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 .
Receipt is acknowledged of the Request for Continued Examination (RCE) under 1.114, the Amendment and Response, all filed 7/28/26.
Claims 11-21 are pending and have been rejected on the merits. Claim 22 was previously cancelled.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/28/26 has been entered.
Withdrawn Rejections
The 103(a) rejections of claims 11-21 over Firoozmand et al. (US 2017/0121671) in view of McCoy et al. (US 2010/0120701) as evidenced by C.A. Batt 2014 “Kluyveromyces” Encyclopedia of Food Microbiology have been withdrawn due to the claim amendments.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 11-21 are rejected under 35 U.S.C. 103 as being unpatentable over Firoozmand et al. (US 2017/0121671) in view of Aquilar et al. (US 2003/0215546) and McCoy et al. (US 2010/0120701) as evidenced by C.A. Batt 2014 “Kluyveromyces” Encyclopedia of Food Microbiology.
Regarding Claims 11, 12, 14, 15, 16: Firoozmand discloses an emulsion containing a microorganism, oil and water [abstract]. Firoozmand discloses that the microorganism can be a yeast and that the microorganism can be inactivated [0007; 0021; 0102]. Firoozmand discloses that the emulsion contains .0001% to about 10 % inactive microorganism (yeast) [0008]; discloses 0.01% to 99% oil [0008]; and water at 41-50% and also at 57% [0065; 0076]. Firoozmand discloses oil in water emulsions and discloses where the amount of water is greater than the amount of oil [0008; 0044, 0048, 0049, 0066; 0076]. Firoozmand discloses emulsions having a particle size of less than 100 µm [Fig 8]. Regarding the form of the cells in claims 15 and 16 since dry and in suspension are the forms available it would have been obvious to one of ordinary skill in the art to select the form of yeasts as desired by one of ordinary skill in the art.
Firoozmand discloses the emulsion is stable for a period of time of minutes to hours to years depending on the intended use [0030]. Firoozmand does not disclose the stability at 25C, however this is considered to be room temperature and since the experiments of Firoozmand are performed at room temperature and it therefore would have been obvious that the stability would have occurred at 25°C. Firoozmand discloses that the cells are whole, and therefore “unbroken” [0031]. Firoozmand does not disclose the inclusion of exogenous emulsifier, thickener and stabilizer which is commensurate with the recitation of “wherein the composition is free of exogenous emulsifier, exogenous thickener, and exogenous stabilizer.”
Firoozmand does not disclose that the inactivated cells are Kluyveromyces cells selected from one or more of Kluyveromyces marxianus, Kluyveromyces lactis, Kluyveromyces hubeiensis, Kluyveromyces wickerhamii, and Kluyveromyces thermotolerans cell.
Firoozmand does not disclose the particle size of the yeast at 2 to 5 um.
Aquilar discloses an edible emulsion mixture containing live microorganisms wherein the composition is formed at 35°C or less and held at 8°C or less [abstract; 0031]. Aquilar discloses the mixture comprising live microorganisms, oil, and water [abstract]. Aquilar discloses stability of the emulsion after at least 3 weeks [0020]. Aquilar discloses that the microorganism in the emulsion can be a yeast [0075; 0077]. Aquilar discloses oil in water emulsions where the oil is 30 to 75% [0087]; water is 15 to 60% [0083]; microorganisms are 5% to 50%; 15% to 25% [0073]. Aquilar discloses imparting flavor and nutritional properties to the food in which it is incorporated [0020].
McCoy discloses probiotic yeast that are administered in oil in water or water in oil emulsion [0061-0062]. McCoy discloses Kluyveromyces as a probiotic yeast and host cell for modification [0003; 0059; 0061; 0080; claims 1 and 10]. McCoy specifically discloses Kluyveromyces lactis [0006; 0010]. McCoy discloses providing the yeast as a food supplement and in food stuff [0026; 0048; 0061]. McCoy discloses providing the yeast in killed form (inactivated) [0065]. Batt teaches that Kluyveromyces cells have a particle size of 3 to 5 µm [abstract] therefore it is inherent that the Kluyveromyces of McCoy would have had a particle size in 2 to 5µm.
At the effective filing date at the invention it would have been obvious to one of ordinary skill in the art to modify the yeast of Firoozmand to include the Kluyveromyces of McCoy since the Firoozmand allows for single celled microorganisms inclusive of yeasts and since Kluyveromyces are yeasts and are food safe yeasts.
Further it would have been obvious to one of ordinary skill in the art to modify the quantity of yeast as in Aquilar since the amounts of yeast at 5 to 50% are overlapping with the disclosure in Firoozmand of .0001% to 10% and since the amounts in Aquilar can impart flavor and nutritional properties to the food in which it is incorporated.
Further regarding the process steps of the claim, since there is no evidence that the recited process produces a product that is materially different from what is disclosed in the prior art, claim 11 has been considered regarding its disclosure of the composition.
“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. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior art was made by a different process.” In re Thorpe, 777 F.2d 695, 698.
Although Aquilar does not explicitly disclose microorganism at 15 to 70%, one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Aquilar overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
Although Firoozmand does not explicitly disclose oil at 1 to 40%, 20% to 40% one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Firoozmand overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
Although Firoozmond does not explicitly disclose water at 18 to 84% one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Firoozmond overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
“Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding Claim 13: Firoozmand as modified discloses as discussed above in claim 11. Firoozmand does not disclose that the Kluyveromyces cell comprises 30 to 55% protein, 1 to 5% fat, and 15-30% fiber. However, the claim is merely a description of the nutrient components of Kluyveromyces. Since Firoozmand as modified discloses Kluyveromyces lactic and marxianus, it is inherent that the cells would have contained the protein, fat and fiber in the claimed range.
Regarding Claim 17: Firoozmand as modified discloses as discussed above in claim 11. Firoozmand discloses vegetable oil (soybean oil) and olive oil [0029; 0099].
Regarding Claim 18: Firoozmand discloses a method of making an emulsion containing a microorganism, oil and water [abstract]. Firoozmand discloses that the microorganism can be a yeast and that the microorganism can be inactivated [0007; 0021; 0102]. Firoozmand discloses that the emulsion contains .0001% to about 10 % inactive microorganism (yeast) [0008]; discloses 0.01% to 99% oil [0008]; and water at 42-49% [0065]. Firoozmand discloses emulsions having a particle size of less than 100 µm [Fig 8]. Firoozmand discloses shear emulsifying the mixture of water and oil, and yeast; Firoozmand discloses a mixture of cells and water and adding the oil during the process of mixing [0101-0103]. Regarding the form of the cells in claims 15 and 16 since dry and in suspension are the forms available it would have been obvious to one of ordinary skill in the art to select the form of yeasts as desired by one of ordinary skill in the art.
Firoozmand discloses the emulsion is stable for a period of time of minutes to hours to years depending on the intended use [0030]. Firoozmand does not disclose the stability at 25C, however this is considered to be room temperature and since the experiments of Firoozmand are performed at room temperature and it therefore would have been obvious that the stability would have occurred at 25°C. Firoozmand discloses that the cells are whole, and therefore “unbroken” [0031]. Firoozmand does not disclose the inclusion of exogenous emulsifier, thickener and stabilizer which is commensurate with the recitation of “wherein the composition is free of exogenous emulsifier, exogenous thickener, and exogenous stabilizer.”
Firoozmand does not disclose that the inactivated cells are Kluyveromyces cells selected from one or more of Kluyveromyces marxianus, Kluyveromyces lactis, Kluyveromyces hubeiensis, Kluyveromyces wickerhamii, and Kluyveromyces thermotolerans cell.
Firoozmand does not disclose the particle size of the yeast at 2 to 5 um.
Aquilar discloses an edible emulsion mixture containing live microorganisms wherein the composition is formed at 35°C or less and held at 8°C or less [abstract; 0031]. Aquilar discloses the mixture comprising live microorganisms, oil, and water [abstract]. Aquilar discloses stability of the emulsion after at least 3 weeks [0020]. Aquilar discloses that the microorganism in the emulsion can be a yeast [0075; 0077]. Aquilar discloses oil in water emulsions where the oil is 30 to 75% [0087]; water is 15 to 60% [0083]; microorganisms are 5% to 50%; 15% to 25% [0073]. Aquilar discloses imparting flavor and nutritional properties to the food in which it is incorporated [0020].
McCoy discloses probiotic yeast that are administered in oil in water or water in oil emulsion [0061-0062]. McCoy discloses Kluyveromyces as a probiotic yeast and host cell for modification [0003; 0059; 0061; 0080; claims 1 and 10]. McCoy specifically discloses Kluyveromyces lactis [0006; 0010]. McCoy discloses providing the yeast as a food supplement and in food stuff [0026; 0048; 0061]. McCoy discloses providing the yeast in killed form (inactivated) [0065]. Batt teaches that Kluyveromyces cells have a particle size of 3 to 5µm [abstract] therefore it is inherent that the Kluyveromyces of McCoy would have had a particle size in 2 to 5µm.
At the effective filing date at the invention it would have been obvious to one of ordinary skill in the art to modify the yeast of Firoozmand to include the Kluyveromyces of McCoy since the Firoozmand allows for single celled microorganisms inclusive of yeasts and since Kluyveromyces are yeasts and are food safe yeasts.
Further it would have been obvious to one of ordinary skill in the art to modify the quantity of yeast as in Aquilar since the amounts of yeast at 5 to 50% are overlapping with the disclosure in Firoozmand of .0001% to 10% and since the amounts in Aquilar can impart flavor and nutritional properties to the food in which it is incorporated.
Although Aquilar does not explicitly disclose microorganism at 15 to 70%, one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Aquilar overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness. Although Firoozmond does not explicitly disclose oil at 1 to 40%, 20% to 40% one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Firoozmand overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness. In re Malagari 182 USPQ 549,553.
Although Firoozmand does not explicitly disclose water at 18 to 84% one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Firoozmond overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness. In re Malagari 182 USPQ 549,553.
Although Firoozmand does not explicitly disclose oil at 1 to 40%, 20% to 40% one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Firoozmand overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
“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. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior art was made by a different process.” In re Thorpe, 777 F.2d 695, 698.
Regarding Claim 19: Firoozmand as modified discloses as discussed above in claim 11. Firoozmand discloses the composition in food [0020; 0022].
Regarding Claims 20 and 21: Firoozmand discloses as discussed above in claim 19 above. Firoozmand does not disclose that the food product is a beverage.
McCoy discloses wherein a food product can be a beverage [0048]. McCoy discloses yogurt which is known to be used as a sauce [0026]. McCoy also discloses that the yeast can be provided as a paste, syrup, gel, or slurry which is also a form in which sauces are provided [0062].
At the effective filing date of the invention it would have been obvious to one ordinary skill in the art to modify the composition of Firoozmand to include the composition in a beverage or sauce as in McCoy since the composition of Firoozmand is meant for edible compositions.
Response to Arguments
The 103(a) rejections of claims 11-21 over Firoozmand et al. (US 2017/0121671) in view of McCoy et al. (US 2010/0120701) as evidenced by C.A. Batt 2014 “Kluyveromyces” Encyclopedia of Food Microbiology have been withdrawn due to the claim amendments.
The Applicant asserts that McCoy and Batt do not correct the deficiencies of Firoozmand. The Examiner maintains that primary reference Firoozmand is not deficient because it discloses stability of its emulsion for hours and years and also the experiments of Firoozmand have been interpreted as occurring at room temperature.
The rejection has been modified.
Declaration dated 7/28/26 has been acknowledged.
The Applicants assert various examples with amounts of microorganisms at various ranges within the claimed range to cite unexpected results.
However, the Examiner notes that at 10% Kluyveromyces cells which is also disclosed by Firoozmand, stability was achieved at the 7 day mark. Firoozmand at 10% is able to achieve the stability claimed by the higher ranges of Kluyveromyces cells. Applicants results do not present a new and unexpected function.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FELICIA C TURNER whose telephone number is (571)270-3733. The examiner can normally be reached Mon-Thu 8:00-4:00 pm.
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/Felicia C Turner/Primary Examiner, Art Unit 1793
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