DETAILED ACTION
Note that the examiner of record in your application has changed. The examiner’s contact information is set forth at the end of the office action.
Claims 1-20 are pending.
Status of Claims
Claims 1-20 are pending. Claims 6-9 have been withdrawn. Claims 1, 5, 10-12 and 15 have been amended. Claims 16-20 are newly added.
Claims 1-5 and 10-20 are under examination.
Withdrawn Claim Objections and/or Rejections
The rejection of claim 15 under 35 USC 101 as set forth on pp. 2 of the previous office action (mailed on 04/01/2026) has been withdrawn in view of the amended claims.
The rejection of claim 11 under 35 USC 112(b) for being indefinite as set forth on pp. 6-9 of the previous office action (mailed on 04/01/2026) has been withdrawn in view of the amended claims.
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 (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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
1.Claims 1-5, 10-11, and 16-20 are rejected under 35 U.S.C. 102(a)(1)as being anticipated by Gerhardt et al., (EP 3653121A1) (effectively filed on 11/14/2018).
Instant claim 1 recites “a calibrator adapted for calibrating a sensor device adapted for detecting analyte molecules in a fluid sample of a subject, the calibrator comprising: a calibration matrix having a capture surface with calibration receptors being immobilized thereon adapted for reversibly binding a known amount of the analyte molecules in a fluid sample of the subject, wherein the bound analyte molecules represent calibration molecules usable for calibrating the sensor device; and a regeneration assembly configured to regenerate the capture surface by releasing the calibration molecules from the capture surface into an aqueous solution to form a calibration fluid for calibrating the sensor device”.
Instant claim 11 recites “a calibrator adapted for calibrating a sensor device adapted for detecting analyte molecules in a fluid sample of a subject, the calibrator comprising: a calibration matrix having a capture surface with calibration receptors being immobilized thereon adapted for reversibly binding a known amount of the analyte molecules in a fluid sample of the subject, wherein the bound analyte molecules represent calibration molecules usable for calibrating the sensor device; a regeneration assembly configured to regenerate the capture surface by releasing the calibration molecules from the capture surface into an aqueous solution to form a calibration fluid for calibrating the sensor device: a capillary pump configured to remove a fluid from the capture surface”.
Gerhardt teaches a calibrator adapted for calibrating a sensor device adapted for detecting analyte molecules in a fluid sample that is an aqueous solution of a subject (see whole document, see claim 1 of ‘121, see abstract, see figure 1) (instant claim 2), the calibrator comprising:
a calibration matrix having a capture surface with calibration receptors being immobilized thereon adapted for reversibly binding a known amount of the analyte molecules in a fluid sample of the subject (see claim 1 of ‘121, see [0009] – [0010]), wherein the bound analyte molecules represent calibration molecules usable for calibrating the sensor device (see [0013], see [0036]); and
a regeneration assembly configured to regenerate the capture surface by releasing the calibration molecules from the capture surface into an aqueous solution to form a calibration fluid for calibrating the sensor device (see [0015]), (instant claims 1 and 11).
Gerhardt teaches a capillary pump configured to remove liquid from the capture surface (see [0007] teaching the use of an absorbent pad, which is known in the art to remove liquid from capture surfaces) (instant claim 11). Gerhardt teaches supplying different voltage (electrolytic cleaning) to the sensor device to release the analytes from the substance to regenerate the surface for subsequent use (see figure 2, see abstract, see [0016], see [0022] – [0027]) (instant claims 3-4). Gerhardt teaches wherein the electrolysis assembly comprises: at least three spatially separated electrically conductive areas on the capture surface (see claims 1 and 4 of ‘121, see figure 6 where 134, 138, and 140 are spatially conductive areas); and
a power supply configured to implement: a first setting in which a voltage sufficient to electrolyse the aqueous solution received on the capture surface is supplied across a first pairwise combination of said at least three conductive areas (see [0069], see [0099]); and
a second setting in which a voltage sufficient to electrolyse the aqueous solution received on the capture surface is supplied across a second pairwise combination of said at least three conductive areas (see [0099], see [0106], see claim 3 of ‘121), the second pairwise combination being different from said first pairwise combination (see claim 3 of ‘121) (instant claim 5).
Gerhardt teaches wherein the calibration fluids with different concentrations are formed by at least one of: activating the regeneration assembly at different time intervals to release the calibration molecules from the capture surface, thereby resulting in different concentrations (see [0028], see [0045], see [0090]) (instant claim 10). Gerhardt teaches wherein the at least three spatially separated electrically conductive areas are arranged relative to each other in an interdigitated configuration (see figures 3-5) (instant claim 16). Gerhardt teaches wherein the at least three spatially separated electrically conductive areas comprise an array of conductive areas in which the spacing between adjacent conductive areas alternates between a larger separation and a smaller separation, wherein the power supply is configured to supply a voltage sufficient to electrolyse the aqueous solution across adjacent conductive areas spaced by the larger separation, the adjacent conductive areas spaced by the smaller separation being of the same polarity as each other (see figure 6 where 134, 138, and 140 are spatially conductive areas, see [0021] “The plurality of spatially separated electrically conductive areas may comprise an array of conductive areas in which the spacing between adjacent conductive areas alternates between a larger and a smaller separation, wherein the power supply may be configured to supply the voltage across adjacent conductive areas spaced by the larger separation, the adjacent conductive areas spaced by the smaller separation being of the same polarity as each other.”) (instant claim 17). Gerhardt teaches wherein the at least three spatially separated electrically conductive areas comprise a grid of electrically conductive strips, the power supply being configured to implement a first mode in which a voltage sufficient to electrolyse the aqueous solution is supplied across parallel strips extending in a first direction, and a second mode in which a voltage sufficient to electrolyse the aqueous solution is supplied across parallel strips extending in a second direction, the second direction being different from the first direction (see figure 6 where 134, 138, and 140 are spatially conductive areas, see [0022] “The plurality of spatially separated electrically conductive areas may comprise a grid of electrically conductive strips, the power supply being configured to implement: a first mode in which the voltage (profile) is supplied across parallel strips extending in a first direction; and a second mode in which the voltage is supplied across parallel strips extending in a second direction, the second direction being different from the first direction.”) (instant claim 18).
Gerhardt teaches herein the power supply is configured to switch a polarity of the voltage across the at least three spatially separated electrically conductive areas, or to superimpose an AC voltage on a DC voltage to switch the polarity of the voltage (see [0023] “ the power supply may be configured to switch the polarity of the voltage across the respective electrically conductive areas or superimpose a larger AC voltage to a DC voltage to switch the polarity of the electrodes and direction of the electric field.”) (instant claim 19). Gerhardt teaches wherein the power supply is configured to apply the voltage as a gradually increasing voltage, or to apply the voltage in pulses or bursts (see [0090] “to reduce the risk of local build-up of an undesirably high analyte 128 concentration during regeneration of the surface 124, a gradual change in pH may be effected by gradually increasing the voltage. In alternative examples, the voltage may be applied in relatively short pulses or burst”) (instant claim 20).
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 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.
2.Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Gerhardt as applied to claims 1-5, 10-11, and 16-20 above, in view of Heikenfeld et al., (US20190142311A) (effectively filed on 09/22/2015).
The teachings of Gerhardt as it pertains to the claims 1-5, 10-11, and 16-20 are discussed in the 35 USC 102 rejection above.
Instant claim 14 recites “a method for calibrating a sensor for detecting an analyte in a fluid sample of a subject, the method comprising: a) receiving, with a calibrator, a fluid sample of the subject; wherein the calibrator comprises a calibration matrix having a capture surface with calibration receptors being immobilized thereon; b) reversibly binding, with the calibration receptors, a known amount of analyte molecules in the fluid sample of the subject, wherein the bound analyte molecules represent calibration molecules usable for calibrating the sensor; and c) regenerating the capture surface, with a regeneration assembly, by releasing the calibration molecules from the capture surface into an aqueous solution to form a calibration fluid; and d) transporting the released calibration molecules to the sensor device for calibrating the sensor device”.
Gerhardt teaches a method for calibrating a sensor for detecting an analyte in a fluid sample of a subject (see whole document, see claim 1 of ‘121, see abstract, see figure 1), the method comprising: a) receiving, with a calibrator, a fluid sample of the subject; wherein the calibrator comprises a calibration matrix having a capture surface with calibration receptors being immobilized thereon (see claim 1 of ‘121, see [0009] – [0010]);
b) reversibly binding, with the calibration receptors, a known amount of analyte molecules in the fluid sample of the subject, wherein the bound analyte molecules represent calibration molecules usable for calibrating the sensor (see claim 1 of ‘121, see [0009] – [0010]); and
c) regenerating the capture surface, with a regeneration assembly, by releasing the calibration molecules from the capture surface into an aqueous solution to form a calibration fluid (see [0015]) (instant claim 14).
Gerhard teaches a body fluid monitoring apparatus for detecting an analyte in a fluid sample of a subject (see abstract, see [0031]), the body fluid monitoring apparatus comprising: the calibrator according to claim 1; a sensor having a capture surface with sensor molecules being immobilized thereon for detecting the analyte in the fluid sample (see abstract, see [0012]) (instant claim 12).
Gerhardt does not teach transporting the released calibration molecules to the sensor device for calibrating the sensor device. Gerhardt does not teach wherein the sensor is in fluid communication with the calibrator at least in a calibration event; and a fluid collection assembly for supplying the fluid sample to the calibrator and the sensor, nor does Gerhardt teach a transport channel to accommodate the calibrator and sensor.
Heikenfeld teaches transporting the released calibration molecules to the sensor device for calibrating the sensor device (see whole document, see [0007]) (instant claim 14). Heikenfeld teaches wherein the sensor is in fluid communication with the calibrator at least in a calibration event (see claims 3 and 6 of ‘311); and a fluid collection assembly for supplying the fluid sample to the calibrator and the sensor (see [0083] – [0084], see abstract teaching a bifurcated biofluid transport paths) (instant claim 12). Heikenfeld teaches a transport channel arranged to accommodate both the calibrator and the sensor (see abstract, see [0010], see [0096]) (instant claim 13).
It would have been obvious to one of ordinary skill in the art at the time of the instant application to combine the device taught by Gerhardt with the method of transporting the released calibration molecules to the sensor device of Heikenfeld. Heikenfeld teaches that employing bifurcated biofluid transport paths allows for calibration and biofluid sensing (see [0010]). Heikenfeld teaches that transporting the calibration molecules to the sensor device would allow for the calibration medium to not need to provide a concentration of analyte or analytes greater than the concentration found in real sweat (the biofluid), as the initial sweat would reach the calibration sensor would dilute the analyte and allow for calibration (see [0071]). The artisan would have reasonable expectation of success based on the cumulative disclosure of these prior art references at the time the instant application was filed.
3.Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gerhardt and Heikenfeld et al., as applied to claims 12-14 above, in view of Pluta et al., (US 20160166187A1) (effectively filed on 10/27/2008).
The teachings of Gerhardt and Heikenfeld as they pertain to claims 12-14 are discussed in the 35 USC 103 above.
Gerhardt does not teach a non-transitory computer-readable medium having stored thereon a program element.
Pluta teaches a non-transitory computer-readable medium having stored thereon a program element for calibrating a sensor for detecting an analyte in a fluid of a subject, when executed by a processor (see [0007], see [0016], see [0035], see claims 19-20 of ‘187) (instant claim 15).
It would have been obvious to one of ordinary skill in the art at the time of the instant application to combine the device taught by Gerhardt with the method of transporting the released calibration molecules to the sensor device of Heikenfeld, with the non-transitory computer-readable medium taught by Pluta. Pluta teaches that a computer readable medium, when executed, performs tasks such as transmitting electromagnetic signals to the sensor array (see [0012]), obtaining electromagnetic impedance readings about the patient, analyzes the electromagnetic impedance readings to determine differences, calculates the impedance value representing the difference using an equivalent circuit model and individual adjustment factor data, and can compare data (see [0007]). The artisan would have reasonable expectation of success based on the cumulative disclosure of these prior art references at the time the instant application was filed.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MCKENZIE A DUNN whose telephone number is (571)270-0490. The examiner can normally be reached Monday-Tuesday 730 am -530pm, Wednesday-Friday 730 am-430 pm.
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/MCKENZIE A DUNN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
