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
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.
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) 13-15, 37-38, 40-41 & 45-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kent et al. (WO 2023/015159) in view of Tehrani et al. (US 2015/0034081) and one of ordinary skill in the art, as evidence by KSR, 550 U.S. at 417.
13.
Kent et al. teaches a method of controlling delivery of neurostimulation therapy comprising:
A method for controlling delivery of a neurostimulation therapy…
E.G. via the disclosed neurostimulation system configured to deliver stimulation to a patient and control stimulation delivery based on physiological conditions and detected patient characteristics, [0010]-[0012], [0137]-[0140].
“…providing neurostimulation therapy synchronously with an inspiration phase of a patient’s respiratory cycle…
E.G. via the disclosed synchronizing/gating stimulation phases of a patient’s respiratory cycle, including inspiration and expiration phases. Kent further teaches delivering stimulation during selected respiratory phases and synchronizing stimulation to specific points with the respiratory cycle, [0011].
“…receiving an acceleration signal from an implanted accelerometer…”
E.G. via the disclosed neurostimulation device including one or more sensors, such as IMUs and accelerometers, configured to generate motion data responsive to movement, vibration or motion of the user for processing by the neurostimulation device; Kent, [0138]-[0140]
However, Kent doe not explicitly teach:
“…identifying a first series of respiration phase transition events based on information from the acceleration signal.
Tehrani teaches:
Processing accelerometer-derived information associated with breathing activity.
E.G via obtaining sensed data from accelerometer 122 and processing the sensed data to determine breathing parameters and breathing events; [0140].
Identifying respiration phase transition events.
E.G. via the disclosed determination when an inspiration period has ended and an expiration cycle has begun; [0141].
Identifying additional respiratory phase transitions
E.G. via the disclosed detection of the end of an inhalation period and the beginning of an exhalation period based on respiratory waveform analysis; [0142].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the respiratory-phase synchronized neurostimulation system of Kent et al. with the accelerometer-based respiratory event detection techniques taught by Tehrani et al. in order to determine respiratory phase transition events from accelerometer-derived information and use those detected phase transitions to control delivery of respiratory-synchronized neurostimulation.
Such modification would have represented the substitution of one known respiratory sensing technique for another known respiratory sensing technique to obtain the predictable results of identifying respiratory phases for controlling stimulation delivery. A person of ordinary skill in the art would have recognized the accelerometer-derived respiratory information, as taught by Tehrani et al., could be used to provide respiratory phase information for the respiratory-gated neurostimulation system of Kent et al. See KSR.
14.
“…providing the neurostimulation therapy during the inspiration phase without providing the neurostimulation therapy during one or more other phases of the patient’s respiratory cycle...”
E.G. via the disclosed synchronizing stimulation to particular phases of the respiratory cycle and selectively providing stimulation during inspiratory phases while not providing stimulation during other respiratory phases; Kent [0011].
15.
“…providing the neurostimulation therapy intermittently throughout the patient’s respiratory cycle…”
E.G. via the disclosed deliverance of stimulation pulses and stimulation bursts over time and controlling the timing of stimulation relative to physiological events; Kent [0010]-[0012].
Further, it would have been obvious to one of ordinary skill in the art that asynchronous stimulation would be delivered intermittently according to a stimulation program rather than continuously, as intermittent pulse delivery represents a conventional neurostimulation operating mode.
37.
“…providing neurostimulation therapy in a regular pulse pattern by periodically providing neurostimulation and not providing neurostimulation…”
E.G. via the disclosed deliverance of stimulation pulses and bursts according to programmed stimulation parameters including pulse timing, pulse duration, burst timing and stimulation intervals; Kent [0010]-[0012].
38.
“…providing neurostimulation therapy in randomized pulse puatterns…”
E.G. via the disclosed varying stimulation parameters including frequency, timing, phrase and stimulation characteristics, Kent; [0136].
40.
“…after providing neurostimulation therapy asynchronously in the absence of identified respiratory phase transition events, subsequently identifying respiratory phase transition events and providing neurostimulation synchronously with an inspiration phase…”
E.G. via the disclosed respiratory-phase synchronized stimulation, Kent [0011].
And
E.G. via the disclosed identifying respiratory phase transition event, Tehrani, [0141]-[0142].
It would have been obvious to one of ordinary skill in the art that a system configured to continuously monitor respiratory information would resume respiratory-phase synchronized stimulation upon reacquisition of respiratory phase information and would continue asynchronous stimulation while respiratory phase information remained unavailable. Such operation represents a predictable use of known sensing and control techniques to maintain therapy delivery. See KSR.
Claims 41-44 are rejected under 35 U.S.C. as being unpatentable over Kent et al. in view of Tehrani et al. and KSR for substantially the same reasons discussed above with respect to claims 13 and 20-33.
41.
Claim 41 recites a system including an implanted accelerometer, processor circuitry, etc., which corresponds to the method limitations discussed above with respect to claim 13. Kent et al. teaches the corresponding system components and functionality, which Tehrani et al. teaches the threshold-based respiratory event detection techniques discussed above.
42.
Claim 42 corresponds to claim 20 and recited identifying respiration phase transition events based on a relationship between a specified threshold and the acceleration signal. Kent et al. and Tehrani et al. teach the corresponding threshold-based detection functionality as discussed above.
43. & 44.
Claim 43 and 44 correspond respectively to claims 22 and 23 and recite decreasing and increasing sensitivity by adjusting the specified threshold. Such threshold adjustment constitutes a result-effective variable as discussed above and would have been obvious to optimize through routine experimentation. See KSR.
45.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Kent et al. in view of Tehrani et al. for substantially the same reasons discussed above with respect to claim 40.
Specifically, Kent et al. teaches continuing synchronized stimulation upon continued identification of respiration phase transition events and providing asynchronous stimulation when respiration phase transition events are no longer identified. The recited processor circuitry merely performs the same functionality previously discussed with respect to the corresponding method limitations.
Claims 46 and 47 are rejected under 35 U.S.C. as being unpatentable over Kent et al. in view of Tehrani et al. and one of ordinary skill in the art, as evidenced by KSR, 550 U.S. at 417.
Kent et al. teaches synchronized stimulation based on detected respiratory phase transitions and asynchronous stimulation when respiratory synchronization is unavailable. Kent et al., however, does not expressly disclose maintaining stimulation at the same cadence for a specified duration before reverting to asynchronous stimulation.
It would have been obvious to a person of ordinary skill in the art at the time the invention was made to temporarily maintain the previously established stimulation cadence for a finite duration following loss of synchronization and thereafter revert to an asynchronous stimulation mode because such timeout-based fallback control techniques represent well-known and predictable control strategies used to maintain therapy continuity while preventing indefinite operation under degraded sensing conditions. The modification would merely involve applying a known control technique to Kent’s neurostimulation system and would have yielded predictable results. See KSR.
Claim 47 is met by the same modification because reverting to asynchronous stimulation upon expiration of the specified duration constitutes the natural consequence of the timeout-based fallback operation.
48.
Claim 48 recites the corresponding system implementation of the method previously discussed with respect to claim 40. The processor circuitry merely performs the same respiratory phase transition detection, synchronized stimulation, and asynchronous fallback functionality taught by Kent et al. in view of Tehrani et al.
Claim(s) 13-15, 37-38, 40-41 & 45-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kent et al. (WO 2023/015159) in view of Tehrani et al. (US 2015/0034081) and Riahi et al. (WO 2023/186887).
Kent et al. in view of Tehrani et al. teaches:
“…receiving an acceleration signal from an implanted accelerometer…”
E.G. via the disclosed neurostimulation system including an accelerometer configured to generate acceleration information for processing by the neurostimulation device, Kent’s accelerometer/IMU disclosures, [0010]-[0012]
“…identifying respiration phase transition events based on information derived from the acceleration signal…”
E.G. via the disclosed processing accelerometer-derived breathing information to determine respiratory events and respiratory phased transitions, including transitions between inspiration and expiration, Tehrani, [0140]-[0142].
However, Kent et al. and Tehrani et al. do not explicitly teach:
“…determining a jerk signal based on the acceleration signal…”
“…determining an upper jerk threshold and a lower jerk threshold, and…”
“…identifying the first series of respiration phase transition events based on a relationship between the jerk signal, the upper jerk threshold and the lower jerk threshold.
Riahi et al. teaches”
determining a jerk signal based on acceleration information
E.G. Riahi et al. teaches monitoring body movements using activity sensor data and identifying sudden accelerations, i.e. jerks, from sensor signals; (pp. 27, lines 11-16)
evaluating detected events using thresholds
E.G. Riahi et al. teaches evaluating sensed movement information using predetermined thresholds and combinations of predetermined thresholds; (pp. 27, lines 18-25).
Determining physiological events based on relationships between sensed movement information and thresholds
E.G. Riahi et al. teaches quantifying movement events and evaluating the quantified events relative to predetermined threshold for event determination; (pp, 27, lines 11-15).
It would have been obvious to one or ordinary skill in the art at the time the invention was made to modify the accelerometer-based respiratory phase transition detection techniques of Tehrani et al. by utilizing the jerk-based threshold detection techniques taught by Riahi et al.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record, including Kent et al. in view of Tehrani et al. and Riahi et al., teaches accelerometer-based respiratory phase transition detection, threshold-based event detection, and neurostimulation synchronized with a patient’s respiratory cycle. However, the prior art fails to teach or suggest determining respiratory phase transition events using thresholds derived from a moving standard deviation of an acceleration signal and/or a jerk signal, as recited in independent claim 20, 29 and 42. The prior art cited fails to teach or suggest adjusting such statistically-derived thresholds to modify the sensitivity or respiratory phase transition detection, as recited in claims 21-23 and 43-44. Accordingly, the claimed subject matter is considered to define a patentably distinct signal processing technique for identifying respiratory phase transition events.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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