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 .
Election/Restrictions
Applicant’s election without traverse of Species III, i.e. claims 73-78, 81, 83 and newly submitted claims 88-95 in the reply filed on November 24, 2025 is acknowledged.
The examiner notes that the listing of the elected claims, per the ‘Applicant’s Remarks’ filed on November 24, 2025 is different then the claims listed above. The applicant states that the election involves claims 73-79, 81-83 and 88-95. Per the restriction requirement submitted on October 2, 2025, claim 79 is part of the ‘species II’ grouping and claim 82 is of the ‘species I’ grouping (and is currently cancelled). Based on the election and the claims grouped in the restriction requirement responded to, the above claims will be examined.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 68, 73-78, 81, 83 & 88-95 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biel et al. (US 20180168508) in view of Hresko et al. (US 2017/0296056).
Biel et al. discloses:
Claim 68
An externally worn defibrillation device comprising: a sensor interface that includes physiological signal circuitry that is coupled to an electrocardiogram sensing electrode that is configured to be applied to a skin of a patient wearing the defibrillation device, wherein the physiological signal circuitry is configured to generate an electrocardiogram signal that is representative of cardiac activity of the patient;
E.G. via the disclosed external, wearable medical device 100 in the form of a garment 110 , that further includes sensing electrodes 112 that are configured to detect one or more cardiac signals {[0058]-[0061] & (Fig 1)}.
therapy delivery circuitry that is coupled to a therapy electrode that is configured to provide an electrical therapeutic shock to the patient;
E.G. via the disclosed therapy delivery interface 302 that is coupled to the therapy electrodes 114 that provide therapy to the patient {[0068]-[0069] & (Fig. 3)}.
at least one processor configured to process the electrocardiogram signal and control the therapy delivery circuitry to cause the electrical therapeutic shock to be provided to the patient:
E.G. via the disclosed at least one processor 318 {[0069] & (Fig 3)}.
detachment circuitry that is configured to detect a condition that is indicative of presence or absence of an electrical connection
E.G. via the disclosed medical device controller 120 further comprising an electrode falloff detector 324 configured to monitor and to identify elemental fall off during operation of the wearable medical device ([0073]-[0074]).
alarm circuitry configured to, based on absence of the electrical connection, generate an alert
E.G. via the disclosed alarm module 326 based on the alarm profiles/conditions stored in data storage, wherein said profiles/conditions are directly related to the data obtained via the falloff detector 324 {[0076] & (Table)}.
and a user interface configured to output the alert to the patient wearing the defibrillation device.
E.G. via the disclosed user interface 308 coupled to the processor 318, which is further configured to delivery a ‘type of alarm’ such as an audible or visual alert and/or notification to the patient {[0076] & (Table)}.
Biel et al. discloses the claimed invention having an external, wearable medical device in the form of a garment, which provides the claimed externally worn defibrillator device, further comprising a falloff detector and alarm module configured to provide an alert to a patient indicating that said garment should be adjusted based on a falloff event {[0076] and (Table)}. However, the disclosed falloff detector is not directly associated with the battery, i.e. the fall off detector does not explicitly read on the claimed battery detachment circuitry that is configured to detect a condition indicative of presence or absence of an electrical connection between the at least one processor and a rechargeable battery and further generating an alarm specifically indicating that the rechargeable battery is not connected to the defibrillation device.
Hresko et al. discloses a wearable, ambulatory medical device including a sensor and a controller, operatively coupled to said sensor, configured to perform a diagnostic test to identify whether an operational status of said device is in a critical or non-critical operational status and to display instruction and/or alarms to indicate said operational status [0006], wherein the device may provide the patient, via an user interface, with said operation status that more specifically includes connection status issue, when a connection may have failed, when a battery needs to be changed, when one or more components of the garment, i.e. the battery, may be improperly adjusted and needs to be readjusted, and/or one or more components of the system may have been improperly assembled [0095].
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the externally worn defibrillator device comprising the falloff detector and alarm module, as disclosed by Biel et al., with the use of the sensor and a controller configured to identify connection status issues of components directly associated with the system, such as a battery, as taught by Hresko et al., since such a modification would provide the predictable results pertaining to providing the patient with specific information about a detected anomaly associated with one or more portions of the garment that may need to be readjusted [Hresko, 0095].
Claim 73
The externally worn defibrillation device of Claim 68, wherein the alarm circuitry is further configured to pause the alert for a period of time in response to receiving a user input via the user interface.
E.G. via the disclosed security manager 440 which is configured to limit an ability of the remote system to control/obtain information from the ambulatory medical device 100, such as disabling any alarms [Hresko, 0068].
Claim 74:
The externally worn defibrillation device of Claim 73, wherein the alarm circuitry is further configured to reinstate the alert after the period of time has elapsed.
E.G. via the disclosed function of activating an audible alarm based on the interaction of the ambulatory medical device 100 [Biel, 0079].
Claim 75:
The externally worn defibrillation device of Claim 68, wherein the alert is one or more of an audible alert or a tactile alert.
E.G. {Biel, [0076] & (TABLE)}.
Claim 76:
The externally worn defibrillation device of Claim 75, wherein: the alert includes the audible alert: and the defibrillation device further comprises an audio output device that is adjustable to alter a frequency range of the audible alert.
E.G. via the disclosed alarm manager, i.e. alarm module 326, that can be configured to ‘cause’ a higher/lower volume audible alarm [Biel, 0156].
Claim 77:
The externally worn defibrillation device of Claim 75, wherein: the alert includes the audible alert: and the audible alert has a frequency range that is adjustable via a control provided during initial patient fitting of the defibrillation device.
E.G. [Biel, 0156].
Claim 78: The externally worn defibrillation device of Claim 75, wherein: the alert includes the audible alert: and the audible alert has a frequency range that is determined based upon patient response to a hearing test administered during initial patient fitting of the defibrillation device.
E.G. [Biel, 0156].
Claim 81:
The externally worn defibrillation device of Claim 68, wherein the alarm circuitry is further configured to terminate the alert if the rechargeable battery is inserted into a battery charger.
E.G. [Hresko, 0068].
Claim 83:
A medical monitoring device comprising: a sensor interface that includes physiological signal circuitry that is coupled to a physiological sensor that is configured to be adhesively applied to a patient, wherein the physiological signal circuitry is configured to generate a physiological signal that is indicative of a physiological parameter of the patient;
E.G. via the disclosed sensing electrodes 112 that can be adhesively applied to the patient’s body and are configured to detect one or more cardiac signals {Biel, [0060]-[0061] & (Fig 1)}.
at least one processor configured to process the physiological signal and generate physiological data that characterizes the physiological parameter of the patient;
E.G. via the disclosed processor 318, sensor interface 312 that receive information indicative of patient parameters, which is coupled to said sensing electrodes {Biel, [0069] & (Fig 3)}.
a network interface, controlled by the at least one processor, that is configured to transmit the physiological data to a remote server;
E.G. via the disclosed network interface 306 {Biel, [0070] & (Fig 3).
battery detachment circuitry that is configured to detect an electrical connection between the at least one processor and a rechargeable battery, and output a battery status signal indicating that the at least one processor is not electrically connected to the rechargeable battery, thereby rendering the medical monitoring device unable to transmit the physiological data to the remote server;
E.G. via the disclosed medical device controller 120 further comprising an electrode falloff detector 324 configured to monitor and to identify elemental fall off during operation of the wearable medical device (Biel, [0073]-[0074]).
AND
E.G. via the device may provide the patient, via an user interface, with said operation status that more specifically includes connection status issue, when a connection may have failed, when a battery needs to be changed, when one or more components of the garment, i.e. the battery, may be improperly adjusted and needs to be readjusted, and/or one or more components of the system may have been improperly assembled [Hresko, 0095].
and alarm circuitry configured to receive the battery status signal and, responsive to receiving the battery status signal, generate an alert indicating that the at least one processor is not electrically connected to the rechargeable battery.
E.G. via the disclosed alarm module 326 based on the alarm profiles/conditions stored in data storage, wherein said profiles/conditions are directly related to the data obtained via the falloff detector 324 {Biel, [0076] & (Table)}.
Claim 88
The medical monitoring device of Claim 83, further comprising a user interface configured to output the alert to the patient.
E.G. via the disclosed user interface 308 coupled to the processor 318, which is further configured to delivery a ‘type of alarm’ such as an audible or visual alert and/or notification to the patient {Biel, [0076] & (Table)}.
Claim 89:
The medical monitoring device of Claim 88, wherein the alarm circuitry is further configured to pause the alert for a period of time in response to receiving a user input via the user interface.
E.G. via the disclosed security manager 440 which is configured to limit an ability of the remote system to control/obtain information from the ambulatory medical device 100, such as disabling any alarms [Biel, 0068].
Claim 90
The medical monitoring device of Claim 89, wherein the alarm circuitry is further configured to reinstate the alert after the period of time has elapsed.
E.G. via the disclosed function of activating an audible alarm based on the interaction of the ambulatory medical device 100 [Biel, 0079].
Claim 91:
The medical monitoring device of Claim 83, wherein the alert is one or more of an audible alert or a tactile alert.
E.G. {Biel, [0076] & (TABLE)}.
Claim 92:
The medical monitoring device of Claim 91, wherein: the alert includes the audible alert: and the medical monitoring device further comprises an audio output device that is adjustable to alter a frequency range of the audible alert.
E.G. [Biel, 0156].
Claim 93:
The medical monitoring device of Claim 91, wherein: the alert includes the audible alert: and the audible alert has a frequency range that is adjustable via a control provided during initial patient fitting of the medical monitoring device.
E.G. [Biel, 0156].
Claim 94:
The medical monitoring device of Claim 91, wherein: the alert includes the audible alert: and the audible alert has a frequency range that is determined based upon patient response to a hearing test administered during initial patient fitting of the medical monitoring device.
E.G. [Biel, 0156].
Claim 95:
The medical monitoring device of Claim 83, wherein the alarm circuitry is further configured to terminate the alert if the rechargeable battery is inserted into a battery charger.
E.G. [Hresko, 0068].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796