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 .
The amendment filed May 8, 2026, has been entered. Claims 1-7, 10 and 11 remain pending in the application.
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 1-7, 10 and 11 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 has been amended to claim “reacting with a milk coagulation enzyme…” and then “reacting with a microbe-derived lipase…” However, it is unclear what is to be “reacted” in each of these steps.
Claims 2-7, 10 and 11 are included in the rejection as the depend from or otherwise incorporate the limitations of rejected claim 1.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 6 claims the amount of protease used is 20 U or less per 1 g of milk protein. Claim 6 ultimately depends from claim 1, which has been amended to claim the amount of protease used is 3 U or less per 1 g of milk protein. Therefore, claim 6 does not further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 subjecting milk to a lactic acid fermentation (Example 4-adding the pelleted starter culture and allowing to ripen). Reddy et al. further teach reacting with a milk coagulation enzyme (i.e., rennet) to coagulate and precipitate casein molecules in the milk (Example 4-col. 20).
Reddy et al. further teach 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, where all of the claimed steps are taught by Reddy et al., 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.
Response to Arguments
Applicant's arguments filed May 8, 2026, have been fully considered but they are not persuasive.
Applicant argues that Reddy et al. teaches that flavored cheese is prepared by mixing cheese flavor powder obtained by treating milk with protease and lipase, but does not suggest that the enzyme-treated milk itself is obtained as “natural cheese.” (Remarks, p. 5).
This argument is not persuasive. Amended claim 1 does not require that the enzyme treated milk itself is obtained as “natural cheese.” As currently written, Reddy et al. continues to be considered to render obvious the claimed process as set forth in the rejection above, where Reddy et al. teaches all of the claimed steps in the production of a natural cheese.
Applicant further argues that the use of the claimed amounts of lipase and protease “unexpectedly imparts excellent shape retention to the cheese but setting an upper limit to the usage range of this enzyme.” (Remarks, p. 5).
This argument is not persuasive. In the Examples 3-6 shown in Table 2 in the instant specification, only the example with 0.9 U protease/g milk protein and 4.9 LU lipase/g milk protein is said to have retained its shape. Further, there is no requirement that the claimed natural cheese have any particular “shape retention.” From the instant specification at [0058], the amount of protease may be adjusted depending on whether one is “promoting short-chain fatty acid release,” or “improving shape retention.” Given the claimed “natural cheese” is not required to have any particular properties, these showing in the specification are not considered to be commensurate in scope with the claims.
Therefore, all claims continue to be rejected over Reddy et al. where the claimed enzymes are known to be utilized in the production of cheese.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tricia Mallari, can be reached at 571-272-4729. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Nikki H. Dees
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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