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 amendment filed May 29, 2026 with the Remarks has been entered. The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 3 – 6 and 14 – 29
Withdrawn claims: None
Cancelled claims: 1, 2, and 7 – 13
New claims: 14 – 29
Amended claims: 3 – 6
Claims currently under examination: 3 – 6 and 14 – 29
By not repeating the previously presented objection/rejection(s), it is sufficiently clear that said objection/rejection(s) are withdrawn.
Claim Objections
Applicant is advised that should claim 24 be found allowable, claim 25 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 14, 20, 26, and 28 are objected to because of the following informalities:
Claims 14 and 20 recite “inclusive” which is unnecessary given the broadest reasonable interpretation of the ranges recited, and opens the claims to potential misinterpretation.
Claim 14 recites “0.5%, 2.0% other sugars” which should be “0.5% mannitol, 2.0% other sugars” given the context provided in the instant specification (p. 14, Table 8).
Claim 26 recites “+/- 1,276 mg” in (Niacin, Range) of the table, which should be “+/- 1.276 mg” given the context of the claim.
Claim 28 recites “+/- 7802” in (Parameter, 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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15 – 18 are 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 15 recites “Amount (kg/250 kg homogenous fermented food)” regarding the amount of each component in the gelling mixture. There is no support in the instant specification with respect to the homogenous fermented food comprising the precisely recited amounts of the components in the gelling mixture. One of ordinary skill in the art would not have interpreted the disclosure to include the precisely claimed invention of claim 15 because the specification only refers to the gelling mixture as being defined by amounts generically. There is no suggestion to construct the gelling mixture by selecting amounts based on the total mass of the homogenous fermented food. For the purpose of examination, any amount of the gelling agent, gum, coconut flour, and agave inulin is considered to be present in the homogenous fermented food.
Claim 16 recites “Amount (kg/250 kg homogenous fermented food)” regarding the amount of each component in the solid acid mixture. There is no support in the instant specification with respect to the homogenous fermented food comprising the precisely recited amounts of the components in the solid acid mixture. One of ordinary skill in the art would not have interpreted the disclosure to include the precisely claimed invention of claim 16 because the specification only refers to the solid acid mixture as being defined by amounts generically. There is no suggestion to construct the solid acid mixture by selecting amounts based on the total mass of the homogenous fermented food. For the purpose of examination, any amount of the vitamin pre-mixture, dehydrated fruit, and citric acid is considered to be present in the homogenous fermented food.
Claim 18 recites “Amount (kg/250 kg homogenous fermented food)” regarding the amount of each component in the carbohydrate syrup mixture. There is no support in the instant specification with respect to the homogenous fermented food comprising the precisely recited amounts of the components in the carbohydrate syrup mixture. One of ordinary skill in the art would not have interpreted the disclosure to include the precisely claimed invention of claim 18 because the specification only refers to the carbohydrate syrup mixture as being defined by amounts generically. There is no suggestion to construct the carbohydrate syrup by selecting amounts based on the total mass of the homogenous fermented food. For the purpose of examination, any amount of the water, agave syrup, and inulin is considered to be present in the homogenous fermented food.
Claim 17 is rejected as dependent on a rejected base claim.
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.
Claims 5, 6, 14, 16, and 18 – 25 are rejected under 35 U.S.C. 103 as being unpatentable over Cruz Serrano (US 20110212224 A1) in view of Dr. Axe (Agave Nectar: Healthy ‘Natural’ Sweetener or All Hype? Dr. Axe. (2019) Retrieved from: https://draxe.com/nutrition/agave-nectar/), as 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/).
Regarding claim 14, MPEP § 2113.I teaches even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. Therefore, the structure implied by the process steps of claim 14 has been considered when assessing the patentability of the product.
Given the method does not recite specific mixing proportions of each ingredient, the packed food product is interpreted to comprise any amount of each of the recited ingredients. Therefore the structure implied by claim 14 is interpreted to be a fermented packaged food comprising: (a) a living microorganism; (b) glucose; (c) agave inulin comprising a molecular structure with beta 2-1 and beta 2-6 binds; (d) protein; (e) a food grade salt; (f) brewer’s yeast; (g) probiotics; (h) a gelling agent; (i) a gum; (j) a flour; (k) a vitamin pre-mixture; (l) a dehydrated fruit; (m) citric acid; (n) agave syrup; and (o) water.
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 is fermented ([0031]). Cruz Serrano teaches the functional food comprises: (a) biologically alive probiotics (i.e., a living microorganism – [0001]; [0003]; Claim 1; Claim 10); (b) glucose ([0097]); (c) agave inulin ([0079] – [0085]; [0093]; [0097]); (d) protein (Abstract; [0028]); (e) pyridoxine chlorohydrate (i.e., a food grade salt – [Abstract]); (f) yeast (i.e., brewer’s yeast – Abstract); (g) probiotics ([0047]; [0079] – [0085]); (h) gelatin (i.e., a gelling agent – [0094]); (i) xanthan gum (i.e., a gum – [0094]); (j) wheat flour ([0057]); (k) a vitamin supplement (i.e., a vitamin pre-mixture – [0095]); (l) powered cranberries (i.e., dehydrated fruit – [0079] – [0085]); (m) citric acid ([0095]); (n) high fructose syrup ([0111]); and (o) water [0097]). Cruz Serrano teaches the functional food is packaged ([0091]; [0110]).
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).
With respect to the combination of all of the above recited components according to the teachings of Cruz Serrano, MPEP § 2131.02 states, a reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." According to the teachings of Cruz Serrano described above, one of ordinary skill in the art would have at once envisaged a functional food comprising all ingredients from (a) through (o).
Cruz Serrano does not teach the high fructose syrup is agave syrup.
Dr. Axe teaches agave syrup is a high fructose syrup (p. 3, paragraph 2).
Cruz Serrano and Dr. Axe are combinable because they are concerned with the same field of endeavor, namely, high fructose syrups. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have selected agave syrup as the high fructose syrup in the functional food of Cruz Serrano, because agave syrup is a known high fructose syrup suitable for use in foods. MPEP § 2144.06.II states an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).
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 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]). 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.
Given the structure implied by the process steps of claim 14 is rendered obvious by Cruz Serrano, the product of claim 14 is rendered obvious by Cruz Serrano.
Regarding claim 5, 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 is fermented ([0031]).
While Cruz Serrano does not teach the fermentation is performed under the precisely claimed process conditions, this recitation is directed toward a method of production of the product of claim 5. MPEP § 2113.I teaches even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. Therefore, the structure implied by the process steps of claim 5 have been considered when assessing the patentability of the product.
The structure implied by claim 5 is interpreted to be the fermented packaged food of claim 14.
Therefore, the product of claim 5 is rendered obvious by Cruz Serrano.
Regarding claim 6, Cruz Serrano teaches the functional food comprises 1 x 106 CFUs of probiotics ([0047]).
While Cruz Serrano is silent with respect to whether the probiotics have a 2 decimal logarithm of growth, this recitation is directed toward a method of production of the product of claim 6. MPEP § 2113.I teaches even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. Therefore, the structure implied by the process steps of claims 6 have been considered when assessing the patentability of the product.
The structure implied by claim 6 is interpreted to be the packed food product of claim 14 wherein the inoculum has a CFU concentration of at least 5x103 to lx 1014 CFU in the total inoculum.
Therefore, the product of claim 6 is rendered obvious by Cruz Serrano.
Regarding claim 16, Cruz Serrano teaches the functional food comprises a vitamin supplement (i.e., a vitamin pre-mixture – [0095]); powered cranberries (i.e., dehydrated fruit – [0079] – [0085]); and citric acid ([0095]).
Regarding claim 18, the modified functional food of Cruz Serrano comprises water ([0097]); agave syrup, and agave inulin ([0079] – [0085]; [0093]; [0097]).
Regarding claim 19, Cruz Serrano teaches the functional food comprises a protein solid mixture comprising gelatin (i.e., gelling agent – [0094]).
Regarding claim 20, Cruz Serrano teaches the dehydrated fruit is powered cranberries ([0079] – [0085]).
While Cruz Serrano does not teach the precisely claimed humidity, pH, density, and particle size of the powdered cranberries prior to their addition to the functional food, this recitation is directed toward a method of production of the product of claim 20. MPEP § 2113.I teaches even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. Therefore, the structure implied by the process steps of claim 20 have been considered when assessing the patentability of the product.
The structure implied by claim 20 is interpreted to be the packed food product of claim 14.
Therefore, the product of claim 20 is rendered obvious by Cruz Serrano.
Regarding claim 21, Cruz Serrano teaches the probiotic comprises L. casei, L. rhamsnosus, L. paracasei, L. rauteri, L. lactis, L. fermentum, L. gasseri, L. jahnsonii, L. acidopillus, L. cripanus, L. amylovorus, L. delbrueckii or L. bulgaricas (Claim 3).
Regarding claim 22, Cruz Serrano teaches the probiotic comprises B. breve, B. infantis, B. bifidum, B. bacterium, B. lactis, B. animalis, B. suis or B. longum (Claim 4).
Regarding claim 23, Cruz Serrano teaches the probiotic comprises S. sanguis, S. bovis, S. cremoris, S. thermophilus or S. gallalytius (Claim 5).
Regarding claims 24 and 25, Cruz Serrano teaches the flour is wheat flour ([0057]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Cruz Serrano (US 20110212224 A1) as applied to claim 14 above, and further in view of Fairbairn et al. (The Impact of Single Amino Acids on Growth and Volatile Aroma Production by Saccharomyces cerevisiae Strains. Frontiers in Microbiology. Vol 8. Article 2554. (2017)).
Cruz Serrano teaches adding amines while preparing the probiotic to encourage the sustainability of living probiotics (Lactobacillus, Bifidus, Streptococcus and yeast) there are different probiotic strains that require different types of amines to promote their life ([0027]). While Cruz Serrano lists vitamins as sources of amines, proteins are known amine sources, and Cruz Serrano further teaches the optional addition of proteins ([0028]). Cruz Serrano teaches this mixture that ends up being a "culture broth" ([0030]).
Cruz Serrano does not teach the protein added to the “culture broth” (i.e., inoculum) has the precisely claimed aminogram.
Fairbairn investigates the impact of individual amino acids on the growth and aromatics production of Saccharomyces cerevisiae (i.e., yeast). Fairbairn teaches single amino acids have an effect on four growth parameters: lag phase, maximum growth rate, total biomass formation, and time to complete fermentation (Abstract). Fairbairn teaches the heatmap of Figure 1E summarizes all four growth parameters measured, where high values are colored red and low values are colored blue and the color intensity represents variation in the levels across the color scale, shown below:
PNG
media_image1.png
576
860
media_image1.png
Greyscale
Fairbairn further teaches single amino acid treatments result in a predictable production of aromatic compounds, with linear correlation between amino acid concentration and the concentration of aromatic compounds that are directly derived from these amino acids (Abstract). Fairbairn teaches a higher valine concentration linearly increases the production of isobutanol and isobutryic acid, a higher leucine and isoleucine concentration linearly increases the production of isoamyl alcohol, isovaleric acid, and isoamyl acetate, a higher phenylalanine concentration linearly increases the production of 2-phenylethanol, and a higher threonine concentration linearly increases the production of propanol (p. 6, paragraphs 3 and 5).
Cruz Serrano and Fairbairn are combinable because they are concerned with the same field of endeavor, namely, yeast culture broths. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have adjusted the concentrations of each of the precisely claimed amino acids in the “culture broth” (i.e., inoculum) of Cruz Serrano during routine optimization to find the “culture broth” (i.e., inoculum) with the desired growth behavior and aromatic production. MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed amino acid concentrations in the inoculum would thus be obvious.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Cruz Serrano (US 20110212224 A1) as applied to claim 14 above, and further in view of Parapouli et al. (Saccharomyces cerevisiae and its industrial applications. AIMS Microbiology. Vol 6, Iss 1. Pp. 1 – 31. (2020)) and De Man (A Medium for the Cultivation of Lactobacilli. Journal of Applied Bacteriology. Vol 23. Iss 1. Pp. 130 – 135. (1960)).
Cruz Serrano does not teach the yeast (i.e., brewer’s yeast) is Saccharomyces cerevisiae.
Parapouli teaches Saccharomyces cerevisiae has been an essential component of human civilization because of its extensive use in food and beverage fermentation in which it has a high commercial significance (p. 4, paragraph 3). Parapouli teaches S. cerevisiae is involved in the production of many fermented beverages, such as wine, beer and cider; distilled beverages, such as rum, vodka, whisky, brandy, and sake; whereas in other alcoholic beverages worldwide, from fruits, honey, and tea, S. cerevisiae is also involved (p. 4, paragraph 3). Parapouli teaches S. cerevisiae, also known as baker's yeast or simply ‘the yeast’, is the most common yeast species in bread and in sourdoughs (p. 11, paragraph 4). Parapouli teaches a great variety of yeasts have been isolated and characterized from cocoa beans fermentations, with S. cerevisiae being among the most prevalent in several studies (p. 15, paragraph 3).
Cruz Serrano and Parapouli are combinable because they are concerned with the same field of endeavor, namely, yeast. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have selected Saccharomyces cerevisiae as the yeast in the functional food of Cruz Serrano, as taught by Parapouli because S. cerevisiae has a broad utility in food and beverages and is suitable for the intended use of fermentation.
Cruz Serrano does not teach the functional food comprises a food grade salt composition comprising the precisely claimed salts.
De Man teaches lactobacilli broth comprises yeast extract and 5.0 g/L sodium acetate, 2.0 g/L potassium phosphate dibasic, 2.0 g/L ammonium citrate, 0.2 g/L magnesium sulfate, and 0.005 g/L manganese sulfate (p. 132, paragraph 3). Based on the recited composition, the salt comprises 54.05% sodium acetate, 21.62% potassium phosphate dibasic, 21.62% ammonium citrate, 2.16% magnesium sulfate, and 0.54% manganese sulfate.
Cruz Serrano and De Man are combinable because they are concerned with the same field of endeavor, namely, fermentation. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included yeast extract and the food grade salts in the proportions described in the lactobacillus medium of De Man, in the composition of Cruz Serrano because De Man provides that it was known for the recited salts to be successfully used and published at the time of filing, which means it was within the general skill of a worker in the art to select the recited salts for use in fermentation, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See § MPEP 2144.07.
While De Man does not teach the sodium acetate is sodium acetate anhydrous, MPEP § 2144.06.II states an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). One of ordinary skill in the art would have substituted sodium acetate with sodium acetate anhydrous before the effective filing date of the application because sodium acetate anhydrous and sodium acetate are functional equivalents of each other.
While De Man does not teach the ammonium citrate is ammonium citrate dibasic, MPEP § 2144.06.II states an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). One of ordinary skill in the art would have substituted ammonium citrate with ammonium citrate dibasic before the effective filing date of the application because ammonium citrate dibasic and ammonium citrate are functional equivalents of each other.
The table below shows the salts of the Lactobacilli medium salt profile of De Man compared to the composition of claim 4 of the instant application. The salt composition of De Man is similar to that of claim 4, however De Man does not disclose a composition with proportions identical to those of claim 4.
Component
Claim 4 – Salt (food grade) profile (%)
De Man – Lactobacilli medium salt profile (%)
Obviousness Analysis
Sodium acetate, anhydrous
54.35
54.05
Merely close
Potassium phosphate, dibasic
21.74
21.62
Merely close
Ammonium citrate, dibasic
21.74
21.62
Merely close
Magnesium sulfate
2.17
2.16
Merely close
Manganese sulfate
0
0.54
Merely close
Total
100
100
Regarding the similar proportions of each salt in the food grade salt of the instant application and the lactobacilli medium of De Man, MPEP § 2144.05.I states “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.").” In the instant case, the proportions of the food grade salt of the instant application and the lactobacilli medium of De Man are so close, one skilled in the art would have expected them to have the same properties.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Cruz Serrano (US 20110212224 A1) as applied to claim 14 above, and further in view of Nourished Kitchen (Coconut Flour. Nourished Kitchen. (2020). Retrieved from: https://nourishedkitchen.com/baking-with-coconut-flour/).
Cruz Serrano does not teach the flour is coconut flour.
Nourished Kitchen teaches coconut flour is a popular alternative to regular flour because it's relatively low in carbohydrates while being high in protein and fiber (p. 1, paragraph 1). Nourished Kitchen teaches coconut flour is also naturally gluten-free (p. 1, paragraph 1). Nourished Kitchen teaches coconut flour is best suited to replace all purpose flour (i.e., wheat flour) in a 1:4 ratio (coconut flour:wheat flour – p. 4, paragraph 1).
Cruz Serrano and Nourished Kitchen are combinable because they are concerned with the same field of endeavor, namely, flours. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have replaced the wheat flour in a 1:4 ratio with coconut flour, as taught by Nourished Kitchen in the composition of Cruz Serrano because coconut flour is relatively low in carbohydrates while being high in protein and fiber, and coconut flour is naturally gluten-free.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Cruz Serrano (US 20110212224 A1) as applied to claim 16 above, and further in view of MNT (A complete guide to B vitamins. Medical News Today. (November 21, 2020). Retrieved from Wayback Machine Archive - https://web.archive.org/web/20201121164400/https://www.medicalnewstoday.com/articles/325292) and Lenntech (Recommended daily intake of vitamins and minerals. Lenntech. (2016). Retrieved from: https://www.lenntech.com/recommended-daily-intake.htm).
Cruz Serrano teaches the vitamin pre-mixture comprises vitamin E, pyridoxine chlorohydrate, folic acid, vitamin B12 and ascorbic acid (Abstract).
Cruz Serrano does not teach the vitamin pre-mixture comprises nisin.
MNT teaches getting too little niacin (i.e., nisin) can cause a niacin (i.e., nisin) deficiency. Severe niacin (i.e., nisin) deficiency leads to pellagra (p. 8, paragraph 4). MNT teaches if pellagra goes untreated, it can lead to severe memory problems, behavioral changes, and suicidal behavior. It may also lead to an extreme loss of appetite or death (p. 8, paragraph 5).
Cruz Serrano and MNT are combinable because they are concerned with the same field of endeavor, namely, vitamins. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included niacin (i.e., nisin) in the functional food, as taught by MNT, because niacin (i.e., nisin) supplementation can prevent the undesirable side effects of niacin (i.e., nisin) deficiency such as memory problems, behavioral changes, and suicidal behavior.
Cruz Serrano does not teach the vitamin pre-mixture comprises thiamine.
MNT teaches a person with a thiamin deficiency may experience weight loss, little or no appetite, memory problems or confusion, heart problems, tingling and numbness in the hands and feet, loss of muscle mass, and poor reflexes (p. 5, paragraph 2).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included thiamine in the functional food, as taught by MNT, because thiamine supplementation can prevent the undesirable side effects of thiamine deficiency such as weight loss, little or no appetite, memory problems or confusion, heart problems, tingling and numbness in the hands and feet, loss of muscle mass, and poor reflexes.
Cruz Serrano does not teach the vitamin pre-mixture comprises riboflavin.
MNT teaches having a severe riboflavin deficiency can lead to anemia and cataracts (p. 7, paragraph 2).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included riboflavin in the functional food, as taught by MNT, because riboflavin supplementation can prevent the undesirable side effects of riboflavin deficiency such as anemia and cataracts.
Cruz Serrano is silent with respect to the amounts of each vitamin per 100g of the vitamin pre-mixture.
Lenntech teaches humans need a certain daily intake of food supplements (p. 1, paragraph 1). Lenntech provides the following chart detailing the daily recommended intake of each vitamin:
Vitamin
Recommended daily intake
Niacin (i.e., nisin)
18 mg/day
Ascorbic acid
75 mg/day
Folate (i.e., folic acid)
400 µg/day
Vitamin B12
6 µg/day
Vitamin E
10 mg/day
Thiamin (i.e., thiamine)
1.4 mg/day
Riboflavin
1.6 mg/day
Pyridoxine
2 mg/day
One of ordinary skill in the art would have been motivated to adjust the content of the vitamins in the vitamin pre-mix such that, when the vitamin pre-mix is added to the functional food, the vitamins included therein are less than the recommended daily intake values to provide supplementation to the vitamins already present in a person’s diet.
Given Cruz Serrano teaches no more than 5g of vitamin pre-mixture is added per L of total mix ([0029]); and that the functional food comprises nutrients (i.e., vitamins) within the international daily intake standards for healthy human consumption ([0049]), a vitamin-pre mixture comprising the precisely claimed vitamin amounts in 100g of pre-mixture is encompassed by the modified functional food of Cruz Serrano.
Claims 26 – 29 are rejected under 35 U.S.C. 103 as being unpatentable over Cruz Serrano (US 20110212224 A1) as applied to claim 14 above, and further in view of Lenntech (Recommended daily intake of vitamins and minerals. Lenntech. (2016). Retrieved from: https://www.lenntech.com/recommended-daily-intake.htm).
Regarding claim 26, Cruz Serrano teaches the functional food comprises a vitamin supplement ([0095]).
Cruz Serrano does not teach the functional food comprises the precisely claimed amounts of each B vitamin in the B-complex.
Lenntech teaches humans need a certain daily intake of food supplements (p. 1, paragraph 1). Lenntech provides the following chart detailing the daily recommended intake of each vitamin:
Vitamin
Recommended daily intake
Niacin (i.e., nisin)
18 mg/day
Ascorbic acid
75 mg/day
Folate (i.e., folic acid)
400 µg/day
Vitamin B12
6 µg/day
Vitamin E
10 mg/day
Thiamin (i.e., thiamine)
1.4 mg/day
Riboflavin
1.6 mg/day
Pyridoxine
2 mg/day
One of ordinary skill in the art would have been motivated to adjust the content of the vitamins in the functional food such that they are less than the recommended daily intake values to provide supplementation to the vitamins already present in a person’s diet. A comparison between the precisely claimed vitamin amounts and the recommended daily intakes is shown below:
Vitamin
Claim 26 – Vitamins mg in 100 g
Lenntech – Vitamins Daily Intake
Niacin (i.e., nisin)
8.50 ± 1.276
18 mg/day
Ascorbic acid
47.70 ± 7.155
75 mg/day
Folate (i.e., folic acid)
0.33 ± 0.050
400 µg/day
Vitamin B12
0.0015 ± 0.0002
6 µg/day
Vitamin E
8.37 ± 1.256
10 mg/day
Thiamin (i.e., thiamine)
0.68 ± 0.102
1.4 mg/day
Riboflavin
0.73 ± 0.109
1.6 mg/day
Pyridoxine
0.80 ± 0.120
2 mg/day
The range of mg/ 100g of each vitamin listed above, none to the recommended daily value, as disclosed by Lenntech, overlaps with the claimed ranges recited in the table above. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 27, Cruz Serrano does not teach the functional food comprises the precisely claimed amounts of each mineral.
Lenntech teaches humans need a certain daily intake of food supplements (p. 1, paragraph 1). Lenntech provides the following chart detailing the daily recommended intake of each mineral:
Mineral
Recommended daily intake
Calcium
1000 mg/day
Magnesium
350 mg/day
Potassium
3500 mg/day
Phosphorus
1000 mg/day
Iron
15 mg/day
Zinc
15 mg/day
One of ordinary skill in the art would have been motivated to adjust the content of the minerals vitamins in the functional food such that they are less than the recommended daily intake values to provide supplementation to the minerals already present in a person’s diet. A comparison between the precisely claimed mineral amounts and the recommended daily intakes is shown below:
Mineral
Claim 27 – Minerals mcg in 100 g
Lenntech – Recommended daily intake
Calcium
1.41 ± 0.211
1000 mg/day
Magnesium
2.32 ± 0.348
350 mg/day
Potassium
10.47 ± 1.570
3500 mg/day
Phosphorus
11.14 ± 1.672
1000 mg/day
Iron
0.62 ± 0.093
15 mg/day
Zinc
0.55 ± 0.082
15 mg/day
The range of mcg/ 100g of each mineral listed above, none to the recommended daily value, as disclosed by Lenntech, overlaps with the claimed ranges recited in the table above. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 28, while Cruz Serrano does not explicitly state the functional food has precisely claimed properties at 25 °C ± 5 °C prior to packing, MPEP § 2112.01.I states where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In this case, the functional food and the homogenous fermented food are substantially identical in composition, therefore they inherently have the same properties, including the precisely claimed properties of claim 28. 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 the precisely claimed properties of the functional food at 25 °C ± 5 °C prior to packing does not render novel the previously unappreciated precisely claimed properties.
Regarding claim 29, while Cruz Serrano does not explicitly state the functional food has precisely claimed properties at 25 °C ± 5 °C after 8 months, MPEP § 2112.01.I states where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In this case, the functional food and the homogenous fermented food are substantially identical in composition, therefore they inherently have the same properties, including the precisely claimed properties of claim 28. 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 the precisely claimed properties of the functional food at 25 °C ± 5 °C after 8 months does not render novel the previously unappreciated precisely claimed properties.
Response to Arguments
Applicant's arguments filed May 29, 2026 have been fully considered but they are not persuasive.
Applicant argues the claims as amended are not anticipated or rendered obvious by Cruz Serrano (p. 17, paragraph 5).
Applicant’s argument has been carefully considered however the argument is not persuasive. See the rejection of claims 3 – 6 and 14 – 29 over Cruz Serrano.
Conclusion
No claims are allowed.
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.
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793
/L.J.M./Examiner, Art Unit 1793
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