DETAILED ACTION
Status of the claims
1. Claims 1-6, 8-15 and 21 are pending.
Status of the Rejections
2. Rejection of claims under Karumanchi et al. and Bhansali et al. are withdrawn in view of applicant’s amendments. New grounds of rejection as follow:
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.
Claim(s) 1-3, 5 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhenzhong et al. (Electroanalysis, 2013, 1765-1772).
Claims 1-3 and 21. Zhenzhong et al. teach a sensor for detection of an analyte in a sample (electrochemical biosensor for detection of estradiol 17E in effluents; see abstract), wherein the sensor comprises:
electrochemical cell (three electrode cell; see section 2.5) comprises:
a working electrode (gold working electrode) comprising:
a recognition layer disposed on a surface of the working electrode, wherein the recognition layer comprises a nuclear receptor immobilized on the surface of the working electrode and capable of binding to the analyte (tagged ER-α immobilized on working electrode using EDC/NHS; see section 2.3.2);
a reference electrode; and
a counter electrode (see section 2.5);
wherein binding of the analyte to the recognition layer comprises:
binding of the analyte to the nuclear receptor, thereby inducing a conformation change in the nuclear receptor (binding of estradiol 17E with tagged ER-α causes conformation change in ER-α; see section 3.3.1);
and
a measurement circuit operably coupled to the electrochemical cell wherein the measurement circuit is configured to:
i) apply a potential to the working electrode (see Fig. 1 and section 3.3.2); and
ii) detect a change in an electrical property at the working electrode caused by the binding of the analyte to the nuclear receptor, wherein said binding is correlative to a concentration of the analyte in the sample (detecting change in current causing binding between the estradiol 17E and ER-α and binding is correlative to concentration of estradiol 17E; see Fig. 1 and section 3.3.2).
Zhenzhong et al. do not teach a substrate and the electrochemical cell disposed on the substrate. However, it would be obvious to one of ordinary skill in the art to dispose the electrodes of Zhenzhong et al. onto a substrate to form a more compact electrochemical cell assembly.
Claim 5. Zhenzhong et al. teach the measurement circuit is configured to detect the change in the electrical property via electrochemical impedance spectroscopy (EIS), capacitance spectroscopy, field-effect transduction, cyclic voltammetry (CV), differential pulse voltammetry (DPV), square wave voltammetry (SWV), or amperometry (square wave voltammetry is used to detection; see section 3.2.1).
Claim(s) 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhenzhong et al. as applied to claim 1 above, and further in view of Zhao et al. (Molecules, 2023, 28, 6619).
Claim 8 and 9. Zhenzhong et al. teach analyte is estradiol 17E but not teach the analyte comprises cortisol; the nuclear receptor comprises a glucocorticoid receptor (GR); wherein the GR is immobilized to the recognition layer.
However, Zhao et al. teach electrochemical immunosensor for detection of cortisone with the use of glucocorticoid receptor wherein the GR is adsorbed to the recognition layer to bind and detect cortisone (see section 2.1 and Scheme 1).
Since, Zhao et al. and Zhenzhong et al. are to same field of endeavor i.e. electrochemical detecting analyte with receptor, therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Zhao et al. teaching that Zhenzhong et al. sensor could be functionalize with glucocorticoid receptor for detection of cortisol.
Claims 10 and 11. modified Zhenzhong et al. teach the recognition layer comprises a self-assembled monolayer (SAM), wherein the SAM is functionalized for the covalent bonding of the GR to the SAM (alkanethiol SAM i.e SAM is functionalized with carboxylic group to bind with receptor. GR; see section 2.3.2).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhenzhong et al. and Zhao et al. as applied to claim 11 above, and further in view of Tamir (US 2017/0067889).
Claims 12-13. Zhenzhong et al. do not teach SAM comprises mercaptoundecanol (MUDOL) and 11-mercaptoundecanoic acid (MUDA).
However, Karumanchi et al. teach SAM is comprised of mixed SAM comprising 10% to 50% first linker component and 10% to 50% of second linker component [0016] and Tamir et al. teach SAM formed on electrode surface for binding of capture molecule could include mercaptoundecanol and 11-mercaptoundecanoic acid [0047][0034].
Therefore, selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.07) and thus one could have form SAM of Karamanchi et al. of mercaptoundecanol and 11-mercaptoundecanoic acid to yield similar results with reasonable expectation.
Claim(s) 6 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhenzhong et al. as applied to claim 1 above, and further in view of Karumanchi et al. (US 2022/0373510).
Claims 6 and 15. Zhenzhong et al. do not teach a plurality of working electrodes, wherein each of the plurality of working electrodes is functionalized with a different nuclear receptor and wherein each different nuclear receptor binds to a different analyte wherein each receptor is different from each other; and wherein each receptor binds to a different analyte than the analyte of the other receptors. Zhenzhong et al. also do not teach a wireless communication module configured to transmit data corresponding to the analyte concentration to a remote computing device.
However, Karumanchi et al. teach an electrochemical test strip for detection of analyte comprised of first and second working electrodes which are each functionalized with different capture molecules to detect different analytes; [0008] and also teaches wireless system interface with the electrochemical test strip to transmit data to smartphone in order to provide results quickly, saving cost and time [0104].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Karumanchi et al. teaching to add additional working electrodes to Zhenzhong et al. sensor because it would allow to detect additional endocrine disrupting chemicals in hospital effluents and moreover connect the biosensor with wireless system to transmit data to smartphone quickly in order to perform tests at high frequency.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhenzhong et al. as applied to claim 1 above, and further in view of Naeem et al. (IEEE Sensors Journal, 2024, 5746).
Claim 14. Zhenzhong et al. do not teach the sensor is integrated into a wearable device selected from a transdermal patch, a wristband, a tooth-mounted sensor, or a smart textile.
However, Naeem et al. teach electrochemical sensing offers advantage of real-time measurement and potential for miniaturization to allow POC and wearable applications for continuous monitoring and avoid bulky external potentiostats to carry out electrochemical readout (see page 5754, section C).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Naeem et al. teaching to miniaturize the biosensor of Zhenzhong et al. for wearable application for continuous monitoring of analytes.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-7 and 15 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.
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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/GURPREET KAUR/
Primary Examiner
Art Unit 1759
Prosecution Insights