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 .
Response to Amendment
Applicant’s Amendments filed 11th March 2026 have been entered. Claims 1-26, 52, 54 & 70 are pending.
Response to Arguments
Applicant’s arguments are moot with regards to claim 26 due to the newly applied art in light of the claim amendments.
Applicant argues that Toth ‘intends that a sensor for evaluation sPO2 is present somewhere a system that happens to include the patch. Applicant respectfully submits that, when taken in view of the entire specification as a whole, Toth does not provide explicitly or inherent support for the assertion that Toth discloses the an oxygen saturation sensor disposed in or on the substrate’.
Examiner respectfully disagrees with the Applicant’s analysis of Toth’s entire specification. Toth further utilizes the ‘module’ with the ‘patch’, disclosing coupling between them in Para. [0084]. Further, Toth specifies ‘patch/module’ as a pair including a sensor configured to assess change in oxygen saturation level in Para. [0226] ‘the patch/module pair may include a hydration sensor in accordance with the present disclosure, to assess the hydration state of the tissues, a change in color of the tissues, a change in oxygen saturation level, or the like.’. Applicant’s arguments are not persuasive.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 7 is objected to because of the following informalities:
Claim 7, ‘wherein substrate’ should likely read ‘wherein the substrate’.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9, 14, 23-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9, ‘the one or more impedance cardiography electrodes’, there is insufficient antecedent basis for this limitation in this claim.
Claim 14, ‘wherein the one or more sensors arranged to measure oxygen saturation’, there is insufficient antecedent basis for this limitation in this claim.
Claim 14, ‘or both’, this limitation implies recitation of a plurality of sensors arranged to measure oxygen saturation, however, claim 1 only recites ‘an oxygen saturation sensor’ as a sensor included in the plurality of sensors, rendering the scope of claim 14 indefinite.
Claim 23, ‘where each impedance cardiography electrode’, this limitation implies a plurality of impedance cardiography electrodes, but Claim 1 only recites ‘an impedance cardiography electrode’ as a sensor included in the plurality of sensors, rendering the scope of claim 23 indefinite. Examiner interprets the indefinite limitation to read ‘wherein the impedance cardiography electrode’, as best understood by the disclosure.
Claim 23, ‘where each impedance cardiography electrode comprises a first portion on a first surface and a second portion on a second surface of the substrate, the second surface being opposite the first surface’, it is unclear how an impedance cardiography electrode can comprise first and second portions on first and second surfaces of a substrate. It appears that this claim was meant to specify placement of a plurality of impedance cardiography electrodes on a substrate, however, with Claim 1 only reciting ‘an impedance cardiography electrode’ as a sensor included in the plurality of sensors, the scope of this claim is rendered indefinite.
Claim 24, ‘a first impedance cardiography electrode’ and ‘a second impedance cardiography electrode’, it is unclear whether either of these electrodes are the previously recited ‘an impedance cardiography electrode’ of claim 1 or not, rendering the scope of claim 24 indefinite.
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.
Claim 26 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20180070841 A1 to Honore et al. (hereinafter, Honore).
Regarding Claim 26, Honore discloses a monitoring patch (Honore: Abstract) comprising:
a substrate having an adhesive external surface (Honore: Para. [0070]; [0122-0123]);
a plurality of sensors disposed in and/or on the substrate, wherein the plurality of sensors includes: an accelerometer; and a strain gauge, wherein the monitoring patch is free of a sensor arranged to measure oxygen saturation, a lactate sensor, an impedance cardiography electrode, or a combination thereof (Honore: Para. [0043] “The wearable patch may include a sensor assembly having an acoustic sensor, an accelerometer, a strain gauge, and two thermometers.”; [0122-0123]).
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.
Claim(s) 1-25, 54, and 70 are rejected under 35 U.S.C. 103 as being unpatentable over US 20150335288 A1 to Toth et al. (hereinafter, Toth) in view of US 20180263539 A1 to Javey et al. (hereinafter, Javey) in further view of US 20220192600 A1 to Bang et al. (hereinafter, Bang).
Regarding Claim 1, Toth discloses a monitoring patch (Toth: Abstract) comprising:
a substrate having an adhesive surface (Toth: Para. [0017] “including a substrate, an adhesive coupled to the substrate formulated for attachment to the skin of a subject”);
a plurality of sensors disposed in and/or on the substrate (Toth: Para. [0017] “one or more sensors and/or electrodes each in accordance with the present disclosure coupled to the substrate, arranged, configured, and dimensioned to interface with the subject.”), wherein the plurality of sensors includes:
an oxygen saturation sensor (Toth: Para. [0084]; Para. [0226]);
Toth does not explicitly disclose the plurality of sensors including a lactate sensors.
However, Javey teaches:
a lactate sensor (Javey: Para. [0054] “FIG. 1c illustrates an example schematic of the sensor array (including, in this example, glucose, lactate, sodium, potassium and temperature sensors).”);
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the sensors of Toth to include a lactate sensor as taught by Javey since Toth teaches being able to include various types of sensors as desired including a sweat sensor (Toth: Para. [0042] and [0195]) and in order to conduct a multiplexed perspiration analysis (Javey: Para. [0054] ‘the sensor array (including, in this example, glucose, lactate, sodium, potassium and temperature sensors) for multiplexed perspiration analysis’).
Toth in view of Javey does not explicitly disclose the inclusion of an impedance cardiography electrode.
However, Bang teaches including an impedance cardiography electrode (Bang: Para. [0113] “system 10 is configured to measure Impedance Cardiography (ICG) via one or more of electrodes 110a, 110b, 210a, and/or 210b.”).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the sensors of Toth to include one or more impedance cardiography electrodes as taught by Bang since Toth teaches being able to include various types of sensors/electrodes as desired (Toth: Para. [0042] and [0161]) and in order to more accurately diagnose a patient than by analyzing a single data type (Bang: Para. [0128] “Analyzing data from multiple sensors types can enable system 10 to more accurately diagnose a patient than by analyzing a single data type (e.g. to generate a more accurate diagnosis and/or to generate a different type of diagnosis than otherwise possible with a single type of data).”)
Regarding Claim 2, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 1. Toth further discloses a sweat analyte sensor (Toth: Para. [0042]).
Toth does not explicitly disclose a sweat biosensor array.
However, Javey further teaches further comprising a sweat biosensor array (Javey: Para. [0009]; “a flexible substrate with a sweat analyte sensor array.”).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the sensors of Toth to include a sweat biosensor array as taught by Javey since Toth teaches being able to include various types of sensors as desired including a sweat sensor (Toth: Para. [0042] and [0195]) and in order to conduct a multiplexed perspiration analysis (Javey: Para. [0054] ‘the sensor array (including, in this example, glucose, lactate, sodium, potassium and temperature sensors) for multiplexed perspiration analysis’).
Regarding Claim 3, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 2. Toth further discloses a sweat analyte sensor (Toth: Para. [0042]).
Toth does not explicitly disclose a sweat biosensor array configured to detect Na+, K+, or a combination thereof.
However, Javey further teaches wherein the sweat biosensor array (Javey: Para. [0009]; “a flexible substrate with a sweat analyte sensor array.”) is configured to detect Na+, K+, or a combination thereof (Javey: Para. [0054] “FIG. 1c illustrates an example schematic of the sensor array (including, in this example, glucose, lactate, sodium, potassium and temperature sensors).”).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the sensors of Toth to include a sweat biosensor array as taught by Javey since Toth teaches being able to include various types of sensors as desired including a sweat sensor (Toth: Para. [0042] and [0195]) and in order to conduct a multiplexed perspiration analysis (Javey: Para. [0054] ‘the sensor array (including, in this example, glucose, lactate, sodium, potassium and temperature sensors) for multiplexed perspiration analysis’).
Regarding Claim 4, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 1. Toth further discloses a sweat analyte sensor (Toth: Para. [0042]).
Toth does not explicitly disclose a sweat biosensor array configured to detect pH, glucose, lactate, an alkali metal ion, an alkaline earth metal ion, or a combination thereof.
However, Javey further teaches wherein the sweat biosensor array (Javey: Para. [0009]; “a flexible substrate with a sweat analyte sensor array.”). is configured to detect pH, glucose, lactate, an alkali metal ion, an alkaline earth metal ion, or a combination thereof (Javey: Para. [0054] “FIG. 1c illustrates an example schematic of the sensor array (including, in this example, glucose, lactate, sodium, potassium and temperature sensors).”).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the sensors of Toth to include a sweat biosensor array as taught by Javey since Toth teaches being able to include various types of sensors as desired including a sweat sensor (Toth: Para. [0042] and [0195]) and in order to conduct a multiplexed perspiration analysis (Javey: Para. [0054] ‘the sensor array (including, in this example, glucose, lactate, sodium, potassium and temperature sensors) for multiplexed perspiration analysis’).
Regarding Claim 5, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 2. Toth further discloses a sweat analyte sensor (Toth: Para. [0042]).
Toth does not explicitly disclose a sweat biosensor array configured to measure sodium, pH, potassium, glucose, lactate, or a combination thereof.
However, Javey further teaches wherein the sweat biosensor array (Javey: Para. [0009]; “a flexible substrate with a sweat analyte sensor array.”). is configured to measure sodium, pH, potassium, glucose, lactate, or a combination thereof (Javey: Para. [0054] “the sensor array (including, in this example, glucose, lactate, sodium, potassium and temperature sensors).”).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the sensors of Toth to include a sweat biosensor array as taught by Javey since Toth teaches being able to include various types of sensors as desired including a sweat sensor (Toth: Para. [0042] and [0195]) and in order to conduct a multiplexed perspiration analysis (Javey: Para. [0054] ‘the sensor array (including, in this example, glucose, lactate, sodium, potassium and temperature sensors) for multiplexed perspiration analysis’).
Regarding Claim 6, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 1. Toth further discloses wherein the sensor includes a subcutaneous sensor (Toth: Para. [0072] “One or more of the microelectrodes may have a needle-like shape, the microelectrode including an insulated region and an exposed region (so as to interface with local tissues). The microelectrode may have a length such that the exposed region is positioned within the epidermal layer, the dermal layer, and/or the hypodermal layer of the skin upon attachment of the patch to the surface thereof. In aspects, one or more of the microelectrodes may be shaped so as to penetrate down a root of a follicle, to reach a sweat gland, a sebaceous gland, a muscle, a vessel, an arrector pili follicular muscle, or the like upon attachment of the patch interface to the skin.”).
Toth does not explicitly disclose a lactate sensor.
However, Javey further teaches a lactate sensor (Javey: Para. [0054] ‘the sensor array (including, in this example, glucose, lactate, sodium, potassium and temperature sensors)’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the sensors of Toth to include a lactate sensor as taught by Javey since Toth teaches being able to include various types of sensors in configurations as desired (Toth: Para. [0042] and [0072] and [0195]) and in order to conduct a multiplexed perspiration analysis (Javey: Para. [0054] ‘the sensor array (including, in this example, glucose, lactate, sodium, potassium and temperature sensors) for multiplexed perspiration analysis’).
Regarding Claim 7, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 6. Toth further discloses wherein substrate comprises a first side and a second side opposite the first side (Toth: Para. [0017]; Fig. 3f appears to have a first side and a second side opposite the first side, viewed as two symmetrical sides of one substrate.),
Toth does not explicitly disclose a lactate sensor.
However, Javey further teaches including a lactate sensor (Javey: Para. [0054] “FIG. 1c illustrates an example schematic of the sensor array (including, in this example, glucose, lactate, sodium, potassium and temperature sensors).”).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the monitoring patch of Toth by rearranging its components and incorporating a lactate sensor as taught by Javey in order to conduct a multiplexed perspiration analysis (Javey: Para. [0054] ‘the sensor array (including, in this example, glucose, lactate, sodium, potassium and temperature sensors) for multiplexed perspiration analysis’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the monitoring patch of Toth by rearranging its components and incorporating a lactate sensor as taught by Javey since Toth teaches being able to include various types of sensors in configurations as desired including a sweat sensor (Toth: Para. [0042] and [0195]) and in order to conduct a multiplexed perspiration analysis (Javey: Para. [0054] ‘the sensor array (including, in this example, glucose, lactate, sodium, potassium and temperature sensors) for multiplexed perspiration analysis’).
Further, arranging the lactate sensor on the first side of the substrate. The particular placement of the lactate sensor (on the first side of the substrate) in a monitoring patch is held to be an obvious matter of design choice to one skilled in the art. See MPEP 2144.04 VI. C.. The proposed arrangement involves a straightforward adaptation of known components to yield expected results of spatial optimization of the components for the monitoring patch.
Regarding Claim 8, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 7, further comprising a power source (Toth: Para. [0295]) or a connection for a power source (Toth: Para. [0310]; Para. [0459]).
Toth does not explicitly disclose the connection for a power source being disposed on the second side.
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the monitoring patch of Toth by rearranging its components, arranging the connection for a power source to be disposed on the second side of the substrate. The particular placement of the connection for a power source (disposed on the second side of the substrate) in a monitoring patch is held to be an obvious matter of design choice to one skilled in the art. See MPEP 2144.04 VI. C.. The proposed arrangement involves a straightforward adaptation of known components to yield expected results of spatial optimization of the components for the monitoring patch.
Regarding Claim 9, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 7. Toth does not explicitly disclose the inclusion of one or more impedance cardiography electrodes disposed on the second side.
However, Bang teaches the inclusion of one or more impedance cardiography electrodes (Bang: Para. [0113] ‘configured to measure Impedance Cardiography (ICG) via one or more of electrodes 110a, 110b, 210a, and/or 210b.’) are disposed on the second side (Bang: Para. [0086] ‘first electrode 110a and second electrode 110b shown (collectively or singularly electrode 110 herein). Electrodes 110 can be positioned on opposite ends of housing 101, such that they are positioned approximately a distance equal to L.sub.D from each other. ’; Fig. 3 item 110b, is one ICG electrode disposed on the second side)
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the sensors of Toth to include one or more impedance cardiography electrodes disposed on the second side as taught by Bang since Toth teaches being able to include various types of sensors/electrodes as desired (Toth: Para. [0042] and [0161]) and in order to more accurately diagnose a patient than by analyzing a single data type (Bang: Para. [0128] “Analyzing data from multiple sensors types can enable system 10 to more accurately diagnose a patient than by analyzing a single data type (e.g. to generate a more accurate diagnosis and/or to generate a different type of diagnosis than otherwise possible with a single type of data).”)
Regarding Claim 10, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 1. Toth further discloses further comprising a temperature sensor (Toth: Para. [0042] “a temperature sensor”).
Regarding Claim 11, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 1. Toth further discloses further comprising an electrocardiogram (ECG) surface electrode (Toth: Para. [0406] “a macro-electrode useful for providing a reference electrode to the microelectrodes, an electrode for measuring an ECG, EMG, ERG, signal, etc.”).
Regarding Claim 12, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 1. Toth further discloses further comprising a strain gauge (Toth: Para. [0195] “surface strain sensor (e.g. via integration of stretch sensors into the patch”).
Regarding Claim 13, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 1. Toth further discloses further comprising an accelerometer (Toth: Para. [0287] “the system includes a kinetic module including an accelerometer”).
Regarding Claim 14, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 1. wherein the one or more sensors arranged to measure oxygen saturation (Toth: Para. [0226] “a hydration sensor in accordance with the present disclosure, to assess the hydration state of the tissues, a change in color of the tissues, a change in oxygen saturation level, or the like.”)
include NIR emitter/detectors, IR emitter/detectors, or both (Toth: Para. [0221] “an embedded hydration sensor into a patch/module pair may include, embedding a visible, near infrared, or infrared emitter into the module”).
Regarding Claim 15, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 1. Toth further discloses circuitry is operably connected to the sensor (Toth: Para. [0289] “may include one or more sensors and/or microcircuitry configured to interface with the sensor(s), the sensors configured to monitor one or more physiologic, environmental, and/or physical parameters locally on the subject”; Fig. 3f) and
wherein the circuitry comprises a connector for connecting to a power source (Toth: Para. [0281] “a module may include a power source, a housing, one or more interconnects, signal conditioning circuitry, communication circuitry, a processor, a transceiver, a transducer, one or more sensors, an antenna, a buzzer, a button, a light source, and/or the like, configured to generate one or more signals (e.g. physiologic, electrophysiologic, and/or physical signals) or a feedback signal in accordance with the present disclosure.”).
The specific placement of circuitry on a second side of the substrate and the specific placement of the plurality of sensors comprising a sensor disposed in or on the first side are absent from Toth.
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the monitoring system of Toth to specify the positioning of components as a matter of design choice. The particular placement of the circuitry and sensors (circuitry on a second side of the substrate, the second side being opposite a first side, a sensor disposed in or on the first side) in the monitoring patch is held to be an obvious matter of design choice to one skilled in the art. See MPEP 2144.04 VI. C.. The proposed arrangement involves a straightforward adaptation of known components to yield expected results of spatial optimization of the components for the monitoring patch.
Regarding Claim 16, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 15. Toth further discloses wherein the power source is operably coupled to the substrate (Toth: Para. [0148] “the physiologic monitoring system may include one or more modules, each module may include a power source (e.g. a battery, a rechargeable battery, an energy harvesting transducer, microcircuit, and an energy reservoir, a thermal gradient harvesting transducer, a kinetic energy harvesting transducer, a radio frequency energy harvesting transducer, a fuel cell, a biofuel cell, etc.)”).
Regarding Claim 17, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 16. Toth further discloses wherein the power source is remotely located from the patch (Toth: Para. [0196]).
Regarding Claim 18, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 15. Toth further discloses further comprising a detachable wireless transmitter or transceiver configured to operably connect to the circuitry (Toth: Para. [0356] “a dongle or accessory for a mobile computing device… configured to coordinate communication with one or more patches/modules…”).
Regarding Claim 19, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 18. Toth further discloses wherein the detachable wireless transmitter or transceiver is (Toth: Para. [0356] “a dongle or accessory for a mobile computing device… configured to coordinate communication with one or more patches/modules…”)
a detachable Bluetooth transmitter or transceiver (Toth: Para. [0241]).
Regarding Claim 20, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 1. Toth further discloses wherein the monitoring patch is configured to connect to a mobile phone, a tablet, or a desktop computer (Toth: Para. [0355] ‘the host device may be operably worn/held by the subject, located near to the subject, integrated into a bedside alarm clock, or housed in an accessory (e.g. a purse, a backpack, a wallet, etc.). In aspects, the host device may be a mobile computing device (e.g. a smartphone, a tablet computer, a pager, etc.). In aspects, the host device may be a local router, a data recorder, a network hub, a server, a secondary mobile computing device, a router, a repeater, etc.’; Para. [0356] ‘the host device may be configured to coordinate communication with one or more patches/modules’; Note: Emphasis added).
Regarding Claim 21, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 1. Toth further discloses wherein the monitoring patch is configured to operably communicate with a remote server (Toth: Para. [0355] ‘the host device may be operably worn/held by the subject, located near to the subject, integrated into a bedside alarm clock, or housed in an accessory (e.g. a purse, a backpack, a wallet, etc.). In aspects, the host device may be a mobile computing device (e.g. a smartphone, a tablet computer, a pager, etc.). In aspects, the host device may be a local router, a data recorder, a network hub, a server, a secondary mobile computing device, a router, a repeater, etc.’; Para. [0356] ‘the host device may be configured to coordinate communication with one or more patches/modules’; Note: Emphasis added).
Regarding Claim 22, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 1. Toth further discloses wherein the substrate is configured to be bilaterally symmetrical, having a left portion and a right portion (Toth: Fig. 3f, when bilaterally divided, the substrate appears to be symmetrical, having a left portion and a right portion.).
Regarding Claim 23, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 1. Toth does not explicitly disclose a first or second impedance cardiography electrode and their position on the substrate.
However, Bang further teaches the inclusion of a first and second impedance cardiography electrode, and some placement options (Bang: Para. [0086] “Implantable device 100 can comprise one or more electrical components, such as first electrode 110a and second electrode 110b shown (collectively or singularly electrode 110 herein). Electrodes 110 can be positioned on opposite ends of housing 101, such that they are positioned approximately a distance equal to L.sub.D from each other. At least a portion of each electrode 110 can be positioned outside of housing 101, such that each electrode 110 is in contact with the tissue of the patient. For example, a surface of an electrode 110 can be coplanar with a portion of housing 101 surrounding the electrode 110 surface, such that the outer surface of implantable device 100 is relatively smooth at the electrode 110 location (e.g. electrode 110 does not protrude beyond an outer surface of housing 101)..”).
However, the specific placement where a first impedance cardiography electrode is positioned within the first portion and a second impedance electrode is positioned within the second portion is absent from Bang.
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the sensors of Toth by rearranging its components and incorporating one or more impedance cardiography electrodes as taught by Bang since Toth teaches being able to include various types of sensors/electrodes as desired (Toth: Para. [0042] and [0161]) and in order to more accurately diagnose a patient than by analyzing a single data type (Bang: Para. [0128] ‘Analyzing data from multiple sensors types can enable system 10 to more accurately diagnose a patient than by analyzing a single data type (e.g. to generate a more accurate diagnosis and/or to generate a different type of diagnosis than otherwise possible with a single type of data).’).
Further, arranging where each impedance cardiography electrode comprises a portion on a first surface and a portion on a second surface of the substrate, the second surface being opposite the first surface. is a matter of design choice. The particular placement of each impedance cardiography electrode (comprises a portion on a first surface and a portion on a second surface of the substrate) in a monitoring patch is held to be an obvious matter of design choice to one skilled in the art. See MPEP 2144.04 VI. C.. The proposed arrangement involves a straightforward adaptation of known components to yield expected results of spatial optimization of the components for the monitoring patch.
Regarding Claim 24, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 23. Toth further discloses wherein the substrate is configured to be bilaterally symmetrical, having a first side and a second side opposite the first side (Toth: Para. [0017]; Fig. 3f appears to have a first side and a second side opposite the first side, viewed as two symmetrical sides of one substrate.).
Toth does not explicitly disclose impedance cardiography electrodes and their position on the substrate.
However, Bang further teaches the inclusion of a first and second impedance cardiography electrode, and some placement options including where electrodes are coplanar with the substrate (Bang: Para. [0086] “Implantable device 100 can comprise one or more electrical components, such as first electrode 110a and second electrode 110b shown (collectively or singularly electrode 110 herein). Electrodes 110 can be positioned on opposite ends of housing 101, such that they are positioned approximately a distance equal to L.sub.D from each other. At least a portion of each electrode 110 can be positioned outside of housing 101, such that each electrode 110 is in contact with the tissue of the patient. For example, a surface of an electrode 110 can be coplanar with a portion of housing 101 surrounding the electrode 110 surface, such that the outer surface of implantable device 100 is relatively smooth at the electrode 110 location (e.g. electrode 110 does not protrude beyond an outer surface of housing 101).”).
The specific placement wherein a first impedance cardiography electrode is positioned within the first substrate portion and a second impedance electrode is positioned within the second substrate portion is absent from Bang.
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the sensors of Toth by rearranging its components and incorporating one or more impedance cardiography electrodes as taught by Bang since Toth teaches being able to include various types of sensors/electrodes as desired (Toth: Para. [0042] and [0161]) and in order to more accurately diagnose a patient than by analyzing a single data type (Bang: Para. [0128] ‘Analyzing data from multiple sensors types can enable system 10 to more accurately diagnose a patient than by analyzing a single data type (e.g. to generate a more accurate diagnosis and/or to generate a different type of diagnosis than otherwise possible with a single type of data).’).
Further, arranging wherein a first impedance cardiography electrode is positioned within the first substrate portion and a second impedance electrode is positioned within the second substrate portion is a matter of design choice. The particular placement of the impedance cardiography electrodes (within the first substrate portion; within the second substrate portion) in a monitoring patch is held to be an obvious matter of design choice to one skilled in the art. See MPEP 2144.04 VI. C.. The proposed arrangement involves a straightforward adaptation of known components to yield expected results of spatial optimization of the components for the monitoring patch.
Regarding Claim 25, Toth in view of Javey in further view of Bang discloses the monitoring patch according to claim 1. Toth further discloses wherein the substrate is comprised of two or more layers (Toth: Para. [0477] “The patch includes one or more electrically insulating layers ”).
Regarding Claim 54, Toth in view of Javey in further view of Bang discloses a monitoring patch kit (Toth: Abstract) comprising: a plurality of patches comprising: a first patch comprising a monitoring patch according to claim 1 (See rejection of Claim 1 above. Toth further discloses a second patch (Toth: Para. [0148] “may include one or more patches, each patch adapted for attachment to the body of the subject”).
Regarding Claim 70, Toth in view of Javey in further view of Bang discloses a method, comprising: receiving data from one or more sensors on one or more monitoring patches according to claim 1 (See rejection of Claim 1 above.). Toth further discloses the one or more monitoring patches being positioned on a subject (Toth: Para. [0148] “may include one or more patches, each patch adapted for attachment to the body of the subject”).
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Toth in view of Javey and Bang in further view of US 20190030230 A1 to Connor.
Regarding Claim 52, Toth in view of Javey in further view of Bang discloses a system for combination use, comprising: a monitoring patch of claim 1 coupled to a patient (See rejection of Claim 1 above).
Toth does not explicitly disclose a mechanical circulatory support device operably coupled to the patient.
However, Connor teaches a mechanical circulatory support device operably coupled to the patient (Connor: Para. [0023];[0049]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the monitoring system of Toth to include a mechanical circulatory support device as taught by to adjust the circulatory assistance device in real time based on analysis of the biometric parameters to help prevent tissue degradation, promote wound healing, and help avoid amputation. (Connor: Para. [0014] “wherein the implanted circulatory assistance device assists in management of the person's cardiac rhythm and/or assists in pumping the person's blood, and wherein the operation of the implanted circulatory assistance device is controlled and/or adjusted in real time based on analysis of the biometric parameter. This system can help to prevent tissue degradation, can promote wound healing, and may even help to avoid amputation.”).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SHAWN CURTIS BROUGHTON/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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