DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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(s) 1-3, 5-7, 11, 16-30, 32, 33, 35-51, 53-55, 59, 64-78, 80, 81, and 83-100 are rejected under 35 U.S.C. 103 as being unpatentable over Markel(US 20190125262 A1) in view of Longinotti-Buitoni(US 20180184735 A1), herein after referred to as Buitoni (both cited previously).
Regarding claim 1, Markel discloses a method for physiological analysis, the method comprising: a plurality of sensors, a plurality of conductors(The garment comprises a plurality of ECG sensors (or electrodes) integrated with the garment 101. For example, the garment 101 comprises ten sensors (or electrodes) disposed at locations generally associated with a twelve-lead ECG[0042]), and a hub, wherein the plurality of conductors electrically connect the plurality of sensors to the hub; releasably mounting associated on-board electronics to the hub and electrically connecting the associated on-board electronics to the hub(In an exemplary scenario, the central location 150 may comprise a communication hub by which measurement circuitry may electrically access the electrodes[0045]); using at least one sensor to acquire physiological data from a wearer of the garment; using the associated on-board electronics to generate a physiological profile based on at least one output from the plurality of sensors; communicating at least one aspect of the physiological profile to a processor located off or on the compression garment(Sub-step 1251 may, for example, be performed by one or more processors. Such processor(s) may, for example, be integrated in same garment as the ECG sensors and/or integrated in a different garment. Such processor(s) may also, for example, be located in a device (e.g., a personal electronic device) separate from the garment[0121]); and using the processor to analyze the at least one aspect of the physiological profile and generate a physiological assessment based on the analysis(The exemplary system 1500 additionally comprises one or more user interface modules 1530. Such user interface module(s) 1530 may, for example, operate to communicate information with a user (e.g., receive input information from such user and/or output information to such user)[0229]). Markel fails to explicitly disclose providing a compression garment; providing a wearable sensor array and coupling the wearable sensor array to the compression garment.
However, Buitoni teaches a garment system for monitoring electrical signals from a wearer's skin, wherein the electrical signals comprise the wearer's electrocardiogram (ECG), may include: a garment body formed of a compression fabric[0029]. A peripheral sensor (e.g. a sensor that is not part of the module such as a body sensor or interactive sensor, which sensors may be, for example an ink-based sensor or a traditional sensors, such as one implemented by an integrated circuit soldered on a rigid or flexible printed circuit board (PCBs)) may be connected to the smart module in any way. Such a connection may be, for example, made by a wire and/or a cable. Such a wire and/or cable may be fixed on the garment in any way[0277]. The sensor management unit 1921 may be a processor that is placed on the garment (e.g., on the back) in connection with an interface for connecting the sensors to the processor[0160]. A “power trace” (such as described elsewhere in the disclosure) may be used to supply power to a printed and/or physical sensor and/or a detector array strategically located on the apparel (“intelligent sensor”)[0282]. It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow the fabric of the garment to be made with compression qualities to keep the garment in close contact with the patients skin for signal monitoring.
Regarding claim 2, Markel in view of Buitoni discloses a method according to claim 1, wherein the compression garment has stretchable portions(Markel - One or more regions of extra elasticity may be formed in the garment to ensure that each of such sensors adequately contacts and remains in contact with the chest of the user[0036]).
Regarding claim 3, Markel in view of Buitoni discloses a method according to claim 2, Markel fails to disclose the stretchable portions stretch in a single dimension. However, Buitoni discloses (The sensors are held against the body by a support mechanism that can be expanded in a direction perpendicular to the sensor/inner surface of the garment... The support may be configured to expand in one direction (the direction perpendicular to the sensor and the wearer's body) but not a direction parallel to the skin of the person's body (e.g., the sensor and/or inner fabric of the garment[0013])).
It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow the fabric of the garment to stretch in specific directions to keep the garment in close contact with the patients skin for signal monitoring.
Regarding claim 5, Markel in view of Buitoni discloses a method according to claim 1, wherein the wearable sensor array is coupled to the compression garment so that the wearable sensor array faces a portion of skin of the wearer (Markel - portions of a sensor that need (or prefer) direct contact with the subject skin may be secured to the inside of the garment[0030]).
Regarding claim 6, Markel in view of Buitoni discloses a method according to claim 4, wherein the wearable sensor array is coupled to the compression garment, but Markel fails to specify so that the wearable sensor array faces away from a portion of skin of the wearer. However, Buitoni teaches sensors may include, for example: environmental sensors (detecting environmental temperature, humidity, etc.), camera(s) for visual detection, including fight levels/intensity, audio detectors (e.g., detecting user voice volume, tenor, etc.[0228]).
It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow the sensor array to face away from the skin of the wearer to provide relatively accurate and movement insensitive measurements over a sustained period of time.
Regarding claim 7, Markel In view of Buitoni discloses a method according to claim 6, wherein the compression garment comprises holes aligned with the sensors of the wearable sensor array so as to allow the sensors to directly contact the skin of the wearer(Markel - portions of a sensor that need (or prefer) direct contact with the subject skin may be secured to the inside of the garment[0030]).
Regarding claim 11, Markel in view of Buitoni discloses a method according to claim 1, however the following limitations “wherein the wearable sensor array is coupled to a portion of the compression garment, and then that portion of the compression garment is attached to another portion of the compression garment” describe the make of the method have no effect on the final outcome of the product and renders the claim to be additional non-limiting information.
Regarding claim 16, Markel in view of Buitoni discloses a method according to claim 1, Markel further discloses wherein the associated on board electronics are provided in one or more modules so as to enable computing power of the associated on-board electronics to be adjusted "on demand" (Markel - a health-care facility may communicate requests to the system implementing the method 1200 for additional information (e.g. additional cardiac information, user information, baseline ECG information, additional information from other
physiological and /or non-physiological sensors, location information, etc.).In response to such requests, the system implementing the method 1200 may acquire, analyze and/or communicate additional requested information to the request or[0119]; In other words, the various components and/or modules of the system 1500 might not be co-located in a single electrical device. For example, various modules of the system 1500 may be integrated in a plurality of different garments. Also for example, a first set of modules of the system 1500 may be integrated in a garment (e.g. sensor information acquisition modules and communication modules),and a second set of modules of the system 1500 may be implemented in a personal electronic device (e.g. ,information processing modules and/or other communication modules[0220])).
Regarding claim 17, Markel in view of Buitoni discloses a method according to claim 16, Markel further discloses wherein the hub comprises a USB-type connector allowing modules to be serially chained onto the hub( Markel - sub-step 1252 may comprise sorting information in a memory that may be read by another device via a hardwire port(e.g. a USB and/or FireWire port)[0126]).
Regarding claim 18, Markel in view of Buitoni discloses a method according to claim 1, Markel further discloses wherein a heat mitigator is disposed on the compression garment between the associated on-board electronics and at least one from a group consisting of the compression garment and the a portion of skin of the wearer (Markel – an extra layer of thermally insulative fabric and/or a moisture isolation layer may be disposed on the garment 701 between the sensor 762 and the body of the garment wearer to reduce the impact of the body temperature and/or moisture on the air sensor measurements[0073]).
Regarding claim 19, Markel in view of Buitoni discloses a method according to claim 1, wherein the plurality of sensors comprise at least one from a group consisting of a heart rate sensor, a respiration sensor, a body temperature sensor, and an orientation sensor (para[0027]- Such physiological sensors may, for example and without limitation, comprise: heart monitoring sensors (e.g., heart rate monitoring sensors, electrocardiogram (ECG or EKG) sensors),body temperature sensors, breath-rate/ respiration sensors(e.g., pressure-based(e.g., material stress, air pressure/bladder ,etc.), acoustic-based, etc.),skin conductivity sensors, oxygen saturation
sensors, blood perfusion sensors, etc.)[0027]).
Regarding claim 20, Markel in view of Buitoni discloses a method according to claim 1, but Markel fails to disclose wherein the plurality of conductors comprise at least one serpentine conductor. However, Buitoni discloses the SMS may include an electronic board. Connections to the SMS may be made by connectors including wire ribbon material (e.g., a stitched zig-zag connector) that may be included as part of the garment[0106](Fig. 7A and 7B).
It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow one serpentine connector to provide garments to maintain reliable contact.
Regarding claim 21, Markel in view of Buitoni discloses a method according to claim 1, but Markel fails to disclose further comprising: mounting at least one haptic device to the compression garment, wherein the at least one haptic device is electrically connected to the hub and further wherein the at least one haptic device is configured to selectively apply a physical signal to the wearer; and using the physiological assessment to cause the associated on-board electronics to actuate the at least one haptic device so as to deliver the physical signal to the wearer.
However, Buitoni discloses a garment may include a plurality of sensors (as described below and illustrated in FIGS. 8A-8B illustrate a collar that may be included as part of the garment and includes a plurality of sensors (any of which may be included or omitted) to detect parameters indicative of a wearer's emotional state. Sensors may include, for example: environmental sensors (detecting environmental temperature, humidity, etc.), camera(s) for visual detection, including light levels/intensity, audio detectors (e.g., detecting user voice volume, tenor, etc.). The collar may also include any of the other sensors mentioned herein and incorporated by reference (motion sensors, position sensors, acceleration sensors, etc.). In addition, the collar may include one or more outputs (haptic outputs) to provide output, including feedback, to the wearer. Haptic outputs may include olfactory (scent emitting) outputs, tactile output (vibration, pinch, etc.), and the like. The collars described and shown in FIGS. 8A-8B may be configured as an emotion communication receiver (ECR)[0228].
It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow the associated electronics to actuate the at least one haptic device to deliver a physical signal for providing correct and adequate status of an individual.
Regarding claim 22, Markel in view of Buitoni discloses a method according to claim 1, wherein the compression garment is made of multiple panels(Markel – One or more regions of extra elasticity may be formed in the garment to ensure that each of such sensors adequately contacts with the chest of the user[0036]).
Regarding claim 23, Markel in view of Buitoni discloses a method according to claim 22, wherein the multiple panels are made of stretchable materials(Markel – One or more regions of extra elasticity may be formed in the garment to ensure that each of such sensors adequately contacts with the chest of the user[0036]).
Regarding claim 24, Markel in view of Buitoni discloses a method according to claim 22, but Markel fails to specify wherein the multiple panels provide stretch directionality. However, Buitoni teaches the sensors are held against the body by a support mechanism that can be expanded in a direction perpendicular to the sensor/inner surface of the garment... The support may be configured to expand in one direction (the direction perpendicular to the sensor and the wearer's body) but not a direction parallel to the skin of the person's body (e.g., the sensor and/or inner fabric of the garment[0013])).
It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow the fabric of the garment to stretch in specific directions to keep the garment in close contact with the patients skin for signal monitoring.
Regarding claim 25, Markel in view of Buitoni discloses a method according to claim 24, but Markel fails to specify wherein the stretch directionality enables total garment compression. However, Buitoni teaches the extended-wear monitoring garment may be flexible, compressive, and configured to continuously conform to a wearer's body when worn. The extended-wear monitoring garment may be configured to move with a wearer's body. A body sensor may be, for example, a printed sensor or a physical sensor and may be sufficiently flexible or extensible in at least one direction in order to maintain the flexibility of the shirt.[0044]
It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow the fabric of the garment to stretch in specific directions to keep the garment in close contact with the patients skin for signal monitoring.
Regarding claim 26, Markel in view of Buitoni discloses a method according to claim 24, but Markel fails to specify wherein the stretch directionality reduces motion artifact. However, Buitoni teaches the sensors are held against the body by a support mechanism that can be expanded in a direction perpendicular to the sensor/inner surface of the garment... The support may be configured to expand in one direction (the direction perpendicular to the sensor and the wearer's body) but not a direction parallel to the skin of the person's body (e.g., the sensor and/or inner fabric of the garment[0013]). Allowing movement in the garment only in a perpendicular direction minimizes the degree of motion of the patient, therefore reducing motion artifact.
It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow the fabric of the garment to stretch in specific directions to keep the garment in close contact with the patients skin for signal monitoring.
Regarding claim 27, Markel in view of Buitoni discloses a method according to claim 1, but Markel fails to specify wherein the compression garment is made of a single panel. However, Buitoni teaches a garment system may be a single, unitary garment (e.g., shirt, sweater, pants, unitard, etc.) or it may be a collection of garments that are specifically adapted to be worn together, such as an undershirt with one or more of a harness, overshirt, bra, etc.)[0015].
It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow the garment to be made of a single panel for ease of manufacture and cost efficiency.
Regarding claim 28, Markel in view of Buitoni discloses a method according to claim 27, however the following limitations “wherein the single panel is cut of material that defines a front and a back of the compression garment and the compression garment includes only a single seam” describe the make of the method have no effect on the final outcome of the product and renders the claim to be additional non-limiting information.
Regarding claim 29, Markel in view of Buitoni discloses a method according to claim 1, but Markel fails to specify wherein modifying appliques are included to apply local compression and reduce motion artifact. However, Buitoni teaches in some variations, the method of forming the garments may also include the addition of ‘stretching limiters’ made, e.g., of stripes of polyurethane material with limited elongation. They may be positioned by thermal welding in the inner part of the garment, in proximity of long ink traces (e.g. respiration traces), in order to prevent overstretching (e.g. during wearing) that could either break a trace, or determine permanent elongation, that must be avoided for functional and aesthetic reasons. To enhance their strength, they may be positioned in a way to run between two seams[0128]. Allowing movement in the garment only in a perpendicular direction minimizes the degree of motion of the patient, therefore reducing motion artifact.
It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow the fabric of the garment to stretch in specific directions to keep the garment in close contact with the patients skin for signal monitoring.
Regarding claim 30, Markel in view of Buitoni discloses a method according to claim 29, but Markel fails to specify wherein the appliques limit stretch of the compression garment. However, Buitoni teaches in some variations, the method of forming the garments may also include the addition of ‘stretching limiters’ made, e.g., of stripes of polyurethane material with limited elongation. They may be positioned by thermal welding in the inner part of the garment, in proximity of long ink traces (e.g. respiration traces), in order to prevent overstretching (e.g. during wearing) that could either break a trace, or determine permanent elongation, that must be avoided for functional and aesthetic reasons. To enhance their strength, they may be positioned in a way to run between two seams[0128].
It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow the fabric of the garment to stretch in specific directions to keep the garment in close contact with the patients skin for signal monitoring.
Regarding claim 32, Markel in view of Buitoni discloses a method according to claim 29, but Markel fails to disclose wherein the appliques limit compression garment motion artifact. However, Buitoni teaches in some variations, the method of forming the garments may also include the addition of ‘stretching limiters’ made, e.g., of stripes of polyurethane material with limited elongation. They may be positioned by thermal welding in the inner part of the garment, in proximity of long ink traces (e.g. respiration traces), in order to prevent overstretching (e.g. during wearing) that could either break a trace, or determine permanent elongation, that must be avoided for functional and aesthetic reasons. To enhance their strength, they may be positioned in a way to run between two seams[0128]. Allowing movement in the garment only in a perpendicular direction minimizes the degree of motion of the patient, therefore reducing motion artifact.
It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow the fabric of the garment to stretch in specific directions to keep the garment in close contact with the patients skin for signal monitoring.
Regarding claim 33, Markel in view of Buitoni discloses a method according to claim 1, wherein the associated on-board electronics include a rechargeable battery power source(Markel - Additionally, central location 150 may also, for example, comprise a power supply (e.g., a battery) or be conductively coupled to a power supply (e.g., a power supply integrated into the garment 101 and/or off-garment[0047]). While Markel does not explicitly state a rechargeable battery, it would be obvious to one of ordinary skill in the art based on optimization to include a rechargeable battery since Markel already discloses a battery and rechargeable batteries are commonly used in similar medical devices.
Regarding claim 35, Markel in view of Buitoni discloses a method according to claim 1, but Markel fails to disclose wherein the associated on-board electronics interact with a removable central processing unit. However, Buitoni teaches where it may be possible to remove the sensors or a portion of the sensor module prior to laundering[0038]. An SMS that is integrated into the garment...an integrated SMS can manage a larger number of connections with the different sensors, and may processes the signals and communicates with the phone by means of a single mini-USB cable (e.g., independently of the number of signals processed)[0107].
It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow for the electronics temporarily connected to the garment to be removed for washing.
Regarding claim 36, Markel in view of Buitoni discloses a method according to claim 1, but Markel fails to specify wherein the physiological assessment is provided to the wearer of the compression garment in real-time. However, Buitoni teaches such a communication
platform may be configured to accurately detect, process, compare, transfer and communicate, in real time, physiological signals of the wearer (such as a person, an animal, etc.)[0033].
It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow for the physiological assessment to be provided in real-time as such monitoring may allow early and effective intervention, and medica! assistance may be obtained based on monitored physiological characteristics before a particular health issue becomes fatal.
Regarding claim 37, Markel in view of Buitoni discloses a method according to claim 36, wherein the physiological assessment is provided through visible or audible feedback (Markel -for example in response to analysis performed at sub-step 1251, sub-step 1255 may comprise providing behavioral instructions to the user. For example, sub-step 1255 may comprise audibly
and/or visibly outputting instructions to the user regarding steps to take to minimize risk (e.g., sit down, lie down, breathe deeply, slow down, walk, take a particular drug, dial 911, drink water, etc.); para [0133]- Sub-step 1255 may, for example, comprise providing ECG results to a user. For example, sub-step 1255 may comprise outputting a graphical display of present ECG readings, a graphical display of ECG information that caused generation of an alert, etc. Sub-step 1255 may also, for example, comprise providing ECG analysis results to a user[0131]). Markel fails to disclose the real-time element, however, Buitoni discloses assessment is provided in real-time (such a communication platform may be configured to accurately detect, process, compare, transfer and communicate, in real time, physiological signals of the wearer (such as a person, an animal, etc.)[0033]).
It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow for the physiological assessment to be provided in real-time as such monitoring may allow early and effective intervention, and medica! assistance may be obtained based on monitored physiological characteristics before a particular health issue becomes fatal.
Regarding claim 38, Markel in view of Buitoni discloses a method according to claim 36, wherein the physiological assessment provides a warning to the wearer based on an aberration in the physiological profile (Markel - for example in response to analysis performed at sub-step 1251, sub-step 1255 may comprise providing behavioral instructions to the user. For example, sub-step 1255 may comprise audibly and/or visibly outputting instructions to the user regarding steps to take to minimize risk (e.g., sit down, lie down, breathe deeply, slow down, walk, take a particular drug, dial 911, drink water, etc.)[0131]; Sub-step 1255 may, for example, comprise providing an alert to a user (e.g., the garment wearer) of the system implementing the method 12:00[0130]).
Regarding claim 39, Markel in view of Buitoni discloses a method according to claim 1, wherein the physiological assessment comprises a graphical representation of the at least one aspect of the physiological profile (Markel - sub-step 1255 may comprise outputting a graphical display of present ECG readings, a graphical display of ECG information that caused generation of an alert, etc.[0133]).
Regarding claim 40, Markel in view of Buitoni discloses a method according to claim 1, wherein the physiological assessment comprises at least one indirect measurement derived from multiple sensor readings (Markel - For example, in an exemplary scenario, sub-step 1351 may comprise analyzing various non-ECG sensors and determine that the user is walking outside on a cool day. Sub-step 1351 may then, for example, comprise selecting a particular baseline ECG with which to compare a current ECG. In another exemplary scenario, sub-step 1351 may comprise analyzing various non-ECG sensors and determine that the user is shoveling snow. Sub-step 1351 may then, for example, comprise selecting a particular baseline ECG with which to compare a current ECG. Additionally, for example, in the snow-shoveling scenario, sub-step 1351 may comprise identifying snow-shoveling as an inherently dangerous cardiovascular activity, causing an increased level of analytical scrutiny and/or triggering communication with a health care facility for real-time monitoring by a health-care professional[0169]).
Regarding claim 41, Markel in view of Buitoni discloses a method according to claim 40, wherein the indirect measurement includes a derived heart rate, heart rate variability, respiration rate, respiration volume, skin temperature, body core temperature, body hydration, skin conductance level, or skin conductance response (Markel - Such physiological sensors may, for
example and without limitation, comprise: heart monitoring sensors (e.g., heart-rate monitoring sensors, electrocardiogram (ECG or EKG) sensors), body temperature sensors, breath-rate/respiration sensors (e.g., pressure-based (e.g., material stress, air pressure/bladder, etc.), acoustic-based, etc.), skin conductivity sensors, oxygen saturation sensors, blood perfusion sensors, etc.)[0027]).
Regarding claim 42, Markel in view of Buitoni discloses a method according to claim 40, wherein the indirect measurement includes an activity classification (Markel - For example, in an exemplary scenario, sub-step 1351 may comprise analyzing various non-ECG sensors and determine that the user is walking outside on a cool day[0169]).
Regarding claim 43, Markel in view of Buitoni discloses a method according to claim 42, wherein the activity classification includes sitting, standing, laying down, or walking(Markel - For example, in an exemplary scenario, sub-step 1351 may comprise analyzing various non-ECG sensors and determine that the user is walking outside on a cool day[0169]. Such garments may, for example, generally correspond to articles of clothing that a person may wear throughout the course of typical life activities (e.g., sleeping, eating, walking, working, exercising, watching television, doing household chores, traveling, socializing, etc.)[0026]).
Regarding claim 44, Markel in view of Buitoni discloses a method according to claim 1, wherein the physiological assessment comprises an estimation of data quality for at least one output from a first sensor, based on at least one output from a second sensor(Markel - Further for example, sub-step 1251 may comprise determining a difference (or trend) between a current cardiac signal and at least one previous cardiac signal, and determining the existence of a cardiac pathology based, at least in part, on spectral analysis of the determined difference (or trend)[0115]).
Regarding claim 45, Markel in view of Buitoni discloses a method according to claim 1, wherein the physiological assessment comprises an estimation of an wearer’s activity and posture(Markel - Such non-physiological sensors may also, for example, comprise situational sensors that operate to monitor characteristics of a physical situation (e.g., a task or activity) in which the subject is engaged. Such situation (or activity) sensors may, for example and without limitation, comprise: weight sensors, impact sensors, force sensors, pressure sensors, accelerometers, inclinometers, motion sensors, speed and/or velocity sensors, etc.[0029]
Regarding claim 46, Markel in view of Buitoni discloses a method according to claim 1, wherein the physiological assessment comprises an estimation of anomalous behavior (Markel -the exemplary method 1200 may begin executing in response to detecting an elevated body temperature and/or heart rate; para[0095])
Regarding claim 47, Markel in view of Buitoni discloses a method according to claim 1, but Markel fails to disclose wherein the compression garment is machine washable. However, Buitoni teaches the present extended-wear monitoring garment may include body sensors, conductive traces, and/or interactive sensors are configured to withstand immersion in water. Thus, in general, the wearable communication platforms described herein may be washed (e.g., washed in water)[0040]).
It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow for the electronics temporarily connected to the garment to be removed for washing.
Regarding claim 48, Markel in view of Buitoni discloses a method according to claim 1, wherein the compression garment connected to external devices(Markel - Circuitry at the central location 1610 operates to receive ECG signals from the various in-garment electrodes, prepare information describing such signals for transmission (e.g., characterizing such signals in terms of a set of voltage potential differences), and utilize a low-power transceiver to transmit ECG information to a personal electronic device 1650 worn by the user (e.g., in a belt holster). The personal electronic device 1650 then, for example, operates as a medium-power transceiver, transmitting the ECG information to a laptop computer 1670, which then analyzes the ECG information[0234]).
Regarding claim 49, Markel discloses a system for physiological analysis, the method comprising: mounting a plurality of sensors, a plurality of conductors(The garment comprises a plurality of ECG sensors (or electrodes) integrated with the garment 101. For example, the garment 101 comprises ten sensors (or electrodes) disposed at locations generally associated with a twelve-lead ECG[0042]), and a hub to a compression garment, wherein the plurality of conductors electrically connect the plurality of sensors to the hub, and mounting associated on-board electronics to at least one of the compression garment and the hub and electrically connecting the associated on-board electronics configured to be releasably mounted to the hub(In an exemplary scenario, the central location 150 may comprise a communication hub by which measurement circuitry may electrically access the electrodes[0045]); using at least one sensors is configured to acquire physiological data from a wearer of the garment; using the associated on-board electronics to generate a physiological profile based on at least one output from the plurality of sensors;(Sub-step 1251 may, for example, be performed by one or more processors. Such processor(s) may, for example, be integrated in same garment as the ECG sensors and/or integrated in a different garment. Such processor(s) may also, for example, be located in a device (e.g., a personal electronic device) separate from the garment[0121]); and using the processor to analyze the at least one aspect of the physiological profile and generate a physiological assessment based on the analysis(The exemplary system 1500 additionally comprises one or more user interface modules 1530. Such user interface module(s) 1530 may, for example, operate to communicate information with a user (e.g., receive input information from such user and/or output information to such user)[0229]). Markel fails to explicitly disclose a compression garment, and wearable sensor array configure to be coupled to be releasably mounted to the hub.
However, Buitoni teaches a garment system for monitoring electrical signals from a wearer's skin, wherein the electrical signals comprise the wearer's electrocardiogram (ECG), may include: a garment body formed of a compression fabric[0029]. A peripheral sensor (e.g. a sensor that is not part of the module such as a body sensor or interactive sensor, which sensors may be, for example an ink-based sensor or a traditional sensors, such as one implemented by an integrated circuit soldered on a rigid or flexible printed circuit board (PCBs)) may be connected to the smart module in any way. Such a connection may be, for example, made by a wire and/or a cable. Such a wire and/or cable may be fixed on the garment in any way[0277]. The sensor management unit 1921 may be a processor that is placed on the garment (e.g., on the back) in connection with an interface for connecting the sensors to the processor[0160]. A “power trace” (such as described elsewhere in the disclosure) may be used to supply power to a printed and/or physical sensor and/or a detector array strategically located on the apparel (“intelligent sensor”)[0282]. It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow the fabric of the garment to be made with compression qualities to keep the garment in close contact with the patients skin for signal monitoring.
Regarding claim 50, Markel in view of Buitoni discloses a system according to claim 49, wherein the compression garment has stretchable portions(Markel - One or more regions of extra elasticity may be formed in the garment to ensure that each of such sensors adequately contacts and remains in contact with the chest of the user[0036]).
Regarding claim 51, Markel in view of Buitoni discloses a system according to claim 50, Markel fails to disclose the stretchable portions stretch in a single dimension. However, Buitoni discloses (The sensors are held against the body by a support mechanism that can be expanded in a direction perpendicular to the sensor/inner surface of the garment... The support may be configured to expand in one direction (the direction perpendicular to the sensor and the wearer's body) but not a direction parallel to the skin of the person's body (e.g., the sensor and/or inner fabric of the garment[0013])).
It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow the fabric of the garment to stretch in specific directions to keep the garment in close contact with the patients skin for signal monitoring.
Regarding claim 53, Markel in view of Buitoni discloses a system according to claim 49, wherein the wearable sensor array is coupled to the compression garment so that the wearable sensor array faces a portion of skin of the wearer (Markel - portions of a sensor that need (or prefer) direct contact with the subject skin may be secured to the inside of the garment[0030]).
Regarding claim 54, Markel in view of Buitoni discloses a system according to claim 49, wherein the soft electronics assembly is mounted to the compression garment, but Markel fails to specify so that the wearable sensor array faces away from a portion of skin of the wearer. However, Buitoni teaches sensors may include, for example: environmental sensors (detecting environmental temperature, humidity, etc.), camera(s) for visual detection, including fight levels/intensity, audio detectors (e.g., detecting user voice volume, tenor, etc.[0228]).
It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow the sensor array to face away from the skin of the wearer to provide relatively accurate and movement insensitive measurements over a sustained period of time.
Regarding claim 55, Markel In view of Buitoni discloses a system according to claim 54, wherein the compression garment comprises holes aligned with the sensors of the wearable sensor array so as to allow the sensors to directly contact the skin of the wearer(Markel - portions of a sensor that need (or prefer) direct contact with the subject skin may be secured to the inside of the garment[0030]).
Regarding claim 59, Markel in view of Buitoni discloses a system according to claim 49, however the following limitations “wherein the wearable sensor array is coupled to a portion of the compression garment, and then that portion of the compression garment attached to another portion of the compression garment” describe the make of the method have no effect on the final outcome of the product and renders the claim to be additional non-limiting information.
Regarding claim 64, Markel in view of Buitoni discloses a system according to claim 49, Markel further discloses wherein the associated on board electronics are provided in one or more modules so as to enable computing power of the associated on-board electronics to be adjusted "on demand" (Markel - a health-care facility may communicate requests to the system implementing the method 1200 for additional information (e.g. additional cardiac information, user information, baseline ECG information, additional information from other
physiological and /or non-physiological sensors, location information, etc.).In response to such requests, the system implementing the method 1200 may acquire, analyze and/or communicate additional requested information to the request or[0119]; In other words, the various components and/or modules of the system 1500 might not be co-located in a single electrical device. For example, various modules of the system 1500 may be integrated in a plurality of different garments. Also for example, a first set of modules of the system 1500 may be integrated in a garment (e.g. sensor information acquisition modules and communication modules),and a second set of modules of the system 1500 may be implemented in a personal electronic device (e.g. ,information processing modules and/or other communication modules[0220])).
Regarding claim 65, Markel in view of Buitoni discloses a system according to claim 64, Markel further discloses wherein the hub comprises a USB-type connector allowing modules to be serially chained onto the hub( Markel - sub-step 1252 may comprise sorting information in a memory that may be read by another device via a hardwire port(e.g. a USB and/or FireWire port)[0126]).
Regarding claim 66, Markel in view of Buitoni discloses a system according to claim 49, Markel further discloses wherein a heat mitigator is disposed on the compression garment between the associated on-board electronics and at least one from a group consisting of the compression garment and a portion of skin of the wearer (Markel – an extra layer of thermally insulative fabric and/or a moisture isolation layer may be disposed on the garment 701 between the sensor 762 and the body of the garment wearer to reduce the impact of the body temperature and/or moisture on the air sensor measurements[0073]).
Regarding claim 67, Markel in view of Buitoni discloses a system according to claim 49, wherein the plurality of sensors comprise at least one from a group consisting of a heart rate sensor, a respiration sensor, a body temperature sensor, and an orientation sensor (para[0027]- Such physiological sensors may, for example and without limitation, comprise: heart monitoring sensors (e.g., heart rate monitoring sensors, electrocardiogram (ECG or EKG) sensors),body temperature sensors, breath-rate/ respiration sensors(e.g., pressure-based(e.g., material stress, air pressure/bladder ,etc.), acoustic-based, etc.),skin conductivity sensors, oxygen saturation
sensors, blood perfusion sensors, etc.)[0027]).
Regarding claim 68, Markel in view of Buitoni discloses a system according to claim 49, but Markel fails to disclose wherein the plurality of conductors comprise at least one serpentine conductor. However, Buitoni discloses the SMS may include an electronic board. Connections to the SMS may be made by connectors including wire ribbon material (e.g., a stitched zig-zag connector) that may be included as part of the garment[0106](Fig. 7A and 7B).
It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow one serpentine connector to provide garments to maintain reliable contact.
Regarding claim 69, Markel in view of Buitoni discloses a system according to claim 49, but Markel fails to disclose further comprising: at least one haptic device configured to be mounted to the compression garment, wherein the at least one haptic device is electrically connected to the hub and further wherein the at least one haptic device is further configured to selectively apply a physical signal to the wearer; and wherein the associated on-board electronics are configured to actuate the at least one haptic device so as to deliver the physical signal to the wearer based on the physiological assessment of the wearer.
However, Buitoni discloses a garment may include a plurality of sensors (as described below and illustrated in FIGS. 8A-8B illustrate a collar that may be included as part of the garment and includes a plurality of sensors (any of which may be included or omitted) to detect parameters indicative of a wearer's emotional state. Sensors may include, for example: environmental sensors (detecting environmental temperature, humidity, etc.), camera(s) for visual detection, including light levels/intensity, audio detectors (e.g., detecting user voice volume, tenor, etc.). The collar may also include any of the other sensors mentioned herein and incorporated by reference (motion sensors, position sensors, acceleration sensors, etc.). In addition, the collar may include one or more outputs (haptic outputs) to provide output, including feedback, to the wearer. Haptic outputs may include olfactory (scent emitting) outputs, tactile output (vibration, pinch, etc.), and the like. The collars described and shown in FIGS. 8A-8B may be configured as an emotion communication receiver (ECR)[0228].
It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow the associated electronics to actuate the at least one haptic device to deliver a physical signal for providing correct and adequate status of an individual.
Regarding claim 70, Markel in view of Buitoni discloses a system according to claim 49, wherein the compression garment is made of multiple panels(Markel – One or more regions of extra elasticity may be formed in the garment to ensure that each of such sensors adequately contacts with the chest of the user[0036]).
Regarding claim 71, Markel in view of Buitoni discloses a system according to claim 70, wherein the multiple panels are made of stretchable materials(Markel – One or more regions of extra elasticity may be formed in the garment to ensure that each of such sensors adequately contacts with the chest of the user[0036]).
Regarding claim 72, Markel in view of Buitoni discloses a system according to claim 70, but Markel fails to specify wherein the multiple panels provide stretch directionality. However, Buitoni teaches the sensors are held against the body by a support mechanism that can be expanded in a direction perpendicular to the sensor/inner surface of the garment... The support may be configured to expand in one direction (the direction perpendicular to the sensor and the wearer's body) but not a direction parallel to the skin of the person's body (e.g., the sensor and/or inner fabric of the garment[0013])).
It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow the fabric of the garment to stretch in specific directions to keep the garment in close contact with the patients skin for signal monitoring.
Regarding claim 73, Markel in view of Buitoni discloses a system according to claim 72, but Markel fails to specify wherein the stretch directionality enables total garment compression. However, Buitoni teaches the extended-wear monitoring garment may be flexible, compressive, and configured to continuously conform to a wearer's body when worn. The extended-wear monitoring garment may be configured to move with a wearer's body. A body sensor may be, for example, a printed sensor or a physical sensor and may be sufficiently flexible or extensible in at least one direction in order to maintain the flexibility of the shirt.[0044]
It would be obvious to one of ordinary skill in the art to configure the garment system with health-monitoring of Markel with the physiological monitoring garments of Buitoni. Doing so would allow the fabric of the garment to stretch in specific directions to keep the garment in close contact with the patients skin for signal monitoring.
Regarding claim 74, Markel in view of Buitoni discloses a system according to claim 72, but Markel fails to specify wherein the stretch directionality reduces motion artifact. However, Buitoni teaches the sensors are held against the body by a support mechanism that can be expanded in a dire