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 § 103
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries 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 nonobviousness.
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) 21-26, 28-31, 35-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20130231711 to Kaib in view of US 20090264783 to Xi et al. (hereinafter “Xi”).
Regarding claims 21 and 35. (New) Kaib discloses a wearable cardioverter defibrillator (WCD) system and method (para 0044, fig. 1), comprising: a support structure configured to be worn by a patient (para 0044, wearable treatment device 100”);a power source (para 0044 “power supply”);an energy storage module configured to receive an electric charge from the power source, and to store the received electric charge (para 0044, 0065, 0128);a discharge circuit coupled to the energy storage module, wherein the discharge circuit is controllable to discharge the electric charge stored in the energy storage module (para 0048, 0049, etc.);one or more sensors coupled to the support structure and configured to acquire physiological signals while the support structure is worn by the patient, wherein at least one first sensor of the one or more sensors is configured to acquire electrocardiogram (ECG) data of the patient (para 0051, sensors 110);a processor (para 0044, 0052, 0056, etc.) configured to: determine, from the physiological signals, whether the patient suffered an atrial arrhythmia during an aggregation period based at least in part on operations comprising (para 0044, 0053, 0073, etc.): identify, from the physiological signals, heart beats during a segment of the aggregation period; [] detect variation in the time delays as heart rate variability (HRV) (para 0053, 0080, 0082, 0094, etc. “identify heart rate variability based on R-R intervals in ECG signals”); and a user interface that includes a screen configured to display the compared one or more values on the screen (para 0018, 0052).
Kaib fails to explicitly disclose detect time delays between the identified heartbeats, wherein the time delays correspond to beat-to-beat intervals; derive one or more values from the detected time delays for the segment; and compare the derived one or more values of the segment with one or more values derived from detected time delays of other segments of the aggregation period.
Xi, from a similar field of endeavor teaches that it is known that arrhythmia (i.e., AF) can be monitored by comparing RR interval variability (as measured from an ECG signal) or changes in RR interval variability to a corresponding variability threshold, such that arrhythmia (AF) is detected when the variability threshold is exceeded (para 0071, 0083). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Kaib with the known teachings of Xi to provide the predictable result of determining arrythmia.
Regarding claim 22. (New) Kaib as modified by Xi renders obvious the WCD system of claim 21, wherein the processor is configured to: determine whether the ECG data of the patient falls within a predefined zone during the aggregation period, wherein the predefined zone is defined by specific values of heart rate and QRS width; and in response to a determination that the ECG data of the patient falls within the predefined zone, perform the operations to detect the HRV, to determine whether the patient suffered the atrial arrhythmia during the aggregation period (Xi, para 0043, 0062).
Regarding claim 23. (New) Kaib as modified by Xi renders obvious the WCD system of claim 21, wherein the processor is configured to determine representative heart rates of segments, during the aggregation period, from the ECG data of the patient (see rejection of claim 21).
Regarding claim 24. (New) Kaib as modified by Xi renders obvious the WCD system of claim 21, wherein the ECG data acquired during the aggregation period corresponds to ECG data from one or more segments falling within a predefined zone (see rejection of claim 21; the claim does not provide any details regarding the period or zone. Under its broadest reasonable interpretation, these segments are considered to be arbitrary.).
Regarding claim 25. (New) Kaib as modified by Xi renders obvious the WCD system of claim 21, wherein the user interface is further configured to display a scatterplot depicting the HRV or RR variability (RRV), where each point on the scatterplot is a representative value of the segment (Kaib para 0018, 0045, etc.; Xi, para 0077-0078, figs 3, 4c, etc.).
Regarding claim 26. (New) Kaib as modified by Xi renders obvious the system of claim 21, wherein the user interface is further configured to display a graph depicting balance between sympathetic nervous system (SNS) activity of the patient and parasympathetic nervous system (PNS) activity of the patient, and wherein the SNS activity increases heart rate of the patient and the PNS activity decreases the heart rate of the patient (Kaib para 0018, 0045, etc.; display is capable of displaying various graphs; para 0082 “medical condition sensors 110 may measure sympathetic and parasympathetic nervous system activity, and controller 105 may identify heart rate variability based on R-R intervals in ECG signals or a spectral analysis of heart rate variable frequencies”).
Regarding claim 28. (New) Kaib as modified by Xi renders obvious the WCD system of claim 21, wherein the user interface is further configured to display a graph of a physical pressure index reflecting a standard deviation of the beat-to-beat intervals (Xi, fig 3).
Regarding claim 29. (New) Kaib as modified by Xi renders obvious the WCD system of claim 21, wherein the user interface is further configured to display a scatterplot depicting the HRV or RR variability (RRV), where R is a point corresponding to the peak of QRS complex of an ECG wave in the ECG data and RR is an interval between successive R's (Kaib para 0018, 0045, etc.; Xi, para 0077-0078, figs 3, 4c, etc.).
Regarding claim 30. (New) Kaib as modified by Xi renders obvious the WCD system of claim 21, further comprising a trigger configured to be actuated for preventing the discharge of the electric charge stored in the energy storage module, wherein the processor is further configured to register moments that the trigger was actuated, and wherein the screen is further configured to display, along a horizontal direction, indicators for the registered moments (Kaib para 0012, 0096).
Regarding claim 31. (New) Kaib as modified by Xi renders obvious the WCD system of claim 21, further comprising a memory configured to store different portions of the ECG data as one or more data files, each data file of the one or more data files including a time stamp, wherein the screen is configured to display the one or more data files (Kaib, para 0074, etc., Xi, figs 3, 4, etc.).
Regarding claim 36. (New) Kaib as modified by Xi renders obvious the method of claim 35, wherein displaying the compared one or more values is performed while the patient is wearing the support structure and has been continuously wearing the support structure since the acquisition of the physiological signals (para 0078).
Regarding claim 37. (New) Kaib as modified by Xi renders obvious the method of claim 35, further comprising displaying a scatterplot depicting the HRV or RR variability (RRV) on the screen, wherein the HRV or RRV is derived from the plurality of segments (Kaib para 0018, 0045, etc.; Xi, para 0077-0078, figs 3, 4c, etc.).
Regarding claim 38. (New) Kaib as modified by Xi renders obvious the method of claim 35, wherein the WCD system further includes a trigger, and the method further comprising: registering moments that the trigger was actuated; and displaying, by the screen, indicators for the registered moments along a horizontal direction (Kaib para 0012, 0096, Xi figs 3-4, etc.).
Regarding claim 39. (New) Kaib as modified by Xi renders obvious the method of claim 35, further comprising displaying a scatterplot depicting the HRV or RR variability (RRV) on the screen, where R is a point corresponding to the peak of QRS complex of an ECG wave in the ECG data and RR is an interval between successive R's (Kaib para 0018, 0045, etc.; Xi, para 0077-0078, figs 3, 4c, etc.).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20130231711 to Kaib in view of US 20090264783 to Xi et al. (hereinafter “Xi”) as applied to claims above, and further in view of WO 2006093372 to Kwon et al (Hereinafter “Kwon”).
Regarding claim 27. (New) Kaib as modified by Xi renders obvious the WCD system of claim 26, but fails to disclose wherein the user interface is further configured to display an emotional status of the patient that is derived based on the balance between the SNS activity and the PNS activity of the patient.
Kwon, from a similar field of endeavor teaches that it is known that the mental or emotional status of human are influenced by the interaction between parasympathetic nerves and sympathetic nerves (description). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Kaib as modified by Xi with the teachings of Kwon to determine the mental or emotional status of the human based on the interaction between parasympathetic nerves and sympathetic nerves.
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20130231711 to Kaib in view of US 20090264783 to Xi et al. (hereinafter “Xi”) as applied to claims above, and further in view of US 20080051668 to Bardy.
Regarding claim 40. (New) Kaib as modified by Xi renders obvious the method of claim 35, but fails to disclose further comprising displaying diagnostics related to atrial arrhythmia burden (AAB) of the patient on the screen.
Bardy, from a similar field of endeavor teaches a diagnostic module forming a patient status comprising a form of atrial arrhythmia reflected by the burden (para 0015). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Kaib as modified by Xi with the teachings of Bardy to determine burden represented by the cardiac rhythm.
Allowable Subject Matter
Claim 32-34 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.
Conclusion
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/SANA SAHAND/Examiner, Art Unit 3796
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