20% of the total amino acid composition of the protein isolate, as claimed. Any of the other disclosed embodiments would have a higher content of glutamic acid and glutamine together.
Claim 38 is therefore anticipated.
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.
Claim 29 is 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 95 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.
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. ‘When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.’ In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).” Therefore, the method of Wnukowski necessarily results in a protein isolate with less than 1% carbohydrates, as claimed.
wherein the protein isolate has a nitrogen solubility (NS) of more than 75% (p. 4, lines 10-12).
and 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. ‘When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.’ In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).” Therefore, the method of Wnukowski necessarily results in a protein isolate with an EAI of more than 20 m2/g, 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.
Response to Arguments
As a preliminary matter, it is noted that Applicant cites the instant specification by paragraph number (e.g., p. 3, last ¶, p. 4, ¶ 1, p. 6, ¶ 1). However, the instantly filed specification does not use paragraph numbers, and instead uses line numbers. Additionally, the paragraph numbers of the US Pre-grant Publication (US 2023/0138142 A1) corresponding to the instant application do not correspond to Applicant’s citations. It is therefore unclear what document Applicant is referencing.
Claim Rejections – 35 U.S.C. § 101:
Upon consideration of Applicant’s amendments to independent claim 29 to include the features that the protein isolate has a nitrogen solubility (NS) of more than 75% and an emulsion forming capacity expressed as an Emulsion Activity Index (EAI) of more than 20 m2/g, it is determined that the claimed protein isolate possesses markedly different characteristics than the natural counterpart. It is considered that the extracted and purified protein would not function the same as in nature, i.e., as a storage protein, and that the natural counterpart protein in the seed would not necessarily have the claimed NS and EAI within the seed.
As such, the rejection of claims 29 and 37-38 under 35 U.S.C. § 101 has been withdrawn.
Applicant’s arguments with respect to claim 37 (p. 4, ¶ 3 – p. 5, ¶ 3) are therefore moot.
Claim Rejections – 35 U.S.C. § 103: Applicant’s arguments filed on 19 July 2026 have been fully considered, but they are not persuasive.
Applicant first argued that the proposed modification of Wnukowski in view of Murray would not yield the claimed product: an isolate having, simultaneously, less than 1wt% fat and less than 0.2 wt% phenolic compounds, at a protein content of at least 95 wt%, while presenting the recited functional profile (p. 5, ¶ 4). Applicant argued that the combination cannot achieve less than 1wt% fat and less than 0.2 wt% phenolic compounds at the same time because Wnukowski removes protein-associated phenolic compounds by its ethanol-induced precipitation, wherein residual lipid co-precipitates with, and remains associated with, the proteins solid (pp. 5-6, bridging ¶). Applicant argued that Murray’s fat removal acts on free fat present in the aqueous phase, and applying Murray’s chilling step before Wnukowski’s ethanol-induced precipitation removes additional free fat from the aqueous phase, but it does not remove the protein-associated fat that co-precipitates with the protein during precipitation; applying Murray’s step after precipitation is unavailing because the residual fat is then within the protein solid rather than a free aqueous layer that can be skimmed (p. 6, ¶ 2). Applicant argued that where Wnukowski already separates a fatty layer by centrifugation at 10°C and yet obtains isolates containing 2 to 15 wt% lipid illustrates that aqueous fat separation within an ethanol-precipitation process leaves substantial protein-associated fat in the final isolate (Id.). Applicant asserted that the alternative is to adopt Murray’s dilution induced micellization, thereby abandoning Wnukowski’s ethanol-induced precipitation and the mechanism by which Wnukowski removes protein-bound phenolic compounds to below 0.2 wt% (p. 6, ¶ 3). Applicant further argued that for the same reasons, there is no reasonable expectation of success in arriving at the claimed subject matter (pp. 6-7, bridging ¶).
Applicant’s arguments have been considered, but they are not persuasive. Applicant’s arguments are premised on the unsupported assertion that there is substantial fat bound to the proteins. Applicant has not provided any evidence of “protein-associated fat” that is not removed by chilling and skimming.
“Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). Examples of statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor.” See MPEP § 716.01(c)(II).
In the present case, Applicant’s assertion of inoperability of the prior art is based on argument, and not on objective evidence. “Argument does not replace evidence where evidence is necessary”. MPEP § 2145(I). Objective evidence of unexpected results must be submitted in an appropriate affidavit or declaration. MPEP § 716.01(c) §§ (I)&(II). Therefore, Applicant’s arguments cannot be found persuasive. It remains that merely applying the fat removal step of Murray prior to the ethanol-induced precipitation step of Wnukowski would have been obvious to one of ordinary skill in the art, and given that Murray discloses a rapeseed protein isolate comprising 0.93% fat, one of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention.
Applicant’s arguments with respect to claims 37 and 38 (p. 7, ¶ 2) 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.
Claims 29 and 37-38 are rejected as presented hereinabove.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/JAMES P. SHELLHAMMER/Examiner, Art Unit 1793
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759
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