DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt of the Responses and Amendments after Non-Final Office Action filed 05/11/2026 and 05/15/2026 is acknowledged.
Applicant has overcome the following rejections by virtue of the amendment or cancellation of the claims: (1) the 35 U.S.C. §112(b) rejections of claims 1-12 have been withdrawn; and (2) the 35 U.S.C. §103 rejections of claims 2 and 7-8 over Nishimura have been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1, 3-6, 9-14
Withdrawn claims: 13-14
Previously cancelled claims: None
Newly cancelled claims: 2, 7-8
Amended claims: 4
New claims: None
Claims currently under consideration: 1, 3-6, 9-12
Currently rejected claims: 1, 3-6, 9-12
Allowed claims: None
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.
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 and 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Sato (WO2018079758A1; English translation relied on for citations) in view of Hirano (EP 0642740A1).
Regarding claims 1 and 3-6, Sato teaches a milk composition and a fermented milk composition comprising sterilized raw milk (page 6, lines 50-55); and an enzyme-containing composition that may contain a mixture of the enzymes peroxidase and protease (page 1, lines 13-15, 46; page 4, lines 13-15) as recited in present claims 1 and 4. The milk and the fermented milk composition are considered to be present in a container (page 2, lines31-32). Sato teaches that the protease may have an activity of 0.01-100 PU/g (page 5, lines 32-33), which is considered to fall within the range recited in present claim 6.
Sato does not teach that the enzyme-containing composition has a ratio of protease activity to peroxidase activity measured in U/mL of less than 2.5 or from 0.01 to 2.5 as recited in present claim 1 and present claim 3, respectively. Sato also does not teach that the peroxidase has an activity of 1-100 U/mL as recited in present claim 5.
However, Hirano teaches a fermented milk composition wherein peroxidase is added to the milk to be fermented in order to improve smoothness and water retention with reduced hardness in the resulting fermented milk composition (column 4, lines 1-9). Hirano teaches that the peroxidase have an activity of at least 0.2 U/g, such as 1-2 U/g (column 3, lines 48-51), which is considered to fall within the range recited in present claim 5.
It would have been obvious for a person of ordinary skill in the art prior to the effective date of the present invention to have included peroxidase in Sato to provide an activity of at least 0.2 U/g, such as 1-2 U/g as taught by Hirano. Since Sato teaches that its enzyme-containing composition for its fermented milk composition may comprise a peroxidase in addition to a protease (page 4, lines 13-15), but does not teach features of peroxidase suitable for producing a fermented milk composition, a skilled practitioner would have been motivated to consult an additional reference such as Hirano in order to determine a suitable amount of peroxidase for such a purpose. In consulting Hirano, the practitioner would find that the addition of such a peroxidase improves the smoothness and water retention with reduced hardness in the fermented milk composition, thereby providing motivation to use such a peroxidase in the fermented milk composition of Sato. A protease activity of 0.01-100 PU/g as disclosed in Sato and a peroxidase activity of 1-2 U/g as disclosed in Hirano provides ratios of protease activity to peroxidase activity which at least overlap the claimed ratios of less than 2.5 and from 0.01 to 2.5 as recited in present claim 1 and present claim 3 (e.g., a protease activity of 1 PU/g and a peroxidase activity of 1 U/g provides a ratio of protease activity to peroxidase activity of 1 which falls within the ranges recited in present claims 1 and 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.I.
Claims 1 and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Shows (US 2021/0198618; previously cited) in view of UniProt (Accession No. A0A6H0CXF6, Database UniProt [online], 2020; IDS citation) as evidenced by ABSS (comparison between amino acid sequence of SEQ ID NO:1 and amino acid sequence of A0A6H0CXF6; previously cited).
Regarding claims 1, 9, 10, 11, and 12, Shows teaches a milk or fermented milk composition filled in a container (corresponding to fermented dairy product as the fermentation product and the fermentation vessel as the container), wherein the milk or fermented milk composition comprises an enzyme-containing composition [0002], [0014], [0219], [0272], wherein the enzyme in the enzyme-containing composition may be catalase-peroxidase from the actinomycete Streptomyces [0206]-[0207] as recited in present claims 1, 9, 10, and 11.
The milk or fermented milk composition of Shows comprises milk, but Shows does not disclose that the milk in the milk or fermented milk composition is sterilized. However, sterilization is known in the art to be a common step in the production of fermented milk products as sterilization kills bacteria and deactivates other components (e.g., enzymes) which may interfere with fermentation. Therefore, it would have been obvious for the milk in the milk or fermented milk composition of shows to be sterilized milk.
Shows does not teach that the enzyme-containing composition has a ratio of a protease activity to a peroxidase activity of 2.5 or less as recited in present claim 1; or that the catalase-peroxidase is one of (a) and (b) as recited in present claim 12.
However, UniProt teaches a catalase-peroxidase from the actinomycete Streptomyces (page 1, line beginning “OS” to 2nd line beginning “OC”). This catalase-peroxidase has an amino acid sequence that is 98.5% similar to SEQ ID NO:1 and has several deleted and substituted amino acids when compared to SEQ ID NO:1. Therefore, the catalase-peroxidase of UniProt is (b) as recited in present claim 12.
It would have been obvious for a person of ordinary skill in the art to have modified the catalase-peroxidase in the composition of Shows to be the catalase-peroxidase taught by UniProt. Since Shows discloses that the enzyme in the composition may be catalase-peroxidase from the actinomycete Streptomyces [0206]-[0207], but does not disclose such an enzyme, a skilled practitioner would have been motivated to consult an additional reference such as UniProt in order to find a suitable enzyme, thereby rendering present claim 12 obvious. “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol. "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.).” MPEP 2144.07.
In regard to the composition having a ratio of a protease activity to a peroxidase activity of 2.5 or less as recited in present claim 1, the combination of prior art teaches an enzyme-containing composition comprising the enzyme as recited in dependent claims 9, 10, 11, and 12. Since the prior art teaches a composition comprising the same enzyme as claimed and instantly disclosed, the composition of the prior art would necessarily have the claimed ratio of protease activity to peroxidase activity. Regarding product claims, when the ingredient recited in the reference is substantially identical to that of the claims, claimed properties are presumed to be present in the product of the prior art. “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s function, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F .3d 1342, 1347, 51 USPQ2d 1943. 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function, or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). MPEP §2112.I. Therefore, the claimed ratio recited in present claim 1 is rendered obvious.
Response to Arguments
Claim Rejections – 35 U.S.C. §112(b) of claims 1-12: Applicant canceled claims 2 and 7-8, thereby mooting their rejections. Applicant amended the remaining claims to fully address the rejections. Therefore, the rejections of the remaining claims are withdrawn.
Claim Rejections – 35 U.S.C. §103 of claims 1-5 and 7-8 over Nishimura; claims 1 and 5-6 over Debnath: Applicant’s arguments with respect to claim(s) 1-8 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections – 35 U.S.C. §103 of claims 1 and 9-12 over Shows and UniProt as evidenced by ABSS: Applicant's arguments filed 05/15/2026 have been fully considered but they are not persuasive.
Applicant amended claim 1 to be directed toward a milk or fermented milk composition comprising an enzyme-containing composition. Applicant argued that Shows is directed to processes for enhancing yeast growth/productivity using peroxidase and that Shows does not mention milk in any capacity (Applicant’s Remarks, page 6, 2nd paragraph).
However, Shows teaches that the fermentation product (i.e., the product produced by yeast fermentation with peroxidase) may be a fermented dairy product. Therefore, Shows discloses a milk or fermented milk composition comprising an enzyme-containing composition.
Applicant then argued that the sterilized milk in the present invention has no activity from endogenous lactoperoxidase and thus prevents generation of undesirable hydrogen peroxide. Applicant argued that the claimed ratio of protease activity to peroxidase activity does not cause curdling in the milk or fermented milk product, thereby representing an unexpected result indicative of non-obviousness (Applicant’s Remarks, page 6, 3rd paragraph – page 7, 1st paragraph).
However, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., sterilized milk having no endogenous lactoperoxidase activity) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claims merely require sterilized raw milk and the enzyme composition.
Also, as described above in the current rejections of amended claim 1, the prior art either directly discloses that the milk in the milk or fermented milk composition is sterilized (i.e., Sato, page 6, lines 50-55); or the prior art renders the incorporation of sterile milk obvious due to sterilization of milk being a common step in the formation of fermented milk products. Therefore, the prior art and knowledge in the field of the art renders the claimed sterilized milk, and consequently any asserted benefits of sterilized milk, obvious.
In regard to the claimed ratio of protease activity to peroxidase activity not causing curdling in the milk or fermented milk product, it is known in the art that curdling of milk and fermented milk products (beyond of what is normally expected in the milk or fermented milk products such as yogurt) is not a feature desired by consumers. Therefore, a skilled practitioner consulting the cited prior art references would be motivated not to induce additional curdling in the milk or fermented milk products, and thus the practitioner would be motivated to select amounts of enzymes which would not induce additional curdling in the milk or fermented milk products. Such usage of enzymes is within the ambit of the skilled practitioner as evidenced by at least Hirano which discloses that the peroxidase is used to increase smoothness of the milk or fermented milk product (column 4, lines 1-2). Furthermore, the effect of enzymes on the curdling of milk is known in the art (e.g., enzymes in rennet are used to curdle milk into making cheese). For at least these reasons, finding the optimal amount of enzymes to produce the desired product without curdling is not considered to be an unexpected result.
Since the prior art has been shown to render the claims obvious and Applicant’s arguments have been shown to be unpersuasive, the rejections of claims 1 and 9-12 are maintained as written herein.
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.
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/K.P.K./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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