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 May 23, 2023. The earliest effective filing date of the application is November 24, 2020.
Priority
The present application is a 371 National Stage Application of PCT/EP2021/082078 which has a filing date of November 18, 2021.
Status of Application
The amendment filed November 5, 2025 with the Remarks has been entered. The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1 – 32
Withdrawn claims: 1 – 14
Amended claims: 15 – 32
Claims currently under examination: 15 – 32
The status of the objections and rejections regarding the disclosure upon entry of the present amendment stands as follows:
Objections: The previous objections to claims 15 – 32 are withdrawn in light of Applicant’s amendments.
35 U.S.C. § 112 Rejections: The previous rejections under 35 U.S.C. § 112(b) of claims 15 – 32 have been withdrawn in light of Applicant’s amendments.
35 U.S.C. § 103 Rejections: The previous rejections under 35 U.S.C. § 103 of claims 15 – 32 in view of Barron are maintained.
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.
Claims 15 – 23 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Barron (US 20120288588 A1) in view of Shen et al. (The impact of hempseed dehulling on chemical composition, structure properties and aromatic profile of hemp protein isolate. Food Hydrocolloids. Vol. 106 (2020) – IDS Filed on May 23, 2023) and Pickardt et al. (US 20120009287 A1).
Regarding claim 15, the preamble of claim 15 merely states that the method produces a protein preparation produced from hemp seeds, with
- a protein content of more than 65% by mass relative to a dry mass, and
- a fat content less than 6% by mass relative to the dry mass, determined according to a Soxhlet method using hexane as solvent,
- wherein the protein preparation has a brightness L* of greater than 70, determined according to CIE-L*a*b* color measurement when the protein preparation has a d90 particle size less than 250 µm, or after grinding of the protein preparation to a d90 particle size less than 250 µm.
According to the instant specification, the method of claim 15 necessarily produces the protein preparation as described above (p. 3, paragraph 3). MPEP § 2111.02.II teaches, “[i]f the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the noted preamble merely states the purpose or intended use of the claimed composition. Therefore, the preamble does not limit the claim.
Barron teaches a method of making hemp protein concentrate comprising the steps of:
squeezing whole hemp seeds through a screw press, thereby extracting substantially all of the oil from the seed (i.e., mechanically partially de-oiling the hemp seeds – [0060]);
extracting more fat (i.e., oil) from the squeezed hemp seeds with a double solvent extraction process wherein 95% ethanol (i.e., 95% ethanol and 5% water) is used as a solvent until less than 1% fat remains, after grinding the squeezed hemp seeds into a powder ([0060]).
Regarding the term “partial” when referring to de-oiling, any amount less than total oil removal is considered “partial” de-oiling. Because additional oil is recovered from the extraction step (b) of Barron, the squeezing of the hemp seeds by a screw press in step (a) of Barron is a partial de-oiling. Barron teaches the resulting hemp protein concentrate is a dry powder, therefore the high-protein hemp seed solids (i.e., the raffinate) produced by step (b) are necessarily dried ([0060]).
Barron does not teach shelling the hemp seeds until a residual shell fraction of less than 18% by mass is obtained, or provision of shelled hemp seeds having a residual shell fraction of less than 18% by mass, relative to the dry mass of the hemp seeds in each case.
Shen investigates the effect of dulling hemp seeds prior to further processing on the color of hemp protein isolate (HPI – p. 3, 3.1 Impact of dehulling on extraction yield and color hemp protein, paragraph 2). Shen teaches the color of protein powder is one of the most important characteristics that may influence the consumer's acceptance (p. 3, 3.1 Impact of dehulling on extraction yield and color hemp protein, paragraph 2). Shen teaches the dehulled HPI of the study exhibits as a bright white powder, while the non-dehulled HPI is dark green (p. 3, 3.1 Impact of dehulling on extraction yield and color hemp protein, paragraph 2). Shen teaches the more appealing (lighter) color of dehulled HPI was associated with the lower contents of total phenolics compounds and chlorophyll (p. 3, 3.1 Impact of dehulling on extraction yield and color hemp protein, paragraph 2). Shen teaches since hemp seed hulls are abundant in various types of phenolic compounds, the dark color of non-dehulled HPI could be ascribed to the more phenolic compounds isolated during extraction compared to dehulled HPI (p. 3, 3.1 Impact of dehulling on extraction yield and color hemp protein, paragraph 2).
Barron and Shen are combinable because they are concerned with the same field of endeavor, namely, processing hemp seeds. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to dehull (i.e., shell) hemp seeds until a residual shell fraction of less than 18% by mass is obtained prior to step (a) in the method of Barron, as taught by Shen, because dehulling hemp seeds before further processing results in a hemp protein isolate with a desirable light color, and lacking chlorophyll flavor, which is attractive to consumers.
Barron does not teach an average temperature of the hemp seeds is maintained below 100°C during step (a), squeezing the hemp seeds through a screw press (i.e., mechanically partially de-oiling the hemp seeds).
Pickardt teaches a method of making sunflower seed protein isolate comprising the steps of:
dehulling the sunflower seeds to a residual hull content of less than 5% by weight or the provision of sunflower seeds with a residual hull content of less than 5% by weight ([0016]);
mechanically de-oiling the dehulled sunflower seeds through pressing with a screw press to a fat or oil content of the dehulled sunflower seeds of 10 – 35% weight ([0017]; [0039]);
extracting by one or more extraction steps with at least one solvent to produce a de-oiled flour containing proteins, wherein at least one of the extraction steps further de-oils the partially de-oiled dehulled sunflower seeds ([0018]).
Pickardt teaches controlling the temperature/cooling during the pressing step (ii) to be under 80 °C ([0039]). Pickardt teaches Maillard reactions and other protein modifications are reduced by the temperature control in step (ii), as are reactions of other secondary substances with proteins ([0039]).
Barron and Pickardt are combinable because they are concerned with the same field of endeavor, namely, processing seeds to obtain protein isolates. 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 maintained a temperature below 80°C during step (a), squeezing the hemp seeds through a screw press (i.e., mechanically partially de-oiling the hemp seeds) in the method of Barron as taught by Pickardt because Maillard reactions and other protein modifications are reduced by the temperature control, as are reactions of other secondary substances with proteins.
Barron does not teach a fraction of sucrose is also separated in step (b).
Pickardt teaches, during the extraction step (iii), extraction takes place through a combination of at least two extraction solvents of different polarity in such a way that obtained hydrophilic secondary substances are extracted before, with or after the oil ([0044]). Pickardt teaches during this hydrophilic extraction, an alcohol or alcohol solution mixed with water removes the majority of plant's aromatic substances and other secondary plant substances (i.e., sugars – [0130]; [0132]). Pickardt teaches the sugar substances can be used as carrier substance for phenolic substances, e.g. during subsequent drying, for the production of another form of application ([0132]). Pickardt teaches the alcoholic solution containing sugar can be used directly for fermentation to bio-ethanol ([0137]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize a hydrophilic extraction step in step (b) of Barron to remove the secondary substances from the pressed hemp seeds to obtain a sugar-containing-alcohol extract, as taught by Pickardt because the alcoholic solution containing sugar can be used directly for fermentation to bio-ethanol.
Barron does not teach the solvent of step (b), the 95% ethanol, has a water content in the range between > 6% by mass and < 14% by mass.
Pickardt teaches the extraction step (iii) is carried out with a solvent or a solvent mixture in several extraction stages comprising a combination of at least one lipophilic extraction stage with a lipophilic solvent or solvent mixture and at least one hydrophilic extraction stage with a hydrophilic solvent or solvent mixture ([0022]). Pickardt teaches, during the extraction step (iii), the extraction of moderately hydrophilic secondary substances, more particularly phenolic acids and aroma substances through an ethanol solvent at a concentration of more than 60%, wherein the proteins are not dissolved or only to small extent ([0046]). Pickardt also teaches, during the extraction step (iii), a second extraction of lipophilic components with a lipophilic solvent, such as 95% ethanol, up to complete de-oiling to a residual oil content of at most 5% ([0047]). By increasing the concentration of the extraction solvent ethanol by decreasing the water content, the extraction solvent becomes more lipophilic, influencing the degree of extraction of the oils into the solvent. Therefore, the concentration of water in the ethanol is a result-effective variable.
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 selected hydrophilic and lipophilic ethanol solvents with water content in the range between > 6% by mass and < 14% by mass, as taught by Pickardt in the method of Barron because adjusting the water content of the ethanol controls the lipophilicity of the solvent, thereby controlling the degree of absorption of oil into the solvent. One of ordinary skill in the art would have been motivated to adjust the lipophilicity of the solvent to achieve the desired degree of hydrophilic secondary substances and lipophilic oil extraction from the hemp seed.
Regarding claim 16, Barron does not teach the hemp seeds are provided with a residual shell fraction of less than 10% by mass, or are shelled until this residual shell fraction remains.
Shen investigates the effect of dulling hemp seeds prior to further processing on the color of hemp protein isolate (HPI – p. 3, 3.1 Impact of dehulling on extraction yield and color hemp protein, paragraph 2). Shen teaches the color of protein powder is one of the most important characteristics that may influence the consumer's acceptance (p. 3, 3.1 Impact of dehulling on extraction yield and color hemp protein, paragraph 2). Shen teaches the dehulled HPI of the study exhibits as a bright white powder, while the non-dehulled HPI is dark green (p. 3, 3.1 Impact of dehulling on extraction yield and color hemp protein, paragraph 2). Shen teaches the more appealing (lighter) color of dehulled HPI was associated with the lower contents of total phenolics compounds and chlorophyll (p. 3, 3.1 Impact of dehulling on extraction yield and color hemp protein, paragraph 2). Shen teaches since hemp seed hulls are abundant in various types of phenolic compounds, the dark color of non-dehulled HPI could be ascribed to the more phenolic compounds isolated during extraction compared to dehulled HPI (p. 3, 3.1 Impact of dehulling on extraction yield and color hemp protein, paragraph 2).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to dehull (i.e., shell) hemp seeds until a residual shell fraction of less than 18% by mass is obtained prior to step (a) in the method of Barron, as taught by Shen, because dehulling hemp seeds before further processing results in a hemp protein isolate with a desirable light color, and lacking chlorophyll flavor, which is attractive to consumers.
Regarding claim 17, Barron does not teach the average temperature of the shelled hemp seeds is maintained below 80 °C during the mechanical partial de-oiling
Pickardt teaches a method of making sunflower seed protein isolate as described above. Pickardt teaches pressing (in step (ii) above) the sunflower seeds with a low residual hull content through screw presses (i.e., mechanically partially de-oiling the sunflower seeds – [0039]). Pickardt teaches controlling the temperature/cooling during the pressing step (ii) to be under 80 °C ([0039]). Pickardt teaches Maillard reactions and other protein modifications are reduced by the temperature control in step (ii), as are reactions of other secondary substances with proteins ([0039]).
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 maintained a temperature below 80°C during step (a), squeezing the hemp seeds through a screw press (i.e., mechanically partially de-oiling the hemp seeds) in the method of Barron as taught by Pickardt because Maillard reactions and other protein modifications are reduced by the temperature control, as are reactions of other secondary substances with proteins.
Regarding claim 18, Barron teaches in step (b), fat (i.e., oil) is extracted from the squeezed hemp seeds until less than 1% fat (i.e., oil) remains ([0060]).
Regarding claim 19, Barron does not teach the solvent of step (b), the 95% ethanol, has a water content in the range between > 10% by mass and < 14% by mass.
Pickardt teaches a method of making sunflower seed protein isolate as described above. Pickardt teaches the extraction step (iii) is carried out with a solvent or a solvent mixture in several extraction stages comprising a combination of at least one lipophilic extraction stage with a lipophilic solvent or solvent mixture and at least one hydrophilic extraction stage with a hydrophilic solvent or solvent mixture ([0022]). Pickardt teaches, during the extraction step (iii), the extraction of moderately hydrophilic secondary substances, more particularly phenolic acids and aroma substances through an ethanol solvent at a concentration of more than 60%, wherein the proteins are not dissolved or only to small extent ([0046]). Pickardt also teaches, during the extraction step (iii), a second extraction of lipophilic components with a lipophilic solvent, such as 95% ethanol, up to complete de-oiling to a residual oil content of at most 5% ([0047]). By increasing the concentration of the extraction solvent ethanol by decreasing the water content, the extraction solvent becomes more lipophilic, influencing the degree of extraction of the oils into the solvent. Therefore, the concentration of water in the ethanol is a result-effective variable.
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 selected hydrophilic and lipophilic ethanol solvents with water content in the range between > 10% by mass and < 14% by mass, as taught by Pickardt in the method of Barron because adjusting the water content of the ethanol controls the lipophilicity of the solvent, thereby controlling the degree of absorption of oil into the solvent. One of ordinary skill in the art would have been motivated to adjust the lipophilicity of the solvent to achieve the desired degree of hydrophilic secondary substances and lipophilic oil extraction from the hemp seed.
Regarding claim 20, Barron does not teach the water fraction is selected to be highest in the first stage of a multistage extraction, and is lower in one or more subsequent stages.
Pickardt teaches the concentration of the extraction solvent in the last extraction stage is preferably increased to such an extent that subsequent drying can take place in a particularly simple and gentle manner ([0022]).
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 increased the concentration of the extraction solvent (i.e., decreased the water fraction) in the later stages of extraction, as taught by Pickardt in the method of Barron because doing so would allow for simple and gentle drying of the protein concentrate.
Regarding claim 21, Barron does not teach a temperature of the solvent is selected to be between 30 °C and 75 °C during the performance of the one or more extraction steps.
Pickardt teaches extraction of lipophilic components with a lipophilic solvent can be completed at a temperature of 31 – 60 °C ([0047]). Pickardt teaches extraction of hydrophilic components with a hydrophilic solvent can be completed at a temperature of 40 – 80 °C ([0046]).
Both ranges of extraction temperature, 31 – 60 °C and 40 – 80 °C, as disclosed by Pickardt, overlap with the claimed range of between 30 °C and 75 °C. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 22, Barron teaches the double solvent extraction of step (b) occurs for a total of two hours ([0060]).
Regarding the limitation “temperatures of the solvent of > 45 °C”, in claim 21, which claim 22 depends upon, the temperature of the solvent is selected to be between 30 °C and 75 °C. It is interpreted the solvent temperature of claim 22 intended to be from 45 – 75 °C.
Barron does not teach the temperature of the solvent is selected to be between 45 °C and 75 °C during the performance of the one or more extraction steps.
Pickardt teaches extraction of lipophilic components with a lipophilic solvent can be completed at a temperature of 31 – 60 °C ([0047]). Pickardt teaches extraction of hydrophilic components with a hydrophilic solvent can be completed at a temperature of 40 – 80 °C ([0046]).
Both ranges of extraction temperature, 31 – 60 °C and 40 – 80 °C, as disclosed by Pickardt, overlap with the claimed range of between 45 °C and 75 °C. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 23, Barron teaches squeezing hemp seeds through a screw press, thereby extracting substantially all of the oil from the seed (i.e., mechanically partially de-oiling the hemp seeds – [0060]).
Barron does not teach the mechanical partial de-oiling is carried out until a residual oil content between > 8% by mass and < 40% by mass remains.
Pickardt teaches mechanically de-oiling dehulled sunflower seeds through pressing to a fat or oil content of the dehulled sunflower seeds of 10 – 35% by weight ([0017]). Pickardt teaches the press cake resulting from the mechanically de-oiling dehulled sunflower seeds has optimal stability, extractability, and functional properties when it has a fat or oil content of 10 – 35% by weight (Figure 2; [0042]).
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 carried out step (a) of Barron until a residual oil content between 10 – 35% by weight remains as taught by Pickardt because the resulting press cake has the optimal stability, extractability, and functional properties when it has a fat or oil content of 10 – 35% by weight.
Regarding claim 31, Barron teaches enzymes may be included in the extraction solvent of step (b) ([0060]). Therefore, the hemp seed solids (i.e., the raffinate) are treated with enzymes before drying.
Claims 24 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Barron (US 20120288588 A1) in view of Shen et al. (The impact of hempseed dehulling on chemical composition, structure properties and aromatic profile of hemp protein isolate. Food Hydrocolloids. Vol. 106 (2020) – IDS Filed on May 23, 2023) and Pickardt et al. (US 20120009287 A1) as applied to claim 1 above, and further in view of Buhr (Mechanical Processing. In: Edible Fats and Oils Processing: Basic Principles and Modern Practices. The American Oil Chemists Society. (1990)).
Regarding claim 24, Barron does not teach the shelled hemp seeds are conditioned before the mechanical partial de- oiling by adjusting the temperature of the seeds to a value between 30 °C and 60 °C and the moisture of the seeds to a water content in the seeds between 2 and 8% by mass.
Buhr teaches mechanical pressing principles and techniques for extracting oil from seeds. Buhr teaches cooking (conditioning) is a very important step consisting of heating the flaked or broken seed prior to mechanical pressing (p. 45, col. 1, paragraph 7). Buhr teaches the purpose of cooking (conditioning) is to coagulate the protein, reduce the viscosity of the oil and thus make it easier for the oil to separate from the ruptured cell (p. 45, col. 1, paragraph 7). Buhr teaches another important function of cooking (conditioning) is to control the moisture level of the seed before it enters the prepress (p. 45, col. 1, paragraph 7). Buhr teaches this is necessary because broken or flaked seed will deteriorate quickly, particularly if the material is subjected to high temperature and moisture conditions or is of poor quality (p. 45, col. 1, paragraph 7). Buhr also teaches all oilseeds have an enzyme system which can influence oil quality (p. 45, col. 1, paragraph 8). Buhr teaches processing conditions are important in the control of the action of these enzymes (p. 45, col. 1, paragraph 8). Buhr teaches the objective is to inactivate them at an early stage in the process by heat treatment in the cooker (conditioner – p. 45, col. 2, paragraph 1). Buhr teaches too extensive a heat treatment can have other negative effects on the oil and meal quality, therefore it is important to evaluate the time, moisture and temperature of the flaked or broken seed (p. 45, col. 2, paragraph 3).
Barron and Buhr are combinable because they are concerned with the same field of endeavor, namely, mechanically de-oiling seeds by pressing. 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 cooked (i.e., conditioned) the shelled hemp seeds prior to mechanical partial de-oiling by adjusting the temperature of the seeds to a value between 30 °C and 60 °C and the moisture of the seeds to a water content in the seeds between 2 and 8% by mass, as taught by Buhr in the method of Barron because cooking (i.e., conditioning) the shelled hemp seeds make it easier for the oil to separate from the ruptured cells of the seeds while controlling the temperature and moisture of the shelled hemp seeds allows one to maintain oil quality.
Regarding claim 28, Barron does not teach the partially de-oiled hemp seeds are flaked to a flake thickness of < 2 mm before the one or more extraction steps is/are performed.
Buhr teaches mechanical pressing principles and techniques for extracting oil from seeds. Buhr teaches preparing the seed for oil extraction therefore requires breaking the cell walls to expose the interior cells for mechanical prepressing and solvent extraction (p. 45, paragraph 6). Buhr teaches breaking the cell walls allows for maximum penetration of the solvent into the cells (p. 45, paragraph 6). Buhr teaches this process is usually accomplished by heating the seed to 40°C so the seed will not shatter but will be pliable enough for rolling or flaking with a roller mill (p. 45, paragraph 6). Buhr teaches size reduction by itself, while not sufficient to release the oil, will ease extraction of the oil by increasing the surface area of the seed (p. 45, paragraph 6).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to flake the squeezed hemp seeds to a flake thickness of < 2 mm before step (a) of Barron (i.e., before the extraction of step (b) of Barron), as taught by Buhr because breaking the cell wall and increasing the surface area of the seed by flaking eases the extraction of oil.
Claims 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Barron (US 20120288588 A1) in view of Shen et al. (The impact of hempseed dehulling on chemical composition, structure properties and aromatic profile of hemp protein isolate. Food Hydrocolloids. Vol. 106 (2020) – IDS Filed on May 23, 2023) and Pickardt et al. (US 20120009287 A1) as applied to claim 1 above, and further in view of Oseyko et al. (Technological and chemical aspects of storage and complex processing of industrial hemp seeds. Ukrainian Food Journal. Volume 9. Issue 3. Pp. 545 – 560. (September 30, 2020)).
Regarding claim 25, Barron does not teach the hemp seeds are cooled before and/or during mechanical treatment steps to a temperature < 20 °C.
Oseyko teaches according to Canadian researchers, the conditions for long-term storage of hemp seeds (66 months) to preserve seeds' viability are a temperature of 5 °C and moisture content of 6% (p. 546, paragraph 3).
Barron and Oseyko are combinable because they are concerned with the same field of endeavor, namely, processing hemp seeds. 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 stored hemp seeds at 5 °C prior to mechanical treatment (i.e., shelling and mechanical partial de-oiling), as taught by Oseyko in the method of Barron because storing hemp seeds at 5 °C preserves the seeds viability for up to 66 months.
Regarding claim 26, Barron does not teach the partially de-oiled, optionally ground or flaked hemp seeds are conditioned before the one or more extraction steps is/are performed by reduction of the moisture to a residual moisture of < 8% by mass.
Oseyko teaches according to Canadian researchers, the conditions for long-term storage of hemp seeds (66 months) to preserve seeds' viability are a temperature of 5 °C and moisture content of 6% (p. 546, paragraph 3).
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 stored hemp seeds with 6% moisture content prior to mechanical treatment (i.e., shelling and mechanical partial de-oiling), as taught by Oseyko in the method of Barron because storing hemp seeds with 6% moisture content preserves the seeds viability for up to 66 months.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Barron (US 20120288588 A1) in view of Shen et al. (The impact of hempseed dehulling on chemical composition, structure properties and aromatic profile of hemp protein isolate. Food Hydrocolloids. Vol. 106 (2020) – IDS Filed on May 23, 2023) and Pickardt et al. (US 20120009287 A1) as applied to claim 1 above, and further in view of Vishwanathan et al. (Influence of particle size on protein extractability from soybean and okara. Journal of Food Engineering. Vol 102. Pp. 240–246 (2011)).
Regarding claim 27, Barron does not teach a particle size of the partially de-oiled hemp seeds is brought to a d90 value of < 2 mm before the one or more extraction steps is/are performed, wherein a fine grain fraction with a particle size less than 100 µm constitutes < 50% by mass thereof.
Vishwanathan teaches a method for extracting protein from soy and okara by a multi-stage solvent extraction. Vishwanathan teaches during a three-step-sequential extraction, protein recovery from coarse fractions (355–710 µm) was low, more so with soybean (42.1%) than okara (72.1% – p. 244, paragraph 2). Vishwanathan teaches maximum protein recovery of 97.0% was achieved with soybean flour while it was 93.4% with okara flour from their respective fine fractions (<75 µm – p. 244, paragraph 2). Vishwanathan teaches the total soluble solids in the extracts increased from 50% to 86% and 49% to 62% in soybean and okara, respectively with decrease in particle size (coarse to fine fractions – p. 244, paragraph 2). Vishwanathan teaches protein extraction was affected by particle size probably due to an increase in the relative surface area of the ground material (p. 244, paragraph 2).
Barron and Vishwanathan are combinable because they are concerned with the same field of endeavor, namely, extracting protein from plant matter by multi-stage solvent extraction. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to bring the squeezed hemp seeds to a d90 value of < 2 mm, wherein a fine grain fraction with a particle size less than 100 µm constitutes < 50% by mass thereof during grinding before the extraction of step (b) in the method of Barron, as taught by Viswanathan because decreasing particle size increases protein extraction efficiency due to an increase in the relative surface area of the ground material.
Claims 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Barron (US 20120288588 A1) in view of Shen et al. (The impact of hempseed dehulling on chemical composition, structure properties and aromatic profile of hemp protein isolate. Food Hydrocolloids. Vol. 106 (2020) – IDS Filed on May 23, 2023) and Pickardt et al. (US 20120009287 A1) as applied to claim 1 above, and further in view of PAC (Rotary Evaporators for Ethanol Extraction. Production Automation Corporation. (2019). Retrieved from: https://blog.gotopac.com/2019/01/07/rotary-evaporators-for-ethanol-extraction-temperature-uses/).
Regarding claim 29, Barron does not teach the drying of the raffinate takes place at a temperature of < 120 °C.
Pickardt teaches evaporation of the alcohol and drying of the extracted sunflower seed solids from step (iii) in a rotation evaporator (i.e., rotary evaporator) in order to obtain sunflower protein concentrate ([0162]).
PAC teaches rotary evaporators allow one of the most efficient and environmentally friendly ways of removing a volatile solvent from a non-volatile sample (p. 1, paragraph 1). PAC teaches gentle agitation promotes thorough evaporation and reduces the risk of bumping or flash boiling (p. 5, paragraph 4). PAC teaches rotary evaporators use vacuum distillation to evaporate solvent from raw or processed materials (p. 3, paragraph 1). PAC teaches the introduction of a vacuum allows greater distillation capacity (p. 3, paragraph 2). PAC teaches as a general rule of thumb, the water bath temperature is set twenty degrees higher than the desired vapor temperature. PAC teaches for ethanol, the recommended vapor temp is 15 – 20 °C (p. 4, paragraph 2). According to the rule of thumb recommended by PAC, the bath temperature of the evaporation would be 35 – 40 °C, and the condenser temperature would be -5 – 0 °C (p. 4, 20/40/60 Rule). While claim 29 of the instant application does not detail whether the drying temperature is referring to the vapor or solid phase, all temperatures taught by PAC are below 120 °C.
Barron, Pickardt, and PAC are combinable because they are concerned with the same field of endeavor, namely, removal of an ethanol solvent from a non-volatile sample. 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 rotary evaporated (i.e., dried) the hemp seed solids (i.e., the raffinate) resulting from step (b) of Barron at a vapor temperature of 15 – 20 °C, a bath temperature of 35 – 40 °C, and a condenser temperature of -5 – 0 °C, as taught by PAC because rotary evaporation is efficient and environmentally friendly. Rotary evaporation also promotes thorough evaporation and reduces the risk of bumping or flash boiling.
Regarding claim 30, Barron does not teach the drying of the raffinate is carried out in a vacuum dryer, wherein at the end of the drying the pressure is reduced to < 500 mbar.
Pickardt teaches evaporation of the alcohol and drying of the raffinate in a rotation evaporator (i.e., rotary evaporator) in order to obtain sunflower protein concentrate ([0162]).
PAC teaches rotary evaporators allow one of the most efficient and environmentally friendly ways of removing a volatile solvent from a non-volatile sample (p. 1, paragraph 1). PAC teaches gentle agitation promotes thorough evaporation and reduces the risk of bumping or flash boiling (p. 5, paragraph 4). PAC teaches rotary evaporators use vacuum distillation to evaporate solvent from raw or processed materials (p. 3, paragraph 1). PAC teaches the introduction of a vacuum allows greater distillation capacity (p. 3, paragraph 2). PAC teaches for ethanol, the recommended vapor temp is 15 – 20 °C (p. 4, paragraph 2). According to a rule of thumb recommended by PAC, the vacuum pressure of the evaporation would be, at its highest, 27.03 torr (i.e., 36.03 mbar – p. 4, 20/40/60 Rule).
Barron, Pickardt, and PAC are combinable because they are concerned with the same field of endeavor, namely, removal of an ethanol solvent from a non-volatile sample. 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 rotary evaporated (i.e., dried) the hemp protein solids (i.e., the raffinate) resulting from step (b) of Barron at a vapor temperature of 15 – 20 °C, and a vacuum pressure of 27.03 torr (i.e., 36.03 mbar), as taught by PAC because rotary evaporation is efficient and environmentally friendly. Rotary evaporation also promotes thorough evaporation and reduces the risk of bumping or flash boiling.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Barron (US 20120288588 A1) in view of Shen et al. (The impact of hempseed dehulling on chemical composition, structure properties and aromatic profile of hemp protein isolate. Food Hydrocolloids. Vol. 106 (2020) – IDS Filed on May 23, 2023) and Pickardt et al. (US 20120009287 A1) as applied to claim 1 above, and further in view of Kaptay (On the size and shape dependence of the solubility of nano-particles in solutions. International Journal of Pharmaceutics. Volume 430, Issues 1–2, Pp. 253-257. (July 1, 2012)).
Regarding claim 32, Barron teaches the resulting hemp protein concentrate is a dry powder, therefore the high-protein hemp seed solids (i.e., the raffinate) produced by step (b) are necessarily dried ([0060]).
Barron does not teach after drying, high-protein hemp seed solids (i.e., the raffinate) is ground to a defined particle size distribution with a d90 value of < 500 µm.
Kaptay teaches the solubility of solid particles is found to increase with increasing its specific surface area (Abstract). By decreasing particle size, the total surface area of a ground powder is increased. Because decreasing the particle size increases the solubility of the protein powder, the particle size is a result-effective variable.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to grind the raffinate to a defined particle size distribution with a d90 value of < 500 µm after drying in the method of Barron, as taught by Kaptay because the solubility of the protein powder can be controlled by its particle size (i.e., surface area).
Response to Arguments
Applicant's arguments filed November 5, 2025 have been fully considered but they are not persuasive.
Applicant argues Shen is not suitable for use in combination with Barron (p. 8, paragraph 2).
Applicant’s argument has been carefully considered however the argument is not persuasive. In response to applicant's argument that Shen is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Shen is in the same field of endeavor as Barron, namely processing hemp seeds, and Shen is reasonably pertinent to the particular problem the inventor is concerned, namely, the lightness of the hemp protein isolate. Shen teaches dehulling the hemp seeds results in a protein isolate with light color because the darkening phenolics present in the hull are removed before processing (p. 3, 3.1 Impact of dehulling on extraction yield and color hemp protein, paragraph 2). While it is true that Barron and Shen utilize different extraction techniques to create hemp protein isolate, the removal of the hemp seed hulls, which Shen teaches cause the darkening of the hemp protein isolate, prior to any type of extraction would inherently lighten the resulting isolate relative to an isolate produced with hemp seeds and hulls.
Applicant argues there is no suggestion whatsoever from Barron, Shen, or Pickardt that one of ordinary skill in the art could use an alcohol-water mixture with a water content in a range between > 6% by mass and < 14% by mass (p. 8, paragraph 4).
Applicant’s argument has been carefully considered however the argument is not persuasive. The Office appreciates the clarity provided with respect to the use of 20 – 40% water in the exemplary extractions of Pickardt. While the claimed range of 6 – 14% water in the extraction medium is not used in the examples of Pickardt, the reference describes a predictable effect resulting from the controlled adjustment of the water content in the extraction medium (i.e., adjusting the water content of the ethanol controls the lipophilicity of the solvent). Therefore the Office has argued the water content of the extraction medium is a result effective variable. MPEP § 2144.05.III.C states applicants may rebut a prima facie case of obviousness based on optimization of a variable disclosed in a range in the prior art by showing that the claimed variable was not recognized in the prior art to be a result-effective variable. Therefore, while Pickardt does not explicitly teach extraction mediums with a water content between 6 and 14%, such percentages are prima facie obvious in view of the teachings of Pickardt.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/L.J.M./
Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793