Prosecution Insights
Last updated: July 17, 2026
Application No. 18/561,309

IMPROVED METHOD FOR PREPARATION OF PROTEIN-ENRICHED PRODUCTS FROM PLANT MATERIAL

Non-Final OA §103§112
Filed
Nov 16, 2023
Priority
May 17, 2021 — NL 2028223 +1 more
Examiner
GWARTNEY, ELIZABETH A
Art Unit
1759
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Napiferyn Biotech Sp Z O O
OA Round
2 (Non-Final)
36%
Grant Probability
At Risk
2-3
OA Rounds
4y 4m
Est. Remaining
71%
With Interview

Examiner Intelligence

Grants only 36% of cases
36%
Career Allowance Rate
243 granted / 668 resolved
-28.6% vs TC avg
Strong +35% interview lift
Without
With
+34.9%
Interview Lift
resolved cases with interview
Typical timeline
7y 0m
Avg Prosecution
70 currently pending
Career history
731
Total Applications
across all art units

Statute-Specific Performance

§101
1.8%
-38.2% vs TC avg
§103
80.7%
+40.7% vs TC avg
§102
5.7%
-34.3% vs TC avg
§112
6.2%
-33.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 668 resolved cases

Office Action

§103 §112
DETAILED ACTION The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The Amendment filed April 2, 2026 has been entered. Claim 11 is cancelled. Claim 21 is new. Claims 1-10, 12-19 and 21 are pending examination. The Response filed April 2, 2026 has been considered. A new grounds of rejection under 35 U.S.C. 112 (b) and 35 U.S.C. 103 is set forth below. This Office Action is non-final. Drawings The drawings are objected to because there are no units on the y-axis of Figures 24, 25, 29, 30 and 46. Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 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 1-10, 12-19 and 21 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. Regarding claim 1, the recitation “separating the mixture obtained in step f) into a third liquid fraction, further referred to as spent third solvent and a third solid fraction” renders the claim indefinite. First, there is no antecedent basis for the term “the mixture.” Does “adding a third solvent to the second solid fraction obtained in step 3)” obtain a mixture? Second, it is not clear which term is used to describe the “liquid fraction in step g) – Is “the mixture” from f) separating into a third liquid fraction and a third solid fraction or spent third solvent and a third solid fraction? Third, it is not clear if the third liquid fraction is the same or different as the recovered third solvent in step f). The specification states that spent third solvent is a result of separation (p. 13/L17-21). It is not clear how the spent third liquid could be recovered in step f) before the separation step of g). 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 present instance: -claim 14 recites the broad recitation “rotary evaporators, wiped-film evaporators, scraped-film evaporators, falling-film evaporators, rising-film evaporators, short-path evaporators”, and the claim also recites “preferably being a falling-film evaporator” which is the narrower statement of the range/limitation. The claim(s) 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. Regarding claims 12-14, the recitation “The process according to claim 11” renders the claim indefinite because a claim cannot depend from a cancelled claim. Regarding claim 21, the recitation “wherein the third solvent added in step f) preferably comprises less than 2 wt% water. It is not clear if the limitation on water content is optional or required. With respect to the prior art, the solvent does not have to comprise less than 2 wt% water. Claims 2-10, 15-19 and 21 are rejected because they depend from a rejected base claim. 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. 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 1-10, 12-16, 18, 19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Wnukowski et al. (WO 2019/011904-cited in IDS filed 11/16/2023). Regarding claims 1, 9, 18 and 21, Wnukowski et al. disclose a method for isolating protein from plant material (i.e., plant protein-enriched product) wherein the plant material comprises between 10 and 50 wt% on a dry weight basis of proteins (p. 3/L16-18) comprising the steps of: (a) crushing or comminuting the plant material to products a solid cake; (b) extracting the solid cake obtained in step (a) using a first solvent comprising at least 90 wt% of water, based on the total weight of the first solvent, to obtain a mixture of a first solid fraction and a first liquid fraction; (c) separating the first liquid fraction from the first solid fraction; (d) preparing a protein concentrate from the first liquid fraction obtained in step (c); (e) adding a second solvent to the protein concentrate obtained in step (d) wherein the second solvent comprises at least 90 wt% of an alcohol having 1 to 5 carbon atoms being miscible with water at room temperature, based on the total weight of the second solvent; (f) separating the mixture obtained in step (e) into a second liquid fraction and a second solid fraction; (g) adding a third solvent to the second solid fraction obtained in step (f), said third solvent comprising at least 90 wt% of an apolar and lipophilic organic ester having up to 5 carbon atoms, based on the total weight of the third solvent, wherein the apolar and lipophilic organic ester having up to 5 carbon atoms is at least partially miscible with the first solvent and fully miscible with the second solvent at room temperature, and wherein the amount of the third solvent is chosen such that the overall liquid phase does not separate into distinct liquid phases; (h) separating the mixture obtained in step (g) into a third liquid fraction (i.e., spent third solvent) and a third solid fraction; and (i) subjecting the third solids fraction obtained in step (h) to a drying process to obtain a protein isolate (i.e., protein enriched product) having a protein content of at least 90 wt% based on total dry weight of the protein isolate (p. 3/L16-p.4/L17, p. 6/L1-p. 7/L6). Here, given Wnukowski et al. disclose a separating step h) wherein the mixture is separated in to a third liquid fraction and a third solid fraction (i.e., spent third solvent), the third liquid fraction is considered recovered. Wnukowski et al. does not disclose the third solvent is an azeotropic mixture comprising organic ester, the alcohol having 1 to 5 carbon atoms, and less than 10 wt% water. However, given Wnukowski et al. disclose a third solvent comprising at least 90 wt% apolar and lipophilic organic solvent, the third solvent could comprise an additional 10 wt% of a different solvent. Wnukowski et al. disclose the apolar and lipophilic ester is at least partially miscible and fully miscible with the second solvent having an alcohol with 1 to 5 carbon atoms (p. 6/L23-26). Wnukowski et al. also disclose wherein the third solvent is chosen such that the overall liquid phase does not separate into distinct liquid phases (p. 6/L26-28). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have made the third solvent of Wnukowski et al. comprising 90 wt% of an apolar and lipophilic organic solvent; 10 wt% of an alcohol having 1 to 5 carbon atoms and 0 wt% water, and arrive at the present invention with a reasonable expectation of success. The composition would not be expected to separate into distinct liquid phases and no further separation by distillation would be possible (i.e., azeotropic mixture). Regarding claims 2 and 3, Wnukowski et al. disclose all of the claim limitations as set forth above. Wnukowski et al. is silent with respect the amount of (a) plant protein isolate produced in a batch; or (b) the amount of solid cake extracted in a batch or per hour in a continuous production process. The mere scaling of a process capable of being scaled up or down does not establish patentability of a claim to an old process so scaled (see MPEP§ 2144.05). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to have scaled the process of Wnukowski et al. to a particular batch size or process rate depending on the purpose of the process. Regarding claims 4 and 6, Wnukowski et al. disclose all of the claim limitations as set forth above. While Wnukowski et al. disclose a process wherein the first solvent comprises 90% of an organic ester and 10% of an alcohol having 1 to 5 carbons, a prima facie case of obviousness exists where the claimed range or amounts do not overlap with the prior art are merely close. The claimed amounts are so close to those of Wnukowski et al. that prima facie one skilled in the art would have expected them to have the same properties (MPEP §2144.05 I.) Regarding claim 5, Wnukowski et al. disclose all of the claim limitations as set forth above. Wnukowski et al. disclose wherein the apolar solvent (i.e., organic ester) is ethyl acetate (p. 13/L22-26). Regarding claim 7, Wnukowski et al. disclose all of the claim limitations as set forth above. Wnukowski et al. disclose wherein the alcohol having 1 to 5 carbon atoms is selected from the group consisting of methanol, ethanol, propanol, iso-propanol, butanol, iso-butanol, and combinations thereof (p. 11/L29-31). Regarding claim 8, Wnukowski et al. disclose all of the claim limitations as set forth above. Wnukowski et al. disclose the alcohol having 1 to 5 carbon atom can be ethanol (p. 11/L29-31). Regarding claim 10, Wnukowski et al. disclose all of the claim limitations as set forth above. While Wnukowski et al. is silent with respect to generating a spent third solvent, given Wnukowski et al. disclose a process substantially similar to that of the present invention, it necessarily follow that upon drying the third solid fraction, a spent third solvent would be generated. Regarding claim 12, Wnukowski et al. disclose all of the claim limitations as set forth above. Given Wnukowski et al. disclose separating a mixture into a third liquid solvent (i.e., spent third solvent) and a third solid fraction, identical to the claimed separation step, inherently the spent third solvent comprises at least 10 wt% water. Regarding claim 13, Wnukowski et al. disclose all of the claim limitations as set forth above. Wnukowski et al. disclose a step of drying the third solid fraction in a vacuum dryer at a pressure of 10 mbar (i.e., 1 kPa- p. 23/L30-33). This step would result in the recovery of a portion of the spent third solvent. Regarding claim 14, Wnukowski et al. disclose all of the claim limitations as set forth above. While Wnukowski et al. does not disclose the claimed evaporators, Wnukowski et al. disclose vacuum drying (i.e., vacuum evaporator). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have used any type of evaporator to dry the third solid fraction, including the claimed evaporators and arrive at the present invention with a reasonable expectation of success. Regarding claim 15, Wnukowski et al. disclose all of the claim limitations as set forth above. Wnukowski et al. disclose that hexane should not be used as a solvent because it is considered noxious (p. 14/L27-30). Wnukowski et al. disclose the process is performed without using organic or mineral solvent having 6 or more carbon atoms (p. 15/L3-4). Regarding claim 16, Wnukowski et al. disclose all of the claim limitations as set forth above. Wnukowski et al. disclose wherein the plant material is selected from the group consisting of oilseeds, including rapeseed, canola, sunflower, safflower and cottonseed, pulses, including soybeans and other beans, legumes and peas, including chickpea, red, green, yellow and brown lentils and combinations thereof (p. 7/L7-32). Regarding claim 19, Wnukowski et al. disclose all of the claim limitations as set forth above. Wnukowski et al. disclose a process wherein native and functional protein isolates are obtained (Abstract, p. 2/L25-28). Wnukowski et al. disclose a protein isolate comprising at least 70 wt% of native plant-based protein based on dry matter (p. 4/L18-22). Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Wnukowski et al. (WO 2019/011904-cited in IDS filed 11/16/2023) as applied to claim 1, and further in view of Wnukowski et al. (WO 2020/016222-cited in IDS filed 11/16/2023)(“Wnukowski et al. ‘222). Regarding claim 17, Wnukowski et al. disclose all of the claim limitations as set forth above. While Wnukowski et al. disclose a step (d) preparing a protein concentrate from the first liquid fraction obtained in step (c) and (e) adding a second solvent to the protein concentrate obtained in step (d) wherein the second solvent comprises at least 90 wt% of an alcohol having 1 to 5 carbon atoms being miscible with water at room temperature, based on the total weight of the second solvent, the reference is silent with respect to adding the second solvent to the first solid fraction. Wnukowski et al. ‘222 teaches a process of preparing a protein-fiber concentrate from plant material comprising identical steps to the process of Wnukowski et al. with the exception of at step d) adding the second solvent to the first solid fraction rather than to a concentrated first liquid fraction. Wnukowski et al. and Wnukowski et al. ‘222 are combinable because they are concerned with the same field of endeavor, preparing plant protein-enriched products. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have added the second solvent to the first solid fraction, as taught by Wnukowski et al. ‘222 in order to obtain a product enriched in both protein and fiber. Response to Arguments Applicant’s arguments with respect to claims 1-10, 12-19 and 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH A GWARTNEY whose telephone number is (571)270-3874. The examiner can normally be reached M-F: 9 a.m. - 5 p.m. EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at 571-272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. ELIZABETH A. GWARTNEY Primary Examiner Art Unit 1759 /ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759
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Prosecution Timeline

Nov 16, 2023
Application Filed
Dec 03, 2025
Non-Final Rejection mailed — §103, §112
Apr 02, 2026
Response Filed
Jun 02, 2026
Non-Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

2-3
Expected OA Rounds
36%
Grant Probability
71%
With Interview (+34.9%)
7y 0m (~4y 4m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 668 resolved cases by this examiner. Grant probability derived from career allowance rate.

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