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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/19/2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. However, the non-patent literature publication titled, “NOSOVA et al., Effect of Lactobacillus…” or that portion which caused it to be listed has not been submitted. According to 37 CFR 1.98 Content of information disclosure statement, it is required to submit a legible copy of each non-patent literature publication or that portion which caused it to be listed. The information referred to in the non-patent literature document “NOSOVA et al.” has not been considered.
Status of Claims
Claims 1-8, 11 and 13-19 are pending in this application. Claims 1-8 and 16 are under examination. Claims 11, 13-15 and 17-19 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of claims 1-8 and 16 in the reply filed on 03/09/2026 is acknowledged. Claims 11, 13-15 and 17-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 5-7 are rejected under 35 U.S.C. 112(a), as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The invention appears to employ specific strains of Lacticaseibacillus rhamnosus and Streptococcus thermophilus. It is unclear if all restriction on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
The examiner could find evidence that a deposit had been made in the specification. However, it is not clear if the deposit meets all of the criteria set forth in 37 CFR 1.801-1.809. Applicant or applicant's representative may provide assurance of compliance with the requirements of 35 U.S.C § 112, first paragraph, in the following manner.
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and averring the following may be sufficient to overcome an objection and rejection based on a lack of availability of biological material.
1. Identifies declarant.
2. States that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
3. States that the deposited material has been accorded a specific (recited) accession number.
4. States that all restriction on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
5. States that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
6. States that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
7. That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
Alternatively, it may be averred that deposited material has been accepted for deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure (e.g. see 961 OG 21, 1977) and that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
Additionally, the deposit must be referred to in the body of the specification and be identified by deposit (accession) number, date of deposit, name and address of the depository and the complete taxonomic description.
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 5-7 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 5 recites the limitation, “wherein the starter culture comprises one or more Lacticaseibacillus rhamnosus strains, wherein the one or more Lacticaseibacillus rhamnosus strains comprise or consist of.” The phrase “wherein the starter culture comprises” allows for one or more Lacticaseibacillus rhamnosus strains as well as other ingredients to be in the starter culture. The claim then recites the limitation “comprise or consist of.” If the limitation of “consist of” was applied, it is unclear if additional strains of Lacticaseibacillus rhamnosus can be in the composition as is outlined with the limitation “wherein the starter culture comprises…” or if the composition is restricted to only strains listed in parts (a)-(c). For the purpose of examination, the phrase “comprise or consist of” will be viewed as “comprise”.
Claim 6 recites the limitation, “wherein the starter culture comprises one or more Streptococcus thermophilus strains, wherein the one or more Streptococcus thermophilus strains comprise or consist of.” The phrase “wherein the starter culture comprises” allows for one or more Streptococcus thermophilus strains as well as other ingredients to be in the starter culture. The claim then recites the limitation “comprise or consist of.” If the limitation of “consist of” was applied, it is unclear if additional strains of Streptococcus thermophilus can be in the composition as is outlined with the limitation “wherein the starter culture comprises…” or if the composition is restricted to only strains listed in parts (a)-(c). For the purpose of examination, the phrase “comprise or consist of” will be viewed as “comprise”.
Claims 5-7 recite the limitation, “or a mutant thereof” in regards to specific strains of Lacticaseibacillus rhamnosus and Streptococcus thermophilus. This limitation is recited several times in claims 5-7 after each strain deposit accession number. Upon further review of the specification, it is noted that the specification does not provide a precise definition of the mutant(s) to allow a person skilled in the art to identify and/or produce the mutant(s). For example, on page 26 lines 7-9 of the specification it states, “In some embodiments, the mutant strain is obtained by using the deposited strain as starting material. In some embodiments the mutant strain is a strain having all of the identifying characteristics of the strain deposited.” Information such as identifying characteristics of the strain are not listed or any other specifics given on the mutant strain. There is not adequate structural or functional description that defines the boundaries or specific characteristics of the mutation. For the purpose of examination, “or mutant thereof” in relation to the specific strains of Lacticaseibacillus rhamnosus and Streptococcus thermophilus will be construed as any strain of Lacticaseibacillus rhamnosus and Streptococcus thermophilus.
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.
Claim 1-4, 6, 8 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zourari et al. WO 2013030280.
Regarding claim 1-3 and 8, Zourari teaches a method for producing a thermophilic fermented dairy composition having a cream flavor, as required by claim 1 (process for manufacturing fermented milk products capable of producing diacetyl at thermophilic temperature, pg. 1 L4-6; flavor notes described as creamy, pg. 10 L5-6).
Zourari discloses the method comprises (a) fermenting a milk substrate inoculated with a starter culture to produce a thermophilic fermented dairy composition, as required by claim 1 (making a fermented milk by adding one or more thermophilic bacterial strains and carrying out the fermentation process, pg. 3 L18-24, claim 1). Zourari teaches fermenting at a temperature of 37-45 °C (pg. 3 L23-24, claim 1). This is within the claim 1 range of above about 33 °C.
Zourari teaches (b) decreasing an acetaldehyde content and increasing a diacetyl content in the thermophilic fermented dairy composition. This is shown in Example 2, Table 2, Column CBS 130345 of Zourari, where the composition has been stored at 9°C for 1 day, 1 week and 2 weeks. Zourari discloses the diacetyl at 1 day of storage is 19 mg/kg and after 1 week of storage is 28 mg/kg, and the acetaldehyde at 1 day of storage is 12 mg/kg and after 1 week of storage is 11 mg/kg (pg. 9, Lines 1-10 and Table 2, Column CBS 1030345, Row Diacetyl). Thus, Zourari teaches decreasing an acetaldehyde content and increasing a diacetyl content in the composition, as required by claim 1, as well as storing the thermophilic fermented dairy composition, as required by claim 2, since the composition is stored from 1 day, 1 week and 2 weeks (pg. 9, Lines 1-10 and Table 2, Column CBS 1030345, Row Diacetyl). Example 2 of Zourari also teaches wherein the acetaldehyde content is decreased and the diacetyl content is increased in the thermophilic fermented dairy composition during storage, as required by claim 3, and teaches wherein the thermophilic fermented dairy composition (a) is stored at 9 °C and (b) is stored for at least about 1 day and 1 week, as required by claim 8 (pg. 9, L1-10 and Table 2, Column CBS 1030345, Row Diacetyl). This is within the claim 8 range of storage temperature of about 9 °C and storage time of at least about 1 day.
Regarding claim 4, Zourari teaches the method of claim 1, as described above. Zourari teaches (a) the acetaldehyde content is decreased after 1 week of storage to 11 mg/kg and the diacetyl content is increased to 28 mg/kg, to produce a ratio of acetaldehyde to diacetyl that is 11:28 or a ratio of about 0.4 (pg. 9, Lines 1-10 and Table 2, Column CBS 1030345). This is within the claimed ratio of less than 1. Zourari teaches the diacetyl content is increased to 28 mg/kg or 28 ppm (pg. 9 Table 2, Column CBS 1030345, Row Diacetyl 1 week). This is within the claimed range of diacetyl content increased to at least 1 ppm.
Regarding claim 6, Zourari discloses the method of claim 1, as described above. Zourari teaches wherein the starter culture comprises Streptococcus thermophilus strains, wherein the Streptococcus thermophilus strains comprise a mutant (thermophilic lactic acid bacterial strain of Streptococcus thermophilus is used; pg. 4 L11-15, pg. 8 L18-21, claim 3). It is noted that any Streptococcus thermophilus strain is considered to meet the claim requirement of “a mutant thereof” for the specific Streptococcus thermophilus strains discussed in parts (a)-(c), specifically strains DSM33651, DSM33849 and DSM33829, respectively. See 112(b) rejection for claims 5-7 above.
Regarding claim 16, Zourari discloses the method of claim 1, as described above. Zourari teaches wherein the milk substrate is a cow milk (the milk used is 4% skimmed cow milk; pg. 8 L15-17 Example 2).
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 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Zourari et al. WO 2013030280 as applied to claim 1 above, and further in view of Henriksson US 20130142908.
Regarding claim 5, Zourari discloses the method of claim 1, as described above. Zourari teaches wherein the starter culture comprises (a) adding one or more thermophilic lactic acid bacterial strains to milk (pg. 3 L18-20). However, Zourari does not state that the starter culture comprises Lacticaseibacillus rhamnosus strains.
Henriksson teaches a method of improvement of the survival rate of probiotic strains by adding Lactobacillus strains that enhance the survival rate of probiotic strains in food [0001]. Henriksson states that live probiotic cultures are fermented in dairy products such as yogurt, but that during storage of the fermented dairy product, the survival rate of the probiotic decreases in the product [0003]. Henriksson teaches wherein the starter culture comprises Lactobacillus strains such as Lacticaseibacillus rhamnosus (Lactobacillus rhamnosus), wherein the Lacticaseibacillus rhamnosus strain comprises (c) the strain deposited under accession number DSM22193 in a fermented dairy product where the medium is milk [0019], [0021], [0047-0049].
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 Zourari in view of Henriksson to incorporate the teachings of Henriksson by having the starter culture comprise Lacticaseibacillus rhamnosus strain DSM22193 because this strain enhances the survival rate of probiotic strains in food, as recognized by Henriksson [0001], [0003], [0006].
Regarding claim 7, Zourari discloses the method of claim 1, as described above. Zourari teaches wherein the starter culture comprises (g)-(i) the Streptococcus thermophilus strain mutant (thermophilic lactic acid bacterial strain of Streptococcus thermophilus is used; pg. 4 L11-15, pg. 8 L18-21, claim 3). It is noted that any Streptococcus thermophilus strain is considered to meet the claim requirement of “a mutant thereof” for the specific Streptococcus thermophilus strains discussed in parts (g)-(i), specifically strains DSM33651, DSM33849 and DSM33829, respectively. See 112(b) rejection for claims 5-7 above.
Zourari does not state that the starter culture comprises Lacticaseibacillus rhamnosus strain deposited under accession number DSM22193 but does recognize using more than one thermophilic lactic acid bacterial strain (pg. 3 L18-20).
Henriksson teaches a method of improvement of the survival rate of probiotic strains by adding Lactobacillus strains that enhance the survival rate of probiotic strains in food [0001]. Henriksson states that live probiotic cultures are fermented in dairy products such as yogurt, but that during storage of the fermented dairy product, the survival rate of the probiotic decreases in the product [0003]. Henriksson teaches wherein the starter culture comprises Lacticaseibacillus rhamnosus strain deposited under accession number DSM22193 in a fermented dairy product where the medium is milk [0019], [0021], [0047-0049].
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 Zourari in view of Henriksson to incorporate the teachings of Henriksson by having the starter culture comprise Lacticaseibacillus rhamnosus strain DSM22193 because this strain enhances the survival rate of probiotic strains in food, as recognized by Henriksson [0001], [0003], [0006].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE GERLA whose telephone number is (571)270-0904. The examiner can normally be reached Mon.-Wed. and Fri. 7-12 pm; Th. 7-2pm.
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/S.R.G./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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