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 Claims
Receipt of Remarks/Amendments filed on 10/30/2025 is acknowledged. Claims 2, 12, and 17 are cancelled. Claims 13-16 and 18 are non-elected claims, and are withdrawn. Claims 20-21 are new. Claims 1, 3-11, and 19-21 are presented for examination on the merits for patentability.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/05/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the Examiner.
Modified Rejection As Necessitated by the Amendment Filed 10/30/2025
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.
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, 3-5, 7-11, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi et al. (EP 0976829 B1, cited in the IDS; Of record), and in view of Rinas et al. (DE 4116744 A1, machine translated in IP.com), hereinafter Rinas.
Yamaguchi discloses a novel enzyme, which acts upon side chain amido groups in protein and thereby releases side chain carboxyl groups and ammonia, i.e. deamidating amido groups in protein [0001].
Regarding Claims 1 and 7, Yamaguchi teaches the production of a coffee whitener using deamidated wheat gluten (Examples 11 and 13). Specifically, 5 g of deamidated wheat gluten was mixed with corn syrup, polysorbate 60 and water; the mixture was heated and mixed with dipotassium hydrogen phosphate and heated; Partially hydrogenated coconut oil and monoglyceride were added, and the resulting mixture, homogenized under a pressure of 211 kg/cm2, which is equivalent to 207 bar, producing a coffee whitener containing deamidated gluten ([0113], [0118], [0130]-[0131], [0135]).
Yamaguchi does not expressly teach the carbohydrate-hydrolyzing enzyme in Claim 1.
Rinas is in a related field and teaches the production of seasoning from plant raw material where the substrate is finely distributed in water is hydrolyzed by proteases, peptidases, glutaminases, and maceration enzymes, i.e. cellulases, pectinases, or amylases (Abstract). The combination produces a seasoning with no bitter taste (Abstract). Rinas relates that seasonings are obtained by hydrolysis of amino acids obtained from vegetable protein, i. e. glutamic acid, increasing the individual taste of food (p. 5). The proteases hydrolyze and expose the amino acids; the glutaminases converts glutamine to glutamic acid; the starch, cellulose and other carbohydrates, which contributes to the aroma, are also cleaved by adding macerating enzymes, such as cellulase, pectinases, glucanases and amylases (p. 5; Claims 4 and 7-8). Rinas expressly teaches cellulase (p. 3).
Yamaguchi expressly teaches the production of enzyme-digested liquid seasoning, and welcomes the addition of other enzymes (Example 20). Rinas is in the seasoning field and teaches addition of maceration enzyme including cellulases (Abstract). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to use the cellulase maceration enzyme of Rinas combined with the glutaminase enzyme in the composition of Yamaguchi to produce a seasoning with the desired flavor and aroma, with less bitter taste.
Regarding Claims 3-4, Yamaguchi teaches treating 45g gluten in a total of about 195 g composition with 50 units of protein-deamidating enzyme, 0.1% glutaminase F100, and 0.75% proteinase M, and mixing together with the gluten in brine, reading on the simultaneous addition of enzymes and on the glutaminase (Example 20).
Regarding Claims 5 and 20, Yamaguchi teaches treating 45g gluten in a total of about 195 g composition with 0.1% glutaminase F100 in the production of enzyme-digested liquid seasoning (Example 20). The 0.1% glutaminase is within the claimed ratios based on the amount of enzyme with respect to the total weight of composition. While the exact ratio is not disclosed by Yamaguchi, it is generally noted that differences in concentrations and ratios do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such ratio is critical. "[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). Given that applicant did not point out the criticality of the ratio of protein containing composition to protein-deamidase the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to determine where in a disclosed set of ranges is the optimum Ratio. NOTE: MPEP 2144.05.
Regarding Claim 8, Rinas expressly teaches cellulase (p. 3).
Regarding Claims 9-10, Rinas teaches that the various enzymes can be processed in a single step in a mixture, but that it is preferable that the enzymes are added in a multi-step process (p. 5). The first enzymatic reaction comprises the mixture of proteases; followed by deamination by adding glutaminase, and preferably with the macerating enzyme (p. 6).
Regarding the order of steps, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to add the various enzymes in a single step in a mixture, or in a multi-step process as taught by Rinas, depending on the hydrolysis yield and desired aroma.
The Examiner notes that the Applicant does not disclose the criticality of the steps. The instant situation is amenable to the type of analysis set forth in Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious). Thus the claimed variation of steps would have been obvious to a skilled artisan. Unless Applicant demonstrates the criticality of the order of addition and that the prior art is not the same product as the instant application, changes in sequence of adding ingredients has been rendered to be prima facie obvious Note MPEP § 2144.04 [R-1] In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious).
Regarding Claim 11, Yamaguchi describes suspending and dissolving 2.0 mg portion of deamidated gluten powder and enzyme-untreated in 1.0 ml of 40 mM Britton-Robinson buffer having a pH value of from 3 to 12, and showed the deamidated gluten has markedly improved dispersibility and solubility, with solubility of less than 40% at around pH 4-11 (Example 12; Fig. 12).
Regarding Claim 21, Yamaguchi expressly teaches homogenization under a pressure of 211 kg/cm2, which is equivalent to 207 bar (Example 13). One skilled in the art would start at this pressure and modify accordingly as a matter of experimentation and optimization, arriving at the claimed pressure. The adjustment of particular conventional working conditions is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi in view of Rinas, as applied to Claim 1 above, and further in view of Rommi et al. (Food Bioprocess Technol (2015) 8:2392–2399, machine translated in IP.com), hereinafter Rommi.
Regarding Claim 6, in the event that Yamaguchi does not teach the press cake, it is still rendered obvious over Yamaguchi in view of Rommi.
Rommi relates that rapeseed cold-pressed cake has gained growing interest as a potential
plant-based protein source for use as animal feed, and noted how rapeseed protein has favorable features for human use (Introduction). Rommi teaches that rapeseed press cake has high carbohydrate content, and phytates and phenolics negatively impacts its digestibility and sensory properties, but are resolved by use of proteases and/or cell wall-degrading enzymes (Introduction).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Yamaguchi and Rommi to use the method taught by Yamaguchi to prepare a rapeseed press cake or other plant-based protein press cake with better digestibility and sensory properties.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable Yamaguchi in view of Rinas, as applied to Claim 1 above, and further in view of Alting et al. (WO 2016/129998 A1), hereinafter Alting.
Yamaguchi is silent on spray drying.
Alting discloses a method for preparing an aqueous dispersion comprising colloidal protein particles dispersed in an aqueous fluid, which colloidal protein particles comprise caseinate and one or more plant proteins, and food products comprising the same (Abstract). Alting also teaches using deaminated sodium caseinate wherein the dispersion comprising sodium caseinate is stirred it with protein glutaminase prior to homogenization (Example 5; p. 5). Alting expressly teaches an example wherein oat bran powder with or without sodium caseinate, and rice kernel powder with or without sodium caseinate, and the dispersion in is homogenized at a pressure of 35 MPa, which is equivalent to 350 bar, before spray-drying (Example 2).
Regarding Claim 19, Alting teaches while aqueous colloidal dispersion may be used in the preparation of a food product etc., or the hybrid protein particles may be obtained from the colloidal dispersion by drying the aqueous dispersion via generally known drying techniques, e.g. drum drying, spray drying or freeze-drying to give a powder (p. 13, pp. 28-29). Spray drying is particularly useful in obtaining a powder of particles having a core-shell morphology, with increased dispersibility (pp. 13-14).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to improve upon the method of Yamaguchi and use the spray-drying technique of Alting to obtain protein particles from the colloidal dispersion after the deamidase treatment if a core-shell morphology is desired and/or increase the dispersibility of the composition.
Response to Remarks:
Applicant appears to traverse the combination of Rinas with Yamaguchi because Yamaguchi teaches deamidated gluten and coffee whitener in Examples 11 and 13, and Rinas teaches seasoning products. Applicant submits hindsight bias.
The Examiner has considered the argument but was not persuaded. The Examiner also cited Example 20 of Yamaguchi in the previous Office Action (102 section, p. 7), which teaches production of liquid seasoning. Therefore Rinas is highly compatible with Yamaguchi. The motivation for the combination is clarified supra.
Further in response to Applicant's argument that the Examiner's conclusion of obviousness is based upon i hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant submits Yamaguchi in view of Rinas fails to disclose both a step of subjecting the plant-based protein-containing composition to a protein-deamidase treatment and a step of subjecting the plant-based protein-containing composition to a carbohydrate-hydrolyzing enzyme, making the claimed order of steps nonobvious in accordance with Ex parte Chau, a necessary prerequisite for applying this reasoning [In re Burhans] is evidence that the process steps themselves were known and used in the cited prior art...”.
The Examiner traverses the argument. As discussed above, Rinas teaches the addition of in a multi-step process (p. 5). The first enzymatic reaction comprises the mixture of proteases; followed by deamination by adding glutaminase, and preferably with the macerating enzyme (p. 6). As such, there is guidance from the prior art, which is modifiable.
Applicant further submits that the Examples of the present disclosure demonstrate that a treatment process including a carbohydrate-hydrolyzing enzyme, a protein-deamidase, and high-pressure homogenization yields superior properties and characteristics as compared to the individual treatments alone. Applicant cited its Example 1 and Fig. 2 as evidence of a significant synergistic effect between the carbohydrate-hydrolyzing enzyme, the protein-deamidase, and high-pressure homogenization. Applicant related that the combination of the combination of a carbohydrate-hydrolyzing enzyme and a protein-deamidase achieved an emulsion instability index of 0.040, which is lower than carbohydrate-hydrolyzing enzyme alone, 0.251, and the protein deamidase alone, 0.043. Applicant also remarked that the combination treatment achieved improved foam stability as compared to the carbohydrate-hydrolyzing enzyme alone or the protein deamidase alone.
The Examiner considered the argument but was not persuaded. First and foremost, the claims are drawn to a method of treatment of a plant-based protein containing composition comprising the steps of: mixing the plant-based protein-containing composition with an aqueous medium, treating with deamidase, homogenizing at high pressure, and further comprises treatment a carbohydrate-hydrolyzing enzyme. Yamaguchi teaches the high pressure homogenization and the protein demidase treatment. In order to be convincing, the comparison between the instant claim steps and the closest prior art must be made.
Applicant’s reliance upon the data provided in Fig. 2 to demonstrate that the instantly claimed method has superior effects has been fully and carefully considered, but fails to be probative of nonobviousness of the instantly claimed subject matter. Firstly, the data fails to demonstrate the method of treating the composition were unexpectedly greater than what would have already been expected by one of ordinary skill in the art at the time of the invention. In the instant case, Applicant pointed to the exceptional solubility of the protein to be higher. It is expected that the same method taught by Yamaguchi, which teaches the same deamidase treatment and homogenization at high pressure, would result in the same solubility. Please see MPEP §716.02(b)[R-2], which states, “The evidence relied upon should establish ‘that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.’ Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992)”. Any differences between the claimed invention and the prior art is expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. The burden is on the Applicant to establish that the results are in fact unexpected, unobvious, and of statistical and practical significance. See MPEP 716.02(b).
The Examiner notes that while Fig. 2 appears to show that adding the homogenization step to the enzyme treatments improved protein solubility, Fig. 10 appears to not show a significant increase. Figure 2 probes the protein stability of soy flour, whereas Figure 10 probes the protein stability of sesame press cake. This raises the question of whether the showing of unexpected results is commensurate in scope to all plant-based proteins given the information shown in in Figure 10 for sesame, or if the unexpected result only applies to soy proteins.
Regarding Example 2, the Examiner argues that the difference between the emulsion instability index of the combination of a carbohydrate-hydrolyzing enzyme and a protein-deamidase (0.040) does not differ from deamidase alone (0.043).
Regarding the remark that the combination treatment achieved improved foam stability as compared to the carbohydrate-hydrolyzing enzyme alone or the protein deamidase alone, and that the viscosity improves with the inclusion of carbohydrate-hydrolyzing enzyme, the Examiner notes that the difference in viscosity in Table 1 between variants 3 (62 mPas) and 4 (59 mPas) is not significant. Table 2 shows the instability index, but there appears to be little difference between variants 3 (0.043) and 4 (0.040); and the difference in foam stability in Table 3 between variants 3 (85%) and 4 (87%) is also not significant.
As above, because the closest prior art Yamaguchi teaches the same steps of deamidation and homogenization, Applicant must compare with Yamaguchi in order to be convincing.
Lastly, the Examiner notes that additive effect is not necessarily sufficient to overcome a prima facie cases of obviousness because such an effect can either be expected or unexpected (716.02(a).I).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3-4, 7 and 9-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-12 of co-pending Application 18/246,455, hereinafter ‘455.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same subject matter and composition components.
Both the instant claims and ‘455 are drawn to processes of treating protein in plant-based products, and requires mixing a plant-based composition with aqueous solvent, followed by enzymatic treatment with glutamines and carbohydrate-hydrolyzing enzymes, and homogenization.
Therefore, the claims are drawn to the same subject matter and are not patentably distinct from the instant claims.
Claims 1, 3-7 and 9-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, d 11, and 19 of co-pending Application 18/002,542, hereinafter ‘542.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same subject matter and composition components.
Both the instant claims and ‘542 are drawn to processes of treating protein in plant-based products, and requires mixing a plant-based composition with aqueous solvent, followed by enzymatic treatment with glutamines and carbohydrate-hydrolyzing enzymes, and homogenization. Further, the composition is in the form of press cake.
Therefore, the claims are drawn to the same subject matter and are not patentably distinct from the instant claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure. Amano et al., US 2009/0123598 A1.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.Y.S./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792