DETAILED ACTION
Background
The amendment dated July 08, 2025 (amendment) amending claims 1, 14,16-19, 24 and 26 has been entered. All claims 1 and 4-29 have been examined. Claims 2-3 have been canceled.
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 .
Claim Objections
Claims 1, 24 and 26 are objected to because of the following informalities:
In claim 1, at line 4 after “culture comprising” recite --Kluyveromyces lactis-- in italics;
In claim 24, at line 2 after “yeast comprising” recite --Kluyveromyces lactis-- in italics; and,
In claim 1, at line 2 after “yeast comprising” recite --Kluyveromyces lactis-- in italics.
Appropriate correction is required.
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.
Claim 22 is 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.
Claim 22 recites the limitation "fermented vegetable protein " in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Nowhere does the claim or claim 1 from which it depends recite a fermented vegetable protein; rather the claims recite a modulated protein composition; so, it is unclear what one is drying to meet the claim.
The Office interprets the claimed fermented vegetable protein broadly as including either the vegetable protein itself or a modulated protein composition containing it.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4-6, 10, 12-17, 20, 23, 25-27 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ben-Harb et al., “Design of microbial consortia for the fermentation of pea-protein-enriched emulsions”, International Journal of Food Microbiology 293 (2019) 124–136 (Ben-Harb), of record.
Regarding instant claims 1, 4-6, 10, 23 and 26, Ben-Harb at 3.2.1 on pages 129-130 discloses fermentation of pea proteins (a “vegetable protein”, also a legume protein as in claim 4 and a pea protein as in claim 5), as well as a composition “comprising a vegetable protein” in claim 26) in a mixed emulsion (ME) with a microbial consortia (a “modulation mixture”) which comprises (at 3.2.3 in the paragraph bridging pages 131 and 132 and Fig. 3 on page 131 at M4 and M7) yeast as Kluyveromyces lactis (which is a “volatile modulating yeast culture” or a “volatile modulating yeast” in claim 26), and further including, Lactobacillus plantarum and Lactobacillus lactis (“active lactic acid bacteria culture” in claims 1 and 26) to form a modulated protein composition. The vegetable protein, lactic acid bacteria culture and volatile modulating yeast culture disclosed at 3.2.3 of Ben-Harb comprises a modulation mixture which is fermented by both the volatile modulating yeast culture and the lactic acid bacteria culture under volatile modulation conditions wherein fermentation is carried out at 28 °C (claims 6 and 10) to form a modulated protein composition. The modulated protein composition of Ben-Harb comprises a composition produced by the method of claim 1 (claim 23) and comprises a vegetable protein, an active lactic acid bacteria culture and a volatile modulating yeast (claim 26).
Regarding instant claims 12-13, 15-17 and 20, Ben-Harb at 3.2.5, at the top of the left hand column on page 132 discloses that after fermentation in M7 levels of off-favor producing hexanal and heptanal (claim 15) were much lower (decreased aldehyde content in claim 13), so the Kluyveromyces lactis.yeast and lactic acid bacteria culture in M7 of Ben-Harb thereby modulates the off-flavor molecule content as a volatile modulating yeast culture (claim 12). The Office considers a disclosure of hexanal and heptanal, to mean n-hexanal and n-heptanal, which are, respectively, the same thing as (E)-2-heptanal content, (E)-2-hexanal content at a level that modulates an aroma or flavor of the protein composition (claim 16). In addition, Ben-Harb at page 132, right hand, last two paragraphs, discloses increased flowery and fruity notes, significantly increasing fruity ester content to a level that modulates an aroma or flavor of the protein composition (claim 17). Sere also Fig. 4B on page 133. Still further, Ben-Harb discloses in the GC-MS chromatogram D on page 134 significantly increased fruity ester content (compare chromatogram B) for each of ethyl acetate, propanoic acid ethyl ester, acetic acid methyl and propyl esters, butanoic acid ethyl ester, hexanoic acid ethyl ester, octanoic acid ethyl ester and acetic acid phenylethyl ester, or 8 fruity esters (claim 20). See also the 1st sentence of the last paragraph on page 134 of Ben-Harb attributing fruity aromas in M7 (which comprise lactic acid bacteria culture and volatile modulating yeast culture) to the growth of Kluyveromyces lactis and Lactobacillus lactis.
Regarding instant claim 14, the fermenting of a pea protein using a volatile modulating yeast culture of Kluyveromyces lactis and a lactic acid bacteria culture M7 in Ben-Harb appears to comprise substantially the same method as claimed and therefore produces substantially the same composition as claimed. Accordingly, absent a clear showing as to how the method or product ketone content of the Ben-Harb differs from that of volatile modulating yeast and the vegetable protein as claimed, the Office considers the Ben-Harb method to significantly decrease overall ketone content in a pea protein to a level that modulates an aroma or flavor of the protein composition as claimed. See MPEP 2112.01.I.
Regarding instant claim 25, the Office considers the modulated protein composition M7, the 1st sentence of the last paragraph on page 134 and Fig. 4B on page 133 of Ben-Harb and the claimed composition to be substantially the same thing. Accordingly, absent a clear showing as to how the chemical makeup of the vegetable protein of Ben-Harb differs from that as claimed, the Office considers the M7 product composition of Ben-Harb to comprise the claimed vegetable protein that contains measurable amounts of at least 5 different fruity ester molecules. See MPEP 2112.01.I.
Regarding instant claims 27 and 29, Ben-Harb at 1., in the 1st sentence on page 124 discloses food protein for use in food products including dairy products.
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 1, 4-17, 20, 23-27 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over US2015/0366233 A1 to Brown et al. (Brown).
Regarding instant claims 1, 4-11, 23-24 and 26, Brown at [0012] on page 2 discloses inoculating (“fermenting”) a plant source (“vegetable protein” claims 1 and 26) including a nut, seed or legume protein (claim 4) with an active lactic acid bacteria culture as a flavorant and, additionally, adding a microbial mixture (at [0012] on page 2) including Kluyveromyces lactis (a “volatile modulating yeast culture” in claim 1 and a “volatile modulating yeast” in claims 24 and 26) in a culture (“modulation mixture”) to form (at [0011]) a milk product or a cheese replica (“modulated protein composition” and composition produced by the method - claim 23). Further, at [0045] and [0228] Brown discloses fermenting purified plant proteins and pea protein (claim 5) in an aqueous medium. Further still, at [0232] Brown discloses the pea protein modulation mixture fermented under volatile modulation conditions (claims 6-7) or fermentation conditions (claims 10-11), wherein fermentation is carried out at 30 °C (claims 6 and 10) overnight (interpreted as being 12 hours - claims 7 and 11) to form the modulated protein composition, followed by (at [0232]) inactivation (claim 8) at 85 °C for 30 minutes, thereby heating the modulated protein composition at a temperature and a time sufficient to inactivate the volatile modulating yeast culture (claim 9) forming a deactivated volatile modulating yeast (claim 24).
Further regarding instant claims 1, 24 and 26, Brown does not disclose an example of fermenting a modulation mixture comprising Kluyveromyces lactis as a volatile modulating yeast culture and an active lactic acid bacteria culture as in claim 1; further, Brown does not disclose an example of a composition comprising a vegetable protein, active lactic acid bacteria and a deactivated volatile modulating yeast as Kluyveromyces lactis as in claim 24; and, still further, Brown does not disclose an example of a composition comprising a vegetable protein, a yeast as a volatile modulating yeast and an active lactic acid bacteria culture (claim 26).
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Brown to combine its active lactic acid bacteria culture with a volatile modulating yeast culture and with a Kluyveromyces lactis as the volatile modulating yeast and by inactivating the culture to form a deactivated volatile modulating yeast as a Kluyveromyces lactis. Brown discloses at [0012] on page 2 that it is desirable to make dairy free milk products and cheese from a modulation mixture of a vegetable protein, an active lactic acid bacteria culture as a flavorant and Kluyveromyces lactis, which is a volatile modulating yeast.
Yet still further regarding instant claim 24, the Office considers the aqueous suspension composition of claim 24 to include the pea protein aqueous mixture of disclosed at [0012] on page 2, and at [0045] and [0228] of Brown which does not contain an emulsifier.
Regarding instant claims 12-17, the Office considers claimed volatile modulating yeast culture and that as disclosed at [0012] on page 2 of Brown as Kluyveromyces lactis to be substantially the same thing. Accordingly, absent a clear showing as to how the volatile modulating yeast of Brown differs from that as claimed, the Office considers the volatile modulating yeast of Brown when used to ferment a vegetable protein as in Brown at [0055] and [0228] as a volatile modulating yeast culture that modulates off-favor molecule content as in claim 12; a volatile modulating yeast culture that modulates off-flavor molecules that comprise at least one of aldehyde content, alcohol content, ketone content or furan content as in claim 13; a volatile modulating yeast culture that significantly decreases overall ketone content to a level that modulates an aroma or flavor of the protein composition as in claim 14; a volatile modulating yeast culture that modulates at least one of heptanal content, hexanal content, pentenol, heptanone, or furan content as in claim 15; a volatile modulating yeast culture that decreases at least one of (E)-2-heptanal content, (E)-2-hexanal content, 1-penten-3-ol content, 6-methyl-5-hepten-2-one content, or trans-2-(2-pentenyl)furan content to a level that modulates an aroma or flavor of the protein composition as in claim 16; and a volatile modulating yeast that increases the fruity ester content to a level that modulates an aroma or flavor of the protein composition as in claim 17.
Regarding instant claims 20 and 25, the Office considers claimed modulated protein composition and that of a pea protein as disclosed at [0012] on page 2, and at [0045] and [0228] of Brown that has been fermented with active lactic acid bacteria and Kluyveromyces lactis to be substantially the same thing. Accordingly, absent a clear showing as to how the chemical makeup of the modulated protein composition of Brown differs from that as claimed, the Office considers the modulated protein composition of pea protein as disclosed at [0012] on page 2, and at [0045] and [0228] of Brown and fermented with active lactic acid bacteria and Kluyveromyces lactis to comprise a modulated protein composition that contains measurable amounts of at least 5 different fruity ester molecules as in claim 20; and to be a modulated protein composition comprising a vegetable protein that contains measurable amounts of at least 5 different fruity ester molecules as in claim 25. See MPEP 2112.01.I.
Regarding instant claims 27 and 29, Brown at [0011] discloses non-dairy milk and cheese products (“food products”) as a non-dairy fermented food (claim 29).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over US2015/0366233 A1 to Brown et al. (Brown) as applied to claim 1 above, and further in view of DD 278058 A1 to ADW DDR (ADW), of record.
All references to ADW refer to the machine translation, a copy of which was submitted by Applicants.
As applied to claim 1, Brown at [0012] on page 2, and at [0045] and [0228] of Brown discloses a method of providing a modulation mixture of a volatile modulating yeast comprising Kluyveromyces lactis culture, active lactic acid bacteria culture and a vegetable protein and fermenting the mixture under volatile modulation conditions to form a modulated protein composition.
Regarding instant claims 21 and 22, Brown does not disclose drying the modulated protein composition to produce a powder as in claim 21 and does not disclose drying a fermented vegetable protein to produce a powder.
The Office interprets the claimed fermented vegetable protein broadly as including either the vegetable protein itself or the modulated protein composition containing it.
ADW at Abstract (57) one page 2 discloses fermenting leguminous seeds with yeast and lactic acid bacteria (as Lactobacillus) to, among other things, (at the bottom of page 3) eliminate flatulence and off-flavors. At the top of page 5, in the first example, ADW discloses fermenting at 35 °C for 6 hours, subjecting the product to high heating and then spray drying to form powdered food additives such as (at the bottom of page 2 in the Abstract) dairy products, such as cheese.
Before effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of ADW for Brown to dry and form a powder of its modulated protein composition as in claim 21 or dry the fermented vegetable protein from its product to form a powder as in claim 22. Both references disclose forming food products for use in milk or cheese analogs by fermenting leguminous vegetable proteins with yeast and lactic acid bacteria to reduce their off flavors. The ordinary skilled artisan reading Brown would have desired to convert its product into a powder to make it shelf stable for use as functional additive in its dairy product analogs as in ADW.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over US2015/0366233 A1 to Brown et al. (Brown) as applied to claim 27, above, and further in view of US 2018/0368443 A1 to Seo et al. (Seo), of record.
As applied to claim 27, Brown at [0012] on page 2, and at [0045] and [0228] of Brown discloses a food product comprising a modulated protein composition made by a method of providing a modulation mixture of a volatile modulating yeast culture comprising Kluyveromyces lactis, an active lactic acid bacteria culture and a vegetable protein and fermenting the mixture under volatile modulation conditions to form the modulated protein composition.
Brown does not disclose a cereal-based food as in claim 28.
Seo at Abstract discloses concentrating protein in grain via fermentation wherein at [0030], the process comprises inoculating the grain powder with lactic acid bacteria. The Seo products have an increased protein content. Seo at [0009] discloses that grain powder can include soybean which is a legume, and also that grains, like rice and corn comprise seeds. Further, Seo at [0034] discloses that its product can be used as an additive for animal feed which (at [0002]) generally comprises grain or cereal.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Seo for Brown to include its modulated protein composition into a cereal-based food or to use a cereal as a source of its vegetable protein. Both references disclose treating seeds or pulses with yeast and lactic acid bacteria proteins. The ordinary skilled artisan working with Brown would have desired to ferment a soybean or other seed material as in Seo to produce a modulated protein containing composition having improved flavor for use in a cereal based food that is a milk product or a milk.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
The art of record taken alone or in combination does not disclose the claimed method of providing a modulation mixture comprising a vegetable protein, an active lactic acid bacteria culture, and a volatile modulating yeast culture comprising Kluyveromyces lactis and additionally comprises at least one of another Kluyveromyces species, a Torulaspora species or a Yarrowia species and fermenting the modulation mixture under volatile modulation conditions to form a modulated protein composition.
Ben-Harb at 3.2.1 on pages 129-130 discloses fermentation of pea proteins with a microbial consortia which comprises (at 3.2.3 in the paragraph bridging pages 131 and 132 and Fig. 3 on page 131 at M4 and M7) yeast as Kluyveromyces lactis and, further including Lactobacillus plantarum and Lactobacillus lactis to form a modulated protein composition. However, Ben-Harb at Table 3, page 128, lines 6-7 (from the bottom of Table 3, last column "selected"="X") and in its discussion at 3.2.3 at page 132, left-hand col. in the 1st full paragraph does not disclose selected compositions generated from Kluyveromyces lactis cultures combined with lactic acid bacteria and additionally a volatile modulating yeast culture comprising at least one of another Kluyveromyces species, a Torulaspora species or a Yarrowia species. Rather, Ben-Harb selects other compositions for their higher relative growth rate. The ordinary skilled artisan in Ben-Harn would not be motivated to add the claimed additional culture of at least one of another Kluyveromyces species, a Torulaspora species or a Yarrowia species to its fermentation mixture.
DD 278058 A1 to ADW DDR (ADW) at Abstract (57) one page 2 discloses fermenting leguminous seeds with yeast and lactic acid bacteria (as Lactobacillus) to, among other things, (at the bottom of page 3) eliminate flatulence and off-flavors. At the top of page 5, in the first example, ADW discloses fermenting at 35 °C for 6 hours, subjecting the product to high heating and then spray drying to form powdered food additives such as (at the bottom of page 2 in the Abstract) dairy products, such as cheese. ADW does not disclose a volatile modulating yeast comprising Kluyveromyces lactis or any other Kluyveromyces species; and does not disclose a Torulaspora species or a Yarrowia species.
US2015/0366233 A1 to Brown et al. (Brown) at [0012] on page 2, and at [0045] and [0228] discloses pea and legume proteins in aqueous suspensions fermented with active lactic acid bacteria and Kluyveromyces lactis to make milk and cheese products. However, Brown does not disclose or suggest additional volatile modulating yeasts of another Kluyveromyces species, a Torulaspora species or a Yarrowia species.
Claims 18 and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
In view of the amendments to 1, 10-11, 24 and 26, the following rejections have been withdrawn:
The rejections of claims 14, 16 and 17 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in regard to the term “significantly”;
The rejections of claims 18-19 under 35 U.S.C. 102(a)(1) as being anticipated by Ben-Harb et al., “Design of microbial consortia for the fermentation of pea-protein-enriched emulsions”, International Journal of Food Microbiology 293 (2019) 124–136;
The rejections of claims 7-9, 11, 21-22 and 24-25 under 35 U.S.C. 103 as being unpatentable over Ben-Harb et al., “Design of microbial consortia for the fermentation of pea-protein-enriched emulsions”, International Journal of Food Microbiology 293 (2019) 124–136 in view of DD 278058 A1 to ADW DDR; and,
The rejections of claim 28 under 35 U.S.C. 103 as being unpatentable over Ben-Harb et al., “Design of microbial consortia for the fermentation of pea-protein-enriched emulsions”, International Journal of Food Microbiology 293 (2019) 124–in view of US 2018/0368443 A1 to Seo et al.
The remarks accompanying the amendment dated July 08, 2025 (Reply) have been fully considered but they are not found persuasive for the following reasons:
Regarding the position taken in the Reply that the present inventors have reported successful fermentation, for example, regarding modulation of off-flavors and increase in fruity ester content (see application Table 4, pub. paragraphs 0066-0067), respectfully composition M7 (Fig. 3) of Ben-Harb is cited as anticipating art. Accordingly, a showing of comparative results is not relevant to the anticipation rejection. Further, nothing on the record distinguishes the rejected claims 1, 4-6, 10, 12-17, 20, 23, 25-27 and 29 from the art of Ben-Harb.
Regarding the position taken in the Reply that Ben-Harb rejects the use of Kluyveromyces lactis based on an observation that it does not combine well with lactic acid bacteria (see Ben-Harb, Table 3, page 128, lines 6-7 from the bottom of Table 3, last column "selected"="X")), respectfully composition M7 of Ben-Harb reads on the rejected claims. Nothing about the performance of M7 of Ben-Harb distinguishes the rejected claims 1, 4-6, 10, 12-17, 20, 23, 25-27 and 29 from the art, particularly in view of the discussion in Ben-Harb at 3.2.5 of reduced off-flavors in M7. The position taken amounts to a teaching away argument and does not address an anticipation rejection over Ben-Harb and so does not overcome the anticipation rejection. See MPEP 2131.05.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW E MERRIAM whose telephone number is (571)272-0082. The examiner can normally be reached M-H 8:00A-5:30P and alternate Fridays 8:30A-5P.
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/ANDREW E MERRIAM/Examiner, Art Unit 1791