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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 10-11 the reply filed 02/09/2026 is acknowledged. Claims 1-9 and 12-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claim status
Claims 1-13 filed 03/06/2024 are pending in the application. Claims 10-11 are previously presented. Claims 1-9 and 12-13 are withdrawn without traverse in response to the restriction requirement. Claims 10-11 are hereby examined on the merits.
Claim Objections
Claim 10 is objected to because of the following informalities: the claim should be presented in an independent form by incorporating the subject matter of claim 1, and “obtain fermented milk” in the last line should read “obtain the fermented milk”. For the purpose of examination, claim 10 is interpreted to read:
A method for producing fermented milk comprising: a fermentation step of adding a lactic acid bacterium according to a formula milk comprising raw material milk, followed by fermentation to thereby obtain the fermented milk, wherein the lactic acid bacterium belongs to Streptococcus thermophilus, and satisfying at least one of the conditions selected from the group consisting of the following (a) and (b): (a) when cultured at 43°C in a 10% skimmed milk powder medium, (a1) the time from start of the culture until a pH of a culture solution becomes 4.7 or lower is 7 hours or less, and (a2) the pH of the culture solution 20 hours after the start of the culture becomes 4.1 or higher, and (b) when cultured until the pH of the culture solution becomes 4.7 or less in a 10% skimmed milk powder medium at 43°C, followed by storage at 10°C for 10 days, (bl) a viable bacterial count in the culture solution after the storage becomes 1 x 108 cfu/g or more, and (b2) the pH of the culture solution after the storage becomes 4.2 or higher.
Appropriate correction is required.
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.
Claims 10-11 are 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 10 recites “(a1) the time from start of the culture until a pH of a culture solution becomes 4.7 or lower is 7 hours or less” and (a2) the pH of the culture solution 20 hours after the start of the culture becomes 4.1 or higher”. It is unclear what the culture solution is referring to. Is it the 10% skimmed milk powder medium that is inoculated with the Streptococcus Thermophilus? Appropriate correction is required.
Claim 10 recites “(b) when cultured until the pH of the culture solution becomes 4.7 or less in a 10% skimmed milk powder medium at 43 °C”. There is insufficient antecedent basis for the limitation “the culture solution” in the claim.
Claim 11 depends from claim 10 and therefore necessarily incorporate the indefinite subject matter therein. 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 10-11 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 Garault WO 2018/091063 A1 (hereinafter referred to as Garault).
Regarding claim 10, Garault teaches a method of producing fermented milk comprising adding a lactic acid bacterium to a formula milk comprising raw material milk, and fermenting to obtain fermented milk (page 12, line 27-32; page 7, line 15-page 8, line 6), wherein the lactic acid bacteria is Streptococcus Thermophilus CNCM I-5030 and/or CNCM I-4992 (page 12, line 31), and where the fermented milk comprises at least 108 CFU/g Streptococcus Thermophilus CNCM I-5030 and/or CNCM I-4992 (page 8, line 1-6).
Further, Garault teaches that the Streptococcus Thermophilus CNCM I-5030 and/or CNCM I-4992 have good milk acidification properties, low post-acidification during storage, and high viability (the para. that bridges pages 16 and 17, and the para. that bridges pages 1 and 2), for example, Example 1 as well as Fig. 2 shows that when culturing Streptococcus Thermophilus CNCM I-5030 in ~12% skimmed milk (e.g., 137.5 g skimmed milk is mixed with 1 liter water, Example 1) at 37 °C, it take less than 400 min for the culture medium to read a pH of 4.7 (see Fig. 1), and the pH of the medium is above 4.2 after a culture duration of 20 hours (e.g., 1200 min) (see Fig. 1), and Example 2 along with Fig. 3 has shown that the medium that is cultured with Streptococcus Thermophilus CNCM I-5030 after storage at 10 °C for 28 days has minimal acidity change, and there is almost no change to viable Streptococcus Thermophilus CNCM I-5030 (see Fig. 3 and page 16, line 15-24, note that in Fig. 3, Y-axis is the CFU loss , and X-axis is dornic acidity increase).
Regarding the condition (a) when cultured at 43°C in a 10% skimmed milk powder medium, (a1) the time from start of the culture until a pH of a culture solution becomes 4.7 or lower is 7 hours or less, and (a2) the pH of the culture solution 20 hours after the start of the culture becomes 4.1 or higher, or (b) when cultured until the pH of the culture solution becomes 4.7 or less in a 10% skimmed milk powder medium at 43°C, followed by storage at 10°C for 10 days, (b1) a viable bacterial count in the culture solution after the storage becomes 1 x 108cfu/g or more, and (b2) the pH of the culture solution after the storage becomes 4.2 or higher, it is noted that both Garault and the claimed invention are drawn to preparation of fermented milk with good milk acidification property, low post-acidification and high viability during storage; further, Garault teaches that when Streptococcus Thermophilus CNCM I-5030 is used to culture ~12% skimmed milk at a temperature of 37 °C, it is able to drop the pH the medium to 4.7 in less than 7 hours, maintain the medium at a pH above 4.2 after 20 hours, and the medium after storage at 10 °C for 28 days has minimal acidity change, and there is almost no change to viable Streptococcus Thermophilus. Further, concentrations of the skimmed milk by Garault and the claimed invention are similar, and both are culturing milk at optimal or sub-optimal culture temperature range of Streptococcus Thermophilus (note that 43 °C appears be more optimal than 37 °C). Therefore, there is a reasonable probability that the Streptococcus Thermophilus CNCM I-5030 strain as disclosed by Garault either is identical to the Streptococcus Thermophilus as recited in the instant claim thus meeting the conditions about acidification, pH, post-acidification and viability as recited in the instant claims, or that the Streptococcus Thermophilus CNCM I-5030 strain is sufficiently similar to the Streptococcus Thermophilus as recited in the instant claim - that whatever differences exist in the properties of acidification, post-acidification and viability are not patentably significant. 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.
Regarding claim 11, Garault teaches combining a lactobacillus strain with the Streptococcus Thermophilus (page 14, line 1-22).
Conclusion
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/CHANGQING LI/Primary Examiner, Art Unit 1791
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