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 Objections
Claim 4 objected to because of the following informalities: In claim 4, line 2, “remove device” should read “remote device”. 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 1-10 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process for a continuous multianalyte monitoring system) without significantly more.
Step 1:
The claimed invention of claims 1-10 is directed to statutory subject matter as the claims recite a system for continuous multianalyte monitoring.
Step 2A, Prong One:
Regarding claims 1-10, the recited steps are directed to mental process, i.e., concepts that can be performed in a mental process (see MPEP 2106.04(a)(2) subsection (III)). The courts have found that concepts performed in a human mind falls within the judicial exceptions, often labelled as “abstract ideas”.
Specifically, the following limitations recite mental process.
Regarding claim 1, the limitation of “determine a choline state based on one or more signals from the first set of electrodes;” (mental process: observation and decision).
Regarding claim 1, the limitation of “determine a tissue oxygen state based on one or more signals from the second set of electrodes” (mental process: observation and decision).
Regarding claim 1, the limitation of “initiate an alarm condition based on the one or more signals from the first set of electrodes and the one or more signals from the second set of electrodes.” (mental process: observation and decision).
Regarding claim 3, the limitation of “the alarm condition is generated” (mental process: observation, evaluation and decision).
Regarding claim 4, the limitation of “the alarm condition is generated” (mental process: observation, evaluation and decision).
Regarding claim 8, the limitation of “receive and store signals from the percutaneous multianalyte sensor” (mental process: observation).
Regarding claim 8, the limitation of “determine a real-time physical condition value based on the received signals” (mental process: observation and decision).
Regarding claim 8, the limitation of “determine whether the user has been exposed to an opioid based on the real-time physical condition value” (mental process: observation and decision).
Regarding claim 8, the limitation of “generate user interface data for … a graph of the choline and tissue oxygen levels, the graph representing a first axis corresponding to time, a second axis corresponding to one or more of the choline levels or tissue oxygen levels, and the physical condition value.” (mental process with pen and pencil).
Regarding claim 9, the limitation of “maintain historical real-time insulin condition values” (mental process: observation and evaluation).
Regarding claim 10, the limitation of “store threshold values that are indicative of opioid exposure;” (mental process: observation and decision).
Regarding claim 10, the limitation of “determine a choline state based on one or more signals from the first set of working electrodes;” (mental process: observation and decision).
Regarding claim 10, the limitation of “determine a tissue oxygen state based on one or more signals from the second set of working electrodes;” (mental process: observation and decision).
Regarding claim 10, the limitation of “determine an opioid condition based on at least the choline state and the tissue oxygen state,” (mental process: observation and decision).
Regarding claim 10, the limitation of “initiate an alarm condition based on the opioid condition.” (mental process: observation and decision).
Step 2A, Prong Two:
The claims, including dependent claims, are analyzed as a whole to determine whether additional limitations are recited such that the claims amount to significantly more than the abstract idea.
Regarding claim 1, the additional element of “A multi-analyte sensor system” amounts to a particular technological environment or field or use (MPEP § 2106.05(h)).
Regarding claim 1, the additional element of “a sensor probe” amounts to a particular technological environment or field or use (MPEP § 2106.05(h)).
Regarding claim 1, the additional element of “a first set of electrodes including one or more first working electrodes configured to transduce choline into electrical signals;” amounts to insignificant extra-solution activity (MPEP § 2106.05(g)).
Regarding claim 1, the additional element of “a second set of electrodes including one or more second working electrodes configured to transduce tissue oxygen into electrical signals” amounts to insignificant extra-solution activity (MPEP § 2106.05(g)).
Regarding claim 1, the additional element of “a third set of electrodes including one or more third electrodes that provide working and counter electrode functionality for the first set of electrodes and the second set of electrodes;” amounts to a particular technological environment or field or use (MPEP § 2106.05(h)).
Regarding claim 1, the additional element of “an electronics module” amounts to mere generic computer component (MPEP § 2106.05(f).
Regarding claim 1, the additional element of “control circuitry” amounts to mere generic computer component (MPEP § 2106.05(f).
Regarding claim 1, the additional element of “transmit sensor data” amounts to insignificant extra-solution activity (MPEP § 2106.05(g)).
Regarding claim 2, the additional element of “wherein the control circuitry is a component of the electronics module” amounts to mere generic computer component (MPEP § 2106.05(f).
Regarding claim 3, the additional element of “a local device” amounts to mere generic computer component (MPEP § 2106.05(f).
Regarding claim 4, the additional element of “a remove device” amounts to mere generic computer component (MPEP § 2106.05(f).
Regarding claim 5, the additional element of “the sensor probe further comprises a fourth set of electrodes including one or more third working electrodes configured to transduce glucose into electrical signals.” Amounts to insignificant extra-solution activity (data gathering/output) (MPEP § 2106.05(g)).
Regarding claims 5-6, the additional element of “the sensor probe” amounts to a particular technological environment or field or use (MPEP § 2106.05(h)).
Regarding claim 6, the additional element of “detect tissue impedance.” amounts to insignificant extra-solution activity (MPEP § 2106.05(g)).
Regarding claims 7, the additional element of “accelerometer” amounts to a particular technological environment or field or use (MPEP § 2106.05(h)).
Regarding claim 8, the additional element of “A continuous multianalyte monitoring system” amounts to a particular technological environment or field or use (MPEP § 2106.05(h)).
Regarding claim 8, the additional element of “a skin-mounted sensor control unit,” amounts to a particular technological environment or field or use (MPEP § 2106.05(h)).
Regarding claim 8, the additional element of “a percutaneous multianalyte sensor including an insertion portion configured for transcutaneous positioning in a subcutaneous tissue of a user” amounts to a particular technological environment or field or use (MPEP § 2106.05(h)).
Regarding claim 8, the additional element of “sensed levels of choline and tissue oxygen in the subcutaneous tissue of the user;” amounts to insignificant extra-solution activity (data gathering/output) (MPEP § 2106.05(g)).
Regarding claim 8, the additional element of “an adhesive patch disposed on a bottom surface of the skin-mounted sensor control unit and configured to adhere the skin-mounted sensor control unit to skin of the user;” amounts to a particular technological environment or field or use (MPEP § 2106.05(h)).
Regarding claim 8, the additional element of “a transceiver configured for wireless communication with the skin-mounted sensor control unit;” amounts to insignificant extra-solution activity (data gathering/output) (MPEP § 2106.05(g)).
Regarding claim 8, the additional element of “sensed levels of choline and tissue oxygen;” amounts to (insignificant extra-solution activity (data gathering/output) (MPEP § 2106.05(g)).
Regarding claim 8, the additional element of “sensed levels of choline and oxygen;” amounts to insignificant extra-solution activity (data gathering/output) (MPEP § 2106.05(g)).
Regarding claim 8, the additional element of “the real-time physical condition value;” amounts to insignificant extra-solution activity (data gathering/output) (MPEP § 2106.05(g)).
Regarding claim 8, the additional element of “generate user interface data for rendering on a touch-interface display to visually display a graph of the choline and tissue oxygen levels” amounts to insignificant extra-solution activity (data gather/output) (MPEP § 2106.05(g)).
Regarding claim 9, the additional element of “the control circuitry” amounts to mere generic computer component (MPEP § 2106.05(f).
Regarding claim 9, the additional element of “data storage” amounts to mere generic computer component (MPEP § 2106.05(f).
Regarding claim 10, the additional element of “A multi-analyte sensor system” amounts to a particular technological environment or field or use (MPEP § 2106.05(h)).
Regarding claim 10, the additional element of “a sensor probe” amounts to a particular technological environment or field or use (MPEP § 2106.05(h)).
Regarding claim 10, the additional element of “transduce choline into first electrical signals” amounts to insignificant extra-solution activity (data gathering/output) (MPEP § 2106.05(g)).
Regarding claim 10, the additional element of “transduce tissue oxygen into second electrical signals” amounts to insignificant extra-solution activity (data gathering/output) (MPEP § 2106.05(g)).
Regarding claim 10, the additional elements of “a first set of working electrodes”, “a second set of working electrodes”, “a third set of electrodes” amounts to a particular technological environment or field or use (MPEP § 2106.05(h)).
Regarding claim 10, the additional element of “wirelessly transmit sensor data;” amounts to insignificant extra-solution activity (data gather/output) (MPEP § 2106.05(g)).
Regarding claim 10, the additional element of “the control circuitry” amounts to mere generic computer component (MPEP § 2106.05(f).
Regarding claim 10, the additional element of “data storage” amounts to mere generic computer component (MPEP § 2106.05(f).
Regarding claimed a system for continuous multianalyte monitoring disclosed in the applicant’s specification, the specification does not sufficiently describe a concrete technological improvement attributable to the claimed invention of the system for continuous multianalyte monitoring although the specification describes the continuous multianalyte monitoring as a physiological signal detection device, a particular technological environment or field or use and Insignificant extra solution activity do not integrate a judicial exception. Regarding claims 1-00, the judicial exception is not integrated into a practical application.
Step 2B:
The claims 1-10 do not include additional elements that are sufficient to amount significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements, including “electronics module”, “transceiver”, “control circuitry”, “local device”, and “remove device” are recited at a high level of generality and are used for extra-solution activity, such as data gathering necessary to perform the abstract idea as well as part of generic measuring equipment used to perform extra-solution data delivery functions to perform the abstract idea as well as part generic computer equipment used to perform extra-solution data delivery computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)). Therefore, these elements do not provide an inventive concept sufficient to transform the claimed abstract idea into patent eligible subject matter.
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.
Claims 1-4, and 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Ray” (US20230240589A1).
Regarding claim 1.
Ray teaches A multi-analyte sensor system (continuous analyte monitoring system 104) (Paragraph 0080, 0082, 0083) comprising:
a sensor probe (continuous analyte sensor 202) (Paragraphs 0082, 0302) comprising:
a first set of electrodes including one or more first working electrodes (WE 1) configured to transduce choline into electrical signals (Paragraph 0304: “continuous choline sensor device can be provided, for example, using choline oxidase enzyme that generates hydrogen peroxide with the oxidation of choline. Thus, in one example, at least one enzyme domain comprises choline oxidase (COX) adjacent at least one WE surface, Thus, in one example, at least one enzyme domain comprises choline oxidase (COX) adjacent at least one WE surface, optionally with one or more electrodes and/or interference membranes positioned in between the WE surface and the at least one enzyme domain. The catalysis of the choline using COX results in creation of hydrogen peroxide which can be detectable using, among other techniques, amperometry, voltametric and impedimetric methods.”, and Fig. 9D illustrates WE1 (first set of working electrode), WE2 (second set of working electrode), and RE (reference electrode));
a second set of electrodes including one or more second working electrodes (WE 2) configured to transduce tissue oxygen into electrical signals (Paragraph 0232: “The terms “indwelling,” “in dwelling,” “implanted,” or “implantable” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to objects including sensors that are inserted, or configured to be inserted, subcutaneously (i.e. in the layer of fat between the skin and the muscle), intracutaneously (i.e. penetrating the stratum corneum and positioning within the epidermal or dermal strata of the skin), or transcutaneously (i.e. penetrating, entering, or passing through intact skin), which may result in a sensor that has an in vivo portion and an ex vivo portion. The term “indwelling” also encompasses an object which is configured to be inserted subcutaneously, intracutaneously, or transcutaneously, whether or not it has been inserted as such.”, Paragraph 0291: “the one or more interference blocking membranes are deposited adjacent the working electrode and/or the electrode surface”,” the electrode surface to attenuate one or all analytes diffusing thru the sensing region but for oxygen”, Paragraph 0292: “the working electrode used comprised platinum and the potential applied was about 0.5 volts.”, Paragraph 0293: “sensing oxygen level changes electrochemically, for example in a Clark type electrode setup, or in a different configuration can be carried out,”, “Based on changes of potential, oxygen concentration changes can be recorded,”, “Accordingly, a multi-analyte sensor for both alcohol and oxygen can therefore be provided.”,” sensing oxygen level changes electrochemically, for example in a Clark type electrode setup, or in a different configuration can be carried out,”); and
a third set of electrodes including one or more third electrodes that provide working (additional wires or electrodes) and counter electrode (counter electrode) functionality for the first set of electrodes (WE1) and the second set of electrodes (WE2) (Paragraph 0319: “Additional wires can be used, for example, as a reference and/or counter electrode”, “the single WE is a conductive trace on a substrate, with two or more active surfaces positioned about the longitudinal axis of the trace”, paragraph 0320: “WE1 represents a first working electrode surface configured to operate at P1, for example, and is electrically insulated from second working electrode surface WE2 that is configured to operate at P2, and RE represents a reference electrode RE electrically isolated from both WE1, WE2.”, “Additional electrodes, such as a counter electrode can be used”, Paragraph 0321: “One or more additional electrodes can be present such as a reference electrode and/or a counter electrode.”, and Paragraph 0330: “a glycol sensor configuration is provided using multiple working electrodes WEs that provides for utilizing signal transduced from both Wes”);
an electronics module (sensor electronics module 204) configured to electrically interface with the sensor probe (continuous analyte sensor(s) 202) (Paragraph 0085: “sensor electronics module 204 includes electronic circuitry associated with measuring and processing the continuous analyte sensor data, including prospective algorithms associated with processing and calibration of the sensor data”),
the electronics module including a transceiver (sensor electronics module 204) configured to transmit sensor data (Paragraph 0049: “continuous analyte monitoring system 104 is configured to continuously measure one or more analytes and transmit the analyte measurements to display device 107 for use by application 106. In some embodiments, continuous analyte monitoring system 104 transmits the analyte measurements to display device 107 through a wireless connection (e.g., Bluetooth connection, WiFi connection and/or NFC).”, Paragraph 0081: “Sensor electronics module 204 may be in wireless communication (e.g., directly or indirectly) with one or more of display devices 210, 220, 230, and 240.”, and Paragraph 0085: “Sensor electronics module 204 can be physically connected to continuous analyte sensor(s) 202 and can be integral with (non-releasably attached to) or releasably attachable to continuous analyte sensor(s) 202”); and
control circuitry (electronic circuitry) communicatively coupled to the electronics module (sensor electronics module 204) (Paragraph 0085: “sensor electronics module 204 includes electronic circuitry associated with measuring and processing the continuous analyte sensor data, including prospective algorithms associated with processing and calibration of the sensor data. Sensor electronics module 204 can be physically connected to continuous analyte sensor(s) 202 and can be integral with (non-releasably attached to) or releasably attachable to continuous analyte sensor(s) 202.”, Paragraph 0049: “continuous analyte monitoring system 104 is configured to continuously measure one or more analytes and transmit the analyte measurements to display device 107 for use by application 106”, Paragraph 0051: “Decision support engine 114 refers to a set of software instructions with one or more software modules, including data analysis module (DAM) 116”, “decision support engine 114 executes partially on one or more local devices, such as display device 107, and partially on one or more computing devices in a private or a public cloud”,” decision support engine 114 executes entirely on one or more local devices, such as display device 107 or analyte sensor system 104 (e.g., sensor electronics module 204 of FIG. 2 )”, Paragraph 0081: “Sensor electronics module 204 may be in wireless communication (e.g., directly or indirectly) with one or more of display devices 210, 220, 230, and 240.”, Paragraph 0086: “Display devices 210, 220, 230, and 240 may be examples of display device 107 illustrated in FIG. 1 used to display sensor data to a user of FIG. 1 and/or receive input from the user.”, Paragraph 0214: “FIG. 7 is a block diagram depicting a computing device 700 configured to execute a decision support engine (e.g., decision support engine 114)”, “computing device 700 includes a processor 705, memory 710, storage 715, a network interface 725, and one or more I/O interfaces 720. In the illustrated embodiment, processor 705 retrieves and executes programming instructions stored in memory 710, as well as stores and retrieves application data residing in storage 715. Processor 705 is generally representative of a single CPU and/or GPU, multiple CPUs and/or GPUs, a single CPU and/or GPU having multiple processing cores,”, and Paragraph 0216: “Decision support engine 114 is executed by computing device 700 to perform operations 402-416 of method 400 in FIG. 4”) and configured to:
determine a choline state based on one or more signals from the first set of electrodes (Paragraph 0082: “the continuous analyte sensor 202 provides a data stream indicative of the concentration of one or more analytes in the user. The data stream may include raw data signals, which are then converted into a calibrated and/or filtered data stream used to provide estimated analyte value(s) to the user.”, and Paragraph 0304: “continuous choline sensor device can be provided, for example, using choline oxidase enzyme that generates hydrogen peroxide with the oxidation of choline”);
determine a tissue oxygen state based on one or more signals from the second set of electrodes (Paragraph 0293: “sensing oxygen level changes electrochemically, for example in a Clark type electrode setup, or in a different configuration can be carried out, for example by coating the electrode with one or more membranes of one or more polymers, such as NAFION”, “sensing oxygen level changes electrochemically, for example in a Clark type electrode setup, or in a different configuration can be carried out, for example by coating the electrode with one or more membranes of one or more polymers, such as NAFION™. Based on changes of potential, oxygen concentration changes can be recorded,”, and Paragraph 0323: “Signal extracted can then be analyzed to measure the concentration of the two different analytes.”); and
Initiate an alarm condition based on the one or more signals from the first set of electrodes and the one or more signals from the second set of electrodes (Paragraph 0088: “The plurality of display devices may include a custom display device specially designed for displaying certain types of displayable sensor data associated with analyte data received from sensor electronics module. In certain embodiments, the plurality of display devices may be configured for providing alerts/alarms based on the displayable sensor data”, and Paragraph 0373: “ Accordingly, a simple user interface to just deliver warnings can be implemented. In some embodiments, the user interface could be a single light-emitting diode (LED) that is illuminated when the sensor electronics determines sepsis risk is present. Two LEDs or a two-color LED could be green when the monitor is operational and detects low risk, and red when a sepsis risk is detected and a warning is issued”).
Regarding claim 2, Ray teaches the multi-analyte sensor system of claim 1 (See rejection of claim 1 above).
Ray teaches wherein the control circuitry (control circuitry) is a component of the electronics module (sensor electronics module 204) (Paragraph 0085: “sensor electronics module 204 includes electronic circuitry associated with measuring and processing the continuous analyte sensor data, including prospective algorithms associated with processing and calibration of the sensor data. Sensor electronics module 204 can be physically connected to continuous analyte sensor(s) 202 and can be integral with (non-releasably attached to) or releasably attachable to continuous analyte sensor(s) 202.”, “Electronics can be affixed to a printed circuit board (PCB), or the like, and can take a variety of forms. For example, the electronics can take the form of an integrated circuit (IC), such as an Application-Specific Integrated Circuit (ASIC), a microcontroller, and/or a processor.”).
Regarding claim 3, Ray teaches the multi-analyte sensor system of claim 1 (See rejection of claim 1 above).
Ray teaches wherein the alarm condition is generated on a local device (Paragraph 0373: “The housing 1428 of the sensor assembly 1400 can include a user interface for delivering messages to the patient regarding sepsis status.”, “Accordingly, a simple user interface to just deliver warnings can be implemented. In some embodiments, the user interface could be a single light-emitting diode (LED) that is illuminated when the sensor electronics determines sepsis risk is present”; the examiner notes that Ray’s sensor assembly locally provides a warning when the sensor electronics determines that a risk condition is present. ).
Regarding claim 4, Ray teaches the multi-analyte sensor system of claim 3 (See rejection of claim 3 above).
Ray teaches wherein the alarm condition is generated on a remove device (Paragraph 0088: “the plurality of display devices may be configured for providing alerts/alarms based on the displayable sensor data. Display device 210 is an example of such a custom device. In some embodiments, one of the plurality of display devices is a smartphone, such as display device 220 which represents a mobile phone, using a commercially available operating system (OS), and configured to display a graphical representation of the continuous sensor data (e.g., including current and historic data). Other display devices can include other hand-held devices, such as display device 230 which represents a tablet, display device 240 which represents a smart watch, medical device 208”,).
Regarding claim 6, Ray teaches the multi-analyte sensor system of claim 1 (See rejection of claim 1 above).
Ray teaches wherein the sensor probe is configured to detect tissue impedance (Paragraph 0247: “The phrases “signal medium” or “transmission medium” shall be taken to include any form of modulated data signal, carrier wave, and so forth. The phrase “modulated data signal” means a signal that has one or more of its characteristics set or changed in such a matter as to encode information in the signal.”, Paragraph 0248: “The terms “transducing” or “transduction” and their grammatical equivalents as are used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refer without limitation to optical, electrical, electrochemical, acoustical/mechanical, or colorimetrical technologies and methods. Electrochemical properties include current and/or voltage, inductance, capacitance, impedance, transconductance, and potential.”, and Paragraph 0249: “Transcutaneous continuous multi-analyte sensors can be used in vivo over various lengths of time. The continuous multi-analyte sensor systems discussed herein can be transcutaneous devices, in that a portion of the device may be inserted through the host's skin and into the underlying soft tissue while a portion of the device remains on the surface of the host's skin”).
Regarding claim 7, Ray teaches the multi-analyte sensor system of claim 1 (See rejection of claim 1 above).
Ray teaches further comprising an accelerometer associated with the electronics module (Paragraph 0081: “sensor electronics module 204 may also be in wireless communication (e.g., directly or indirectly) with one or more medical devices, such as medical devices 208 (individually referred to herein as medical device 208 and collectively referred to herein as medical devices 208), and/or one or more other non-analyte sensors 206 (individually referred to herein as non-analyte sensor 206 and collectively referred to herein as non-analyte sensor 206).”, and Paragraph 0091: “Non-analyte sensors 206 may include, but are not limited to, an altimeter sensor, an accelerometer sensor, a temperature sensor, a respiration rate sensor.”).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ray in view of “Shah” (US20190246962A1).
Regarding claim 5, Ray teaches the multi-analyte sensor system of claim 1 (See rejection of claim 1 above).
Ray does not teach wherein: the sensor probe further comprises a fourth set of electrodes including one or more third working electrodes configured to transduce glucose into electrical signals.
Shah teaches wherein: the sensor probe further comprises a fourth set of electrodes including one or more third working electrodes configured to transduce glucose into electrical signals (Paragraph 0018: “the first working electrodes 202 are transducers configured to detect, or measure, glucose concentration. The second working electrodes 206 can be configured to measure the concentration of a second analytes such as, but not limited to lactate, oxygen, ROS, ketones or the like”, Paragraph 0019: “FIGS. 2A and 2B further include optional third working electrodes 210 formed on third electrode trace 212”, Paragraph 0026: “the analyte sensor 101 a is intended to be placed in subcutaneous tissue where the plurality of working electrodes within the sensor array 101 produce signals related to the analyte each transduced is configured to measure or detect (e.g., glucose, tissue oxygen, lactate, ROS, ketone”, and Paragraph 0030: “in many embodiments the sensor array 101 having the plurality of working electrodes is inserted into the subcutaneous tissue via a single point of insertion.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ray with Shah by incorporating Shah’s distinct glucose sensitive working electrode and associated counter-reference electrode into Ray’s multi-analyte sensor probe because such modification would have predictably enabled simultaneous monitoring of choline, tissue oxygen, and glucose through a single insertion, thereby providing additional physiological information while reducing the burden associated with multiple sensor insertion (Ray, Paragraph 0324; Shah, Paragraph 0015).
Claim 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Ray in view of “Insler” (US20170172522A1).
Regarding claim 8.
Ray teaches A continuous multianalyte monitoring system (continuous analyte monitoring system 104) (Paragraphs 0080, 0082, 0083), comprising:
a skin-mounted sensor control unit (Sensor electronics module 204) (paragraph 0085: “Sensor electronics module 204 can be physically connected to continuous analyte sensor(s) 202”, “Sensor electronics module 204 may include hardware, firmware, and/or software that enables measurement of levels of analyte(s) via a continuous analyte sensor(s) 202”, Paragraph 0089: “a plurality of different display devices can be in direct wireless communication with a sensor electronics module (e.g., such as an on-skin sensor electronics module 204 that is physically connected to continuous analyte sensor(s) 202) during a sensor session to enable a plurality of different types and/or levels of display and/or functionality associated with the displayable sensor data.”, and Paragraph 0371: “FIGS. 14A-14C illustrate an exemplary implementation of a sensor system 104 implemented as a wearable device such as an on-skin sensor assembly 1400”), comprising:
a percutaneous multianalyte sensor (continuous analyte sensor 202) including an insertion portion configured for transcutaneous positioning in a subcutaneous tissue of a user (Paragraph 0082: “a continuous analyte sensor 202 may comprise a sensor for detecting and/or measuring analyte(s). The continuous analyte sensor 202 may be a multi-analyte sensor configured to continuously measure two or more analytes or a single analyte sensor configured to continuously measure a single analyte as a non-invasive device, a subcutaneous device, a transcutaneous device, a transdermal device, and/or an intravascular device.”, Paragraph 0232: “The terms “indwelling,” “in dwelling,” “implanted,” or “implantable” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to objects including sensors that are inserted, or configured to be inserted, subcutaneously (i.e. in the layer of fat between the skin and the muscle), intracutaneously (i.e. penetrating the stratum corneum and positioning within the epidermal or dermal strata of the skin), or transcutaneously (i.e. penetrating, entering, or passing through intact skin), which may result in a sensor that has an in vivo portion and an ex vivo portion. The term “indwelling” also encompasses an object which is configured to be inserted subcutaneously, intracutaneously, or transcutaneously, whether or not it has been inserted as such.”, Paragraph 0371: “The housing 1428 may include a through-hole 1480 that cooperates with a sensor inserter device (not shown) that is used for implanting the sensor 1338 under the skin of a subject.”),
the percutaneous multianalyte sensor (continuous analyte sensor 202) being configured to sense levels of choline and tissue oxygen in the subcutaneous tissue of the user (Paragraph 0293: “sensing oxygen level changes electrochemically, for example in a Clark type electrode setup, or in a different configuration can be carried out,”, “Based on changes of potential, oxygen concentration changes can be recorded,”, and Paragraph 0304: “continuous choline sensor device can be provided, for example, using choline oxidase enzyme that generates hydrogen peroxide with the oxidation of choline.”); and
an adhesive patch (adhesive patch 1426) disposed on a bottom surface of the skin-mounted sensor control unit (Sensor electronics module 204) and configured to adhere the skin-mounted sensor control unit to skin of the user (Paragraph 0371: “FIGS. 14A-14B, on-skin sensor assembly comprises a housing 1428. An adhesive patch 1426 can couple the housing 1428 to the skin of the host. The adhesive 1426 can be a pressure sensitive adhesive (e.g., acrylic, rubber based, or other suitable type) bonded to a carrier substrate (e.g., spun lace polyester, polyurethane film, or other suitable type) for skin attachment. The housing 1428 may include a through-hole 1480 that cooperates with a sensor inserter device (not shown) that is used for implanting the sensor 1338 under the skin of a subject.”);
a transceiver (telemetry module in sensor electronics module 204) configured for wireless communication with the skin-mounted sensor control unit (sensor electronics module 204) (Paragraph 0085: “a telemetry module for transmitting data from the sensor electronics module to one or more display devices.”, and Paragraph 0089: “a plurality of different display devices can be in direct wireless communication with a sensor electronics module (e.g., such as an on-skin sensor electronics module 204 that is physically connected to continuous analyte sensor(s) 202)”); and
control circuitry (electronic circuitry) configured to (Paragraph 0085: “sensor electronics module 204 includes electronic circuitry associated with measuring and processing the continuous analyte sensor data, including prospective algorithms associated with processing and calibration of the sensor data. Sensor electronics module 204 can be physically connected to continuous analyte sensor(s) 202 and can be integral with (non-releasably attached to) or releasably attachable to continuous analyte sensor(s) 202.”, Paragraph 0049: “continuous analyte monitoring system 104 is configured to continuously measure one or more analytes and transmit the analyte measurements to display device 107 for use by application 106”, Paragraph 0051: “decision support engine 114 may provide decision support recommendations to the user via application 106. Decision support engine 114 provides decision support recommendations based on information included in user profile 118.”, Paragraph 0214: “FIG. 7 is a block diagram depicting a computing device 700 configured to execute a decision support engine (e.g., decision support engine 114)”, “computing device 700 includes a processor 705, memory 710, storage 715, a network interface 725, and one or more I/O interfaces 720. In the illustrated embodiment, processor 705 retrieves and executes programming instructions stored in memory 710, as well as stores and retrieves application data residing in storage 715. Processor 705 is generally representative of a single CPU and/or GPU, multiple CPUs and/or GPUs, a single CPU and/or GPU having multiple processing cores,”)
receive and store signals from the percutaneous multianalyte sensor related to sensed levels of choline and tissue oxygen (Paragraph 0082: “the continuous analyte sensor 202 provides a data stream indicative of the concentration of one or more analytes in the user. The data stream may include raw data signals, which are then converted into a calibrated and/or filtered data stream used to provide estimated analyte value(s) to the user.”, “a continuous analyte sensor 202 may comprise a sensor for detecting and/or measuring analyte(s). The continuous analyte sensor 202 may be a multi-analyte sensor configured to continuously measure two or more analytes or a single analyte sensor configured to continuously measure a single analyte as a non-invasive device, a subcutaneous device, a transcutaneous device, a transdermal device, and/or an intravascular device.”, Paragraph 0293: “sensing oxygen level changes electrochemically, for example in a Clark type electrode setup, or in a different configuration can be carried out,”, and Paragraph 0304: “The catalysis of the choline using COX results in creation of hydrogen peroxide which can be detectable using, among other techniques, amperometry, voltametric and impedimetric methods.”);
determine a real-time physical condition value based on the received signals related to sensed levels of choline and oxygen (Paragraph 0053: “DAM 113 of decision support engine 114 is configured to process the set of inputs 128 to determine one or more metrics 130. Metrics 130, discussed in more detail below with respect to FIG. 3 , may, at least in some cases, be generally indicative of the health or state of a user, such as one or more of the user's physiological state”, Paragraph 0095: “each one of metrics 130 may correspond to one or more values, e.g., discrete numerical values, ranges, or qualitative values (high/medium/low, stable/unstable, etc.)”, “inputs 128 may be processed by DAM 113 to output metrics 130”, Paragraph 0107: “DAM 116 determines or computes the user's metrics 130 based on inputs 128”, Paragraph 0195: “Risk stratification may refer to the process of assigning a health risk status to a user, and using the risk status assigned to the user to direct and improve care.”, and Paragraph 0198: “Decision support engine 114 may use the machine learning models and/or the rule-based models to generate a disease prediction based on continuous analysis of data (e.g., analyte data and, in some cases, non-analyte data) for the user collected over various time periods.”, the examiner notes that the forementioned sensor data and metrics 130 reasonably could consist choline, tissue oxygen data, and physical condition value);
generate user interface data for rendering on a touch-interface display to visually display a graph of the choline and tissue oxygen levels, the graph representing a first axis corresponding to time, a second axis corresponding to one or more of the choline levels or tissue oxygen levels, and the physical condition value (Paragraph 0046: “The term “analyte” as used herein is a broad term used in its ordinary sense, including, without limitation, to refer to a substance or chemical constituent in a biological fluid (for example, blood, interstitial fluid, cerebral spinal fluid, lymph fluid or urine) that can be analyzed. Analytes can include naturally occurring substances, artificial substances, metabolites, and/or reaction products. Analytes for measurement by the devices and methods may include, but may not be limited to”, Paragraph 0053: “DAM 113 of decision support engine 114 is configured to process the set of inputs 128 to determine one or more metrics 130. Metrics 130,Metrics 130, discussed in more detail below with respect to FIG. 3 , may, at least in some cases, be generally indicative of the health or state of a user, such as one or more of the user's physiological state, trends associated with the health or state of a user, etc.”, Paragraph 0072: “output 144 generated by decision support engine 114 may be stored in user profile 118. Output 144 may be indicative of the current health of a user,”, Paragraph 0086: “Display devices 210, 220, 230, and/or 240 are configured for displaying displayable sensor data, including analyte data, which may be transmitted by sensor electronics module 204. Each of display devices 210, 220, 230, or 240 can include a display such as a touchscreen display 212, 222, 232, and/or 242 for displaying sensor data to a user and/or receiving inputs from the user.”,” one of the plurality of display devices is a smartphone, such as display device 220 which represents a mobile phone, using a commercially available operating system (OS), and configured to display a graphical representation of the continuous sensor data (e.g., including current and historic data)”, “a graphical user interface (GUI) may be presented to the user for such purposes”, Paragraph 0095: “FIG. 3 illustrates example inputs 128 on the left, application 106 and DAM 116 in the middle, and metrics 130 on the right. In certain embodiments, each one of metrics 130 may correspond to one or more values, e.g., discrete numerical values, ranges, or qualitative values (high/medium/low, stable/unstable, etc.). Application 106 obtains inputs 128 through one or more channels (e.g., manual user input, sensors, other applications executing on display device 107, etc.).”, and Paragraph 0155: “Note that lactate area under the curve refers to the area on a graph between the lactate curve (e.g., representation of continuous lactate measurements depicted on the graph in relation to time) and the time axis, where time is measured on the X axis and lactate is measured on the Y axis.”; the examiner notes that the forementioned sensor data and metrics 130 reasonably could consist choline, tissue oxygen data, and physical condition value).
Ray does not teach determine whether the user has been exposed to an opioid based on the real-time physical condition value.
Insler teaches determine whether the user has been exposed to an opioid based on the real-time physical condition value (Paragraph 0004: “Exemplary embodiments of the present technology are directed to a method for detecting the need for and providing assistance to an individual suspected of overdosing on an opiate. The method includes measuring one or more physiological parameters of the individual and transmitting an alert if the parameters were to cross a threshold and put the individual in danger.”, “By monitoring either one or a combination of respiratory rate, heart rate, and/or blood pressure, the device can recognize an overdose, and respond effectively.”, Paragraph 0005: “There are many physical changes that may occur during overdose and tracking several physical parameters with multiple sensors provides the most accurate assessment of the state of the patient and reduces false positives while avoiding disastrous false negatives (missing an actual overdose). Significant drops in respiratory rate, SpO2, and heart rate (and/or other physiological data) below a certain threshold triggers the device. This threshold can be based on both an absolute number (such as heart rate less than 50 beats per minute, or respiratory rate less than 5 beats per minute) and a percentage change from the baseline of the individual (pulse reduced by greater than 25% of baseline pulse).”); and
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ray with Insler by incorporating Insler’s opioid-overdose determination, because such modification would have improved the accuracy of assessing the user’s condition and reduced false-overdose determination (Insler, Paragraph 0005).
Regarding claim 9, Ray in view of Insler teaches the multi-analyte sensor system of claim 8 (See rejection of claim 8 above).
Ray teaches wherein the control circuitry (electronic circuitry) is further configured to maintain historical real-time insulin condition values in data storage (other components useful for signal processing and data storage) of the control circuitry (Paragraph 0085: “sensor electronics module 204 includes electronic circuitry associated with measuring and processing the continuous analyte sensor data, including prospective algorithms associated with processing and calibration of the sensor data. Sensor electronics module 204 can be physically connected to continuous analyte sensor(s) 202 and can be integral with (non-releasably attached to) or releasably attachable to continuous analyte sensor(s) 202.”, “sensor electronics module 204 can include a potentiostat, a power source for providing power to the sensor, other components useful for signal processing and data storage, and a telemetry module for transmitting data from the sensor electronics module to one or more display devices.”, Paragraph 0046: “The term “analyte” as used herein is a broad term used in its ordinary sense, including, without limitation, to refer to a substance or chemical constituent in a biological fluid (for example, blood, interstitial fluid, cerebral spinal fluid, lymph fluid or urine) that can be analyzed. Analytes can include naturally occurring substances, artificial substances, metabolites, and/or reaction products. Analytes for measurement by the devices and methods may include, but may not be limited to”, “, or a drug or pharmaceutical composition, including but not limited to insulin (e.g., exogenous or endogenous);”, Paragraph 0049: “continuous analyte monitoring system 104 is configured to continuously measure one or more analytes and transmit the analyte measurements to display device 107 for use by application 106.”, “The transmission of analyte measurements may be broadcast or on-demand and continuous (e.g., fully continuous, semi-continuous, or periodic)”, Paragraph 0052: ” application 106 provides a set of inputs 128, including the analyte measurements received from continuous analyte monitoring system 104, that are stored in user profile 118”, Paragraph 0058: “user profile 118 is dynamic because at least part of the information that is stored in user profile 118 may be revised over time and/or new information may be added to user profile 118 by decision support engine 114”, Paragraph 0062: “data stored in historical records database 112 may maintain time series data collected for users over a period of time such users use continuous analyte monitoring system 104 and application 106”, and Paragraph 214: “computing device 700 includes a processor 705, memory 710, storage 715, a network interface 725, and one or more I/O interfaces 720. In the illustrated embodiment, processor 705 retrieves and executes programming instructions stored in memory 710, as well as stores and retrieves application data residing in storage 715. Processor 705 is generally representative of a single CPU and/or GPU, multiple CPUs and/or GPUs, a single CPU and/or GPU having multiple processing cores,”).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ray in view of Insler and “Rogers” (WO2022261492A1), and “Ning” ("Metabolomics analysis of serum in a rat heroin self-administration model undergoing reinforcement based on 1H-nuclear magnetic resonance spectra", BMC Neurosci (2018) 19:4).
Regarding claim 10.
Ray teaches A multi-analyte sensor system (continuous analyte monitoring system 104) (Paragraphs 0080,0082, 0083) comprising:
a sensor probe (continuous analyte sensor 202) (Paragraph 0082: “a continuous analyte sensor 202 may comprise a sensor for detecting and/or measuring analyte(s)”) comprising:
a first set of working electrodes (WE1) configured to transduce choline into first electrical signals (Paragraph 0304: “continuous choline sensor device can be provided, for example, using choline oxidase enzyme that generates hydrogen peroxide with the oxidation of choline. Thus, in one example, at least one enzyme domain comprises choline oxidase (COX) adjacent at least one WE surface, Thus, in one example, at least one enzyme domain comprises choline oxidase (COX) adjacent at least one WE surface, optionally with one or more electrodes and/or interference membranes positioned in between the WE surface and the at least one enzyme domain. The catalysis of the choline using COX results in creation of hydrogen peroxide which can be detectable using, among other techniques, amperometry, voltametric and impedimetric methods.”, Paragraph 0320: “WE1 represents a first working electrode surface configured to operate at P1, for example, and is electrically insulated from second working electrode surface WE2 that is configured to operate at P2, and RE represents a reference electrode RE electrically isolated from both WE1, WE2.” and Fig. 9D illustrates WE1 (first set of working electrode), WE2 (second set of working electrode), and RE(reference electrode));
a second set of working electrodes (WE2) configured to transduce tissue oxygen into second electrical signals (Paragraph 0293: “sensing oxygen level changes electrochemically, for example in a Clark type electrode setup, or in a different configuration can be carried out,”, Paragraph 0320: “WE1 represents a first working electrode surface configured to operate at P1, for example, and is electrically insulated from second working electrode surface WE2 that is configured to operate at P2, and RE represents a reference electrode RE electrically isolated from both WE1, WE2.” and Fig. 9D illustrates WE1 (first set of working electrode), WE2 (second set of working electrode), and RE(reference electrode)); and
a third set of electrodes (additional wires / one or more additional electrodes) that are configured to provide reference and counter electrode functionality for the first set of working electrodes and the second set of working electrodes (Paragraph 0319: “Additional wires can be used, for example, as a reference and/or counter electrode”, Paragraph 0320: “WE1 represents a first working electrode surface configured to operate at P1, for example, and is electrically insulated from second working electrode surface WE2 that is configured to operate at P2, and RE represents a reference electrode RE electrically isolated from both WE1, WE2.”, “Additional electrodes, such as a counter electrode can be used” and Paragraph 0321: “One or more additional electrodes can be present such as a reference electrode and/or a counter electrode.”);
an electronics module (sensor electronics module 204) configured to electrically interface with the sensor probe (continuous analyte sensor(s) 202) (Paragraph 0085: “sensor electronics module 204 includes electronic circuitry associated with measuring and processing the continuous analyte sensor data, including prospective algorithms associated with processing and calibration of the sensor data”),
the electronics module including a transceiver configured to wirelessly transmit sensor data (Paragraph 0049: “continuous analyte monitoring system 104 is configured to continuously measure one or more analytes and transmit the analyte measurements to display device 107 for use by application 106. In some embodiments, continuous analyte monitoring system 104 transmits the analyte measurements to display device 107 through a wireless connection (e.g., Bluetooth connection, WiFi connection and/or NFC).”, Paragraph 0081: “Sensor electronics module 204 may be in wireless communication (e.g., directly or indirectly) with one or more of display devices 210, 220, 230, and 240.”, Paragraph 0085: “Sensor electronics module 204 can be physically connected to continuous analyte sensor(s) 202 and can be integral with (non-releasably attached to) or releasably attachable to continuous analyte sensor(s) 202”, “a telemetry module for transmitting data from the sensor electronics module to one or more display devices.”, and Paragraph 0089: “a plurality of different display devices can be in direct wireless communication with a sensor electronics module (e.g., such as an on-skin sensor electronics module 204 that is physically connected to continuous analyte sensor(s) 202)”); and
control circuitry (electronics circuitry) communicatively coupled to the electronics module (sensor electronics module 204) (Paragraph 0085: “sensor electronics module 204 includes electronic circuitry associated with measuring and processing the continuous analyte sensor data, including prospective algorithms associated with processing and calibration of the sensor data. Sensor electronics module 204 can be physically connected to continuous analyte sensor(s) 202 and can be integral with (non-releasably attached to) or releasably attachable to continuous analyte sensor(s) 202.”, Paragraph 0049: “continuous analyte monitoring system 104 is configured to continuously measure one or more analytes and transmit the analyte measurements to display device 107 for use by application 106”, “continuous analyte monitoring system 104 is configured to continuously measure one or more analytes and transmit the analyte measurements to display device 107 for use by application 106”, Paragraph 0051: “Decision support engine 114 refers to a set of software instructions with one or more software modules, including data analysis module (DAM) 116”, “decision support engine 114 may provide decision support recommendations to the user via application 106. Decision support engine 114 provides decision support recommendations based on information included in user profile 118.”, Paragraph 0214: “FIG. 7 is a block diagram depicting a computing device 700 configured to execute a decision support engine (e.g., decision support engine 114)”, “computing device 700 includes a processor 705, memory 710, storage 715, a network interface 725, and one or more I/O interfaces 720. In the illustrated embodiment, processor 705 retrieves and executes programming instructions stored in memory 710, as well as stores and retrieves application data residing in storage 715. Processor 705 is generally representative of a single CPU and/or GPU, multiple CPUs and/or GPUs, a single CPU and/or GPU having multiple processing cores,”, and Paragraph 0216: “Decision support engine 114 is executed by computing device 700 to perform operations 402-416 of method 400 in FIG. 4.”) and
configured to:
determine a choline state based on one or more signals from the first set of working electrodes (Paragraph 0082: “the continuous analyte sensor 202 provides a data stream indicative of the concentration of one or more analytes in the user. The data stream may include raw data signals, which are then converted into a calibrated and/or filtered data stream used to provide estimated analyte value(s) to the user.” And Paragraph 0304: “continuous choline sensor device can be provided, for example, using choline oxidase enzyme that generates hydrogen peroxide with the oxidation of choline”);
determine a tissue oxygen state based on one or more signals from the second set of working electrodes (Paragraph 0293: “sensing oxygen level changes electrochemically, for example in a Clark type electrode setup, or in a different configuration can be carried out, for example by coating the electrode with one or more membranes of one or more polymers, such as NAFION”, Paragraph 0293: “sensing oxygen level changes electrochemically, for example in a Clark type electrode setup, or in a different configuration can be carried out, for example by coating the electrode with one or more membranes of one or more polymers, such as NAFION™. Based on changes of potential, oxygen concentration changes can be recorded,”, and Paragraph 0323: “Signal extracted can then be analyzed to measure the concentration of the two different analytes.”);
However, Ray does not teach store threshold values that are indicative of opioid exposure;
determine an opioid condition based on at least the choline state and the tissue oxygen state, and initiate an alarm condition based on the opioid condition.
Insler teaches control circuitry (processor) communicatively coupled to the electronics module (Computer system 200) (Paragraph 0018: “the at least one of the one or more physiological parameters is peripheral capillary oxygen saturation (SpO2), its threshold being 85% or 10-15 percent decrease below a baseline established for the individual.”, and Paragraph 0042: “By monitoring more than one physiological parameter, the device is able to more accurately predict and respond to an overdose. The computer system includes a processor that is programmed with an algorithm designed to determine when an overdose has occurred.”) and configured to:
store threshold values that are indicative of opioid exposure (Paragraph 0018: “The processor includes instructions stored in a memory: to receive the measured physiological parameters from the one or more sensors and compare each such parameter to a predetermined threshold for said parameter; and to trigger an alarm, if one or more of the thresholds are crossed”);
determine an opioid condition (Paragraph 0005: “An opioid overdose is notable for sedation, reduced breathing rate, peripheral capillary oxygen saturation (SpO2), heart rate, and blood pressure. If untreated, it may lead to reduced oxygenation, cyanosis, organ damage and death”, “There are many physical changes that may occur during overdose and tracking several physical parameters with multiple sensors provides the most accurate assessment of the state of the patient and reduces false positives while avoiding disastrous false negatives (missing an actual overdose). Significant drops in respiratory rate, SpO2, and heart rate (and/or other physiological data) below a certain threshold triggers the device.”, and Paragraph 0042: “By monitoring more than one physiological parameter, the device is able to more accurately predict and respond to an overdose. The computer system includes a processor that is programmed with an algorithm designed to determine when an overdose has occurred.”), and
Rogers teaches determine an opioid condition based on at least the tissue oxygen state (Page 21, lines 12-14: “the implantable device comprises an implantable, closed-loop system that senses the presence of dangerously low tissue oxygenation that results from a drug overdose (e.g., opioid overdose)”, Page 21, lines 17-18: “The implantable device in certain embodiments integrates micro-scale, wireless oximeters for measuring tissue oxygen saturation (rStCb)”, and Page 21, lines 20-22: “The implantable device is a fully-implanted, closed-loop system that detects decreased tissue oxygenation that is an indicator of overdose”).
Ning teaches determine an opioid condition based on at least the choline state (Page 1, Background, right column, line 9: “Heroin (diacetylmorphine) is an opioid”, Abstract: “The concentration of phenylalanine, glutamine, and choline, the precursors of major neurotransmitters, increased during the reinstatement stage”, Page 3, Results, right column, lines 27-29: “Notably, the relative concentrations of three compounds, choline, glutamine and phenylalanine were elevated”, and Page 6, Discussion (Neurotransmitters), right column, lines 35-38: “Together, these results could depict a pathway through which the level of choline in the blood regulates the function of cholinergic neurons and then influences heroin relapse behavior.”).
Insler teaches initiate an alarm condition based on the opioid condition (Paragraph 0007: “when an overdose is recognized, the device responds with an alarm lasting for a short duration (about 20 seconds)”, and Paragraph 0022: “The processor includes instructions stored in a memory: to receive the measured physiological parameters from the one or more sensors and compare each such parameter to a predetermined threshold for said parameter; and to trigger an alarm, if one or more of the thresholds are crossed. The alarm is capable of being aborted. Aborting the alarm requires pressing both switches, and if the alarm is not aborted, the processor instructs transmitting of an alert to one or more contacts”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ray with Rogers’s determination of an opioid condition from decreased tissue oxygen because decreased tissue oxygenation would have indicated opioid overdose (Rogers, Page 21, lines 11-22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ray with Ning’s opioid-associated choline indicator because Ning reports that choline concentration would have increased following heroin re-exposure (Ning, Abstract (Result), Page 3, right column, lines 27-29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ray with Insler’s multi-parameter threshold analysis because monitoring multiple physiological parameters would have improved prediction and reduced false determination (Insler, Paragraphs 0015,0042).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MORGAN S SHIM whose telephone number is (571)272-9032. The examiner can normally be reached Mon-Fri 7:30AM-4:30PM.
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/MORGAN SANGJO SHIM/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
