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
The Applicant filed Amendments to the Claims and Remarks on September 30, 2025 in response to the Examiner’s Non-Final Office Action, mailed June 30, 2025.
Amendments to the Claims
At this time, claims 1-24 are pending. Claims 1, 9, and 17-24 have been amended. The Applicant asserts that no new matter is added. (Remarks, pg. 9)
Claim Rejections
Applicant’s arguments, see Remarks, pg. 9-12, filed September 30, 2025, with respect to the rejection of claims 1-24 under 35 U.S.C. § 101 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Schnell et al. (US 2021/0196964) in view of Jadidi et al. (US 2011/0105941) and further in view of Moffitt et al. (US 10,842,997).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-5, 9-13, and 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Schnell et al. (US 2021/0196964, hereinafter referred to as Schnell) in view of Jadidi et al. (US 2011/0105941, hereinafter referred to as Jadidi).
Regarding amended, independent claim 1, Schnell discloses devices, systems, and techniques for managing electrical stimulation therapy and/or sensing of physiological signals such as brain signals. Schnell further discloses an electrical stimulation method ([0008]: “…a method includes obtaining…a brain signal representative of electrical activity of a brain of a patient…”) for determining quality of an electrical-stimulation signal ([0134]: “In some examples, programmer 104 may control IMD 106 to check signal quality across all electrodes and leads… for the purpose or guiding the user to selection of an appropriate sensing electrode configuration.”) adapted for use in an electrical-stimulation device for performing an electrical stimulation ([0047]: “…an implantable medical device (IMD) 106 configured to deliver adaptive deep brain stimulation to a patient 112.”), comprising:
generating the electrical-stimulation signal (stimulation generator 202 in Fig. 2; [0097]: “Stimulation generator 202, under the control of processor 210, generates stimulation signals for delivery to patient 112…”); and
sampling the electrical-stimulation signal (processor 210 in Fig. 2; [0116]: “…processor 210 periodically samples the signal according to a predetermined frequency or after a predetermined amount of time.”).
Schnell is silent to performing a fast Fourier transform on the sampled electrical-stimulation signal;
determining whether a signal quality of the electrical-stimulation signal on which the fast Fourier transform was performed meets a threshold; and
performing the electrical stimulation when the determination of the signal quality meets the threshold.
However, Jadidi teaches providing an electrical stimulation in response to measured muscular activity through electrodes applied to an individual, wherein the quality of the connectivity of the electrodes to the skin is monitored and the electrical stimulation signal is changed based on said quality measurement. Jadidi further teaches performing a fast Fourier transform on the sampled electrical-stimulation signal ([0032]: “…said apparatus is for measuring EMG signals from said electrodes when the electrodes are applied to the skin and the amplitude of the said frequency of the monitoring signal in signals received at said inputs as determined by said Fourier transform analyser is measured for monitoring the quality of the electrical connection between the electrodes and the skin.”);
determining whether a signal quality of the electrical-stimulation signal on which the fast Fourier transform was performed meets a threshold ([0049]; [0042]: …the means for providing a feedback signal upon the detection of EMG signals indicative of a muscular activity is prevented from so doing if the amplitude of the said frequency of the monitoring signal in signals received at said inputs is …is not below a preset threshold level of voltage sufficient to provide a set level of current, or …if the amplitude of the said frequency of the monitoring signal in signals received at said inputs is not below a preset threshold level of voltage sufficient to provide a set level of current, e.g. if the amplitude of the said frequency of the monitoring signal in signals received at said inputs is not below a preset threshold level of voltage sufficient to provide a set level of current.”); and
performing the electrical stimulation when the determination of the signal quality meets the threshold ([0042]; [0050]: “…the feedback signal is modulated if the quality of the electrical connection between the electrodes is changed.”).
Jadidi is of a similar pursuit to that of the instant application and Schnell in using physiological parameters for adjustment and applying a fast Fourier transform to the sampled electrical-stimulation signal. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Schnell to include a fast Fourier transform performed on a sampled signal, i.e. feedback signal, in order to ensure that proper stimulation signal quality is achieved to provide the patient with effective therapy.
Regarding claim 2, in view of the Schnell/Jadidi combination, Schnell discloses when the signal quality meets the threshold, calculating an impedance value corresponding to the electrical-stimulation signal ([0070]: “Programmer 104 may also be capable of completing functional tests (e.g., measuring the impedance of electrodes 116, 118 of leads 114).”) according to the sampled electrical-stimulation signal by using the electrical stimulation device so as to perform the electrical stimulation on a target area ([0059]: “…the stimulation electrode combination can be selected for a particular patient 112 and target tissue site (e.g., selected based on the patient condition).”).
Regarding claim 3, in view of the Schnell/Jadidi combination, Schnell is silent to sampling a voltage signal of the electrical-stimulation signal and performing the fast Fourier transform on the sampled voltage signal.
However, Jadidi teaches sampling a voltage signal of the electrical-stimulation signal and performing the fast Fourier transform on the sampled voltage signal ([0028]: “The means for determining the received signal of said frequency, may be provided to determine and optionally to record the voltage amplitude of said monitoring signal required to achieve said preset current level between said electrode pair(s). Thus, the quality of the connection between the electrodes through a material to which they are connected may be determined.”; [0032]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Schnell to include a fast Fourier transform performed on a sampled voltage signal, i.e. feedback signal, in order to ensure that proper stimulation signal quality is achieved to provide the patient with effective therapy.
Regarding claim 4, in view of the Schnell/Jadidi combination, Schnell is silent to sampling a current signal of the electrical-stimulation signal and performing the fast Fourier transform on the sampled current signal.
However, Jadidi teaches sampling a current signal of the electrical-stimulation signal and performing the fast Fourier transform on the sampled current signal ([0028]: “Preferably, the apparatus further comprises circuit means adapted to provide a preset monitoring signal current between said first electrode and said reference electrode, and optionally also circuit means adapted to provide a preset monitoring signal current between said second electrode and said reference electrode.”; [0032]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Schnell to include a fast Fourier transform performed on a sampled current signal, i.e. feedback signal, in order to ensure that proper stimulation signal quality is achieved to provide the patient with effective therapy.
Regarding claim 5, in view of the Schnell/Jadidi combination, Schnell is silent to determining whether a first frequency of the voltage signal on which the fast Fourier transform was performed and a second frequency of the current signal on which the fast Fourier transform was performed are equal to a predetermined frequency to determine whether the signal quality of the electrical-stimulation signal meets the threshold.
However, Jadidi teaches determining whether a first frequency of the voltage signal on which the fast Fourier transform was performed and a second frequency of the current signal on which the fast Fourier transform was performed are equal to a predetermined frequency to determine whether the signal quality of the electrical-stimulation signal meets the threshold ([0049]; [0042]: …the means for providing a feedback signal upon the detection of EMG signals indicative of a muscular activity is prevented from so doing if the amplitude of the said frequency of the monitoring signal in signals received at said inputs is …is not below a preset threshold level of voltage sufficient to provide a set level of current, or …if the amplitude of the said frequency of the monitoring signal in signals received at said inputs is not below a preset threshold level of voltage sufficient to provide a set level of current, e.g. if the amplitude of the said frequency of the monitoring signal in signals received at said inputs is not below a preset threshold level of voltage sufficient to provide a set level of current.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Schnell to include determining whether the first and second frequencies meet a critical value criterion in order to deliver safe and effective levels of therapy to a patient.
Regarding amended, independent claim 9, in view of the Schnell/Jadidi combination, Schnell discloses an electrical-stimulation device configured to perform electrical stimulation ([0047]: “…an implantable medical device (IMD) 106 configured to deliver adaptive deep brain stimulation to a patient 112.”), comprising:
an electrical-stimulation signal-generating circuit (stimulation generator 202 in Fig. 2), configured to generate an electrical- stimulation signal ([0097]: “Stimulation generator 202… generates stimulation signals for delivery to patient 112…”); and
a sampling module (processor 210 in Fig. 2), configured to sample the electrical-stimulation signal ([0116]: “…processor 210 periodically samples the signal according to a predetermined frequency or after a predetermined amount of time.”).
Schnell is silent to a fast Fourier transform calculation module, configured to perform a fast Fourier transform on the sampled electrical-stimulation signal; and
a determination module, configured to determine whether a signal quality of the sampled electrical-stimulation signal on which the fast Fourier transform was performed meets a threshold,
wherein the electrical-stimulation device is configured to perform electrical stimulation when the determination of the signal quality meets the threshold.
However, Jadidi teaches a fast Fourier transform calculation module ([0049]: “The Fourier transform analyser is preferably a DFT analyser, such as an FFT analyser.”), configured to perform a fast Fourier transform on the sampled electrical-stimulation signal ([0032]: “…said apparatus is for measuring EMG signals from said electrodes when the electrodes are applied to the skin and the amplitude of the said frequency of the monitoring signal in signals received at said inputs as determined by said Fourier transform analyser is measured for monitoring the quality of the electrical connection between the electrodes and the skin.”); and
a determination module, configured to determine whether a signal quality of the sampled electrical-stimulation signal on which the fast Fourier transform was performed meets a threshold ([0042]: …the means for providing a feedback signal upon the detection of EMG signals indicative of a muscular activity is prevented from so doing if the amplitude of the said frequency of the monitoring signal in signals received at said inputs is …is not below a preset threshold level of voltage sufficient to provide a set level of current, or …if the amplitude of the said frequency of the monitoring signal in signals received at said inputs is not below a preset threshold level of voltage sufficient to provide a set level of current, e.g. if the amplitude of the said frequency of the monitoring signal in signals received at said inputs is not below a preset threshold level of voltage sufficient to provide a set level of current.”),
wherein the electrical-stimulation device is configured to perform electrical stimulation when the determination of the signal quality meets the threshold ([0042]; [0050]: “…the feedback signal is modulated if the quality of the electrical connection between the electrodes is changed.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Schnell to include a fast Fourier transform performed on a sampled signal, i.e. feedback signal, in order to ensure that proper stimulation signal quality is achieved to provide the patient with effective therapy.
Regarding claim 10, in view of the Schnell/Jadidi combination, Schnell discloses that the electrical-stimulation device further comprises a calculation module (programmer 104 in Fig. 1), wherein when the signal quality meets the threshold, an impedance of the electrical-stimulation signal is calculated ([0070]: “Programmer 104 may also be capable of completing functional tests (e.g., measuring the impedance of electrodes 116, 118 of leads 114).”) according to the sampled electrical-stimulation signal by using the calculation module so as to perform the electrical stimulation on a target area ([0059]: “…the stimulation electrode combination can be selected for a particular patient 112 and target tissue site (e.g., selected based on the patient condition).”).
Regarding claim 11, in view of the Schnell/Jadidi combination, Schnell is silent to that the sampling module samples a voltage signal of the electrical-stimulation signal, and the fast Fourier transform calculation module performs the fast Fourier transform on the sampled voltage signal.
However, Jadidi teaches that the sampling module samples a voltage signal of the electrical-stimulation signal, and the fast Fourier transform calculation module ([0049]) performs the fast Fourier transform on the sampled voltage signal ([0028]: “The means for determining the received signal of said frequency, may be provided to determine and optionally to record the voltage amplitude of said monitoring signal required to achieve said preset current level between said electrode pair(s). Thus, the quality of the connection between the electrodes through a material to which they are connected may be determined.”; [0032]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Schnell to include a fast Fourier transform performed on a sampled voltage signal, i.e. feedback signal, in order to ensure that proper stimulation signal quality is achieved to provide the patient with effective therapy.
Regarding claim 12, in view of the Schnell/Jadidi combination, Schnell discloses that the sampling module samples a current signal of the electrical-stimulation signal, and the fast Fourier transform calculation module performs the fast Fourier transform on the sampled current signal.
However, Jadidi teaches that the sampling module samples a current signal of the electrical-stimulation signal, and the fast Fourier transform calculation module performs the fast Fourier transform on the sampled current signal ([0028]: “Preferably, the apparatus further comprises circuit means adapted to provide a preset monitoring signal current between said first electrode and said reference electrode, and optionally also circuit means adapted to provide a preset monitoring signal current between said second electrode and said reference electrode.”; [0032]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Schnell to include a fast Fourier transform performed on a sampled current signal, i.e. feedback signal, in order to ensure that proper stimulation signal quality is achieved to provide the patient with effective therapy.
Regarding claim 13, in view of the Schnell/Jadidi combination, Schnell is silent to that the determination module determines whether a first frequency of the voltage signal on which the fast Fourier transform was performed and a second frequency of the current signal on which the fast Fourier transform was performed are equal to a predetermined frequency to determine whether the signal quality of the electrical-stimulation signal meets the threshold.
However, Jadidi teaches that the determination module determines whether a first frequency of the voltage signal on which the fast Fourier transform was performed and a second frequency of the current signal on which the fast Fourier transform was performed are equal to a predetermined frequency to determine whether the signal quality of the electrical-stimulation signal meets the threshold ([0049]; [0042]: …the means for providing a feedback signal upon the detection of EMG signals indicative of a muscular activity is prevented from so doing if the amplitude of the said frequency of the monitoring signal in signals received at said inputs is …is not below a preset threshold level of voltage sufficient to provide a set level of current, or …if the amplitude of the said frequency of the monitoring signal in signals received at said inputs is not below a preset threshold level of voltage sufficient to provide a set level of current, e.g. if the amplitude of the said frequency of the monitoring signal in signals received at said inputs is not below a preset threshold level of voltage sufficient to provide a set level of current.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Schnell to include determining whether the first and second frequencies meet a critical value criterion in order to deliver safe and effective levels of therapy to a patient.
Regarding amended, independent claim 17, in view of the Schnell/Jadidi combination, Schnell discloses a non-transitory computer-readable storage medium storing one or more instructions ([0094]: “Memory 211 may store computer-readable instructions that, when executed by processor 210, cause IMD 106 to perform various functions.”) and cooperating with an electrical-stimulation device for performing an electrical stimulation ([0047]: “…an implantable medical device (IMD) 106 configured to deliver adaptive deep brain stimulation to a patient 112.”), wherein when the one or more instructions are executed by the electrical- stimulation device, the electrical-stimulation device executes a plurality of steps comprising:
generating an electrical-stimulation signal ([0097]: “Stimulation generator 202, under the control
of processor 210, generates stimulation signals for delivery to patient 112…”); and
sampling the electrical-stimulation signal ([0116]: “…processor 210 periodically samples the
signal according to a predetermined frequency or after a predetermined amount of time.”).
Schnell is silent to performing a fast Fourier transform on the sampled electrical-stimulation signal;
determining whether a signal quality of the electrical-stimulation signal on which the fast Fourier transform was performed meets a threshold; and
performing the electrical stimulation when the determination of the signal quality meets the threshold.
However, Jadidi teaches performing a fast Fourier transform on the sampled electrical-stimulation signal ([0032]: “…said apparatus is for measuring EMG signals from said electrodes when the electrodes are applied to the skin and the amplitude of the said frequency of the monitoring signal in signals received at said inputs as determined by said Fourier transform analyser is measured for monitoring the quality of the electrical connection between the electrodes and the skin.”); and
determining whether a signal quality of the electrical-stimulation signal on which the fast Fourier transform was performed meets a threshold ([0042]: …the means for providing a feedback signal upon the detection of EMG signals indicative of a muscular activity is prevented from so doing if the amplitude of the said frequency of the monitoring signal in signals received at said inputs is …is not below a preset threshold level of voltage sufficient to provide a set level of current, or …if the amplitude of the said frequency of the monitoring signal in signals received at said inputs is not below a preset threshold level of voltage sufficient to provide a set level of current, e.g. if the amplitude of the said frequency of the monitoring signal in signals received at said inputs is not below a preset threshold level of voltage sufficient to provide a set level of current.”); and
performing the electrical stimulation when the determination of the signal quality meets the threshold ([0042]; [0050]: “…the feedback signal is modulated if the quality of the electrical connection between the electrodes is changed.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Schnell to include a fast Fourier transform performed on a sampled signal, i.e. feedback signal, in order to ensure that proper stimulation signal quality is achieved to provide the patient with effective therapy.
Regarding amended claim 18, in view of the Schnell/Jadidi combination, Schnell discloses that
when the signal quality meets the threshold, calculating an impedance value corresponding to the electrical-stimulation signal ([0070]: “Programmer 104 may also be capable of completing functional tests (e.g., measuring the impedance of electrodes 116, 118 of leads 114).”) according to the sampled electrical-stimulation signal by using the electrical stimulation device, so as to perform the electrical stimulation on a target area ([0059]: “…the stimulation electrode combination can be selected for a particular patient 112 and target tissue site (e.g., selected based on the patient condition).”).
Regarding amended claim 19, in view of the Schnell/Jadidi combination, Schnell is silent to sampling a voltage signal of the electrical-stimulation signal and performing the fast Fourier transform on the sampled voltage signal.
However, Jadidi teaches sampling a voltage signal of the electrical-stimulation signal and performing the fast Fourier transform on the sampled voltage signal ([0028]: “The means for determining the received signal of said frequency, may be provided to determine and optionally to record the voltage amplitude of said monitoring signal required to achieve said preset current level between said electrode pair(s). Thus, the quality of the connection between the electrodes through a material to which they are connected may be determined.”; [0032]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Schnell to include a fast Fourier transform performed on a sampled voltage signal, i.e. feedback signal, in order to ensure that proper stimulation signal quality is achieved to provide the patient with effective therapy.
Regarding amended claim 20, in view of the Schnell/Jadidi combination, Schnell is silent to sampling a current signal of the electrical-stimulation signal and performing the fast Fourier transform on the sampled current signal.
However, Jadidi teaches sampling a current signal of the electrical-stimulation signal and performing the fast Fourier transform on the sampled current signal ([0028]: “Preferably, the apparatus further comprises circuit means adapted to provide a preset monitoring signal current between said first electrode and said reference electrode, and optionally also circuit means adapted to provide a preset monitoring signal current between said second electrode and said reference electrode.”; [0032]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Schnell to include a fast Fourier transform performed on a sampled current signal, i.e. feedback signal, in order to ensure that proper stimulation signal quality is achieved to provide the patient with effective therapy.
Regarding amended claim 21, in view of the Schnell/Jadidi combination, Schnell is silent to determining whether a first frequency of the voltage signal on which the fast Fourier transform was performed and a second frequency of the current signal on which the fast Fourier transform was performed are equal to a predetermined frequency to determine whether the signal quality of the electrical-stimulation signal meets the threshold.
However, Jadidi teaches determining whether a first frequency of the voltage signal on which the fast Fourier transform was performed and a second frequency of the current signal on which the fast Fourier transform was performed are equal to a predetermined frequency to determine whether the signal quality of the electrical-stimulation signal meets the threshold ([0049]; [0042]: …the means for providing a feedback signal upon the detection of EMG signals indicative of a muscular activity is prevented from so doing if the amplitude of the said frequency of the monitoring signal in signals received at said inputs is …is not below a preset threshold level of voltage sufficient to provide a set level of current, or …if the amplitude of the said frequency of the monitoring signal in signals received at said inputs is not below a preset threshold level of voltage sufficient to provide a set level of current, e.g. if the amplitude of the said frequency of the monitoring signal in signals received at said inputs is not below a preset threshold level of voltage sufficient to provide a set level of current.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Schnell to include determining whether the first and second frequencies meet a critical value criterion in order to deliver safe and effective levels of therapy to a patient.
Claims 6-8, 14-16, and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over the Schnell/Jadidi combination in view of Moffitt et al. (US 10,842,997, hereinafter referred to as Moffitt).
Regarding claim 6, in view of the Schnell/Jadidi combination, the Schnell/Jadidi combination does not disclose that the predetermined frequency is between 1 kHz and 1 MHz.
However, Moffitt teaches a device and method utilizing Machine learning to optimize spinal cord stimulation. Moffit further teaches that the predetermined frequency is between 1 kHz and 1 MHz (col. 6, li. 52-56: “By way of example and not limitation, the selective modulation may be delivered within a frequency range selected from the following frequency ranges: 2 Hz to 1,200 Hz; 2 Hz to 1,000 Hz...”).
While Moffitt does not identically claim the predetermined frequency range of 1 kHz to 1 MHz, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant' s invention to engage in routine experimentation to discover the optimal predetermined frequency range. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding claim 7, in view of the Schnell/Jadidi/Moffitt combination, the Schnell/Jadidi combination does not disclose that the predetermined frequency is between 480 kHz and 520 kHz.
However, Moffitt teaches that the predetermined frequency is between 480 kHz and 520 kHz (col. 6, li. 52-56: “By way of example and not limitation, the selective modulation may be delivered within a frequency range selected from the following frequency ranges: 2 Hz to 1,200 Hz; 2 Hz to 1,000 Hz...”).
While Moffitt does not identically claim the predetermined frequency range of 480 kHz to 520 kHz, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant' s invention to engage in routine experimentation to discover the optimal predetermined frequency range. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding claim 8, in view of the Schnell/Jadidi/Moffitt combination, Schnell discloses that outside the electrical stimulation stage, the electrical stimulation method further comprises:
when the first frequency and the second frequency do not equal the predetermined frequency, determining whether a voltage of the electrical-stimulation signal meets or exceeds a predetermined voltage value ([0076]: “…system 100 may adjust the one or more parameters defining the electrical stimulation in response to the sensed signal …exceeding the upper threshold of the homeostatic window, but may not adjust the one or more parameters defining the electrical stimulation such that they fall below the lower limit or exceed the upper limit of the therapeutic window.”); and
when the voltage is lower than the predetermined voltage value, raising the voltage by a set amount and then resampling the electrical-stimulation signal (“Increase stimulation amplitude” 2106 in Fig. 21).
Schnell does not disclose that when the voltage meets or exceeds the predetermined voltage value, reporting to an external control device that tissue impedance cannot be calculated.
However, Schnell does teach displaying impedance status to the user ([0129]: “Information such as impedance status for the system and event summary may also be provided in the home screen 402.”). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to include reporting to the user on an external control device (such as user interface 400) if the impedance cannot be calculated. This serves to alert user to any errors in determining electrical-stimulation signal quality.
Regarding claim 14, in view of the Schnell/Jadidi/Moffitt combination, the Schnell/Jadidi combination does not disclose that the predetermined frequency is between 1 kHz and 1 MHz.
However, Moffitt teaches that the predetermined frequency is between 1 kHz and 1 MHz (col. 6, li. 52-56: “By way of example and not limitation, the selective modulation may be delivered within a frequency range selected from the following frequency ranges: 2 Hz to 1,200 Hz; 2 Hz to 1,000 Hz...”).
While Moffitt does not identically claim the predetermined frequency range of 1 kHz to 1 MHz, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant' s invention to engage in routine experimentation to discover the optimal predetermined frequency range. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding claim 15, in view of the Schnell/Jadidi/Moffitt combination, the Schnell/Jadidi combination does not disclose that the predetermined frequency is between 480 kHz and 520 kHz.
However, Moffitt teaches that the predetermined frequency is between 480 kHz and 520 kHz (col. 6, li. 52-56: “By way of example and not limitation, the selective modulation may be delivered within a frequency range selected from the following frequency ranges: 2 Hz to 1,200 Hz; 2 Hz to 1,000 Hz...”).
While Moffitt does not identically claim the predetermined frequency range of 480 kHz to 520 kHz, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant' s invention to engage in routine experimentation to discover the optimal predetermined frequency range. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding claim 16, in view of the Schnell/Jadidi/Moffitt combination, Schnell discloses that outside the electrical stimulation stage, when the first frequency and the second frequency do not equal the predetermined frequency, the determination module determines whether a voltage of the electrical-stimulation signal meets or exceeds a predetermined voltage value ([0076]: “…system 100 may adjust the one or more parameters defining the electrical stimulation in response to the sensed signal …exceeding the upper threshold of the homeostatic window, but may not adjust the one or more parameters defining the electrical stimulation such that they fall below the lower limit or exceed the upper limit of the therapeutic window.”), and
when the voltage is lower than the predetermined voltage value, the determination module raises the voltage by a set amount and then resamples the electrical-stimulation signal (“Increase stimulation amplitude” 2106 in Fig. 21).
Schnell does not disclose that when the voltage meets or exceeds the predetermined voltage value, the determination module reports to an external control device that tissue impedance cannot be calculated.
However, Schnell does teach displaying impedance status to the user ([0129]: “Information such as impedance status for the system and event summary may also be provided in the home screen 402.”). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to include reporting to the user on an external control device (such as user interface 400) if the impedance cannot be calculated. This serves to alert user to any errors in determining electrical-stimulation signal quality.
Regarding amended claim 22, in view of the Schnell/Jadidi/Moffitt combination, the Schnell/Jadidi combination does not disclose that the predetermined frequency is between 1 kHz and 1 MHz.
However, Moffitt teaches that the predetermined frequency is between 1 kHz and 1 MHz (col. 6, li. 52-56: “By way of example and not limitation, the selective modulation may be delivered within a frequency range selected from the following frequency ranges: 2 Hz to 1,200 Hz; 2 Hz to 1,000 Hz...”).
While Moffitt does not identically claim the predetermined frequency range of 1 kHz to 1 MHz, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant' s invention to engage in routine experimentation to discover the optimal predetermined frequency range. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding amended claim 23, in view of the Schnell/Jadidi/Moffitt combination, the Schnell/Jadidi combination does not disclose that the predetermined frequency is between 480 kHz and 520 kHz.
However, Moffitt teaches that the predetermined frequency is between 480 kHz and 520 kHz (col. 6, li. 52-56: “By way of example and not limitation, the selective modulation may be delivered within a frequency range selected from the following frequency ranges: 2 Hz to 1,200 Hz; 2 Hz to 1,000 Hz...”).
While Moffitt does not identically claim the predetermined frequency range of 480 kHz to 520 kHz, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant' s invention to engage in routine experimentation to discover the optimal predetermined frequency range. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding amended claim 24, in view of the Schnell/Jadidi/Moffitt combination, Schnell discloses that outside the electrical stimulation stage, the steps executed by the electrical-stimulation device further comprise:
when the first frequency and the second frequency do not equal the predetermined frequency, determining whether a voltage of the electrical-stimulation signal meets or exceeds a predetermined voltage value ([0076]: “…system 100 may adjust the one or more parameters defining the electrical stimulation in response to the sensed signal …exceeding the upper threshold of the homeostatic window, but may not adjust the one or more parameters defining the electrical stimulation such that they fall below the lower limit or exceed the upper limit of the therapeutic window.”); and
when the voltage is lower than the predetermined voltage value, raising the voltage by a set amount and then resampling the electrical-stimulation signal (“Increase stimulation amplitude” 2106 in Fig. 21).
Schnell does not disclose that when the voltage meets or exceeds the predetermined voltage value, reporting to an external control device that tissue impedance cannot be calculated.
However, Schnell does teach displaying impedance status to the user ([0129]: “Information such as impedance status for the system and event summary may also be provided in the home screen 402.”). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to include reporting to the user on an external control device (such as user interface 400) if the impedance cannot be calculated. This serves to alert user to any errors in determining electrical-stimulation signal quality.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Corey et al. (US 2016/0147964); and
Debarros et al (US 2021/0370070).
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/M.G.S./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796