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 .
Applicant’s amendment of claims 1, 2, 6 and the addition of new claims 10, in the paper of 2/20/2026, is acknowledged. Applicants' arguments filed on 2/20/2026, have been fully considered and are deemed to be persuasive to overcome some of the rejections previously applied. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. Claims 1-10 are at issue and present for examination.
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 rejection of claim(s) 1-5, 7-9 under 35 U.S.C. 103 as being unpatentable over Wang et al., US 2020/027598) and Combes et al., Annals of the New York Academy of Sciences, Vol 613, No. 1, pp 559-563, Dec 1990 is withdrawn based upon applicants amendment of the claims that recites “wherein the protein deamidase is an enzyme that exhibits an action of decomposing an amide group-containing side chain of a protein without crosslinking the protein”.
Claim(s) 1-6, 7-9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al., US 2020/027598), Yamaguchi et al. (Eur. J. Biochem. Vol 268, pp 1410-1421, 2001) and Combes et al., Annals of the New York Academy of Sciences, Vol 613, No. 1, pp 559-563, Dec 1990 .
Wang et al., US 2020/027598 further teach a liquid enzyme preparation of transglutaminase and a preparation method thereof, wherein the liquid enzyme preparation is a liquid preparation of transglutaminase EC2.3.2.13, and its components and amounts thereof are as follows: the liquid preparation of transglutaminase has an enzyme activity of 10-1000 u/ml, a water activity regulator is present in an amount of 30-80 w/v %, a redox potential regulator is present in an amount of 0.0075-1 w/v %, a food preservative is present in an amount of 0-0.1 w/v % (a sulfite), and a pH regulator is added to a final volume of 100%. The preparation method thereof comprises purification of an enzyme solution, mixing, sterilization, filling, and obtaining of a final product (see abstract and supporting text). Wang et al. teach the effects of different water activity regulators on the enzyme activity of transglutaminase (Table 5-1 and supporting text) and they teach that sorbitol, malitol, glycerol or any combination thereof was preferred for stabilizing the enzyme activity of transglutaminase.
Yamaguchi et al. teach a protein deamidating enzyme from Chryseobacterium proteolyticum. Yamaguchi et al. teach the isolation and cloning of said protein deamidating enzyme from Chryseobacterium proteolyticum and teach that the enzyme had activity against several proteins including insoluble wheat gluten. Yamaguchi et al. further teach the above enzyme characterization in view of the enzymatic modification of proteins to improve protein functionality for the use of proteins in food ingredients. Yamaguchi et al. teach that the enzyme showed a broad pH optimum between pH 5 and pH 7 (Fig 5A).
Combes et al. teach the stabilizing effect of a number of polyhydric alcohols and they teach that increasing concentrations of sorbitol (36% w/v to 72% w/v) had increased effect on enzyme (lysozyme) stability, and sorbitol was better than numerous other polyhydric alcohols such as xylitol, erythritol, glycerol and ethylene glycol (see Figure 1 and supporting text).
One of skill in the art before the effective filing date would have been motivated to create a liquid enzyme preparation comprising the protein deamidating enzyme from Chryseobacterium proteolyticum as taught by Yamaguchi et al. and 30% (w/v) or more sorbitol as taught by Combes et al. and having a pH of 5.5 or more and a sulfite to maintain/preserve enzyme activity as taught by Wang et al. (enzyme activity of 10-1000 u/ml) of protein deamidating enzyme (claims 1-6) and methods of its use and preparation for enzyme stabilization and prevention of inhibition (claims 7-9) as taught by Wang et al. for its commercial value for improving the color, flavor and taste of products. The motivation for such liquid enzyme preparations and methods of use in enzyme stabilization and inhibition of precipitation are based upon the teachings of Yamaguchi et al., Wang et al. and Combes et al. as above that teach that 30% (w/v) or greater is beneficial in the stabilization of enzymes. One of skill in the art before the effective filing date would have been further motivated to vary the various components of the liquid enzyme preparation such as the sulfite component of 0.1 w/v% to 0.2 w/v% as taught by Wang et al as a means of analyzing and achieving the best stabilized liquid enzyme preparations. The expectation of success is high based upon the high level of skill in the art of protein isolation and stabilization as illustrated by Yamaguchi et al., Wang et al. and Combes et al. who teach all that is required to practice the obvious methods and make the obvious preparations.
Thus, claim(s) 1-6, 7-9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al., US 2020/027598), Yamaguchi et al. (Eur. J. Biochem. Vol 268, pp 1410-1421, 2001) and Combes et al., Annals of the New York Academy of Sciences, Vol 613, No. 1, pp 559-563, Dec 1990 .
Remarks
No claim is allowed.
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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rgh
4/27/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652
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