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 .
Claim status
Claims 1-14 filed 12/27/2023 are pending in the application and are hereby examined on the merits.
Claim Objections
Claim 1 is objected to because of the following informalities: “Bulgaricus” should read “bulgaricus”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: “fermenting said mixture to provide a fermented food product” should read “fermenting said mixture to provide the fermented food product”. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: “wherein the additional strain is Bifidobacterium or lactic acid bacteria” should read “wherein the at least one, two, three or more additional strains is Bifidobacterium or lactic acid bacteria”. Appropriate correction is required.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claims 1-7 and 10-14 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Larrere WO 2021/028725 A1 (cited in the IDS filed 12/27/2023, hereinafter referred to as Larrere).
Regarding claims 1-7 and 10-14, Larrere teaches a method of making a fermented plant-based composition (e.g., a fermented food product such as yogurt, yogurt drink, kefir, cheese, etc., page 10, line 5-11), the method comprising inoculating a vegetal base with an inoculum that comprises a homofermentative lactic acid bacteria and a heterofermentative bifidobacteria, and fermenting (page 13, line 9- page 14, line 5); wherein the amount of homofermentative lactic acid bacteria in the plant-based composition is at least 105 CFU/gram (page 15, line 29-32) and wherein the homofermentative lactic acid bacteria is Lactobacillus bulgaricus such as Lactobacillus bulgaricus I-1632 and Lactobacillus bulgaricus I-1519 (page 15, line 19-21; Examples 1 and 2).
Regarding the limitation about Lactobacillus bulgaricus being Lactobacillus bulgaricus I-5288, both Larrere and the claimed invention disclose Lactobacillus bulgaricus used for making a fermented food and a method of preparing a fermented plant-based composition comprising inoculating a vegetal base with Lactobacillus bulgaricus and fermenting, demonstrating a reasonable probability that the Larrere’ s Lactobacillus bulgaricus strain I-1632 or I-1519 strain is either identical to or is a sufficiently similar mutant or variant of the claimed Lactobacillus bulgaricus I-5288- that whatever differences exist are not patentably significant (note that instant specification recites on page 4, line 15-34 that Lactobacillus bulgaricus I-5288 shall be taken to includes functional equivalent bacteria derived therefrom such as mutants, variants, or genetically transformed bacteria). As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. [citation omitted] Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products.
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Larrere WO 2021/028724 A1 (cited in the IDS filed 12/27/2023, hereinafter referred to as Larrere2).
Regarding claims 1-14, Larrere2 teaches a method of making a fermented plant-based composition (e.g., a fermented food product such as yogurt, yogurt drink, kefir, cheese, etc. page 11, line 25-30), the method comprising inoculating a vegetal base with an inoculum that comprises Lactobacillus bulgaricus, and a LAB (e.g., Lactococcus species Bifidobacterium), and fermenting (page 15, line 3-20); wherein the amount of Lactobacillus bulgaricus in the plant-based composition is at least 105 CFU/gram (page 17, line 4-8), wherein the inoculum is fresh, frozen, dried or lyophilized (page 21, line 20), and wherein the inoculum includes at least 105 CFU/gram of each strain including Lactobacillus bulgaricus (page 22, line 10-17). Additionally, Examples 1-2 and page 5, line 7-8 teach that suitable Lactobacillus bulgaricus used for the method is Lactobacillus bulgaricus I-1632 or Lactobacillus bulgaricus I-1519.
Regarding the limitation about Lactobacillus bulgaricus being Lactobacillus bulgaricus I-5288, both Larrere2 and the claimed invention disclose Lactobacillus Bulgaricus used for making a fermented food and a method of preparing a fermented plant-based composition comprising inoculating a vegetal base with Lactobacillus bulgaricus and fermenting, demonstrating a reasonable probability that the Larrere2’ s Lactobacillus bulgaricus strain I-1632 or I-1519 strain is either identical to or is a sufficiently similar mutant or variant of the claimed Lactobacillus bulgaricus I-5288- that whatever differences exist are not patentably significant (note that instant specification recites on page 4, line 15-34 that Lactobacillus bulgaricus I-5288 shall be taken to includes functional equivalent bacteria derived therefrom such as mutants, variants, or genetically transformed bacteria). As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. [citation omitted] Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products.
Claim Rejections - 35 USC § 103
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.
Claims 1-7 and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kaneko US Patent Application Publication No. 2016/0044931 A1 (hereinafter referred to as Kaneko).
Regarding claims 1-7 and 10-14, Kaneko teaches a method of making a soy milk fermented substance with a taste and flavor or smooth physicality similar to that of yogurt obtained from fermenting milk (0013), the method comprising inoculating a vegetal base (e.g., soy milk) with an inoculum (e.g., a lactic acid bacteria mixture starter) that comprises a Lactobacillus bulgaricus that is capable of generating 0.4 g/L or more of D-lactic acid in the fermented substance and a Streptococcus thermophilus that is capable of accumulating 0.4 g/L or more of fructose in the fermented substance, and fermenting (0015-0016; 0045); wherein the amount of Lactobacillus bulgaricus in the soy milk fermented substance is 1 x102 to 1 x107 CFU/ml (0045), and wherein the Lactobacillus bulgaricus strain suitable for use is Lactobacillus bulgaricus Lb. 505, Lb. 511 and Lb. 863 strains (0093).
The amount of Lactobacillus bulgaricus as disclosed by Kaneko overlaps with the amount as recited in claim 2 (assuming a density of ~1 g/ml for the soy milk fermented substance). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Regarding the limitation about Lactobacillus bulgaricus being Lactobacillus bulgaricus I-5288, both Kaneko and the claimed invention disclose Lactobacillus Bulgaricus used for making a fermented food and a method of preparing a soy milk fermented substance with a taste and flavor or smooth physicality similar to that of cow milk yogurt comprising inoculating a vegetal base with Lactobacillus Bulgaricus and fermenting, demonstrating a reasonable probability that the each of Kaneko’s Lactobacillus Bulgaricus Lb. 505, Lb. 511 and Lb. 863 strain is either identical to or is a sufficiently similar mutant or variant of the claimed Lactobacillus bulgaricus I-5288- that whatever differences exist are not patentably significant (note that instant specification recites on page 4, line 15-34 that Lactobacillus bulgaricus I-5288 shall be taken to includes functional equivalent bacteria derived therefrom such as mutants, variants, or genetically transformed bacteria). As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. [citation omitted] Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products.
Claims 2 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kaneko US Patent Application Publication No. 2016/0044931 A1 (hereinafter referred to as Kaneko) in view of Holtmeyer WO 2014/104887 A1 (hereinafter referred to as Holtmeyer).
Regarding claims 2 and 8-9, Kaneko teaches an inoculum (e.g., a lactic acid bacteria mixture starter) for fermenting a substrate (e.g., soy milk) to produce a fermented substance with a taste and flavor or smooth physicality similar to that of yogurt obtained from fermenting milk (0013), wherein the inoculum comprises a Lactobacillus Bulgaricus that is capable of generating 0.4 g/L or more of D-lactic acid in the fermented substance and a Streptococcus thermophilus that is capable of accumulating 0.4 g/L or more of fructose in the fermented substance (0016); wherein the Lactobacillus bulgaricus strain suitable for use is Lactobacillus Bulgaricus Lb. 505, Lb. 511 and Lb. 863 strains (0093).
Regarding the limitation about Lactobacillus bulgaricus being Lactobacillus bulgaricus I-5288, both Kaneko and the claimed invention disclose Lactobacillus bulgaricus used for making a fermented vegetal food, demonstrating a reasonable probability that the each of Kaneko’s Lactobacillus bulgaricus Lb. 505, Lb. 511 and Lb. 863 strain is either identical to or is a sufficiently similar mutant or variant of the claimed Lactobacillus bulgaricus I-5288- that whatever differences exist are not patentably significant (note that instant specification recites on page 4, line 15-34 that Lactobacillus bulgaricus I-5288 shall be taken to includes functional equivalent bacteria derived therefrom such as mutants, variants, or genetically transformed bacteria). As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. [citation omitted] Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products.
Further, Kaneko teaches that a starter for making a fermented product (e.g., yogurt) such as a commercial starter is provided in a freeze-dried form (0051). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have provided the lactic acid bacteria mixture starter in freeze-dried form with reasonable expectation of success, for the reason that such a form is known to be suitable for a starter for fermentation.
Kaneko teaches a starter comprising Lactobacillus bulgaricus for fermenting a substrate to make a fermented substance, but is silent regarding the amount of Lactobacillus bulgaricus in the inoculum.
Holtmeyer in the same field of endeavor teaches a starter in freeze-dried form comprising Lactobacillus bulgaricus for fermenting a substrate (e.g., dairy base) to make a fermented substance, the starter comprising at least 107 cfu/g viable Lactobacillus bulgaricus (page 2, line 24-page 4, line 3).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Kaneko by providing a freeze-dried lactic acid bacteria mixture starter comprising at least 107 cfu/g viable Lactobacillus bulgaricus with reasonable expectation of success, for the reason that prior art has established that such an amount of at least 107 cfu/g viable Lactobacillus bulgaricus is suitable in an inoculum or stater culture for fermentation.
Conclusion
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/CHANGQING LI/Primary Examiner, Art Unit 1791