DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 3-6, 9-12, and 16-19 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Barry (US 20200330036 A1).
Regarding claim 1, Barry teaches an analyte sensor system (analyte sensor system 101) comprising: an analyte sensor (analyte sensor 138), the analyte sensor comprising:
a sensor substrate (substrate 404);
a first electrode mechanically coupled to the sensor substrate; a first electrode trace mechanically coupled to the sensor substrate and electrically coupled to the first electrode; a second electrode mechanically coupled to the sensor substrate; a second electrode trace mechanically coupled to the sensor substrate and electrically coupled to the first electrode ([0195] “Electrodes 211a, 212a could be electrically connected to their respective contacts 211b, 212b via circuit traces on the planar substrate;” Fig. 3D, first electrode 212b, first conductive contact 334, second electrode 211b, second conductive contact 324); and
an analog front end (AFE) circuit (potentiostat 210) mechanically coupled to the sensor substrate, electrically coupled to the first electrode trace, and electrically coupled to the second electrode trace ([0172] “In the example depicted in FIG. 2, through a first input port 211 for sensor data the potentiostat 210 is coupled to an analyte sensor 138, such as a glucose sensor to generate sensor data from the analyte. The potentiostat 210 may be coupled to a working electrode 211 and reference electrode 212 that form a part of sensor 138.”);
and a sensor electronics assembly (ASIC 205);
and a connector electrically coupling the analog front end circuit to the sensor electronics assembly (Fig. 2; [0171] “the sensor electronics 112 may comprise an application-specific integrated circuit (ASIC) 205 coupled to a user interface 222. The ASIC 205 may further include a potentiostat 210, a telemetry module 232 for transmitting data from the sensor electronics 112”).
Regarding claim 3, Barry teaches the analyte sensor system of claim 1, wherein the sensor electronics assembly receives at least one digital signal from the AFE across the connector ([0173] “In some example implementations, the potentiostat 210 may include a resistor that translates a current value from sensor 138 into a voltage value, while in some example implementations, a current-to-frequency converter (not shown) may also be configured to integrate continuously a measured current value from sensor 138 using, for example, a charge-counting device. In some example implementations, an analog-to-digital converter (not shown) may digitize the analog signal from sensor 138 into so-called “counts” to allow processing by the processor module 214. The resulting counts may be directly related to the current measured by the potentiostat 210, which may be directly related to an analyte level, such as a glucose level, in the host.”).
Regarding claim 4, Barry teaches the analyte sensor system of claim 1, wherein the AFE circuit comprises an AFE substrate that is mechanically coupled to the sensor substrate (Fig. 3C, electronics module 135/ASIC 205, sensor 138; [0172] “In the example depicted in FIG. 2, through a first input port 211 for sensor data the potentiostat 210 is coupled to an analyte sensor 138.”).
Regarding claim 5, Barry teaches the analyte sensor system of claim 1, wherein the AFE circuit comprises an analog-to-digital converter electrically coupled to convert an analog electrical signal generated by the first electrode and the second electrode to a digital signal (Fig. [0173] “In some example implementations, the potentiostat 210 may include a resistor that translates a current value from sensor 138 into a voltage value, while in some example implementations, a current-to-frequency converter (not shown) may also be configured to integrate continuously a measured current value from sensor 138 using, for example, a charge-counting device. In some example implementations, an analog-to-digital converter (not shown) may digitize the analog signal from sensor 138 into so-called “counts” to allow processing by the processor module 214. The resulting counts may be directly related to the current measured by the potentiostat 210, which may be directly related to an analyte level, such as a glucose level, in the host.”).
Regarding claim 6, Barry teaches the analyte sensor system of claim 5, further comprising an output connector to couple the analyte sensor to a sensor electronics assembly, wherein the AFE circuit comprising: a first analog input electrically coupled to the first electrode trace; a second analog input electrically coupled to the second electrode trace; and at least one digital output electrically coupled to output connector (Fig. 3D; [0173] “In some example implementations, the potentiostat 210 may include a resistor that translates a current value from sensor 138 into a voltage value, while in some example implementations, a current-to-frequency converter (not shown) may also be configured to integrate continuously a measured current value from sensor 138 using, for example, a charge-counting device. In some example implementations, an analog-to-digital converter (not shown) may digitize the analog signal from sensor 138 into so-called “counts” to allow processing by the processor module 214. The resulting counts may be directly related to the current measured by the potentiostat 210, which may be directly related to an analyte level, such as a glucose level, in the host.”).
Regarding claim 9, Barry teaches the analyte sensor system of claim 1, further comprising an enclosure mechanically coupled to the sensor substrate, wherein the AFE circuit is positioned within the enclosure ([0203] “substrate 404 may be sized and shaped to mechanically interface with housing 128 and electrically interface with sensor electronics 112 [including potentiostat 210] inside housing 128.”).
Regarding claim 10, Barry teaches the analyte sensor system of claim 9, wherein the enclosure is bonded to the sensor substrate using a bonding agent ([0217] “In some instances, a sealing member 628 may be liquid dispensed (e.g., adhesive, gel, epoxy) or a solid material (e.g., elastomer, polymer). The sealing member 628 may be an assembled component that is welded (e.g., laser or ultrasonic, hot plate), or otherwise permanently attached (e.g., anisotropic adhesive film, pressure sensitive adhesive, cyanoacrylate, epoxy, or other suitable adhesive) to create a sealed region or cavity. In some embodiments, the sealing member 628 may be used to physically secure or couple at least a portion of sensor 138 to wearable assembly 600 and/or to provide a sealed region for at least a proximal portion of sensor 138.”).
Regarding claim 11, Barry teaches the analyte sensor system of claim 9, wherein the enclosure is molded on the sensor substrate ([0349] “FIG. 31 further shows a cap or an overmolded cap 3100 comprising a base material 3102, for example polycarbonate, plastic, metal, or any other material with suitable strength to maintain a seal. … When overmolded cap 3100 is placed over and/or within the cavity of housing 622, conductive elastomeric pucks 3106 and 3108 press against portions of sensor 138 and contacts 324, 334, thereby securing the portions of sensor 138 to their respective contacts 324, 334.”).
Regarding claim 12, Barry teaches the analyte sensor system of claim 1, wherein: the connector comprises a sensor-side contact and an electronics-side contact, and the sensor-side contact and the electronics-side contact are in physical contact with one another to electrically couple the analog front end circuit to the sensor electronics assembly (Fig. 2; [0171] “the sensor electronics 112 may comprise an application-specific integrated circuit (ASIC) 205 coupled to a user interface 222. The ASIC 205 may further include a potentiostat 210, a telemetry module 232 for transmitting data from the sensor electronics 112”).
Regarding claim 16, Barry teaches the analyte sensor system of claim 1, wherein the AFE circuit comprises an AFE power circuit, coupled to the connector, for receiving power from the sensor electronics assembly (Fig. 2; potentiostat 210, battery 234; [0171] “the sensor electronics 112 may comprise an application-specific integrated circuit (ASIC) 205 coupled to a user interface 222. The ASIC 205 may further include a potentiostat 210, a telemetry module 232 for transmitting data from the sensor electronics 112”).
Regarding claim 17, Barry teaches the analyte sensor system of claim 1, wherein the AFE circuit comprises an AFE communication circuit, coupled to the connector, for communicating with the sensor electronics assembly (Fig. 2; potentiostat 210, battery 234; [0171] “the sensor electronics 112 may comprise an application-specific integrated circuit (ASIC) 205 coupled to a user interface 222. The ASIC 205 may further include a potentiostat 210, a telemetry module 232 for transmitting data from the sensor electronics 112”).
Regarding claim 18, Barry teaches the analyte sensor system of claim 1, wherein the sensor electronics assembly comprises a sensor electronics power circuit, coupled to the connector, for providing power to the AFE circuit (Fig. 2; potentiostat 210, battery 234; [0171] “the sensor electronics 112 may comprise an application-specific integrated circuit (ASIC) 205 coupled to a user interface 222. The ASIC 205 may further include a potentiostat 210, a telemetry module 232 for transmitting data from the sensor electronics 112”).
Regarding claim 19, Barry teaches the analyte sensor system of claim 1, wherein the sensor electronics assembly comprises a sensor electronics communication circuit, coupled to the connector, for communicating with the AFE (Fig. 2; potentiostat 210, battery 234; [0171] “the sensor electronics 112 may comprise an application-specific integrated circuit (ASIC) 205 coupled to a user interface 222. The ASIC 205 may further include a potentiostat 210, a telemetry module 232 for transmitting data from the sensor electronics 112”).
Claim(s) 20-23 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Windmiller (US 20200297997 A1).
Regarding claim 20, Windmiller teaches a method of providing data from an analyte sensor to sensor electronics, comprising: positioning a sensor-side element of a contactless connector and an electronics-side element of the contactless connector to generate a wireless connection between the sensor-side element and the electronics-side element ([0101] “The microneedle analyte-selective sensor 20 preferably comprises … a printed circuit board containing the electronic circuitry required to transduce biochemical signals to digital data that are wirelessly transmitted to an external device via the embedded wireless transceiver”); transmitting power from the sensor electronics to the analyte sensor via the wireless connection; and transmitting a data signal from the analyte sensor to the sensor electronics via the wireless connection ([0066] “The electromagnetic coupling constitutes a means to convey or transfer at least one of information and power between the analyte-selective sensor and therapeutic delivery mechanism. The conveyance or transfer is either unidirectional (analyte-selective sensor to therapeutic delivery mechanism or therapeutic delivery mechanism to analyte-selective sensor) or bidirectional in nature (analyte-selective sensor to and from therapeutic delivery mechanism). The information or power transfer is either achieved wirelessly via electromagnetic waves propagating through free space or facilitated by means of an electrical connector featuring at least two conductive pads. In one scenario, the act of mechanically coupling both the analyte-selective sensor and therapeutic delivery mechanism instigates the exchange of at least one of electromagnetic information and energy between the two modalities. The use of a wireless transmission is by means of BLUETOOTH, Wi-Fi, NFC, RFID, cellular radio, ZigBee, Thread, ANT, a proprietary radio technology, a proprietary microwave technology, a proprietary millimeter-wave technology, inductive coupling, capacitive coupling, resonant coupling, or light waves.” [0078] “An electromagnetic energy conveyance mechanism is an electromagnetic mechanism designed to transfer information and/or power either unidirectionally from sensor to infusion system or bidirectionally between the sensor and the infusion system. Alternatively, an intermediary, such as a third device, can effectuate the transaction between said sensor and infusion system. The conveyance mechanism can take the form of a wireless electromagnetic transmission”).
Regarding claim 21, Windmiller teaches the method of claim 20, wherein:
the sensor electronics is positioned in an electronics unit enclosure (Fig. 8A; [0102] “therapeutic delivery system 800 having a body 801”),
the method further comprises mechanically coupling the electronics unit enclosure to the analyte sensor ([0102] “FIG. 8D illustrates the therapeutic delivery system 800 coupled with the microneedle-based analyte-selective sensor 20”), and
transmitting power from the sensor electronics to the analyte sensor is responsive to the mechanical coupling ([0066] “In one scenario, the act of mechanically coupling both the analyte-selective sensor and therapeutic delivery mechanism instigates the exchange of at least one of electromagnetic information and energy between the two modalities.”).
Regarding claim 22, Windmiller teaches the method of claim 20, wherein:
the sensor electronics is positioned in an electronics unit enclosure (Fig. 8A; [0102] “therapeutic delivery system 800 having a body 801”),
the method further comprises mechanically coupling the electronics unit enclosure to the analyte sensor ([0102] “FIG. 8D illustrates the therapeutic delivery system 800 coupled with the microneedle-based analyte-selective sensor 20”), and
transmitting the data signal from the sensor electronics to the analyte sensor is responsive to the mechanical coupling ([0066] “In one scenario, the act of mechanically coupling both the analyte-selective sensor and therapeutic delivery mechanism instigates the exchange of at least one of electromagnetic information and energy between the two modalities.”).
Regarding claim 23, Windmiller teaches the method of claim 20, wherein the data signal is a digital signal ([0101] “The microneedle analyte-selective sensor 20 preferably comprises a … a printed circuit board containing the electronic circuitry required to transduce biochemical signals to digital data that are wirelessly transmitted to an external device via the embedded wireless transceiver.”).
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barry (US 20200330036 A1) in view of Pont (US 20180249919 A1).
Regarding claim 2, Barry teaches the analyte sensor system of claim 1. However, Barry fails to disclose a zero input force connector. Pont teaches systems and methods including a device having integrated sensor arrays constructed and configured to measure and analyze multiple biosignatures concurrently in real time.
Pont discloses wherein the connector is a zero input force (ZIF) connector ([0118] “ In one embodiment, the flexible, replaceable sensor flap and/or the flexible replaceable communications flap are connected to the electronic core via a zero insertion force (ZIF) connector.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Barry to include a zero input force (ZIF) connector as disclosed in Pont to allow for the replacement of the sensors and communications interfaces without replacing the electronic core (Pont [0118]).
Claim(s) 7 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barry (US 20200330036 A1) in view of Windmiller (US 20200297997 A1).
Regarding claim 7, Barry teaches the analyte sensor system of claim 6, wherein: the first analog input and the second analog input are positioned on a first side of the AFE circuit (Fig. 3D; [0172] “The potentiostat 210 may be coupled to a working electrode 211 and reference electrode 212 that form a part of sensor 138. The potentiostat may provide a voltage to one of the electrodes 211, 212 of analyte sensor 138 to bias the sensor for measurement of a value (e.g., a current) indicative of the analyte concentration in a host (also referred to as the analog portion of the sensor).”). However, Barry fails to disclose the AFE circuit being bonded to the sensor substrate. Windmiller teaches a device and method for the coupling of an analyte-selective sensor and an infusion system into a singular body-worn device.
The combination of Barry/Windmiller discloses and the first side of the AFE circuit is bonded to the sensor substrate (Barry: substrate 404; Windmiller: [0068] “Another embodiment places the analog front end within the analyte-selective sensor”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Barry to include the AFE circuit being bonded to the sensor substrate as disclosed in Windmiller so that the sensor has the electronic circuitry required to transduce biochemical signals to digital data so they may be wirelessly transmitted to an external device via an embedded wireless transceiver (Windmiller [0101]).
Regarding claim 13, Barry teaches the analyte sensor system of claim 1. However, Barry fails to disclose a contactless connector. Windmiller discloses the connector being a contactless connector ([0066] “The electromagnetic coupling constitutes a means to convey or transfer at least one of information and power between the analyte-selective sensor and therapeutic delivery mechanism. The conveyance or transfer is either unidirectional (analyte-selective sensor to therapeutic delivery mechanism or therapeutic delivery mechanism to analyte-selective sensor) or bidirectional in nature (analyte-selective sensor to and from therapeutic delivery mechanism). The information or power transfer is either achieved wirelessly via electromagnetic waves propagating through free space”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Barry to include a contactless connector as disclosed in Windmiller to allow for information and/or power transfer between the analyte-selective sensor and the electronics assembly in such a way that the two are easy to decouple, enabling the unabated operation of the analyte-selective sensor when the electronics assembly needs replacing (Windmiller [0059]).
Regarding claim 14, the combination of Barry/Windmiller discloses the analyte sensor system of claim 13, wherein: the connector comprises a sensor-side element and an electronics-side element, and the sensor-side element and the electronics-side element are positioned to inductively couple the sensor-side element and the electronics-side element (Windmiller: [0066] “The use of a wireless transmission is by means of BLUETOOTH, Wi-Fi, NFC, RFID, cellular radio, ZigBee, Thread, ANT, a proprietary radio technology, a proprietary microwave technology, a proprietary millimeter-wave technology, inductive coupling, capacitive coupling, resonant coupling, or light waves.”).
Regarding claim 15, the combination of Barry/Windmiller discloses the analyte sensor system of claim 13, wherein the analyte sensor is configured to receive power from the sensor electronics via the contactless connector (Windmiller: [0066] “The electromagnetic coupling constitutes a means to convey or transfer at least one of information and power between the analyte-selective sensor and therapeutic delivery mechanism. The conveyance or transfer is either unidirectional (analyte-selective sensor to therapeutic delivery mechanism or therapeutic delivery mechanism to analyte-selective sensor) or bidirectional in nature (analyte-selective sensor to and from therapeutic delivery mechanism). The information or power transfer is either achieved wirelessly via electromagnetic waves propagating through free space”).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barry (US 20200330036 A1) in view of Reggiardo (US 20090083003 A1).
Regarding claim 8, Barry teaches the analyte sensor system of claim 1, wherein: the AFE circuit comprises a power input (Fig. 2; potentiostat 210, battery 234;). However, Barry fails to disclose a power conditioning capacitor. Reggiardo teaches a method and apparatus for providing a peak detection circuit between the power supply and the analog front end circuitry of the transmitter unit in a continuous glucose monitoring system.
Reggiardo discloses and the analyte sensor further comprises a first power conditioning capacitor coupled to the sensor substrate and electrically connected to the power input (Fig. 2, sensor 101, analog interface 201, peak detection unit 210, power supply 207; [0023] “the peak detection circuit in one embodiment may be provided between the power supply and the analog front end circuitry of the transmitter unit in the continuous glucose monitoring system such that in the case where power supply voltage drooping occurs, the peak detection circuit may be configured to isolate the delicate circuitry of the analog front end of the transmitter unit from the power supply, and rather allow the electrometer and the analog front end circuitry of the transmitter to draw the necessary power from a capacitor of the peak detection circuit to ensure continuous and proper operation.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Barry to include a power conditioning capacitor coupled to the sensor substrate and electrically connected to the power input as disclosed in Reggiardo to allow the electrometer and the analog front end circuitry of the transmitter to draw the necessary power from a capacitor of the peak detection circuit to ensure continuous and proper operation (Reggiardo [0023]).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Windmiller (US 20200297997 A1) in view of Roesicke (US 20070237678 A1).
Regarding claim 24, Windmiller teaches the method of claim 20. However, Windmiller fails to disclose the data signal as an analog signal. Roesicke teaches a system for determining the concentration of an analyte in a body fluid which comprises an analytical test element and an instrument separate therefrom. Roesicke discloses wherein the data signal is an analog signal ([0071] “Of course the data which are transmitted within the test strip using a transponder system can be digital as well as analog data. For example, such an internal transponder system on the test strip can be used to galvanically decouple the electric circuits on an electrochemical test strip wherein energy is transmitted from the instrument to the detection area and the measurement signals, e.g. as analog voltage or current values, are in turn transmitted from the detection area to the instrument.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Windmiller to include a wireless data signal as an analog signal as disclosed in Roesicke to allow for a simpler electrochemical system in which the transponder processes and stores no digital information but rather processes the analog signal current and transmits it to the reading module (Roesicke [0056]).
Conclusion
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/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791