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 .
Status of Claims
This action is a final rejection
Claims 1-24, 33-34 are pending
Claims 25-32 were previously cancelled
Claims 1-2, 4-8, 12-13, 22-24, 33 were amended
Claim 34 was added
Claims 8, 34 are objected
Claims 1-24, 33-34 are rejected under 35 USC § 101
Claims 1-2, 6-7, 10-11, 14-16, 22-24, 33 are rejected under 35 USC § 102
Claims 3-5, 9, 12-13, 17-21 are rejected under 35 USC § 103
Priority
Acknowledgement is made of Applicant’s claim for a domestic priority date of 12-1-2021
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2-8-2023, 2-27-2023, and 7-11-2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-24, 33 are not patent eligible because the claimed invention is directed to an abstract idea without significantly more.
Analysis
First, claims are directed to one or more of the following statutory categories: a process, a machine, a manufacture, and a composition of matter. Regarding claims 1-24, 33 the claims recite an abstract idea of “health monitoring of a patient via geofencing”.
Independent claims 1, 22, 33 are rejected under 35 U.S.C 101 based on the following analysis.
-Step 1 (Does the claim fall within a statutory category? YES): claims 1, 22, 33 recite a method, system and a non-transitory computer-readable storage medium, respectively.
-Step 2A Prong One (Does the claim fall within at least one of the groupings of abstract ideas?: YES): The claimed invention:
determining, ..., that a current of the patient corresponds to a designated area... in response to receiving, ..., input data comprising an indication of the current of the patient;
in response to the determination, generating, ..., output data comprising one or more datasets of patient data for a data submission, wherein the patient data is stored ... for a patient ... configured to generate at least a portion of the patient data;
and transmitting, ..., the output data to complete the data submission.
belonging to the grouping of mental processes under concepts performed in the human mind (including an observation, evaluation, judgement, opinion) as it recites: “health monitoring of a patient via geofencing”. Alternatively, the selected abstract idea belongs to the grouping of certain methods of organizing human activity under managing personal behavior or relationships or interactions between people as it recites “health monitoring of a patient via geofencing” (refer to MPP 2106.04(a)(2)). Accordingly this claim recites an abstract idea.
-Step 2A Prong Two (Are there additional elements in the claim that imposes a meaningful limit on the abstract idea? NO).
Claims 1, 22, 33 recite:
processing circuitry of a medical device of a patient or a computing device of the patient, the computing device configured for wireless communication with the medical device;
a medical system;
input device;
health monitoring service;
memory;
medical device;
output device;
Claim 22 recites:
processing circuitry of a medical device of a patient or a computing device of the patient, the computing device configured for wireless communication with the medical device, the processing circuitry executing logic for a monitoring application stored in memory ;
Claim 33 recites:
A non-transitory computer-readable storage medium comprising program instructions that, when executed by processing circuitry of a medical device, of a patient or a computing device of the patient, the computing device configured for wireless communication with the medical device;
Amount to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. Support for this can be found in the specification, paragraphs (0056-0065) (refer to MPEP 2106.05(f)). Accordingly, these additional elements, when considered separately and as an ordered combination do not integrate the judicial exception/abstract idea into a “practical application” of the judicial exception because they do not impose any meaningful limit on practicing the judicial exception.
-Step 2B (Does the additional elements of the claim provide an inventive concept?: NO. As discussed previously with respect to Step 2A Prong Two,
Claims 1, 22, 33 recite:
Claims 1, 22, 33 recite:
processing circuitry of a medical device of a patient or a computing device of the patient, the computing device configured for wireless communication with the medical device;
a medical system;
input device;
health monitoring service;
memory;
medical device;
output device;
Claim 22 recites:
processing circuitry of a medical device of a patient or a computing device of the patient, the computing device configured for wireless communication with the medical device, the processing circuitry executing logic for a monitoring application stored in memory ;
Claim 33 recites:
A non-transitory computer-readable storage medium comprising program instructions that, when executed by processing circuitry of a medical device, of a patient or a computing device of the patient, the computing device configured for wireless communication with the medical device.
Amount to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. Support for this can be found in the specification, paragraphs (0056-0065) (refer to MPEP 2106.05(f)). Accordingly, even when viewed as a whole the claim does not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible.
Dependent Claims:
Step 2A Prong One: The following dependent claims recites additional limitations that further define the abstract idea of “health monitoring of a patient via geofencing”” claims 1-22, 24, 33-34
Step 2A Prong Two (Are there additional elements in the claim that imposes a meaningful limit on the abstract idea? NO). The following dependent claims 1-24, 33-34 amount to no more than mere instructions to apply the exception using a generic computer, or merely using a computer as a tool to implement the abstract idea as even in combination, these additional elements do not integrate the abstract idea into a practical application and do not amount to significantly more than the abstract idea itself.. (refer to MPEP 2106.05(f)). Accordingly, the claims as a whole do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Step 2B (Does the additional elements of the claim provide an inventive concept?: NO). As discussed previously with respect to Step 2A Prong Two, the following dependent claims 1-24, 33-34 amount to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). Accordingly, the additional elements alone, and in combination do not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 6-7, 10-11, 14-16, 22-24, 33 are rejected by 35 U.S.C. 102(a)(1) as being anticipated by Volpe et.al. (US 20170258401 A1) hereinafter “Volpe”
Regarding claim 1, 22, 33 Volpe teaches:
determining, by processing circuitry (processor) of a medical device of a patient (ambulatory medical device.. designed for moving with a patient) or a computing device of the patient, the computing device configured for wireless communication with the medical device, that a current of the patient corresponds to a designated area of a medical system (determine whether the ambulatory medical device is within a predefined range of a reference location... the reference location may refer to a caregiver facility) in response to receiving, by an input device (proximity monitoring component 414 ), input data comprising an indication of the current of the patient (technologies and techniques include GPS devices, dead reckoning processes, signal strength calculations, cellular network services, WiFi network services, BLUETOOTH network services, BLE beacon technologies, radio frequency identification (RFID) devices, indoor beacons, triangulation techniques, and indoor positioning systems); (See at least [0007] via: “...An ambulatory medical device is capable of and designed for moving with a patient as the patient goes about his or her daily routine...”; in addition see at least [0010] via: “...The ambulatory medical device includes at least one sensor configured to acquire data descriptive of a patient; a memory; a user interface; and at least one processor coupled with the memory, the at least one sensor, and the user interface. The at least one processor is configured to determine whether the ambulatory medical device is within a predefined range of a reference location and to initiate location-specific processing in response to determining that the ambulatory medical device is within the predefined range, the location-specific processing comprising at least one of issuing a notification and adapting the user interface.....”; in addition see at least [0011] via: “...In the ambulatory medical device, the reference location may refer to at least one of a fixed geographic location, .... The at least one processor may be configured to determine whether the ambulatory medical device is within the predefined range using at least one of a location of a cellular tower, dead reckoning, a global positioning system, indoor positioning system, triangulation, an indoor beacon, and signal strength. The reference location may refer to a physical location ..”; in addition see at least [0015] via: “...In the ambulatory medical device, the reference location may refer to a caregiver facility and the location-specific processing may include adapting the user interface to interact with a caregiver. In the ambulatory medical device, the at least one processor may be further configured to determine whether the ambulatory medical device is within at least one other predefined range of at least one other reference location and to initiate the location-specific processing in response to determining that the ambulatory medical device is within the at least one other predefined range...”; in addition see at least [0051] via: “...The proximity monitoring component 414 illustrated in FIG. 4 is configured to monitor for and detect occurrences of the controller 120 being within one or more predefined ranges of one or more reference locations. When executing according to any of various configurations, the proximity monitoring component 414 detects such occurrences by executing any of a variety of proximity detection processes. These processes may, for example, detect proximity with reference to a coordinate system (e.g., a geographic coordinate system) and/or detect proximity with reference to one or more range identifiers (e.g., identifiers that indicate the controller 120 is within one or more predefined ranges of a reference location). For example, the reference location may be based on one or more predetermined geographic coordinates (e.g., GPS coordinates of a certain physical location) or a location of a base station device (e.g., base station 300). In implementations involving base station locations, typically base stations may be associated with a physical location (e.g., a patient's home, place of work, or other location). In yet some examples, the reference location may be based on a mobile device such as a patient, caregiver or other predetermined person's smartphone or tablet. As such, one or more proximity detection processes may include detecting proximity to one or more such devices..”; in addition see at least [0052] via: “...The proximity monitoring component 414 may utilize a variety of technologies and techniques to determine the geographic location of the controller 120. Examples of these technologies and techniques include GPS devices, dead reckoning processes, signal strength calculations, cellular network services, WiFi network services, BLUETOOTH network services, BLE beacon technologies, radio frequency identification (RFID) devices, indoor beacons, triangulation techniques, and indoor positioning systems...”)
in response to the determination, generating, by the processing circuitry (medical device 100 ), output data comprising one or more datasets of patient data for a data submission (uploading ... patient data) to a health monitoring service, wherein the patient data is stored in memory (to a or a remote computer system) for a patient having a medical device (medical device 100.. location-specific processing component 416 ) configured to generate (perform calculations of arrhythmia burdens) at least a portion of the patient data(patient data); (See at least [0040] via: “... FIG. 1 illustrates an example medical device 100 that is external, ambulatory, and wearable by the patient 102. As shown, the medical device 100 includes a ... a medical device controller 120, ..”; in addition see at least [0044] via: “...information relating to the patient's medical condition and/or device status information over a period of time may be communicated by the base station 300 to a remote server through which a caregiver, such as a physician, may remotely monitor the patient's medical condition...”; in addition see at least [0045] via: “...FIG. 4 shows a schematic of an example of the controller 120 of FIGS. 1, 2A, 2B and 3. The controller 120 includes at least one processor 418, location adaptation component 410, a proximity monitoring component 414, a location-specific processing component 416, a sensor interface 412, an optional therapy delivery interface 402, data storage 404 (which may include location data store 430), an optional network interface 406, a user interface 408, and the battery 212. The sensor interface 412 may be coupled to any one or combination of sensors to receive information indicative of patient parameters...”; in addition see at least [0046] via: “... the network interface 406 may be configured to communicate with a server (e.g., a remote server) where a caregiver can access information related to the patient or with a base station (e.g., the base station 300) that is associated (e.g., paired) with the controller 120...”; in addition see at least [0049] via: “... the processor 418 includes one or more processors that each can perform a series of instructions that result in manipulated data and/or control the operation of the other components of the controller 120. ... when executing a specific software process as provided herein (e.g., FIGS. 5-8), the processor 418 is configured to make specific logic-based determinations based on input data received, and further capable of providing one or more outputs that can be used to control or otherwise inform subsequent processing to be carried out by the processor 418 and/or other processors or circuitry with which processor 418 is communicatively coupled. Thus, the processor 418 reacts to specific input stimulus in a specific way and generates a corresponding output based on that input stimulus...”; in addition see at least [0033] via: “...processes that monitor the location of a medical device and execute location-specific processing upon detecting that the medical device is within a predetermined range of a reference location... this location-specific processing includes executing automated tasks that issue localized notifications to the patient .. ... For example, the localized notifications may include reminders to ... upload certain medical device data or patient data to a base station, smartphone, or remote computer system...”; in addition see at least [0034] via: “...the location-specific processing includes execution of one or more tasks, other than notification tasks, based on the location of the device. For example, these other tasks may include downloading and/or applying software upgrades, uploading medical device and/or patient data to a base station, mobile device, smartphone, or a remote computer system, changing device configuration parameters, updating or downloading new treatment data, changing or adding new monitoring and/or treatment thresholds and parameters, or instructions to the patient...”; in addition see at least [0059] via: “...the location-specific processing component 416 can be configured to perform calculations of arrhythmia burdens and immediately transmit such information to a remote server. When executing according to this configuration, the location-specific processing component 416 monitors the signal quality and if the signal quality deteriorates or a disconnection of an electrode occurs, the location-specific processing component 416 instead records an onset and an exit event corresponding to the portion of the recording of interest and transmits the information at a later time. Other types of trends, metrics, and/or statistics may be calculated and transmitted to a remote server...”; in addition see at least [0060] via: “...a physiological patient monitor (e.g., a cardiac monitor) or an external ambulatory treatment device (e.g., a wearable defibrillator or pacing device) including the location-specific processing component 416 may exchange information relating to cardiac monitoring and/or treatment thresholds with a remote server based on proximity to a reference location. In general, such information can include patient information, device status information, and other operational data. A cardiac monitor or a defibrillator including the location-specific processing component 416 may exchange patient information such as ECG information, such as atrial fibrillation (AF) threshold values, changes in QRS (e.g.: width, height, or other such parameter), change in (s-t) t-wave, ventricular tachycardia (VT) thresholds, ventricular fibrillation (VF) thresholds, tachycardia (e.g., above a specified threshold), bradycardia (e.g., heart rate falling below a specified threshold, significant pauses (e.g., triggered by a predetermined threshold), and pre-ventricular contractions (PVCs), e.g., when a count threshold is exceeded. Patient information may include patient reported symptom information, e.g., when the patient reports (e.g., by activation of a user interface element) dizziness, palpitations, chest pain, etc.). Other patient information may include change in patient fluid levels (e.g., based on an radio-frequency wave sensor), respiration information, accelerometer-detected patient falls, walk test activation, thresholds, parameters and associated data, cardiac sounds or measures such as an S3, S4, or prolonged electromechanical activation times (EMAT). The data may be configured to be exchanged on a continuous, periodic, or aperiodic basis...”) and
transmitting (transmit), by an output device (output devices ), to the health monitoring service(remote computer system) , the output data (arrhythmia burdens) to complete the data submission.(See at least [0044] via: “...information relating to the patient's medical condition and/or device status information over a period of time may be communicated by the base station 300 to a remote server through which a caregiver, such as a physician, may remotely monitor the patient's medical condition...”; in addition see at least [0048] via: “... the user interface 408 includes one or more physical interface devices such as input devices, output devices, and combination input/output devices and a software stack configured to drive operation of the devices. These user interface elements may render visual, audio, and/or tactile content, including content relating to location-specific processing. For instance, in some examples, the user interface 408 includes a microphone, the speaker 204, the display 220, and the response buttons 210. Thus the user interface 408 may receive input or provide output, thereby enabling a user to interact with the controller 120...”; in addition see at least [0049] via: “... the processor 418 includes one or more processors that each can perform a series of instructions that result in manipulated data and/or control the operation of the other components of the controller 120. ... when executing a specific software process as provided herein (e.g., FIGS. 5-8), the processor 418 is configured to make specific logic-based determinations based on input data received, and further capable of providing one or more outputs that can be used to control or otherwise inform subsequent processing to be carried out by the processor 418 and/or other processors or circuitry with which processor 418 is communicatively coupled...”; in addition see at least [0059] via: “...the location-specific processing component 416 can be configured to perform calculations of arrhythmia burdens and immediately transmit such information to a remote server...”)
Regarding claim 2 Volpe teaches the invention as claimed and detailed with respect to claim 1. Volpe also teaches:
wherein determining that the current location of the patient corresponds to the designated area of the medical system further comprises: initiating an active operating mode for a monitoring application of the computing device, wherein the monitoring application (cardiac event detector 426 to monitor the cardiac activity of the patient) is to run in a foreground of the computing device (medical device 100). (See at least [0033] via: “...apparatus and processes that monitor the location of a medical device and execute location-specific processing upon detecting that the medical device is within a predetermined range of a reference location. In various examples, this location-specific processing includes executing automated tasks that issue localized notifications to the patient or other recipients and/or adapting the user interface of the medical device to increase its relevance to the patient while the patient is within range of the reference location, and/or adapting the user interface of the medical device to increase its relevance to persons associated with the reference location. For example, the localized notifications may include reminders to maintain serviceable components of the medical device, while any materials needed to do so are readily at hand, download and/or apply software upgrades, upload certain medical device data or patient data to a base station, smartphone, or remote computer system, download and/or apply device configuration parameters, treatment data, monitoring and/or treatment thresholds and parameters, and new or updated instructions to the patient...”; in addition see at least [0040] via: “... FIG. 1 illustrates an example medical device 100 that is external, ambulatory, and wearable by the patient 102. As shown, the medical device 100 includes a ... a medical device controller 120, ..”; in addition see at least [0047] via: “...the controller 120 includes a cardiac event detector 426 to monitor the cardiac activity of the patient and identify cardiac events experienced by the patient based on received cardiac signals..”; in addition see at least [0060] via: “...a physiological patient monitor (e.g., a cardiac monitor) or an external ambulatory treatment device (e.g., a wearable defibrillator or pacing device) including the location-specific processing component 416 may exchange information relating to cardiac monitoring and/or treatment thresholds with a remote server based on proximity to a reference location. In general, such information can include patient information, device status information, and other operational data. A cardiac monitor or a defibrillator including the location-specific processing component 416 may exchange patient information such as ECG information, such as atrial fibrillation (AF) threshold values, changes in QRS (e.g.: width, height, or other such parameter), change in (s-t) t-wave, ventricular tachycardia (VT) thresholds, ventricular fibrillation (VF) thresholds, tachycardia (e.g., above a specified threshold), bradycardia (e.g., heart rate falling below a specified threshold, significant pauses (e.g., triggered by a predetermined threshold), and pre-ventricular contractions (PVCs), e.g., when a count threshold is exceeded. Patient information may include patient reported symptom information, e.g., when the patient reports (e.g., by activation of a user interface element) dizziness, palpitations, chest pain, etc.)... The data may be configured to be exchanged on a continuous, periodic, or aperiodic basis...”)
Regarding claim 6 Volpe teaches the invention as claimed and detailed with respect to claim 1. Volpe also teaches:
wherein determining that the current location of the patient corresponds to the designated area of the medical system further comprises: communicating, by the output device, an acknowledgement to a device of the health monitoring service in response to a connection request from that device. (See at least [0053] via: “...the proximity monitoring component 414 is configured to detect proximity by detecting one or more range identifiers without reference to a coordinate system. These range identifiers may include identifiers of networks available to the controller 120, identifiers of other devices available to the controller 120 via a network, identifiers of other devices detectable by the proximity monitoring component 414 (e.g., RFID tags), signal strength information, express range identifiers (e.g., as defined by the IBEACON standard as published by APPLE Inc. BLE beacon technologies, among others)..”; in addition see at least [0055] via: “...The location-specific processing component 416 illustrated in FIG. 4 is configured to execute location-specific tasks such as issuing specialized, location-oriented notifications in response to the controller being within a predefined range of a reference location. The location-specific processing component 416 may be configured to issue these notifications to a patient, a caregiver near the patient, such as a family member, a designated person, or a loved one, and/or another such caregiver located at a remote location. For example, proximity-based notifications may be issued to both the patient and another designated person other than the patient. In some implementations, such notifications may be issued to the patient and a designated person other than the patient at substantially the same time. In some cases, the notifications may be issued with a preconfigured, programmable time delay, such that first the patient is notified, and if the patient does not response to the notification (e.g., by acknowledging the notification), a designated person other than the patient is notified after expiration of the time delay. Communication channels for these notifications may include the user interface 408, the patient interface pod 140, a user interface of another medical device, a user interface of a programmable device (e.g., a smart phone, tablet computer, personal computer, etc.), and the like...”)
Regarding claim 7 Volpe teaches the invention as claimed and detailed with respect to claim 1. Volpe also teaches:
wherein determining that the current location of the patient corresponds to the designated area of the medical system further comprises: in response to the indication of the current location of the patient from a location service, initiating a function call to trigger the transmitting to the health monitoring service. (See at least [0053] via: “...the proximity monitoring component 414 is configured to detect proximity by detecting one or more range identifiers without reference to a coordinate system. These range identifiers may include identifiers of networks available to the controller 120, identifiers of other devices available to the controller 120 via a network, identifiers of other devices detectable by the proximity monitoring component 414 (e.g., RFID tags), signal strength information, express range identifiers (e.g., as defined by the IBEACON standard as published by APPLE Inc. BLE beacon technologies, among others)..”; in addition see at least [0055] via: “...The location-specific processing component 416 illustrated in FIG. 4 is configured to execute location-specific tasks such as issuing specialized, location-oriented notifications in response to the controller being within a predefined range of a reference location. The location-specific processing component 416 may be configured to issue these notifications to a patient, a caregiver near the patient, such as a family member, a designated person, or a loved one, and/or another such caregiver located at a remote location. For example, proximity-based notifications may be issued to both the patient and another designated person other than the patient. In some implementations, such notifications may be issued to the patient and a designated person other than the patient at substantially the same time. In some cases, the notifications may be issued with a preconfigured, programmable time delay, such that first the patient is notified, and if the patient does not response to the notification (e.g., by acknowledging the notification), a designated person other than the patient is notified after expiration of the time delay. Communication channels for these notifications may include the user interface 408, the patient interface pod 140, a user interface of another medical device, a user interface of a programmable device (e.g., a smart phone, tablet computer, personal computer, etc.), and the like...”)
Regarding claim 10 Volpe teaches the invention as claimed and detailed with respect to claim 1. Volpe also teaches:
wherein a programmable beacon communicates the indication to prompt a monitoring application to identify, for the data submission, a missed transmission or a pending transmission of interrogation data of the medical device. (See at least [0044] via: “..the controller 120 may be in communication with a base station 300 as shown in FIG. 3. The base station 300 includes an antenna 302, a battery charging bay 304, one or more buttons 306, a speaker 308, a display 310, and one or more communication interfaces 312, 314, and 316. The base station 300 communicates with the controller 120 via, for example, a wireless communication connection 318 (e.g., BLUETOOTH, Wireless USB, ZigBee, and Wireless Ethernet). The information received by the base station 300 may be communicated over a wired or wireless communication network shortly after it is received by the base station 300, or alternatively, may be stored in a memory of the base station 300 and communicated over the network at a later time. For example, information relating to the patient's medical condition and/or device status information over a period of time may be communicated by the base station 300 to a remote server through which a caregiver, such as a physician, may remotely monitor the patient's medical condition...”; in addition see at least [0116] via: “..In this example, the patient 102 next visits her caregiver, whose office is located at the geographic location 1222. As the patient nears her caregiver's office, the proximity monitoring component tracks the geographic location of the controller (e.g., via GPS), calculates a distance between the medical device and the geographic location 1222, and, where the distance is less than a threshold value, determines that the medical device has entered the predefined range 1210. In response to making this determination, the proximity monitoring component 414 notifies the location adaptation component 410. The location adaptation component 410, in turn, adapts the operation of the medical device so that the user interface presents the caregiver menu button 1008 on the display 220...”; in addition see at least [0117] via: “..a medical device can ascertain proximity, including a degree of proximity, to one or more base stations in a certain region. For example, BLE beacons associated with the bases station may periodically cast a beacon signal containing a universally unique identifier (UUID), and information regarding the location of the base station. A medical device may detect these signals and determine its proximity from the one or more base stations based on the information in the signals. ... Based on the signal strength, and information contained in the signal, a medical device may provide different types of notifications and/or use different notification modes based on proximity of the medical device to a base station...”; in addition see at least [0059] via: “...within a cardiac monitor or an ambulatory external defibrillator (e.g., a wearable defibrillator), the location-specific processing component 416 can be configured to perform calculations of arrhythmia burdens and immediately transmit such information to a remote server. When executing according to this configuration, the location-specific processing component 416 monitors the signal quality and if the signal quality deteriorates or a disconnection of an electrode occurs, the location-specific processing component 416 instead records an onset and an exit event corresponding to the portion of the recording of interest and transmits the information at a later time. ... The location-specific processing component 416 may be configured to calculate metrics relating to pauses and/or blocks, including a corresponding total burden and/or duration, missed beats (e.g., a count of such missed beats), asystole, etc. The location-specific processing component 416 may be configured to calculate supraventricular tachycardia metrics, including total burden and/or duration, premature atrial contraction (PAC) counts...”)
Regarding claim 11 Volpe teaches the invention as claimed and detailed with respect to claim 1. Volpe also teaches:
wherein a programmable beacon communicates the indication to prompt a monitoring application to identify, for the data submission, a missed transmission or a pending transmission of interrogation data of the medical device (See at least [0044] via: “..the controller 120 may be in communication with a base station 300 as shown in FIG. 3. The base station 300 includes an antenna 302, a battery charging bay 304, one or more buttons 306, a speaker 308, a display 310, and one or more communication interfaces 312, 314, and 316. The base station 300 communicates with the controller 120 via, for example, a wireless communication connection 318 (e.g., BLUETOOTH, Wireless USB, ZigBee, and Wireless Ethernet). The information received by the base station 300 may be communicated over a wired or wireless communication network shortly after it is received by the base station 300, or alternatively, may be stored in a memory of the base station 300 and communicated over the network at a later time. For example, information relating to the patient's medical condition and/or device status information over a period of time may be communicated by the base station 300 to a remote server through which a caregiver, such as a physician, may remotely monitor the patient's medical condition...”; in addition see at least [0116] via: “..In this example, the patient 102 next visits her caregiver, whose office is located at the geographic location 1222. As the patient nears her caregiver's office, the proximity monitoring component tracks the geographic location of the controller (e.g., via GPS), calculates a distance between the medical device and the geographic location 1222, and, where the distance is less than a threshold value, determines that the medical device has entered the predefined range 1210. In response to making this determination, the proximity monitoring component 414 notifies the location adaptation component 410. The location adaptation component 410, in turn, adapts the operation of the medical device so that the user interface presents the caregiver menu button 1008 on the display 220...”; in addition see at least [0117] via: “..a medical device can ascertain proximity, including a degree of proximity, to one or more base stations in a certain region. For example, BLE beacons associated with the bases station may periodically cast a beacon signal containing a universally unique identifier (UUID), and information regarding the location of the base station. A medical device may detect these signals and determine its proximity from the one or more base stations based on the information in the signals. ... Based on the signal strength, and information contained in the signal, a medical device may provide different types of notifications and/or use different notification modes based on proximity of the medical device to a base station...”; in addition see at least [0059] via: “...within a cardiac monitor or an ambulatory external defibrillator (e.g., a wearable defibrillator), the location-specific processing component 416 can be configured to perform calculations of arrhythmia burdens and immediately transmit such information to a remote server. When executing according to this configuration, the location-specific processing component 416 monitors the signal quality and if the signal quality deteriorates or a disconnection of an electrode occurs, the location-specific processing component 416 instead records an onset and an exit event corresponding to the portion of the recording of interest and transmits the information at a later time. ... The location-specific processing component 416 may be configured to calculate metrics relating to pauses and/or blocks, including a corresponding total burden and/or duration, missed beats (e.g., a count of such missed beats), asystole, etc. The location-specific processing component 416 may be configured to calculate supraventricular tachycardia metrics, including total burden and/or duration, premature atrial contraction (PAC) counts...”)
Regarding claim 14 Volpe teaches the invention as claimed and detailed with respect to claim 1. Volpe also teaches:
wherein generating, by the processing circuitry, the output data further comprises: generating the output data comprising a patient history as the data submission for the health monitoring service, wherein the patient history comprises a journal memorializing symptoms that are recorded by the patient or the medical device. (See at least [0060] via: “.. a physiological patient monitor (e.g., a cardiac monitor) or an external ambulatory treatment device (e.g., a wearable defibrillator or pacing device) including the location-specific processing component 416 may exchange information relating to cardiac monitoring and/or treatment thresholds with a remote server based on proximity to a reference location. In general, such information can include patient information, device status information, and other operational data. A cardiac monitor or a defibrillator including the location-specific processing component 416 may exchange patient information such as ECG information, such as atrial fibrillation (AF) threshold values, changes in QRS (e.g.: width, height, or other such parameter), change in (s-t) t-wave, ventricular tachycardia (VT) thresholds, ventricular fibrillation (VF) thresholds, tachycardia (e.g., above a specified threshold), bradycardia (e.g., heart rate falling below a specified threshold, significant pauses (e.g., triggered by a predetermined threshold), and pre-ventricular contractions (PVCs), e.g., when a count threshold is exceeded. Patient information may include patient reported symptom information, e.g., when the patient reports (e.g., by activation of a user interface element) dizziness, palpitations, chest pain, etc.). Other patient information may include change in patient fluid levels (e.g., based on an radio-frequency wave sensor), respiration information, accelerometer-detected patient falls, walk test activation, thresholds, parameters and associated data, cardiac sounds or measures such as an S3, S4, or prolonged electromechanical activation times (EMAT). The data may be configured to be exchanged on a continuous, periodic, or aperiodic basis...”; in addition see at least [0103] via: “.. In response to a selection of the caregiver menu button, the controller may provide, for example, access to historical patient information..”)
Regarding claim 15 Volpe teaches the invention as claimed and detailed with respect to claim 1. Volpe also teaches:
wherein generating, by the processing circuitry, the output data further comprises: in response to a request for a patient history, generating the output data comprising a journal memorializing symptoms that are recorded by the patient or the medical device. (See at least [0060] via: “.. a physiological patient monitor (e.g., a cardiac monitor) or an external ambulatory treatment device (e.g., a wearable defibrillator or pacing device) including the location-specific processing component 416 may exchange information relating to cardiac monitoring and/or treatment thresholds with a remote server based on proximity to a reference location. In general, such information can include patient information, device status information, and other operational data. A cardiac monitor or a defibrillator including the location-specific processing component 416 may exchange patient information such as ECG information, such as atrial fibrillation (AF) threshold values, changes in QRS (e.g.: width, height, or other such parameter), change in (s-t) t-wave, ventricular tachycardia (VT) thresholds, ventricular fibrillation (VF) thresholds, tachycardia (e.g., above a specified threshold), bradycardia (e.g., heart rate falling below a specified threshold, significant pauses (e.g., triggered by a predetermined threshold), and pre-ventricular contractions (PVCs), e.g., when a count threshold is exceeded. Patient information may include patient reported symptom information, e.g., when the patient reports (e.g., by activation of a user interface element) dizziness, palpitations, chest pain, etc.). Other patient information may include change in patient fluid levels (e.g., based on an radio-frequency wave sensor), respiration information, accelerometer-detected patient falls, walk test activation, thresholds, parameters and associated data, cardiac sounds or measures such as an S3, S4, or prolonged electromechanical activation times (EMAT). The data may be configured to be exchanged on a continuous, periodic, or aperiodic basis...”; in addition see at least [0103] via: “.. In response to a selection of the caregiver menu button, the controller may provide, for example, access to historical patient information..”)
Regarding claim 16 Volpe teaches the invention as claimed and detailed with respect to claim 1. Volpe also teaches:
wherein generating, by the processing circuitry, the output data further comprises: in accordance with a schedule stored in the memory, generating the output data comprising the one or more datasets of the patient data for the data submission that corresponds to a scheduled timeslot before a current time. (See at least [0060] via: “.. a physiological patient monitor (e.g., a cardiac monitor) or an external ambulatory treatment device (e.g., a wearable defibrillator or pacing device) including the location-specific processing component 416 may exchange information relating to cardiac monitoring and/or treatment thresholds with a remote server based on proximity to a reference location. In general, such information can include patient information, device status information, and other operational data. A cardiac monitor or a defibrillator including the location-specific processing component 416 may exchange patient information such as ECG information, such as atrial fibrillation (AF) threshold values, changes in QRS (e.g.: width, height, or other such parameter), change in (s-t) t-wave, ventricular tachycardia (VT) thresholds, ventricular fibrillation (VF) thresholds, tachycardia (e.g., above a specified threshold), bradycardia (e.g., heart rate falling below a specified threshold, significant pauses (e.g., triggered by a predetermined threshold), and pre-ventricular contractions (PVCs), e.g., when a count threshold is exceeded. Patient information may include patient reported symptom information, e.g., when the patient reports (e.g., by activation of a user interface element) dizziness, palpitations, chest pain, etc.). Other patient information may include change in patient fluid levels (e.g., based on an radio-frequency wave sensor), respiration information, accelerometer-detected patient falls, walk test activation, thresholds, parameters and associated data, cardiac sounds or measures such as an S3, S4, or prolonged electromechanical activation times (EMAT). The data may be configured to be exchanged on a continuous, periodic, or aperiodic basis...”; in addition see at least [0103] via: “.. In response to a selection of the caregiver menu button, the controller may provide, for example, access to historical patient information..”)
Regarding claim 23 Volpe teaches the invention as claimed and detailed with respect to claim 22. Volpe also teaches:
wherein the computing device comprises the input device, the output device, and the processing circuitry. (See at least [0010] via: “...The ambulatory medical device includes at least one sensor configured to acquire data descriptive of a patient; a memory; a user interface; and at least one processor coupled with the memory, the at least one sensor, and the user interface. The at least one processor is configured to determine whether the ambulatory medical device is within a predefined range of a reference location and to initiate location-specific processing in response to determining that the ambulatory medical device is within the predefined range, the location-specific processing comprising at least one of issuing a notification and adapting the user interface...”; in addition see at least [0048] via: “...the user interface 408 includes one or more physical interface devices such as input devices, output devices, and combination input/output devices and a software stack configured to drive operation of the devices. ..”)
Regarding claim 24 Volpe teaches the invention as claimed and detailed with respect to claims 22 and 23. Volpe also teaches:
wherein the computing device further comprises communication circuitry that includes a BLUETOOTH module communicatively coupled to the medical device and configured to store timestamped one or more datasets of the patient data in response to one or more data downloads from the medical device. (See at least [0044] via: “...In some examples, the controller 120 may be in communication with a base station 300 as shown in FIG. 3. The base station 300 includes an antenna 302, a battery charging bay 304, one or more buttons 306, a speaker 308, a display 310, and one or more communication interfaces 312, 314, and 316. The base station 300 communicates with the controller 120 via, for example, a wireless communication connection 318 (e.g., BLUETOOTH, Wireless USB, ZigBee, and Wireless Ethernet). The information received by the base station 300 may be communicated over a wired or wireless communication network shortly after it is received by the base station 300, or alternatively, may be stored in a memory of the base station 300 and communicated over the network at a later time. For example, information relating to the patient's medical condition and/or device status information over a period of time may be communicated by the base station 300 to a remote server through which a caregiver, such as a physician, may remotely monitor the patient's medical condition..”; in addition see at least [0039] via: “...Some medical devices as disclosed herein can be used as cardiac monitors in certain cardiac monitoring applications, such as holter monitoring, mobile cardiac telemetry (MCT) and/or continuous event monitoring (CEM) applications. In some instances, the medical devices may carry out monitoring in periodic or aperiodic time intervals or times. For example, the monitoring during intervals or times can be triggered by a user action or another event. The one or more durations between the periodic or aperiodic intervals or times can be user-configurable..”; in addition see at least [0057] via: “...the device may adaptively learn about the patient's movements with respect to proximity to the base station over time. In adaptively providing notifications based on proximity, the device may also take into account the time of the day, the priority of the notification, the device status and, patient condition in determining when and whether to provide proximity-based notifications. As such, the device may adapt its notifications to make them more relevant to the patient in accordance with the patient's current activity. For example, if the patient is sleeping, or taking a nap, the device may suppress some or all such notifications until the patient is awake and still proximate to the base station...” )
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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
non-obviousness.
Claims 3-4, 5, 9, 12-13, 17-18 are rejected under 35 U.S.C. 103 as being un-patentable by Volpe et.al. (US 20170258401 A1) hereinafter “Volpe” in view of Fryman et.al. (US 20220037012 A1) hereinafter “Fryman”
Regarding claim 3 Volpe teaches the invention as claimed and detailed with respect to claim 1. However Volpe is silent the following claim that is taught by Fryman:
wherein a device (hospital server) of the health monitoring service (hospital administrator ...location detection system 202 ) communicates the indication in a message (transmit messages to the medical devices), wherein the health monitoring service is operating on a computing system (enterprise server 203 ) within the designated area (geo-fenced area) or on a computing system of an external location to the designated area. (See at least [0043] via: “...The location detection system 202 can allow geo-fences to be drawn on a map and notify the enterprise server 203 when a medical device crosses the geo-fences (e.g., when the medical device enters a geo-fenced area, exits a geo-fenced area, or both). If a hospital administrator wishes to take certain actions (e.g., track the locations of medical devices, transmit messages to the medical devices, request additional information from the user(s) at the medical device(s), etc.) in response to medical devices entering or exiting specific areas of the hospital (e.g., rooms, floors, wings, buildings, or clinical care areas such as emergency room, operating room, intensive care unit, etc.), he or she may configure the location detection system 202 to monitor movements of medical devices across the boundaries of such areas. In response to the notification from the location detection system 202 that a medical device has entered a designated geo-fenced area, the enterprise server 203 may transmit further instructions, for example, to the hospital server in communication with the medical device..”; in addition see at least [0045] via: “..The enterprise server 203 may be a server in charge of the entire hospital or enterprise that can communicate with all hospital servers in the hospital or enterprise (e.g., the hospital environment 200). The enterprise server 203 may send instructions to the location detection system 202 to identify the medical devices that the location detection system 202 should monitor and to define the gen-fencing boundaries that the enterprise server 203 should be notified about. In response to a notification from the location detection system 202 indicating that a monitored medical device has entered a new geo-fenced area, the enterprise server 203 may take certain designated actions such as log the location change of the medical device, instruct the hospital server connected to the medical device to transmit certain messages to the medical device, and the like. ..”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Volpe to incorporate the teachings of Freeman. Those in the art would have recognized that Volpe’s teaching regarding an ambulatory medical device that includes a sensor configured to acquire data descriptive of a patient, a memory, a user interface, and at least one processor coupled with the memory, whereby the one processor is configured to determine whether the ambulatory medical device is within a predefined range of a reference location could be modified by Fryman’s teaching regarding techniques for facilitating hospital server-initiated transmission of messages to medical devices of patients requesting clinical medical data of patients located within a certain perimeter of the hospital. The combination of Volpe and Fryman is useful to achieve faster response times and increased efficiency of medical personnel regarding treatment of patients arriving from within a given distance from a hospital by receiving medical data of the patient ahead of their arrival.
Regarding claim 4 Volpe teaches the invention as claimed and detailed with respect to claim 1. However Volpe is silent the following claim that is taught by Fryman:
wherein a device of the health monitoring service communicates the indication in a message, wherein the health monitoring services is operating on a computing system comprising at least one of a local computing system (enterprise server 203 ) or a remote computing system. (See at least [0043] via: “...The location detection system 202 can allow geo-fences to be drawn on a map and notify the enterprise server 203 when a medical device crosses the geo-fences (e.g., when the medical device enters a geo-fenced area, exits a geo-fenced area, or both). If a hospital administrator wishes to take certain actions (e.g., track the locations of medical devices, transmit messages to the medical devices, request additional information from the user(s) at the medical device(s), etc.) in response to medical devices entering or exiting specific areas of the hospital (e.g., rooms, floors, wings, buildings, or clinical care areas such as emergency room, operating room, intensive care unit, etc.), he or she may configure the location detection system 202 to monitor movements of medical devices across the boundaries of such areas. In response to the notification from the location detection system 202 that a medical device has entered a designated geo-fenced area, the enterprise server 203 may transmit further instructions, for example, to the hospital server in communication with the medical device..”; in addition see at least [0045] via: “..The enterprise server 203 may be a server in charge of the entire hospital or enterprise that can communicate with all hospital servers in the hospital or enterprise (e.g., the hospital environment 200). The enterprise server 203 may send instructions to the location detection system 202 to identify the medical devices that the location detection system 202 should monitor and to define the gen-fencing boundaries that the enterprise server 203 should be notified about. In response to a notification from the location detection system 202 indicating that a monitored medical device has entered a new geo-fenced area, the enterprise server 203 may take certain designated actions such as log the location change of the medical device, instruct the hospital server connected to the medical device to transmit certain messages to the medical device, and the like. ..”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Volpe to incorporate the teachings of Freeman. Those in the art would have recognized that Volpe’s teaching regarding an ambulatory medical device that includes a sensor configured to acquire data descriptive of a patient, a memory, a user interface, and at least one processor coupled with the memory, whereby the one processor is configured to determine whether the ambulatory medical device is within a predefined range of a reference location could be modified by Fryman’s teaching regarding techniques for facilitating hospital server-initiated transmission of messages to medical devices of patients requesting clinical medical data of patients located within a certain perimeter of the hospital. The combination of Volpe and Fryman is useful to achieve faster response times and increased efficiency of medical personnel regarding treatment of patients arriving from within a given distance from a hospital by receiving medical data of the patient ahead of their arrival.
Regarding claim 5 Volpe teaches the invention as claimed and detailed with respect to claim 1. However Volpe is silent the following claim that is taught by Fryman:
wherein determining that the current location of the patient corresponds to the designated area of the medical system further comprises: determining that the current location of the patient corresponds to the designated area of the medical system based upon receiving a message (location detection system 202 ... notify the enterprise server 203 when a medical device crosses the geo-fences) from a device (enterprise server 203 ) of the health monitoring service (hospital administrator ...location detection system 202) operating on the computing system within the designated area. (See at least [0043] via: “...The location detection system 202 can allow geo-fences to be drawn on a map and notify the enterprise server 203 when a medical device crosses the geo-fences (e.g., when the medical device enters a geo-fenced area, exits a geo-fenced area, or both). If a hospital administrator wishes to take certain actions (e.g., track the locations of medical devices, transmit messages to the medical devices, request additional information from the user(s) at the medical device(s), etc.) in response to medical devices entering or exiting specific areas of the hospital (e.g., rooms, floors, wings, buildings, or clinical care areas such as emergency room, operating room, intensive care unit, etc.), he or she may configure the location detection system 202 to monitor movements of medical devices across the boundaries of such areas. In response to the notification from the location detection system 202 that a medical device has entered a designated geo-fenced area, the enterprise server 203 may transmit further instructions, for example, to the hospital server in communication with the medical device..”; in addition see at least [0045] via: “..The enterprise server 203 may be a server in charge of the entire hospital or enterprise that can communicate with all hospital servers in the hospital or enterprise (e.g., the hospital environment 200). The enterprise server 203 may send instructions to the location detection system 202 to identify the medical devices that the location detection system 202 should monitor and to define the gen-fencing boundaries that the enterprise server 203 should be notified about. In response to a notification from the location detection system 202 indicating that a monitored medical device has entered a new geo-fenced area, the enterprise server 203 may take certain designated actions such as log the location change of the medical device, instruct the hospital server connected to the medical device to transmit certain messages to the medical device, and the like. ..”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Volpe to incorporate the teachings of Freeman. Those in the art would have recognized that Volpe’s teaching regarding an ambulatory medical device that includes a sensor configured to acquire data descriptive of a patient, a memory, a user interface, and at least one processor coupled with the memory, whereby the one processor is configured to determine whether the ambulatory medical device is within a predefined range of a reference location could be modified by Fryman’s teaching regarding techniques for facilitating hospital server-initiated transmission of messages to medical devices of patients requesting clinical medical data of patients located within a certain perimeter of the hospital. The combination of Volpe and Fryman is useful to achieve faster response times and increased efficiency of medical personnel regarding treatment of patients arriving from within a given distance from a hospital by receiving medical data of the patient ahead of their arrival.
Regarding claim 9 Volpe teaches the invention as claimed and detailed with respect to claim 1. However Volpe is silent the following claim that is taught by Fryman:
wherein a location service for the health monitoring system communicates, over a network, the indication to prompt a monitoring application to identify, for the data submission, a missed transmission or a pending transmission of interrogation data of the medical device. (See at least [0015] via: “... when the hospital server detects that the medical device has moved near a new patient that the medical device is not associated with in the hospital records, the hospital server may request additional information about the new patient from the medical device. The hospital server may transmit a message to the medical device for presentation on the display of the medical device, where the message asks the user at the medical device to confirm that the medical device should be associated with the patient in the hospital records. The user may input an answer into the medical device, and the answer may be transmitted to the hospital server, and the hospital records may be updated according to the answer...”; in addition see at least [0043] via: “...The location detection system 202 can allow geo-fences to be drawn on a map and notify the enterprise server 203 when a medical device crosses the geo-fences (e.g., when the medical device enters a geo-fenced area, exits a geo-fenced area, or both). If a hospital administrator wishes to take certain actions (e.g., track the locations of medical devices, transmit messages to the medical devices, request additional information from the user(s) at the medical device(s), etc.) in response to medical devices entering or exiting specific areas of the hospital (e.g., rooms, floors, wings, buildings, or clinical care areas such as emergency room, operating room, intensive care unit, etc.), he or she may configure the location detection system 202 to monitor movements of medical devices across the boundaries of such areas...”; in addition see at least [0041] via: “...As illustrated in FIG. 2, the hospital environment 200 includes a location detection system 202, an enterprise server 203, a hospital server 206A, and a hospital server 206B connected to a network 204, and additionally, a medical device 208A in communication with the hospital server 206A,and a medical device 208B in communication with the hospital server 206B...”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Volpe to incorporate the teachings of Freeman. Those in the art would have recognized that Volpe’s teaching regarding an ambulatory medical device that includes a sensor configured to acquire data descriptive of a patient, a memory, a user interface, and at least one processor coupled with the memory, whereby the one processor is configured to determine whether the ambulatory medical device is within a predefined range of a reference location could be modified by Fryman’s teaching regarding techniques for facilitating hospital server-initiated transmission of messages to medical devices of patients requesting clinical medical data of patients located within a certain perimeter of the hospital. The combination of Volpe and Fryman is useful to achieve faster response times and increased efficiency of medical personnel regarding treatment of patients arriving from within a given distance from a hospital by receiving medical data of the patient ahead of their arrival.
Regarding claim 12 Volpe teaches the invention as claimed and detailed with respect to claim 1. However Volpe is silent the following claim that is taught by Fryman:
wherein a computing system for operating the health monitoring service communicates, over a network, a request for patient input as the data submission, wherein the request comprises content for presentation in a user interface (UI) view of the computer device, wherein the UI view comprises UI elements configured to receive the patient input. (See at least [0015] via: “... when the hospital server detects that the medical device has moved near a new patient that the medical device is not associated with in the hospital records, the hospital server may request additional information about the new patient from the medical device. The hospital server may transmit a message to the medical device for presentation on the display of the medical device, where the message asks the user at the medical device to confirm that the medical device should be associated with the patient in the hospital records. The user may input an answer into the medical device, and the answer may be transmitted to the hospital server, and the hospital records may be updated according to the answer...”; in addition see at least [0043] via: “...The location detection system 202 can allow geo-fences to be drawn on a map and notify the enterprise server 203 when a medical device crosses the geo-fences (e.g., when the medical device enters a geo-fenced area, exits a geo-fenced area, or both). If a hospital administrator wishes to take certain actions (e.g., track the locations of medical devices, transmit messages to the medical devices, request additional information from the user(s) at the medical device(s), etc.) in response to medical devices entering or exiting specific areas of the hospital (e.g., rooms, floors, wings, buildings, or clinical care areas such as emergency room, operating room, intensive care unit, etc.), he or she may configure the location detection system 202 to monitor movements of medical devices across the boundaries of such areas...”; in addition see at least [0041] via: “...As illustrated in FIG. 2, the hospital environment 200 includes a location detection system 202, an enterprise server 203, a hospital server 206A, and a hospital server 206B connected to a network 204, and additionally, a medical device 208A in communication with the hospital server 206A, and a medical device 208B in communication with the hospital server 206B...”; in addition see at least [0069] via: “...At block 508...the message request may include data indicative of the content of the message to be output ..., data indicative of the options to be presented to the user ... (e.g., as selectable user interface elements) including the content associated with the options (e.g., “Yes,” “No,” etc.) and the parameters associated with the options (e.g., option identifiers, other identifiers associated with the options such as patient identifiers, CCA identifiers, etc. to be associated with the medical device upon user selection of the corresponding user interface elements). In response, the medical device may output the one or more indications via the output devices of the medical device using the data included or associated with the received message request. For example, the one or more indications may include two user interface elements that, upon user selection, provides a corresponding indication to the hospital server...”; in addition see at least [0070] via: “...At block 510, the server receives an indication from the medical device that a user at the medical device has selected, via the one or more input devices of the medical device, a user interface element that was outputted on the medical device in response to the unregulated message request..”; in addition see at least [0071] via: “...At block 512, the server causes one or more database entries to be created or updated in a hospital database based on the selected user interface element. For example, in the event that the unregulated message request requested confirmation from the user at the medical device that the medical device is to be associated with a given clinical care area or a given patient, the hospital server may update the hospital database to include such association(s) indicated by the user selection made at the medical device..”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Volpe to incorporate the teachings of Freeman. Those in the art would have recognized that Volpe’s teaching regarding an ambulatory medical device that includes a sensor configured to acquire data descriptive of a patient, a memory, a user interface, and at least one processor coupled with the memory, whereby the one processor is configured to determine whether the ambulatory medical device is within a predefined range of a reference location could be modified by Fryman’s teaching regarding techniques for facilitating hospital server-initiated transmission of messages to medical devices of patients requesting clinical medical data of patients located within a certain perimeter of the hospital. The combination of Volpe and Fryman is useful to achieve faster response times and increased efficiency of medical personnel regarding treatment of patients arriving from within a given distance from a hospital by receiving medical data of the patient ahead of their arrival.
Regarding claim 13 Volpe teaches the invention as claimed and detailed with respect to claim 1. However Volpe is silent the following claim that is taught by Fryman:
wherein the computing device comprises the processing circuitry and generating, by the processing circuitry, the output data further comprises: in accordance with a request for patient input, generating the output data comprising patient responses to queries provided in the request, wherein the request comprises content for presentation in a user interface (UI) view of the computing device, wherein the UI view comprises UI elements configured to receive the patient input, wherein each UI element is rendered to present the content for a corresponding query and an input control for the patient to submit a patient response for that query. (See at least [0015] via: “... when the hospital server detects that the medical device has moved near a new patient that the medical device is not associated with in the hospital records, the hospital server may request additional information about the new patient from the medical device. The hospital server may transmit a message to the medical device for presentation on the display of the medical device, where the message asks the user at the medical device to confirm that the medical device should be associated with the patient in the hospital records. The user may input an answer into the medical device, and the answer may be transmitted to the hospital server, and the hospital records may be updated according to the answer...”; in addition see at least [0043] via: “...The location detection system 202 can allow geo-fences to be drawn on a map and notify the enterprise server 203 when a medical device crosses the geo-fences (e.g., when the medical device enters a geo-fenced area, exits a geo-fenced area, or both). If a hospital administrator wishes to take certain actions (e.g., track the locations of medical devices, transmit messages to the medical devices, request additional information from the user(s) at the medical device(s), etc.) in response to medical devices entering or exiting specific areas of the hospital (e.g., rooms, floors, wings, buildings, or clinical care areas such as emergency room, operating room, intensive care unit, etc.), he or she may configure the location detection system 202 to monitor movements of medical devices across the boundaries of such areas...”; in addition see at least [0041] via: “...As illustrated in FIG. 2, the hospital environment 200 includes a location detection system 202, an enterprise server 203, a hospital server 206A, and a hospital server 206B connected to a network 204, and additionally, a medical device 208A in communication with the hospital server 206A, and a medical device 208B in communication with the hospital server 206B...”; in addition see at least [0069] via: “...At block 508...the message request may include data indicative of the content of the message to be output ..., data indicative of the options to be presented to the user ... (e.g., as selectable user interface elements) including the content associated with the options (e.g., “Yes,” “No,” etc.) and the parameters associated with the options (e.g., option identifiers, other identifiers associated with the options such as patient identifiers, CCA identifiers, etc. to be associated with the medical device upon user selection of the corresponding user interface elements). In response, the medical device may output the one or more indications via the output devices of the medical device using the data included or associated with the received message request. For example, the one or more indications may include two user interface elements that, upon user selection, provides a corresponding indication to the hospital server...”; in addition see at least [0070] via: “...At block 510, the server receives an indication from the medical device that a user at the medical device has selected, via the one or more input devices of the medical device, a user interface element that was outputted on the medical device in response to the unregulated message request..”; in addition see at least [0071] via: “...At block 512, the server causes one or more database entries to be created or updated in a hospital database based on the selected user interface element. For example, in the event that the unregulated message request requested confirmation from the user at the medical device that the medical device is to be associated with a given clinical care area or a given patient, the hospital server may update the hospital database to include such association(s) indicated by the user selection made at the medical device..”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Volpe to incorporate the teachings of Freeman. Those in the art would have recognized that Volpe’s teaching regarding an ambulatory medical device that includes a sensor configured to acquire data descriptive of a patient, a memory, a user interface, and at least one processor coupled with the memory, whereby the one processor is configured to determine whether the ambulatory medical device is within a predefined range of a reference location could be modified by Fryman’s teaching regarding techniques for facilitating hospital server-initiated transmission of messages to medical devices of patients requesting clinical medical data of patients located within a certain perimeter of the hospital. The combination of Volpe and Fryman is useful to achieve faster response times and increased efficiency of medical personnel regarding treatment of patients arriving from within a given distance from a hospital by receiving medical data of the patient ahead of their arrival.
Regarding claim 17 Volpe teaches the invention as claimed and detailed with respect to claim 1. Volpe also teaches:
wherein generating, by the processing circuitry, the output data comprises: [in response to identifying a request that is past due to the computing system operating the health monitoring service,] generating the output data comprising the one or more datasets of the patient data corresponding to the past due request (See at least [0059] via: “...within a cardiac monitor or an ambulatory external defibrillator (e.g., a wearable defibrillator), the location-specific processing component 416 can be configured to perform calculations of arrhythmia burdens and immediately transmit such information to a remote server. When executing according to this configuration, the location-specific processing component 416 monitors the signal quality and if the signal quality deteriorates or a disconnection of an electrode occurs, the location-specific processing component 416 instead records an onset and an exit event corresponding to the portion of the recording of interest and transmits the information at a later time. ... The location-specific processing component 416 may be configured to calculate metrics relating to pauses and/or blocks, including a corresponding total burden and/or duration, missed beats (e.g., a count of such missed beats), asystole, etc. The location-specific processing component 416 may be configured to calculate supraventricular tachycardia metrics, including total burden and/or duration, premature atrial contraction (PAC) counts...”)
However although Volpe teaches generating patient output by the medical device, Volpe is silent requesting from the health monitoring service a response that is past due to the health monitoring service as taught by Fryman:
response to identifying a request that is past due to the computing system operating the health monitoring service. (See at least [0015] via: “... when the hospital server detects that the medical device has moved near a new patient that the medical device is not associated with in the hospital records, the hospital server may request additional information about the new patient from the medical device. The hospital server may transmit a message to the medical device for presentation on the display of the medical device, where the message asks the user at the medical device to confirm that the medical device should be associated with the patient in the hospital records. The user may input an answer into the medical device, and the answer may be transmitted to the hospital server, and the hospital records may be updated according to the answer...”; in addition see at least [0043] via: “...The location detection system 202 can allow geo-fences to be drawn on a map and notify the enterprise server 203 when a medical device crosses the geo-fences (e.g., when the medical device enters a geo-fenced area, exits a geo-fenced area, or both). If a hospital administrator wishes to take certain actions (e.g., track the locations of medical devices, transmit messages to the medical devices, request additional information from the user(s) at the medical device(s), etc.) in response to medical devices entering or exiting specific areas of the hospital (e.g., rooms, floors, wings, buildings, or clinical care areas such as emergency room, operating room, intensive care unit, etc.), he or she may configure the location detection system 202 to monitor movements of medical devices across the boundaries of such areas...”; in addition see at least [0041] via: “...As illustrated in FIG. 2, the hospital environment 200 includes a location detection system 202, an enterprise server 203, a hospital server 206A, and a hospital server 206B connected to a network 204, and additionally, a medical device 208A in communication with the hospital server 206A, and a medical device 208B in communication with the hospital server 206B...”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Volpe to incorporate the teachings of Freeman. Those in the art would have recognized that Volpe’s teaching regarding an ambulatory medical device that includes a sensor configured to acquire data descriptive of a patient, a memory, a user interface, and at least one processor coupled with the memory, whereby the one processor is configured to determine whether the ambulatory medical device is within a predefined range of a reference location could be modified by Fryman’s teaching regarding techniques for facilitating hospital server-initiated transmission of messages to medical devices of patients requesting clinical medical data of patients located within a certain perimeter of the hospital. The combination of Volpe and Fryman is useful to achieve faster response times and increased efficiency of medical personnel regarding treatment of patients arriving from within a given distance from a hospital by receiving medical data of the patient ahead of their arrival.
Regarding claim 18 Volpe teaches the invention as claimed and detailed with respect to claim 1. Volpe also teaches:
wherein generating, by the processing circuitry, the output data comprises: [in response to receiving a request from the computing system operating the health monitoring service], generating the output data comprising the one or more datasets of the patient data for the data submission that corresponds to the request received from the device. (See at least [0059] via: “...within a cardiac monitor or an ambulatory external defibrillator (e.g., a wearable defibrillator), the location-specific processing component 416 can be configured to perform calculations of arrhythmia burdens and immediately transmit such information to a remote server. When executing according to this configuration, the location-specific processing component 416 monitors the signal quality and if the signal quality deteriorates or a disconnection of an electrode occurs, the location-specific processing component 416 instead records an onset and an exit event corresponding to the portion of the recording of interest and transmits the information at a later time. ... The location-specific processing component 416 may be configured to calculate metrics relating to pauses and/or blocks, including a corresponding total burden and/or duration, missed beats (e.g., a count of such missed beats), asystole, etc. The location-specific processing component 416 may be configured to calculate supraventricular tachycardia metrics, including total burden and/or duration, premature atrial contraction (PAC) counts..”)
However although Volpe teaches generating patient output by the medical device, Volpe is silent receiving from the health monitoring service a request for a response as taught by Fryman
in response to receiving a request from the computing system operating the health monitoring service (See at least [0015] via: “... when the hospital server detects that the medical device has moved near a new patient that the medical device is not associated with in the hospital records, the hospital server may request additional information about the new patient from the medical device. The hospital server may transmit a message to the medical device for presentation on the display of the medical device, where the message asks the user at the medical device to confirm that the medical device should be associated with the patient in the hospital records. The user may input an answer into the medical device, and the answer may be transmitted to the hospital server, and the hospital records may be updated according to the answer...”; in addition see at least [0043] via: “...The location detection system 202 can allow geo-fences to be drawn on a map and notify the enterprise server 203 when a medical device crosses the geo-fences (e.g., when the medical device enters a geo-fenced area, exits a geo-fenced area, or both). If a hospital administrator wishes to take certain actions (e.g., track the locations of medical devices, transmit messages to the medical devices, request additional information from the user(s) at the medical device(s), etc.) in response to medical devices entering or exiting specific areas of the hospital (e.g., rooms, floors, wings, buildings, or clinical care areas such as emergency room, operating room, intensive care unit, etc.), he or she may configure the location detection system 202 to monitor movements of medical devices across the boundaries of such areas...”; in addition see at least [0041] via: “...As illustrated in FIG. 2, the hospital environment 200 includes a location detection system 202, an enterprise server 203, a hospital server 206A, and a hospital server 206B connected to a network 204, and additionally, a medical device 208A in communication with the hospital server 206A, and a medical device 208B in communication with the hospital server 206B...”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Volpe to incorporate the teachings of Freeman. Those in the art would have recognized that Volpe’s teaching regarding an ambulatory medical device that includes a sensor configured to acquire data descriptive of a patient, a memory, a user interface, and at least one processor coupled with the memory, whereby the one processor is configured to determine whether the ambulatory medical device is within a predefined range of a reference location could be modified by Fryman’s teaching regarding techniques for facilitating hospital server-initiated transmission of messages to medical devices of patients requesting clinical medical data of patients located within a certain perimeter of the hospital. The combination of Volpe and Fryman is useful to achieve faster response times and increased efficiency of medical personnel regarding treatment of patients arriving from within a given distance from a hospital by receiving medical data of the patient ahead of their arrival.
Claims 19, 21 are rejected under 35 U.S.C. 103 as being un-patentable by Volpe in further view of Lyon et.al. (US 9314159 B) hereinafter “Lyon”
Regarding claim 19 Volpe teaches the invention as claimed and detailed with respect to claim 1. However, Volpe is silent the following claim that is taught by Lyon:
wherein generating, by the processing circuitry, the output data comprises: responsive to an alarm generated by the medical device for the patient, generating the output data comprising the one or more datasets of the patient data for the data submission that indicates a health alert for the patient. (See at least [column 1, lines 59-64] via: “.... a medical device facilitates monitoring of a patient. The medical system includes a main patient monitor collecting patient physiological parameter data, and also capable of transmitting the collected patient physiological parameter data. The main patient monitor alarms if the collected data is determined to reach a predetermined value. ..”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Volpe to incorporate the teachings of Lyon. Those in the art would have recognized that Volpe’s teaching regarding an ambulatory medical device that includes a sensor configured to acquire data descriptive of a patient, a memory, a user interface, and at least one processor coupled with the memory, whereby the one processor is configured to determine whether the ambulatory medical device is within a predefined range of a reference location and to initiate patient data upload and transmittal to a remote computer system at the location of a caregiver could be modified to include Lyon’s teaching regarding a remote patient monitoring system providing patient physiological data and alerts/alarms from a patient monitor to a remote patient monitor. The combination of Volpe and Lyon is useful to medical personnel deciding optimal medical treatment to be given to a patient that is located within a given perimeter or radius of a hospital facility “whereby the medical professional is alerted as to physiological data of the monitored patient, and provided alerts or alarms when predetermined levels are reached” (Lyon Abstract)
Regarding claim 21 Volpe teaches the invention as claimed and detailed with respect to claim 1. However, Volpe is silent the following claim that is taught by Lyon:
further comprising: responsive to an alarm generated by the medical device for the patient, communicating, between a device of the health monitoring service and a patient device, a cancellation of the alarm based on one or more cancellation criteria. (See at least [column 4, lines 64-67 and column 5, lines 1--6] via: “....If several caregivers receive alarms pertaining to the same patient, and one of the alerted caregivers responds, other caregivers may be notified that the patient is being attended to. If the attending to the patient caregiver still needs additional help, the caregiver may be able to send another alarm to solicit further help. Alternatively, upon arrival at the patient's side or resolution as to the patient needs, one caregiver may terminate alarms sent to others and may further be able to follow up with a message as to the resolution of the issue...”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Volpe to incorporate the teachings of Lyon. Those in the art would have recognized that Volpe’s teaching regarding an ambulatory medical device that includes a sensor configured to acquire data descriptive of a patient, a memory, a user interface, and at least one processor coupled with the memory, whereby the one processor is configured to determine whether the ambulatory medical device is within a predefined range of a reference location and to initiate patient data upload and transmittal to a remote computer system at the location of a caregiver could be modified to include Lyon’s teaching regarding a remote patient monitoring system providing patient physiological data and alerts/alarms from a patient monitor to a remote patient monitor. The combination of Volpe and Lyon is useful to medical personnel deciding optimal medical treatment to be given to a patient that is located within a given perimeter or radius of a hospital facility “whereby the medical professional is alerted as to physiological data of the monitored patient, and provided alerts or alarms when predetermined levels are reached” (Lyon Abstract)
Claim 20 is rejected under 35 U.S.C. 103 as being un-patentable by Volpe in view of Lyon; in further view of Kochura et.al. (US 20190074089 A1) hereinafter “Kochura”
Regarding claim 20 Volpe teaches the invention as claimed and detailed with respect to claim 1. However, Volpe is silent the following claim that is taught by Lyon:
wherein generating, by the processing circuitry, the output data comprises: responsive to an alarm generated by the medical device for the patient, [determining that a health event corresponding to the alarm is a false positive based on one or more detection criteria; withholding transmission of the output data comprising the health event]. (See at least [column 1, lines 59-64] via: “.... a medical device facilitates monitoring of a patient. The medical system includes a main patient monitor collecting patient physiological parameter data, and also capable of transmitting the collected patient physiological parameter data. The main patient monitor alarms if the collected data is determined to reach a predetermined value. ..”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Volpe to incorporate the teachings of Lyon. Those in the art would have recognized that Volpe’s teaching regarding an ambulatory medical device that includes a sensor configured to acquire data descriptive of a patient, a memory, a user interface, and at least one processor coupled with the memory, whereby the one processor is configured to determine whether the ambulatory medical device is within a predefined range of a reference location and to initiate patient data upload and transmittal to a remote computer system at the location of a caregiver could be modified to include Lyon’s teaching regarding a remote patient monitoring system providing patient physiological data and alerts/alarms from a patient monitor to a remote patient monitor. The combination of Volpe and Lyon is useful to medical personnel deciding optimal medical treatment to be given to a patient that is located within a given perimeter or radius of a hospital facility “whereby the medical professional is alerted as to physiological data of the monitored patient, and provided alerts or alarms when predetermined levels are reached” (Lyon Abstract)
However although Volpe and Lyon teach generating an alarm indicating a health alert for the patient they are silent regarding determining that the alarm is a false positive as taught by Kochura:
determining that a health event corresponding to the alarm is a false positive based on one or more detection criteria; withholding transmission of the output data comprising the health event (See at least [0057] via: “...referring to step 204 in some embodiments, user baseline program 200 receives information from another individual based on medical monitoring program 300 determining or predicting one state and/or level of urgency associated with a user (referring to FIG. 3, No branch of decision step 309). However, the actual state of the user differs from the state of the user determined and/or predicted by one or more models. In one example, a doctor reviews a notification generated by medical monitoring program 300 and the received sensor data, and the doctor determines that a model is generating a false-positive result. If the doctor contacts the user and verifies that the model generated a false-positive result, then the doctor may flag the model for modifying
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Volpe and Lyon to incorporate the teachings of Kochura. Those in the art would have recognized that Volpe’s and Lyon’s teaching regarding an ambulatory medical device that is capable of generating an alarm to indicate a health alert of the patient could be modified by Kochura that teaches whether the alarm is a false positive. The combination of Volpe, Lyon and Kochura is useful to medical personnel in deciding optimal medical treatment to be given to a patient.
Allowable Subject Matter
Regarding claim 8 Volpe teaches the invention as claimed and detailed with respect to claim 1. However, claims 8 is objected as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and if rewritten to overcome the rejection(s) under 35 USC § 101 set forth in this Office action. The reason for the indication of allowable subject matter is that claim 8 is not taught by Volpe and no analogous art was found teaching the following limitation:
wherein determining that the current of the patient corresponds to the designated area of the medical system further comprises: in response to a function call, triggering transmission, by a monitoring application of the computing device , of the one or more datasets of the patient data to the health monitoring service, wherein the triggering comprises executing logic for the monitoring application, wherein a second application initiates the function call based on the indication of the current of the patient, wherein the function call causes the monitoring application to run on the processing circuitry
Regarding claim 34 Volpe teaches the invention as claimed and detailed with respect to claim 1. However, claims 34 is objected as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and if rewritten to overcome the rejection(s) under 35 USC § 101 set forth in this Office action. The reason for the indication of allowable subject matter is that claim 34 is not taught by Volpe and no analogous art was found teaching the following limitation
wherein determining that the current location of the patient corresponds to the designated area of the medical system comprises receiving, by a first application executed by the processing circuitry, the input data comprising the indication of the current location of the patient,
wherein generating the output data comprises:
by the first application in response to the input data comprising the indication of the current location of the patient, changing an operating mode of a second application executed by the processing circuitry; and
generating the output data by the second application in response to the changing of the operating mode of the second application
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure, and is listed in the attached form PTO-892 (Notice of References Cited). Unless expressly noted otherwise by the Examiner, all documents listed on form PTO-892 are cited in their entirety.
Nyquist (US 20190046035 A1) - LOCATION BASED PATIENT MONITORING - teaches: patient monitoring systems, apparatus, and methods that use information corresponding to the geographic location of patient.
Cronin (US 20180004909 A1) - CAREGIVER CONNECTED WEARABLE- teaches: a caregiver module is provided for use with a patient medical device, including a sensor to obtain a sensor signal related to the use of the patient medical device; an analog-to-digital converter to convert the sensor signal to corresponding sensor data; and a controller to transmit the sensor data to a wearable device, wherein the sensor data is transmitted in the same form as created by the converter. Various embodiments provide a wearable device for processing sensor data received from the caregiver module, including: memory storing processing instructions for interpreting sensor data of multiple types; and a processor to: receive configuration information associated with the caregiver module, receive sensor data of a first type from the caregiver module, and execute the processing instructions based on the configuration information, wherein the configuration information alters the operation of the processing instructions to interpret sensor data of the first type.
Response to Arguments
Applicant's arguments filed 1-27-2026, have been fully considered but not found
persuasive.
Applicant amended independent claims 1, 22, 33 and dependent claims 2, 4-8, 12-13, 23-24
as posted in the above analysis.
In response to applicant's arguments regarding claim rejection under 35 U.S.C § 101.
Several steps are taken in the analysis as to whether an invention is rejected under 101. The first step is to determine if the claim falls within a statutory category. In this case it does for claims 1, 22 and 33 since the claims recite a method, system and a non-transitory computer-readable storage medium, respectively.
The second step under 2A prong one is to determine if the claims recite an abstract idea, which would be the case if the invention can be grouped as either: a) mathematical concepts; (b) mental processes; or (c) certain methods of organizing human activity (encompassing (i) fundamental economic principles, (ii) commercial or legal interactions or (iii) managing personal behavior or relationships or interactions between people). The current invention is classified as an abstract idea since it may be grouped as a mental process under concepts performed in the human mind as it recites “health monitoring of a patient via geofencing”. Alternatively, the selected abstract idea belongs to the grouping of certain methods of organizing human activity under managing personal behavior or relationships or interactions between people as it recites “health monitoring of a patient via geofencing”
The third step under 2A Prong Two is to determine if additional elements in the claim imposes a meaningful limit on the abstract idea in order to integrate it into a practical idea. The current invention does not represent a practical idea since the additional elements amount to mere instructions to implement an abstract idea on a computer, or merely use a generic computer as a tool to implement the abstract idea.
the fourth step under 2B is to determine if additional elements of the claim provide an inventive concept. An invention may be classified as an inventive concept if a computer-implemented processes is determined to be significantly more than an abstract idea (and thus eligible), where generic computer components are able in combination to perform functions that are not merely generic, and non-conventional even if generic computer operations on a generic computing device is used to implement the abstract idea. The current invention does not represent an inventive concept since the additional elements amount to mere instructions to implement an abstract idea on a computer, or merely use a generic computer as a tool to implement the abstract idea.
Step 2A Prong ONE
The Applicant argues that Claims 1, 22 and 33 do not recite an abstract idea. The
The Applicant argues that claims 1, 22, 33 require specialized, non-generic hardware (e.g., medical device, patient computing device, input device, output device and health monitoring service) to transmit the output data to the health monitoring service to complete the data submission to the health monitoring service, steps that cannot be performed in the human mind or with pen and paper. As such, Applicant's claims do not recite a mental process and therefore are subject matter eligible.
The Applicant further argues that claims 1, 22, 33 do not recite certain methods of organizing human activity under managing personal behavior or relationships or interactions between people since the claims are not directed to this sub-groupings of methods of organizing human activity. In contrast to organizing human activity or allowing communication between parties, the claims recite techniques that, enable communication between devices ( a medical device of a patient, and computing device of the patient, and a health monitoring service) beneficial to the patient's medical care.
The Examiner disagrees since the Applicant’s arguments are not persuasive. The method used to select the abstract idea, is to strip the additional elements from the claims. As seen below the recited boldened words constitute the abstract idea after stripping the un-boldened additional elements of amended limitation of claims 1, 22, 33:
Claims 1, 22, 33:
determining, by processing circuitry of a medical device of a patient or a computing device of the patient, the computing device configured for wireless communication with the medical device, that a current location of the patient corresponds to a designated area of a medical system in response to receiving, by an input device, input data comprising an indication of the current location of the patient;
in response to the determination, generating, by the processing circuitry, output data comprising one or more datasets of patient data for a data submission to a health monitoring service, wherein the patient data is stored in memory for patient and the medical device is configured to generate at least a portion of the patient data; and
transmitting, by an output device, to the health monitoring service, the output data to complete the data submission.
The selected abstract idea (boldened limitations) of claims 1, 22, 23 can be implemented by pencil and paper and thus belong to the grouping of mental processes under concepts performed in the human mind (including an observation, evaluation, judgement, opinion) as it recites “health monitoring of a patient via geofencing”. Alternatively, the selected abstract idea belongs to the grouping of certain methods of organizing human activity under managing personal behavior or relationships or interactions between people as it recites “health monitoring of a patient via geofencing”. (refer to MPP 2106.04(a)(2)). Accordingly the claims recite an abstract idea.
Step 2A Prong TWO
The Applicant argues that even if the claims recite an abstract idea the claims as a whole integrate the recited judicial exception into a practical application of the exception, and thus are not "directed to" the judicial exception.
The Applicant argues that the claims recite technological improvements, namely providing a technological improvement in the technology of data submission between a patient device and a health monitoring service resulting in reduction or elimination of delays and inefficiencies related to patient care, for instance, by increasing the likelihood that the patient's clinician has up-to-date and complete information at a clinic visit. Specifically the claims are directed to the particular technical solution of triggering a patient device to transmit, to a device of a health monitoring service, datasets of patient data that provides an improvement in data submission from a patient device to a health monitoring service. Accordingly, the system recited in claims 1, 22, 23 provides an improvement to data submission between a patient device and a health monitoring service
The Examiner disagrees with the Applicant’s arguments since they are not persuasive. The Applicant interprets practical application colloquially. What is required for the invention to be directed to a practical application is a demonstration of improvement to the functioning of a computer, or to any other technology or technical field that the invention has recited.
The Examiner restates that claims 1, 22 and 33 do not integrate the abstract idea into a practical application since they do not recite additional elements that impose a meaningful limit on the abstract idea:
Claims 1, 22, 33 recite the following additional element:
Claims 1, 22, 33 recite:
processing circuitry of a medical device of a patient or a computing device of the patient, the computing device configured for wireless communication with the medical device;
a medical system;
input device;
health monitoring service;
memory;
medical device;
output device;
Claim 22 recites:
processing circuitry of a medical device of a patient or a computing device of the patient, the computing device configured for wireless communication with the medical device, the processing circuitry executing logic for a monitoring application stored in memory ;
Claim 33 recites:
A non-transitory computer-readable storage medium comprising program instructions that, when executed by processing circuitry of a medical device, of a patient or a computing device of the patient, the computing device configured for wireless communication with the medical device.
The elements as recited above for claims 1, 22, 33 amount to additional elements that are recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). Accordingly, the claim as a whole does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
In order to integrate the abstract idea into a practical idea the Applicant could demonstrate at least one of the conditions enumerated below applies:
Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP 2106.05(e) and Vanda Memo
The Applicant has not demonstrated any of the above listed conditions. As a result, the Examiner restates the rejection of the invention under 35 USC §101.
Step 2B
Similar to the analysis under Step 2A Prong Two, the additional elements amount to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). The use of generic computer components, in combination, do not perform functions that are not merely generic, and non-conventional even if the generic computer operations on a generic computing device is used to implement the abstract idea. Accordingly, the claim does not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible.
In order evaluate whether the claim recites additional elements that amount to an inventive concept what could be shown is:
Adding a specific limitation (unconventional other than what is well-understood, routine, conventional (WURC) activity in the field - see MPEP 2106.05(d)
The Applicant has not demonstrated the above listed condition.
In response to applicant's arguments regarding claim rejection under 35 U.S.C § 103.
The Applicant argues that Fyman fails to disclose the following amended limitation of claims 1, 22, 33:
“determining, by processing circuitry of a medical device of a patient or a computing device of the patient, the computing device configured for wireless communication with the medical device, that a current of the patient corresponds to a designated area of a medical system in response to receiving, by an input device, input data comprising an indication of the current of the patient”
The Examiner agrees and instead uses Volpe to teach the above limitation. Specifically:
“The processing circuitry of a medical device of a patient” corresponding to Volpe [0007], [0010]
“computing device configured for wireless communication with the medical device” taught by Volpe [0052]
“current location of the patient corresponds to a designated area of a medical system” taught by Volpe [0010], [0011], [0015]
“in response to receiving, by an input device, input data comprising an indication of the current of the patient” taught by Volpe [0051], [0052], [0015]
The Applicant further argues that Volpe fails to disclose the following amended limitation of claim 2:
“wherein determining that the current location of the patient corresponds to the designated area of the medical system further comprises: initiating an active operating mode for a monitoring application of the computing device, wherein the monitoring application is to run in a foreground of the computing device”
The Examiner disagrees since the Applicant’s arguments are not persuasive. Specifically:
“initiating an active operating mode for a monitoring application of the computing device, wherein the monitoring application is to run in a foreground of the computing device” is taught by Volpe [0033], [0040], [0047].
For reasons of record and as set forth above, the examiner maintains the rejection of claims 1-24, 33-34 as being directed to a judicial exception without significantly more, and thereby being directed to non-statutory subject matter under 35 USC §101 in addition to maintaining the rejection under 35 USC §102 and 35 USC §103. In reaching this decision, the Examiner considered all evidence presented and all arguments actually made by Applicant.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE L MACCAGNO whose telephone number is (571)270-5408. The examiner can normally be reached M-F 8:00 to 5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached at (571)270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PIERRE L MACCAGNO/Examiner, Art Unit 3687
/MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687
Prosecution Insights