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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 4, 5, and 7-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, claim 1 has been amended to recite “the fermented milk is not subjected to heat treatment from the fermentation step to filling the fermented milk into containers”. However, this is not specifically recited in the specification and therefore raises an issue of new matter. It is noted that the fermentation step includes heating according to the specification, since according to the specification the fermentation temperature range is generally from 30 to 60 °C, which temperatures are greater than room temperature and therefore require heating (see PGPUB specification, [0026], see also Examples 1-3 recites the temperature that fermentation is carried out at). It is noted that “heat treatment” is broad and could include any heating. It is additionally noted that “Any negative limitation or exclusionary proviso must have basis in the original disclosure” MPEP 2173.05(i).
Regarding claim 7, claim 7 has been amended to recite “the medium is not subjected to heat treatment from the fermentation step to the lactic acid bacterium addition step”. However, this is not specifically recited in the specification and therefore raises an issue of new matter. It is noted that the fermentation step includes heating according to the specification, since according to the specification the fermentation temperature range is generally from 30 to 60 °C, which temperatures are greater than room temperature and therefore require heating (see PGPUB specification, [0026] see also Examples 1-3 recites the temperature that fermentation is carried out at). It is noted that “heat treatment” is broad and could include any heating. It is additionally noted that “Any negative limitation or exclusionary proviso must have basis in the original disclosure” MPEP 2173.05(i).
Claims 2, 4, 5 and 8 are rejected by virtue of their dependence on a rejected base claim.
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 1, 2, 4, 5, and 7-8 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.
Regarding claim 1, claim 1 has been amended to recite “the fermented milk is not subjected to heat treatment from the fermentation step to filling the fermented milk into containers”. It is unclear if this is requiring the fermentation step to not include heating because the claim recites “from the fermentation step” which language appears to include the fermentation step. It is noted that in the specification, the fermentation step includes heating, since according to the specification the fermentation temperature range is generally from 30 to 60 °C, which temperatures are greater than room temperature and therefore require heating (see PGPUB specification, [0026] see also Examples 1-3 recites the temperature that fermentation is carried out at). Additionally, it is unclear how the fermented milk is not subjected to heat treatment from the fermentation step to filling the fermented milk into containers. Namely, since fermented milk is obtained from the fermentation step and therefore is only present after the fermentation step it is unclear how the fermented milk is not subjected to heat treatment “from the fermentation step”.
Regarding claim 7, claim 7 has been amended to recite “the medium is not subjected to heat treatment from the fermentation step to the lactic acid bacterium addition step”. It is unclear if this is requiring the fermentation step to not include heating because the claim recites “from the fermentation step” which language appears to include the fermentation step. It is noted that in the specification, the fermentation step includes heating.
Claims 2, 4, 5 and 8 are rejected by virtue of their dependence on a rejected base claim.
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.
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.
Claims 1, 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Folkenberg et al. US 2013/0164408 in view of Francois et al. US 2013/0177671 in view of Nilsson US 2012/0128822 in view of Garault et al. US 2020/0187517 in view of Rizo et al. US 2005/0220964.
Regarding claim 1, Folkenberg discloses a method for producing fermented milk ([0025]) comprising: a starter inoculation step of inoculating a starter to raw material milk ([0026]). The method comprises a fermentation step of fermenting the raw material milk to which the starter is inoculated to obtain fermented milk ([0027]). The method comprises a lactic acid bacterium addition step of adding a lactic acid bacterium to the fermented milk ([0028], [0082]); wherein the starter does not include Bifidobacterium ([0025], [0024]). Folkenberg discloses that the fermentation step is a step of fermenting the raw milk material to which the starter is inoculated until an acidity of the raw material milk to which the starter is inoculated reaches a pH of 4.5 ([0077]). It is noted that Folkenberg discloses that post treating of the milk after fermentation is optional and therefore teaches that the fermented milk is not subjected to heat treatment from the fermentation step to filling the fermented milk into containers (claim 1).
Claim 1 differs from Folkenberg in the recitation that the method further comprises a stirring step of stirring the fermented milk after the fermentation step but before the lactic acid bacterium addition step.
Francois discloses preparing a fermented dairy product comprising fermenting milk containing lactic acid bacteria ([0017], [0024]) and after fermentation stirring the obtained product prior to adding additives ([0024]). Francois discloses stirring so as reach the targeted viscosity ([0024], [0056]).
It would have been obvious to one of ordinary skill in the art to modify the method of Folkenberg to include a stirring step of stirring the fermented milk after the fermentation step but before the lactic acid bacterium addition step as suggested by Francois in order to obtain a product with a desired viscosity.
Additionally, Nilsson discloses a method of producing a fermented milk which comprises a stirring step of stirring the fermented milk after the fermentation step and before a second bacteria addition step ([0015]-[0027]). Thus, Nilsson recognizes it was a known technique in the art to stir fermented milk (the fermented milk is mixed the distribute flavorings) ([0024]) prior to a step of adding a second amount of bacteria to the fermented milk ([0025]). Therefore, it additionally would have been obvious to one of ordinary skill in the art to modify the method of Modified Folkenberg to such that the stirring step of stirring the fermented milk after the fermentation step is carried out before the lactic acid bacterium addition step as suggested by Nilsson, it has been held that “Applying a known technique to a known method, or product ready for improvement to yield predictable results” supports a conclusion of obviousness (MPEP 2143.I.D)
Claim 1 differs from Modified Folkenberg in the recitation that the lactic acid bacterium is at least one selected from the group consisting of Lactobacillus gasseri, Lactobacillus delbrueckii subsp. bulgaricus OLL1073R-1 strain, Lactobacillus plantarum, Lactobacillus casei and Bifidobacterium.
It is noted that Folkenberg discloses that “one may add extra bacteria (e.g. lactobacillus bulgaricus) ([0082]) and thus does not limit the particular lactic acid bacteria which can be added as extra bacteria.
Garault teaches that additional bacteria added to fermented milk (yogurt) include strains of Bifidobacterium and/or Lactobacillus acidophilus and/or Lactobacillus casei ([0009]). Garault discloses that these additional lactic acid bacteria strains are intended to impart various properties to the finished product, such as that of providing organoleptic qualities ([0009]). It would have been obvious to one of ordinary skill in the art to modify the extra bacteria of Modified Folkenberg to be at least one of Lactobacillus casei and Bifidobacterium as suggested by Garault based on the desired organoleptic qualities of the finished product.
Additionally, Rizo discloses that microorganisms that can be added after fermentation of a fermented milk product include Lactobacillus gasseri, Lactobacillus plantarum, Lactobacillus casei and Bifidobacterium ([0016]) in order to augment the probiotic properties of the fermented milk product ([0016]). It is noted that Folkenberg already discloses “adding further microorganisms” ([0028]) and “one may add extra bacteria (e.g. lactobacillus bulgaricus) ([0082]) and thus does not limit the particular lactic acid bacteria which can be added as extra bacteria. Rizo recognizes that suitable/desirable microorganisms that can be added after fermentation of a fermented milk product include Lactobacillus gasseri, Lactobacillus casei, Lactobacillus plantarum and Bifidobacterium. It would have been obvious to one of ordinary skill in the art to modify Modified Folkenberg such that the lactic acid bacterium is at least one selected from the group consisting of Lactobacillus gasseri, Lactobacillus casei, Lactobacillus plantarum and Bifidobacterium as taught by Rizo in order to augment the probiotic properties of the fermented milk with suitable/desirable microorganisms. It has been held that the selection of a known material based on its suitability for its intended use supports a conclusion of obviousness (MPEP 2144.07). Additionally, it has been held that “Combining prior art elements according to known methods to yield predictable results” supports a conclusion of obviousness (MPEP 2143.I.A).
Regarding claim 2, claim 2 is rejected for the same reasons given above as for claim 1.
Regarding claim 4, Modified Folkenberg discloses that the starter includes Lactobacillus bulgaricus (‘408, [0026], [0024]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Folkenberg et al. US 2013/0164408 in view of Francois et al. US 2013/0177671 in view of Nilsson US 2012/0128822 in view of Garault et al. US 2020/0187517 in view of Rizo et al. US 2005/0220964 in view of Horiuchi et al. US 2010/0021585.
Regarding claim 5, claim 5 differs from Modified Folkenberg in the recitation that the fermentation step of fermenting the raw material milk to which the starter is inoculated is carried out until an acidity of the raw material milk to which the starter is inoculated reaches 0.7% or more.
Horiuchi discloses a method for producing fermented milk and discloses that the fermentation step is carried out until the acidity reaches a predetermined level in the fermentation process ([0021], [0022]) and discloses specifically fermenting milk until an acidity of 0.7% is reached ([0034], [0042], [0051]). It would have been obvious to one of ordinary skill in the art to modify the method of Modified Folkenberg such that the fermentation step of fermenting the raw material milk to which the starter is inoculated is carried out until an acidity of the raw material milk to which the starter is inoculated reaches 0.7% as taught by Horiuchi, since Horiuchi shows that a fermentation step of fermenting a raw material milk to which the starter is inoculated is commonly carried out until an acidity of the raw material milk to which the starter is inoculated reaches 0.7% and one of ordinary skill in the art would have been motivated to carry out the fermentation step to a common predetermined acidity level suitable for the raw material milk to which the starter is inoculated for producing fermented milk. It has been held that combining prior art elements according to known methods to yield predictable results supports a conclusion of obviousness (MPEP 2143.I.A).
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Folkenberg et al. US 2013/0164408 in view of Francois et al. US 2013/0177671 in view of Nilsson US 2012/0128822 in view of Garault et al. US 2020/0187517 in view of Rizo et al. US 2005/0220964 as evidenced by the New York Times (“How to Make Yogurt at Home”) in view of Horiuchi et al. US 2010/0021585.
Regarding claim 7, Folkenberg discloses a method for producing a lactic acid bacterium starter (fermented milk/yogurt) ([0025], [0073]-[0075]) comprising: a starter inoculation step of inoculating a starter to a medium including a milk component and water (milk obviously comprises water and a milk component) ([0026], [0041]). Folkenberg discloses that the starter does not include Bifidobacterium ([0025], [0024]). The method comprises a fermentation step of fermenting the medium after the starter inoculation step ([0027]). The method comprises a lactic acid bacterium addition step of adding a lactic acid bacterium to the medium after the fermentation step ([0028], [0082]). Folkenberg discloses that post treating of the milk after fermentation is optional and therefore teaches that the medium is not subjected to heat treatment from the fermentation step to the lactic acid bacterium addition step (claim 1)
Claim 7 differs from Folkenberg in the recitation that the method further comprises a stirring step of stirring the fermented medium after the fermentation step but before the lactic acid bacterium addition step.
Francois discloses preparing a fermented dairy product comprising fermenting milk containing lactic acid bacteria ([0017], [0024]) and after fermentation stirring the obtained product prior to adding additives ([0024]). Francois discloses stirring so as reach the targeted viscosity ([0024], [0056]). It would have been obvious to one of ordinary skill in the art to modify the method of Folkenberg to include a stirring step of stirring the fermented milk after the fermentation step but before the lactic acid bacterium addition step as suggested by Francois in order to obtain a product with a desired viscosity.
Additionally, Nilsson discloses a method of producing a fermented milk which comprises a stirring step of stirring the fermented milk after the fermentation step and before a second bacteria addition step ([0015]-[0027]). Thus, Nilsson recognizes it was a known technique in the art to stir fermented milk (the fermented milk is mixed the distribute flavorings) ([0024]) prior to a step of adding a second amount of bacteria to the fermented milk ([0025]). Therefore, it additionally would have been obvious to one of ordinary skill in the art to modify the method of Modified Folkenberg to such that the stirring step of stirring the fermented milk after the fermentation step is carried out before the lactic acid bacterium addition step as suggested by Nilsson, it has been held that “Applying a known technique to a known method, or product ready for improvement to yield predictable results” supports a conclusion of obviousness (MPEP 2143.I.D)
Claim 7 differs from Modified Folkenberg in the recitation that the lactic acid bacterium is at least one selected from the group consisting of Lactobacillus gasseri, Lactobacillus delbrueckii subsp. bulgaricus OLL1073R-1 strain, Lactobacillus plantarum, Lactobacillus casei and Bifidobacterium.
It is noted that Folkenberg discloses that “one may add extra bacteria (e.g. lactobacillus bulgaricus) ([0082]) and thus does not limit the particular lactic acid bacteria which can be added as extra bacteria.
Garault teaches that additional bacteria added to fermented milk (yogurt) include strains of Bifidobacterium and/or Lactobacillus acidophilus and/or Lactobacillus casei ([0009]). Garault discloses that these additional lactic acid bacteria strains are intended to impart various properties to the finished product, such as that of providing organoleptic qualities ([0009]). It would have been obvious to one of ordinary skill in the art to modify the extra bacteria of Modified Folkenberg to be at least one of Lactobacillus casei and Bifidobacterium as suggested by Garault based on the desired organoleptic qualities of the finished product.
Additionally, Rizo discloses that microorganisms that can be added after fermentation of a fermented milk product include Lactobacillus gasseri, Lactobacillus plantarum, Lactobacillus casei and Bifidobacterium ([0016]) in order to augment the probiotic properties of the fermented milk product ([0016]). It is noted that Folkenberg already discloses “adding further microorganisms” ([0028]) and “one may add extra bacteria (e.g. lactobacillus bulgaricus) ([0082]) and thus does not limit the particular lactic acid bacteria which can be added as extra bacteria. Rizo recognizes that suitable/desirable microorganisms that can be added after fermentation of a fermented milk product include Lactobacillus gasseri, Lactobacillus casei, Lactobacillus plantarum and Bifidobacterium. It would have been obvious to one of ordinary skill in the art to modify Modified Folkenberg such that the lactic acid bacterium is at least one selected from the group consisting of Lactobacillus gasseri, Lactobacillus casei, Lactobacillus plantarum and Bifidobacterium as taught by Rizo in order to augment the probiotic properties of the fermented milk with suitable/desirable microorganisms. It has been held that the selection of a known material based on its suitability for its intended use supports a conclusion of obviousness (MPEP 2144.07). Additionally, it has been held that “Combining prior art elements according to known methods to yield predictable results” supports a conclusion of obviousness (MPEP 2143.I.A).
Further regarding claim 7, Folkenberg teaches that the method is for obtaining fermented milk (fermented milk product can be yogurt) ([0073], [0075]) and the fermented milk of Folkenberg in view of Francois in view of Garault in view of Rizo is capable of being used as a lactic acid bacterium starter for obtaining fermented milk by fermenting raw material milk as evidenced by the New York Times, which teaches that fermented milk (yogurt) can be used as a starter for fermenting raw material milk (Pg. 1, 6th paragraph). Thus, Folkenberg in view of Francois in view of Garault in view of Rizo as evidenced by the New York Times teaches that the lactic acid bacterium starter comprises a substance (yogurt) obtained by fermenting the medium in the fermentation step, and the lactic acid bacterium added to the medium in the lactic acid bacterium addition step.
Further regarding claim 7, claim 7 differs from Modified Folkenberg in the recitation that the fermentation step of fermenting the raw material milk to which the starter is inoculated is carried out until an acidity of the raw material milk to which the starter is inoculated reaches 0.6% to 1.2%.
Horiuchi discloses a method for producing fermented milk and discloses that the fermentation step is carried out until the acidity reaches a predetermined level in the fermentation process ([0021], [0022]) and discloses specifically fermenting milk until an acidity of 0.7% is reached ([0034], [0042], [0051]). It would have been obvious to one of ordinary skill in the art to modify the method of Modified Folkenberg such that the fermentation step of fermenting the raw material milk to which the starter is inoculated is carried out until an acidity of the raw material milk to which the starter is inoculated reaches 0.7% as taught by Horiuchi, since Horiuchi shows that a fermentation step of fermenting a raw material milk to which the starter is inoculated is commonly carried out until an acidity of the raw material milk to which the starter is inoculated reaches 0.7% and one of ordinary skill in the art would have been motivated to carry out the fermentation step to a common predetermined acidity level suitable for the raw material milk to which the starter is inoculated for producing fermented milk. It has been held that combining prior art elements according to known methods to yield predictable results supports a conclusion of obviousness (MPEP 2143.I.A).
Regarding claim 8, Modified Folkenberg discloses that the starter comprises Lactobacillus bulgaricus (‘408, [0026], [0024]).
Response to Arguments
Applicant's arguments filed 12/31/2025 have been fully considered but they are not persuasive.
On pg. 4 of the remarks Applicant argues that the new limitations are supported through implicit disclosure of the specification.
This argument has not been found convincing it is noted that “heat treatment” is broad and includes any type of heating and is not limited to heat treatment temperatures sufficient for sterilization or to kill probiotic bacteria. It is additionally noted that the language of the claims appears to imply that the fermentation step does not include heating and that is also not specifically taught in the specification. “Any negative limitation or exclusionary proviso must have basis in the original disclosure” MPEP 2173.05(i).
On pg. 6 of the remarks Applicant argues that Nilsson is fundamentally incompatible with the claimed invention. Applicant argues that one seeking to combine Folkenberg with Nilsson would adopt and integrated approach and include heat treatment. On Pg. 7 Applicant argues that there is no motivation to combine Folkenberg and Nilsson.
This argument has not been found persuasive Nilsson was only relied upon to further show that the steps already made obvious by Folkenberg and Francois, would additionally be obvious because Nilsson shows that it was a known technique in the art to stir fermented milk (the fermented milk is mixed the distribute flavorings) ([0024]) prior to a step of adding a second amount of bacteria to the fermented milk ([0025]). And that therefore, it additionally would have been obvious to one of ordinary skill in the art to modify the method of Modified Folkenberg to such that the stirring step of stirring the fermented milk after the fermentation step is carried out before the lactic acid bacterium addition step as suggested by Nilsson, since it has been held that “Applying a known technique to a known method, or product ready for improvement to yield predictable results” supports a conclusion of obviousness (MPEP 2143.I.D).
In response to Applicants arguments regarding Francois, Folkenberg already teaches adding the additional microorganisms in the step of adding additives and since Francois teaches stirring prior to an additive addition step to obtain the desired viscosity of the product, the prior art as a whole is seen to teach performing a stirring step prior to a lactic acid bacterium addition step and after a fermentation step, to obtain a product with a desired viscosity.
On pg. 8 of the remarks Applicant argues that the proposed combination would not achieve improved viability because Nilssons heat treatment would kill off bacteria.
This argument has not been found persuasive, Folkenberg has not been modified to include Nilssons heat treatment.
On Pg. 8 of the remarks Applicant argues that the data in the specification demonstrates unexpected superiority of the overall claimed method.
The examiner notes that the data provided in the examples does not establish criticality of the stirring step after fermentation but prior to the addition of additional lactic acid bacteria. Each of the examples show data for adding the additional bacteria after fermentation and stirring compared to the comparative examples which add all of the lactic acid bacteria in the inoculation step prior to fermentation and stirring. The examples do not compare adding the additional lactic acid bacteria after fermentation and prior to stirring vs after fermentation and after stirring. While test example 1 has mixing after adding the additional bacteria and test example 2 does not, test example 1 contains additional/different ingredients not in test example 2 and therefore they cannot be directly compared.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY AXTELL whose telephone number is (571)270-0316. The examiner can normally be reached M-F 9:00- 5:30.
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/A.A/
Ashley AxtellExaminer, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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