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 1 objected to because of the following informalities: Claim 1 recites ‘’a temperature sensor embedded in the flexible housing, at to the contact zone and facing the contact zone”. For examining purposes, the claim will be interpreted to say “’a temperature sensor embedded in the flexible housing, at the contact zone and facing the contact zone”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 5, 6, 9-12, 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Golda (US 20200237309 A1) in view of Al-Ali (US 20170055896 A1).
Regarding claim 1, Golda teaches a vital signs monitoring system, the vital signs monitoring system comprising a wearable patch (wearable device 100) ([0162] The device 100 monitors physiological signals and/or collects data representative thereof. The collected data may then be transmitted wirelessly or by wire connection, in real time, to the nearby base station) and a mobile computing device ([0021] a circuit may include (ii) at least one signal processing module for receiving and/or accepting signals from the at least one sensor in some implementations also providing for transforming such signals for storage as patient data; and/or (iii) at least one memory module for receiving and/or accepting and storing patient data, and/or (iv) at least one data communication module for transferring patient data, stored or otherwise to an external device), the wearable patch including: a flexible housing ([0021] Moreover, systems hereof may be established to measure and/or process such signals of a patient using or including any one or more of the following elements: (a) a circuit, sometimes flexible as in or on or forming a flexible or flex circuit board, embedded in or on a flat elastic substrate or board having a top surface and a bottom surface, the circuit having one or more of (i) at least one sensor mounted in or on or adjacent the bottom surface of the flat elastic substrate) which includes a contact zone (Fig 1; patient side or circuit side 102), which is a thermally conductive material ([0058] on the patient side 102, the ECG electrodes 108, 109 and 110 may be left exposed for substantially direct patient skin contact (though likely with at least a conductive gel applied therebetween); and/or, in many implementations, the patient side electrodes 108, 109 and/or 110 may be covered by a conductive adhesive material), and a border region around the contact zone [[0092] As shown in FIGS. 1O and 1O1, three isolated conductive portions 113c may be disposed separated from each other by a body portion 113b which may be non-conductive. These could then correspond to the electrodes 108, 109, 110 from the above-described examples, and as more particularly shown schematically in FIG. 1P (note the scale is exaggerated for the adhesive 113a and thus, exact matching to the electrodes of device 100 is not necessarily shown)); an adhesive on at least part of the border region (Fig 1P; adhesive 113)); an electrocardiogram sensor embedded in the flexible housing ([0034] These are the ECG electrodes 508 and 509), a photoplethysmogram sensor embedded in the flexible housing (Fig 1G; the PPG (photoplethysmograph) device/sensor 511); a temperature sensor embedded in the flexible housing (Fig 1G; a temperature sensor 515), at the contact zone and facing the contact zone ([0034] With many electrical components removed from the bottom, subject facing layer, here layer 503a, this layer 503a remains extremely flexible and has the capability to conform to a wide variety of body types, sizes and shapes and body motions. Only a few components remain on this lower layer 503a; typically, in this implementation, the actual sensors themselves. These are the ECG electrodes 508 and 509, the PPG (photoplethysmograph) device/sensor 511, a temperature sensor 515); and a microprocessor which includes a wireless radio for transmitting data to the mobile computing device ([0162] The device transmits the physiologic signals wirelessly or by wire (e.g., USB) to a nearby base station for interpretation and further transmission, if desired. The wireless transmission may use Bluetooth, Wi-Fi, Infrared, RFID (Radio Frequency IDentification) or another wireless protocol), the mobile computing device including: a memory (Fig 4; a main memory 404); a processor (Fig 4; at least one processor 402); a wireless radio ([0162] The device transmits the physiologic signals wirelessly or by wire (e.g., USB) to a nearby base station for interpretation and further transmission, if desired. The wireless transmission may use Bluetooth, Wi-Fi, Infrared, RFID (Radio Frequency IDentification) or another wireless protocol); and a screen ([0115] data can be collected from the patient in the patient's real-world circumstances. Then, after collection, the data can be transmitted from its storage on device 100 back to the desired computing resource (FIG. 4, e.g.), and such transmission might be wireless or wired or come combination of both, as for example a blue tooth or Wi-Fi connection to a personal computer (FIG. 4 for one example) which might then communicate the data over the internet to the designated computer for final analysis), wherein the memory is configured for machine learning ([0113] data analysis operation 304 for analyzing the data for determination of the relative health and/or for condition diagnosis of a patient. Computing systems, e.g., a computer (could be of many types, whether hand-held, personal or mainframe or other; see FIG. 4 and description below) could be used for this analysis; however, it could be that sufficient intelligence might be incorporated within the electronics 103 of device 100 such that some analysis might be operable on or within device 100 itself) ([0168] A variety of these steps may be performed by hardware components or may be embodied in machine-executable instructions, which may be used to cause a general-purpose or special-purpose processor programmed with the instructions to perform the steps) and to instruct the processor to convert the electrocardiogram data, the photoplethysmogram data and the temperature data into vital signs data and to display the vital signs data on the screen ([0119] Many more combinations of the four physiologic parameters are possible, and the ability of software hereof to display and highlight possible problems will greatly aid the physician in diagnosis. Thus, a system as described hereof can provide beneficial data interpretation) ([0122] Data/Results Presentation, whether including one or more graphical user interface(s) (GUIs) perhaps more particularly with an overall Summary and/or General Statistics and/or Anomaly Summary of Patient triggered event(s)).
Golda fails to fully teach a contact zone, which is a thermally conductive material, and a border region around the contact zone, wherein the electrocardiogram sensor includes a first electrode which is on the border region and a second electrode which is either on the border region or is for releasable attachment on a user at a site remote to the wearable patch.
However, Al-Ali teaches a contact zone (Fig 6C; aperture 404), which is a thermally conductive material ([0126] Under the through-hole vias 410 is an aperture 404 which extends through the mounting frame 330 and through the bottom base 310 of the wireless sensor 102. The aperture 404 provides access from the temperature sensor 218 to the patient's skin when the wireless sensor 102 is worn by the patient. The aperture 404 and the through-hole vias 410 are filled with thermally conductive material 402) ([0123] The aperture 704 and the through-hole vias 710 are filled with electrically conductive material to form the ECG electrode 702) and a border region around the contact zone (Fig 7B; bottom base 310), an adhesive on at least part of the border region ([0103] The bottom surface of the bottom base 310 is then coated with a high tack, medical-grade adhesive); an electrocardiogram sensor embedded in the flexible housing ([0120] ECG lead electrode 707 and the ECG electrode 702 by which the electrical signals of the patient's heart can be sensed. Illustratively, when the electrodes 702 and 707 are positioned as depicted in FIG. 7A), wherein the electrocardiogram sensor includes a first electrode which is on the border region (Fig 7E; electrode 702) and a second electrode which is either on the border region or is for releasable attachment on a user at a site remote to the wearable patch (Fig 7B; electrode 702) ([0121] The ECG lead 706 can be extended from the reel 708 and locked in the desired position, thereby enabling placement of the ECG lead electrode 707 at a desired location on the patient's chest).
It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Golda to include a contact zone, which is a thermally conductive material, and a border region around the contact zone, wherein the electrocardiogram sensor includes a first electrode which is on the border region and a second electrode which is either on the border region or is for releasable attachment on a user at a site remote to the wearable patch. Doing so allows the contact zone to be conductively attached to the electrodes and allows for one electrode to releasably attach to a site other than on the patch for acquiring signals from other locations on the body.
Regarding claim 5, Golda teaches the vital signs monitoring system of claim 4, but fails to teach wherein the second electrode is on the border region. However, Al-Ali teaches wherein the second electrode is on the border region (Fig 7B; electrode 707). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Golda to include wherein the second electrode is on the border region. Doing so allows for the option of having the electrode on the patch or releasably attached to another site for acquiring signals from other locations on the body.
Regarding claim 6, Golda teaches a wearable vital signs monitoring patch (wearable device 100) ([0162] The device 100 monitors physiological signals and/or collects data representative thereof. The collected data may then be transmitted wirelessly or by wire connection, in real time, to the nearby base station) for use with a mobile computing device ([0021] a circuit may include (ii) at least one signal processing module for receiving and/or accepting signals from the at least one sensor in some implementations also providing for transforming such signals for storage as patient data; and/or (iii) at least one memory module for receiving and/or accepting and storing patient data, and/or (iv) at least one data communication module for transferring patient data, stored or otherwise to an external device), the wearable vital signs monitoring patch comprising: a flexible housing ([0021] Moreover, systems hereof may be established to measure and/or process such signals of a patient using or including any one or more of the following elements: (a) a circuit, sometimes flexible as in or on or forming a flexible or flex circuit board, embedded in or on a flat elastic substrate or board having a top surface and a bottom surface, the circuit having one or more of (i) at least one sensor mounted in or on or adjacent the bottom surface of the flat elastic substrate) which includes a contact zone (Fig 1; patient side or circuit side 102), which is a thermally conductive material; an adhesive on at least part of the border region; an electrocardiogram sensor embedded in the flexible housing ([0034] These are the ECG electrodes 508 and 509); a photoplethysmogram sensor embedded in the flexible housing; (Fig 1G; the PPG (photoplethysmograph) device/sensor 511); a temperature sensor embedded in the flexible housing (Fig 1G; a temperature sensor 515), located at the contact zone and facing the contact zone ([0034] With many electrical components removed from the bottom, subject facing layer, here layer 503a, this layer 503a remains extremely flexible and has the capability to conform to a wide variety of body types, sizes and shapes and body motions. Only a few components remain on this lower layer 503a; typically, in this implementation, the actual sensors themselves. These are the ECG electrodes 508 and 509, the PPG (photoplethysmograph) device/sensor 511, a temperature sensor 515); and a microprocessor which includes a wireless radio for transmitting data to the mobile computing device ([0162] The device transmits the physiologic signals wirelessly or by wire (e.g., USB) to a nearby base station for interpretation and further transmission, if desired. The wireless transmission may use Bluetooth, Wi-Fi, Infrared, RFID (Radio Frequency IDentification) or another wireless protocol).
Golda fails to fully teach which includes a contact zone, which is a thermally conductive material and a border region around the contact zone; an adhesive on at least part of the border region; wherein the electrocardiogram sensor includes a first electrode which is on the border region and a second electrode which is either on the border region or is for releasable attachment on a user at a site remote to the wearable patch.
However, Al-Ali teaches a contact zone (Fig 6C; aperture 404), which is a thermally conductive material ([0126] Under the through-hole vias 410 is an aperture 404 which extends through the mounting frame 330 and through the bottom base 310 of the wireless sensor 102. The aperture 404 provides access from the temperature sensor 218 to the patient's skin when the wireless sensor 102 is worn by the patient. The aperture 404 and the through-hole vias 410 are filled with thermally conductive material 402) ([0123] The aperture 704 and the through-hole vias 710 are filled with electrically conductive material to form the ECG electrode 702) and a border region around the contact zone (Fig 7B; bottom base 310); an adhesive on at least part of the border region ([0103] The bottom surface of the bottom base 310 is then coated with a high tack, medical-grade adhesive); an electrocardiogram sensor embedded in the flexible housing ([0120] ECG lead electrode 707 and the ECG electrode 702 by which the electrical signals of the patient's heart can be sensed. Illustratively, when the electrodes 702 and 707 are positioned as depicted in FIG. 7A), wherein the electrocardiogram sensor includes a first electrode which is on the border region (Fig 7E; electrode 702) and a second electrode which is either on the border region or is for releasable attachment on a user at a site remote to the wearable patch (Fig 7B; electrode 702) ([0121] he ECG lead 706 can be extended from the reel 708 and locked in the desired position, thereby enabling placement of the ECG lead electrode 707 at a desired location on the patient's chest).
It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Golda to include a contact zone, which is a thermally conductive material and a border region around the contact zone; an adhesive on at least part of the border region; wherein the electrocardiogram sensor includes a first electrode which is on the border region and a second electrode which is either on the border region or is for releasable attachment on a user at a site remote to the wearable patch. Doing so allows the contact zone to be conductively attached to the electrodes and allows for one electrode to releasably attach to a site other than on the patch for acquiring signals from other locations on the body.
Regarding claim 9, Golda teaches the wearable vital signs monitoring patch of claim 8, but fails to teach wherein the second electrode is on the border region. However, Al-Ali teaches wherein the second electrode is on the border region (Fig 7B; electrode 707). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Golda to include wherein the second electrode is on the border region. Doing so allows for the option of having the electrode on the patch or releasably attached to another site for acquiring signals from other locations on the body.
Regarding claim 10, Golda teaches a method of monitoring a user’s vital signs, the method comprising: a user selecting the vital signs monitoring system of claim 5; the user providing a power source to the wearable patch ([0089] power source on board may include a battery and this can then also be re-charged between uses); the user releasably attaching the wearable patch to a selected skin surface ([0089] After a monitoring period is over, a physician, technician, patient or other person may then remove the device from the patient body, in some instances remove the adhesive, in some instances with alcohol); the electrocardiogram sensor sending and receiving electrical signals, the photoplethysmogram sensor sending and receiving light signals, and the temperature sensor sensing the user’s temperature, all to provide a data set ([0003] medical monitoring devices, systems and/or methods for parameter determination, in some instances for long-term sensing and/or recording of cardiac and/or respiratory and/or temperature and/or audio data of one or more individuals) ([0021] a circuit may include (ii) at least one signal processing module for receiving and/or accepting signals from the at least one sensor in some implementations also providing for transforming such signals for storage as patient data); the wireless radio sending the data set to the mobile computing device ([0021] at least one data communication module for transferring patient data, stored or otherwise to an external device) ([0089] [0089] After a monitoring period is over, a physician, technician, patient or other person may then remove the device from the patient body, in some instances remove the adhesive, in some instances with alcohol, and may establish a data communication connection for data transfer, e.g., by wireless communication or by insertion/connection of a USB or like data connector to download the data); the mobile computing device analyzing the data set to provide a vital signs reading ([0089] The data may then be processed and/or interpreted and in many instances, interpreted immediately if desired) ([0113] data analysis operation 304 for analyzing the data for determination of the relative health and/or for condition diagnosis of a patient. Computing systems, e.g., a computer (could be of many types, whether hand-held, personal or mainframe or other; see FIG. 4 and description below) could be used for this analysis; however, it could be that sufficient intelligence might be incorporated within the electronics 103 of device 100 such that some analysis might be operable on or within device 100 itself) ([0162] The device 100 monitors physiological signals and/or collects data representative thereof. The collected data may then be transmitted wirelessly or by wire connection, in real time, to the nearby base station); and the mobile computing device displaying the vital signs reading ([0120] data analysis time may be relatively quick, at approximately less than 15 minutes, less than 10 minutes, and less than 5 minutes in some implementations, and might be achieved with a user-friendly GUI (Graphic User Interface) to guide the physician through the analysis software) ([0121] Data/Results Presentation, whether including one or more graphical user interface(s) (GUIs) perhaps more particularly with an overall Summary and/or General Statistics and/or Anomaly Summary of Patient triggered event(s); presentation of additional levels of detail whether of Strip view(s) of anomaly data by incident (previous, next) Blood Oxygen saturation, stress correlation or the like; and/or allowing care provider bookmarking/annotations/notes by incident and/or Print capability).
Regarding claim 11, Golda teaches the method of claim 10 wherein the displaying the vital signs reading is in real time ([0162] The collected data may then be transmitted wirelessly or by wire connection, in real time, to the nearby base station).
Regarding claim 12, Golda teaches a vital signs monitoring system, the vital signs monitoring system comprising a wearable patch (wearable device 100) ([0162] The device 100 monitors physiological signals and/or collects data representative thereof. The collected data may then be transmitted wirelessly or by wire connection, in real time, to the nearby base station), a mobile computing device ([0021] a circuit may include (ii) at least one signal processing module for receiving and/or accepting signals from the at least one sensor in some implementations also providing for transforming such signals for storage as patient data; and/or (iii) at least one memory module for receiving and/or accepting and storing patient data, and/or (iv) at least one data communication module for transferring patient data, stored or otherwise to an external device) ([0162] The device transmits the physiologic signals wirelessly or by wire (e.g., USB) to a nearby base station for interpretation and further transmission, if desired. The wireless transmission may use Bluetooth, Wi-Fi, Infrared, RFID (Radio Frequency IDentification) or another wireless protocol) ([0168] FIG. 4 is an example of computing resources or a computer system 400); the wearable patch including: a flexible housing ([0021] Moreover, systems hereof may be established to measure and/or process such signals of a patient using or including any one or more of the following elements: (a) a circuit, sometimes flexible as in or on or forming a flexible or flex circuit board, embedded in or on a flat elastic substrate or board having a top surface and a bottom surface, the circuit having one or more of (i) at least one sensor mounted in or on or adjacent the bottom surface of the flat elastic substrate) which includes a contact zone (Fig 1; patient side or circuit side 102), which is a thermally conductive material ([0058] on the patient side 102, the ECG electrodes 108, 109 and 110 may be left exposed for substantially direct patient skin contact (though likely with at least a conductive gel applied therebetween); and/or, in many implementations, the patient side electrodes 108, 109 and/or 110 may be covered by a conductive adhesive material); and a border region around the contact zone [[0092] As shown in FIGS. 1O and 1O1, three isolated conductive portions 113c may be disposed separated from each other by a body portion 113b which may be non-conductive. These could then correspond to the electrodes 108, 109, 110 from the above-described examples, and as more particularly shown schematically in FIG. 1P (note the scale is exaggerated for the adhesive 113a and thus, exact matching to the electrodes of device 100 is not necessarily shown)); an adhesive on at least part of the border zone (Fig 1P; adhesive 113)); an electrocardiogram sensor embedded in the flexible housing ([0034] These are the ECG electrodes 508 and 509); a photoplethysmogram sensor embedded in the flexible housing (Fig 1G; the PPG (photoplethysmograph) device/sensor 511); a temperature sensor embedded in the flexible housing (Fig 1G; a temperature sensor 515), proximate to the contact zone and facing the contact zone ([0034] With many electrical components removed from the bottom, subject facing layer, here layer 503a, this layer 503a remains extremely flexible and has the capability to conform to a wide variety of body types, sizes and shapes and body motions. Only a few components remain on this lower layer 503a; typically, in this implementation, the actual sensors themselves. These are the ECG electrodes 508 and 509, the PPG (photoplethysmograph) device/sensor 511, a temperature sensor 515); and a microprocessor which includes a wireless radio for transmitting data to the mobile computing device ([0162] The device transmits the physiologic signals wirelessly or by wire (e.g., USB) to a nearby base station for interpretation and further transmission, if desired. The wireless transmission may use Bluetooth, Wi-Fi, Infrared, RFID (Radio Frequency IDentification) or another wireless protocol), the mobile computing device including: a memory (Fig 4; a main memory 404); a processor (Fig 4; at least one processor 402); a wireless radio ([0162] The device transmits the physiologic signals wirelessly or by wire (e.g., USB) to a nearby base station for interpretation and further transmission, if desired. The wireless transmission may use Bluetooth, Wi-Fi, Infrared, RFID (Radio Frequency IDentification) or another wireless protocol); and a screen ([0115] data can be collected from the patient in the patient's real-world circumstances. Then, after collection, the data can be transmitted from its storage on device 100 back to the desired computing resource (FIG. 4, e.g.), and such transmission might be wireless or wired or come combination of both, as for example a blue tooth or Wi-Fi connection to a personal computer (FIG. 4 for one example) which might then communicate the data over the internet to the designated computer for final analysis); wherein the memory is configured for machine learning ([0113] data analysis operation 304 for analyzing the data for determination of the relative health and/or for condition diagnosis of a patient. Computing systems, e.g., a computer (could be of many types, whether hand-held, personal or mainframe or other; see FIG. 4 and description below) could be used for this analysis; however, it could be that sufficient intelligence might be incorporated within the electronics 103 of device 100 such that some analysis might be operable on or within device 100 itself) ([0168] A variety of these steps may be performed by hardware components or may be embodied in machine-executable instructions, which may be used to cause a general-purpose or special-purpose processor programmed with the instructions to perform the steps).
Golda fails to fully teach a remote computer; a contact zone, which is a thermally conductive material and a border region around the contact zone; an adhesive on at least part of the border zone; and the remote computer including: a memory; a processor; and a wireless radio; and to convert the electrocardiogram data, the photoplethysmogram data and the temperature sensor data into vital signs data and send the vital signs data to the mobile computing device.
However, Al-Ali teaches a remote computer ([0074] The patient monitor 106 includes a display 120, and a docking station, which is configured to mechanically and electrically mate with a portable patient monitor 122 also having a display 130), a contact zone (Fig 6C; aperture 404), which is a thermally conductive material ([0126] Under the through-hole vias 410 is an aperture 404 which extends through the mounting frame 330 and through the bottom base 310 of the wireless sensor 102. The aperture 404 provides access from the temperature sensor 218 to the patient's skin when the wireless sensor 102 is worn by the patient. The aperture 404 and the through-hole vias 410 are filled with thermally conductive material 402) ([0123] The aperture 704 and the through-hole vias 710 are filled with electrically conductive material to form the ECG electrode 702) and a border region around the contact zone (Fig 7B; bottom base 310), an adhesive on at least part of the border zone ([0103] The bottom surface of the bottom base 310 is then coated with a high tack, medical-grade adhesive); an electrocardiogram sensor embedded in the flexible housing ([0120] ECG lead electrode 707 and the ECG electrode 702 by which the electrical signals of the patient's heart can be sensed. Illustratively, when the electrodes 702 and 707 are positioned as depicted in FIG. 7A); and the remote computer including: a memory; a processor; and a wireless radio, ([0074] The patient monitor 106 is a processing device, and therefore includes the necessary components to perform the functions of a processing device, including at least one processor, a memory device, a storage device, input/output devices, and communications connections, all connected via one or more communication buses); and to convert the electrocardiogram data, the photoplethysmogram data and the temperature sensor data into vital signs data and send the vital signs data to the mobile computing device ([0075] the display 120, alone or in combination with the display 130 of the portable patient monitor 122, may present a wide variety of measurement and/or treatment data in numerical, graphical, waveform, or other display indicia. For example, the display 120 can display a variety of patient-specific configurations and/or parameters, such as the patient's weight, age, type of treatment, type of disease, type of medical condition, nutrition, hydration and/or length of stay, among others).
It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Golda to include a remote computer; a contact zone, which is a thermally conductive material and a border region around the contact zone; an adhesive on at least part of the border zone; and the remote computer including: a memory; a processor; and a wireless radio; and to convert the electrocardiogram data, the photoplethysmogram data and the temperature sensor data into vital signs data and send the vital signs data to the mobile computing device. Doing so allows for a second computing system to provide additional monitoring and processing of data.
Regarding claim 15, Golda teaches the vital signs monitoring system of claim 14, wherein the electrocardiogram sensor includes two electrodes ([0034] These are the ECG electrodes 508 and 509); of which one is on the border region (Fig 1G; These are the ECG electrodes 508 and 509).
Golda fails to fully teach of which one is on the border region and one which is configured for placement on a user’s skin remote to the wearable patch.
However, Al-Ali teaches wherein the electrocardiogram sensor includes two electrodes ([0120] ECG lead electrode 707 and the ECG electrode 702 by which the electrical signals of the patient's heart can be sensed. Illustratively, when the electrodes 702 and 707 are positioned as depicted in FIG. 7A), of which one is on the border region (Fig 7E; electrode 702) and one which is configured for placement on a user’s skin remote to the wearable patch (Fig 7B; electrode 707) ([0121] The ECG lead 706 can be extended from the reel 708 and locked in the desired position, thereby enabling placement of the ECG lead electrode 707 at a desired location on the patient's chest). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Golda to include of which one is on the border region and one which is configured for placement on a user’s skin remote to the wearable patch. Doing so allows for one electrode to attach to a location other than the patch for collecting data another region of the body.
Regarding claim 16, Golda teaches the vital signs monitoring system of claim 14, but fails to teach wherein the second electrode is on the border region.
However, Al-Ali teaches wherein the second electrode is on the border region (Fig 7B; electrode 707). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Golda to include wherein the second electrode is on the border region. Doing so allows for signals to be collected at the site of the patch.
Regarding claim 17, Golda teaches a method of monitoring a user’s vital signs, the method comprising: a user selecting the vital signs monitoring system of claim 16; the user providing a power source to the wearable patch ([0089] power source on board may include a battery and this can then also be re-charged between uses); the user releasably attaching the wearable patch to a selected skin surface ([0089] After a monitoring period is over, a physician, technician, patient or other person may then remove the device from the patient body, in some instances remove the adhesive, in some instances with alcohol); the electrocardiogram sensor sending and receiving electrical signals, the photoplethysmogram sensor sending and receiving light signals and the temperature sensor sensing the user’s temperature, all to provide a data set ([0003] medical monitoring devices, systems and/or methods for parameter determination, in some instances for long-term sensing and/or recording of cardiac and/or respiratory and/or temperature and/or audio data of one or more individuals) ([0021] a circuit may include (ii) at least one signal processing module for receiving and/or accepting signals from the at least one sensor in some implementations also providing for transforming such signals for storage as patient data); the wireless radio sending the data set to the mobile computing device ([0021] at least one data communication module for transferring patient data, stored or otherwise to an external device) ([0089] After a monitoring period is over, a physician, technician, patient or other person may then remove the device from the patient body, in some instances remove the adhesive, in some instances with alcohol, and may establish a data communication connection for data transfer, e.g., by wireless communication or by insertion/connection of a USB or like data connector to download the data).
Golda fails to fully teach the mobile computing device sending the data set to the remote computer; the remote computer analyzing the data set to provide a vital signs reading; the remote computer sending the vital signs reading to the mobile computing device and the mobile computing device displaying the vital signs reading on the screen.
However, Al-Ali teaches the mobile computing device sending the data set to the remote computer ([0074] The patient monitor 106 is configured to wirelessly communicate with the wireless sensor 102. The patient monitor 106 includes a display 120, and a docking station, which is configured to mechanically and electrically mate with a portable patient monitor 122 also having a display 130) ([0075] In an embodiment, the display 120, alone or in combination with the display 130 of the portable patient monitor 122, may present a wide variety of measurement and/or treatment data in numerical, graphical, waveform, or other display indicia); the remote computer analyzing the data set to provide a vital signs reading ([0074] The patient monitor 106 is a processing device, and therefore includes the necessary components to perform the functions of a processing device); the remote computer sending the vital signs reading to the mobile computing device ([0075] the display 120, alone or in combination with the display 130 of the portable patient monitor 122, may present a wide variety of measurement and/or treatment data in numerical, graphical, waveform, or other display indicia. For example, the display 120 can display a variety of patient-specific configurations and/or parameters, such as the patient's weight, age, type of treatment, type of disease, type of medical condition, nutrition, hydration and/or length of stay, among others); and the mobile computing device displaying the vital signs reading on the screen ([[0077] FIG. 1B is a functional block diagram of an embodiment of the display 120 of the disclosed patient monitor 106 and the display 130 of the portable patient monitor 122. Display 120 of the patient monitor 106 can be configured to present patient physiological data 124, patient turn data 126, and/or additional, optional patient data 128). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Golda to include the mobile computing device sending the data set to the remote computer; the remote computer analyzing the data set to provide a vital signs reading; the remote computer sending the vital signs reading to the mobile computing device and the mobile computing device displaying the vital signs reading on the screen. Doing so allows for the mobile computing device to separately present data from the remote computer and for the two devices to be connected wirelessly for accurately updating signals.
Regarding claim 18, Golda teaches the method of claim 17, wherein the displaying the vital signs reading is in real time ([0162] The collected data may then be transmitted wirelessly or by wire connection, in real time, to the nearby base station).
Claim(s) 2, 7, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Golda (US 20200237309 A1) in view of Al-Ali (US 20170055896 A1), further on view of Trapero (US 11156965 B1).
Regarding claim 2, Golda teaches the vital signs monitoring system of claim 1, but fails to teach wherein the flexible housing comprises silicon. However, Trapero teaches wherein the flexible housing comprises silicon ([86] The smart patch of FIG. 12 can use a combination of skin-friendly materials with biocompatible substrates to achieve a thin, flexible, and elastic patch to be attached to the user. The substrate of the patch assembly 1200 can be made from thermoplastic polyurethane material (TPU), or variations of silicon and other elastic adhesives). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Golda to include wherein the flexible housing comprises silicon. Doing so allows the housing to comprise a flexible material in order to conform to the site of recording signals.
Regarding claim 7, Golda teaches the vital signs monitoring system of claim 6, but fails to teach wherein the flexible housing comprises silicon. However, Trapero teaches wherein the flexible housing comprises silicon ([86] The smart patch of FIG. 12 can use a combination of skin-friendly materials with biocompatible substrates to achieve a thin, flexible, and elastic patch to be attached to the user. The substrate of the patch assembly 1200 can be made from thermoplastic polyurethane material (TPU), or variations of silicon and other elastic adhesives). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Golda to include wherein the flexible housing comprises silicon. Doing so allows the housing to comprise a flexible material in order to conform to the site of recording signals.
Regarding claim 13, Golda teaches the vital signs monitoring system of claim 12, but fails to teach wherein the flexible housing comprises silicon. However, Trapero teaches wherein the flexible housing comprises silicon ([86] The smart patch of FIG. 12 can use a combination of skin-friendly materials with biocompatible substrates to achieve a thin, flexible, and elastic patch to be attached to the user. The substrate of the patch assembly 1200 can be made from thermoplastic polyurethane material (TPU), or variations of silicon and other elastic adhesives). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Golda to include wherein the flexible housing comprises silicon. Doing so allows the housing to comprise a flexible material in order to conform to the site of recording signals.
Claim(s) 3, 4, 8, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Golda (US 20200237309 A1) in view of Al-Ali (US 20170055896 A1), Trapero (US 11156965 B1), further on view of Pieri (US 20210345899 A1).
Regarding claim 3, Golda teaches the wearable vital signs monitoring patch of claim 2, but fails to teach wherein the thermally conductive material is a silicon thermal pad or a graphite thermal pad. However, Pieri teaches wherein the thermally conductive material is a silicon thermal pad or a graphite thermal pad ([0034] A first conducting shield layer 9A is in contact with the graphite layer 10A, and a second conducting shield layer 9B is in contact with the optional graphite layer 10B. The first and second conducting shield layers 9A, 9B substantially conform to the shape of their respective graphite layers 11A, 11B). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Golda to include wherein the thermally conductive material is a silicon thermal pad or a graphite thermal pad. Doing so provides a conducting material that can retrieve signals from the body through the patch.
Regarding claim 4, Golda teaches the wearable vital signs monitoring patch of claim 3, but fails to teach wherein the temperature sensor is a thermistor. However, Pieri teaches wherein the temperature sensor is a thermistor ([0068] A temperature sensor may be a thermistor). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Golda to include wherein the temperature sensor is a thermistor. Doing so allows for accurate and effective temperature monitoring/sensing.
Regarding claim 8, Golda teaches the wearable vital signs monitoring patch of claim 7, but fails to teach wherein the thermally conductive material is a silicon thermal pad or a graphite thermal pad. However, Pieri teaches wherein the thermally conductive material is a silicon thermal pad or a graphite thermal pad ([0034] A first conducting shield layer 9A is in contact with the graphite layer 10A, and a second conducting shield layer 9B is in contact with the optional graphite layer 10B. The first and second conducting shield layers 9A, 9B substantially conform to the shape of their respective graphite layers 11A, 11B). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Golda to include wherein the thermally conductive material is a silicon thermal pad or a graphite thermal pad. Doing so provides a conducting material that can retrieve signals from the body through the patch.
Regarding claim 14, Golda teaches the wearable vital signs monitoring patch of claim 13, but fails to teach wherein the thermally conductive material is a silicon thermal pad or a graphite thermal pad. However, Pieri teaches wherein the thermally conductive material is a silicon thermal pad or a graphite thermal pad ([0034] A first conducting shield layer 9A is in contact with the graphite layer 10A, and a second conducting shield layer 9B is in contact with the optional graphite layer 10B. The first and second conducting shield layers 9A, 9B substantially conform to the shape of their respective graphite layers 11A, 11B). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Golda to include wherein the thermally conductive material is a silicon thermal pad or a graphite thermal pad. Doing so provides a conducting material that can retrieve signals from the body through the patch.
Conclusion
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794