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 Objections
Claim 6 is objected to because of the following informalities:
Claim 6 includes a typographical error of “the modulation functions”, which the Examiner presumes is meant to state, “the modulation function”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recites the limitation "the at least one objective measurement" in the first line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Parker et al. (US 20140236257, hereinafter referred to as Parker).
Regarding independent claim 1, Parker discloses an automated method of controlling a neural stimulus. Parker further discloses a method of adjusting stimulation for a patient having an implantable stimulator device (implantable device 100 in Fig. 1; [0072]: “Device 100 comprises an implanted control unit 110, which controls application of neural stimuli, and controls a measurement process for obtaining a measurement of a neural response evoked by the stimuli from each of a plurality of electrodes.”), comprising:
(a) applying a waveform (stimulus electrode(s) 122 in Fig. 1; [0072]: “…an electrode array 120 consisting of a three by eight array of electrodes 122, each of which may be selectively used as either the stimulus electrode or sense electrode, or both.”) comprising time-varying pulses to the patient ([0012]: “…applying the neural stimulus to a neural pathway in order to give rise to an evoked action potential on the neural pathway, the stimulus being applied as defined by a set of parameter values…”), wherein the time-varying pulses are formed using a modulation function to modulate at least one of a plurality of time-invariant pulse parameters of the pulses ([0031]: “The control variable could be one or more of the total stimulus charge, stimulus current, pulse amplitude, phase duration, interphase gap duration, pulse shape, repetition rate, electrode selection and electrode combination.”), wherein the modulation function comprises at least one of a modulation shape or modulation parameters that size the modulation shape ([0175]: “The present invention recognises that there are a number of ways to adjust the stimulus parameters (such as stimulus shape and amplitude) in order to optimise the selectivity and efficiency of recruitment.”);
(b) obtaining at least one measurement for the applied waveform (sense electrode(s) 122 in Fig. 1; [0072]: “…an electrode array 120 consisting of a three by eight array of electrodes 122, each of which may be selectively used as either the stimulus electrode or sense electrode, or both.”), wherein the at least one measurement comprises a neural response evoked by recruitment of neural fibers in the patient's tissue in response to the applied waveform ([0013]: “…measuring a neural compound action potential response evoked by the stimulus and deriving from the measured evoked response a feedback variable…”; [0074]: “Such a pulse applied to the spinal cord produces an evoked response. The strength of the evoked response is related to the neural recruitment, and the shape of the evoked response is related to the distribution of fibre types being recruited. “; [0075]: “…a measure of the recruitment of the fibres being stimulated.”);
(c) determining the effectiveness of the time-varying pulses for the patient using the at least one measurement ([0014]: “…comparing the feedback variable to a therapy map, the therapy map defining a therapeutic relationship of control variable to feedback variable, and determining from the therapy map a required change in the control variable in order to improve alignment of the feedback variable with the therapy map…”); and
(d) if the time-varying pulses are ineffective, adjusting the modulation function to adjust the time-varying pulses applied to the patient ([0015]-[0016]: “altering one or more of the stimulus parameter values to effect the required change in the control variable; and …iteratively performing the applying, measuring, comparing and altering, in order to improve alignment of the feedback variable with the therapy map over time.”).
Regarding claim 2, Parker discloses an initial step determining the time-invariant pulse parameters for use with the patient (“parameter selector” step in Fig. 12; [0164]).
Regarding claim 3, Parker discloses that the at least one measurement obtained for the waveform is indicative of the effectiveness of the time-varying pulses for the patient ([0112]: “…embodiments of the present invention may measure the strength of the evoked response and use this as the feedback point for control of the stimulus levels.”).
Regarding claim 4, Parker discloses (e) repeating steps (a) through (d) ([0175]: “The stimulus optimisation process in this embodiment occurs automatically, and may be completed within minutes and therefore performed regularly, as opposed to clinical optimisation.”).
Regarding claim 5, Parker discloses that the time-invariant pulse parameters comprise a pulse amplitude, a pulse width, and a pulse frequency ([0031]: “The control variable could be one or more of the total stimulus charge, stimulus current, pulse amplitude, phase duration, interphase gap duration, pulse shape, repetition rate, electrode selection and electrode combination.”).
Regarding claim 6, Parker discloses that the modulation functions is periodic to periodically modulate the at least one time-invariant pulse parameter ([0175]: “to search for an optimally efficient set of stimulus pulse parameters, the present embodiment provides for automated optimisation of the stimulus pulse parameters based on measurement of the evoked response arising from test stimuli having varied stimulus parameters. The stimulus optimisation process in this embodiment occurs automatically, and may be completed within minutes and therefore performed regularly, as opposed to clinical optimisation.”).
Regarding claim 7, Parker discloses that the modulation function is non-periodic ([0029]: “Fitting of the therapy map to an individual may be effected by a clinical fitting process under the control of a clinician.”).
Regarding claim 8, Parker discloses that the at least one non-periodic function arbitrarily modulates the at least one of the time-invariant pulse parameters ([0029]: “Fitting of the therapy map to an individual may be effected by a clinical fitting process under the control of a clinician. Alternatively the therapy map may be partly or wholly defined in an automated manner based on one or more of: user control inputs for preferred stimulus intensity; automated determinations of an electrode array-to-nerve distance d, and/or automated estimations of a stimulus threshold and comfort level for a given d.”).
Regarding claim 9, Parker discloses that the at least one measurement is obtained using the implantable stimulator device (implantable device 100 having electrode(s) 122 in Fig. 1; [0072]: “Device 100 comprises an implanted control unit 110, which controls application of neural stimuli, and controls a measurement process for obtaining a measurement of a neural response evoked by the stimuli from each of a plurality of electrodes.”).
Regarding claim 10, Parker discloses that the at least one objective measurement comprises at least one feature derived from one or more evoked compound action potentials sensed at the implantable stimulator device ([0112]: “…embodiments of the present invention may measure the strength of the evoked response and use this as the feedback point for control of the stimulus levels.”; [0147]: “… using neural response measurements, provides a method to objectively quantify the stimulation threshold and may thus permit effective use of sub-threshold stimuli. Using this threshold and its potential variations due to posture, a stimulus parameter can be selected which is below psychophysical threshold, so that continual excitation can be achieved which is below sensation threshold, and independent of posture.”).
Regarding claim 11, Parker discloses that the evoked compound action potentials vary as the at least one of the time-invariant pulse parameters is modulated, and wherein the at least one measurement quantifies a degree of the variance of the evoked compound action potentials ([0147]: “… using neural response measurements, provides a method to objectively quantify the stimulation threshold and may thus permit effective use of sub-threshold stimuli.”).
Regarding claim 12, Parker discloses that the at least one measurement for the applied waveform further comprises a subjective measurement determined based on feedback from the patient ([0092]: “To provide a therapy map which best approximates the desire curve of therapeutic benefit, the embodiment of FIG. 20 provides a therapy map 2002 which has a number of different target feedback variable values 2004, one of which is chosen at any given time based on the average control variable value.”; [0093]: “The therapy map 2002 is derived by first obtaining "comfort points" 2006, by adjusting the current to the patient's comfort level, for several different postures.”).
Regarding claim 13, Parker discloses that the at least one subjective measurement comprises a rating provided from the patient relevant to a symptom of the patient ([0093]; "comfort points" 2006 in Fig. 20; [0127]).
Regarding claim 14, Parker discloses the at least one subjective measurement comprises a stimulation threshold indicative of a strength of stimulation perceived by the patient ([0093]: “A stimulus intensity band 2008 associated with each comfort point 2006 is defined either side of the comfort point and each band 2008 is of a width which encompasses some or all of the distance to the next comfort point.”; [0127]).
Regarding claim 15, Parker discloses that step (c) comprises determining a score for the applied waveform using the at least one measurement (a “therapy map” as seen in Figs. 20-24d; [0029]), and
determining the effectiveness of the time-varying pulses for the patient using the score ([0092]: “To provide a therapy map which best approximates the desire curve of therapeutic benefit, the embodiment of FIG. 20 provides a therapy map 2002 which has a number of different target feedback variable values 2004, one of which is chosen at any given time based on the average control variable value.”; [0029]: “…the therapy map may be partly or wholly defined in an automated manner based on one or more of: user control inputs for preferred stimulus intensity; automated determinations of an electrode array-to-nerve distance d, and/or automated estimations of a stimulus threshold and comfort level for a given d.”).
Regarding claim 16, Parker discloses that the effectiveness of the time-varying pulses for the patient is determined by comparing the score to at least one threshold ([0035]: “…the feedback variable may comprise a measure of neural response amplitude. In such embodiments, the parameter search space may be explored by iteratively applying stimuli and measuring neural responses in order to identify a "perception" threshold for stimulus current, below which no evoked response arises from stimulus.” [0036]: “… where the feedback variable comprises a measure of neural response amplitude, the control variable and stimulus parameters may be refined on an ongoing basis in order to adaptively control the stimuli in response to postural changes of the user so as to maintain the evoked response amplitude at a fixed point above the perception threshold as defined by the therapy map.”; [0030]-[0044]; [0092]-[0093]).
Regarding claim 17, Parker discloses that a plurality of measurements are obtained for the applied waveform ([0030]-[0044]; [0092]-[0093]), wherein each of the plurality of measurements are weighted when determining the score (a “therapy map” as seen in Figs. 20-24d) for the applied time-varying pulses.
Regarding claim 18, Parker discloses that the method uses an external device in communication with the implantable stimulator device ([0036]: “…a remote control of the implant…”).
Regarding claim 19, Parker discloses that the at least one measurement for the applied waveform is received at the external device, and wherein steps (c) and (d) are performed using the external device ([0036]: “The body map may be predefined and based on patient feedback to clinical trial stimuli, or may be subject to revision during ongoing use for example by way of user input upon a remote control of the implant.”).
Regarding claim 20, Parker discloses that the modulation function is adjusted by adjusting the modulation shape or one or more of the modulation parameters ([0074]: “…amplitude (A) and width (t) with an interphase gap .phi., as shown in FIG. 2. Such a pulse applied to the spinal cord produces an evoked response. The strength of the evoked response is related to the neural recruitment, and the shape of the evoked response is related to the distribution of fibre types being recruited. Considering the parameters A, t, .phi., it is possible to adjust these parameters in a systematic manner so as to obtain a desired evoked response output.”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Vansickle et al. (US 2014/0277267);
Doan et al. (US 2014/0364920);
Molnar et al. (US 2018/0110991); and
Cholette et al. (US 2018/0369573).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY G SCHLUETER whose telephone number is (703)756-4601. The examiner can normally be reached M-F 9:00am-5:30pm EST.
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/M.G.S./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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