DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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.
(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 1-4, 6-7, 10-17, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sullivan (US 2016/0000349).
Regarding claims 1 and 15, Sullivan discloses the claimed wearable cardioverter defibrillator (WCD), comprising:
a support structure configured to be worn by a patient (e.g. defibrillator system 1 including belt as shown in Figure 1);
an energy storage module configured to store an electrical charge (e.g. power supply 17);
a discharge circuit coupled to the energy storage module (e.g. therapy pad 7);
a user interface configured to receive one or more inputs from the patient (e.g. display 25)
one or more electrodes configured to render an electrocardiogram (ECG) signal of the patient while the patient is wearing the support structure (e.g. electrode assembly 11); and
a processor configured to:
receive the ECG signal from the one or more electrodes;
detect, based on the ECG signal, an occurrence of a type of arrhythmia (e.g. arrythmia detection at 150);
determine, based on the detected type of arrhythmia, whether a shock criterion is met (e.g. determination that event is not noise at 168); and
in response to a determination that the shock criterion is met, determine a confirmation time period to confirm the detected type of arrhythmia, wherein a duration of the confirmation time period is based on the detected type of arrhythmia (e.g. determination of longer delay if VT is determined and shorter delay if VF is determined, as shown in the top of Figure 9 and disclosed in [0098]);
determine whether the confirmation time period has elapsed or not (e.g. determination that the time period is up);
in response to a determination that the confirmation time period has elapsed, determine whether the shock criterion is still met (e.g. necessarily performed); and
in response to a determination that the shock criterion is still met, cause the user interface to generate a shock alert signal to warn the patient of an impending shock (e.g. alert device 13).
Regarding claim 2, Sullivan additionally discloses wherein the processor is further configured to continue, in response to a determination that the confirmation time period has not elapsed, to receive the ECG signal of the patient. (e.g. ECG data is constantly received).
Regarding claim 3, Sullivan additionally discloses wherein the user interface is further configured to output an alarm in response to the shock alert signal (e.g. alert device 13).
Regarding claim 4, Sullivan additionally discloses wherein the confirmation time period is shorter when the detected type of arrhythmia is ventricular fibrillation (VF) than for ventricular tachycardia (VT) (e.g. as shown in Figure 9).
Regarding claims 6 and 17, Sullivan additionally discloses displaying, via the user interface, the detected type of arrhythmia and providing information on potential therapy to the patient based on the detected type of arrhythmia (e.g. display device 25).
Regarding claim 7, Sullivan additionally discloses wherein the processor is further configured to cause the user interface to display the detected type of arrhythmia and provide information on potential therapy to the patient based on the detected type of arrhythmia (e.g. display screen 25).
Regarding claims 10 and 20, Sullivan additionally discloses wherein the processor is further configured to extend the confirmation time period upon detection of noise on the ECG signal (e.g. noise detection delay as shown in Figure 10).
Regarding claim 11, Sullivan additionally discloses wherein the processor is further configured to evaluate historical data of a certain type of arrhythmia associated with the patient to optimize the confirmation time period for future events (e.g. historical data as discloses in [0054]).
Regarding claim 12, Sullivan additionally discloses wherein the processor is further configured to determine, based on the detected type of arrhythmia, a response time period in response to the shock alert signal (e.g. prevention of defibrillation as taught in [0023], wherein the delay periods are different for VT and VF as disclosed in Figure 9).
Regarding claim 13, Sullivan additionally discloses wherein the processor is further configured to: control the discharge circuit to discharge the stored electrical charge when the response time period has elapsed and an input has not been received at the user interface; and control the discharge circuit to not discharge the stored electrical charge when an input has been received at the user interface prior to the response time period elapsing. (e.g. prevention of defibrillation as taught in [0023], wherein the delay periods are different for VT and VF as disclosed in Figure 9).
Regarding claim 14, Sullivan additionally discloses wherein to control the discharge circuit to not discharge the stored electrical charge, the processor is configured to return to an idle state to determine, from the ECG signal, whether another shock criterion is met (e.g. return to idle state 200 as shown in Figure 8).
Regarding claim 16, Sullivan additionally discloses receiving an input, via the user interface, from the patient to defer or divert a therapy based on the detected type of arrhythmia (e.g. prevention of defibrillation by user input as taught in [0023]).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sullivan in view of Donnelly US 2010/0298899).
Regarding claim 5, Sullivan discloses the claimed invention except the express mention of a processor is further configured to adjust the confirmation time period based on a position of the patient or a movement of the patient. Donnelly discloses that it was known in the art to delay treatment based on movement of a patient (e.g. delay treatment if patient activity is indicative of motion as discloses in Figure 5). It would have been obvious to one having ordinary skill in the art to include the motion sensing of Donnelly in the device of Sullivan in order to provide the system with the predictable results of a reliable means of determining if the patient needs immediate treatment.
Allowable Subject Matter
Claims 8-9 and 18-19 are objected to 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.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record does not disclose determining a confirmation time period from patient movement using a motion sensor along with the other elements of the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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/Amanda K Hulbert/ Primary Examiner, Art Unit 3792
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