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 .
DETAILED ACTION
Claims 1-20 are pending and under examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/28/2025 has been entered.
Claim Objections
Claim 2 is objected to because of the following informalities: the claim contains convoluted and redundant language. Claim 2 may be amended to recite: The method according to claim 1, wherein the fava bean composition provided in step i. has been heat treated or sterilized to reduce microbial content, or wherein the method further comprises a step of:
iii. heat treating or sterilizing the fava bean composition to reduce microbial content.
Appropriate correction is required.
Response to Arguments
Applicant's arguments filed 07/28/2025 have been fully considered but they are not persuasive. Applicant argues that it is evident that fermentation affects a sieved and diluted suspension differently compared to the composition of the instant invention. However, Applicant provides no objective evidence using sieved or diluted fababean suspensions to demonstrate that they are fermented differently.
Applicant argues that McKay shows no data regarding the content of divicine and isouramil. However, vicine and convicine are precursors of divicine and isouramil, as evidenced by Rizello (Abstract), and when vicine and convicine are degraded, the aglycone derivatives, i.e., divicine and isouramil cannot be detected, as evidenced by Rizello (Abstract). Therefore, it is considered that the method of McKay inherently results in the degradation of divicine and isouramil.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the teachings of McKay, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, one of ordinary skill in the art would have motivated to combine both the enzyme and the fermentation step in order to determine whether the time required to degrade the glycosides is reduced.
Claim Rejections - 35 USC § 112(b)
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 3, 6, 7, and 12 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 3, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 6 recites dosage of betaglucosidase at least 0.1 wt% based on the amount of the fava bean composition, but does not recite how many units of betaglucosidase should be present in the mass. An enzyme amount is known to one of ordinary skill in the art as enzyme activity units and the enzyme concentration is indicated as units per volume. Simply requiring a weight percentage renders the enzyme amount indefinite. Therefore, one of ordinary skill would not know what amount or concentration of betaglucosidase is required by the claim.
Regarding claim 7, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 7 also recites a dosage of Lactobacillus plantarum at a concentration of at least 0.01 wt%, but does not recite how many CFUs should be present in the volume. A bacterial amount is known to one of ordinary skill in the art as colony forming units (CFUs), and bacterial concentration is indicated as CFU per volume, as widely known to any one of ordinary skill in the art. Simply requiring a weight percent renders the bacterial amount indefinite. One of ordinary skill would not know the standard of obtaining the recited concentration of Lactobacillus plantarum.
Regarding claim 12, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 12 also recites: whereby the remainder of the fava bean composition defines a liquid fraction of the fava bean composition. This whereby clause is indefinite as it is uncertain whether any additional method step and/or the step of collecting a liquid fraction is required by the 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.
It is of note that claims 13, 15, and 17-19 are product-by-process claims. See MPEP 2113.I, which states "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process."
Claims 1-9, 11, 13, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over A.M. McKay (Hydrolysis of vicine and convicine from fababeans by microbial β-glucosidase enzymes, J. of Applied Bacteriology 1992, 72, 475-478, in IDS 11/12/2021) as evidenced by Rizzello et al. (Degradation of vicine, convicine, and their aglycones during fermentation of faba bean flour. SCIENTIFIC REPORTS 2016, 6:32452, in the 11/12/2021 IDS).
Regarding claims 1, 3, and 13, McKay teaches dehulled, ground (i.e., crushed and/or homogenized), and sieved fababeans, i.e., fava beans, suspended in water at 0.8% w/v (p. 476, col 1., Preparation of fababeans). Although the concentration of dry matter taught by McKay differs from that of the instant claim, MPEP§ 2144.05 II states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.")” The selection of dry matter content wt% of the fababean composition would have been a matter of routine optimization on the part of the artisan of ordinary skill.
McKay teaches incubation of fababeans with Lactobacillus plantarum (Abstract), which produces intracellular β-glucosidase (p. 477, col. 2, para. 1). McKay teaches that L. plantarum eliminated vicine after 2 days (p. 477, col. 1, Table 1, and para. 1), i.e., vicine was reduced by at least 90 wt%. McKay teaches that incubation of purified vicine and convicine for 2h with β-glucosidase isolated from A. oryzae resulted in complete elimination of both glycosides (p. 477, col. 1, para. 2). Vicine and convicine are precursors of divicine and isouramil, as evidenced by Rizello (Abstract), and when vicine and convicine are degraded, the aglycone derivatives, i.e., divicine and isouramil cannot be detected, as evidenced by Rizello (Abstract). Therefore, it is considered that the method of McKay inherently results in the degradation of divicine and isouramil.
It would have been obvious to one of ordinary skill in the art to subject the fababean composition to both Lactobacillus plantarum and the β-glucosidase isolated from A. oryzae, based on the teachings of McKay. One of ordinary skill in the art would have been motivated to do so in order to ensure complete degradation of vicine/convicine or to decrease the time required to degrade vicine and convicine.
Regarding claim 2, McKay teaches sterilization of ground beans by autoclaving, i.e., heat treatment (p. 476, col 1., Preparation of fababeans).
Regarding claim 4, McKay teaches that incubation of fababean suspension with concentrated culture filtrate of Aspergillus oryzae, induced for extracellular β -glucosidase production, results in complete degradation of the glycosides (Abstract), i.e., vicine and convicine., i.e., a sum content of less than 65 mg/kg.
Regarding claim 5, vicine and convicine are precursors of divicine and isouramil, as evidenced by Rizello (Abstract), and when vicine and convicine are degraded, the aglycone derivatives, i.e., divicine and isouramil cannot be detected, as evidenced by Rizello (Abstract). Therefore, it is considered that the method of McKay inherently results in the complete degradation of divicine and isouramil, i.e., a sum content of less than 150 mg/kg.
Regarding claim 6, McKay teaches that β-glucosidase isolated from A. oryzae was incubated with purified vicine and convicine at 60˚C for 2 hours. (p. 477, col. 1, para. 2). It would have been obvious to one of ordinary skill in the art to have treated a fababean composition with β-glucosidase isolated from A. oryzae at 60˚C for 2 hours based on the teachings of McKay. One of ordinary skill in the art would have been motivated to do so because McKay teaches that incubation of purified vicine and convicine with β-glucosidase isolated from A. oryzae at 60˚C for 2 hours resulted in complete elimination of both glycosides (p. 477, col. 1, para. 2), and teaches that microbial enzyme incubations can be carried out at temperatures as high as 60˚C, thus reducing the risk of contamination by spoilage and pathogenic microorganisms (p. 477, col. 2, para. 2).
Regarding claim 7, McKay teaches that fababean suspensions were inoculated with L. plantarum and incubated at 30˚C for 1 or 2 days (Table 1), i.e., at least 10 hours. Although the temperature taught by McKay differs from that of the instant claim, see MPEP§ 2144.05 II. The selection of incubation temperature would have been a routine matter of optimization on the part of the artisan of ordinary skill, said artisan recognizing that incubation temperature may affect vicine/convicine concentrations.
Regarding claim 8, as discussed above, McKay teaches different time and temperature conditions for β-glucosidase treatment, 60˚C for 2 hours. (p. 477, col. 1, para. 2), and for L. plantarum treatment, 30˚C for 1 or 2 days (Table 1). It would have been obvious to one of ordinary skill in the art to subject the fababean composition to both the β-glucosidase isolated from A. oryzae and Lactobacillus plantarum using the time and temperature conditions taught by McKay. One of ordinary skill in the art would have been motivated to do so in order to ensure complete degradation of vicine/convicine or to decrease the time required to degrade vicine and convicine.
Regarding claim 9, McKay teaches incubation of fababean suspensions with L. plantarum, which produces β-glucosidase. Therefore, the fababean suspension incubated with L. plantarum at 30˚C for 1 or 2 days (Table 1), as taught by McKay, would be simultaneously subjected to β-glucosidase and L. plantarum. Although the temperature taught by McKay differs from that of the instant claim, see MPEP§ 2144.05 II. The selection of incubation temperature would have been a routine matter of optimization on the part of the artisan of ordinary skill, said artisan recognizing that incubation temperature may affect vicine/convicine concentrations.
Regarding claims 11 and 20, McKay teaches that incubation of fababean suspension with concentrated culture filtrate of Aspergillus oryzae, induced for extracellular β-glucosidase production, results in complete degradation of the glycosides (Abstract), i.e., vicine and convicine. As stated, vicine and convicine are precursors of divicine and isouramil, as evidenced by Rizello (Abstract), and when vicine and convicine are degraded, the aglycone derivatives, i.e., divicine and isouramil, cannot be detected, as evidenced by Rizello (Abstract). Therefore, it is considered that complete degradation of vicine and convicine as taught by McKay, inherently results in the complete degradation of divicine and isouramil, i.e, a total sum content of vicine, convicine, divicine, and isouramil of less than 1500 mg/kg and a sum content of divicine, and isouramil of less than 50 mg/kg.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over A.M. McKay, 1992 (Hydrolysis of vicine and convicine from fababeans by microbial β-glucosidase enzymes, in IDS 11/12/2021) as applied to claim 1 above, and further in view of Jakubczyk et al., (Peptides obtained from fermented faba bean seeds as potential inhibitors of an enzyme involved in the pathogenesis of metabolic syndrome, LWT - Food Science and Technology 105: 306-313, 10 February 2019, in IDS 11/12/2021).
McKay teaches incubation of faba bean suspensions with L. plantarum but does not teach L. plantarum 299v.
However, Jakubczyk teaches fermentation of faba seeds, which were grounded with a laboratory mill, with L. plantarum 299v (Page 2, Section 2.2).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have used L. plantarum 299v, as taught by Jakubczyk, to reduce vicine/convicine content of a fababean suspension, as taught by McKay. One of ordinary skill in the art would have been motivated to do so because Jakubczyk teaches that fermentation of fababean with L. plantarum 299v may be used as a method to modify the activity of nutrient compounds and improve the properties of food (Conclusion). One of ordinary skill in the art would have had a reasonable expectation of success because McKay and Jakubczyk are in the same field of endeavor of fababean fermentation with L. plantarum.
Claims 12 and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over A.M. McKay (Hydrolysis of vicine and convicine from fababeans by microbial β-glucosidase enzymes 1992, in IDS 11/12/2021), as applied to claim 1 above, and further in view of Sozer Aykal (WO 2015/158959 A1, cited in IDS 11/12/2021).
McKay teaches fababean suspensions incubated with L. plantarum and extracellular β-glucosidase, resulting in a fababean composition with reduced or undetectable vicine and convicine. McKay does not teach a solid fraction and does not teach a food product or method of manufacturing said food product.
However, regarding claim 12, Sozer Aykal teaches a method of fermenting fababean fractions with L. plantarum to reduce vicine and convicine to form a dough or flour, i.e., solid fractions (p. 7, lines 26-32).
Regarding claims 14 and 15, Sozer Aykal teaches a faba bean composition incubated with L. plantarum to reduce vicine and convicine levels (Abstract; Page 4, lines 20-25) and teaches that it be used as an ingredient for the manufacture of food products and animal feed (Page 7, lines 25-32). Sozer Aykal teaches a method of manufacturing a bread product using a faba bean composition (Page 9, lines 17-41).
Regarding claims 16 and 17, Sozer Aykal teaches that the faba bean composition may be mixed with oat flour (Claim 19), and may be used as a meat analog (Claim 14).
Regarding claims 18 and 19, as stated above, Sozer Aykal teaches that the faba bean composition may be used as a meat analog (Claim 14).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have used the methods of degrading vicine and convicine from a fababean composition, as taught by McKay, to produce fababean flour or dough for use as a food product, as taught by Sozer Akyal. One of ordinary skill in the art would have been motivated to do so because Sozer Aykal teaches that toxic vicine and convicine are considered antinutritional factors that limit the use of fababeans in foods or animal feed (p. 1, lines 21-26). One of ordinary skill in the art would have a reasonable expectation of success because McKay and Sozer Aykal are in the same field of endeavor of fababean fermentation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL EMILY MARTIN whose telephone number is (703)756-1416. The examiner can normally be reached M-Th 8:30-16:00, F 8:30-10:00 EST.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/RACHEL EMILY MARTIN/Examiner, Art Unit 1657