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 .
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 after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.114 has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 CFR 1.114.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 06/26/2026 has been entered.
Claim status
The examiner acknowledges the amendment made to instant claims on 06/26/2026.
Claims 1-9, 11-14, 16-18, 23, 25 and 28 are pending in the application. Claims 1 are currently amended. Claims 10, 15, 19-22, 24 and 26-27 remain cancelled. Rest of claims are previously presented. Claims 1-9, 11-14, 16-18, 23, 25 and 28 and are hereby examined on the merits.
Examiner Note
Any objections and/or rejections that are made in the previous actions and are not repeated below, are hereby withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: the inoculation size in the line 2 from the bottom is not correctly formatted. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: “ a plant” should read “the second plant”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 11 recites that the acidification kinetics is measured at a temperature below 39 °C. However, claim 1 from which claim 11 depends, recites that the acidification kinetics is measured at a temperature of 37 °C. As such, claim 11 fails to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 9, 11-12, 16, 18, 23 and 28 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 Liu CN111206001 A (English translation relied upon for reference, hereinafter referred to as Liu), and evidenced by Olias, “An Updated Review of Soy-Derived Beverages: Nutrition, Processing, and Bioactivity”, Foods 2023, 12, 2665 (hereinafter referred to as Olias).
Regarding claims 1-7, 9, 11-12, 16, 18, 23 and 28, Liu teaches a Lactococcus lactis subsp. lactis strain CCFM 1092 that has the properties of 1) growing fast in a plant-based substrate (e.g., when the strain is inoculated in soymilk with an inoculum size of 106-107 CFU/ml at a temperature of 37 °C for 6 hours, there is an increase of 2 orders for the viable cell count of the strain, Abstract; 0064), and 2) being capable of acidifying the plant-based substrate very fast (e.g., when the strain is used to ferment soy milk with an inoculum size of 107 CFU/g at 37 °C, it could drop the pH of the soy milk to 4.64 in 6 hours, Abstract; 0066; Fig. 4). Liu further teaches freeze-drying the strain to make a start culture, which necessarily results in dried powder (0013). Liu further teaches making a fermented soybean milk using the strain (Example 4; 0067-0072).
Regarding the growth profile of Lactococcus lactis subsp. lactis strain CCFM 1092, Liu as recited above teaches that when the strain is inoculated in soy milk with an inoculum size of 106-107 CFU/ml at a temperature of 37 °C for 6 hours, there is an increase of 2 orders for the viable cell count of the strain (Abstract; 0064). Note that soy milk is known to contain ~3-4 wt % protein (see Olias Table 1 and page 9, 4.1 for evidence) thus the protein content of the soy milk is comparable to the aqueous preparation of claim 1. Further, Liu teaches that the sucrose content of the soy milk is 0.27% (e.g., 2.7 g/L, see para. 0070). Given that sucrose is the main carbohydrate (97%) of soy milk (see Olias page 9, 4.1 for evidence), the soymilk contain less glucose than the aqueous preparation of claim 1. It thus follows that Lactococcus lactis subsp. lactis strain CCFM 1092 will grow even faster if there were more glucose in the soymilk, since Lactococcus lactis subsp. lactis requires carbohydrates such as glucose for culturing or growth (see para. 0034-0035 of Liu).
Regarding the acidification kinetics of Lactococcus lactis subsp. lactis strain CCFM 1092, Liu as recited above teaches that when the strain is used to ferment soy milk with an inoculum size of 107 CFU/g at 37 °C, it could drop the pH of the soy milk to 4.64 in 6 hours (Abstract; 0066. Fig. 4). Note that the protein content of the soy milk is comparable to the aqueous preparation of claim 1. Further, since inoculation of soy milk with 107 CFU/ g CCFM 1092 which is about 107 CFU/ml CCFM 1092 for 6 hours will result in a pH of 4.64, then inoculation of soy milk with 106 CFU/ml CCFM 1092 for 6 hours will result a pH of ~5.5 (calculation: the original pH of the soy milk is ~6.5, then the amount of [H]+ produced by 107 CFU/ml CCFM 1092 in 6 hours is about (10-4.64 - 10-6.5), thus if 106 CFU/ml CCFM 1092 is used to inoculate the soy milk for 6 hours, then the amount of [H]+ produced in 6 hours is about (10-4.64 - 10-6.5)/10, and the corresponding pH is -log ((10-4.64 - 10-6.5)/10) which is about ~5.5). Further, it follows that CCFM 1092 will reasonably produce more acid if there were more glucose in the soy milk, since in a fermentation process, Lactococcus species generally digests a sugar into acid.
As set forth above, Lactococcus lactis subsp. lactis strain CCFM 1092 has comparable or essential similar acidification kinetic and growth profile as the bacterial strain as recited in claims 1-2, 4-7 and 11, demonstrating a reasonable probability that CCFM 1092 is either identical to or is sufficiently similar to the Lactococcus lactis strains as recited in claims 1-7, 9, and 11 (e.g., DSM 33924-DM33928 or mutants thereof) - that whatever differences exist are not patentably significant. Note that claim 2 does not recite an inoculum size in measuring growth of the strain. 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. Therefore, it logically follows that the Lactococcus lactis subsp. lactis strain CCFM 1092 as disclosed by Liu has the acidification kinetics and growth profiles in plants as recited in claims 1-2, 4-7 and 11.
Further, Liu teaches making a fermented soybean milk using the strain, then upon fermentation, the fermented soybean milk necessarily contains Lactococcus lactis subsp. lactis strain CCFM 1092 that originates from fermentation in aqueous preparation derived from a plant. Regardless, where it appears that the Liu’ s Lactococcus lactis subsp. lactis strain CCFM 1092 is either identical to or is sufficiently similar to the Lactococcus lactis strains as recited in the claims, the limitation about where the strain originates is met.
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Liu as applied claims 1 and 12 above, further in view of Shelaih, “Temperature sensitivity of proteinase negative variants of Lactic Streptococci”, Journal of Dairy Science, 1983, 66, pages 2287-2289 (hereinafter referred to as Shelaih).
Regarding claim 8, Liu teaches a Lactococcus lactis subsp. lactis strain CCFM 1092. Liu is silent regarding that the strain is protease negative.
Shelah in the same field of endeavor teaches that compared with the protein (e.g., proteinase) positive strain, the protein negative variant of a lactic culture such as Lactococcus lactis subsp. lactis (e.g., Streptococcus lactic) and Lactococcus lactis subsp. cremoris (e.g., Streptococcus cremoris), collectively produces more acid at higher temperature in a substrate such as nonfat dry milk (e.g., 40 C° and 42 °C) thus making them usable at high cheese-making temperature, although the protein negative variant grows slower (Abstract; page 2287, left hand column, “Methods and Procedures”).
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 Liu by constructing the protein negative strain of Lactococcus lactis subsp. lactis strain CCFM 1092 such that the strain can be used produce more acid in a high temperature condition. Note that construction of a protein negative mutant of a LAB through gene approach is well known before the effective filling date of the claimed invention.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Liu as applied claims 1 and 12 above, further in view of Beckmann WO2010/136320 A1 (cited in the IDS filed 01/19/2024, hereinafter referred to as Beckmann).
Regarding claims 13-14, Liu as recited above teaches a method of making a fermented soybean milk by inoculating a Lactococcus lactis subsp. lactis strain with soybean milk. Liu is silent regarding another strain such as those listed in claims 13-14.
Beckmann in the same field of endeavor teaches a method of making a fermented soybean-based food comprising inoculating a liquid comprising soy protein with a combination of a mesophilic LAB such as Lactococcus lactis subsp. lactis and a thermophilic LAB such as S. thermophilus and Lactobacillus delbrueckii subsp. bulgaricus and fermenting the inoculated liquid, in which the combination of the mesophilic LAB and the thermophilic LAB could reduce the amount of undesired flavor components in soybean (page 4, line 15-page 5, line 10; page 7, line 6-9).
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 Liu by including a thermophilic LAB (e.g., S. thermophilus or Lactobacillus delbrueckii subsp. bulgaricus) in the starter culture of Liu with reasonable expectation of success, for the reason that prior art has established that fermenting a liquid comprising soybean with the combination of Lactococcus lactis subsp. lactis and S. thermophilus or Lactobacillus delbrueckii subsp. bulgaricus would reduce the amount of undesired flavor components in soybean. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have included both S. thermophilus and Lactobacillus delbrueckii subsp. bulgaricus in the starter culture of Liu with reasonable expectation of success, for the reason that "it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). MPEP 2144.06. In the instant case, Beckmann has established that each of S. thermophilus and Lactobacillus delbrueckii subsp. bulgaricus is a thermophilic LAB suitable for combining with Lactococcus lactis subsp. lactis in fermenting a soybean-based liquid for reducing the undesired flavor components of soybean thus a skilled artisan would have been motivated to combine the two thermophilic LAB.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Liu as applied claims 1 and 12 above, further in view of Coic WO2010/136321 A1 (cited in the IDS filed 01/19/2024, hereinafter referred to as Coic).
Regarding claim 17, Liu as recited above teaches a method of making a fermented soybean milk by inoculating a Lactococcus lactis subsp. lactis strain with soybean milk. Liu is silent regarding at least one propionic bacterium.
Coic in the same field of endeavor teaches a method of making a fermented soybean-based food comprising inoculating a liquid comprising soy protein with a mesophilic flavoring generating cultures selected from a group of Lactococcus lactis, Leuconostoc mesenteroides, Propionibacterium, Lactobacillus paracasei, Lactobacillus fermentum, Lactobacillus plantarum and Lactobacillus casei (page 4, line 14-29; page 5, line 2-8).
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 Liu by including Propionibacterium in the Lactococcus lactis-containing starter culture of Liu with reasonable expectation of success, for the reason that "it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). MPEP 2144.06. In the instant case, Coic has established that each of Lactococcus lactis and Propionibacterium is a mesophilic cultures suitable for creating flavor in a substrate that comprises soybean thus a skilled artisan would have been motivated to combine the two mesophilic culture.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Liu as applied claim 1 above, further in view of De Buyser EP 0521331 A2 (hereinafter referred to as De Buyser).
Regarding claim 25, Liu as recited above teaches a method of making a fermented soybean milk by inoculating a Lactococcus lactis subsp. lactis strain with soybean milk. Soybean milk is known to contain ~3-4 wt % protein (see Olias Table 1 and page 9, 4.1 for evidence). Liu further teaches that soymilk contains 0.27 g/100 ml sucrose (e.g., 2.7 g/L, 0070) thus being silent regarding a sugar content being 1-10%.
De Buyser in the same field of endeavor teaches a method of making a fermented soybean milk comprising inoculating soybean milk with a composition comprising Lactococcus lactis subsp. lactis and fermenting the soybean milk (page 2, line 43-47). Further, De Buyser teaches that Lactococcus species generally require carbohydrates for fermentation. Consequently, the growth of Lactococcus species shall be poor and the soy milk shall not sufficiently gel if the amount of carbohydrates naturally present in soy milk is too small. Accordingly, it may be desirable to add a supplemental carbon source. The final sugar concentration should range between 0.1 and 5 % by weight of the soy milk (page 3, line 7-1).
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 Liu by supplementing the soybean milk of Liu with sugar to a final amount of as much as 5% for the effective growth of Lactococcus and sufficient gelling of the soybean milk.
The amount of sugar as disclosed by De Buyser overlaps with the range as recited in claim 25. 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).
Response to Arguments
Applicant's arguments filed 06/26/2026 have been fully considered and the examiner’s response is shown below:
The 35 USC 112 rejection of claim 13 is withdrawn in view of the amendment made to the claim.
Regarding the 35 USC 102/103 rejection over Liu, applicant argues on pages 7-8 of the Remarks that Liu teaches a 2-4% culture which results in undefined starting cell densities, and that the soy milk of Liu contains 0.27% sucrose which is a different substrate from the claim. Applicant goes on to argue that these differences are not trivial. Applicant then concludes that Liu does not teach the claimed kinetic performance thus In re Best is not applicable, and Liu does not anticipate or render obvious the instant claims.
The argument is considered but found unpersuasive because:
Regarding the acidification kinetics of Lactococcus lactis subsp. lactis strain CCFM 1092, Liu as recited above teaches that when the strain is used to ferment soy milk with an inoculum size of 107 CFU/g at 37 °C, it could drop the pH of the soy milk to 4.64 in 6 hours (Abstract; 0066. Fig. 4). Note that the protein content of the soy milk is comparable to the aqueous preparation of claim 1. Further, since inoculation of soy milk with 107 CFU/ g CCFM 1092 which is about 107 CFU/ml CCFM 1092 for 6 hours will result in a pH of 4.64, then inoculation of soy milk with 106 CFU/ml CCFM 1092 for 6 hours will result a pH of ~5.5 (calculation: the original pH of the soy milk is ~6.5, then the amount of [H]+ produced by 107 CFU/ml CCFM 1092 in 6 hours is about (10-4.64 - 10-6.5), thus if 106 CFU/ml CCFM 1092 is used to inoculate the soy milk for 6 hours, then the amount of [H]+ produced in 6 hours is about (10-4.64 - 10-6.5)/10, and the corresponding pH is -log ((10-4.64 - 10-6.5)/10) which is about ~5.5). Further, it follows that CCFM 1092 will reasonably produce more acid if there were more glucose in the soy milk, since in a fermentation process, Lactococcus species generally digests a sugar into acid.
Regarding the growth profile of Lactococcus lactis subsp. lactis strain CCFM 1092, Liu as recited above teaches that when the strain is inoculated in soy milk with an inoculum size of 106-107 CFU/ml at a temperature of 37 °C for 6 hours, there is an increase of 2 orders for the viable cell count of the strain (Abstract; 0064). Note that soy milk is known to contain ~3-4 wt % protein (see Olias Table 1 and page 9, 4.1 for evidence) thus the protein content of the soy milk is comparable to the aqueous preparation of claim 1. Further, Liu teaches that the sucrose content of the soy milk is 0.27% (e.g., 2.7 g/L, see para. 0070). Given that sucrose is the main carbohydrate (97%) of soy milk (see Olias page 9, 4.1 for evidence), the soymilk contain less glucose than the aqueous preparation of claim 1. It thus follows that Lactococcus lactis subsp. lactis strain CCFM 1092 will grow even faster if there were more glucose in the soymilk, since Lactococcus lactis subsp. lactis requires carbohydrates such as glucose for culturing or growth (see para. 0034-0035 of Liu).
As set forth above, Lactococcus lactis subsp. lactis strain CCFM 1092 has comparable or essential similar acidification kinetic and growth profile as the bacterial strain as recited in claims 1-2, 4-7 and 11, demonstrating a reasonable probability that CCFM 1092 is either identical to or is sufficiently similar to the Lactococcus lactis strains as recited in claims 1-7, 9, and 11 (e.g., DSM 33924-DM33928 or mutants thereof) - that whatever differences exist are not patentably significant. Note that claim 2 does not recite an inoculum size in measuring growth of the strain. See in Re Best.
Unfortunately, applicant has not been able to show, by convincing evidence, that CCFM 1092 as disclosed by prior art is either genetically or functionally different from the strains of claim 1.
For the reasons set forth above, applicant’s arguments regarding claims 13-14 on pages 9-10 of the Remarks, and regarding claim 25 on page 11 of the Remarks are not persuasive, either.
Regarding claim 8, applicant argues on page 9 of the Remarks that Liu recites a different fermentation conditions than claim 1 (e.g., 2-4% culture).
The argument is considered but found unpersuasive because claim 1 is not about fermenting using the strain, rather, claim 1 is directed to a strain per se, as such, applicant is arguing a feature that is not even claimed. Further, 2-4% culture actually encompasses the inoculum size of 106 CFU/ml (see para. 0069 of Liu), rendering applicant’s argument unpersuasive.
Regarding claim 17, applicant argues on page 10 of the Remarks that the lactobacillus delbrueckii subsp. lactis strain LbO5-14 as disclosed by Coic is not described as being able to acidify as claimed in the present claims.
The argument is considered but found persuasive because lactobacillus delbrueckii subsp. lactis strain LbO5-14 is not what the office action relies upon for rejection, rather, the office action relies upon the teaching of Coic that in making a fermented soybean-based food, a mesophilic flavoring generating culture such as Propionibacterium can be included in the starter culture. Further, it is very unclear where applicant gets the information about LbO5-14- for the record, Coic does not teach such a specific strain.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANGQING LI whose telephone number is (571)272-2334. The examiner can normally be reached 9:00-5:00.
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/CHANGQING LI/Primary Examiner, Art Unit 1791
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