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 written in response to the Applicants Remarks filed 4/7/26. Claims 11-21 are pending and have been rejected on the merits. Claim 22 was previously cancelled.
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) and in view of 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 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.
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 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 Firoozmand does not explicitly disclose microorganism at 15 to 70%, it would have been obvious to one having ordinary skill in the art at the time of the invention to adjust the amount of microorganism for providing to the composition a higher amount of the nutritional benefits of the probiotic yeast, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272.
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. In re Malagari 182 USPQ 549,553.
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. In re Malagari 182 USPQ 549,553.
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 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.
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.
Although Firoozmand does not explicitly disclose microorganism at 15 to 70%, it would have been obvious to one having ordinary skill in the art at the time of the invention to adjust the amount of microorganism for providing to the composition a higher amount of the nutritional benefits of the probiotic yeast, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272.
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.
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
4. Applicant's arguments filed 4/7/26 have been fully considered but they are not persuasive.
5. The Applicants assert that Firoozmand does not disclose composition with microorganisms at more than 10%. The Applicants assert that the instant composition and that of Firoozmand are different. The Applicants assert that the instant invention is to an oil in water emulsion due to the presence of Kluyveromyces. The Applicants assert that the emulsions in Firoozmand are all oil in water emulsion regardless of the amount of water and oil. The Applicants assert that the Examiner has relied “ex post facto” that any strain can be applied to Firoozmand’s technical solution. The Applicants assert that only Kluyveromyces gives excellent long term stability.
Applicant is using known components to obtain expected results. There is nothing patentable unless the applicant, by a proper showing, further establishes a coaction or cooperative relationship between the selected ingredients, which produces a new, unexpected, and useful function. It is not seen where Applicant has provided support for unexpected results. In the absence of a showing of unexpected results, the amounts claimed are merely a matter of choice and well within the skill of the art. At most the amounts are seen merely as optimization.
In the absence of unexpected results, it is not seen how the claimed invention differs from the teachings of the prior art. Applicant's claims are drawn to a combination of known components which produces expected results.
Further regarding Applicants argument that the emulsion of Firoozmand is an oil in water emulsion no matter the proportions of oil and water, the Examiner maintains the Firoozmand achieves an oil in water emulsion and discloses proportions of oil and water that are within the Applicants claimed range. Applicants cannot re-write the application for the reference application. Every patent is presumed valid and that presumption includes the presumption of operability. MPEP 716.07
Further Applicants arguments are attorney arguments. Further, the Examiner notes, if a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. See, e.g., In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990). Rebuttal evidence and arguments can be presented in the specification, In re Soni, 54 F.3d 746, 750, 34 USPQ2d 1684, 1687 (Fed. Cir. 1995), by counsel, In re Chu, 66 F.3d 292, 299, 36 USPQ2d 1089, 1094-95 (Fed. Cir. 1995), or by way of an affidavit or declaration under 37 CFR 1.132, e.g., Soni, 54 F.3d at 750, 34 USPQ2d at 1687; In re Piasecki, 745 F.2d 1468, 1474, 223 USPQ 785, 789-90 (Fed. Cir. 1984). However, arguments of counsel cannot take the place of factually supported objective evidence. See, e.g., In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
Conclusion
6. 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.
7. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at 571-272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Felicia C Turner/Primary Examiner, Art Unit 1793
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