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 Claims
Claims 6-9, 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 currently pending.
Election/Restrictions
Applicant’s election without traverse of Group II, Claims 21-22, 24-25 and 30, and of species ascorbate oxidase as a multicopper oxidase enzyme oxygen scavenger, in the reply filed on 1/8/2026 is acknowledged.
Claims 1-5, 9-10, 12-16, 18-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and species, there being no allowable generic or linking claims.
Claims 21-22, 24-25 and 30 are being examined in this application, insofar as they read on the elected species of ascorbate oxidase.
Claim Objections
Claims 21-22, 24-25 and 30 are objected to because of the following informalities:
Claim 21, please add a space between the recitation of “(Currently amended)” and the recitation of “An electrochemical” on line 1. In addition, please remove the extra space after the recitation of “scavenger,” on line 2.
Claims 21-22, 24-25 and 30 are improperly numbered. The numbering of claims is not in accordance with 37 CFR 1.126, which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. In the instant case, claim 9 has been canceled and renumbered.
In the interest of compact prosecution, misnumbered claims 21-22, 24-25 and 30 have been renumbered as claims 22-23, 25-26 and 31, respectively.
The remainder of this office action will refer to the claims using their new numbers.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 22-23 and 25-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 22 is directed to an electrochemical biosensor comprising a multicopper enzyme oxygen scavenger, an electrochemical assay containing a reductase enzyme, and a substrate comprising ascorbate. As disclosed in the instant specification, said multicopper enzyme oxygen scavenger, reductase enzyme, and ascorbate are naturally occurring. There is no indication in the instant specification that the claimed multicopper enzyme oxygen scavenger, reductase enzyme, and ascorbate have any characteristics that are different from the naturally occurring multicopper enzyme oxygen scavenger, reductase enzyme, and ascorbate, respectively. Thus, multicopper enzyme oxygen scavenger, reductase enzyme, and ascorbate do not have markedly different characteristics from their natural counterparts in their natural state, and are “product of nature” exceptions. Accordingly, claim 22 is directed to an exception. In addition, claim 22 does not include any additional features that could add significantly more to the exception. Therefore, claim 22 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 23 recites the multicopper enzyme oxygen scavenger is ascorbate oxidase or bilirubin oxidase, claim 25 recites the reductase enzyme is nitrite reductase, and claim 26 recites the reductase enzyme is nitrate reductase. As disclosed in the instant specification, said ascorbate oxidase, bilirubin oxidase, nitrite reductase, and nitrate reductase are naturally occurring. There is no indication in the instant specification that the claimed ascorbate oxidase, bilirubin oxidase, nitrite reductase, and nitrate reductase have any characteristics that are different from the naturally occurring ascorbate oxidase, bilirubin oxidase, nitrite reductase, and nitrate reductase, respectively. Thus, ascorbate oxidase, bilirubin oxidase, nitrite reductase, and nitrate reductase do not have markedly different characteristics from their natural counterparts in their natural state, and are “product of nature” exceptions. Accordingly, claims 23 and 25-26 are directed to an exception. In addition, claims 23 and 25-26 do not include any additional features that could add significantly more to the exception. Therefore, claims 23 and 25-26 do not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
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 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 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.
Claims 22-23, 25-26 and 31 are rejected 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.).
The instant claims recite an electrochemical biosensor comprising a multicopper enzyme oxygen scavenger, an electrochemical assay containing a reductase enzyme, and a substrate comprising ascorbate.
Inal teaches an electrochemical metabolite sensor for detecting metabolites in biological samples obtained non-invasively (Title, p.3 line 12) comprising oxidases (p.5 line 1), nitrite reductase, nitrate reductase (p.15 line 32-33), and a screen-printed electrode (p.12 line 19). The sensor comprises electrodes for multiple detection of different metabolites with different enzymes combined with mediators and inkjet-printed on different substrates (p.5 line 12-15).
Inal does not teach said oxidases include ascorbate oxidase (claims 21-22) and a substrate includes ascorbate (claim 21).
However, Inal does teach an electrochemical sensor for detecting metabolites in biological samples obtained non-invasively comprises oxidases and electrodes for amperometric tests, wherein the sensor comprises electrodes for multiple detection of different metabolites with different enzymes combined with mediators and inkjet-printed on different substrates (p.5 line 12-15).
Sempionatto teaches an electrochemical sensor, a noninvasive sensing device (p.1806 col left – para 1), comprising a vitamin C bioelectronic sensor that relies on the immobilization of ascorbate oxidase (a multicopper enzyme that catalyzes the oxidation of ascorbate (ascorbic acid) to dehydroascorbate using oxygen as an electron acceptor to produce water) on screen-printed electrodes for amperometric determination of vitamin C in stimulated sweat (p.1805 col right – para 2; Figure 1).
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 ascorbate oxidase and ascorbate in an electrochemical sensor for detecting metabolites in biological samples obtained non-invasively, since Inal and Sempionatto both disclose an electrochemical sensor for detecting metabolites in biological samples obtained non-invasively, and Sempionatto discloses that the electrochemical sensor comprises ascorbate oxidase is useful for the rapid in vitro detection of vitamin C in untreated raw saliva and tears following pill or juice intake (Abstract). 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 and routine practice to incorporate ascorbate oxidase and ascorbate, with a reasonable expectation for successfully obtaining an electrochemical sensor for detecting metabolites in biological samples obtained non-invasively.
Conclusion
No claims are allowed.
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