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 Group I, claims 1-7, 10 and 11, in the reply filed on September 18, 2025, 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)).
With applicant’s response, claims 8 and 9 were canceled.
Claim Rejections - 35 USC § 103
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.
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, 3-7, 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Reddy et al. (US 6,406,724; cited on IDS filed August 3, 2023) as evidenced by Promod 215 (2024. https://www.biocatalysts.com/enzyme-products/promod-215mdp; downloaded 02/04/2026).
Regarding claims 1 and 7, Reddy et al. teach a method of producing natural cheese, comprising a step of having a lipase and a protease act on milk (col. 15 lines 30-43).
Reddy et al. teach that the lipase may be a microbe derived lipase (col. 15 lines 44-56).
Reddy et al. teach that the protease may be a fungal protease. Reddy specifically teach Promod 215 as a protease for use in their invention. The data sheet for Promod 215 shows that it is isolated from Aspergillus. Aspergillus is a filamentous fungus per the instant specification at [0054-0055].
Therefore, it would have been obvious to have combined milk with a microbe-derived lipase and a filamentous fungus-derived protease in the production of a natural cheese as the claimed lipase and protease were taught in the prior art to be utilized in the production of cheeses.
Regarding claims 3-6 to the amounts of lipase and protease to be utilized in the process, Reddy et al. teach lipase is generally used at a level of about 0.05 to 0.4 % (col. 15 lines 57-59), and the protease is generally used at a level of about 0.01 to about 1% (col. 15 line 66-col. 16 line 2).
Reddy et al. does not report the amount of lipase by LU per g of milk fat, or protease by U per gram of milk protein, or a ratio between the two enzymes. However, Reddy et al. states the enzymes are added to provide the desired flavor profile (col. 16 lines 31-32). Therefore, one of ordinary skill would have recognized that the amount of enzyme to be included in the preparation could be adjusted based on the desired amount of lipolysis and proteolysis to occur, and the conditions (e.g., time and temperature) under which the reaction was occurring. Thus, arriving at the enzyme amount as claimed would have required no more than routine experimentation and would have been expected to provide the desired flavor profile to the resultant cheese composition.
Regarding claims 10 and 11, Reddy et al. teach using their combination of enzymes to provide a cheese to be used in processed cheese products (col. 10 lines 61-65).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Reddy et al. (US 6,406,724; cited on IDS filed August 3, 2023) as evidenced by Promod 215 as applied to claim 1 above, and further in view of Ishigaki et al. (US 2019/0345465).
Reddy et al. teach a method as detailed above with regard to claim 1.
Reddy et al. teach that the microbial lipase may be sourced form Candida cylindracea (col. 15 lines 53-56). Reddy et al. are silent as to the lipase comprising a polypeptide as recited in claim 2.
Ishigaki et al. teach a modified lipase from Candida cylindracea for utilization in cheeses [0033; 0093-0094]. Specific lipases according to the invention of Ishigaki et al. included variant 3 G429M [0068]. G429M is the same lipase as in the instant invention at Table 1. Therefore, the lipase of Ishigaki et al. is considered to comprise a polypeptide sequence according to claim 2.
One of ordinary skill before the instant invention would have found it obvious to have utilized the lipase of Ishigaki et al. in the cheese making process of Reddy et al., as both Reddy et al. and Ishigaki et al. teach the use of microbial-derived lipases are known to be utilized in cheese production. Further, Ishigaki et al. teaches that their modified lipases improve cheese flavor [0093]. Therefore, one of ordinary skill would have had a reasonable expectation that the inclusion of the lipase of Ishigaki et al. in the cheese making process of Reddy et al. would improve the flavor of the resultant cheese product. Additionally, this would have required no more than routine experimentation, as microbial lipases were known to be utilized in cheese production well before the instant invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIKKI H. DEES whose telephone number is (571)270-3435. The examiner can normally be reached 10:00 am-5:00 pm ET.
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Nikki H. Dees
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791