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 .
Applicant’s amendment and response filed on 6/22/2026 have been received and entered into the case. Claims 6-8, 11, 17, 23, 26-29, and 32-42 have been canceled. Claims 1-5, 9-10, 12-16, 18-22, 24-25, and 30 are pending, Claims 1-5, 9-10, 12-16, 18-20 have been withdrawn, and Claims 21-22, 24-25 and 30 have been considered on the merits, insofar as they read on the elected species of ascorbate oxidase. All arguments have been fully considered.
Withdrawn Objections
Objections are withdrawn in view of applicant’s amendments.
Withdrawn Rejections
Rejections under 35 U.S.C. 101 are withdrawn in view of applicant’s amendments.
Rejections of Claims 22-23, 25-26 and 31 under 35 U.S.C. 103 as being unpatentable over Inal et al (WO 2019/224628 A1; 11/28/2019. Cited on IDS) in view of Sempionatto et al (ACS Sens. 2020;5:1804-1813.) are withdrawn in view of applicant’s amendments.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 21-22, 24 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Monteiro TC (Development of point-of-care tests using enzyme (NiR & PON) based electrochemical biosensors. 2020;1-190. Cited on IDS).
The instant claims recite an electrochemical biosensor comprising: a multicopper oxidase (MCO) enzyme oxygen scavenger, an electrochemical assay containing a reductase enzyme, and a substrate comprising ascorbate, wherein the ascorbate is immobilized in a dried state and is not exposed to oxygen or light, and wherein the ascorbate is immobilized around but not directly on a working electrode containing the reductase enzyme.
Monteiro teaches an electrochemical biosensor comprising: a multicopper oxidase (MCO) enzyme oxygen scavenger, an electrochemical assay containing a reductase enzyme, and a substrate comprising ascorbate, wherein the ascorbate is immobilized around but not directly on a working electrode containing the reductase enzyme, the multicopper oxidase (MCO) enzyme oxygen scavenger is ascorbate oxidase or bilirubin oxidase, the reductase enzyme is nitrite reductase, and the electrochemical biosensor further comprises a screen-printed electrode (Figure 3.7, p.67 para 2).
The limitation of “wherein the ascorbate is immobilized in a dried state and is not exposed to oxygen or light” is regarded as a product by process type limitation. The patentability of a product does not depend on its method of production. If the claimed product is the same or obvious from a product in the prior art (i.e. the product disclosed in the cited reference), the claim is unpatentable even though the reference product was made by a different process. When the prior art discloses a product which reasonably appears to be identical with or slightly different than the claimed product-by-process, rejections under 35 U.S.C 102 and/or 35 U.S.C 103 are proper. (MPEP 2113) In addition, Monteiro teaches a dried state where no sample pre-supplementation step would be required (p.80 para 2).
Therefore the reference anticipates the claimed subject matter.
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 of this title, 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.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Monteiro TC (Development of point-of-care tests using enzyme (NiR & PON) based electrochemical biosensors. 2020;1-190. Cited on IDS) as applied to claims 21-22, 24 and 30 above.
Monteiro does not teach the reductase enzyme is nitrate reductase (claim 25).
However, Monteiro does teach nitrate reductase is being used in the field of biosensing for determination of nitrate (p.57 para 3).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate nitrate reductase depends on the desired application, since Monteiro discloses that nitrate reductase is being used in the field of biosensing for determination of nitrate. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to incorporate nitrate reductase with a reasonable expectation for successfully obtaining an electrochemical biosensor.
Response to Arguments
Applicant argues that cited references do not teach selecting a multicopper oxidase (MCO) enzyme oxygen scavenger for the purpose of depleting dissolved oxygen in a reductase based electrochemical assay as amended in claim 21. However, these arguments are moot since those rejections are withdrawn in view of applicant’s amendments.
Conclusion
No claims are allowed.
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 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 mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759
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