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 .
Drawings
The Applicant is reminded to carefully review the drawing figures and the accompanying specification to ensure that all reference numerals present in the drawing figures are defined within the specification.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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, 4-10, 13-17, and 21-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hresko et al. (U.S. 2022/0273960), herein Hresko. Regarding claim 1, Hresko discloses a medical system operable to provide training to a patient (“An external medical device is provided which is configured to provide a user with access to one or more training modules.”, Abstract), the medical system comprising: a wearable medical device 100 comprising an alert button (“The controller 120 can include response buttons”, paragraph [0095] and Figure 1), the wearable medical device configured to deliver therapy to the patient (“The wearable medical device 100 can also optionally include a plurality of therapy electrodes 114”, paragraph [0093]) upon detection of a cardiac condition of the patient based on patient electrocardiogram (ECG) data (“The therapy electrodes 114 are configured to deliver one or more therapeutic defibrillating shocks, pacing pulses”, paragraph [0093]) and output an alert prior to providing the therapy (“when the controller 120 determines that the patient is experiencing cardiac arrhythmia, the speaker can issue an audible alarm to alert the patient and bystanders to the patient's medical condition”, paragraph [0095]); one or more remote servers (“the remote location can include equipment for securely receiving such medical data over the network”, paragraph [0109]); and a mobile device 120 comprising at least one processor 318 and a user interface 308 (see Figure 3), the mobile device in communication with the wearable medical device and the one or more remote servers (“the network interface 306 may be configured to communicate with a server (e.g., a remote server)”, paragraph [0098]), the at least one processor configured to: receive a first communication from the one or more remote servers; and control, based on the received first communication, the user interface to output a first instruction to the patient through the user interface, wherein the first instruction instructs the patient to press the alert button when the alert is output, and wherein the alert button is configured to override delivery of the therapy (“the controller 120 can instruct the patient to press and hold one or both of the response buttons on the medical device controller 120 to indicate that the patient is conscious, thereby instructing the medical device controller 120 to withhold the delivery of one or more therapeutic defibrillating shocks”, paragraph [0095]).
Regarding claim 2, Hresko discloses that the first communication comprises one of a text message provided on the user interface or a notification provided via a patient application (“Aspects of the present disclosure are directed to monitoring and/or therapeutic medical devices that allow a user (e.g., a patient) to access training demonstrations, video and audio lessons, and/or text instructions”, paragraph [0066]).
Regarding claim 4, Hresko discloses that the first instruction comprises a training video (“Aspects of the present disclosure are directed to monitoring and/or therapeutic medical devices that allow a user (e.g., a patient) to access training demonstrations, video and audio lessons, and/or text instructions”, paragraph [0066]).
Regarding claim 5, Hresko discloses that the wearable medical device is operable to send a second communication to the mobile device when the patient presses the alert button (“For example, as part of the training module related to patient treatment, a screen with the instruction “Press Response Button Now” could be displayed. Similarly, in a training module related to monitoring garment fit, a screen with the message “Check Garment” can be provided. For instance, such a screen may additionally instruct the patient to check that the garment is securely fitted and not too loose about the patient's torso. Such a screen may also instruct the patient to make sure that the round electrodes touch his or her skin and that nothing is between the electrodes and skin.”, paragraph [0119]).
Regarding claim 6, Hresko discloses that the second communication causes a training completion indication to be provided on the user interface (“At the completion of a particular training module, as shown by screen 526, the user can be provided with a screen informing him or her that the selected training module has been completed.”, paragraph [0121]).
Regarding claim 7, Hresko discloses that the one or more remote servers are operable to schedule initiation of the training mode based on a scheduled training frequency, patient use of the wearable medical device, and/or when the patient ECG data indicates that a noise threshold has been exceeded (“A required or mandatory module can be requested by a caregiver or service representative, or can be scheduled according to a predetermined schedule that is created before the user receives the device. An example of a required training module could be a follow-up training module scheduled after the user has had the device for a few weeks and which reviews information provided to the user during initial device set up.”, paragraph [0125]).
Regarding claim 8, Hresko discloses that the wearable medical device comprises at least one therapy electrode 320/322/324 in communication with an energy source, the at least one therapy electrode configured to deliver a shock to the patient based on the patient ECG data (see Figure 3 and “The therapy delivery interface 302 (if included) may be coupled to one or more electrodes that provide therapy to the patient including, for example, one or more therapy electrodes 320, pacing electrodes 322, and/or TENS electrodes 324.”, paragraph [0097]).
Regarding claim 9, Hresko discloses a method for training a patient to override delivery of a therapy, the method comprising: providing a wearable medical device 100 comprising an alert button to the patient (“The controller 120 can include response buttons”, paragraph [0095] and Figure 1), the wearable medical device configured to deliver the therapy to the patient (“The wearable medical device 100 can also optionally include a plurality of therapy electrodes 114”, paragraph [0093]) upon detection of a cardiac condition of the patient based on patient electrocardiogram ECG data (“The therapy electrodes 114 are configured to deliver one or more therapeutic defibrillating shocks, pacing pulses”, paragraph [0093]) and output an alert prior to providing the therapy (“when the controller 120 determines that the patient is experiencing cardiac arrhythmia, the speaker can issue an audible alarm to alert the patient and bystanders to the patient's medical condition”, paragraph [0095]); receiving a first communication via one or more remote servers; and providing, based on the received first communication, a first instruction to the patient through a user interface of a mobile device to press the alert button when the alert is output, wherein the alert button is configured to override the delivery of the therapy (“the controller 120 can instruct the patient to press and hold one or both of the response buttons on the medical device controller 120 to indicate that the patient is conscious, thereby instructing the medical device controller 120 to withhold the delivery of one or more therapeutic defibrillating shocks”, paragraph [0095]).
Regarding claim 10, Hresko discloses that the first communication comprises one of a text message provided on the user interface of the mobile device or a notification provided via a patient application (“Aspects of the present disclosure are directed to monitoring and/or therapeutic medical devices that allow a user (e.g., a patient) to access training demonstrations, video and audio lessons, and/or text instructions”, paragraph [0066]).
Regarding claim 13, Hresko discloses transmitting, via the wearable medical device, a second communication to the mobile device when the patient presses the alert button (“For example, as part of the training module related to patient treatment, a screen with the instruction “Press Response Button Now” could be displayed. Similarly, in a training module related to monitoring garment fit, a screen with the message “Check Garment” can be provided. For instance, such a screen may additionally instruct the patient to check that the garment is securely fitted and not too loose about the patient's torso. Such a screen may also instruct the patient to make sure that the round electrodes touch his or her skin and that nothing is between the electrodes and skin.”, paragraph [0119]).
Regarding claim 14, Hresko discloses that the second communication causes a training completion indication to be provided on the mobile device (“At the completion of a particular training module, as shown by screen 526, the user can be provided with a screen informing him or her that the selected training module has been completed.”, paragraph [0121]).
Regarding claim 15, Hresko discloses that the one or more remote servers are operable to schedule initiation of the training mode based on a scheduled training frequency, patient use of the wearable medical device, and/or when the patient ECG data indicates that a noise threshold has been exceeded (“A required or mandatory module can be requested by a caregiver or service representative, or can be scheduled according to a predetermined schedule that is created before the user receives the device. An example of a required training module could be a follow-up training module scheduled after the user has had the device for a few weeks and which reviews information provided to the user during initial device set up.”, paragraph [0125]).
Regarding claim 16, Hresko discloses a non-transitory computer readable medium, encoded with instructions stored thereon for training a patient to override delivery of a therapy, that when executed by at least one computing device, cause the at least one computing device to perform operations for training the patient to override the delivery of the therapy, the operations comprising: receiving, via one or more remote servers, a communication at a mobile device, wherein: a wearable medical device 100 includes an alert button (“The controller 120 can include response buttons”, paragraph [0095] and Figure 1), and the wearable medical device is configured to deliver the therapy to the patient (“The wearable medical device 100 can also optionally include a plurality of therapy electrodes 114”, paragraph [0093]) upon detection of a cardiac condition of the patient based on patient electrocardiogram ECG data (“The therapy electrodes 114 are configured to deliver one or more therapeutic defibrillating shocks, pacing pulses”, paragraph [0093]) and output an alert prior to providing the therapy (“when the controller 120 determines that the patient is experiencing cardiac arrhythmia, the speaker can issue an audible alarm to alert the patient and bystanders to the patient's medical condition”, paragraph [0095]); and controlling, based on the received communication, a user interface of the mobile device to output a first instruction to the patient to press the alert button when the alert is output, wherein the alert button is configured to override the delivery of the therapy (“the controller 120 can instruct the patient to press and hold one or both of the response buttons on the medical device controller 120 to indicate that the patient is conscious, thereby instructing the medical device controller 120 to withhold the delivery of one or more therapeutic defibrillating shocks”, paragraph [0095]).
Regarding claim 17, Hresko discloses that the communication comprises a text message provided on the mobile device and/or a notification provided via a patient application (“Aspects of the present disclosure are directed to monitoring and/or therapeutic medical devices that allow a user (e.g., a patient) to access training demonstrations, video and audio lessons, and/or text instructions”, paragraph [0066]).
Regarding claim 21, Hresko discloses that the processor is further configured to initiate a training mode based on the received first communication, and in the training mode, the processor is further configured to control the user interface to output the first instruction to the patient (“For example, as part of the training module related to patient treatment, a screen with the instruction “Press Response Button Now” could be displayed. Similarly, in a training module related to monitoring garment fit, a screen with the message “Check Garment” can be provided. For instance, such a screen may additionally instruct the patient to check that the garment is securely fitted and not too loose about the patient's torso. Such a screen may also instruct the patient to make sure that the round electrodes touch his or her skin and that nothing is between the electrodes and skin.”, paragraph [0119]).
Regarding claim 22, Hresko discloses that the processor is further configured to initiate a training mode based on the received first communication, in the training mode, the processor is further configured to control the user interface to output a second instruction to the patient, the second instruction is associated with a fitting of a garment to the patient, and the garment is associated with the wearable medical device (“For example, as part of the training module related to patient treatment, a screen with the instruction “Press Response Button Now” could be displayed. Similarly, in a training module related to monitoring garment fit, a screen with the message “Check Garment” can be provided. For instance, such a screen may additionally instruct the patient to check that the garment is securely fitted and not too loose about the patient's torso. Such a screen may also instruct the patient to make sure that the round electrodes touch his or her skin and that nothing is between the electrodes and skin.”, paragraph [0119]).
Regarding claim 23, Hresko discloses initiating a training mode based on the received first communication; and controlling, in the training mode, the user interface to output the first instruction to the patient (“For example, as part of the training module related to patient treatment, a screen with the instruction “Press Response Button Now” could be displayed. Similarly, in a training module related to monitoring garment fit, a screen with the message “Check Garment” can be provided. For instance, such a screen may additionally instruct the patient to check that the garment is securely fitted and not too loose about the patient's torso. Such a screen may also instruct the patient to make sure that the round electrodes touch his or her skin and that nothing is between the electrodes and skin.”, paragraph [0119]).
Regarding claim 24, Hresko discloses initiating a training mode based on the received first communication; and controlling, in the training mode, the user interface to output a second instruction to the patient, wherein: the second instruction is associated with a fitting of a garment to the patient, and the garment is associated with the wearable medical device (“For example, as part of the training module related to patient treatment, a screen with the instruction “Press Response Button Now” could be displayed. Similarly, in a training module related to monitoring garment fit, a screen with the message “Check Garment” can be provided. For instance, such a screen may additionally instruct the patient to check that the garment is securely fitted and not too loose about the patient's torso. Such a screen may also instruct the patient to make sure that the round electrodes touch his or her skin and that nothing is between the electrodes and skin.”, paragraph [0119]).
Regarding claim 25, Hresko discloses that the operations further comprising: initiating a training mode based on the received communication; and controlling, in the training mode, the user interface to output the first instruction to the patient (“For example, as part of the training module related to patient treatment, a screen with the instruction “Press Response Button Now” could be displayed. Similarly, in a training module related to monitoring garment fit, a screen with the message “Check Garment” can be provided. For instance, such a screen may additionally instruct the patient to check that the garment is securely fitted and not too loose about the patient's torso. Such a screen may also instruct the patient to make sure that the round electrodes touch his or her skin and that nothing is between the electrodes and skin.”, paragraph [0119]).
Regarding claim 26, Hresko discloses that the operations further comprising: initiating a training mode based on the received communication; and controlling, in the training mode, the user interface to output a second instruction to the patient, wherein: the second instruction is associated with a fitting of a garment to the patient, and the garment is associated with the wearable medical device (“For example, as part of the training module related to patient treatment, a screen with the instruction “Press Response Button Now” could be displayed. Similarly, in a training module related to monitoring garment fit, a screen with the message “Check Garment” can be provided. For instance, such a screen may additionally instruct the patient to check that the garment is securely fitted and not too loose about the patient's torso. Such a screen may also instruct the patient to make sure that the round electrodes touch his or her skin and that nothing is between the electrodes and skin.”, paragraph [0119]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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