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 .
This office action is in response to the application filed on December 22, 2023. The earliest effective filing date of the application is June 23, 2021.
Priority
The present application is a 371 National Stage Application of PCT/MX2021/000021 which has a filing date of June 23, 2021.
Status of Application
The status of the claims stands as follows:
Pending claims: 1 – 13
Withdrawn claims: None
Claims currently under examination: 1 – 13
Drawings
The subject matter of this application admits of illustration by a drawing to facilitate understanding of the invention. Applicant is required to furnish a drawing under 37 CFR 1.81(c). No new matter may be introduced in the required drawing. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). In this case, Figure 1 on page 24 is incorporated into the text of the instant specification. The drawing in its current state is illegible and requires its own drawing sheet.
Claim Objections
Claim 3 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, the claim has not been further treated on the merits.
Claims 4 – 13 are objected to under 37 CFR 1.75(c) as being in improper form because a claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims have not been further treated on the merits.
Claims 2 – 13 are objected to because of the following informalities:
Claim 2 recites “agave inulin with a molecular structure with beta 2-1 and beta 2-6 binds, resistant to hydrolysis by human digestive enzymes, but that they can be fermented by native lactic acid bacteria from the human gastrointestinal tract” which should be rewritten as “agave inulin comprising a molecular structure with beta 2-1 and beta 2-6 binds that are resistant to hydrolysis by human digestive enzymes, but fermentable by native lactic acid bacteria from the human gastrointestinal tract” to avoid misinterpretation.
Claims 2 – 13 recite “where” which should be “wherein”.
Claim 3 recites “+/- 1305” in (Leucine, Range) of the table, which should be “+/- 1.305” according to the instant specification (p. 7, Table 1).
Claim 3 recites “+/- 0600” in (Threonine, Range) of the table, which should be “+/- 0.600” according to the instant specification (p. 7, Table 1).
Claims 3, 4, 7 – 12 have a period before reciting the table. The “.” should be a “:”
Claims 3 – 5, 7 – 11, and 13 fail to end in a period. All claims must end with a period. Including a period after the table, in addition to the revision suggested above, would resolve this issue.
Claim 5 recites “+/- s” in (Time, Operation range) of the table, which should be “+/- 5” according to the instant specification (p. 10, Table 3).
Claim 7 recites “1730” in (Coconut flour, Amount) of the table, which should be “1.730” according to the instant specification (p. 11, Table 4).
Claim 9 recites “*” in (Thiamine, Range) of the table, which appears to be included in error. “*” is interpreted to have no significance.
Claim 11 recites “+/- 7.802” in (Chemical, pH, Range) of the table, which should be “+/- 0.5” given the context provided in the instant specification (Tables 10, 13, and 14).
Claim 11 recites “+/- 7802” in (Chemical, Solid concentration, Range) of the table, which should be “+/- 7.802” given the context provided in the instant specification (Tables 10, 13, and 14).
Claims 11 – 13 refer to Tables 11 and 12 of the instant specification. MPEP § 2173.05(s) states "Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
Claim 12 recites “inoculate at 25 +/- 5 °C” while also reciting the food is at “25 +/- 3 °C” in (Physical, Temperature, Unit, Measure, and Range). According to the instant specification , it appears the food is at 25 +/- 3 °C (p. 20, line 1; p. 20, Table 13).
Claim 12 recites “2.000” in (Physical, Viscosity, Range) of the table, which should be “2000” given the context provided in the instant specification (Tables 10, 13, and 14).
Claim 12 recites “7802” in (Chemical, Solid concentration, Range) of the table, which should be “7.802” given the context provided in the instant specification (Tables 10, 13, and 14).
Claim 12 recites “Where” after the table, which should be “wherein” because claim 12 is one sentence.
Claim 13 recites “1.600” in (Physical, Viscosity, Range) of the table, which should be “1600” given the context provided in the instant specification (Tables 10, 13, and 14).
Claim 13 recites “+/- 7802” in (Chemical, Solid concentration, Range) of the table, which should be “+/- 7.802” given the context provided in the instant specification (Tables 10, 13, and 14).
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.
Claims 1 – 13 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.
Claim 1 does not have a transitional phrase or a body, which renders the claim indefinite. Claims require a preamble, transitional phrase, and a body to properly claim an applicant’s invention. In this case, claim 1 has a preamble, which asserts the invention is a food in controlled dynamic fermentation, and has the intended purpose of generating bacteriostasis in alive and metabolically active microorganisms, allowing for stable shelf life at room temperature for up to 8 months, however, there is no description of the metes and bounds of the food, and one of ordinary skill in the art would not be apprised of the scope of the contents of the food. For the purpose of examination, Claim 1 is interpreted to claim “a food in controlled dynamic fermentation for generating bacteriostasis in alive and metabolically active microorganisms, allowing for stable shelf life at room temperature for up to 8 months, comprising at least one microorganism.”
Claims 2 – 4 and 6 recite the limitation "the first fermentation". There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, “the first fermentation” is interpreted to be the food.
Claim 3 recites “mg/L” which renders the claim indefinite. The basis of the “liters” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, “mg/L” is interpreted to be mg amino acid/L total fermentation ingredients.
Claim 4 recites the phrase "typically" which renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purpose of examination, the recitation “Saccharomyces cerevisiae or any other used in the bakery or brewing industry” is considered to be limiting.
Claim 4 fails to disclose the basis (i.e., weight, volume, molar, etc) of the individual salt percentages of the food grade salt composition. The basis of the individual salt percentages of the food grade salt composition is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, the individual salt percentages of the food grade salt composition is interpreted to be by weight.
Claim 7 recites “inoculated in a food that requires 3 mixtures for preparing a total of 200 kg” which renders the claim indefinite. It is unclear what constitutes "a food that requires 3 mixtures for preparing a total of 200 kg" and therefore it is not clear what food is being inoculated.
Claims 7 – 10 fail to disclose the proportions of each of the three mixtures to prepare 200 kg of food, which renders these claims indefinite because the total of the three mixtures is greater than 200 kg as recited in claims 7 – 10. It is unclear what are the metes and bounds of the food product of the instant invention without clarity with respect to the mixing proportions of the three mixtures.
Claim 8 fails to disclose the basis (i.e., weight, volume, molar, etc) of the amounts and ranges of the ingredients recited in the table. The basis of the amounts and ranges of the ingredients recited in the table are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, the amounts and ranges of the ingredients recited in the table are interpreted to be by kilogram.
Claims 5, 6, and 11 – 13 are rejected as dependent on a rejected base claim.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cruz Serrano (US 20110212224 A1).
Regarding claim 1, the broadest reasonable interpretation of claim 1 is a food comprising a living microorganism.
Cruz Serrano teaches a functional food comprising a mixture of probiotics and prebiotics such that the probiotics are capable of remaining biologically alive (i.e., in controlled dynamic fermentation – [0001]; [0003]; Claim 1; Claim 10). Cruz Serrano teaches the functional food allows the symbiotic action between different strains of probiotics and prebiotics, ensuring that said probiotics and prebiotics are recognized by probiotics in order to benefit from them, thus achieving two conditions, the first one being to keep alive and active the probiotic strains and the second one being to achieve reproduction of said probiotic strains under biophysical and biochemical conditions of temperature, osmotic pressure and pH ([0003]).
With respect to the intended use recited in the preamble, namely, “for generating bacteriostasis in alive and metabolically active microorganisms, allowing for stable shelf life at room temperature for up to 8 months”, while Cruz Serrano is silent with respect to the length of time wherein the functional food remains stable at room temperature, the instant specification states physical, chemical, nutritional and biological parameters of the fermented foods are described after 8 months of stability, which represent the biological threshold after which probiotic bacteria start having viability problems due to acidity, lack of carbohydrate substrates, proteins and osmotic pressure modification, as a result of acidification and solid substrates decrease (p. 22, paragraph 2). Cruz Serrano emphasizes the ability of the functional food to maintain a biologically alive fermentation (i.e., a controlled dynamic fermentation) under specific biophysical and biochemical conditions including temperature, osmotic pressure, and pH ([0003]). Therefore, because the functional food of Cruz Serrano is kept biologically alive (i.e., in controlled dynamic fermentation) by controlling the temperature, osmotic pressure, and pH, the functional food of Cruz Serrano inherently allows for a stable shelf life at room temperature for up to 8 months. Furthermore, MPEP § 2112.I states “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer”. In this case, the fact that Cruz Serrano is silent with respect to whether the functional food is able to maintain a stable shelf life of up to 8 months does not render novel the previously unappreciated shelf life of the functional food of Cruz Serrano. Therefore, the functional food of Cruz Serrano would be suitable for the recited intended use.
Claim 2 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cruz Serrano (US 20110212224 A1), as applied to claim 1 above, and further evidenced by The Green Labs (Organic Agave Inulin Powder 90%. The Green Labs. (n.d.) Retrieved from: https://www.thegreenlabs.com/organic-agave-inulin-powder-90/) and GPO (Prebiotic Type Spotlight: Inulin. Global Prebiotic Association. (February 2024). Retrieved from: https://prebioticassociation.org/prebiotic-type-spotlight-inulin/).
Regarding claim 2, the broadest reasonable interpretation of claim 2 is a food comprising a living microorganism and agave inulin with a molecular structure with beta 2-1 and beta 2-6 binds, resistant to hydrolysis by human digestive enzymes, but that they can be fermented by native lactic acid bacteria from the human gastrointestinal tract.
Cruz Serrano teaches the prebiotic in the functional food comprises agave inulin ([0015]).
While Cruz Serrano is silent with respect to whether the agave inulin has a molecular structure with beta 2-1 and beta 2-6 binds, as evidenced by The Green Labs, agave inulin inherently comprises beta 2-1 and beta 2-6 binds (p. 1, paragraph 2).
While Cruz Serrano is silent with respect to whether the agave inulin is resistant to hydrolysis by human digestive enzymes but the agave inulin can be fermented by native lactic acid bacteria from the human gastrointestinal tract, as evidenced by GPO, in the human body, plant inulin is not readily digested, fermented, or absorbed in the initial gastrointestinal tract (i.e., resistant to hydrolysis by human digestive enzymes – p. 2, paragraph 2). As evidenced by GPO, inulin is instead digested in the distal portion of the colon by pulling in water, managing constipation, and promoting the growth of colonic microbiota (i.e., native lactic acid bacteria from the human gastrointestinal tract – p. 2, paragraph 2).
Therefore the functional food of Cruz Serrano anticipates the limitations of claim 2.
Conclusion
No claims are allowed.
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/L.J.M./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793