DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim status
Claims 21-41 are currently pending for examination.
Claim Rejections - 35 USC § 103
3. 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.
4. 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.
5. Claims 23-38 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Nova et al. (Nova; US 2003/0212311) in view of Volpe et al. (Volpe; US 2008/0312709).
For claim 23, Nova discloses a system comprising:
an ambulatory medical device [E.g. 0001: a portable medical device that is capable of delivering therapy and triggering and/or communicating with an alarm system, 0006: a therapy-delivering, portable medical device capable of triggering and/or communicating with an alarm system, as well as a related system and method therefor. The portable medical device may be configured to deliver therapy to a patient, wherein the therapy delivered to the patient may be any or combination of medial therapies, e.g., defibrillation, drugs, etc., for any one or combination of medical applications, such as stroke, cardiac arrest, acute myocardial infarction (AMI), diabetic shock, etc. The portable medical device may be configured to allow an operator located at the alarm system to control or provide medical therapy to the user of the portable medical device via signals transmitted over a communication link. The portable medical device is configured to establish a communication link with an alarm system such as a residential or business alarm, upon the occurrence of a triggering event. Triggering events may be related to the use, operation or deployment of the portable medical device in an emergency situation, or they may be for service or maintenance purposes, e.g., to report device failures, system checks, etc., 0010] comprising:
at least one sensor configured to acquire electrocardiogram (ECG) signals from a patient [E.g. 0035: the ECG signals analyzed by the detection algorithm are collected by the electrodes 205 and passed through a monitor circuit 318 to an analog-to-digital converter 316. The analog-to-digital converter 316 then passes the digitized signals to microprocessor 306. If the microprocessor 306 detects a shockable rhythm, the microprocessor causes a charging circuit 320 to generate a current causing a storage capacitor (not shown) to charge in preparation for delivery of a defibrillation shock. When the capacitor is fully charged, and delivery of the defibrillation pulse initiated, a discharge circuit 322 coupled to the microprocessor 306 and charge circuit 320 discharges the defibrillation shock to the electrodes 205 for application of the defibrillation shock to the patient 90; 0033-0034];
a network interface configured to communicate with an electronic device distinct from the ambulatory medical device [E.g. 0033: The device 200 also includes a communications interface 303 for establishing a communication link 107 with the alarm system 100, 0043: an alarm system 100 comprising a central control station 110 connected via a publicly switched telephone network (PSTN) 130 (or other network connection, e.g., Internet), and a telephone/network interface 120 to a central monitoring station 140. The telephone/network interface 120 may comprise a network TCP/IP circuit or a telephone modem. As known to one skilled in the art, the telephone/network interface 120 may comprise any circuit capable of providing data communication between a local computing device and a remote computing device, 0006, 0009, 0022, 0027, 0036];
a user interface [E.g. 0023, 0029-0033];
a memory [E.g. 0033: a memory 308 which stores program code necessary for operation of the device] storing alarm information specifying one or more alarms and one or more paths through which the one or more alarms are to be provided [E.g. 0022: a therapy-delivering, portable medical device for triggering and communicating with an alarm system, such as an existing residential or business alarm system, and a related method and system therefor. FIG. 1 is a schematic block diagram of such a device and alarm system. As will be described in more detail below, upon the occurrence of a trigger event, a portable medical device 200 capable of delivering therapy establishes a communication link 107 (if one has not been established already) with an alarm system 100, such as a residential or business alarm system. Once the communication link 107 has been established, the portable medical device 200 sends a notification of the trigger event to the alarm system 100. If the trigger event occurs in an emergency context, the alarm system 100 may alert an emergency assistance resource 150 via a communication link 141 and request emergency assistance. It will be appreciated that an emergency assistance resource 150 can be any emergency assistance service. For example, the emergency assistance resource 150 may comprise any public or private emergency assistance service such as an ambulance, firefighter or police service, or any other third-party security service. In addition to, or perhaps in lieu of, alerting the emergency assistance resource 150, the alarm system 100 may provide information and/or instructions to the portable medical device 200 relating to the operation of the device, treatment of the patient, delivery of therapy, status of the emergency assistance, etc., 0023: In the emergency context, a trigger event is an event frequently associated with the treatment of a patient experiencing a medical emergency. Accordingly, a trigger event may occur as soon as the medical device is deployed from a docking station or wall mount in which it resides when not in use. In such an embodiment, the docking station and/or medical device 200 includes the necessary components for detecting the removal of the device. Such components may include mechanical, electrical, optical, magnetic, etc. switches or sensors, or some combination thereof for detecting removal of the portable medical device. An emergency trigger event can also occur upon activation (turning on) of the portable medical device at an unscheduled or unexpected time (it will be appreciated that the device may self-activate at predetermined times for scheduled maintenance). An emergency trigger event may also occur at any point deemed desirable following activation, e.g., upon attachment of electrodes to the patient in the case of an AED, upon expiration of some predetermined time interval following activation, upon user instruction via the user interface of the medical device, upon detection of a medical condition, requiring delivery of therapy, etc. An emergency trigger event may also occur upon the detection of a predetermined health condition. For example, an emergency trigger event may occur if a monitored patient parameter falls below or exceeds a certain threshold, e.g., a rise in temperature or blood pressure, rise or fall in heart rate, fallen oxygen saturation or increase in expired carbon dioxide. An emergency trigger event may also occur for reasons other than patient treatment, device deployment or device use. For example, an emergency trigger event may occur if the portable medical device is stolen (which may be detected by constantly monitoring a local parameter, such as an ambient temperature, and determining that the device has been removed from its assigned location if a parameter falls outside a predetermined range). Finally, the emergency trigger event may occur as a result of a user-initiated action, such as depressing a "call 911" button with which the medical device or its docking station is equipped. Accordingly, any events that require emergency or security assistance may be considered emergency trigger events, 0024-0025, 0033];
at least one processor coupled to the memory, the network interface, the user interface, and the at least one sensor [E.g. 0033: the portable medical device 200 includes a microprocessor 306 that controls the operation of the device 200. The microprocessor 306 is connected to the user display 204, the speaker 210, the microphone 211, and the input device 314. In portable medical device 200, the microprocessor 306 is also connected to a video camera 213 used to record video images of the operator and/or patient. The microprocessor 306 is also connected to a memory 308 which stores program code necessary for operation of the device. In yet other embodiments of the present invention, the memory stores a voice recognition software module which allows the rescuer or patient to operate the device 200 and respond to visual and/or aural instructions via voice command rather than using the input device 14. Such a module in combination with a microphone would then provide the rescuer or patient with hands-free operation of the device 200. The device 200 also includes a communications interface 303 for establishing a communication link 107 with the alarm system 10, 0035: The ECG signals analyzed by the detection algorithm are collected by the electrodes 205 and passed through a monitor circuit 318 to an analog-to-digital converter 316. The analog-to-digital converter 316 then passes the digitized signals to microprocessor 306, 0036: the portable medical device 200 also includes a communications interface 303 for providing a communications link 107 with the alarm system 100. The communications interface 303 may be configured to provide an aural, visual and/or data communication link between the portable medical device 200 and the alarm system 100. Accordingly, those of ordinary skill in the art will appreciate that the communications interface 303 is constructed with commercially available circuitry appropriate for the particular type of communication link 107. For example, if the communication link 107 is established via a wireless telephony network, communications interface 303 is constructed from components analogous to the electronics used for wireless digital communications with such a network] and configured to
monitor ECG data based on the ECG signals to detect a cardiac abnormality in the patient [E.g. 0034: During defibrillation operation, the microprocessor 306 analyzes an electrocardiogram (ECG) of a patient using an automatic heart rhythm detection algorithm also stored in memory 308 to identify whether the patient is experiencing a shockable heart rhythm, such as ventricular fibrillation, 0035: The ECG signals analyzed by the detection algorithm are collected by the electrodes 205 and passed through a monitor circuit 318 to an analog-to-digital converter 316. The analog-to-digital converter 316 then passes the digitized signals to microprocessor 306. If the microprocessor 306 detects a shockable rhythm, the microprocessor causes a charging circuit 320 to generate a current causing a storage capacitor (not shown) to charge in preparation for delivery of a defibrillation shock. When the capacitor is fully charged, and delivery of the defibrillation pulse initiated, a discharge circuit 322 coupled to the microprocessor 306 and charge circuit 320 discharges the defibrillation shock to the electrodes 205 for application of the defibrillation shock to the patient 90];
identify, based on the alarm information, an alarm of the one or more alarms to be triggered by the cardiac abnormality [E.g. 0022: a therapy-delivering, portable medical device for triggering and communicating with an alarm system, such as an existing residential or business alarm system, and a related method and system therefor. FIG. 1 is a schematic block diagram of such a device and alarm system. As will be described in more detail below, upon the occurrence of a trigger event, a portable medical device 200 capable of delivering therapy establishes a communication link 107 (if one has not been established already) with an alarm system 100, such as a residential or business alarm system. Once the communication link 107 has been established, the portable medical device 200 sends a notification of the trigger event to the alarm system 100. If the trigger event occurs in an emergency context, the alarm system 100 may alert an emergency assistance resource 150 via a communication link 141 and request emergency assistance. It will be appreciated that an emergency assistance resource 150 can be any emergency assistance service. For example, the emergency assistance resource 150 may comprise any public or private emergency assistance service such as an ambulance, firefighter or police service, or any other third-party security service. In addition to, or perhaps in lieu of, alerting the emergency assistance resource 150, the alarm system 100 may provide information and/or instructions to the portable medical device 200 relating to the operation of the device, treatment of the patient, delivery of therapy, status of the emergency assistance, etc., 0025: the device 200 may send a notification of the service trigger event to the alarm system 100 via the communication link 107. In turn, the alarm system may alert a service assistance resource 150 of the service trigger event via communication link 141 and request service assistance. It will be appreciated that the service assistance resource can be any resource for providing public or private service assistance such as field technicians, manufacturer customer support, etc. In addition to, or perhaps in lieu of, alerting a service resource, the alarm system 100, if capable, may provide the device with the required service or simply record the service trigger event and/or results of any self-tests, status reports, service requests, etc. for reporting purposes. For example, if the service trigger event is a request for a software upgrade and the alarm system 100 stores the requested upgrade, the alarm system 100 may download the requested upgrade to the device for installation; 0023-0024]; and
the alarm to output via at least one path of the one or more paths, the one or more paths comprising the network interface configured to communicate with the electronic device [E.g. 0057: the method 700 continues to block 706 with a portable medical device 200 notifies the alarm system 100 of the emergency trigger event via the communication link 107. It will be appreciated that the portable medical device will format and transmit the notification of the emergency trigger event in any form or format suitable for the alarm system. Once the alarm system has been notified of the trigger event, the portable medical device 200 may begin transmitting in block 708 any additional information or data regarding the trigger event, whether patient-related, medical-related, location-related or device-related. As noted above, such information may include, but is not limited to, patient identification data, ECG data, diagnostic data, treatment data, location data, etc. As shown in block 710 (which is shown in phantom since this action is taken by the alarm system 100), upon receipt of the emergency trigger event notification from the medical device, the alarm system 100 may notify emergency resource assistance 150. Accordingly, the emergency resource assistance may dispatch emergency personnel, e.g., ambulance, fire, police, security, etc. in response to the emergency trigger event, 0022, 0027, 0054-0056, 0058-0059] and the user interface of the ambulatory medical device [E.g. 0051-0052, 0024-0025, 0066-0069]
Nova fails to expressly disclose adapt, based on the alarm information, the alarm to output via at least one path of the one or more paths, the one or more paths comprising a path configured to communicate with the electronic device and the user interface of the ambulatory medical device.
However, as shown by Volpe, it was well known in the art of medical devices to include adapting, based on alarm information, the alarm to output via at least one path of the one or more paths, the one or more paths comprising a path configured to communicate with the electronic device and the user interface of the ambulatory medical device [E.g. 0035, 0032-0034].
It would have been obvious to one of ordinary skill in the art of medical devices before the effective filling date of the claimed invention to modify Nova with the teaching of Volpe because adapting alarm characteristics ensures effective notification and thereby enhances patient safety, also it is merely combining prior elements according to known method to yield predictable result.
For claim 24, Nova fails to expressly disclose wherein to adapt the alarm comprises to detect whether an inhibiting factor is present, and, responsive to detecting the presence of the inhibiting factor, to adapt the alarm to increase a likelihood that the alarm will be recognized despite the presence of the inhibiting factor.
However, as shown by Volpe, it was well known in the art of medical devices to include wherein to adapt the alarm comprises to detect whether an inhibiting factor is present, and, responsive to detecting the presence of the inhibiting factor, to adapt the alarm to increase a likelihood that the alarm will be recognized despite the presence of the inhibiting factor [E.g. 0032-0034, 0054, 0071-0072].
It would have been obvious to one of ordinary skill in the art of medical devices before the effective filling date of the claimed invention to modify Nova with the teaching of Volpe in order to increase the reliability of the alarm by enabling adapting it according to different condition and thereby improve the overall system, also it is merely combining prior art elements according to known method to yield predictable result.
For claim 25, Volpe further teaches wherein the inhibiting factor comprises an improper fit of the ambulatory medical device on the patient [E.g. 0040-0043, 0047].
For claim 26, Volpe further teaches wherein the inhibiting factor comprises at least one of an environmental characteristic [0017], a patient characteristic [0015-0016, 0035], or a characteristic affecting the ambulatory medical device [0050-0053, 0056-0060].
For claim 27, Nova in view of Volpe further teaches wherein the ambulatory medical device further comprises a therapy delivery interface coupled to the at least one processor [E.g. Nova; 0006] and the at least one processor is further configured to adapt, based on the alarm information, the alarm to issue via the therapy delivery interface. [E.g. Volpe; 0035]
For claim 28, Nova discloses wherein to adapt the alarm comprises to change the at least one path to comprise the network interface, the user interface, or both the network interface and the user interface [E.g. 0022-0027, 0051-0054, Fig. 17].
For claim 29, Nova discloses wherein to change the one or more paths comprises to transmit the alarm to the electronic device via the network interface [E.g. 0022, 0036, 0043-0044, 0050, 0054, Fig. 17].
For claim 30, Nova discloses wherein the electronic device comprises a personal electronic device and to issue the alarm comprises to issue an alarm via the personal electronic device [E.g. 0027, 0030, 0038, 0040-0042, 0058].
For claim 31, Nova discloses wherein the personal electronic device comprises a smart phone and to issue the alarm via the personal electronic device comprises to issue an alarm via the smart phone [E.g. 0027, 0030, 0038, 0040-0042].
For claim 32, Nova discloses wherein the personal electronic device comprises a smart phone and to issue the alarm via the personal electronic device comprises to place a phone call or send a text message [E.g. 0027, 0036, 0044, 0067-0069].
For claim 33, Nova in view of Volpe further teaches wherein the electronic device comprises a display and to issue the alarm comprises to issue an alarm via the display [E.g. Nova; 0029, 0033 and Volpe; 0051-0055].
For claim 34, Nova discloses a non-transitory computer-readable medium having stored thereon computer-executable instructions that, when executed by one or more processors on a mobile device [E.g. 0023], cause the one or more processors to:
detect an occurrence of an event comprising a cardiac abnormality in a patient detected by a wearable medical device [E.g. 0034: During defibrillation operation, the microprocessor 306 analyzes an electrocardiogram (ECG) of a patient using an automatic heart rhythm detection algorithm also stored in memory 308 to identify whether the patient is experiencing a shockable heart rhythm, such as ventricular fibrillation, 0035: The ECG signals analyzed by the detection algorithm are collected by the electrodes 205 and passed through a monitor circuit 318 to an analog-to-digital converter 316. The analog-to-digital converter 316 then passes the digitized signals to microprocessor 306. If the microprocessor 306 detects a shockable rhythm, the microprocessor causes a charging circuit 320 to generate a current causing a storage capacitor (not shown) to charge in preparation for delivery of a defibrillation shock. When the capacitor is fully charged, and delivery of the defibrillation pulse initiated, a discharge circuit 322 coupled to the microprocessor 306 and charge circuit 320 discharges the defibrillation shock to the electrodes 205 for application of the defibrillation shock to the patient 90, 0023];
identify, responsive to detecting the occurrence of the event, an association between a path and an alarm, wherein an alarm profile received via an interface indicates the alarm to be triggered upon occurrence of the event and includes the association between the path and the alarm [E.g. 0022-0023]; and transmitting the alarm to a personal electronic device [E.g. 0009, 0022-0023].
Nova fails to expressly disclose adapt, responsive to identifying the association, at least one characteristic of the alarm according to the path, wherein adapting the at least one characteristic of the alarm comprises transmitting the alarm to a personal electronic device; and issue an instance of the alarm having the at least one adapted characteristic.
However, as shown by Volpe, it was well known in the art of medical devices to include adapting, based on alarm information, the alarm to output via at least one path of the one or more paths, the one or more paths comprising a path configured to communicate with the electronic device and the user interface of the ambulatory medical device [E.g. 0035, 0032-0034, 0003].
It would have been obvious to one of ordinary skill in the art of medical devices before the effective filling date of the claimed invention to modify Nova with the teaching of Volpe because adapting alarm characteristics ensures effective notification and thereby enhances patient safety, also it is merely combining prior elements according to known method to yield predictable result.
For claim 35, Nova in view of Volpe further teaches wherein the wearable medical device further comprises a therapy delivery interface coupled to the processor [E.g. Nova; 0006], and wherein to adapt the at least one characteristic of the alarm comprises to adapt, based on the alarm profile, the alarm to issue via the therapy delivery interface [E.g. Volpe; 0035].
For claim 36, Nova in view of Volpe discloses wherein to adapt the at least one characteristic of the alarm comprises to change at least one path through which the alarm is issued to comprise a network interface or a user interface [E.g. Nova; 0022-0023, 0009].
For claim 37, Nova discloses wherein to change the at least one path comprises to transmit the alarm to the personal electronic device via a network interface [E.g. 0022, 0027, 0036, 0067-0069].
For claim 38, Nova discloses wherein the personal electronic device comprises a phone and to issue the alarm comprises to place a phone call or send a text message to an intended recipient's phone [E.g. 0027, 0040-0044].
For claim 41, Nova in view of Volpe teaches wherein the personal electronic device comprises a display and to issue the alarm comprises to issue the alarm via the display [E.g. Nova; 0029, 0033 and Volpe; 0051-0055].
6. Claims 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Nova in view of Volpe and further in view of Official Notice.
For claim 39, Nova in view of Volpe fails to expressly disclose wherein to issue the alarm via the personal electronic device comprises to preempt normal functioning of the personal electronic device.
However, examiner takes official notice that wherein to issue the alarm via the personal electronic device comprises to preempt normal functioning of the personal electronic device is well-known in the art of providing an alarm and would have been obvious to one of ordinary skill in the art in order to ensure that a necessary alarm is delivered timely.
For claim 40, Nova in view of Volpe fails to expressly disclose wherein the personal electronic device comprises a smart phone and to preempt normal functioning of the personal electronic device comprises to issue the alarm while the personal electronic device is being used to make a phone call.
However, examiner takes official notice that wherein the personal electronic device comprises a smart phone and to preempt normal functioning of the personal electronic device comprises to issue the alarm while the personal electronic device is being used to make a phone call is well-known in the art of providing an alarm and would have been obvious to one of ordinary skill in the art in order to ensure that a necessary alarm is delivered timely.
Conclusion
7. The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: see PTO-892 Notice of Reference Cited.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED BARAKAT whose telephone number is (571)270-3696. The examiner can normally be reached on 9:00am-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Davetta Goins can be reached on (571) 272-2957. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED BARAKAT/
Primary Examiner, Art Unit 2689
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