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
1. Claims 24-46 are pending and subject to examination on the merits. Claims 24-46 are currently under examination.
Priority
2. Acknowledgement is made of applicant’s claim for foreign priority based on an application filed in Germany (EP2022/081050) on 08 November 2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 07 May 2024 has been considered by the examiner. See initialed and signed PTO/SB/08’s.
Drawings
4. The drawings are to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 9 and 12 are missing on Fig. 1 (the second iteration of 5 should be 9 according to Fig. 4), and 108 is missing in the drawings (appears to be in Fig. 4, denoted as 08 instead of 108). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
5. Claim 24 is objected to because of the following informalities: the phrase “water, with suspension” in claim 24 B) should be amended to “water by suspension” to improve grammar.
6. Claim 24 is objected to because of the following informalities: the phrase “with resuspension” in claim 24 C) should be amended to “by resuspension” to improve grammar.
7. Claims 31, 34-35, and 38 are objected to because of the following informalities: periods in claims are not permitted except at the end of the claim and when used for abbreviations (See MPEP 608.01(m)). Thus, it is suggested to replace, for example, “a.” with “(a)” or “a)”, etc. and “i.” with “(i)” or “i)”, etc. It is noted, the preferred format for sequence identifiers is “SEQ ID NO:” – see MPEP 2422.01 and 37 C.F.R. 1821(c) and (d).
Appropriate corrections are required.
FOR SEQ ID NO: - – See MPEP 2422.01 and 37 C.F.R. 1.821(c) and (d)
Claim Rejections - 35 USC § 112(b)
8. 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.
9. Claims 24-42 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.
10. The term “acidic range” in claim 24 D) renders the claim indefinite. The term “acidic range” is indefinite because the pH is defined in claim 24 A) as having a value <7; therefore, it is unclear what the acidic range is considered in the claim. Claims 25-42 are included in the instant rejection because they do not mitigate the issue.
11. The term “alkalizing” in claim 24 C) renders the claim indefinite. The term “alkalizing” is indefinite because unclear what the base-line or comparison of the pH of the high-protein prewashed phase is, i.e. alkalizing the high-protein prewashed phase compared to the aqueous suspension. Claims 25-42 are included in the instant rejection because they do not mitigate the issue.
12. The term “dwelling” in claim 25 renders the claim indefinite. The term “dwelling” is unclear because there is no recitation of a previous dwelling/incubation step in 24 B); therefore, it is unclear at what part of 24 B) a “dwelling” is supposed to take place.
13. The term “residues” in claim 28 renders the claim indefinite. The term “residues” is unclear because there is no recitation of a residue in claim 24 B). It is recommended to substitute “residues” with the claim language of 24 B), “remnants.”
14. The term “at least 1-5” in claim 28 renders the claim indefinite. The term “at least 1-5” is unclear because 1) there is no comparison of 1-5 times mass to compare it to, i.e. the mass of the pressed hemp, and 2) “at least” makes sense with the recitation of a minimum value but not a range from a minimum value to a maximum value, i.e. at least 1 is 1 or more.
15. The recitation of “15-50o” in claim 29 renders the claim indefinite. The term “15-50o” has no associated units. Therefore, it is unclear what temperature scale this temperature is referencing.
16. The recitation of “30-70 vol%” in claim 34 renders the claim indefinite. The term “30-70 vol%” has no associated reference unit, i.e. v/v, v/wt, etc.
17. The recitation of “10 wt.%” in claim 35 renders the claim indefinite. The term “10 wt.%” has no associated reference unit, i.e. wt/wt, wt/v.
18. The recitation of “10-50 wt.%” in claim 38 renders the claim indefinite. The term “10-50 wt.%” has no associated reference unit, i.e. wt/wt, wt/v.
19. The recitation of “dwell time” in claim 40 renders the claim indefinite. The term “dwell time” after the addition of acid in claim 24 is unclear. It would be clearer if the applicant amended the claim to add an incubation step between steps A-E of claim 24.
Claim Rejections - 35 USC § 103
21. 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.
22. 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.
23. Claims 24-26, 28-32, 34-45 are rejected under 35 U.S.C. 103 as being unpatentable over Teh et al (Teh et al., 2014, Food Measure—cited on the IDS dated 07 May 2024), as evidenced by Biology Insights (Biology Insights, 2026, “Why is the pH of Deionized Water not 7?” downloaded 19 August 2026 from as a PDF <https://biologyinsights.com/why-is-the-ph-of-deionized-water-not-7/> -- cited herein), and in view of Novak and Havlicek (Novak and Havlicek, 2016, Proteomic Profiling and Analytical Chemistry—cited herein). Regarding claims 24-25, 27-32, 36, 39-42 drawn to a method for obtaining proteins from hemp by a) providing hemp pressing remnants, wherein said hemp remnants are provided by mechanical pressing (claim 27); b) prewashing said hemp remnants with water, at a ratio of at least 1:1 (claim 28), at a pH value <7, forming an aqueous low-protein contaminant phase and a high prewashed protein phase, with an incubation time of at least an hour (claim 25) at a temperature between 15-50oC on an agitator with a speed of 3-7m/s (claims 29 and 32); c) extracting proteins by alkalizing the high-protein prewashed phase, to a pH value between 9-11 (claim 31) at a temperature less than 55oC (claim 41), to form an aqueous suspension and further separating a shell fraction and an aqueous protein fraction, where this step is repeated at least once (claims 30-31); d) precipitating proteins with the addition of a short-chain alcohol and an acid shifting the pH to the acidic range to a pH value of 5.0 +/-0.8 (claim 36) with hydrochloric acid (claim 39) and incubating the mixture for at least 10 mins (claim 40), producing a clear and heavy phase; and e) separating the clear and heavy phases into a low protein and high protein phase and subsequently washing the high phase (claim 42), Teh et al. teaches utilizing cold-pressed hemp seed cakes as a by-product after cold-pressing oil extraction process (p. 93, Materials and Methods, paragraph 1) in an alkaline extraction of proteins by first, resuspending the cake at a ratio of 150g of seed cake in 1.5L of deionized water (1:10) (p. 93, Materials and Methods, column 2, paragraph 2), where deionized water often has an acidic pH, typically between 5.5-6.5, as evidenced by Biology Insights (p. 1, paragraph 1). Teh et al. continues to teach adjusting the pH of the defatted cake mixture to 10, agitating the mixture for 1hr in an orbital mixer incubator, centrifuging the mixture to collect the supernatant for 30 mins, resuspending the residue with deionized water and repeating the same alkaline extraction procedure, combining the supernatants and adjusting the pH to the calculated isoelectric point of hemp seed cake to pH 5.0, separating the precipitated protein by centrifugation and washing the precipitated protein and resuspending the protein in deionized water (p. 93, Materials and Methods, column 2, paragraph 2), where the extraction takes place at room temperature. Regarding claim 26, drawn to hemp remnants having a normal distribution over a mean diameter of 1.2-2.5mm and the hemp remnants are already partially de-oiled, Teh et al. teaches the utilization of hemp seed cakes with average diameters of 120µm (Fig. 1) and the cold-pressed hemp seed cakes being the by-product of a cold-pressing oil extraction process (p. 93, Materials and Methods, paragraph 1). Regarding claim 45, drawn to not adding salt during the entirety of the extraction, Teh et al. teaches the addition of deionized water, NaOH, and HCl and does not teach any salt additions (Materials and Methods).
Teh et al. does not teach the addition of a short-chain alcohol having fewer than four carbon atoms (claim 24), agitation with an agitator set to a speed of 3-7 m/s (claim 29), alcohol concentration between 30-70% v/v (claim 34), the addition of water to decrease the alcohol concentration to less than 10% v/v (claim 35), the short-chain alcohol being ethanol (claim 37), the addition of an alkali with a concentration of 10-50% wt/v (claim 38), and an incubation time after the addition of the acid of at least 10 mins (claim 40).
Novak and Havlicek teach the utilization of ethanol to precipitate proteins from solution (p. 57, 4.7 Organic Solvent-Driven Precipitation), where Novak and Havlicek continue to teach 60-80%v/v ethanol concentration to precipitate ballast proteins (p. 58, first paragraph).
The recited agitator speed, alkali concentration of 10-50% wt/v, alcohol concentration between 30-70% v/v decreasing alcohol concentration to 10% v/v, and incubation time of at least 10 mins are variables subject to routine optimization, where routine optimization to determine the optimal working conditions of an invention is not non-obvious. The MPEP states, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP Section 2144.05.
Therefore, it 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 combine the teachings of Teh et al. and Novak and Havlicek to isolate the proteins from a pressed hemp seed cake to extract protein for human nutrition, as taught by Teh et al (Introduction, paragraph 1). One would be motivated to combine these teachings to arrive at the instant claims to produce proteins that are economical and renewable compared to protein derived from animals, as taught by Teh et al (Introduction, paragraph 2). There would be a reasonable expectation of success, yielding no surprising results when combining the teachings of Teh et al. and Novak and Havlicek to isolate proteins from hemp seed cakes utilization alkaline conditions with ethanol, since Teh et al. teaches the protein isolation and Novak and Havlicek teach the enhancement of protein precipitation with the utilization of ethanol.
24. Claims 27, 33, and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Teh et al (Teh et al., 2014, Food Measure—cited on the IDS dated 07 May 2024), as evidenced by Biology Insights (Biology Insights, 2026, “Why is the pH of Deionized Water not 7?” downloaded 19 August 2026 from as a PDF <https://biologyinsights.com/why-is-the-ph-of-deionized-water-not-7/> -- cited herein), in view of Novak and Havlicek (Novak and Havlicek, 2016, Proteomic Profiling and Analytical Chemistry—cited herein), as applied to claims above, and further in view of Bourgeois (Bourgeois, 2020, EP3071045B1—cited herein).
The teachings of Teh et al, as evidenced by Biology Insights, and in view of Novak and Havlicek are discussed above and incorporated into the instant rejection.
Teh et al, as evidenced by Biology Insights, and in view of Novak and Havlicek do not teach the omission of an organic solvent to further extract oil from the hemp seed cake (claim 27), phase separations in a decanter (claim 33), and a gel (claim 46). Bourgeois teaches the extraction of pea proteins in the food industry, where Bourgeois teaches an aqueous slurry of pea proteins (claim 1). Additionally, Bourgeois teaches the utilization of decantation centrifugation to separate the phases (claim 38), and the formation of a protein gel consisting of the protein suspension being subjected to heating and subsequent cooling (paragraph 0162).
Therefore, it 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 combine the teachings of Teh et al, as evidenced by Biology Insights, and in view of Novak and Havlicek with Bourgeois to precipitate proteins from hemp seed cakes utilizing downstream processes such as decantation centrifugation and gel formation to produce feed products, as taught by Bourgeois. One would be motivated to combine these teachings to arrive at the instant claims to produce proteins that are economical and renewable compared to protein derived from animals, as taught by Teh et al (Introduction, paragraph 2). There would be a reasonable expectation of success, yielding no surprising results when combining the teachings of Teh et al. and Novak and Havlicek with Bourgeois to isolate proteins from hemp seed cakes utilization alkaline conditions with ethanol without the use of organic solvents, since Bourgeois teaches the precipitation of plant proteins from peas without the utilization of an organic solvent.
Conclusion
25. All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CIARA A MCKNIGHT whose telephone number is (703)756-4791. The examiner can normally be reached M-F 8:00am-4:30pm.
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/CIARA A MCKNIGHT/Examiner, Art Unit 1656
/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656
Prosecution Insights