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 I (claims 9-22) in the reply filed on 5/18/2026 is acknowledged. Claims 23-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claim Rejections - 35 USC § 102
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 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.
Claims 10 and 16 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fukui (US 20110129568), hereinafter Fukui.
Regarding claim 10, Fukui teaches a fermentation composition having a pH of
6.5-7.5 (para 13), which overlaps with the claimed "pH of 6.0 to 7.4", the
composition comprising:
live bacteria of one or more types of bacteria selected from the group
consisting of lactic acid bacteria and bacteria of the genus 8ifidobacterium (para
40 describes examples of "bacteriocin-producing bacteria in the genus
Bifidobacterium" that can be used; note that these bacteria are live as they
are still "producing bacteria"); milk (para 24); and dead bacterial cells (para
23 describes " dead lactic acid bacterial cells" and para 27 describes "dead
cells of bacteriocin-producing bacteria") of bacteria of the genus Lactococcus
(para 14 describes the invention may "employ lactic acid bacteria in the
genus Lactococcus as the bacteriocin-producing lactic acid bacteria").
Whereas claim 10 is a product claim, the claims recites a method of steps
therein; i.e. "produced by a production method comprising step (A) or (8), and
step (C): (A)" and details/sequence of the respective process steps; i.e. "step (A)
or (8), and step (C)". Therefore, the claim amounts to a product by process
claim. "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 product was
made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964,
966 (Fed. Cir. 1985). See MPEP 2113.
Regarding claim 16, Fukui teaches the fermentation composition according to
claim 10, wherein the live bacteria of one or more types of bacteria selected from
the group consisting of lactic acid bacteria and bacteria of the genus
8ifidobacterium are one or more types of live bacteria selected from the group
consisting of bacteria of the genus Lactococcus, bacteria of the genus
Streptococcus, bacteria of the genus Lactobacillus, and bacteria of the genus
8ifidobacterium (para 40 describes examples of "bacteria in the genus
Bifidobacterium" that can be used; note that these bacteria are live as they
are still "producing bacteria'').
103
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.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Fukui.
Regarding claim 22, Fukui teaches the fermentation composition according to
claim 10, but does not teach that "a difference between pH of the fermentation
composition before refrigerated storage and pH of the fermentation composition
after refrigerated storage for 14 days is less than 1 ". However, Fukui teaches that
acidity (i.e. pH) of the fermentation composition depends on both temperature of
storage (e.g. see Tables 4, 5, 6, respectively, on page 7, which show pH for
storage at 5°C, 10°C and 15°C, respectively; also see para 72) as well as
duration of storage (e.g. see Tables 4, 5, 6 on page 7, each of which show
how pH varies with 4, 7, 13 and 21 days; also see para 72). Given that the pH
of the fermentation composition is a known results effective variable and its
dependence on temperature of storage and days of storage is also known (as
explained above), varying a difference between pH of the fermentation
composition before storage at a first temperature (e.g. refrigerated storage) and
pH of the fermentation composition at a second temperature (i.e. after
refrigerated storage) for a target number of days (such as 14 days) is a certain
value, such as less than 1, would not be cause for undue experimentation.
"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. Therefore, it would have been obvious to one of
ordinary skills in the art before the time of the effective filing of the claimed
invention to modify Fukui so that a difference between pH of the fermentation
composition before refrigerated storage and pH of the fermentation composition
after refrigerated storage for 14 days is less than 1. The ordinary artisan would
have been motivated to modify Fukui for at least the purpose of providing
desirable property of preventing increase in acidity during storage and
transportation (para 9 of Fukui).
Claims 9, 11-15 and 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Fukui, in view of Miura (US 20090317892), hereinafter Miura..
Regarding claim 9, Fukui (US 20110129568) teaches a fermentation composition
having a pH of 6.5-7.5 (para 13), which overlaps with the claimed "pH of 6.0 to
7.4", the composition comprising:
(a) a first amount of live bacteria of one or more types of bacteria selected from the group consisting of lactic acid bacteria and bacteria of the genus Bifidobacterium (para 40 describes examples of "bacteriocin-producing bacteria in the genus Bifidobacterium" that can be used; note that these bacteria are Jive as they are still "producing bacteria");
(b) a milk raw material and/or a fermented product using a milk raw
material (para 24); and
(c) dead bacterial cells (para 23 describes "dead lactic acid bacterial
cells" and para 27 describes "dead cells of bacteriocin-producing bacteria") of bacteria of the genus Lactococcus (para 14 describes the.invention may "employ lactic acid bacteria in the genus Lactococcus as the bacteriocin-producing lactic acid bacteria'').
Fukui does not teach that the first amount of live bacteria is "1 x106 cfu/ml". Miura (US 20090317892) (refer to Figures 4 and 8) teaches that a first amount of live bacteria, measured as "Viable cells (CFU/g in Figures 4 and 8) to which dead bacterial cells have been added (para 29), may vary generally between 1 x106 cfu/ml and 1 x108 cfu/ml depending on type of bacteria and number of storage days (only shown for maximum of 14 days in Figure 4; also see para 29) or based on another ingredient such as buttermilk is added (only shown for maximum of 21 days in Figure B; also see para 35). Given that the first amount of live bacteria is a known results effective variable and its dependence on other properties such type of bacteria, storage days and other ingredients is also known (as explained above), varying the first amount of live bacteria for a given bacteria type such as lactic acid bacteria or bacteria of the genus Bifidobacterium for a target storage time or for other ingredients would not be cause for undue experimentation. "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. Therefore, it would have been obvious to one of ordinary skills in the art before the time of the effective filing of the claimed invention to modify Fukui so that the first amount of live bacteria is a target amount such as "1x106 cfu/ml". The ordinary artisan would have been motivated to modify Fukui for at least the purpose of providing adequate concentration of live bacteria for producing cultures for the ingredients and for a target storage days.
It is noted that in the case where the claimed ranges "overlap or lie inside
the ranges disclosed by the prior art" a prima facie case of obviousness exists (In re Wetheim, 541 F2d 257, 191 USPQ 90 (CCPA 1976),· In re Woodruff, 919 F2d
1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990)).
Regarding claims 11 and 12, Fukui teaches the fermentation composition according to claim 9 or 10, but does not teach "a content concentration of the dead bacterial cells of bacteria of the genus Lactococcus is 1x108 to 1x1010 cells/g". Miura (US 20090317892) teaches that a content concentration of the dead bacterial cells (such as 0.01% disclosed in para 25) as well as other variables such as type of bacteria genus, temperature (para 50) and target acidity (para 25). Given that "a content concentration of the dead bacterial cells" for a given bacteria genus is a known results effective variable and its dependence on other properties such bacteria genus, temperature and target acidity (as explained above), varying "a content concentration of the dead bacterial cells" for a given bacteria type such as bacteria of the genus Lactococcus for a target acidity would not be cause for undue experimentation. "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. Therefore, it would have been obvious to one of ordinary skills in the art before the time of the effective filing of the claimed invention to modify Fukui so that "a content concentration of the dead bacterial
cells of bacteria of the genus Lactococcus" is a target amount such as "1x108 to 1x1010 cells/g"". The ordinary artisan would have been motivated to modify Fukui for at least the purpose of providing target acidity.
Regarding claim 13, Fukui teaches the fermentation composition according to
claim 9, wherein the fermentation composition further comprises a pH adjuster
{i.e. that prevents pH from increasing significantly during storage - see
para 9, which describes that the product is made so that "increase of the
acidity in fermented milk during transportation and storage can be
effectively restricted"; and para 10 that describes "With bacteriocinproducing
lactic acid bacteria being killed, an increase of the cheese-like
flavor can be restricted" and is thus able to "maintain the acidity (pH)" - see
para 13"}.
Regarding claim 14, Fukui teaches the fermentation composition according to
claim 10, wherein the fermentation composition further comprises a pH adjuster,
or the milk raw material for fermentation composition production is a milk raw
material comprising a pH adjuster (i.e. that prevents pH from increasing
significantly during storage - see para 9, which describes that the product
is made so that "increase of the acidity in fermented milk during
transportation and storage can be effectively restricted"; and para 10 that
describes "With bacteriocin-producing lactic acid bacteria being killed, an
increase of the cheese-like flavor can be restricted" and is thus able to
"maintain the acidity (pH)" - see para 13"}.
Regarding claim 15 (and similar claims 17, 18, 19 and 20), Fukui teaches the
fermentation composition according to claim 9 (or claims 11, 12, 13 and 14),
wherein the live bacteria of one or more types of bacteria selected from the group
consisting of lactic acid bacteria and bacteria of the genus Bifidobacterium are
one or more types of live bacteria selected from the group consisting of bacteria
of the genus Lactococcus, bacteria of the genus Streptococcus, bacteria of the
genus Lactobacillus, and bacteria of the genus Bifidobacterium (para 40
describes examples of "bacteria in the genus Bifidobacterium" that can be
used; note that these bacteria are live as they are still "producing
bacteria'].
Regarding claim 21, Fukui teaches the fermentation composition according to
claim 9, but does not teach that "a difference between pH of the fermentation
composition before refrigerated storage and pH of the fermentation composition
after refrigerated storage for 14 days is less than 1 ". However, Fukui teaches that
acidity (i.e. pH) of the fermentation composition depends on both temperature of
storage (e.g. see Tables 4, 5, 6, respectively, on page 7, which show pH for
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JYOTI CHAWLA whose telephone number is (571)272-8212. The examiner can normally be reached M-F 9:30- 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki Dees can be reached at 571-270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JYOTI CHAWLA/Primary Examiner, Art Unit 1791
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