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 .
Response to Arguments
Applicant’s arguments (AA), filed on 04/13/2026, have been fully considered but are not persuasive.
Applicant argues that King has not be shown to disclose the following limitations of amended claim 1: (i) “deliver one or more control pulses to elicit an evoke compound action potential (ECAP) to wake the patient” and (ii) “based on the ECAP, control the stimulation circuitry to adjust subsequent electrical stimulation therapy”, Examiner respectfully disagrees.
Regarding limitation (i) “deliver one or more control pulses to elicit an evoke compound action potential (ECAP) to wake the patient”, as discussed in King, processing circuitry controls the neurostimulation delivery circuit to deliver a paresthesia-causing stimulation [0069]. Examiner asserts that delivering a paresthesia-causing stimulation is an example of elicit[ing] an evoked compound action potential, that is, applying an electrical stimulus which results in synchronous firing of a large population of neurons. Regarding the limitation “one or more pulses”, King states that neurostimulation delivery circuitry can provide “pulsed stimulation” and further discloses modifying the pulsed stimulation by adjusting pulse frequency, width and even amplitude [0041, 0042].
Regarding limitation (ii) “based on the ECAP, control the stimulation circuitry to adjust subsequent electrical stimulation therapy”, as disclosed in King, the processing circuitry is capable of increasing stimulation intensity in response to determining that subsequent apnea events were not suppressed by delivery of neurstimulation at lower levels. Examiner notes that such a determinitation is, at the very least, partially based on the intensity of the elicited ECAP.
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.
Claims 1-3, 6, 7, 9-12, and 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over King et al. (US 2004/0210261), in view of Hettrick et al. (US 2013/0030319).
In re claim 1, King discloses an implantable medical device (FIG. 1: 14), the device comprising:
a memory (FIG. 2: 44) configured to store sensed signals;
one or more sensors configured to determine posture and activity information of a patient for storage as part of the sensed signals (46; [0049]: “posture and activity monitor 46 includes a sensor”);
stimulation generation circuitry (32) configured to deliver electrical stimulation therapy to the patient via a first set of electrodes (18A, 18B, 18C, 18D) of a plurality of electrodes (18A, 18B, 18C, 18D, 26, 38, 40) configured to be implanted proximal to a spinal cord of the patient (FIG. 1; Examiner notes that the claim is being interpreted as only requiring “a first set of electrodes” to be implanted proximal to the spinal cord of the patient not the entire “a plurality of electrodes”)
sensing circuitry (34) configured to sense electrical signals via a second set of electrodes (26; [0034]: “sensor 26 can take the form of one or more electrodes”) of the plurality of electrodes for storage as part of the sensed signals; and
processing circuitry (30) operably coupled to the memory (FIG. 2), the processing circuitry configured to:
control the stimulation generation circuitry to deliver the electrical stimulation therapy to the patient [0041];
*interleaved with the electrical stimulation therapy, control the stimulation generation circuitry to output an impedance measurement signal ([0034]: “detecting impedance”);
*As shown in FIG. 5 stimulation therapy (86) occurs after impedance measurement (82). Although check points occur between the next time the impedance is measured, under the broadest reasonable interpretation (BRI), based on the loop structure the processing circuitry is considered to alternate (interleave) impedance measurement and stimulation delivery.
receive electrical signals via selected electrodes (any set of the “one or more electrodes”) of the second set of electrodes indicating an impedance between the selected electrodes ([0034]; apparent as detecting a change in thoracic impedance indicates an impedance between electrodes);
determine an aspect of respiration activity of the patient based on the impedance ([0034]: “frequency, depth, pattern and variability of respiration”);
responsive to determining the aspect of respiration activity of the patient, determine a patient state (FIG. 5: 84 “apnea/arousal”; Examiner notes the patient state (84) is determined after determining the aspect of respiration activity which occurs during 82) based on
the determined aspect of respiration activity (82; [0067]: “inputs provided by parameter monitor 34”; Examiner notes that the parameter monitor includes one or more electrodes (26) which detect respiration [0034]), and
the posture and activity information of the patient (80; [0067]: “determines whether patient is asleep based on… posture/activity monitor”; Examiner notes patient state is based on information determined at block 80);
responsive to determining the patient state, control the stimulation generation circuitry to deliver one or more control pulses (86; [0041]: “neurostimulation circuitry can provide…pulsed stimulation”) to elicit an evoked compound action potential (ECAP) to wake the patient (90) and interrupt the patient state [0069]; and
based on the ECAP, control the stimulation generation circuitry to adjust subsequent electrical stimulation therapy to the patient (94, [0070]).
King lacks:
determine an aspect of respiration activity of the patient based on the impedance between the selected electrodes that are proximal to the spinal cord of the patient.
Hettrick discloses an analogous spinal cord stimulation (SCS) device (FIG. 1; [0027]) that measures impedance using electrodes located along a patient’s spinal cord ([0055]: “Generally the electrodes may be classified as spinal cord stimulation (SCS) electrodes…”). Hettrick further discloses using the measured impedance to monitor a patient’s respiration rate [0008].
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 second set of electrodes, taught by King, to be located on the lead proximal to the spinal cord, as taught by Hettrick. Accordingly, such a modification would yield “determining respiration activity of the patient based on the impedance between the selected electrodes that are proximal to the spinal cord of the patient.” One would have been motivated to make this modification both because moving the second set of electrodes to the same lead as the first set of electrodes would simplify the manufacturing process by reducing the total number of required leads and because determining impedance between electrodes proximal to the spinal cord is a known alternative to determining impedance between electrodes located proximate the patient’s thoracic cavity (Hettrick, [0055]).
In re claim 2, the proposed combination yields (all mapping directed to King)
wherein the patient state comprises a sleep apnea episode (84)
In re claim 3, the proposed combination yields (all mapping directed to King)
wherein the processing circuitry is further configured to perform a selected action (92, “STORE INFORMATION”) responsive to determining the patient state (FIG. 5), and
wherein the selected action comprises one or more of
storing collected information (92, [0070]),
uploading the collected information to an external computing device, or
outputting an alert.
In re claim 6, the proposed combination yields (all mapping directed to King) wherein the processing circuitry is further configured to:
receive electrical signals via one or more electrodes (38, 40) of the plurality of electrodes, interleaved with the electrical stimulation therapy, indicating a cardiac rhythm of the patient (82; [0067]: “inputs from cardiac pacing/sensing circuit 36”; Examiner notes that cardiac pacing/sensing circuit 36 includes electrodes 38 and 40 which receive signals indicating a cardiac rhythm [0046]); and
determine the patient state (84) based on
the indicated cardiac rhythm of the patient (82; [0067]: “inputs from cardiac pacing/sensing circuit 36”) and based on
the determined aspect of respiration activity (82; [0067]: “inputs provided by parameter monitor 34”) and
the posture and activity information of the patient (80; [0067]: “determines whether patient is asleep based on… posture/activity monitor”)
In re claim 7, the proposed combination yields (all mapping directed to King)
wherein the processing circuitry is further configured to* upload collected information ([0070]: “information related to identified apneas”) for one or more of a sleep study or a mobility study to an external computing device ([0071]: “retrieve the information using a programmer”).
*The limitation “configured to upload collected information for one or more of a sleep study or a mobility study to an external computing device” comprises functional language and is given patentable weight only in how it materially alters or adds structure to the device of the claim. See MPEP 2114. The prior art need only be able to perform the function in order to anticipate the claimed invention. It is clear that the system of King could be operated in the claimed manner if desired, as it is capable of storing information and uploading the information to an external computing device.
In re claim 9, the proposed combination yields (all mapping directed to King unless indicated otherwise) wherein an implantable lead (16A) coupled to the medical device comprises :
the first set of electrodes of the plurality of electrodes (FIG. 1); and
the second set of electrodes of the plurality of electrodes (see modification above In re claim 1),
wherein the second set of electrodes are configured to be implanted such that the electrodes are proximal to a spinal cord (20) of a patient (see modification above In re claim 1; FIG. 1; [0024]).
In re claim 10, see above (In re claim 1)
The proposed combination also yields (all mapping directed to King)
a system (abstract) comprising:
an implantable lead (16A) comprising a plurality of electrodes (18A, 18B, 18C, 18D, 26 (see modification above In re claim 1) 38, 40 ([0045]: “pacing circuitry 36…can be coupled to electrodes 18 on lead 16A”)), the lead configured to be implanted proximal to a spinal cord (20) of a patient (FIG. 1; [0024]);
In re claim 11, see above (In re claim 2).
In re claim 12, see above (In re claim 3).
In re claim 15, see above (In re claim 6).
In re claim 16, see above (In re claim 7).
In re claim 17, see above (In re claim 7).
In re claim 18, see above (In re claim 1).
The proposed combination also yields (all mapping directed to King unless indicated otherwise)
a method for operating an implantable medical device (FIG. 5), the method comprising:
receiving, by processing circuitry (30) located within a housing (15) of the medical device, sensed signals, wherein the sensed signals comprise:
electrical signals received by sensing circuitry (34) via one or more electrodes (26; [0034]: “sensor 26 can take the form of one or more electrodes”) of a plurality of electrodes (18A, 18B, 18C, 18D, 26 (see modification above In re claim 1) 38, 40 ([0045]: “pacing circuitry 36…can be coupled to electrodes 18 on lead 16A”))) on an implantable lead (16A; see modification above In re claim 1) coupled to the implantable medical device (FIG. 1),
wherein the lead is configured to be implanted such that the plurality of electrodes is proximal to a spinal cord (20) of a patient (FIG. 1; [0024]; see modification above In re claim 1);
In re claim 19, see above (In re claim 2).
In re claim 20, see above (In re claim 6).
In re claim 21, the proposed combination yields (all mapping directed to King)
wherein to determine patient state based on the determined aspect of respiration activity, the processing circuity is configured to:
determine distress of the patient based on the determined aspect of respiration activity (82; [0034]: “detects apnea based on respiration”); Examiner notes that under BRI a change in respiration, especially one that indicates a patient is experiencing sleep apnea, is a form of distress); and
determine the patient state based on the distress of the patient (84).
In re claim 22, see above (In re claim 21).
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over King et al (US 2004/0210261) in view Hettrick (US 2013/0030319), in view of Bourget et al. (US 7,957,797).
In re claim 5, the proposed combination yields (all mapping directed to King) wherein the processing circuitry is further configured to:
determine patient state based on:
the determined aspect of respiration activity (see above In re claim 1); and
the posture and activity information of the patient from the one or more sensors (see above In re claim 1).
The proposed combination does not yield wherein the processing circuitry is further configured to:
receive sensor data related to the patient state from one or more sensors external to the device; and
determine patient state based on: the received sensor data from the one or more sensors external to the device;
Bourget discloses an analogous implantable medical device (FIG. 1: 12) that delivers electrical stimulation therapy based on a patient’s state (col. 4, lines 9-15: “patient parameter”). Additionally, Bourget discloses the implantable medical device having one or more external sensors (col. 9, lines 41-48 and lines 56-60). Bourget further discloses the one or more external sensors being configured to wirelessly communicate with a processor of the implantable medical device (col. 9, lines 51-54).
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 implantable medical device of King to receive sensor data related to the patient state from one or more sensors external to the device, as taught by Bourget. Accordingly, such a modification would yield determining the patient state partly based on “the received sensor data from the one or more external sensors”. One would have been motivated to make this modification because including external sensors would allow the device to measure additional physiological parameters, like skin temperature, which would provide more information about a patient’s state (Bourget, col. 9, lines 60-65).
In re claim 14, see above (In re claim 5).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over King et al. (US 2004/0210261), in view Hettrick (US 2013/0030319), in view of Caparso et al. (US 9,669,219).
In re claim 8, the proposed combination does not disclose
wherein the processing circuitry is further configured to determine the patient state at least in part on the time of day.
Caparso discloses an analogous medical device (FIG. 1) configured to determine a patient’s state (FIG. 5: 206). Caparso further discloses using a variety of factors to determine patient state (FIG. 4) including posture (179), activity (180), blood pressure (181) and time of day (182).
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 patient state determination of King to be based at least in part on the time of day, as taught by Caparso. One would have been motivated to make this modification because knowing the time of day would provide additional data that could be used to help determine whether or not a patient is asleep.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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