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
Claims 23 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/21/2025.
Applicant’s election without traverse of Group I, claims 1-13, 17-20 and 22 in the reply filed on 11/21/2025 is acknowledged.
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 1-13, 17-20 and 22 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 1 requires inoculation of the milk with a composition comprising 104 to 1015 CFU/g of viable LAB cells. However, the instant specification states that the milk inoculated with from 104 to 1015 cfu (colony forming units) viable LAB bacteria cells per gram milk. It is not clear if the claims require the CFU as “per grams” of milk since the claim states that the composition comprises 104 to 1015 CFU/g and does not specify that the “/g” is grams of milk. In other words, as written, the “/g” is of the composition of LAB. Clarification is requested. For examination, the claim will be interpreted consistent with the specification which states CFU per grams milk. Dependent claims are includes as they incorporate the issue identified above.
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.
Claim(s) 1-4, 8-11, 19, 22 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/130630 (Ba) in view of WO 2019/243497 (Janzen) (both cited on the IDS filed 12/19/2023).
Ba teaches a process for producing a fermented milk product comprising a method of adding a starter culture of LAB is added to a milk base and then fermenting the milk until a target pH is reached and further processing the fermented milk to obtain a product (abstract and teaching of forming yogurt and cheese).
The LAB is a lactose-deficient lactic acid bacteria (page 2) and is capable of metabolizing a carbohydrate selected from glucose and galactose (page
In a first aspect of the invention, the low pH stable lactase is added to the milk base at the start of the fermentation step. In this aspect the added lactase will convert the lactose of the milk base to glucose and galactose, which will be available for metabolization for the starter culture in addition to the added non-lactose carbohydrate. In this case, it will not be possible to stop the fermentation by depletion of the added non-lactose carbohydrate (page 12). Notably, Ba specifies that the lactase may be added “before” fermentation begins. Page 2 of Ba states, “Furthermore, when the lactase is added before the fermentation step the process of the invention has provided a possibility of reducing or even eliminating the amount of non-lactose carbohydrate to be added to the milk. Thus, the glucose and galactose formed by the enzymatic action of lactase will be available for the growth of the lactose-deficient lactic acid bacteria.” (page 2). This is understood to convey to the ordinary artisan that addition of lactase results in formation of glucose and galactose that will then be available for the growth of the lactose-deficient lactic acid bacteria. Thus, Ba is seen to disclose addition of lactase under conditions where the lactase will hydrolyze the milk to form glucose and galactose. The addition of LAB which is lactose deficient can then metabolize the glucose and galactose. Ba teaches fermentation with the lactose deficient LAB. Ba teaches that by using a combination of a low pH stable lactase and lactose-deficient lactic acid bacteria, it is possible to obtain a fermented milk product, which at the same time has reduced lactose content, an increased sweetness and reduced post-acidification. Furthermore, it has surprisingly been found that the said combination results in a fermented milk product having an increased texture as compared to using lactose-deficient lactic acid bacteria and no lactase and as compared to using a low pH stable lactase and lactose-positive lactic acid bacteria (page 2).
Regarding the amount of milk as 100 L, Ba gives examples where the amount is 100 ml (Example 2) as well as examples where the milk base is 3000 grams (table 10). Depending upon the amount of milk product desired to be made, it would have been obvious to one of ordinary skill to size up or size down the starting milk base.
Regarding the CFU/g of the LAB, Ba does not specify the CFU/g of the LAB composition. However, Janzen discloses a method of making a milk product (cheese) by inoculating a milk with a lactose deficient LAB where the milk is inoculated with from 104 to 1015 CFU/g milk (page 15). Thus, one of ordinary skill in the art would have found it obvious to provide a similar CFU/g milk to the milk base in Ba with a reasonable expectation of providing the LAB in sufficient amounts to adequately inoculate the milk and proceed with fermentation.
Regarding claims 2, 3, and 22, Ba discloses that the LAB may comprise Streptococcus thermophilus Accession No. DSM 28952 (page 30) which is inherently capable of metabolizing glucose and galactose.
Regarding claim 4, Ba discloses formation of yogurt and cheese.
Regarding claim 8, Ba discloses that the LAB is capable of metabolizing one or several carbohydrates selected from sucrose, galactose and/or glucose (page 10).
Regarding claims 9-11, Ba discloses the use of two strains that are both lactose-deficient (page 10); thus, the milk is not inoculated with bacteria cells that are not lactose-deficient.
Regarding claim 19, Ba discloses a target pH value of the fermented milk product is between 3.2 and 4.8 (page 13).
Claim(s) 6, 7, 12, 13, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/130630 (Ba) in view of WO 2019/243497 (Janzen) and further in view of EP 2957180 (Garrigues) (all references cited on the IDS filed 12/19/2023).
Regarding claims 6, 12, 13, 17 and 18, Ba and Janzen do not expressly disclose the amount of lactase added, inactivation of the lactase and how much lactase is hydrolyzed. Garrigues discloses a method of producing a fermented milk with improved control of post acidification by the addition of lactase (Example 4). Garrigues states that it was surprisingly found that addition of lactase significantly reduces post-acidification in comparison with yogurt made without lactase. The amount of lactase added was 3500 NLU/L (Example 4) which his within the range of claims 6 and 17. Garrigues also states that concentrations of 500-5000 NLU/L lactase may be added (page 10). Garrigues does not expressly disclose how much lactose is hydrolyzed, but the amount per liter of lactase added is commensurate in scope with the amount claimed, thus, one of ordinary skill would reasonably expect the activity of the lactase to hydrolyze a similar amount of lactose. It would have been obvious to one of ordinary skill to add lactase in the process of Ba in a similar amount per liter of milk base as disclosed by Garrigues as both references acknowledge the action of lactase to hydrolyze lactose and product glucose and galactose and also results in reduced level of post-acidification due to the reduced content of lactose in the fermented milk product and one of ordinary skill would have reasonably expected to convert the lactose present to lactase using the concentration disclosed by Garrigues (Ba: page 2; Garrigues: Example 4). Additionally, the pH at the end of fermentation (which is not defined) of Ba as modified above would be expected to have a stability commensurate with the claims since the lactase addition is recognized by both Ba and Garrigues as reducing the post-acidification and pH stability due to the reduction in lactose and use of lactose-deficient LAB.
Regarding claim 7, the references do not disclose inactivation after step (a) and before step (b), however, Ba clearly recognizes that low-lactose is desired and that the glucose and galactose formed from hydrolyzing the lactose is necessary for the LAB metabolization. Thus, one of ordinary skill would have found it obvious to allow the lactase to inactivate naturally by depletion of the lactose. Alternatively, once the desired amount of lactose has been hydrolyzed, methods of inactivation of lactase are discussed in Ba, such as heating to 99C for 10 minutes in a thermomixer (page 24).
Claim(s) 5 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/130630 (Ba) in view of WO 2019/243497 (Janzen) and further in view of WO 2015/193459 (Garrigues II) and Redazione, “Pasta Filata: The cheese that melts and stretches”, Italian Food Tech, 2012 (each reference is cited on the IDS filed 12/19/2023).
Ba discloses that fermentation conditions may be selected to form cheese and other milk products but does not specify cottage cheese or pasta filata (stretched curd) or the steps for forming pasta filata cheese. Janzen discloses making pasta filata cheese but does not give an example including the process parameters. Garrigues II discloses a method of producing a fermented milk product including methods of making a pasta filata cheese using a fermented milk product that has been fermented in the presence of lactase (page 11). Garrigues II disclosed acidification of the curds and stretching of the curds. Redazione discloses that in the process of making pasta filata the curds are acidified to boost release of whey and controls undesirable bacterial growth and that the pH has to reach 5.0-5.4 (page 3). It would have been obvious to one of ordinary skill to form pasta filata cheese using the fermented milk of Ba as modified by Janzen above as Ba discloses making cheese and Garrigues II discloses that pasta filata cheese may be made with a milk fermented in the presence of lactase. One of ordinary skill would have found it obvious to use the known method of forming pasta filata cheese as disclosed by Radazione with a reasonable expectation of success based upon the express disclosure of the known methodology.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER C MCNEIL whose telephone number is (571)272-1540. The examiner can normally be reached M-F 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at 571-272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
JENNIFER C. MCNEIL
Primary Examiner
Art Unit 1793
/Jennifer McNeil/ Primary Examiner, Art Unit 1793