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 .
Election/Restrictions
Applicant’s election of claims 1-12 and 16-17 in the reply filed on 01 May 2026 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)).
Claims 13-15 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claim Objections
Claim 17 is objected to because of the following informalities: please write out the names of HCl, CH3COOH and C6H8O7 the first time they are used in the claims. 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 1-12 and 16-17 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.
Claim 1, line 10, step d) recites “adjusting the pH of the liquid fraction obtained in step c” however step c) recites obtaining a liquid fraction and a solid fraction without reciting a step of separating the liquid and solid fractions. It is unclear how to adjust the pH of the liquid fraction without adjusting the pH of the solid fraction as well. The instant specification discloses the separation of the liquid and solid fraction prior to the adjusting of the pH of the liquid fraction (p13, line 20-p14, line 15). For the purpose of examination, claim 1 step d) will be interpreted as: adjusting the pH of the liquid fraction obtained in step c) after the separation of the liquid fraction and the solid fraction of step c).
Claim 5, lines 3-4, recites “a plant seeds:aqueous medium ratio of 1:1 – 1:12 based on the weight of the plant seeds comprising aqueous medium.” It is unclear what the ratio is based on (mass, volume, etc.) since it is only recited that the ratio is based on the weight of the plant seeds comprising aqueous medium and does not indicate how the aqueous medium should be measured. The instant specification discloses a seed:aqueous medium ratio of 1:1 to 1:12 based on the weight of the plant seeds and the aqueous medium (p11, line 34 - p12, line 2). For the purpose of examination, 5 will be interpreted as: …a plant seeds:aqueous medium ratio of 1:1 – 1:12 (w:w).
Claims 2-4, 6-12 and 16-17 are rejected here because they depend from claim 1.
Claim Rejections - 35 USC § 103
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.
Claims 1, 4, 5, 7, 11-12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Wakabayashi (EP 0 883 997 A2).
Regarding claims 1 and 4, Wakabayashi discloses a method of separating and obtaining a lipid/protein complex (lipid-containing composition) and native proteins (protein-containing composition) from oil seeds (p2, lines 3-5). Wakabayashi discloses oil seeds are immersed in water, which meets the limitations of steps a) and b) of the instant claims (p3, lines 31-32). Wakabayashi discloses the seeds are ground after immersing in water and the ground material is introduced to a solid/liquid separator to separate the crude water extracts (liquid fraction) and the residues (solid, carbohydrate containing fraction), which meets the claim 1 c) limitation of comminuting the plant seeds comprising aqueous medium obtained in step b) to obtain a liquid fraction and a solid fraction (p3, lines 32-36).
Wakabayashi discloses an example where the liquid fraction of raw soybean milk comprises lipids at 1.8% and protein at 3.2%, which results in a lipid to protein ratio of 1:1.78, which falls within the claimed range of 10:1 to 1:10 (p6, Example 3, lines 30-34).
Wakabayashi discloses that when a substance having aggregating ability is added to the water extracts the lipids are aggregated with a part of the proteins to form a lipid rich lipid/protein complex (p3, lines 50-52). Wakabayashi discloses the aggregate is recovered as the lipid-rich lipid/protein complex (lipid containing fraction) and simultaneously native proteins are recovered from the non-aggregated fraction (protein containing fraction) (p4, lines 22-23). Wakabayashi discloses the optimum pH for the aggregation is from 4.5-10 (p4, lines 16-17), which overlaps with the claimed range of pH of 4.0-6.5. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Wakabayashi discloses the lipid-rich lipid/protein complex can be separated from the non-aggregated fraction (protein fraction) by centrifugation (p4, lines 42-43).
Regarding claim 5, Wakabayashi discloses an example with 100g of soybeans combined with 1 L of water before grinding, which results in a plant see to aqueous medium ratio of 1:10 which falls within the claimed range of 1:1 to 1:12 (p5, Example 1, lines 12-15).
Regarding claim 7, Wakabayashi discloses the substance having aggregating ability, which is used to adjust pH, may be ascorbic acid, isoascorbic acid, ethylene diamine tetraacetic acid, which meets the claim limitation of acid or acidic medium (p3, lines 50-53).
Regarding claim 11, Wakabayashi discloses the oil seeds may be rapeseeds, sunflower seeds and sesame seeds (p3, lines 28-30).
Regarding claim 12, Wakabayashi discloses a batch wise process (see Examples 1-3, pp5-7), however it is obvious to one or ordinary skill in the art to make continuous a process the prior art discloses as a batch process. In re Dilnot, 319 F.2d 188, 138 USPQ 248 (CCPA 1963) (Claim directed to a method of producing a cementitious structure wherein a stable air foam is introduced into a slurry of cementitious material differed from the prior art only in requiring the addition of the foam to be continuous. The court held the claimed continuous operation would have been obvious in light of the batch process of the prior art) MPEP 2144.04 V. E.
Regarding claim 17, Wakabayashi discloses that when a substance having aggregating ability is added to the water extracts the lipids are aggregated with a part of the proteins to form a lipid rich lipid/protein complex (p3, lines 50-52). Wakabayashi discloses the aggregate is recovered as the lipid-rich lipid/protein complex (lipid containing fraction) and simultaneously native proteins are recovered from the non-aggregated fraction (protein containing fraction) (p4, lines 22-23). Wakabayashi discloses the optimum pH for the aggregation is from 4.5-10 (p4, lines 16-17).
Wakabayashi discloses the substance having aggregating ability, which is used to adjust pH, may be ascorbic acid, isoascorbic acid, ethylene diamine tetraacetic acid, which meets the claim limitation of acid or acidic medium (p3, lines 50-53).
Wakabayashi discloses the use of an acid for adjusting the pH of the solution. Therefore, it would have been obvious to have selected hydrochloric acid, acetic acid or citric acid as the acid of Wakabayashi’s method, as one of ordinary skill would have had the reasonable expectation that any acid would function effectively in the mixture to adjust the pH. This is merely selecting from a group of suitable options, absent a clear showing of the criticality associated with hydrochloric acid, acetic acid or citric acid.
The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol.) MPEP 2144.07.
Claims 2, 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Wakabayashi (EP 0 883 997 A2) as applied to claim 1 above, and further in view of Hua (CN 111528335A).
All citations to Hua refer to the attached English translation.
Regarding claim 2, Wakabayashi discloses oil seeds are immersed in water (p3, lines 31-32).
Wakabayashi does not disclose the duration of immersing the seeds.
Hua, in the field of plant protein processing, discloses a method of preparing linseed protein in an aqueous medium [11]. Hua discloses adding water to linseed, wet refining, stirring, extracting and filtering to remove the slag to obtain a flaxseed slurry [12]. Hua discloses adjusting the pH of the slurry to 5.5-8.5 [14]. Hua discloses water is added for wet refining from 0.5-5 times the weight of the raw material and the stirring extraction time is 0.5-2 hours [18-19], which falls within the claimed range of 30-150 minutes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combined the immersing of seeds of Wakabayashi with the 0.5-2 hour immersing of seeds of Hua since both are drawn to methods of extracting oil seeds and Hua demonstrates that 0.5-2 hrs is an appropriate length of time for immersing prior to filtering, etc.
Regarding claim 6, Wakabayashi discloses the seeds are ground after immersing in water and the ground material is introduced to a solid/liquid separator to separate the crude water extracts (liquid fraction) and the residues (solid, carbohydrate containing fraction) (p3, lines 32-36).
Wakabayashi does not disclose the solid/liquid separator is a filter.
Hua discloses after the flaxseeds are soaked and ground the solution is filtered [43].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the filtering of Hua as the solid/liquid separator of Wakabayashi since Hua discloses filtering is appropriate for separating the solid and liquid fractions of oilseeds after immersion and grinding.
Regarding claim 9, Wakabayashi discloses the lipid-rich lipid/protein complex can be separated from the non-aggregated fraction (protein fraction) by centrifugation (p4, lines 42-43).
Wakabayashi does not disclose the continuous density gradient centrifugation.
Hua discloses the solution of the invention is subjected to disc centrifugation to achieve separation [22]. The instant specification discloses disc centrifugation is a continuous centrifugation method (p4, line 35-p5, line 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to selected the disc centrifugation of Hua as the centrifugation of Wakabayashi since Hua discloses disc centrifugation is appropriate for separating layers in a liquid fraction of a plant seed extract.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Wakabayashi (EP 0 883 997 A2) as applied to claim 1 above, and further in view of Zhang (Zhang et al. Techniques for extraction and isolation of natural products: a comprehensive review. Chin Med. 2018 Apr 17;13:20).
Regarding claim 3, Wakabayashi discloses oil seeds are immersed in water, which meets the limitations of steps a) and b) of the instant claims (p3, lines 31-32).
Wakabayashi does not disclose the immersing takes place in an aqueous medium having a temperature of 60-80oC.
Zhang, in the field of extraction and isolation of natural products, discloses the extraction of natural products progresses through the following stages: (1) the solvent penetrates into the solid matrix; (2) the solute dissolves in the solvents; (3) the solute is diffused out of the solid matrix; (4) the extracted solutes are collected. Any factor enhancing the diffusivity and solubility in the above steps will facilitate the extraction, including the extraction temperature (p1, RH col-p2, LH col: Extraction). Zhang discloses high temperatures increase the solubility and diffusion (p2, LH col, para 3).
Therefore the temperature of immersing is a result effective variable, change the temperature of the aqueous medium and you change the diffusivity and solubility of natural products in the extract. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. Additionally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. MPEP 2144.05 II A. As such, the temperature range recited in claim 3 is merely an obvious variant of the prior art.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Wakabayashi (EP 0 883 997 A2) as applied to claim 1 above, and further in view of Billecke (WO 2021/126408 A1, published 24 June 2021).
Regarding claim 8, Wakabayashi discloses that when a substance having aggregating ability is added to the water extracts the lipids are aggregated with a part of the proteins to form a lipid rich lipid/protein complex (p3, lines 50-52). Wakabayashi discloses the aggregate is recovered as the lipid-rich lipid/protein complex (lipid containing fraction) and simultaneously native proteins are recovered from the non-aggregated fraction (protein containing fraction) (p4, lines 22-23). Wakabayashi discloses the optimum pH for the aggregation is from 4.5-10 (p4, lines 16-17).
Wakabayashi does not disclose heating the liquid fraction to 30-70oC after adjusting the pH.
Billecke, in the field of separating oleosomes from rapeseed, sunflower wherein the process includes soaking the seeds, wet milling the soaked seeds with water, separating the solid and liquid phases, adjusting the pH of the liquid phase, and heating to a temperature of 40-45oC then centrifuging to separate the watery phase and the oily phase [0008] and [0146-0149]. Billecke’s heating to a temperature of 40-45oC after pH adjustment falls within the claimed range of 30-70oC.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the seed soaking, grinding, separating, and pH adjusting of Wakabayashi with the seed soaking, grinding, separating and pH adjusting of Billecke since both are drawn to methods of extracting lipids from oilseeds.
Claims 10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Wakabayashi (EP 0 883 997 A2) as applied to claim 1 above, and further in view of Romero-Guzmán (Romero-Guzmán et al. Influence of soaking time on the mechanical properties of rapeseed and their effect on oleosome extraction, Food and Bioproducts Processing, 121 (2020) 230-237, published 01 April 2020).
Regarding claims 10 and 16, Wakabayashi does not disclose the aqueous medium is a sodium bicarbonate solution and/or has a pH of between 8 and 11.
Romero-Guzmán, in the field of extracting lipids from oil seeds, discloses the seeds of the extraction were soaked in a solution of 0.1 M sodium bicarbonate (NaHCO3) adjusted to a pH of 9.5, Romero-Guzmán discloses the seeds were processed with a twin screw press and two streams were recovered, the press cake and a concentrated slurry (p231, section 2.5 Extraction of oleosomes and recovery of oleosome-rich creams). Romero-Guzmán’s pH of 9.5 falls within the claim 10 range of a pH between 8 and 11 and the claim 16 range of a pH between 8.5 and 9.5, Romero-Guzmán’s 0.1 M sodium bicarbonate solution falls within the claim 16 range of between 0.05-0.5M.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combined the soaking in sodium bicarbonate of Romero-Guzmán with the oil seed processing of Wakabayashi since both are drawn to methods of extracting lipids from oil seeds.
Conclusion
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/C.L.G./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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