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 .
Election/Restrictions
Applicant’s election of 1, 4, 5, 7-9, 14, 15, and 20 in the reply filed on July 13, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 10-11, 16-19 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected composition and product, there being no allowable generic or linking claim.
Claim Status
The status of the claims upon entry of the present amendments stands as follows:
Pending claims:
1, 4, 5, 7-11, 14-20
Withdrawn claims:
10-11, 16-19
Previously canceled claims:
2-3, 6, 12-13
Newly canceled claims:
None
Amended claims:
None
New claims:
None
Claims currently under consideration:
1, 4, 5, 7-9, 14, 15, 20
Currently rejected claims:
1, 4, 5, 7-9, 14, 15, 20
Allowed claims:
None
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 7 is objected to because of the following informalities: “biovar. Diacetylactis” should be “biovar. diacetylactis”. Appropriate correction is required.
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 and 9 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 enablement requirement. The claim(s) contains 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.
It is apparent that Streptococcus thermophilus deposited with DSMZ under accession nos. DSM 28952, DSM 28953, DSM 32599, or DSM 32600 (claim 5) and Lactococcus lactis deposited with DSMZ under accession nos. DSM 32398, DSM 18882, DSM 32399, DSM 18893, DSM 32601, DSM 32602, DSM 32603, DSM 32604, DSM 32605, DSM 32829, DSM 32830, or DSM 32832 (claim 9) are required to practice the claimed invention. As such, the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If not obtainable or available, the requirements of 112(a) may be satisfied by a deposit made readily available to the public.
Presently, there is no process in the specification to describe how the claimed Streptococcus thermophilus or Lactococcus lactis are obtained. Additionally, the deposits of the materials are not publicly available. It is not clear that the invention will work with commonly available material and it is not apparent if the biological materials considered necessary to make and use the invention is both known and readily available to the public. It is known in the art that different subspecies of bacteria have different properties. Thus, it is not clear if the specific Streptococcus thermophilus strains and Lactococcus lactis strains of the claimed invention have the same properties of other Streptococcus thermophilus strains and Lactococcus lactis strains known in the art.
It is noted that Applicants have deposited biological material but the instant specification discloses that a sample of the deposited microorganism should be made available only to an expert approved by the Applicant (p. 17, l. 8-9). If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit, or declaration by Applicants, or by an attorney of record over their signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention would be irrevocably and without restriction released to the public upon issuance of a patent, would satisfy the deposit requirement made herein.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement affidavit, or declaration by Applicant or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and proving that:
(a) During the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) All restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) The deposit will be maintained in a public depository for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
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 1, 4, 5, 7-9, 14, 15, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Garrigues (EP2957180A1) in view of Hoshi (US 2015/0056683 A1).
Regarding claim 1, Garrigues discloses a method of producing a fermented product comprising the steps of fermenting milk (i.e., a milk base) with a starter culture comprising lactic acid bacteria where the fermentation is terminated one a desired pH has been reached ([0002]). Garrigues also teaches that sucrose is added to the milk (i.e., milk base) before fermentation ([0062]), where one of ordinary skill would recognize that “before fermentation” encompasses the claimed time of “at the start of fermentation”. Garrigues also discloses that the lactic acid bacteria can include Streptococcus thermophilus and Lactococcus lactis ([0023]) and that embodiments of the invention use lactose deficient lactic acid bacteria ([0040], (B)) and that fermentation is caried out where the lactic acid bacteria are able to metabolize sucrose ([0062]).
Garrigues does not disclose wherein the at least one lactose-deficient Lactococcus lactis strain capable of metabolizing sucrose comprises one or more selected from lactose-deficient Lactococcus lactis subsp. cremoris strains capable of metabolizing sucrose and Lactococcus lactis subsp. lactis strains capable of metabolizing sucrose.
However, in the same field of endeavor, Hoshi discloses of using lactic acid bacterium for food manufacturing including Lactococcus lactis subsp. cremoris and Lactococcus lactis subsp. lactis.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to substitute the broad Lactococcus lactis of Garrigues with the use of specific subspecies of Lactococcus lactis subsp. cremoris or Lactococcus lactis subsp. lactis as disclosed by Hoshi with a reasonable expectation of success to arrive at a fermented milk. The claim would have been obvious because one of ordinary skill in the art would have been able to make this simple substitution of one known Lactococcus lactis subspecies for another and yield predictable results to one of ordinary skill in the art, see MPEP §2143(B).
Regarding claim 4, Garrigues discloses that the sucrose driven fermentation is immediately terminated when the sucrose is depleted and that the pH after the termination is stable around 4.5 ([0099]), which falls within the claimed range of “3.2 to 4.8”. Thus, it logically follows that the sucrose was added in an amount such that the target pH was 4.5.
Regarding claim 5, Garrigues also discloses that the Streptococcus thermophilus strain can be the strain deposited under the accession no. DSM 28952 or DSM 28953 ([0054]).
Regarding claim 7, Garrigues also discloses that the lactic acid bacteria used can be Leuconostoc spp. or Bifidobacterium spp..
Regarding claim 8, Garrigues also discloses that the fermented milk products of the invention include cheese (e.g., fresh cheese; [0035]).
Regarding claim 9, although Garrigues is silent regarding Lactococcus lactis strains specifically recited in the claim, Garrigues discloses that the lactose-deficient lactic acid bacteria can include Lactococcus lactis ([0023]). The Lactococcus lactis strains disclosed in Garrigues has not been shown to be materially different from those of the claimed invention. Therefore, it would have been obvious to utilize any lactose-deficient L. lactis strain in the method of Garrigues absence evidence to support that the claimed strains result in a unexpected result.
Regarding claims 14 and 15, although Garrigues is silent regarding Streptococcus thermophilus strains specifically recited in the claims, Garrigues discloses that the lactic acid bacteria can include Streptococcus thermophilus ([0023]). The Streptococcus thermophilus of Garrigues has not been shown to be materially different from those of the claimed invention. Therefore, it would have been obvious to utilize any lactose-deficient Streptococcus thermophilus strain in the method of Garrigues absence evidence to support that the claimed strains result in a unexpected result.
Regarding claim 20, Garrigues discloses a method of producing a fermented product comprising the steps of fermenting milk (i.e., a milk base) with a starter culture comprising lactic acid bacteria where the fermentation is terminated one a desired pH has been reached ([0002]). Garrigues also teaches that sucrose is added to the milk (i.e., milk base) before fermentation ([0062]), where one of ordinary skill would recognize that “before fermentation” encompasses the claimed time of “at the start of fermentation”. Garrigues also discloses that the lactic acid bacteria can include Streptococcus thermophilus and Lactococcus lactis ([0023]) and that embodiments of the invention use lactose deficient lactic acid bacteria ([0040], (B)) and that fermentation is caried out where the lactic acid bacteria are able to metabolize sucrose ([0062]).
Garrigues does not disclose wherein the at least one lactose-deficient Lactococcus lactis strain capable of metabolizing sucrose comprises one or more selected from lactose-deficient Lactococcus lactis subsp. cremoris strains capable of metabolizing sucrose and Lactococcus lactis subsp. lactis strains capable of metabolizing sucrose.
However, in the same field of endeavor, Hoshi discloses of using lactic acid bacterium for food manufacturing including Lactococcus lactis subsp. cremoris and Lactococcus lactis subsp. lactis.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to substitute the broad Lactococcus lactis of Garrigues with the use of specific subspecies of Lactococcus lactis subsp. cremoris or Lactococcus lactis subsp. lactis as disclosed by Hoshi with a reasonable expectation of success to arrive at a fermented milk. The claim would have been obvious because one of ordinary skill in the art would have been able to make this simple substitution of one known Lactococcus lactis subspecies for another and yield predictable results to one of ordinary skill in the art, see MPEP §2143(B).
Although the cited prior art does not teach wherein the fermented milk product has one or both of increased gel firmness and increased shear stress, MPEP §2112.01 states where the claimed and prior art are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Because the fermented milk of the claimed invention is made by a substantially identical process, the properties of the claimed invention is obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda S Hawkins whose telephone number is (703)756-1530. The examiner can normally be reached M-Th 8:00a-4:00p, F 8:00a-1:00p ET.
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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.
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/A.S.H./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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