DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-2, 4-11, and 13-22 are pending.
Claims 3 and 12 are cancelled.
Response to Arguments
Applicant’s argument has been fully considered nbut it is moot in light of a new ground of rejection. See discussion below.
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.
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.
Claims 1-2, 4-11, and 13-22 are rejected under 35 U.S.C. 103 as being unpatentable over Chung et al. (US 20150106020 A1, 2015-04-16) (hereinafter “Chung”) in view of Lewicke et al. (US 20090024005 A1, 2009-01-22) (hereinafter “Lewicke”) and Pedley (“Tilt Sensing Using a Three-Axis Accelerometer,” Freescale Semiconductor Application Note, 03/2013).
Regarding claims 1-9, Chung teaches a method of operating an ambulatory medical device (AMD) wearable by a subject or implantable in the subject (e.g., 226, Fig. 1), the method comprising: determining that the subject avoids lying on their left side; and computing a metric predictive of one or both of orthopnea and trepopnea in response to determining that the subject avoids lying on their left side (e.g., [0074], [0127]) [C1].
Note that Chung teaches monitoring and prediction of heart failures (e.g., [0051], [0058]) [C2] and wireless communication and transmission of patient data (e.g., [160]) [C3],
However, Chung does not expressly teach use of multi-axis posture sensor.
Lewicke teaches use of multi-axis posture sensor (e.g., [0069]) [L1], calibration of sensors (e.g., [0069] [L2], detecting posture angles (e.g., [0051]) [L3] for purposes of predicting and monitoring heart failures.
Pedley teaches determining respective directions of a plurality of temporally consecutive gravity vectors relative to the first, second, and third non-parallel axes of the AMD (see, e.g., Sect. 3); computing a plurality of angle changes between temporally consecutive ones of the plurality of gravity vectors using a normalized dot product of the temporally consecutive gravity vectors (see, e.g., Sect. 4). [P1]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Lewicke and Pedley with the invention of Chung such that the method further comprises determining that the subject avoids lying on their left side using a multi-axis posture sensor of the AMD, wherein the posture sensor is configured to provide an electrical posture sensor output representative of alignment of respective first, second, and third non-parallel axes of the AMD with a gravitational field of the earth; the determining including: determining respective directions of a plurality of temporally consecutive gravity vectors relative to the first, second, and third non-parallel axes of the AMD; computing a plurality of angle changes between temporally consecutive ones of the plurality of gravity vectors using a normalized dot product of the temporally consecutive gravity vectors; determining, from the plurality of angle changes, a maximum angle change or a value based on a predetermined percentage of largest angle changes; determining that the subject avoids lying on their left side based on a reduction in the maximum angle change or the value; and computing a metric predictive of one or both of orthopnea and trepopnea in response to determining that the subject avoids lying on their left side (as recited in claim 1); wherein the computing the metric includes: trending, by the AMD, an amount of time that the subject is lying on the left side; and generating an indication of heart failure status of the subject using the trend [C2] (as recited in claim 2); including: generating a status of the one or both of orthopnea and trepopnea of the subject using the determined elevation angle and determined side angle [L3] (as recited in claim 4); wherein the determining that the subject avoids lying on their left side includes: determining the direction of a current gravity vector relative to axes of the posture senso rwhile the subject is stationary; computing an angle change between the current gravity vector and a direction of a previously measured gravity vector relative to the axes of the posture sensor; and computing multiple angle changes and determining that the subject is on their left side using the determined angle changes wherein gravity vectors determined while motion of the subject exceeds a motion threshold are excluded from the multiple angle changes [L3] (as recited in claim 5); including determining the angle change using a dot-product of the current gravity vector and the previously measured gravity vector [L3] (as recited in claim 6); wherein the determining that the subject avoids lying on their left side includes determining that the subject is on their left side using a predetermined percentage of largest angle changes of the multiple angle changes, including identifying the predetermined percentage of largest angle changes and computing a mean of the predetermined percentage of largest angle changes within a monitoring window [L3] (as recited in claim 7); including: calibrating an output of the multi-axis posture sensor to an orientation of the AMD relative to an orientation of the subject; and wherein the determining that the subject avoids lying on their left side includes determining that the subject is stationary and lying on their left side using the calibrated output of the multi-axis posture sensor [L1]-[L3] (as recited in claim 8) in order to accurately predict and monitor heart failures.
Regarding claims 9-11 and 13-22, as discussed above, Chung (in view of Lewicke and Pedley) teaches an ambulatory medical device (AMD), the device comprising: a multi-axis posture sensor configured to provide an electrical posture sensor output representative of alignment of respective first, second, and third non-parallel axes of the AMD with the gravitational field of the earth; and processing circuitry communicatively coupled to the multi-axis posture sensor and configured to: determine that the subject avoids lying on their left side using the posture sensor output; including to: determine respective directions of a plurality of temporally consecutive ones of the plurality of temporally consecutive gravity vectors relative to the first, second, and third non-parallel axes of the AMD; compute a plurality of angle changes between temporally consecutive gravity vectors using a normalized dot product of the temporally consecutive gravity vectors [P1]; determine, from the plurality of angle changes, a maximum angle change or a value based on a predetermined percentage of the largest angle changes; and determine that the subject avoids lying on the left side based on a reduction in the maximum angle change or the value and compute a metric predictive of one or both of orthopnea and trepopnea in response to determining that the subject avoids lying on their left side [C1]-[C2], [L1]-[L3] (as recited in claim 9); wherein the processing circuitry is configured to: detect that the subject is stationary using a calibrated posture sensor output; determine that the subject avoids lying on their left side using the calibrated posture sensor output; and compute, as the metric, an amount of time that the subject is lying on their left side [C1]-[C2], [L1]-[L3] (as recited in claim 10); wherein the processing circuitry is configured to: compute an elevation angle of the subject using the posture sensor output; compute a side angle of the subject using the posture sensor output; and compute, as the metric, an amount of time that the elevation angle of the subject is within a predetermined range of a flat elevation and the side angle indicates that the subject is on their left side [C1]-[C2], [L1]-[L3] (as recited in claim 11); wherein the processing circuitry is configured to: compute the direction of a first gravity vector relative to axes of the posture sensor; compute the direction of a second gravity vector relative to the axes of the posture sensor; compute an angle change between the second gravity vector and the first gravity vector; and compute successive angle changes between temporally consecutive gravity vectors and determine that the subject avoids lying on their left side using the computed successive angle changes [C1]-[C2], [L1]-[L3] (as recited in claim 13); wherein the processing circuitry is configured to: compute a normalized dot-product of the second gravity vector and the first gravity vector to compute the angle change between the second gravity vector and the first gravity vector [C1]-[C2], [L1]-[L3] (as recited in claim 14); wherein the processing circuitry is configured to: compute multiple gravity vectors and compute multiple angle changes between the gravity vectors; identify a predetermined percentile of computed angle changes that have highest values within a monitoring window; compute a mean value of the identified predetermined percentile of computed angle changes; and determine that the subject avoids lying on their left side based on the mean value of the identified predetermined percentile of computed angle changes [C1]-[C2], [L1]-[L3] (as recited in claim 15); wherein the posture sensor is a multi-axis accelerometer; and wherein the processing circuitry is configured to: calibrate an output of the multi-axis accelerometer to an orientation of the AMD relative to the subject; and determine that the subject is stationary and lying on their left side using the calibrated output of the multi-axis accelerometer [C1]-[C2], [L1]-[L3] (as recited in claim 16); including: a communication circuit operatively coupled to the processing circuitry and configured to communicate information to a separate device; and wherein the processing circuitry is configured to: generate an indication of heart failure status of the subject using the amount of time that the subject is lying on their left side; and send the indication to the separate device [C1]-[C3], [L1]-[L3] (as recited in claim 16); including: a communication circuit operatively coupled to the processing circuitry and configured to communicate information to a separate device; and wherein the processing circuitry is configured to: generate an indication of heart failure status of the subject using the metric predictive of one or both of orthopnea and trepopnea; and send the indication to the separate device (as recited in claim 17); a programming device for an ambulatory medical device (AMD), the programming device comprising: a communication circuit configured to communicate information wirelessly with the AMD; a user interface; and a programming control circuit operatively coupled to the communication circuit and user interface; the programming control circuit configured to: receive orientation information of a subject from the AMD, the orientation information including angle-change information corresponding to a plurality of angle changes between temporally consecutive gravity vectors measured by the AMD relative to first, second, and third non-parallel axes of the AMD; compute a metric indicative of the subject avoiding lying on their left side using the orientation information, including by determining a maximum angle change or a value based on a predetermined percentage of the largest angle changes and determining a reduction in the maximum angle change or the value; and produce an indication of heart failure status of the subject according to a comparison of the metric to a trepopnea detection threshold [C1]-[C3], [L1]-[L3] (as recited in claim 18); wherein the programming control circuit is configured to: receive a trend of side angle information of the subject from the AMD; and produce the indication of heart failure status using the trend of side angle information [C1]-[C3], [L1]-[L3] (as recited in claim 19); wherein the programming control circuit is configured to: receive a trend of orientation angle change information from the AMD, wherein the angle change information includes angle changes computed between temporally consecutive gravity vectors measured by the AMD; and produce the indication of heart failure status using the trend of angle change information, including by determining a downward trend in a maximum angle change or a value based on a predetermined percentage of largest angle changes over a plurality of monitoring windows [C1]-[C3], [L1]-[L3] (as recited in claim 20); wherein the reduction in the maximum angle change or the value comprises a downward trend in the maximum angle change or the value over a plurality of monitoring windows [C1]-[C3], [L1]-[L3], [P1] (as recited in claim 21); wherein determining the respective directions of the plurality of temporally consecutive gravity vectors includes determining the respective directions when the subject is stationary, without calibrating the electrical posture sensor output to an orientation of the AMD relative to an orientation of the subject [C1]-[C3], [L1]-[L3], [P1] (as recited in claim 22).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT T LUAN whose telephone number is (571)270-1860. The examiner can normally be reached on 9am-5pm, M-F (generally).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Jackson, can be reached on 571-272-4697. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Scott Luan
/SCOTT LUAN/Primary Examiner, Art Unit 3792
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