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 .
This office action is in response to the application filed on June 7, 2024. The earliest effective filing date of the application is December 10, 2021.
Priority
The present application is a 371 National Stage Application of PCT/EP2022/085120 which has a filing date of December 9, 2022.
Election/Restrictions
Claims 12 – 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 31, 2025.
Applicant’s election of Group I, claims 1 – 11, in the reply filed on October 31, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Status of Application
The Response to the Restriction Requirement has been entered. The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1 – 31
Withdrawn claims: 12 – 31
Amended claims: 3 – 13, 15 – 19, 21 – 31
Claims currently under examination: 1 – 11
Claim Interpretation
Claim 1 recites “A protein preparation, produced from linseed” which has a broadest reasonable interpretation of “any composition comprising linseed protein, regardless of its original source.” While a linseed protein may be prepared by a certain method, or obtained from a certain source, in product claims, the protein itself it considered, regardless of how it is made or where it is from. See MPEP § 2113.I. There is no material difference between, for example, a linseed protein generated in a host plant as a heterologous plant protein and the same protein that may be naturally present in linseed.
Claim 1 recites “determined by the Soxhlet method using hexane as solvent” which is a recitation of how a property of the composition of claim 1 is measured. In this case, the recited method is used to determine the oil content by mass on a dry basis of the protein preparation. The recited method is not a limitation in this case.
Claim 1 recites “determined according to CIE-L*a*b* colour measurement at a d90 particle size of the protein preparation below 250 µm or after grinding the protein preparation to a d90 particle size below 250 µm” which is a recitation of how a property of the composition of claim 1 is measured. In this case, the recited method is used to determine the color of the protein preparation when it is within a given range of particle sizes. The particle size of the protein preparation itself is not claimed. For example, large protein chunks that satisfy the protein, oil, and cyanogenic glycoside content limitations of claim 1 may, when ground to 250 µm, have the lightness claimed, however the protein composition has a particle size of far greater than 250 µm. The chunks would still be encompassed by claim 1 when examining the claim with the broadest reasonable interpretation. This limitation is interpreted to encompass “any protein composition that when ground to below 250 µm has the recited L* value, regardless of the particle size of the protein composition itself”.
Claim 6 recites “determined according to the EC determination method specified in the description” which is a recitation of how a property of the composition of claim 6 is measured. In this case, the recited method is used to determine the emulsifying capacity of the protein preparation. The recited method is not a limitation in this case.
Claim Objections
Claims 1, 6, and 11 are objected to because of the following informalities:
Claim 1 recites “with a” in line 1, which is interpreted to be an unconventional recitation of a transitional phrase. For the purpose of examination, the broadest reasonable interpretation of “with a” is “comprising”. To avoid misinterpretation of the breadth of the claim, replace “with a” with “comprising” or the intended conventional transitional phrase.
Claim 1 recites “the protein preparation has” in line 5, which is interpreted to be an unconventional recitation of a transitional phrase. For the purpose of examination, the broadest reasonable interpretation of “has” is “comprises”. To avoid misinterpretation of the breadth of the claim, replace “has” with “comprises” or the intended conventional transitional phrase.
Claim 6 recites “the emulsifying capacity […] is more than 250 ml/g” which should be rewritten as “the emulsifying capacity […] is more than 250 ml oil/g protein preparation” to avoid misinterpretation of what units and proportions are encompassed by the emulsifying capacity of the protein preparation.
Claim 11 recites “to which […] have also been added” which is interpreted to be an unconventional recitation of a transitional phrase. For the purpose of examination, the broadest reasonable interpretation of “to which […] have also been added” is “ further comprising”. To avoid misinterpretation of the breadth of the claim, replace “to which […] have also been added” with “ further comprising” or the intended conventional transitional phrase. Example: “The protein preparation of claim 1, further comprising legume proteins selected from the group consisting of pea, lentil, bean, field bean, peanut, and soy.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 – 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2 – 11 recite a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the instant case:
Claim 2 recites the broad recitation “a brightness L* of greater than 80”, and the claim also recites “preferably greater than 85, particularly preferably greater than 90” which are narrower statements of the range/limitation.
Claim 3 recites the broad recitation “a cyanogenic glycoside content, expressed as HCN per kg of preparation, of less than 100 mg/kg”, and the claim also recites “preferably less than 50 mg/kg, particularly advantageously less than 30 mg/kg” which are narrower statements of the range/limitation.
Claim 4 recites the broad recitation “the protein content is more than 38% by mass”, and the claim also recites “preferably more than 40% by mass, particularly preferably more than 45% by mass” which are narrower statements of the range/limitation.
Claim 5 recites the broad recitation “the oil content is less than 4% by mass”, and the claim also recites “preferably less than 3% by mass, particularly preferably less than 2% by mass” which are narrower statements of the range/limitation.
Claim 6 recites the broad recitation “the emulsifying capacity […] is more than 250 ml/g”, and the claim also recites “preferably more than 300 ml/g, particularly preferably more than 400 ml/g or more than 500 ml/g” which are narrower statements of the range/limitation.
Claim 7 recites the broad recitation “a protein solubility in water at pH 7 of more than 10%,”, and the claim also recites “preferably more than 20% or more than 30%, particularly preferably more than 40% or more than 45%” which are narrower statements of the range/limitation.
Claim 8 recites the broad recitation “a proportion of alcohol […] of > 0.001% by mass,”, and the claim also recites “preferably > 0.01% by mass, particularly preferably > 0.1% by mass or > 0.4% by mass” which are narrower statements of the range/limitation.
Claim 8 recites the broad recitation “a proportion of alcohol”, and the claim also recites “in particular ethanol” which is the narrower statement of the range/limitation.
Claim 9 recites the broad recitation “a hexane content of > 0.0005% by mass,”, and the claim also recites “preferably > 0.001% by mass,” which is the narrower statement of the range/limitation.
Claim 10 recites the broad recitation "a d90 particle size of less than 500 µm”, and the claim also recites “preferably less than 250 µm, advantageously less than 150 µm, particularly preferably less than 100 µm” which are narrower statements of the range/limitation.
Claim 11 recites the broad recitation “legume proteins from the group of pea, lentil, bean, field bean, peanut or soya,” and the claim also recites “preferably only from the group of pea and soya, particularly preferably only from pea,” which are narrower statements of the range/limitation.
The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purpose of examination, the broadest range recited in each claim is considered.
Claim 6 recites the limitation "the emulsifying capacity" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, “the emulsifying capacity” is interpreted to be “the emulsifying capacity of the protein preparation”.
Claim 11 uses improper Markush language to link group members. The group should be introduced by “selected from the group consisting of”. The list should link all group members by “and”. For example, the Markush language of claim 11 should be written as “legume proteins selected from the group consisting of pea, lentil, bean, field bean, peanut, and soya.”
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1 – 5, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lan et al. (Physicochemical properties and aroma profiles of flaxseed proteins extracted from whole flaxseed and flaxseed meal. Food Hydrocolloids. Vol 104. (2020)), as evidenced by Waszkowiak et al. (Effect of Extraction Method on the Phenolic and Cyanogenic Glucoside Profile of Flaxseed Extracts and their Antioxidant Capacity. J Am Oil Chem Soc. Vol 92. Pp. 1609 – 1619. (2015)) and Guang et al. (Preparation of flaxseed protein isolate and study on its main anti-nutritional factors. Journal of Food Safety and Quality Testing. Vol 9, Iss 6. Pp. 1440 – 1444 (2018) – Google Machine Translation).
Regarding claims 1 – 5, Lan teaches a flax (i.e., linseed) protein isolate (i.e., protein composition) comprising 91.7 ± 3.06 wt% protein, and 1.56 ± 0.18 wt% lipid (i.e., oil) on a wet basis (p. 5, Table 1, FPI). On a dry basis, the flax (i.e., linseed) protein isolate (i.e., protein composition) comprises 94.6 ± 2.82 wt% protein, and 1.61 ± 0.02 wt% lipid (i.e., oil). Lan teaches the flax (i.e., linseed) protein isolate has an L* of 82.11 ± 0.13 (p. 5, Table 1, FPI).
While Lan is silent with respect to the particle size at which the L* of the flax (i.e., linseed) protein isolate (i.e., protein composition) was measured, the instant specification states high temperature processing typically used to remove cyanogenic glycosides results in dark color (p. 2, paragraph 3). The instant specification teaches it is advantageous to keep temperatures below 80 °C to avoid significant color changes (p. 8, paragraph 2). Lan teaches the flax (i.e., linseed) protein isolate (i.e., protein composition) is produced by a method that reaches a maximum temperature of 45 °C (p. 2, paragraph 5 – 6, p. 3, paragraph 1 – 2). Therefore, because the flax (i.e., linseed) protein isolate (i.e., protein composition) of Lan is produced by a low-temperature method (i.e., a maximum temperature of 45 °C), it avoids the discoloration due to heat. In addition to the reported L* of 82.11 ± 0.13, the low-temperature processing further emphasizes the flax (i.e., linseed) protein isolate (i.e., protein composition) of Lan inherently has a brightness L* greater than 80, determined according to CIE-L*a*b* colorimetry with a d90 particle size of the protein preparation smaller than 250 µm or after grinding the protein preparation to a d90 particle size smaller than 250 µm. Furthermore, MPEP § 2112.I states “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer”. In this case, the fact that Lan is silent with respect to the particle size at which the L* of the flax (i.e., linseed) protein isolate (i.e., protein composition) was measured does not render novel the previously unappreciated lightness of the flax (i.e., linseed) protein isolate (i.e., protein composition) of Lan when ground to a d90 of below 250 µm.
With respect to the precisely claimed concentration of cyanogenic glycosides present in the protein composition, Lan teaches the flax (i.e., linseed) protein isolate (i.e., protein composition) is produced by a method known as alkaline extraction–isoelectric precipitation comprising the steps of:
(a) dispersing flaxseed flour in water (1:15, w/v) and adjusting the pH of the suspension to pH 8.5 using 1.0 N NaOH (i.e., performing an aqueous extraction); mechanically stirring at 1,000 rpm for 2 h at room temperature, then centrifuging the suspension at 8,000 rpm for 20 min at 4 C;
(b) repeating the extraction procedure on the residual solids, then pooling the supernatants of the two extractions;
(c) reducing the pH of the collected supernatant to its individual isoelectric point (IEP), then immediately centrifuging the suspension at 5,000 rpm for 5 min at 4 C to accelerate protein precipitation;
(d) re-dispersing the collected protein in ultrapure water and neutralizing to pH 7 using 1.0 N NaOH, then freeze-drying for 90h (p. 3, paragraph 2).
While Lan does not explicitly state the method above reduces the content of cyanogenic glycosides present in the protein composition to below 100mg/kg, expressed as HCN per kg of preparation, as evidenced by Waszkowiak, extraction method strongly affects cyanogenic glucoside content of flaxseed extracts; ethanolic extraction gives extracts rich in antioxidant lignans; aqueous extracts have lower antioxidant activity than ethanolic but cyanogenic glucosides are significantly reduced (p. 1609, Abstract). As evidenced by Waszkowiak, the cyanogenic glycoside content of flaxseed proteins extracted with water (i.e., an aqueous extraction at a pH of 7) comprise about 16 – 17 mg/kg, expressed as HCN per kg (p. 1617, Table 4). Furthermore, as evidenced by Guang, the extraction efficiency of an aqueous isoelectric extraction increases as the pH of the aqueous medium increases until a pH of 9.5 (p. 1441, 2.3 Experimental Methods; p. 1442, 3.1 Results of the single-factor experiment). At an extraction pH of 9.5, flaxseed protein isolate comprises 5 mg/kg, as expressed as HCN per kg (p. 1444, Table 3, Protein isolate). Therefore, because the flax (i.e., linseed) protein isolate (i.e., protein composition) was produced by an aqueous, isoelectric extraction wherein the aqueous medium was at a pH of 8.5, the resulting flax (i.e., linseed) protein isolate (i.e., protein composition) necessarily has a cyanogenic glycoside content, expressed as HCN per kg of preparation, of less than 100 mg/kg. Furthermore, MPEP § 2112.I states “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer”. In this case, the fact that Lan is silent with respect to the cyanogenic glycoside content of the flax (i.e., linseed) protein isolate (i.e., protein composition) does not render novel the previously unappreciated low cyanogenic glycoside content of the flax (i.e., linseed) protein isolate (i.e., protein composition) of Lan.
Regarding claim 7, Lan teaches the flax (i.e., linseed) protein isolate (i.e., protein composition) has about 90% solubility at a pH of 7 (p. 7, Fig. 3. (b)).
Claim 6 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lan et al. (Physicochemical properties and aroma profiles of flaxseed proteins extracted from whole flaxseed and flaxseed meal. Food Hydrocolloids. Vol 104. (2020)), as evidenced by Waszkowiak et al. (Effect of Extraction Method on the Phenolic and Cyanogenic Glucoside Profile of Flaxseed Extracts and their Antioxidant Capacity. J Am Oil Chem Soc. Vol 92. Pp. 1609 – 1619. (2015)) and Guang et al. (Preparation of flaxseed protein isolate and study on its main anti-nutritional factors. Journal of Food Safety and Quality Testing. Vol 9, Iss 6. Pp. 1440 – 1444 (2018) – Google Machine Translation), as applied to claim 1 above, and further evidenced by Karaca et al. (Emulsifying properties of canola and flaxseed protein isolates produced by isoelectric precipitation and salt extraction. Food Research International. Vol 44. Pp. 2991 – 2998. (2011)).
While Lan is silent with respect to the emulsifying capacity of the flax (i.e., linseed) protein isolate (i.e., protein composition), alkaline extraction–isoelectric precipitation produces a flax protein isolate that has an emulsification capacity of about 510 g oil/g protein, as evidenced by Karaca (p. 2996, Figure 3 (a), FPI (black bar)). Given the density of maize germ oil, the oil used to determine emulsifying capacity in the instant specification (p. 19, paragraph 2), is about 0.92 g/mL, the emulsifying capacity of a flax protein isolate produced by isoelectric precipitation (i.e., the emulsifying capacity of the flax (i.e., linseed) protein isolate (i.e., protein composition) is about 550 mL/g.
Claims 1 – 5, 8, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kankaanpaeae-Antila et al. (WO 9622027 A1 – IDS Filed on June 7, 2024) as evidenced by Waszkowiak et al. (Effect of Extraction Method on the Phenolic and Cyanogenic Glucoside Profile of Flaxseed Extracts and their Antioxidant Capacity. J Am Oil Chem Soc. Vol 92. Pp. 1609 – 1619. (2015)) and Guang et al. (Preparation of flaxseed protein isolate and study on its main anti-nutritional factors. Journal of Food Safety and Quality Testing. Vol 9, Iss 6. Pp. 1440 – 1444 (2018) – Google Machine Translation).
Regarding claims 1 – 5, Kankaanpaeae-Antila teaches a method for producing a flaxseed (i.e., linseed) protein meal (i.e., protein composition) comprising the steps of:
a. crushing flaxseeds (i.e., linseed) to remove oil (i.e., mechanically de-oiling) grinding;
b. extracting with water;
c. extracting twice with ethanol (i.e., one or more extracting steps); and
d. drying (p. 10, Example 1).
Kankaanpaeae-Antila teaches the resulting flaxseed (i.e., linseed) protein meal (i.e., protein composition) comprising 45 wt% protein on a dry basis (p. 11, paragraph 3).
While Kankaanpaeae-Antila does not explicitly state the resulting flaxseed (i.e., linseed) protein meal (i.e., protein composition) comprises less than 4% oil by mass, Kankaanpaeae-Antila teaches flaxseeds (i.e., linseed) comprise 38 wt% oil, and that during the crushing step, 30 wt% of the flaxseed (i.e., linseed) is removed as oil (p. 1, paragraph 2; p. 10, Example 1). Therefore in the pressed seed prior to solvent extraction, the crushed seeds comprise about 8 wt% oil. Kankaanpaeae-Antila teaches after ethanol extraction, most of the remaining oil is removed, therefore the flaxseed (i.e., linseed) protein meal (i.e., protein composition) comprises less than 4 wt% oil.
While Kankaanpaeae-Antila does not explicitly state the resulting flaxseed (i.e., linseed) protein meal (i.e., protein composition) has a brightness L* greater than 80, determined according to CIE-L*a*b* colorimetry with a d90 particle size of the protein preparation smaller than 250 µm or after grinding the protein preparation to a d90 particle size smaller than 250 µm, the instant specification states the method of instant claim 13 produces the product of claim 1 (p. 3, paragraph 5). Therefore, because the linseeds are crushed to remove oil (i.e., mechanically de-oiling), ground, extracted with water, then extracted twice with ethanol (i.e., one or more extracting steps), and dried, as in the method of claim 13 of the instant application, the flaxseed (i.e., linseed) protein meal (i.e., protein composition) of Kankaanpaeae-Antila inherently has a brightness L* greater than 80, determined according to CIE-L*a*b* colorimetry with a d90 particle size of the protein preparation smaller than 250 µm or after grinding the protein preparation to a d90 particle size smaller than 250 µm. MPEP § 2112.01.I 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. In this case, the flaxseed (i.e., linseed) protein meal (i.e., protein composition) of Kankaanpaeae-Antila and the protein preparation of claim 1 are produced by substantially identical processes, therefore they inherently have the same properties, including brightness L*. Furthermore, MPEP § 2112.I states “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer”. In this case, the fact that Kankaanpaeae-Antila is silent with respect to the L* of the flaxseed (i.e., linseed) protein meal (i.e., protein composition) when measured at a d90 particle size of smaller than 250 µm does not render novel the previously unappreciated precisely claimed L*.
With respect to the precisely claimed concentration of cyanogenic glycosides present in the protein composition, Kankaanpaeae-Antila teaches the water extraction is a method known in the art as alkaline extraction–isoelectric precipitation comprising the steps of:
(a) adding a 15 to 20-fold amount of hot, 60 to 65 °C water to pressed flax and adjusting the pH of the solution to the range of 9.5 to 10.0 with a dilute NaOH solution, then stirring the suspension at least for a half an hour, then centrifuging to remove insoluble fiber (p. 10, paragraph 3);
(b) if necessary, recycling the sediment fraction back to the alkaline suspension (p. 10, paragraph 3);
(c) adjusting the pH of the filtrate fraction from the centrifugation, which was, if necessary, concentrated, to the isoelectric point (pH 4.2 to 4.5) of proteins with dilute hydrochloric acid, then centrifuging the fine precipitate (p. 10, paragraph 4);
(d) evaporating the filtrate fraction from centrifugation to a dry matter content of at least 10 % (p. 10, paragraph 5);
While Kankaanpaeae-Antila does not explicitly state the method above reduces the content of cyanogenic glycosides present in the protein composition to below 100mg/kg, expressed as HCN per kg of preparation, as evidenced by Waszkowiak, extraction method strongly affects cyanogenic glucoside content of flaxseed extracts; ethanolic extraction gives extracts rich in antioxidant lignans; aqueous extracts have lower antioxidant activity than ethanolic but cyanogenic glucosides are significantly reduced (p. 1609, Abstract). As evidenced by Waszkowiak, the cyanogenic glycoside content of flaxseed proteins extracted with water (i.e., an aqueous extraction at a pH of 7) comprise about 16 – 17 mg/kg, expressed as HCN per kg (p. 1617, Table 4). Furthermore, as evidenced by Guang, the extraction efficiency of an aqueous isoelectric extraction increases as the pH of the aqueous medium increases until a pH of 9.5 (p. 1441, 2.3 Experimental Methods; p. 1442, 3.1 Results of the single-factor experiment). At an extraction pH of 9.5, flaxseed protein isolate comprises 5 mg/kg, as expressed as HCN per kg (p. 1444, Table 3, Protein isolate). Finally, Kankaanpaeae-Antila teaches the washing with ethanol after water extraction removes cyanogenic glycosides (p. 7, paragraph 3). Therefore, because the flaxseed (i.e., linseed) protein meal (i.e., protein composition) was produced by an aqueous, isoelectric extraction wherein the aqueous medium was at a pH of 9.5 – 10, the resulting flax (i.e., linseed) protein isolate (i.e., protein composition) necessarily has a cyanogenic glycoside content, expressed as HCN per kg of preparation, of less than 100 mg/kg. Furthermore, MPEP § 2112.I states “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer”. In this case, the fact that Kankaanpaeae-Antila is silent with respect to the cyanogenic glycoside content of the flaxseed (i.e., linseed) protein meal (i.e., protein composition) does not render novel the previously unappreciated low cyanogenic glycoside content of the flaxseed (i.e., linseed) protein meal (i.e., protein composition) of Kankaanpaeae-Antila.
Regarding claim 8, Kankaanpaeae-Antila teaches, after extraction, the separated solid matter is washed with ethanol, dissolving most of the remaining oil from pressing (p. 11, paragraph 2). Kankaanpaeae-Antila teaches the washing solution is then separated from the solid matter, and the washed solid matter is dried by air drying (p. 11, paragraph 2). Kankaanpaeae-Antila teaches washed solid matter may also be dried by freeze-drying (i.e., a vacuum drying process – p. 8, paragraph 1).
MPEP § 2131.02 states, a reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." According to the teachings of Kankaanpaeae-Antila described above, one of ordinary skill in the art would have at once envisaged drying the washed dry matter by freeze-drying (i.e., a vacuum drying process).
The instant specification states the method of instant claim 13 produces the product of claim 1, with advantageous embodiments found in the dependent claims (p. 3, paragraph 5). The instant specification notably states a preferred drying condition of the present invention is that the drying occurs at < 80 °C (p. 16, paragraph 3; Claim 28), and under a vacuum (p. 16, paragraph 3; Claim 29). Therefore, because the linseeds are crushed to remove oil (i.e., mechanically de-oiling), ground, extracted with water, then extracted twice with ethanol (i.e., one or more extracting steps), and freeze-dried (i.e., dried at a temperature < 80 °C and under a vacuum), the flaxseed protein product of Kankaanpaeae-Antila inherently has a proportion of ethanol of > 0.001% by mass, but less than 1% by mass. MPEP § 2112.01.I 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. In this case, the flaxseed (i.e., linseed) protein meal (i.e., protein composition) of Kankaanpaeae-Antila and the protein preparation of claim 8 are produced by substantially identical processes, therefore they inherently have the same properties, including ethanol content. Furthermore, MPEP § 2112.I states “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer”. In this case, the fact that Kankaanpaeae-Antila is silent with respect to the ethanol content of the flaxseed (i.e., linseed) protein meal (i.e., protein composition) does not render novel the previously unappreciated ethanol content of the flaxseed (i.e., linseed) protein meal (i.e., protein composition) of Kankaanpaeae-Antila.
Regarding claim 9, Kankaanpaeae-Antila teaches residual oil may be removed from crushed flax by extracting with a suitable solvent, such as, for instance hexane (p. 4, paragraph 3). Kankaanpaeae-Antila teaches, after extraction, the separated solid matter is washed with ethanol, dissolving most of the remaining oil from pressing (p. 11, paragraph 2). Kankaanpaeae-Antila teaches the washing solution is then separated from the solid matter, and the washed solid matter is dried by air drying (p. 11, paragraph 2). Kankaanpaeae-Antila teaches washed solid matter may also be dried by freeze-drying (i.e., a vacuum drying process – p. 8, paragraph 1).
MPEP § 2131.02 states, a reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." According to the teachings of Kankaanpaeae-Antila described above, one of ordinary skill in the art would have at once envisaged washing (i.e., removing residual oil from) the dry matter with hexane instead of ethanol, and drying the washed dry matter by freeze-drying (i.e., a vacuum drying process).
The instant specification states the method of instant claim 13 produces the product of claim 1, with advantageous embodiments found in the dependent claims (p. 3, paragraph 5). The instant specification notably states a preferred drying condition of the present invention is that the drying occurs at < 80 °C (p. 16, paragraph 3; Claim 28), and under a vacuum (p. 16, paragraph 3; Claim 29). Therefore, because the linseeds are crushed to remove oil (i.e., mechanically de-oiling), ground, extracted with water, then extracted twice with hexane (i.e., one or more extracting steps), and freeze-dried (i.e., dried at a temperature < 80 °C and under a vacuum), the flaxseed protein product of Kankaanpaeae-Antila inherently has a proportion of hexane of > 0.0005% by mass, but less than 0.005% by mass. MPEP § 2112.01.I 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. In this case, the flaxseed (i.e., linseed) protein meal (i.e., protein composition) of Kankaanpaeae-Antila and the protein preparation of claim 9 are produced by substantially identical processes, therefore they inherently have the same properties, including hexane content. Furthermore, MPEP § 2112.I states “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer”. In this case, the fact that Kankaanpaeae-Antila is silent with respect to the hexane content of the flaxseed (i.e., linseed) protein meal (i.e., protein composition) does not render novel the previously unappreciated hexane content of the flaxseed (i.e., linseed) protein meal (i.e., protein composition) of Kankaanpaeae-Antila.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kankaanpaeae-Antila et al. (WO 9622027 A1 – IDS Filed on June 7, 2024) as evidenced by Waszkowiak et al. (Effect of Extraction Method on the Phenolic and Cyanogenic Glucoside Profile of Flaxseed Extracts and their Antioxidant Capacity. J Am Oil Chem Soc. Vol 92. Pp. 1609 – 1619. (2015)) and Guang et al. (Preparation of flaxseed protein isolate and study on its main anti-nutritional factors. Journal of Food Safety and Quality Testing. Vol 9, Iss 6. Pp. 1440 – 1444 (2018) – Google Machine Translation), as applied to claim 1 above, and further in view of Mueller et al. (WO 2009056097 A1 – Clarivate Machine Translation).
Kankaanpaeae-Antila teaches the crushed flaxseed (i.e., linseed) is ground to a smaller particle size prior to aqueous extraction (p. 10, paragraph 2).
Kankaanpaeae-Antila does not teach the flaxseed (i.e., linseed) protein isolate (i.e., protein composition) has a d90 particle size of less than 500 µm.
Mueller teaches a protein-containing food ingredient produced by a method comprising the steps of: flax coarse meal having a low residual oil content is produced or prepared, parts of native flax protein and soluble roughage from said flax coarse meal being dissolved or at least dispersed by aqueous extraction in an aqueous phase (p. 1, Abstract). Mueller teaches a defatted flax pulp extraction meal is ground by means of a cooled mill under nitrogen atmosphere to particle sizes below 400 microns prior to aqueous extraction (p. 5, paragraph 6).
Kankaanpaeae-Antila and Mueller are combinable because they are concerned with the same field of endeavor, namely, flax (i.e., linseed) protein extracts. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have ground the flaxseed (i.e., linseed) protein meal (i.e., protein composition) to particle sizes below 400 microns (i.e., µm), thereby producing a flaxseed (i.e., linseed) protein meal (i.e., protein composition) with a d90 particle size of less than 500 µm, as taught by Mueller because Mueller shows that it was known for such a thing to have been successfully achieved and published at the time of filing, which means it was within the general skill of a worker in the art to select the claimed particle size when making a flaxseed (i.e., linseed) protein meal (i.e., protein composition), because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP § 2144.07.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lan et al. (Physicochemical properties and aroma profiles of flaxseed proteins extracted from whole flaxseed and flaxseed meal. Food Hydrocolloids. Vol 104. (2020)), as evidenced by Guang et al. (Preparation of flaxseed protein isolate and study on its main anti-nutritional factors. Journal of Food Safety and Quality Testing. Vol 9, Iss 6. Pp. 1440 – 1444 (2018) – Google Machine Translation), as applied to claim 1 above, and further in view of Muryani et al. (WO 2017174699 A1 – Clarivate Machine Translation).
Claim 11 is given the broadest reasonable interpretation of “The protein preparation of claim 1, further comprising legume proteins selected from the group consisting of pea, lentil, bean, field bean, peanut, and soy.”
Lan teaches the flax (i.e., linseed) protein isolate (i.e., protein composition) is an alternative dietary protein or functional food ingredient (p. 1, paragraph 3). Lan teaches the flax (i.e., linseed) protein isolate (i.e., protein composition) presents overall neutral to positive flavors (Abstract).
Lan does not teach the flax (i.e., linseed) protein isolate (i.e., protein composition) comprises legume proteins from the group of pea, lentil, bean, field bean, peanut or soya.
Muryani teaches plant protein fractions from proteins of legumes such as soybean, pea, lupine, bean, chickpea, lentil or peanut; or oilseeds such as sunflower, rape, Camelina or flax; which has a reduced immunoreactivity while having good techno-functional and organoleptic properties (p. 6, paragraphs 4 – 5). Muryani teaches the protein fractions produced should in particular have a light color and good emulsifying properties, taste almost neutral, and in particular have a low bitterness and barely perceptible beany taste (p. 6, paragraph 5). Muryani teaches a plant protein fraction from legumes or oilseeds characterized by a brightness with an L value > 70 determined by CIE-L * a * b colorimetry (Claim 26).
Lan and Muryani are combinable because they are concerned with the same field of endeavor, namely, plant protein extracts with functional properties and light color. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the flax (i.e., linseed) protein isolate (i.e., protein composition) of Lan with the plant protein fractions of Muryani because in this case, the flax (i.e., linseed) protein isolate (i.e., protein composition) of Lan and the pea, lentil, bean, peanut, and/or soy protein fraction(s) of Muryani are suitable for the same purpose, namely, dietary protein supplementation by protein fractions with functional properties and light color. MPEP § 2144.06.I states it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have combined the flax (i.e., linseed) protein isolate (i.e., protein composition) with the pea, lentil, bean, peanut, and/or soy protein fraction(s) of Muryani to form a third composition useful for dietary protein supplementation by protein fractions with functional properties and light color.
Conclusion
No claims are allowed.
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/L.J.M./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793