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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 20, 2026 has been entered.
Applicant's amendment, response and affidavit have been entered. Claim 4 is canceled; claim 24 is added; claims 1, 3, 5 - 15, 17 - 19 and 21 - 24 are pending; claims 1 and 17 - 19 are withdrawn; claims 3, 5 - 15 and 21 - 24 have been considered on the merits. All arguments and the affidavit have been fully considered.
Support for the amendment is found in example 2, page 18 (claim 3) and page 9 (claim 5).
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.
Prior rejections are withdrawn due to canceling phrases considered ambiguous, and clarifying recited cell densities are in the final food product as opposed to a starter inoculation.
Claims 3, 5 – 15 and 21 – 24 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.
In claim 3 lines 1 - 2, it appears that the recitation of "flour" may be omitted based on the disclosure, prior claims and examples. For example, it is unclear if the food compositions are intended to require rice or rice flour; lentil or lentil flour.
In claim 3, line 3, the phrase "viable lactic acid component" appears to lack antecedent basis. While the phrase does not recite "the" it does assume multiple components to the starter that are not previously indicated. It is also unclear whether the starter may include other, non lactic acid components, such as yeast. For purposes of examination, the starter is not limited to only the identified lactic acid bacteria, but may include other microorganisms that are not lactic acid bacteria.
In claim 3, lines 5 - 6, the recitation of "being fermented with said starter" renders the claim indefinite (particularly as further defined by amended claim 5), as it is unclear if the phrase is reciting a process by which the food composition is obtained, an intended use of the components, or a characteristic of the food composition itself. It is unclear how the phrase intends to limit the food composition. For purposes of examination, the claim is interpreted as a fermented food composition.
In claims 5, line 2 and 22 line 2, the recitation of "final fermented food composition" renders claims 5 and 3 indefinite as it is unclear if the final food composition is a distinct product from "the food composition" recited in the preamble and claim 3. For example, claim 3 recites a food composition "being fermented with said starter", whereas claim 5 recites both the food composition of claim 3 and also a "final food composition." In this regard, it is unclear if "the food composition" and the "final food composition" are the same product. For purposes of examination, the claim is interpreted as a fermented food composition wherein the composition has the claimed cell density.
In claim 24, line 3, "said flour or flours" lacks proper antecedent basis.
In claim 24, the recitation of "being fermented with said starter" renders the claim indefinite as it is unclear if the phrase is reciting a process by which the food composition is obtained, an intended use of the components, or a characteristic of the food composition itself. It is unclear how the phrase intends to limit the food composition. For purposes of examination, the claim is interpreted as a fermented food composition.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 21 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 21 recites a starter comprising L. brevis and L. plantarum, which broadens the claim on which it depends, thereby failing to further narrow the claim on which it depends requires the starter to consist of the L. brevis and L. plantarum strains.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Previous rejections under 35 U.S.C. 103 as being unpatentable over Mehta (US 2019/0327981) are withdrawn due to the amendment requiring rice, chickpea flour and lentil, and at the claimed ratio. Mehta does not teach this combination of flour in a food composition.
Claims 3, 5 – 15, 21 – 24 are rejected under 35 U.S.C. 103 as being unpatentable over Kiriyama et al. (JP 2008 283 922A).
Regarding claims 3 and 24, Kiriyama teaches a yoghurt like food or drink (food composition) made from rice 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 with the rice such as chickpea, lentil in order to provide richer flavors (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.
The reference does not teach the composition wherein all three flours are included in the claimed ratio. However, the references teaches that combining the ingredients together results in a richer flavored food composition, thereby motivating one in the art to combine the components and optimize the amounts thereof with a reasonable expectation for obtaining an effective food.
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 and 12 – 13, the reference does not teach food compositions with the claimed amounts of amino acids, GABA 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 claims 8 – 9, 11 and 24, the reference does not teach or require the compositions have tannins, raffinose or saponins. Thus, the compositions must have less than the stated amount.
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 that the prior art does not teach the claimed strains; that lactic acid strains demonstrate markedly different phenotypic and metabolic characteristics within species (dec. p 9 - 11); particularly in L. plantarum and L. brevis (decl. p 12); and as such, one in the art would not expect the claimed strains to exhibit their specific properties (dec. p 15-16).
However, 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 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.
Applicant argues that the claimed strains exhibit distinctive technological and functional characteristics that are superior in performance.
However, the question of whether the strains are distinct from other strains is not raised, but rather, was it obvious to one of ordinary skill in the art to use the instant strains in a food composition and are there unexpected results, advantages or activity tied to the claimed combination of strains. In this case, no evidence of unexpected results has been made of record, but only that applicant merely selected high performers.
Applicant compares a variety of L. plantarum and L. brevis strains with the claimed strains on each of a chickpea, rice flour and quinoa flour substrate (dec. p 18-24); showing the claimed strains exhibit higher performance across a variety of "technological and functional profiles" or metabolic outputs (dec. p 23 - 26).
However, while it is agreed that the evidence provided shows various strains produce different metabolic profiles on the various individual flours, the evidence is not commensurate in scope with the claimed invention. Specifically in that the claims recite a fermented food product requiring two specific strains in combination with of rice flour, chickpea flour and lentil flour. In this regard, the arguments and declaration do not support evidence of an unexpected result, advantage or activity as it pertains to the claimed composition. Further, although the evidence shows the claimed strains have the highest metabolic output compared to the other strains, this is not sufficient to demonstrate an unexpected result, particularly as it applies to the claimed composition.
Applicant argues that the evidence shows that various strains are not functionally equivalent; and therefore one cannot predict characteristics of another.
However, this argument fails to persuade. The evidence shows that the various strains are, in fact, functionally equivalent and that each of the strains share the same characteristics. Specifically, in that the strains all grow on the same substrates, produce the same organic acids, free amino acids, antinutritional factors and phenols, albeit at different rates and amounts. Moreover, the various strains fulfill the same purpose and achieve the same end result making them sufficiently equivalent to perform the same function, as well as sufficiently equivalent to substitute one for the other, and with a reasonable expectation for obtaining a food composition. Applicant admits that the deposited strains are merely selected for their ability to "perform better" (dec, p. 30) which does not rise to the level of unpredictable, unexpected or surprising results.
Applicant argues that the claimed strains were selected based on their nutritional properties based on unexpected results (example 3, dec p. 32 - 37) that are enhanced acidification, organic acid production, increased free amino acids, improved nutritional quality, reduced starch hydrolysis, predicted glycemic index, increased phenolic content and antioxidant activity and reduced concentration of antinutritional factors.
However, while these attributes are acknowledged to be better when including the bacterial strains in a yogurt product versus the yogurt product alone, these data points alone do not show unexpected results. Rather, the comparison between a non-fermented yogurt and yogurt fermented with the instant bacterial strains is insufficient to show the claimed strains impose an unexpected result compared to other strains or even compared to a yogurt without the strains. Further, it is noted that the results relied upon do not support unexpected results of the claimed composition, rendering the arguments incommensurate 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.
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
