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 regard to the application filed on September 1, 2021 and in response to Applicant’s Amendments and Arguments/Remarks filed on March 27, 2026.
Status of Application
The amendment filed March 27, 2026 has been entered. Claims 1, 3, 6, 13, 14, and 17-21 are currently pending in the application. Claims 1, 14, and 19-21 have been amended; claims 2, 4, 5, 7-12, 15, and 16 have been canceled. Claims 1, 3, 6, 13, 14, and 17-21 are hereby examined on the merits.
The previous 112(a) rejections of claims 1, 3, 6, 13, 14, and 17-20 and the previous 112(b) rejections of claims 1, 3, 6, 13, 14, 17, 18, and 20 have been withdrawn in light of applicant’s claim amendments. The previous 112(b) rejection of claim 19 has been partially withdrawn.
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.
Claim 20 is 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 20 is rendered indefinite as the claim is unclear as to what constitutes an “improved” HDL:total cholesterol ratio. An “improved” ratio 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. Is an “improved” ratio one that increases or decreases in value?
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.
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.
Claims 1, 6, 13, 14, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yabumoto et al. (US PG Pub 2011/0123640; listed in IDS dated Sept. 1, 2021) in view of Jacobsen et al. (US PG Pub 2013/0251848; listed on PTO-892 dated March 14, 2024), Marques et al. (BR 102012032927; listed on PTO-892 dated March 14, 2024), and Christensen (“How to Make Milk Kefir”, The Kitchn, 2014; cited on PTO-892 dated March 14, 2024), herein after referred to as Yabumoto, Jacobsen, Marques, and Christensen respectively.
Regarding claims 1, 6, 13, and 18, Yabumoto discloses a fermented milk product (i.e., kefir) and a method of obtaining the product, the method comprising:
a) providing bacterial strains comprising a Lactobacillus kefiri strain (i.e., one Lactobacillus species);
b) providing yeast strains comprising Kazachstania unispora, and Kluyveromyces marxianus (i.e., providing yeast strains comprising at least one Kazachstania species and at least one Kluyveromyces species) (claim 3),
the bacterial and yeast strains of which are cultured separately (i.e., providing a first culture containing bacterial strains and a second culture containing yeast strains) [0020];
c) combining the separately cultured bacterial strains and yeast strains to milk (i.e., adding each culture of strains to milk to form a mixture); and
d) fermenting the milk with the bacterial and yeast strains in order to obtain the fermented milk product (claim 3) where the fermentation is conducted at 25° C (i.e., room temperature) for 24 hours (i.e., at least twenty hours) [0030].
Yabumoto does not explicitly state that the fermented milk product (i.e., kefir) is specifically a pitched kefir. However, where a “pitched” kefir does not involve fermentation of the natural kefir grains themselves, but rather fermentation of selected bacteria and yeast strains (as defined by the applicant on page 9 of the remarks dated March 21, 2025), the product of Yabumoto is considered to be a pitched kefir, since Yabumoto directly ferments bacteria and yeast strains as set forth above and does not use any natural kefir grains.
Yabumoto does not teach that the bacterial strains comprise at least one Acetobacter species, at least one Leuconostoc species, at least one Lactococcus species, and at least two Lactobacillus species including Lactobacillus kefiranofaciens. Yabumoto does teach one Lactobacillus species that is Lactobacillus kefiri. Yabumoto also does not teach that a starting concentration of the bacterial strains is about 104 CFU/mL or that the pitched kefir product comprises a final concentration of 108 CFU/mL of bacteria.
Jacobsen, in the same field of invention, teaches a fermented milk product (claim 37), specifically kefir, made with the bacterial strains of Leuconostoc, Lactococcus, Acetobacter [0143], and Lactobacillus delbrueckii subsp. Bulgaricus (claim 39; [0233]). Jacobsen also teaches that the starting concentration of the bacterial strains is 105-1013 CFU/mL ([0136]-[0137]) and that the final kefir product comprises a final concentration of at least 106 CFU/mL of bacteria [0113]. Jacobsen offers the motivation that kefir is made with these strains at these concentrations in a strong specific relationship as a starter culture [0143]. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of preparing kefir of Yabumoto by incorporating the Leuconostoc, Lactococcus, Acetobacter, and Lactobacillus delbrueckii subsp. Bulgaricus (i.e., a second Lactobacillus species) strains of Jacobsen, thereby arriving at the claimed invention with the reasonable expectation that the strains of Jacobsen are capable of producing kefir and the final kefir product has a typical bacteria count.
The final bacteria concentration range taught by Jacobsen, at least 106 CFU/mL, encompasses the claimed amount of 108 CFU/mL, and where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05.I.
The starting bacteria concentration range taught by Jacobsen, 105-1013 CFU/mL, does not overlap with the claimed amount of about 104 CFU/mL, but is close. Per MPEP 2144.05.I., a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. The difference between the claimed range and that which is claimed is virtually negligible absent any showing of unexpected results or criticality.
Neither Yabumoto nor Jacobsen teach that the yeast strains comprise at least one Pichia species, specifically Pichia fermentans, and at least one Saccharomyces species, specifically Saccharomyces cerevisiae, or that the at least two Lactobacillus species include Lactobacillus kefiranofaciens.
Marques, in the same field of invention, teaches a fermented milk product (Abstract) comprising Pichia fermentans, Saccharomyces cerevisiae, and Lactobacillus kefiranofaciens (i.e., an additional Lactobacillus species including Lactobacillus kefiranofaciens). Marques offers the motivation that these strains offer immunomodulatory action to the food products in which the strains are present (p. 4, first paragraph under “Description of the Invention”). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the yeast and bacteria strains of Yabumoto and Jacobsen by incorporating the Pichia fermentans, Saccharomyces cerevisiae, and Lactobacillus kefiranofaciens strains of Marques, thereby arriving at the claimed invention, with the reasonable expectation that the additional yeast and bacteria strains will offer immunomodulatory action to food products.
None of Yabumoto, Jacobsen, nor Marques teach a starting concentration of yeast strains of about 103 CFU/mL or that the pitched kefir product comprises a final concentration of 106 CFU/mL of yeast. However, differences in concentration or temperature will generally not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. 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). See MPEP 2144.05.II.A. Concentration of yeast strains in a method for fermentation is a result effective variable, as the concentration of yeast is known to affect the fermentation process. Thus, it would have been well within the skill set of one of ordinary skill in the art to perform a routine optimization on the result effective variable, the starting concentration of yeast strains, until achieving the desired output.
None of Yabumoto, Jacobsen, nor Marques teach that the milk is 2 wt.% fat pasteurized milk.
Christensen, in the same field of invention, teaches making kefir with 2 wt.% fat pasteurized milk. Christensen offers the motivation that using pasteurized 2 wt.% milk successfully produces kefir (What Milk to Use?). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have used the 2 wt.% fat pasteurized milk of Christensen as the milk in the method of Yabumoto, Jacobsen, and Marques. One would have been motivated to make this modification in order to utilize a type of milk that is known to successfully produce kefir.
Regarding claims 14, 19, and 20, modified Yabumoto teaches a pitched kefir formed by the method of claim 1 as set forth above. Modified Yabumoto also teaches a method for improving a subject’s intestinal environment by administering the pitched kefir product to a subject ([0008]; [0026]-[0028]).
Modified Yabumoto is silent as to that the method also reduces cholesterol and liver triglycerides in the subject by administering a pitched kefir product to the subject daily for at least about four weeks, wherein the pitched kefir product reduces cholesterol and liver triglycerides.
However, 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 obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Since the composition and method of modified Yabumoto is substantially identical to those claimed, the prior art product and method must necessarily possess the same properties and characteristics as the composition and method claimed. Additionally, since modified Yabumoto already teaches administering the kefir to a subject for improvements in the subject’s health, the administration of the prior art product would also necessarily be for the same benefits as claimed (e.g., reducing cholesterol and liver triglycerides). Therefore, the composition and method taught by modified Yabumoto is considered to possess the beneficial aspects as claimed because the composition and method is substantially the same and thus must necessarily exhibit the same properties.
Claims 3 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Yabumoto et al. (US PG Pub 2011/0123640; listed in IDS dated Sept. 1, 2021) in view of Jacobsen et al. (US PG Pub 2013/0251848; listed on PTO-892 dated March 14, 2024), Marques et al. (BR 102012032927; listed on PTO-892 dated March 14, 2024), and Christensen (“How to Make Milk Kefir”, The Kitchn, 2014; cited on PTO-892 dated March 14, 2024), as applied to claims 1 and 14 above, and further in view of Giardini et al. (WO 2010/109291; listed on PTO-892 dated March 14, 2024), herein after referred to as Giardini.
Modified Yabumoto teaches the method for preparing a kefir product as set forth above with regard to claim 1.
Regarding claims 3 and 17, modified Yabumoto teaches that the bacterial strains comprise Acetobacter pasteurianus, Lactococcus lactis, Lactobacillus kefiranofaciens (Marques: (p. 4, first paragraph under “Description of the Invention”), and Lactobacillus kefiri (Yabumoto: claim 1).
Modified Yabumoto does not teach that the bacterial strains comprise Leuconostoc mesenteroides.
Giardini, in the same field of invention, teaches a kefir product comprising Leuconostoc mesenteroides (claim 1). Giardini offers the motivation that this strain can produce kefir and other fermented milk products with the best growth feature at relatively low temperatures (p. 10). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of modified Yabumoto by incorporating the Leuconostoc mesenteroides strain of Giardini. One would have been motivated to make this modification for the benefit of incorporating a strain with the best growth features at relatively low temperatures.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Yabumoto et al. (US PG Pub 2011/0123640; listed in IDS dated Sept. 1, 2021) in view of Marques et al. (BR 102012032927; listed on PTO-892 dated March 14, 2024), Giardini et al. (WO 2010/109291; listed on PTO-892 dated March 14, 2024), Jacobsen et al. (US PG Pub 2013/0251848; listed on PTO-892 dated March 14, 2024), and Christensen (“How to Make Milk Kefir”, The Kitchn, 2014; cited on PTO-892 dated March 14, 2024).
Yabumoto discloses a fermented milk product (i.e., kefir) and a method of obtaining the product, the method comprising:
a) providing bacterial strains comprising a Lactobacillus kefiri strain;
b) providing yeast strains comprising Kazachstania unispora, and Kluyveromyces marxianus (claim 3),
the bacterial and yeast strains of which are cultured separately (i.e., providing a first culture containing bacterial strains and a second culture containing yeast strains) [0020];
c) combing the separately cultured bacterial strains and yeast strains to milk (i.e., adding each culture of strains to milk to form a mixture); and
d) fermenting the milk with the bacterial and yeast strains in order to obtain the fermented milk product (claim 3) where the fermentation is conducted at 25° C (i.e., room temperature) for 24 hours (i.e., at least twenty hours) [0030].
Yabumoto does not explicitly state that the fermented milk product (i.e., kefir) is specifically a pitched kefir. However, where a “pitched” kefir does not involve fermentation of the natural kefir grains themselves, but rather fermentation of selected bacteria and yeast strains (as defined by the applicant on page 9 of the remarks dated March 21, 2025), the product of Yabumoto is considered to be a pitched kefir, since Yabumoto directly ferments bacteria and yeast strains as set forth above and does not use any natural kefir grains.
Yabumoto is silent as to that the bacterial strains also comprise Acetobacter pasteurianus, Leuconostoc mesenteroides, Lactococcus lactis, and Lactobacillus kefiranofaciens, and that the yeast strains also comprise Pichia fermentans and Saccharomyces cerevisiae.
Marques, in the same field of invention, teaches a fermented milk product (Abstract) comprising Pichia fermentans, Saccharomyces cerevisiae, Acetobacter pasteurianus, Lactococcus lactis, and Lactobacillus kefiranofaciens. Marques offers the motivation that these strains offer immunomodulatory action to the food products in which the strains are present (p. 4, first paragraph under “Description of the Invention”). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the yeast strains of Yabumoto and Jacobsen by incorporating the Pichia fermentans and Saccharomyces cerevisiae strains of Marques, and to have modified the bacterial strains of Yabumoto by incorporating the Acetobacter pasteurianus, Lactococcus lactis, and Lactobacillus kefiranofaciens strains of Marques, thereby arriving at the claimed invention, with the reasonable expectation that the additional strains will offer immunomodulatory action to food products.
Yabumoto and Marques do not teach that the bacterial strains also comprise Leuconostoc mesenteroides.
Giardini, in the same field of invention, teaches a kefir product comprising Leuconostoc mesenteroides (claim 1). Giardini offers the motivation that this strain can produce kefir and other fermented milk products with the best growth feature at relatively low temperatures (p. 10). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Yabumoto and Marques by incorporating the Leuconostoc mesenteroides strain of Giardini. One would have been motivated to make this modification for the benefit of incorporating a strain with the best growth features at relatively low temperatures.
Yabumoto, Marques, and Giardini do not teach that a starting concentration of the bacterial strains is about 104 CFU/mL or that the pitched kefir product comprises a final concentration of 108 CFU/mL of bacteria.
Jacobsen, in the same field of invention, teaches a fermented milk product (claim 37), specifically kefir, made with the bacterial genera of Leuconostoc, Lactococcus, Acetobacter [0143], and Lactobacillus (claim 39; [0233]), as well as that the starting concentration of the bacterial strains is 105-1013 CFU/mL ([0136]-[0137]) and that the final kefir product comprises a final concentration of at least 106 CFU/mL of bacteria [0113]. Jacobsen offers the motivation that kefir is made with these genera at these concentration in a strong specific relationship as a starter culture [0143]. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of preparing kefir of Yabumoto, Marques, and Giardini by using the genera at the taught concentrations of Jacobsen, thereby arriving at the claimed invention with the reasonable expectation that the concentrations of the genera of Jacobsen are capable of producing kefir and the final kefir product has a typical bacteria count.
The final bacteria concentration range taught by Jacobsen, at least 106 CFU/mL, encompasses the claimed amount of 108 CFU/mL, and where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05.I.
The starting bacteria concentration range taught by Jacobsen, 105-1013 CFU/mL, does not overlap with the claimed amount of about 104 CFU/mL, but is close. Per MPEP 2144.05.I., a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. The difference between the claimed range and that which is claimed is virtually negligible absent any showing of unexpected results or criticality.
None of Yabumoto, Marques, Giardini, nor Jacobsen, teach a starting concentration of yeast strains of about 103 CFU/mL or that the pitched kefir product comprises a final concentration of 106 CFU/mL of yeast. However, differences in concentration or temperature will generally not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. 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). See MPEP 2144.05.II.A. Concentration of yeast strains in a method for fermentation is a result effective variable, as the concentration of yeast is known to affect the fermentation process. Thus, it would have been well within the skill set of one of ordinary skill in the art to perform a routine optimization on the result effective variable, the starting concentration of yeast strains, until achieving the desired output.
None of Yabumoto, Marques, Giardini, nor Jacobsen teach that the milk is 2 wt.% fat pasteurized milk.
Christensen, in the same field of invention, teaches making kefir with 2 wt.% fat pasteurized milk. Christensen offers the motivation that using pasteurized 2 wt.% milk successfully produces kefir (What Milk to Use?). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have used the 2 wt.% fat pasteurized milk of Christensen as the milk in the method of Yabumoto, Marques, Giardini, and Jacobsen One would have been motivated to make this modification in order to utilize a type of milk that is known to successfully produce kefir.
Response to Arguments
Applicant’s amendment has overcome the 112(a) rejections of claims 1, 3, 6, 13, 14, and 17-20 and the 112(b) rejections of claims 1, 3, 6, 13, 14, 17, 18, and 20 from the previous office action and therefore, these rejections have been withdrawn. Applicant’s amendment has partially overcome the 112(b) rejection of claim 20 and therefore, part of the previous rejection has been maintained.
Applicant's arguments filed March 27, 2026 have been fully considered but they are not persuasive.
The prior art rejection has been amended in light of applicant’s amendments to the claims, however, the essential prior art rejection has been maintained by the examiner for the following reasons.
Applicant argues that it would not have been obvious to include Lactobacillus kefiranofaciens in the claimed method because it is difficult to isolate Lactobacillus kefiranofaciens from natural kefir grains in order to culture it separately, and that it is implied that Lactobacillus kefiranofaciens does not grow in culture. Applicant argues that the challenges associated with isolating Lactobacillus kefiranofaciens in culture teach away from using Lactobacillus kefiranofaciens in a starter culture (Remarks, p. 9-10).
This argument is not persuasive. The difficultly of isolating Lactobacillus kefiranofaciens is not indicative of the claimed method being patentable; merely because something is difficult does not make it novel or nonobvious. Moreover, the prior art Marques specifically teaches “fermentative process of microorganisms with substrates such as…milk,” where the microorganism includes Lactobacillus kefiranofaciens (Marques: claim 1). Since Marques teaches the specific species and not natural kefir grains in general, it is assumed that Marques is teaching fermentation with the isolated Lactobacillus kefiranofaciens strain. Therefore, the prior art of record does teach a fermented milk product (i.e., kefir) with isolated Lactobacillus kefiranofaciens.
Furthermore, Applicant’s argument that the difficulty of isolating Lactobacillus kefiranofaciens and “its absence from traditional kefir implies it does not grow in culture” contradicts Applicant’s invention and other arguments, where Applicant does use Lactobacillus kefiranofaciens in a culture, merely stating that this use is “highly atypical.” Clearly, Lactobacillus kefiranofaciens can grow in culture, despite it being difficult and/or atypical.
Applicant’s argument that the challenges of isolating Lactobacillus kefiranofaciens teach away from using Lactobacillus kefiranofaciens in a starter culture is not a proper showing of “teaching away,” since the “teaching away” must come from the prior art, not from the general state/properties of the claimed component. Per MPEP 2144.05.III.B., “a prima facie case of obviousness may also be rebutted by showing that the art, in any material respect, teaches away from the claimed invention. U.S. v. Adams, 383 U.S. 39, 51-2 (1966).” Applicant has argued that the difficultly of isolating Lactobacillus kefiranofaciens teaches away from the claimed invention, but has not shown how, where, or why any of the prior art of record teaches away from the claimed invention.
Applicant argues that the specific combination of bacteria and yeast species is required in order to result in the claimed health benefits (i.e., improved cholesterol). Applicant argues that the synergy of the strains produces these unexpected results, citing examples of the instant specification as evidence. Applicant argues that these examples prove the unexpected results as all of the health benefits are improved when compared to commercial, no bacteria, and no yeast kefirs. Applicant argues that not all kefir or fermented milk with similar compositions to that claimed would have the health benefits set forth by Applicant as previous studies in the art show that not all kefir/fermented milk express health benefits such as improving cholesterol (Remarks, p. 11-15).
These arguments are not persuasive. Per MPEP 716.02(a).I., “evidence of a greater than expected result may also be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately (i.e., demonstrating "synergism").” Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). Although Applicant has attempted to show synergism, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. The effects presented by Applicant are an expected effect, as prior art in the same field of invention contemplates that various combinations of bacteria and yeast yield different results (see cited prior art made of record; Bellikci-Koyu et al. states, in “4. Discussion,” that “many different bacteria and yeast might be used for kefir production, and this might lead to distinct effects on metabolism and gut microbiota”).
Applicant has not shown the effects of the claimed product in a subject as compared to a control subject, one that has not consumed any kefir at all. While the claimed composition may be more effective at improving health benefits than other known compositions, the fact that it improves these health benefits at all is not indicative of nonobvious, as these effects are already known in the art.
Where the general state of the prior art in the field of invention shows that various kefir/fermented milk products can improve cholesterol and exhibit other health benefits, it is not unexpected that specific combinations of bacteria and yeasts would also exhibit greater than or equal to these health benefits. It is known that specific combinations can lead to distinct and various effects on a subject’s health, and as such, finding a combination that improves health benefits would have been obvious to one of ordinary skill in the art. Per MPEP 2144.05.II.A., "it is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929).
Lastly, where Applicant argues that the fermented milk products taught by the cited prior art would not be reasonably expected to behave in the same manner and produce the same results as the claimed composition, this argument is not persuasive because if the prior art composition is substantially the same or produced by substantially the same method, it will also possess the same properties and exhibit the same results. Where the prior art teaches the claimed composition, the prior art and claimed composition are reasonably expected to behave the same, as they are substantially similar.
Applicant presents no additional arguments with regard to the rejections of the additional dependent claims, and therefore, the rejections of these claims are maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Bellikci-Koyu et al. (“Effects of Regular Kefir Consumption on Gut Microbiota in Patients with Metabolic Syndrome: A Parallel-Group, Randomized, Controlled Study,” nutrients; 2019, 11, 2089) teaches health-promoting effects of regular kefir.
Fathi et al. (“Kefir drink causes a significant yet similar improvement in serum lipid profile, compared with low-fat milk, in a dairy-rich diet in overweight or obese premenopausal women: A randomized controlled trial,” Journal of Clinical Lipidology; vol. 11, issue 1, 2017, pp. 136-146) teaches reduction in cholesterol from kefir.
Ostadrahimi et al. (“Effect of Probiotic Fermented Milk (Kefir) on Glycemic Control and Lipid Profile In Type 2 Diabetic Patients: A Randomized Double-Blind Placebo-Controlled Clinical Trial,” Iran Journal of Public Health, vol. 44, no. 2, 2015, pp. 228-237) teaches that kefir improves cholesterol, although not at a statistically significant level.
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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/M.E.S./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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