DETAILED ACTION
Status of the Application
Claims 1-3, 5, 8-9, 11-12, 19, 21-22, 27-31 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment of claims 1, 27-28, 31 and cancellation of claim 20 as submitted in a communication filed on 11/11/2025 is acknowledged.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/11/2025 has been entered.
Claims 2, 8-9, 11-12, 19, 22, 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 5/16/2023.
Claims 1, 3, 5, 21, 27-28, 30-31 are at issue and will be examined only to the extent they encompass the elected invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA )
Claims 1, 3, 5, 21, 27-28, 30-31 remain 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 pre-AIA the applicant regards as the invention. New grounds of rejection are necessitated by amendment.
Claim 1 (claims 3, 5, 21, 27-28, 30-31 dependent thereon) as amended is indefinite in the recitation of “…process for controlling a fermentation process of a fermentation mixture comprising at least one plant material selected from Brassicale plants and/or at least one seaweed materials selected from… …and at least one naturally occurring lactic acid bacterial strain in the production of a fermented product, wherein the process comprises the steps of: (i) selecting at least 2 predetermined metabolites before fermentation of the fermentation mixture, the at least 2 predetermined metabolites selected based on their presence in a previous fermented product comprising the same at least one plant material and/or at least one seaweed material and the at least one lactic acid bacterial strain…” for the following reasons. The term “seaweed material selected from brown algae and at least one naturally occurring lactic acid bacterial strain” is unclear because it appears as if the lactic acid bacterial strain is one of the seaweed materials to select from. As known in the art, lactic acid bacteria is not seaweed material. In addition, it is unclear as to how the term “predetermined metabolites selected based on their presence in a previous fermented product comprising the same at least one plant material and/or at least one seaweed material and the at least one lactic acid bacterial strain…” defines the 2 predetermined metabolites because a fermented product comprising the same at least one plant material and/or at least one seaweed material and the at least one lactic acid bacterial strain encompasses a genus of fermented products that can comprise different additional components beyond the same plant material and/or any seaweed material and any lactic acid bacterial strain. Even if the previous fermented product comprises the same plant material and/or the same seaweed material and the same lactic acid bacterial strain, the previous fermented product still encompasses a genus of fermented products, where each of these fermented products can comprise other components in addition to the plant material, seaweed material and lactic acid bacterial strain, thus rendering a diverse genus of fermented products having different sets of metabolites. Therefore, the two predetermined metabolites can change depending on what is used as the “previous fermented product”. For examination purposes, it will be assumed that the fermentation mixture of the preamble comprises at least one plant material from Brassicale plants and at least one naturally occurring lactic acid bacterial strain. No patentable weight will be given to step (i) and it will be assumed that the fermentation mixture comprises at least two metabolites. Correction is required.
Claim 1 (claims 3, 5, 21, 27-28, 30-31 dependent thereon) as amended is indefinite in the recitation of “..(ii) mixing from step (i) the selected at least one plant material and/or at least one seaweed material with the at least one lactic acid bacterial strain in a fermentation reactor providing the fermentation mixture..” for the following reasons. There is no antecedent basis for the “selected” at least one plant material and/or at least one seaweed material. In addition, step (i) refers to a plant material, a seaweed material and a lactic acid bacterial strain in the context of a previous fermentation product. Therefore, there are no plant material, seaweed material and lactic acid bacterial strain in step (i) that can be used to obtain a fermentation mixture. Please note that there is no statement linking the limitation in the preamble of “Brassicale plants” to step (ii). For examination purposes, it will be assumed that step (ii) requires mixing at least one plant material and at least one lactic acid bacterial strain. Correction is required.
Claim 1 (claims 3, 5, 21, 27-28, 30-31 dependent thereon) is indefinite in the recitation of “(iv) controlling the fermentation mixture based on the measurement of the selected at least two predetermined metabolites as compared to a measurement of the selected at least 2 predetermined metabolites in the previous fermented product” for the following reasons. The term “controlling” is unclear in the absence of the specific action intended with the term. As known in the art, “controlling” can be equivalent to monitoring, testing, altering conditions during the fermentation to obtain a particular outcome, etc. In addition, step (iv) requires comparison with a genus of previous fermented products. As explained above, the “previous fermented product” is in fact a genus of genus of fermented products, where each of these fermented products can comprise different components in addition to the plant material and the lactic acid bacterial strain. Therefore, even if any of these “previous” fermented products comprise the predetermined metabolites X and Y, the amount of X and Y in each of these “previous” fermented products would vary because the “previous” fermented products could be obtained from mixtures that comprise more than the same plant material and the same lactic acid bacterial strain. The comparison of the amounts of X and Y from the fermentation mixture of step (iii) with the amounts of X and Y from the “previous” fermented product is meaningless because the basis for comparison variable as it will depend on what is used as the “previous” fermented product. For examination purposes, no patentable weight will be given to step (iv). Correction is required.
Claim 1 (claims 3, 5, 21, 27-28, 30-31 dependent thereon) is indefinite in the recitation of “(v) evaluating the quality and/or uniformity of the fermentation mixture in producing the fermented product by comparing the measurement of the selected at least 2 predetermined metabolites in the fermentation mixture to the measurement of the selected at least 2 predetermined metabolites present in the previous fermented product” for the following reasons. The term “evaluating the quality and/or uniformity of the fermentation mixture” is unclear because quality and uniformity with regard to a fermentation mixture are terms of degree and would depend on what one of skill in the art considers the thresholds beyond which a fermentation mixture meets the desired quality and uniformity. In addition, step (v) requires comparison with a genus of previous fermented products. As explained above, the “previous fermented product” is in fact a genus of genus of fermented products, where each of these fermented products can comprise different components in addition to the plant material and the lactic acid bacterial strain. Therefore, even if any of these “previous” fermented products comprise the predetermined metabolites X and Y, the amount of X and Y in each of these “previous” fermented products would vary because the “previous” fermented products could be obtained from mixtures that comprise more than the same plant material and the same lactic acid bacterial strain. The comparison of the amounts of X and Y from the fermentation mixture of step (iv) with the amounts of X and Y from the “previous” fermented product is meaningless because the basis for comparison variable as it will depend on what is used as the “previous” fermented product. For examination purposes, no patentable weight will be given to step (v). Correction is required.
Claim 1 (claims 3, 5, 21, 27-28, 30-31 dependent thereon) is indefinite in the recitation of “..bacterial strain is selected from the group of genera consisting of Enterococcus, Lactobacillus, ….or Bifidobacterium or combinations thereof” and “…bacterial strain selected from the group of genera consisting of Enterococcus, Lactobacillus… or Bifidobacterium or combinations thereof” for the following reasons. It is unclear as to how a bacterial strain can belong to different genera of microorganisms. Please note that the term “combinations thereof” implies that a lactic acid bacterial strain can be simultaneously, for example, a Lactobacillus strain and a Bifidobacterium strain. For examination purposes, it will be assumed that the claim recites “selected from the group consisting of an Enterococcus strain, a Lactobacillus strain, a Pediococcus strain, a Lactococcus strain and an Bifidobacterium strain”. Correction is required.
Claim 27 is indefinite in the recitation of “wherein the at least 2 predetermined metabolites are measured from an at line or in-line determination or by periodically sampling of the fermented mixture to produce a fermented product” for the following reasons. It is unclear as to how one could measure a metabolite from a determination at line or in line. As written, it is unclear as to what is determined. If the intended measurement is an at line or in line measurement, the claim should be amended accordingly. In addition, the term “periodically sampling of the fermented mixture to produce a fermented product” is unclear and confusing because sampling of the fermented mixture will not lead to the production of a fermented product as currently recited. For examination purposes, it will be assumed that claim 27 simply requires measuring the metabolites. Correction is required.
When amending the claims, applicant is advised to carefully review all examined claims and make the necessary changes to ensure proper antecedent basis and dependency.
Claim Rejections - 35 USC § 112(a) or First Paragraph (pre-AIA )
Claims 1, 3, 5, 21, 27-28, 30-31 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 3, 5, 21, 27-28, 30-31 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a process for the production of benzoic acid by culturing P. acidilactic, P. pentosaceus or L. plantarum in a culture medium that comprises mustard plant material, or a process for the production of lysine by culturing P. acidilactic, P. pentosaceus or L. plantarum in a culture medium that comprises rape or mustard plant material, does not reasonably provide enablement for a process for producing any two metabolites selected from any amino acid, any fatty acid, any bioactive phenol, any aromatic organic acid, any purine compound, any carbohydrate compound and any flavonoid compound by fermenting any naturally occurring lactic acid bacterial strain selected from an Enterococcus strain, a Lactobacillus strain, a Pediococcus strain, a Lactococcus strain and an Bifidobacterium strain, in the presence of any type of plant material from Brassicale plants and/or seaweed material from brown algae under any fermentation conditions. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
These rejections have been discussed at length in the prior Office action. They are maintained for the reasons of record and those set forth below.
Applicant argues that amended claim 1 and claims dependent therefrom comply with the written description and enablement requirements.
Applicant’s arguments have been fully considered but not deemed persuasive to overcome the instant rejections. The Examiner acknowledges the amendments made to claim 1. However, the Examiner disagrees with Applicant’s contention that the claimed invention is adequately described or enabled. The claims as interpreted are directed to a process that requires selecting at least two metabolites having any structure selected from an amino acid, a fatty acid, a bioactive phenol, an aromatic organic acid, a purine compound, a carbohydrate compound and a flavonoid compound, or wherein said metabolites are benzoic acid and lysine, selecting at least one plant material from Brassicale plants and/or seaweed material from brown algae, selecting at least one naturally occurring lactic acid bacterial strain, wherein said strain is selected from an Enterococcus strain, a Lactobacillus strain, a Pediococcus strain, a Lactococcus strain and an Bifidobacterium strain, mixing the plant material with the lactic acid bacterial strain in a fermentation reaction to obtain a fermentation mixture, and allowing the fermentation mixture to ferment to produce a fermented product, wherein said fermented product comprises the at least two metabolites having any structure, or comprises benzoic acid and lysine, wherein oxygen/air is removed prior to the fermentation step. See Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA ) for claim interpretation.
The claims still require a genus of lactic acid bacteria (Enterococcus, Lactobacillus, Pediococcus, Lactococcus and Bifidobacterium) which are naturally-occurring to produce fatty acids, amino acids, bioactive phenols, aromatic organic acids, purines, carbohydrates and/or flavonoid compounds having any structure, The specification fails to disclose which naturally occurring lactic acid bacterial strains from the genera recited are able to endogenously produce any of the recited metabolites, or which specific naturally-occurring species of the genus of lactic acid bacteria recited are able to produce a metabolite as recited having a particular structure (e.g., which specific lactic acid bacterium naturally produces flavonoid compound X). The specification is completely silent as to how one of skill in the art can determine a priori which naturally occurring lactic bacteria are able to endogenously produce any of the metabolites recited.
As stated in prior Office actions, while the specification discloses a limited number of metabolites (e.g., benzoic acid, lysine) made by a limited number of species of lactic acid bacteria upon fermenting plant material from a few Brassica species and/or seaweed material under specific conditions, the specification is completely silent with regard to a correlation and/or criteria that would allow one of skill in the art to determine a priori which combination of lactic acid bacterium, Brassicale plant material or brown algae seaweed material, and fermentation conditions would allow the production of any given fatty acid, amino acid, bioactive phenol, aromatic organic acid, purine, carbohydrate and/or flavonoid compound. One of skill in the art would not expect that fermenting any Brassicale plant material by any lactic acid bacterium from the genera recited would allow the production of any fatty acid, amino acid, bioactive phenol, aromatic organic acid, purine, carbohydrate and/or flavonoid compound. This is also taught by the specification, where there are a few examples showing that certain metabolites are only found when certain bacteria are fermented in the presence of a particular type of plant material.
In the absence of a rational and predictable scheme for determining which combinations of lactic acid bacteria, Brassicale plant materials and/or brown algae seaweed materials, and fermentation conditions would produce the desired metabolites, one of skill in the art would have to test an essentially infinite number of combinations of lactic acid bacteria, Brassicale plant material and/or brown algae seaweed materials, and fermentation conditions, to determine which ones would allow the synthesis of any metabolite or compound as required by the claims. This is not deemed routine experimentation. Therefore, for the reasons of record and those set forth above, one cannot reasonably conclude that the teachings of the specification and/or the prior art adequately describe and enabled the entire scope of the claims.
Claim Rejections - 35 USC § 102 (AIA )
Claims 1, 3, 5, 21, 28, 30-31 remain rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Legarth (WO 2013/029632 published 3/7/2013; cited in the IDS; hereinafter Legarth 1) as evidenced by Tang et al. (Microbial Cell 10(3):49-62, 2023), Niku-Paavola et al. (Journal of Applied Microbiology 86:29-35, 1999) and Teuber (Biotechnology: Biological Fundamentals, Chapter 10, pages 325-366, 1993).
Claims 1, 3, 5, 20-21, 27-28, 30-31 remain rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Legarth (WO 2018/050739 published 3/22/2018; cited in the IDS; hereinafter Legarth 2) as evidenced by Tang et al. (Microbial Cell 10(3):49-62, 2023), Niku-Paavola et al. (Journal of Applied Microbiology 86:29-35, 1999) and Teuber (Biotechnology: Biological Fundamentals, Chapter 10, pages 325-366, 1993).
These rejections have been discussed at length in the prior Office action. They are maintained for the reasons of record and those set forth below.
Applicant argues that none of the cited prior art documents teach or suggest the features of claim 1 as amended.
Applicant’s arguments have been fully considered but not deemed persuasive to overcome the instant rejection. See Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA ) for claim interpretation and an extensive explanation as to why steps (i), (ii), (iv), and (v) have been found indefinite.
Claims 1, 3, 5, 20-21, 28, 30-31 as interpreted are directed in part to a process for producing at least 2 metabolites in a fermented product that comprises at least one plant material from a Brassica species, including Brassica rapa, wherein said process comprises selecting at least two metabolites to produce, selecting a lactic acid bacterium from the genera Enterococcus, Lactobacillus, Pediococcus, Lactococcus and Bifidobacterium, mixing the selected lactic acid bacterium with the plant material to allow fermentation to occur in the absence of oxygen/air so that the at least two metabolites are produced, wherein the at least two metabolites are selected from a fatty acid, an amino acid, a bioactive phenol, a purine, a carbohydrate and a flavonoid compound, or wherein the two metabolites are lysine and benzoic acid. Claim 27 as currently amended is directed in part to the process of claim 1 as described above, wherein the metabolites are measured. See Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA ) for claim interpretation.
It is reiterated herein that Legarth 1 teaches a method for producing a fermented feed product, wherein said fermented feed product comprises lactic acid bacteria (page 2, lines 20-22), wherein said method comprises the fermentation of feed material that comprises plant parts from rape (page 16, lines 25-30). As indicated in prior Office actions, rape is a common name for Brassica rapa as evidenced by the Wikipedia entry for Brassica rapa provided with a prior Office action. Legarth 1 teaches lactic acid bacteria such as Enterococcus faecium, Lactobacillus rhamnosus, Lactobacillus plantarum, Pediococcus acidililactili, and Pediococcus pentosaceus (page 18, lines 1-3). Legarth 1 teaches that lactic acid fermentation is carried out in anaerobic conditions (lack of oxygen/air; page 4, lines 30-32). Since the fermentation is carried out in anaerobic conditions, it follows that oxygen/air are removed from the bioreactor prior to the fermentation process. As known in the art and evidenced by Teuber, lactic acid bacteria is anaerobic bacteria (page 326, left column, Introduction, first paragraph). Legarth 1 teaches that their fermented feed product comprises lactic acid by virtue of the production of lactic acid by the lactic acid bacteria (page 15, lines 27-31), and that their fermented product comprises lactic acid at a concentration of 300 mM or more. As known in the art and evidenced by Tang et al., bacteria such as lactic acid bacteria naturally produce several metabolites, including amino acids (page 51, Abstract), fatty acids (page 50, left column), and polysaccharides (carbohydrates; Abstract; page 52, Exopolysaccharides). Since lactic acid bacteria produce amino acids, it will produce lysine, which is an amino acid. As known in the art and evidenced by Niko-Paavola et al., L. plantarum, which is a lactic acid bacterium naturally produces benzoic acid (page 29, Abstract). Therefore, since it is well known in the art that lactic acid bacteria produce many metabolites including amino acids such as lysine, fatty acids and carbohydrates, Legarth 1 teaches the fermentation with L. plantarum, which produces benzoic acid, and Legarth 1 teaches that their fermentation product comprises lactic acid bacteria, it follows that Legarth 1 teaches selecting these metabolites for their fermentation product by virtue of choosing to produce a fermentation product that comprises lactic acid bacteria such as L. plantarum. As such, the teachings of Legarth 1 anticipate claims 1, 3, 5, 20-21, 28, 30-31 as written/interpreted.
As previously indicated, Legarth 2 teaches a method for producing a fermented feed product that comprises a prebiotic and a probiotic, wherein said method comprises providing a plant material and one or more lactic acid bacteria, wherein said method requires subjecting the plant material to fermentation (page 5, lines 1-14; page 23, Example 1). Legarth 2 teaches that the lactic acid bacteria produces lactic acid and other metabolic products that contribute to the profile of the fermented product (page 5, lines 28-30). Legarth 2 teaches that a major fermentation product of lactic acid bacteria is lactic acid and that in a heterofermentative fermentation, lactic acid bacteria produces lactic acid, acetic acid and ethanol (page 8, lines 24-37). Legarth 2 teaches carrying out the fermentation process under anaerobic conditions (lack of oxygen/air; page 13, lines 6-7). Since the fermentation is carried out in anaerobic conditions, it follows that oxygen/air are removed from the bioreactor prior to the fermentation process. As known in the art and evidenced by Teuber, lactic acid bacteria is anaerobic bacteria (page 326, left column, Introduction, first paragraph). Legarth 2 teaches that their fermented composition comprises 300-500 mM lactic acid, ethanol at a concentration of at least 50 mM and acetic acid at a concentration of at least 50 mM (page 9, line 4). Lactic acid has a molecular weight of 90 g/mol. Legarth 2 teaches lactic acid bacterial strains including Enterococcus. faecium, Lactobacillus rhamnosus, Lactobacillus plantarum, Pediococcus acidililactili, and Pediococcus pentosaceus (page 6, lines 23-27). Legarth 2 teaches that the plant material is plant material from seaweed and Brassica species, including Brassica rapa (page 21, lines 19-37). As evidenced by Tang et al., bacteria such as lactic acid bacteria naturally produces several metabolites, including amino acids (page 51, Abstract), fatty acids (page 50, left column), and polysaccharides (carbohydrates; Abstract; page 52, Exopolysaccharides). Since lactic acid bacteria produce amino acids, it will produce lysine, which is an amino acid. As evidenced by Niko-Paavola et al., L. plantarum, which is a lactic acid bacterium naturally produces benzoic acid (page 29, Abstract). Therefore, since it is well known in the art that lactic acid bacteria produce many metabolites including amino acids such as lysine, fatty acids and carbohydrates, Legarth 2 teaches the fermentation with L. plantarum, which produces benzoic acid, and Legarth 2 teaches that their fermentation product comprises lactic acid bacteria, it follows that Legarth 2 teaches selecting these metabolites for their fermentation product by virtue of choosing to produce a fermentation product that comprises lactic acid bacteria such as L. plantarum. Legarth 2 also teaches analysis of the fermented composition where it was found that it comprises ethanol, lactic acid, acetic acid, and 3-(4’-hydroxyl-3’,5’-dimethoxyphenyl)propionic acid (HDMPPA; page 23, Example 1; aromatic organic acid), thus teaching measuring metabolites in the fermentation product. Therefore, the teachings of Legarth 2 anticipate claims 1, 3, 5, 20-21, 27-28, 30-31 as written/interpreted.
Conclusion
No claim is in condition for allowance.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to DELIA M RAMIREZ, Ph.D., whose telephone number is (571) 272-0938. The examiner can normally be reached on Monday-Friday from 8:30 AM to 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert B. Mondesi, can be reached at (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/DELIA M RAMIREZ/Primary Examiner, Art Unit 1652
DR
March 20, 2026