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 06/17/2026 is acknowledged.
Applicant has overcome the following rejections by virtue of the amendment or cancellation of the claims and/or persuasive remarks: (1) the 35 U.S.C. 112(b) rejection of claim 43 has been withdrawn; (2) the 35 U.S.C. 102(a)(1) rejections of claims 39 and 51-54 over Defaix et al. have been withdrawn; and (3) the 35 U.S.C. 103 rejections of claims 40-42, 44, 45, and 55-58 over Defaix et al. have been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 39-58
Withdrawn claims: None
Previously canceled claims: 1-38
Newly canceled claims: 39-42, 44, 45, and 51-58
Amended claims: 43
New claims: 59-70
Claims currently under consideration: 43, 46-50, and 59-70
Currently rejected claims: 43, 46-50, and 59-70
Allowed claims: None
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 43, 46-49 and 59-70 are rejected under 35 U.S.C. 103 as being unpatentable over Defaix et al. (WO 2019/096862 A1).
Regarding claim 43, Defaix et al. discloses a method for extracting materials from oil seeds (p. 3, ll. 15-17), the method comprising:
mixing an extraction solution that includes water and a salt and has a pH of 5-8 (p. 3, ll. 23-27; p. 4, ll. 18-28) with a quantity of oils seeds that have been dehulled (p. 16, ll. 13-14), cold-pressed (p. 15, ll. 12-13), and milled (p. 15, ll. 3-4) to form a mixture (p. 4, ll. 33-36), where the oil seeds may be sunflower seeds (p. 16, ll. 16-19);
extracting the mixture at a temperature in the range of 10-93°C (p. 4, l. 33 – p. 5, l. 3) for 0.5-6 hours (p. 5, ll. 6-8) to form an extracted mixture having an aqueous phase;
separating the insoluble solids from the aqueous phase using a separation process (p. 3, l. 28; p. 5, ll. 23-28);
lowering the pH of a mixture comprising dissolved proteins to within the range of 4.0-4.5 (specifically, “from 1 to 4”) (p. 6, ll. 25-28, l. 37), which is presumed to create a precipitate;
sequentially filtering the insoluble solids material to obtain a protein target material in a retentate (p. 4, ll. 8-9; p. 9, l. 25 – p. 10, l. 5; p. 10, ll. 22-23, where filtration steps may be repeated); and
drying the retentate (p. 4, l. 10; p. 10, ll. 13-15).
Defaix et al. does not disclose lowering the pH of the permeate in particular or the specific filtration steps of (i) filtering the lowered pH material to form a retentate and a permeate; (ii) drying the retentate to form a dried retentate that comprises a first target material that includes an insoluble sunflower protein and “a controlled level of phytic acid”; (iii) filtering the permeate to form a second retentate and a second permeate; (iv) drying the second retentate to form a dried second retentate that comprises a second target material that includes a soluble sunflower protein; (v) filtering the second permeate to form a third retentate; and (vi) drying the third retentate to form a dried third retentate that comprises a third target material.
However, the instruction in Defaix et al. that the liquid phase may be subject to “one or several membrane filtration(s) to obtain a protein isolate” (p. 4, ll. 8-9) and that the separation/filtration steps may be repeated (p. 10, ll. 22-23) renders the claimed repetition of filtration steps in order to obtain target materials obvious. Further, the material which is subjected to a lowered pH contains the target protein material and phytic acid (p. 6, ll. 25-28; p. 1, l. 37), where protein is the target material (p. 9, ll. 25-28). Obtaining first or second target materials that comprise proteins from first or second retentates would thus be obvious. Subjecting any fraction containing the target material to subsequent processing in order to further purify the material would be obvious. As such, the claimed step of lowering the pH of the permeate obtained after separating insoluble solids from an aqueous phase would be obvious due to comprising dissolved protein material.
As for claim 46, Defaix et al. discloses adding a precipitating material to the aqueous phase to form a precipitate (p. 8, ll. 15-28; p. 7, ll. 28-29; p. 8, l. 34 – p. 9, l. 2).
As for claim 47, Defaix et al. discloses removal of phytic acid via precipitation (p. 8, ll. 15-28; p. 7, ll. 28-29; p. 8, l. 34 – p. 9, l. 2), such that the precipitate is presumed to include phytic acid.
As for claim 48, Defaix et al. discloses adding calcium chloride to the aqueous phase as a precipitating material (p. 8, ll. 15-16; p. 7, ll. 28-29).
As for claim 49, Defaix et al. discloses adding calcium chloride to the aqueous phase as a precipitating material (p. 8, ll. 15-16; p. 7, ll. 28-29) in a molar concentration ranging from 0.01 M to 2 M, with a “concentration of around 0.5 M ± 10% ha[ving] shown particular efficacy” (p. 8, ll. 15-20). Such evidence of optimization suggests to a skilled practitioner that an optimized molar ratio between calcium chloride and phytic acid may be determined via routine experimentation. MPEP 2144.05 II.
Regarding claim 59, Defaix et al. discloses a protein composition comprising an oil seed protein extract (p. 9, ¶25 – p. 10, ¶11), where the oil seeds may be sunflower seeds (p. 16, ll. 16-19), that includes (i) a protein extracted from oil seeds using an organic solvent-free extraction process at a pH of 3-6 (p. 3, ll. 26-32), and (ii) phytic acid in an amount of 0.28 to 6.5 wt.% (p. 3, ll. 21-23).
Defaix et al. does not disclose the composition as being sweet.
However, 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.” Since Defaix et al. discloses producing the material by a substantially identical process as that claimed, the obtained protein composition would have the same properties as those presently claimed, which renders the claimed limitations requiring the protein composition to be sweet obvious to a skilled practitioner.
As for claims 60 and 61, Defaix et al. discloses an earlier prior art reference wherein an oilseed protein extract was obtained comprising 8.4 wt.% phytic acid, although such a value was considered “too high for a viable commercial product” (p. 2, ll. 16-29). The method of Defaix aims to achieve a phytic acid concentration of 4 wt.% or less (p. 3, ll. 21-23). The combined disclosure effectively renders the intermediate range between the two values obvious. MPEP 2144.05 (“A range can be disclosed in multiple prior art references instead of in a single prior art reference depending on the specific facts of the case.”). MPEP 2145 VII further states: “The fact that a ‘combination would not be made by businessmen for economic reasons’ does not mean that a person of ordinary skill in the art would not make the combination because of some technological incompatibility.” The claimed phytic acid concentrations of 5.5-6.5 wt.% (claim 60) and 6 wt.% (claim 61) are thus considered obvious to a skilled practitioner.
As for claims 62-65, Defaix et al. discloses the phytic acid concentration as being in an amount of 4 wt.% or less (p. 3, ll. 21-23), which renders the claimed concentrations of 3.5-4.5 wt.% (claim 62), 4 wt.% (claim 63), 1.5-2.5 wt.% (claim 64), and 2 wt.% (claim 65) obvious to a skilled practitioner.
As for claim 66, Defaix et al. discloses the sunflower protein comprises 91.7-99 wt.% of the protein composition (p. 14, ll. 10-14).
As for claims 67-69, Defaix et al. discloses the protein isolate is comprised of at least 90 wt.% albumin (soluble proteins) (p. 14, ll. 13-14), which suggests as least some portion of the total proteins would be material other than albumin that would be insoluble material. Defaix et al. thus effectively discloses the protein isolate as comprising soluble proteins (claim 67), insoluble proteins (claim 68), and both soluble and insoluble proteins (claim 69).
Regarding claim 70, Defaix et al. discloses a protein composition comprising an oil seed protein extract (p. 9, ¶25 – p. 10, ¶11) including insoluble protein (p. 14, ll. 13-14), where the oil seeds may be sunflower seeds (p. 16, ll. 16-19), that includes (i) a protein extracted from oil seeds using an organic solvent-free extraction process at a pH of 3-6 (p. 3, ll. 26-32), and (ii) phytic acid in an amount of 0.28 to 6.5 wt.% (p. 3, ll. 21-23).
Defaix et al. does not disclose the composition as being sweet.
However, 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.” Since Defaix et al. discloses producing the material by a substantially identical process as that claimed, the obtained protein composition would have the same properties as those presently claimed, which renders the claimed limitations requiring the protein composition to be sweet obvious to a skilled practitioner.
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Defaix et al. (WO 2019/096862 A1) in view of Pearce (U.S. 4,435,319).
As for claim 50, Defaix et al. discloses the method of claim 43.
Defaix et al. does not specifically disclose separation of chlorogenic acid as part of a filtration retentate.
However, Pearce discloses chlorogenic acid as being a polyphenol present in sunflower seed extract that contributes to dark, undesirable color characteristics (c. 1, l. 60 – c. 2, l. 2).
It would have been obvious to one having ordinary skill in the art to separate chlorogenic acid as part of a filtration retentate when practicing the method of Defaix et al. First, the reference indicates that filtration may be used to separate phenolic compounds without clarifying specific types of phenolic compounds (p. 9, ll. 28-30). A skilled practitioner would be motivated to consult Pearce for clarification of such types of compounds and would determine that chlorogenic acid in particular results in undesirable color characteristics (c. 1, l. 60 – c. 2, l. 2). As such, performing filtration in order to separate chlorogenic acid from the sunflower extract would be obvious to a skilled practitioner.
Response to Arguments
Claim Rejections - 35 U.S.C. § 112: Applicant has overcome the 35 U.S.C. § 112(b) rejection of claim 43 based on amendment to the claim. Accordingly, the 35 U.S.C. § 112(b) rejection has been withdrawn.
Claim Rejections - 35 U.S.C. § 102(a)(1) of claims 39 and 51-54 over Defaix et al.: Applicant has overcome the 35 U.S.C. § 102(a)(1) rejections of claims 39 and 51-54 based on cancellation of the claims. Accordingly, the 35 U.S.C. § 102(a)(1) rejections have been withdrawn.
Claim Rejections - 35 U.S.C. § 103 of claims 40-49 and 55-58 over Defaix et al.; and claim 50 over Defaix et al. and Pearce: Applicant’s arguments have been fully considered but they are not persuasive.
Applicant argued that Defaix et al. does not appear to disclose the first target material as comprising “a controlled level of phytic acid to manage the sweetness of the insoluble sunflower protein” (Applicant’s Remarks, p. 7, ¶3).
However, Defaix et al. discloses phytic acid as being present in the obtained protein material (p. 3, ll. 21-23). The phrase “controlled level” is essentially of no practical limitation to the claim, since there would be no distinction between a method producing a protein isolate comprising phytic acid whether with a “controlled level” or without a “controlled level” of the component. The method would still result in a product comprising an amount of phytic acid. Further, no sweetness is required, such that the limitation that the phytic acid is controlled “to manage the sweetness of the insoluble sunflower protein” does not actually meaningfully limit the claim.
Examiner further notes that the claimed method remains viewed as simply a generalized extraction process in terms of not clarifying the material obtained in the fractions or defined process parameters. Obtaining a first target material that “includes an insoluble sunflower protein” could still comprise a relatively broad scope of varying components—material that is insoluble at certain conditions but that may be soluble at other conditions. Merely requiring the sample to “include” insoluble protein is also broad enough that the material may still mostly be comprised of soluble proteins (Defaix et al., p. 5, ll. 31-33, “As the skilled person will directly understand the solid phase contains a small proportion of liquid and conversely the liquid phase will comprise a small proportion of solids or solid particles.”). The same breadth applies to the limitation that “the second target material includes a soluble sunflower protein”. The claim amendments to claim 43 thus do not patentably distinguish the claimed method from that of Defaix et al.
The rejections of claims 43 and 46-50 have been maintained herein.
The rejections of claims 40-42, 44, 45, and 55-58 have been withdrawn due to the cancellation of the claims.
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.
Claims 43, 46-50, and 59-70 are rejected.
No claims are allowed at this time.
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793
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