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 .
Applicant’s amendment and reply filed December 12, 2025 have been received and entered into the case. Claims 1, 3 – 15, 17 – 19 and 21 -23 are pending; claims 1 and 17 – 19 are withdrawn; claims 3 – 15 and 21 – 23 have been considered on the merits. All arguments have been fully considered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 25, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
Previous rejections under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, are withdrawn due to applicant’s response affirming that the microorganisms have been deposited under the Budapest Treaty and that alall restrictions imposed by the depositor on the availability of to the public of the deposited material will be irrevocably removed upon the granting of a patent.
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 – 15 and 21 – 23 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 and its dependents remain indefinite as the following phrases are not adequately defined by the claim language or specification: “fruit-based ingredient,” “vegetable ingredients” and “structuring agent.” While the claim recites ingredients selected from a group for each of these phrases, it is noted that lists identify components that are not what the phrases imply. Specifically, fruit based ingredients name fruits and not “fruit based” ingredients; the recited vegetable ingredients are not all vegetables.
In claims 5 and 22, the recitation of cell density, e.g., cfu/ml, renders the claims indefinite in that it is unclear if the recited cell density is required in the starter (D) or in the final food composition that is “based on” the ingredients.
Response to Arguments
Applicant argues that the claims are amended to be clear and that the cell density clearly refers to density of the final food composition. However, this fails to persuade since the various recited “ingredients” are not what they claim to be (see above) and because it remains unclear if the “cell density” refers to the starter or any cell that might be in a final food composition.
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 3 – 7, 10, 12 – 13, 15 and 21 – 22 remain rejected under 35 U.S.C. 103 as being unpatentable over Mehta (US 2019/0327981).
Regarding claims 3 and 4, Mehta teaches crackers (food compositions) made from (based on) teff flour (a gluten free cereal flour, 0007), water and a starter (0018, 0023, 0041) comprising Lactobacillus brevis (0041) and/or Lactobacillus plantarum (0027), wherein the flour and bacteria are fermented together (0041, abstract, claims). Mehta does not teach the method wherein the bacteria have the claimed deposit number. However, at the time the claims were filed, it would have been obvious to one ordinary skill in the art to substitute other L. brevis and/or L. plantarum strains in the compositions of Mehta as a matter of routine practice, for their similar essential characteristics as lactic acid bacteria and with a reasonable expectation for successfully obtaining a food composition.
Regarding claims 5 and 21 – 22, Mehta does not teach the food composition or fermentation starter wherein it includes the claimed density and ratio of bacterial CFUs. However, the bacteria are indicated to be active components of the fermenting starter for producing the food composition (0009, 0027, experiments). In this regard, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to optimize the concentration of bacteria used to ferment the flours and concentration in a resulting food composition a matter of routine practice and experimentation and with a reasonable expectation for successfully obtaining a food composition.
Regarding claims 6 – 7, 10 and 12 – 13, the reference does not teach food compositions with the claimed amounts of amino acids, GABA, tannins or polyphenols. However, as admitted by applicant in paragraph 0005, fermenting lactic acid bacteria is known to activate endogenous phytase to reduce phytic acid as well as increase polyphenols, amino acids and GABA. In this regard, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to optimize the amounts of these components when making food compositions based on fermented lactic acid bacteria such as L. brevis and/or L. plantarum and with a reasonable expectation for successfully obtaining food compositions.
Regarding claim 15, Mehta teaches the food composition is dehydrated (0029 – 0039).
Thus, the claimed invention as a whole is prima facie obvious, especially in the absence of evidence to the contrary.
Claims 3 – 7, 10, 12 – 14, 21 – 23 remain rejected under 35 U.S.C. 103 as being unpatentable over Kiriyama et al. (JP 2008 283 922A).
Regarding claims 3 and 4, Kiriyama teaches a yoghurt like food or drink (food composition) made from (based on) rice flour (a gluten free cereal flour) (claim 5, p.2 of English Translation), water and starter comprising Lactobacillus brevis and/or Lactobacillus plantarum (p.2-3 of English Translation, example 1) wherein the bacteria are fermented with the flour (example 1). Other legume flours may be included such as pea, buckwheat, soybean, bean, chickpea, lentil (p.2 of English Translation). Kiriyama does not teach the method wherein the bacteria have the claimed deposit number. However, at the time the claims were filed, it would have been obvious to one ordinary skill in the art to substitute other L. brevis and/or L. plantarum strains in the compositions of Kiriyama as a matter of routine practice, for their similar essential characteristics as lactic acid bacteria and with a reasonable expectation for successfully obtaining a food composition.
Regarding claims 5 and 21 – 22, Kiriyama does not teach the yogurt food composition or fermentation starter wherein it includes the claimed density and ratio of bacterial CFUs. However, the bacteria are indicated to be active components of the fermenting starter for producing the food composition (0009, 0027, experiments). In this regard, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to optimize the concentration of bacteria used to ferment the flours and concentration in a resulting food composition a matter of routine practice and experimentation and with a reasonable expectation for successfully obtaining a food composition.
Regarding claims 6 – 7, 10 and 12 – 13, the reference does not teach food compositions with the claimed amounts of amino acids, GABA, tannins or polyphenols. However, as admitted by applicant in paragraph 0005, fermenting lactic acid bacteria is known to activate endogenous phytase to reduce phytic acid as well as increase polyphenols, amino acids and GABA. In this regard, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to optimize the amounts of these components when making food compositions based on fermented lactic acid bacteria such as L. brevis and/or L. plantarum and with a reasonable expectation for successfully obtaining food compositions.
Regarding claim 14, Kiriyama teaches the composition is a yoghurt with a viscosity of 250, 320 or 420 mPA·s (or 0.25, 0.32 or 0.42 Pa·s), which falls within the claimed viscosity range (examples).
Regarding claim 23, Kiriyama does not teach the food composition having the claimed viscosities. However, Kiriyama does teach the food composition is a yoghurt drink as claimed. In this regard, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to optimize the viscosity of the food composition as a matter of routine practice and experimentation with a reasonable expectation for successfully obtaining an effective yoghurt drink composition.
Thus, the claimed invention as a whole is prima facie obvious, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant argues the prior art does not teach the claimed bacterial strains; does not teach suggest or motivate one to select the claimed strains; that the strains are not interchangeable or substitutable since they are not expected to behave the same due to strain unpredictability in fermentation; and that the technical outcomes are different than that of the claims and are therefore technologically unrelated.
Applicant argues that the claimed combination of substrate and strains produces the unexpected effects including products with GABA production, high polyphenol release, reduced tannins, raffinose, phytic acid and saponins; that the prior art is silent on these factors; that the results are strain specific; and that there is an unexpected synergy.
Finally, applicant argues the prior art teaches away from the claimed invention in that Mehta does no teach using pure L. brevis and L. plantarum strains devoid of other species; while Kiriyama requires pretreatment of substrate (flour) rather than “direct fermentation of flour blends” as claimed.
However, these arguments fail to persuade.
Regarding the argument that prior art does not teach the claimed bacterial strains, it is maintained that since the prior art teaches the claimed species are among the preferred lactic acid bacteria in the food compositions, it would have been obvious to one of ordinary skill in the art to substitute other strains of the species in the food products with a reasonable expectation for successfully obtaining the food products, since the strains exhibit the same characteristics essential to the species, e.g., lactic acid fermentation and known for their use in fermented food products. Regarding Mehta, the reference expressly teaches both L. brevis and L. plantarum (0027, experiment 1, claims) in the compositions and does not require an undefined microbial population as argued by applicant. Regarding Kiriyama, although the reference teaches other species of lactic acid bacteria can be used as the starter for the food product, this does not discount the teachings therein insofar as L. brevis and L. plantarum are identified as starters for the food products. In this regard, Kiriyama discloses the starter species are those used in “normal” fermented foods (p.3), indicating the species are well known and used in the art for the claimed purpose.
Regarding the argument that the prior art does not teach, suggest or motivate one in the art to select the claimed strains, while this rationale may support a conclusion of obviousness, it is not the sole rationale (MPEP 2143 I). In this instance, the prior art teaches food compositions wherein both L. brevis and L. plantarum were well known and used as starter species in food products. The references do not identify strains atypical to the species indicating that any strain that successfully ferments the substrate would work in the food products. As such, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to substitute any specific strain in these products with a reasonable expectation for obtaining the food products disclosed therein and with a predictable result.
Regarding the argument that the strains are not interchangeable or substitutable since they are not expected to behave the same due to strain unpredictability in fermentation, arguments presented by applicant cannot take the place of evidence in the record. Merely acknowledging that fermentation is affected by environmental and strain variance alone is insufficient to show the strains are not interchangeable. Moreover, applicant has failed to show that the instant strains would not aid the fermentation processes of either Mehta or Kiriyama. Additionally, applicant has not provided evidence that various strains of L. brevis or L. plantarum demonstrate unpredictability in fermentation.
Regarding the argument that the technical outcomes of the prior art are different than that of the claims and are therefore technologically unrelated, the claimed invention is drawn to a food composition made with lactic acid bacteria as are both Mehta and Kiriyama. In this regard, it is maintained that the technologies are not only related but are the same. Regarding technical outcomes of the various documents, since the claims are drawn to a food product and the prior art teaches food products, it is unclear what applicant regards as the “radically” different technical outcome. Applicant states the manner in which the food products are produced in the prior art differ from the invention on pages 11 – 12 of the reply filed 12.12.2025. However, the claims are not drawn to methods for making food products. Thus, the argument is not commensurate in scope with the claimed invention.
Regarding applicant’s argument that the claimed combination of substrate and strains produces the unexpected effects of high GABA production, high polyphenol release, reduced tannins, raffinose, phytic acid and saponins, while it is appreciated that the claimed strains may exhibit an antinutritional factor profile different or more favorable than other strains (e.g., Table 1), applicant has failed to show that the difference is unexpected or synergistic in nature. Particularly in comparison to the claimed invention which is not limited to a particular substrate or combination of components. Further, it is unclear what applicant argues is synergistic. Applicant does not indicate what combination of components results in a particular activity that is synergistic to any component alone. Moreover, applicant has failed to provide objective evidence of any kind relative to an unexpected result or synergistic activity that is commensurate in scope with the claimed invention.
Regarding applicant’s argument that the prior art teaches away from the claimed invention, while Mehta teaches additional species may be included in the starter, there is no requirement that they all be included. Rather, Mehta teaches at least one microorganism can be used, listing seven, two of which are claimed by applicant (0027) and exemplifying a single microorganism, L. brevis (experiment 1). Thus, the reference does not teach away from using the claimed bacteria alone or in combination with others. Further, since the claims are open ended in nature, the claims do not exclude additional microbes from the starter. In this regard, applicant’s arguments are not commensurate in scope with the claimed invention.
Regarding Kiriyama, applicant argues additional steps are practiced to make the food product rather than the food product itself. However, the claims are drawn to a food product and not a method of making a food product. In this regard, the argument is not commensurate in scope with the claimed invention.
Therefore, for these reasons and those made above, the claims remain rejected absent evidence of an unexpected result, advantage or benefit.
No claims are allowed.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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/RUTH A DAVIS/ Primary Examiner, Art Unit 1699