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 1-21 are pending.
Response to Arguments
Applicant’s argument has been fully considered but 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 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon et al. (US 20220072316 A1, 2022-03-10) (hereinafter “Yoon”) in view of Calfee et al. (US 4803987 A, 1989-02-14) (hereinafter “Calfee”).
Regarding claims 1-21, Yoon teaches a method for managing diurnal and nocturnal pacing for an implantable medical device (IMD) (and an implantable medical device that implements the method) )that includes a temperature sensor, one or more electrodes, one or more pulse generators and a control circuit (e.g., [0276]), the method comprising: sensing, at the temperature sensor, a temperature signal indicative of a core body temperature of a patient within which the IMD is implanted; under control of the control circuit, producing a first moving composite temperature (MCT) signal based on the temperature signal sensed over a first period of time; producing a second MCT signal based on the temperature signal over a second period of time, the second period of time being longer than the first period of time; comparing a current temperature signal to the first and second MCT signals; and controlling a pacing rate for pacing pulses, generated by the one or more pulse generators and delivered to the one or more electrodes, based on one or more relations between the current temperature signal, the first MCT signal and the second MCT signal (e.g., [0371] (“In still other examples, the temperature change may be determined at block 616 by determining a threshold number of consecutive temperature differences that are trending in the same direction. For example, if the difference between the current temperature and a preceding temperature (where each of the current and preceding temperatures may be a single sample point of the temperature signal, a short-term average or a short-term moving average) is positive three consecutive times, an increasing temperature change may be determined at block 616. When the difference is negative three (or more) consecutive times, a decreasing temperature change may be determined at block 616. The individual differences may be any magnitude of change but the consecutive differences trending the same direction may be detected as an increasing or decreasing temperature change at block 616. When the three consecutively determined temperature differences include both positive and negative differences and/or zero differences, no temperature change may be detected by control circuit 306 at block 616. In this way, a threshold difference is not necessarily required in order to detect a temperature change, but a threshold number of consecutive temperature differences in the same direction indicate a rising or falling body temperature.”) (emphasis added); see also, e.g., [0370], [0372]-[0373], [0382]; Figs. 8-11 and associated text ) (as recited in claims 1 and 11).
Yoon does not teach time-constant weight averages of body temperatures. Calfee teaches time-constant weight averages of body temperatures. See, e.g., 11:64-12:46.
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 Calfee with the invention taught by Yoon such that the invention further comprises wherein the first and second MCT signals are produced by two of a) to c): a) calculating a current medium-term average (MTA) temperature signal by summing a time-constant weighted combination of i) a prior MTA temperature signal and ii) the current temperature signal; b) calculating a current long-term average (L TA) temperature signal by summing a time-constant weighted combination of i) a prior L TA temperature signal and ii) the current temperature signal; and c) calculating a current extra long-term average (XL TA) temperature signal as a trend of daily average temperatures by summing a time-constant weighted combination of i) a prior XL TA temperature signal and ii) the current temperature signal (as recited in claims 1 and 11); wherein the controlling the pacing rate includes changing the pacing rate to a nocturnal pacing rate responsive to at least one of: a) the current temperature signal falls below the second MCT signal; or b) the first MCT signal falls below the second MCT signal (e.g., [0370]-[0373], [0382]; Figs. 8-11 and associated text ) (as recited in claims 2 and 12); wherein the controlling the pacing rate includes changing the pacing rate to a diurnal pacing rate responsive to at least one of: a) the first MCT signal rises above the second MCT signal; or b) the first MCT signal rises above a waking threshold signal (e.g., [0370]-[0373], [0382]; Figs. 8-11 and associated text ) (as recited in claims 3 and 13); wherein the controlling the pacing rate includes setting the pacing rate to a diurnal pacing rate when the current temperature signal exceeds a mathematical combination of the first and second MCT signals signal (e.g., [0370]-[0373], [0382]; Figs. 8-11 and associated text ) (as recited in claims 4 and 14); wherein the controlling the pacing rate includes setting one or more sleep thresholds based on i) at least one of the current temperature signal, the first MCT signal or the second MCT signal and ii) one or more offsets, the pacing rate changed responsive to at least one of the current temperature signal or the first MCT signal falling below the one or more sleep thresholds signal (e.g., [0370]-[0373], [0382]; Figs. 8-11 and associated text ) (as recited in claims 5 and 15); wherein the controlling the pacing rate includes setting one or more wake thresholds based on i) at least one of the current temperature signal, the first MCT signal or the second MCT signal and ii) one or more offsets, the pacing rate changed responsive to at least one of the current temperature signal or the first MCT signal rising above the one or more wake thresholds signal (e.g., [0370]-[0373], [0382]; Figs. 8-11 and associated text ) (as recited in claims 6 and 16); wherein the second MCT signal represents a current extra long-term average (XLTA) temperature signal as a trend of daily average temperatures produced by summing a weighted combination of i) a prior XLTA temperature signal and ii) the current temperature signal, the controlling the pacing rate includes setting at least one of a sleep threshold or a wake threshold based on the XLTA temperature signal and one or more offsets (e.g., [0423], [0431]) (as recited in claims 7 and 17); wherein the first period of time corresponds to one of a) to c) and the second period of time corresponds to another one of a) to c): a) a duration between 1-15 minutes; b) a duration between 1-3 hours; and c) a duration between 1-7 days (e.g., [0370]-[0373], [0382], [0423], [0431]) (as recited in claims 8 and 18); wherein the first and second MCT signals are produced by two of a) to c): a) calculating a current medium-term average (MTA) temperature signal by summing a weighted combination of i) a prior MTA temperature signal and ii) the current temperature signal; b) calculating a current long-term average (LTA) temperature signal by summing a weighted combination of i) a prior LTA temperature signal and ii) the current temperature signal; and c) calculating a current extra long-term average (XLTA) temperature signal as a trend of daily average temperatures by summing a weighted combination of i) a prior XLTA temperature signal and ii) the current temperature signal (e.g., [0370]-[0373], [0382], [0423], [0431]) (as recited in claims 9 and 19); wherein the controlling the pacing rate includes i) gradually decreasing the pacing rate to a nocturnal pacing rate at a rate of decrease, or ii) gradually increasing the pacing rate to a diurnal pacing rate at a rate of increase (e.g., [0370]-[0373], [0382]; Figs. 8-11 and associated text ) (as recited in claim 10); wherein the second period of time corresponds to a duration of between 1-7 days and the second MCT signal represents a multi-day nocturnal long-term average (NLTA) temperature signal that trends a daily low temperature (e.g., [0370]-[0373], [0382], [0423], [0431]) (as recited in claim 20); and, as discussed above, implantable medical device (IMO), comprising: a temperature sensor configured to sense a temperature signal indicative of a core body temperature of a patient within which the IMO is implanted; one or more pulse generators configured to generate pacing pulses; one or more electrodes configured to deliver the pacing pulses; and a control circuit configured to: produce a first moving composite temperature (MCT) signal based on the temperature signal sensed over a first period of time by summing a time-constant weighted combination of a first prior temperature average and a current temperature signal; produce a second moving composite temperature (MCT) signal based on the temperature signal over a second period of time by summing a time-constant weighted combination of a second prior temperature average and the current temperature signal, the second period of time being longer than the first period of time; compare the current temperature signal to the first and second MCT signals; and control a pacing rate for the pacing pulses based on one or more relations between the current temperature signal, the first MCT signal and the second MCT signal, wherein, to control the pacing rate, the control circuit is configured to change the pacing rate to a nocturnal pacing rate responsive to at least one of: a) the current temperature signal falls below the second MCT signal; or b) the first MCT signal falls below the second MCT signal (as recited in claim 21) in order to achieve more accurate temperature measurements.
Prior Art of Record
The prior art made of record and not relied upon is considered to be pertinent to applicant's disclosure.
Mullaly et al. (US 9679255 B1, 2017-06-13) teaches signal processing of sensor data using averages based on different time scales.
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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