DETAILED ACTION
Background
The preliminary amendment dated June 14, 2024 (amendment) claims 1-10 and 15, adding new claims 16-24 and canceling claims 11-14 has been entered. Claims 1-10 and 16-24 as filed with the amendment have been examined. Claim 15 has been withdrawn
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 .
Information Disclosure Statement
The references mentioned on page 11, lines 7-19 and page 32, lines 10-12 of the instant specification and not cited in an information disclosure statement have not been made of record. Unless the references are listed in an IDS or a US form 892, citation of references, the Examiner has not considered these references.
Claim Objections
Claim 9 is objected to because of the following informalities:
In claim 9, at line 4, after “skyr,” make --
at line 5 after “quark,” make --.
Appropriate correction is required.
In claims 4-5, 10, 21-22 and 24, at the end of each claim convert all of the subscripted terms --lactose--, --fermented milk product-- and --milk-based substrate-- the regular font and size. The recommended claim end language is “mg/g, based on the total weight of the fermented milk product” and “BLU/L of the milk-based substrate”
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 and 24 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.
In claim 10, at line 2 and in claim 24 at line 2 the term "BLU" is indefinite. Although the term appears to refer to an activity unit of beta-galactosidase, the instant specification provides no guidance, standard or definition for the unit or spell out the acronym. What does the acronym stand for and how is the value determined?
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.
Claims 1-7, 9-10, 16-22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over US2019/0343138 A1 to Ba et al. (Ba) in view of US2019/0008176 A1 to Bilbao Calabuig et al. (Bilbao).
Ba is equivalent to WO2018/130630 A1 to Ba et al., of record.
Regarding instant claims 1, 6 and 16, Ba at Abstract, Table 5 and Table 7 discloses a method for producing a fermented milk product comprising the following steps: providing a milk base (“milk-based substrate comprising lactose”); adding a starter culture comprising at least one lactic acid bacterium and fermenting the milk until a target pH below 5 is reached, wherein the lactic acid bacterium comprising at least one lactose-deficient strain; and adding a low pH stable lactase (“low pH stable beta-galactosidase” in claim 16) at any of the start, during or at the end of the fermentation step (claim 6).
The Office interprets term “low pH stable beta-galactosidase” as referring to a beta-galactosidase that continues to have hydrolytic activity below pH 5.0 as set forth in the instant specification at the paragraph bridging pages 6 and 7.
Further, and regarding instant claims 2 and 17-18, Ba does not disclose a method wherein the beta-galactosidase is present in a concentration of less than 200 g beta-galactosidase enzyme / 1000 kg of milk-based substrate as in claim 1; or, wherein the beta-galactosidase is added to the milk-based substrate in an initial concentration of less than 150 g beta-galactosidase enzyme / 1000 kg of milk-based substrate as in claim 2; or, wherein the beta-galactosidase is added to the milk-based substrate in an initial concentration of 5 - 140 g beta-galactosidase enzyme / 1000 kg of milk-based substrate as in claim 17; or, wherein the beta-galactosidase is added to the milk-based substrate in an initial concentration of 10-70 g beta-galactosidase enzyme / 1000 kg of milk-based substrate as in claim 18. However, at [0082] Ba discloses adding its low pH stable beta-galactosidase at between 100 and 5000 LAU per liter of milk-based substrate, preferably less than 500 LAU/liter of milk.
Bilbao discloses at Abstract a method of making a fermented dairy product by adding a lactase and a lactic acid bacterium culture, fermenting and straining to form (at [0033] a smoother labneh or concentrated or greek yogurt, wherein at [0095] the fermentation is stopped at pH between 4.20 and 4.80. Further, Bilbao discloses at [0097] adding from 0.005 wt% to 0.02 wt% of lactase to the milk-based substrate, or from 50 g to 200 g of lactase per 1000 kg of milk-based substrate, which the claimed less than 150 g of lactase per 1000 kg or milk-based substrate in claim 2 lies within, the claimed 5-140 g lactase per 1000 kg of milk-based substrate in claim 17 lies within and the claimed 10-70 g lactase per 1000 kg of milk-based substrate in claim 18 overlaps. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", the Office considers that a prima facie case of obviousness exists. See MPEP 2144.05.I. The ordinary skilled artisan in Bilbao would have found it obvious to add the claimed amount of beta-galactosidase to its culture of a milk-based substrate because Bilbao discloses that the claimed amount of lactase in an acid pH fermentation yields a desirable strained yogurt or labneh.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Bilbao for Ba to include the claimed amount of less than 200 g of acid pH stable lactase, or less than 150 g of acid pH stable lactase or from 5 -140 g of acid pH stable lactase, or from 10-70 g of acid pH stable lactase to its milk-based substrate culture. Both references disclose fermenting a milk-based substrate comprising lactose to a pH below 5 in the presence of a beta-galactosidase or adding a beta-galactosidase at an acid pH to the culture. The ordinary skilled artisan in Ba would have desired to limit the amount of beta-galactosidase added to the amount used in Bilbao to prevent clogging of strainer devices used to separate whey to make labneh or greek yogurt.
Regarding instant claims 3, 19-20 and 22, SEQ ID No: 2 of Ba as used in Example 2 of Ba at [0155] used to form a beta-galactosidase enzyme appears to share about 99% sequence identity with SEQ ID No: 21 of the present application.
Regarding instant claims 4 and 21, at Table 7 and Example 5 at [0186] and [0190], Ba discloses its products of Test Samples 1 and 3 comprise 1.18 and 1.20 mg/g lactose, based on the total weight of the fermented milk product. In addition, the lower amount of the beta-galactosidase in Test Samples 1 and 3 versus Test Samples 2 and 4 yields a greater amount of lactose in the product. Accordingly, use of an even lower amount of beta-galactosidase as in Ba as modified by Bilbao would be expected to yield an even higher amount of lactose in the product.
Regarding instant claim 5, Ba at [0086] discloses that its milk-based substrate has a lactose content of 30.0 to 70 mg/ml or about 3 to 7 wt% of lactose, based on the total weight of the milk-based substrate.
Regarding instant claim 7, Ba at [0050] discloses that its lactic acid bacterium comprises a lactose deficient strain of Streptococcus Thermophilus and Lactobacillus delbrueckii subsp. Bulgaricus.
Regarding instant claim 9, Ba at [0114]-[0116] discloses several fermented milk products including yogurt, stirred yogurt, drinking yogurt and buttermilk.
Regarding instant claims 10, 21 and 24, the fermented milk product and method of Ba as modified by Bilbao appears to be substantially the same thing as the claimed fermented milk product. Accordingly, absent a clear showing as to how the method of Ba as modified by Bilbao differs from that as claimed, the Office considers the method of Ba at Abstract, Table 5 and Table 7, [0082], Example 5 at [0186] and [0190], Test Sample 2 and SEQ. ID. No. 2 as modified by Bilbao at Abstract, [0033], [0095] and [0097] comprises a beta-galactosidase enzyme having an activity of less than 1130 BLU/L milk-based substrate as in claims 10 and 24 See MPEP 2112.01.I.
Regarding instant claim 22, Ba at [0086] discloses that its milk-based substrate has a lactose content of 30.0 to 70 mg/ml or about 3 to 7 wt% of lactose, based on the total weight of the milk-based substrate which the claimed 4-40 wt% lactose, based on the total weight of the milk-based substrate overlaps. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", the Office considers that a prima facie case of obviousness exists. See MPEP 2144.05.I. The ordinary skilled artisan in Ba would have found it obvious to use a milk-based substrate comprising the claimed amount of lactose because Ba discloses the same milk substrates as are disclosed at page 4, lines 21-32 of the instant specification and because Ba discloses that milk-based substrates comprising the claimed amount of lactose provide a desirable substrate for making its fermented milk product.
Claims 8 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over US2019/0343138 A1 to Ba et al. (Ba) in view of US2019/0008176 A1 to Bilbao Calabuig et al. (Bilbao) as applied to claims 1 above, and further in view of US2020/0305452 A1 to Christensen et al. (Christensen).
As applied to claim 1, Ba at Abstract, Table 5 and Table 7, [0082], Example 5 at [0186] and [0190], Test Sample 2 and SEQ. ID. No. 2 as modified by Bilbao at Abstract, [0033], [0095] and [0097] discloses a Regarding instant claims 1, 6 and 16, Ba at Abstract, Table 5 and Table 7 discloses a method for producing a fermented milk product comprising the following steps: providing a milk-based substrate comprising lactose; fermenting the milk-based substrate with a lactic acid bacterium until a target pH below 5 is reached; and, adding a low pH stable beta-galactosidase enzyme in a concentration of less than 200 g beta-galactosidase enzyme / 1000 kg of milk-based substrate.
Ba does not disclose a method wherein the lactic acid bacterium is selected from the group consisting of: a Streptococcus thermophilus strain having at least 95% sequence identity to DSM22932, DSM22935, DSM24090, DSM24023, DSM32502, DSM32503, DSM32504, DSM32505, DSM32506, DSM32507, DSM25850, DSM25851, and DSM26722 as an claims 8 and 23; or wherein the lactic acid bacterium is selected from the group consisting of: a Lactobacillus delbrueckii subsp. bulgaricus having at least 95% sequence identity to DSM24074, DSM26420, and DSM26421 as in claim 8. However, Ba at [0012] discloses that its lactic acid bacterium comprises at least one lactose-deficient strain and that its method provides a fermented milk product having increased sweetness and reduced post-acidification.
Christensen at Abstract and [0009] discloses methods of making a fermented milk product wherein the fermentation comprises fermenting with a glucose deficient strain of Streptococcus thermophilus in a starter culture, wherein the fermented milk product has an increased level of sweetness. Further, at [0079] Christensen discloses that its desired Streptococcus thermophilus strain includes strain DSM25851.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Christensen for Ba as modified by Bilbao to include the claimed Streptococcus thermophilus strain. Both Ba and Christensen references disclose methods of making a fermented milk product by fermenting with Streptococcus thermophilus strains that result in a fermented milk product having increased sweetness. The ordinary skilled artisan in Ba as modified by Bilbao would have desired to use the Streptococcus thermophilus strain DSM 25851 as in Christensen to increase its sweetness especially where the method comprises adding sucrose as in Example 5 of Ba.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW E MERRIAM whose telephone number is (571)272-0082. The examiner can normally be reached M-H 8:00A-5:30P and alternate Fridays 8:30A-5P.
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/ANDREW E MERRIAM/Examiner, Art Unit 1791
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