DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Amendment filed on July 6, 2026, has been received and entered.
Claim Disposition
3. Claims 2-3 have been cancelled. Claims 1 and 4-15 are pending. Claims 1 and 4-11 are under examination. Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.12(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim. The claims are only being considered to the extent that they pertain to the elected subject matter.
Claim objection
4. Claims 1 and 4-11 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to recite, “…wherein stability [[refers to]] is retained enzymatic activity, and wherein the enzyme is a urease, [[the method]] comprising:…”.
For clarity and precision of claim language it is suggested that claim 4 is amended to depend from claim 4.
For clarity it is suggested that claim 11 is amended to read, “….25 days, and wherein [[where-in]] the enzyme…..”.
Appropriate correction is required.
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.
5. 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.
6. Claim(s) 1 and 4-11 is/are rejected under rejected under 35 U.S.C. 103 as being unpatentable over JP 2005 052044 A (of record in the application) in view of Alev et al. (2019, of record in the application) and Ureta et al. (Critical Reviews in Food Sci. & Nutrition, vol. 61, no. 16, pages 2659-2690).
The primary reference discloses a method to stabilize protocatechuic-acid dioxygenase and a manufacturing method of the stabilized lyophilized product. The stabilization of the enzyme is done by adding a stabilizer to the enzyme, the stabilizer is an aldohexose, a ketohexose, an hexose or an oligosaccharide. The amount of stabilizer is 30% (see claims 1-4, 10-17 of the reference). The claimed invention recites “about” thus the stabilizer weight is anticipated. The primary reference discloses that the type of buffer solution is not particularly limited, but those having a buffering ability in the stable pH range of the enzyme are preferred. For example, various phosphate buffers such as potassium phosphate (K-phosphate), sodium phosphate, tris salt, organic acid salts such as acetic acid, malic acid, and maleic acid, PIPES, TES, MOPS, HEPES, BisTris, Bicine, etc., can be used. The stable pH region, for example, in the case of protocatechuate dioxygenase derived from the genus Pseudomonas, the lower limit at the time of commercialization from the pH stable range of this enzyme is preferably 6.0, more preferably 6.5, and most preferably 7.0, which falls within the claimed range. The invention of claim 1 with no specific enzyme or oligosaccharide is recited as having degree of polymerization of 2-75, therefore the art enzyme and oligosaccharide would meet this limitation and it is construed as an inherent property, thus anticipated. The primary reference obtained good storage and high activity (see for example Table 2 and the entire document). The primary reference does not per se disclose urease, however, the need to stabilized urease is known in the art and has been achieved. One such reference is Alev et al. which discloses urease (urea amidohydrolase) and storage time and temperature and achieved a storage of at least 28 days with activity of above 80%. Thus, Alev et al. achieved storage of urease with very little loss of activity. Furthermore, the art generally reports that oligosaccharides assist with enzyme storage, thus would be obvious to use with urease (see Ureta et al. abstract and the entire document).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the claimed invention as a whole because the combined teaching of the references renders the claims as obvious. Motivation to combine the references exist because they are analogous art. Moreover, the Supreme Court pointed out in KSR, “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 127 S. Ct. at 1741. The Court thus reasoned that the analysis under 35 U.S.C. 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the “inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 1741. The Court further advised that “[a] person of ordinary skill is…a person of ordinary creativity, not an automation.” Id. at 1742. Therefore, the claimed invention was obvious to make and use at the time the invention was made and was prima facie obvious.
Response to Arguments
7. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that the art rejection of record has been altered to reflect changes made to claims. Applicant traverses the rejection of record wherein JP2005052044 was the primary reference by stating that the reference has no teaching of urease. The reference does teach enzyme storage stability and a polysaccharide and the secondary references provides the missing elements. The claimed invention is obvious as outlined above. Applicant is urged to contact the examiner to discuss the remaining issues to place the application in better form.
Conclusion
8. No claims are presently allowable.
9. Applicant’s amendment necessitated the new/modified 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
