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 in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/17/2025 has been entered.
Status of the Claim
Claims 34, 37-38 and 42-48 are pending. Claims 43-48 are withdrawn from consideration. Claims 34, 37-38 and 42 are under examination. Claims 1-33, 35-36 and 39-41 are cancelled. The text of cancelled claims must not be presented in the claims document, see MPEP 714(II)(C)(C). Any objections or rejections not repeated below have been withdrawn.
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 34, 37-38 and 42 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 34 lines 5-10 and part (iii) both recite, “the probiotic strain is selected from Lactobacillus rhamnosus strain…”. The repeated recitation renders the claim indefinite because it is unclear if the composition contains one or more “probiotic strains selected from Lactobacillus rhamnosus strain…” or two or more “probiotic strains selected from Lactobacillus rhamnosus strain...”. With respect to the prior art, a composition comprising one or more “probiotic strains selected from Lactobacillus rhamnosus strain…” is considered to meet the repeated recitation in lines 5-9 and part (iii).
Claim 34 lines 1-5 recite, “which has a target pH of 4.8 to 4.0 and which comprises at least 1.3E+08 CFU viable cells of one or more probiotic strain(s) per gram of product (CFU/g), when measured at least 1 day after fermentation…”. It is unclear if the applicant is claiming a property of the composition or a use of the composition. Claim 34 is directed to a composition for producing a fermented milk product, not to a method of fermenting. With respect to the prior art, claim 34 is met with a composition comprising the components of parts (i), (ii) and (iii) and no more than that.
Claim 34 recites, “a target pH of 4.8 to 4.0” at the beginning and again at the end of the claim. Claim 34 in part (ii) recites “a target pH of from 4.9 to 5.5.” However, in all three locations it is unclear if this is a required pH for the composition or if the pH is not required but only sought after or “targeted.”
Claims 37-38 and 42 are rejected based on their dependence to a rejected base claim.
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.
Claims 34, 37-38 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Garrigues et al. US 20170135360 in view of Johansen et al. US 20150086675.
Regarding claims 34 and 42, Garrigues teaches a composition for producing a fermented milk product, as required by claim 34 (Abstract, [0001]). Garrigues discloses the composition comprises, (i) a lactic acid bacteria starter culture comprising a lactose-deficient lactic acid bacteria strain, as required by claim 34 (lactose deficient lactic acid bacteria (or LAB); Claim 39, [0002], [0090-0094], [0349]), see pg. 12 lines 16-18 of the specification for a definition of “lactose deficient” and which is the same definition provided by Garrigues [0091]. The lactose-deficient lactic acid bacteria strain is capable of metabolizing a non-lactose carbohydrate (lactose deficient LAB capable of metabolizing one or several carbohydrates selected from sucrose, galactose and/or glucose; [0091-0092], [0104-0110], [0361]), wherein the lactose-deficient strain comprises one or more selected from lactose-deficient Streptococcus thermophilus strains and lactose-deficient Lactobacillus strains (Claim 39, [0092-0103], [0111-0113]).
Garrigues teaches, wherein the one or more lactose-deficient Streptococcus thermophilus strains is selected from: (a) the strain deposited with Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH, (Braunschweig, Germany) (DSMZ) under accession number DSM 28952 (Claim 39 [0094-0096]); (b) a strain derived from DSM 28952, wherein the derived strain is able to generate white colonies on a medium containing lactose and X-Gal (Claim 39 [0097]); (c) the strain deposited with DSMZ under accession number DSM 28953 (Claim 39 [0098-0099]); (d) a strain derived from DSM 28953, wherein the derived strain is able to generate white colonies on a medium containing lactose and X-Gal (Claim 39 [0100]), as required by claim 34.
Garrigues discloses wherein the one or more lactose-deficient Lactobacillus strains is selected from: (a) the strain deposited with DSMZ under accession number DSM 28910 (Claim 39 [0101-0102]); and (b) a strain derived from DSM 28910, wherein the derived strain is able to generate white colonies on a medium containing lactose and X-Gal (Claim 39 [0103]), as required by claim 34.
Garrigues also teaches
(ii) a non-lactose carbohydrate (sucrose; [0124]) capable of being metabolized by the lactose-deficient strain(s) [0091-0092], [0367], as required by claim 34.
Regarding claim 34 recitation, “wherein the non-lactose carbohydrate(s) are present in an amount that will be depleted when the fermented milk product reaches a target pH of from 4.9 to 5.5.” Garrigues teaches an amount of non-lactose carbohydrate 30mg/g to 2 mg/g, or 0.2% to 3% [0124] that is similar to what has been disclosed in the specification (pg. 3 L14-16). Therefore, Garrigues teaches the non-lactose carbohydrate as claimed in an amount that would be depleted when the product reaches a target pH.
Garrigues discloses (iii) a probiotic strain selected from a Bifidobacterium animalis subsp. lactis strain, as disclosed in claim 34 and 42 [0064].
Claims 34 and 42 differ from Garrigues in specifically reciting the Bifidobacterium animalis subsp. lactis strain is BB-12® deposited at DSMZ under accession number DSM 15954. Johansen teaches a composition for producing a fermented milk product comprising a lactic acid bacteria starter culture, wherein the strains are selected from Streptococcus thermophilus and Lactobacillus strains (Abstract, [0019], [0053], [0095]) and a non-lactose carbohydrate (galactose; [0030]). Johansen discloses the composition contains a specific strain of Bifidobacterium animalis subsp. lactis, where the strain is BB-12® deposited at DSMZ under accession number DSM 15954 [0160-0163]. The strain BB-12® has boosted growth when used in combination with Streptococcus thermophilus and Lactobacillus strains, but when present in milk alone BB-12® does not grow well (Abstract, [0036]). Johansen further recognizes that it is beneficial to have all these strains used together as a composition for producing a fermented milk product, because when the fermented milk product is consumed it is useful in the diet of persons suffering from overweight or obesity and is useful in reducing the calorie intake of said person [0151-0152].
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Garrigues by using the specific Bifidobacterium animalis subsp. lactis strain BB-12® deposited at DSMZ under accession number DSM 15954 of Johansen, because when this specific BB-12® strain is used in combination with Streptococcus thermophilus and Lactobacillus strains, the probiotic bacterium BB-12® has boosted growth, which BB-12® typically does not grow well when present alone in milk, as recognized by Johansen (Abstract, [0036]). Johansen further recognizes that it is beneficial to have all these strains used together as a composition for producing a fermented milk product, because when the fermented milk product is consumed it is useful in the diet of persons suffering from overweight or obesity and is useful in reducing the calorie intake of said person [0151-0152].
Regarding the recitation in claim 34 lines 1-5 and the wherein clause at the end of claim 34, it is noted, because the prior art teaches a substantially similar composition as shown in the rejection above, it would necessarily be capable of, producing “a fermented milk product which has a target pH of 4.8 to 4.0 and which comprises at least 1.3E+08 CFU viable cells of one or more probiotic strain(s) per gram of product (CFU/g), when measured at least 1 day after fermentation has been completed, wherein the fermented milk product has been kept at about 4 °C from after the fermentation is completed until the measurement.” See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
Regarding claim 37, Garrigues teaches a method of increasing the number of viable probiotic cells in a fermented milk product comprising fermenting a milk base with a composition according to claim 34 to obtain the fermented milk product (Abstract, [0017], [0090-0103]. Therefore, since modified Garrigues teaches a substantially identical composition to claim 34 it would have an increased number of viable probiotic cells as compared to a fermented milk product fermented with the compositions selected from (a) and (b) as recited in claim 37. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
Regarding claim 38, Garrigues teaches the non-lactose carbohydrate(s) are selected from sucrose, galactose and glucose [0091].
Response to Arguments
Applicant's arguments filed 3/17/2025 have been fully considered but they are not persuasive.
Applicant argues, on pgs. 10-11 of their remarks, that having an acidification process be finished by the growth of probiotic bacteria is surprising and unexpected. Applicant states that probiotic bacteria are not well adapted for growth in milk and do not efficiently acidify the milk. Applicant argues that a person of skill in the art would not be able to arrive at the claimed invention because it is not expected and that neither Garrigues nor Johansen, either alone or in combination, teach that a probiotic bacteria can be relied upon for acidification of milk to a target pH of 4.8 to 4.0. However, the Office disagrees for the following reasons.
In Johansen it states that probiotic bacteria Bifidobacterium animalis subsp. lactis does not grow well when present alone in milk [0036], but when combined with Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus, the Bifidobacterium growth is boosted [0036]. Garrigues states that “lactic acid bacteria” or “LAB,” which includes Bifidobacterium spp., refers to bacteria that produces lactic acid [0050]. Garrigues explains during fermentation the consumption of lactose by these bacteria causes the formation of lactic acid, reducing the pH of the product [0050]. Garrigues teaches a starter culture with Streptococcus thermophilus and Lactobacillus delbrueckii, that both have a deficiency in lactose metabolism and are unable to metabolize lactose, but a carbohydrate is added to the milk that can be metabolized by these strains [0115], such as sucrose [0089]. As shown in the above rejection, Garrigues in view of Johansen is a composition comprising a lactose-deficient Streptococcus thermophilus and Lactobacillus strains that would metabolize the sucrose in the composition, and the Bifidobacterium spp. that would metabolize the lactose in the composition. All of these strains would reduce the pH of the composition and the Streptococcus and Lactobacillus strains would help boost the growth of the Bifidobacterium. As the growth of the Bifidobacterium is boosted, producing more bacteria, this would lower the pH since more Bifidobacterium present would result in more secretion of lactic acid as the lactose is metabolized by the Bifidobacterium. Thus, given the information outlined above from Garrigues and Johansen a person of ordinary skill in the art would not find the results of having an acidification process be finished by the growth of probiotic bacteria, such as Bifidobacterium, as surprising or unexpected.
Regarding the recitation in the claims and in the argument about reaching a “target pH of 4.9 to 5.5” and a “target pH of 4.8 to 4.0,” it is noted that the pH is only a “target” and it is not clear that the claimed composition is required to reach this pH. Thus, while the applicant states these pH ranges are unexpected, in particular the target pH of the finished fermented milk product of 4.0 to 4.8 where the acidification process is finished by the growth of the probiotic bacteria, this target pH range is only aimed at being achieved and may or may not be achieved during the acidification process.
Additionally, as shown by the above rejection, Garrigues in view of Johansen teaches a substantially similar composition that would necessarily be capable of, producing “a fermented milk product which has a target pH of 4.8 to 4.0 and which comprises at least 1.3E+08 CFU viable cells of one or more probiotic strain(s).” See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
Conclusion
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/S.R.G./Examiner, Art Unit 1791
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759