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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/21/2025 has been entered.
Response to Arguments
Applicant argues Maschino does not disclose determining a target neural response signal from the identified neural response signals and recurrently adjusting the neurostimulation parameters to reduce a difference between subsequently sensed neural response signals to the target neural response signal. The previous office action also states that this is not taught by Maschino. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The Applicant argues that Libbus refers to adjusting stimulation parameters and comparing the result to a target parameter (paragraphs [0089] and [0091]), but the target parameter is a programmed parameter and not a target neural response signal determined from the detected symptom that is a neurological condition as claimed. The examiner respectfully disagrees as Paragraph [0092] discloses dynamic input 1769 includes physiological sensor circuitry 1727B. The illustrated physiological sensor circuitry includes a heart rate sensor, an activity sensor, a pressure sensor, and impedance sensor. The dynamic input 1769 enables the dynamic adjustment of the effective operating target or target range 1760B based on physiological parameters (symptoms).
Based on target range 1760B being a target neural response based on the detected symptom, as taught in Paragraph [0092], the control system then compares the target neural response to a sensed neural response to generate a stimulation signal (e.g. Paragraphs [0104-0107] and Figures 21A-24D).
Regarding claim 14, Libbus in Paragraph [0090] discloses comparing the sensed parameter(s) received via signal 1764 to the target parameter or target parameter range 1760B for the sensed parameter(s). The controller 1753 receives the feedback result signal 1765, and delivers a stimulation control signal 1766 based on the feedback result signal 1765. The neural stimulator 1726 receives the stimulation control signal and controls the neural stimulation 1767 to adjust the intensity of stimulation to converge to desired neural traffic 1763 as reflected by the comparison of processed sensed signal 1764 to the target 1760B. Therefore, the stimulator circuitry 1726 includes modules to set or adjust any one or any combination of two or more of the following pulse features: the amplitude of the stimulation pulse, the frequency of the stimulation pulse, the burst frequency of the pulse, the wave morphology of the pulse, and the pulse width, which are adjusted to improve convergence (similarity of morphology) of the sensed neural response and the target neural response.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-5, 7, and 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschino et al (US Patent 7,801,601) in view of Libbus et al (US Publication 2006/0135998).
Referring to Claim 1, Maschino et al teaches a computer-implemented method of calibration of an implantable neurostimulation device, the method comprising: sensing one or more symptoms of a neurological condition of a subject using one or more sensors external to the neurostimulation device (e.g. Figure 11, Element 1120 and Figure 8, Element 870 and Column 20 lines 41-64 and Column 24 lines 45-53 discloses an external sensing system to acquire various physiological responses such as mood, satiety, or appetite); delivering neurostimulation to the subject using the neurostimulation device and adjusting neurostimulation parameters based on the sensed one or more symptoms (e.g. Column 24 lines 45-53 discloses delivery of the therapeutic signal is coordinated with characteristics form the sensors); sensing one or more neural response signals resulting from the neurostimulation using a sensor of the neurostimulation device (e.g. Figure 8, Detection unit 895); identifying one or more sensed neural response signals associated with the one or more sensed symptoms (e.g. Figure 8, adaptive stimulation adjustment unit 895 and Column 20 lines 65- Column 21 line 12). However, Maschino et al does not explicitly disclose determining a target neural response signal from the identified neural response signals; and recurrently adjusting the neurostimulation parameters to reduce a difference between subsequently sensed neural response signals to the target neural response signal. Libbus et al teaches that it is known to use determining a target neural response signal from the identified neural response signals; and recurrently adjusting the neurostimulation parameters to reduce a difference between subsequently sensed neural response signals to the target neural response signal as set forth in Figures 21A-24D and Paragraphs [0090], [0092], and [0104]-[0107] to provide stimulation feedback that converges on the desired sensed neural traffic (e.g. Paragraph [0008]. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Maschino et al, with determining a target neural response signal from the identified neural response signals; and recurrently adjusting the neurostimulation parameters to reduce a difference between subsequently sensed neural response signals to the target neural response signal as taught by Libbus et al, since such a modification would provide the predictable results of stimulation feedback that converges on the desired sensed neural traffic.
Referring to Claim 3, Maschino et al in view of Libbus et al teaches the method of claim 1, including: detecting a change in at least one sensed symptom of the one or more sensed symptoms (e.g. Figure 11, Element 1120 and Figure 8, Element 870 and Column 20 lines 41-64 and Column 24 lines 45-53 discloses an external sensing system to acquire various physiological responses such as mood, satiety, or appetite); changing the target neural response signal based on the detected change in the at least one sensed symptom (e.g. Figure 8, adaptive stimulation adjustment unit 895 and Column 21 lines 62- Column 22 line 15 and Libbus et al Paragraphs [0090] and [0092]).
Referring to Claim 4, Maschino et al in view of Libbus et al teaches the method of claim 1, including: detecting a change in at least one sensed symptom of the one or more sensed symptoms (e.g. Figure 11, Element 1120 and Figure 8, Element 870 and Column 20 lines 41-64 and Column 24 lines 45-53); enabling the recurrent adjusting the neurostimulation parameters in response to the detected change in the at least one sensed symptom (e.g. Figure 8, adaptive stimulation adjustment unit 895 and Column 21 lines 62- Column 22 line 15 and Libbus et al Paragraphs [0090], [0092], and [0104]-[0107]).
Referring to Claim 5, Maschino et al in view of Libbus et al teaches the method of claim 1, wherein the sensing the one or more neural response signals includes sensing one or more evoked potential signals, and the target neural response signal is a target evoked potential signal (e.g. Figure 11, Element 1120 and Column 24 lines 32-53 discloses IMD may sense evoked potentials and/or brain waves and Column 24 lines 54-Column 25 line 3 discloses detecting adverse physiological responses and Libbus et al Figures 21A-24D and Paragraphs [0090], [0092], and [0104]-[0107]).
Referring to Claim 7, Maschino et al in view of Libbus et al teaches the method of claim 1, including: sensing the one or more neural response signals using a device separate from the neurostimulation device (e.g. Column 24 lines 32-53 discloses an external sensor senses the evoked potential and/or brain waves); generating the target neural response signal using the separate device (e.g. Column 20 lines 41-64 disclose external unit 870 programs various modules of the IMD and Libbus et al Paragraphs [0090], and [0092]); sending the target neural response signal to the neurostimulation device and storing the target neural response in memory of the neurostimulation device (e.g. Column 20 lines 41-64 disclose external unit 870 programs various modules of the IMD and Libbus et al Paragraphs [0090], [0092], and [0104]-[0107]).
Referring to Claim 14, Maschino et al in view of Libbus et al teaches the method of claim 1, except including determining a measure of similarity of morphology of subsequently sensed neural response signals to morphology of the target neural response signal; and recurrently adjusting the neurostimulation parameters to improve similarity of morphology between subsequently sensed neural response signal and the target neural response signal.
Libbus et al teaches that it is known to use determining a measure of similarity of morphology of subsequently sensed neural response signals to morphology of the target neural response signal; and recurrently adjusting the neurostimulation parameters to improve similarity of morphology between subsequently sensed neural response signal and the target neural response signal as set forth in Paragraph [0090] discloses comparing the sensed parameter(s) received via signal 1764 to the target parameter or target parameter range 1760B for the sensed parameter(s). The controller 1753 receives the feedback result signal 1765, and delivers a stimulation control signal 1766 based on the feedback result signal 1765. The neural stimulator 1726 receives the stimulation control signal and controls the neural stimulation 1767 to adjust the intensity of stimulation to converge to desired neural traffic 1763 as reflected by the comparison of processed sensed signal 1764 to the target 1760B to provide stimulation feedback that converges on the desired sensed neural traffic in order to treat disorders. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Maschino et al, with determining a measure of similarity of morphology of subsequently sensed neural response signals to morphology of the target neural response signal; and recurrently adjusting the neurostimulation parameters to improve similarity of morphology between subsequently sensed neural response signal and the target neural response signal as taught by Libbus et al, since such a modification would provide the predictable results of stimulation feedback that converges on the desired sensed neural traffic in order to treat disorders.
Referring to Claim 15, Maschino et al teaches a medical device system, the system comprising: an implantable neurostimulation device (e.g. Figures 2 and 8, Element 200), including: a therapy circuit configured to deliver electrical neurostimulation to a subject when coupled to implantable electrodes (e.g. Figure 8, stimulation unit 820/860); an internal sensor circuit configured to sense one or more neural response signals resulting in the neurostimulation (e.g. Figure 8, Detection unit 895); at least one external sensor configured to detect at least one symptom of a neurological condition of the subject (e.g. Figure 11, Element 1120 and Figure 8, Element 870 and Column 20 lines 41-64 and Column 24 lines 45-53 discloses an external sensing system to acquire various physiological responses such as mood, satiety, or appetite); an external device (e.g. Figure 8, Element 870) including: an external control circuit configured to: receive information of the at least one detected symptom from the external sensor, and set one or more neurostimulation parameters of the neurostimulation delivered by the neurostimulation device according to the at least one detected symptom (e.g. Column 20 lines 41-64 and Column 24 lines 45-53); determine a target neural response signal associated with the at least one detected symptom (e.g. Figure 8, adaptive stimulation adjustment unit 895 and Column 20 lines 65- Column 21 line 12). However, Maschino et al does not explicitly disclose configure the target neural response signal in the neurostimulation device; wherein the implantable neurostimulation device further includes internal control circuit, operatively coupled to the therapy circuit and the sensor circuit, and configured to recurrently adjust the one or more neurostimulation parameters to reduce a difference between subsequently sensed neural response signals and the target neural response signal. Libbus et al teaches that it is known to use configure the target neural response signal in the neurostimulation device; wherein the implantable neurostimulation device further includes internal control circuit, operatively coupled to the therapy circuit and the sensor circuit, and configured to recurrently adjust the one or more neurostimulation parameters to reduce a difference between subsequently sensed neural response signals and the target neural response signal as set forth in Figures 21A-24D and Paragraphs [0090], [0092], and [0104]-[0107] to provide stimulation feedback that converges on the desired sensed neural traffic (e.g. Paragraph [0008]. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Maschino et al, with configure the target neural response signal in the neurostimulation device; wherein the implantable neurostimulation device further includes internal control circuit, operatively coupled to the therapy circuit and the sensor circuit, and configured to recurrently adjust the one or more neurostimulation parameters to reduce a difference between subsequently sensed neural response signals and the target neural response signal as taught by Libbus et al, since such a modification would provide the predictable results of stimulation feedback that converges on the desired sensed neural traffic.
Referring to Claim 16, Maschino et al in view of Libbus et al teaches the system of claim 15, wherein the external device further includes: a neural signal sensing circuit configured to sense the one or more neural signals (Column 24 lines 45-53 discloses an external sensing system detects evoked potentials and/or brain waves); signal processing circuitry configured to produce the target neural response signal (e.g. Column 20 lines 41-64 enables the user to program the IMD); a communication circuit configured to transfer the target neural response signal to memory of the implantable neurostimulation device (e.g. Column 20 lines 41-64).
Referring to Claim 17, Maschino et al in view of Libbus et al teaches the system of claim 15, wherein the implantable neurostimulation device further includes: a communication circuit configured to receive a prompt from the external device (e.g. Figure 8, communication unit 860); signal processing circuitry configured to produce the target neural response signal in response to a prompt received from the external device (e.g. Figure 8, adaptive stimulation adjustment unit 895).
Referring to Claim 18, Maschino et al teaches an electronic device comprising: one or more sensors configured to detect one or more symptoms of a neurological condition of a subject (e.g. Figure 11, Element 1120 and Figure 8, Element 870 and Column 20 lines 41-64 and Column 24 lines 45-53 discloses an external sensing system to acquire various physiological responses such as mood, satiety, or appetite); a communication circuit configured to transfer information to a separate programming device and a separate neurostimulation device (e.g. Column 20 lines 41-64 discloses communication with an IMD and Column 24 lines 45-53); a control circuit operatively coupled to the one or more sensors and the communication circuit (e.g. Column 20 lines 41-64 and Column 24 lines 45-53); a memory storing an application that includes instructions that when performed by the control circuit, causes the control circuit to perform operations including: communicate one or more neurostimulation parameters of neurostimulation according to the detected one or more symptoms with the separate programming device and the separate neurostimulation device, wherein the neurostimulation is provided by the separate neurostimulation device (e.g. Column 20 lines 41-64 and Column 24 lines 45-53); determine a target neural response signal associated with the detected one or more symptoms (e.g. Figure 8, adaptive stimulation adjustment unit 895 and Column 20 lines 65- Column 21 line 12); initiate a transfer of a target neural response signal to the neurostimulation device (e.g. Column 20 lines 41-64 discloses programming the IMD); communicate a prompt to cause the neurostimulation device to recurrently adjust the one or more neurostimulation parameters to reduce a difference between a neural response signal sensed by the neurostimulation device and the target neural response signal (e.g. Column 20 lines 41-64). However, Maschino et al does not explicitly disclose the neurostimulator to recurrently adjust the one or more neurostimulation parameters to reduce a difference between subsequently sensed neural response signals and the target neural response signal. Libbus et al teaches that it is known to use the neurostimulator to recurrently adjust the one or more neurostimulation parameters to reduce a difference between subsequently sensed neural response signals and the target neural response signal as set forth in Figures 21A-24D and Paragraphs [0090], [0092], and [0104]-[0107] to provide stimulation feedback that converges on the desired sensed neural traffic (e.g. Paragraph [0008]. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Maschino et al, with the neurostimulator to recurrently adjust the one or more neurostimulation parameters to reduce a difference between subsequently sensed neural response signals and the target neural response signal as taught by Libbus et al, since such a modification would provide the predictable results of stimulation feedback that converges on the desired sensed neural traffic.
Referring to Claim 19, Maschino et al in view of Libbus et al teaches the electronic device of claim 18, wherein the application includes instructions that when performed by the control circuit, causes the control circuit to perform operations including: transfer symptom information of the detected symptom to the separate programming device (e.g. Column 24 lines 45-53 ); receive the target neural response signal from the separate programming device (e.g. Column 20 lines 41-64 discloses the external unit can download various parameters).
Referring to Claim 20, Maschino et al in view of Libbus et al teaches the electronic device of claim 18, wherein the one or more sensors, the communication circuit, the control circuit, and the memory are included in a mobile device (e.g. Column 20 lines 41-64 discloses the external unit is a handheld computer or PDA).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschino et al (US Patent 7,801,601) in view of Libbus et al (US Publication 2006/0135998), as applied above, and further in view of Pikov et al (US Publication 2020/0360696).
Referring to Claim 2, Maschino et al in view of Libbus et al teaches the method of claim 1, except including: ending the adjusting of the neurostimulation parameters based on the one or more sensed symptoms; continuing the adjusting of the neurostimulation parameters according to the comparison of subsequently sensed neural response signals to the target neural response signal.
Pikov et al teaches that it is known to use based on sensed measurements and calculations to start, stop or adjust the stimulation parameters as set forth in Paragraph [0126] to provide optimizing therapy based on disease activity. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Maschino et al, with ending the adjusting of the neurostimulation parameters based on the one or more sensed symptoms; continuing the adjusting of the neurostimulation parameters according to the comparison of subsequently sensed neural response signals to the target neural response signal as taught by Pikov et al, since such a modification would provide the predictable results of optimizing therapy based on disease activity.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschino et al (US Patent 7,801,601) in view of Libbus et al (US Publication 2006/0135998), as applied above, and further in view of Carcieri (US Publication 2014/0243926).
Referring to Claim 6, Maschino et al in view of Libbus et al teaches the method of claim 5, including sampling the one or more evoked potential signals (e.g. Column 24 lines 32-53). However, Maschino et al does not disclose generating a template of the target evoked potential signal using one or more sampled evoked potential signals.
Carcieri teaches that it is known to use a database of previously evoked action potentials for reference or a learning mode to identify the resulting evoked potential as set forth in Paragraphs [0067] and [0092] to provide improved therapy by developing references that are customized for the patient. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Maschino et al, with sampling the one or more evoked potential signals and generating a template of the target evoked potential signal using one or more sampled evoked potential signals as taught by Carcieri, since such a modification would provide the predictable results of improved therapy by developing references that are customized for the patient.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschino et al (US Patent 7,801,601) in view of Libbus et al (US Publication 2006/0135998), as applied above, and further in view of Sinclair et al (US Publication 2020/0138324).
Referring to Claim 8, Maschino et al in view of Libbus et al teaches the method of claim 1, except wherein the sensing the one or more neural response signals includes sensing one or more evoked resonant neural activity signals, one or more local field potential signals, or one or more stimulation artifact signals.
Sinclair et al teaches that it is known to use neural response signals include sensing local field potential signals as set forth in Paragraph [0207] to provide increased visibility of high frequency oscillations to optimize therapy based on disease progression. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Maschino et al, with one or more neural response signals includes sensing one or more evoked resonant neural activity signals, one or more local field potential signals, or one or more stimulation artifact signals as taught by Sinclair et al, since such a modification would provide the predictable results of increased visibility of high frequency oscillations to optimize therapy based on disease progression.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschino et al (US Patent 7,801,601) in view of Libbus et al (US Publication 2006/0135998), as applied above, and further in view of Caparso et al (US Publication 2010/0211135).
Referring to Claim 9, Maschino et al in view of Libbus et al teaches the method of claim 1, including: sensing lead impedance of a lead used to deliver the neurostimulation; compare the sensed lead impedance to a specified lead impedance range; send an indication associated with the sensed lead impedance to a user or process when the sensed lead impedance is outside the specified lead impedance range.
Caparso et al teaches that it is known to use sensing lead impedance of a lead to deliver neurostimulation and compare to a range and when out of the range alert the physician of lead failure as set forth in Figure 7A and Paragraph [0020] to provide improved therapy by identifying abnormal operations and alerting the physician of a potential lead failure. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Maschino et al, with sensing lead impedance of a lead used to deliver the neurostimulation; compare the sensed lead impedance to a specified lead impedance range; send an indication associated with the sensed lead impedance to a user or process when the sensed lead impedance is outside the specified lead impedance range as taught by Caparso et al, since such a modification would provide the predictable results of improved therapy by identifying abnormal operations and alerting the physician of a potential lead failure.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschino et al (US Patent 7,801,601) in view of Libbus et al (US Publication 2006/0135998), as applied above, and further in view of Brockway et al (US Publication 2008/0058872).
Referring to Claim 10, Maschino et al in view of Libbus et al teaches the method of claim 1, except including an external device enabling the adjusting the neurostimulation parameters according to a medication schedule of the subject.
Brockway et al teaches that it is known to use an external device enabling the adjusting the neurostimulation parameters according to a medication dosage and scheduling (e.g. Figure 7, Element 720) as set forth in Figure 7 and Paragraph [0022] to provide optimize therapy based on the detected needs and in accordance with medications that could affect measurements. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Maschino et al, with an external device enabling the adjusting the neurostimulation parameters according to a medication dosage and scheduling as taught by Brockway et al, since such a modification would provide the predictable results of optimize therapy based on the detected needs and in accordance with medications that could affect measurements.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschino et al (US Patent 7,801,601) in view of Libbus et al (US Publication 2006/0135998), as applied above, and further in view of Kent et al (US Publication 2016/0121110).
Referring to Claim 11, Maschino et al in view of Libbus et al teaches the method of claim 1, except wherein the one or more sensed symptoms includes a tremor, and the one or more external sensors includes a motion sensor.
Kent et al teaches that it is known to use an external motion sensor to detect tremors as set forth in Paragraphs [0036] and [0037] to provide feedback on the effectiveness of treatment on movement disorders. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Maschino et al, with an external motion sensor to detect tremors as taught by Kent et al, since such a modification would provide the predictable results of feedback on the effectiveness of treatment on movement disorders.
Referring to Claim 12, Maschino et al in view of Libbus et al teaches the method of claim 1, except wherein the one or more sensed symptoms includes abnormal gait of the subject, and the one or more external sensors includes a motion sensor.
Kent et al teaches that it is known to use an external motion sensor to detect gait problems as set forth in Paragraph [0035] to provide feedback on the effectiveness of treatment on movement disorders. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Maschino et al, with an external motion sensor to detect gait problems as taught by Kent et al, since such a modification would provide the predictable results of feedback on the effectiveness of treatment on movement disorders.
Referring to Claim 13, Maschino et al in view of Libbus et al teaches the method of claim 1, wherein the neurostimulation device is an implantable pulse generator that includes the internal sensor (e.g. Figure 8, implantable device 200 with detection unit (sensor) 895). However, Maschino et al does not disclose the one or more external sensors are wearable sensors.
Kent et al teaches that it is known to use a wearable external motion sensor to detect tremors problems as set forth in Paragraphs [0035]-[0037] to provide feedback on the effectiveness of treatment on movement disorders. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Maschino et al, with an external motion sensor to detect tremors as taught by Kent et al, since such a modification would provide the predictable results of feedback on the effectiveness of treatment on movement disorders.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hincapie Ordonez et al (US Publication 2011/0313495) discloses an evoked response detection circuit and a control circuit configured to control the delivery of the neurostimulation pulses using a stimulation intensity.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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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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/William J Levicky/Primary Examiner, Art Unit 3796
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