DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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 4-5, 7, and 15-16 are 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.
Regarding Claims 4 and 15, the claims are indefinite as it is unclear how multiple second energy values of variable sizes can be pulled from the one singular second energy value, particularly as the one energy value is a singular field potential energy value, or how that one value could be multiple end points of a threshold. The Examiner is interpreting that this is only referring to a plurality of second energy values, not one or more.
Regarding Claims 5, 7, and 16, the claims are indefinite as it is unclear how, for the limitations containing the phrase “with the neurostimulator not being turned on for treatment”, the device is detecting or pulling any data during the various states while being turned off.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 5, 10-13, 16, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 20200129757 awarded to Xiao et al.
Regarding Claims 1, 12, and 21, Xiao teaches a system and device for neural stimulation (abstract), comprising: a neurostimulator (therapy system 100, Fig. 1, Para. 0021) comprising a processor and non-transitory computer-readable instructions executed by the processor, the processor configured to execute program instructions (Para. 0022, “IMD 106 includes a therapy module (e.g., which may include processing circuitry, signal generation circuitry or other electrical circuitry configured to perform the functions attributed to IMD 106) that includes a stimulation generator configured to generate and deliver electrical stimulation therapy to patient 112 via a subset of electrodes 116, 118 of leads 114A and 114B, respectively”); and a memory having program instructions stored thereon (Para. 0034, “IMD 106 may comprise a hermetic housing to substantially enclose components, such as a processor, therapy module, and memory”), wherein the program instructions, when loaded and executed by the processor, cause the device to perform the following functions: determine, based on a received local field potential signal, a first energy value of a frequency band of interest in the local field potential signal (Para. 0024, “One example of the feature of interest (e.g., biomarker) within the LFPs is synchronized beta frequency band (13-33 Hz) LFP activity recorded within the sensorimotor region of the subthalamic nucleus (STN) in Parkinson's disease patients. The source of the LFP activity can be considered as a signal source, within the brain of the patient, that outputs an oscillatory electrical voltage”); determine a threshold range in which the first energy value is; and output, according to a stimulation protocol corresponding to the threshold range, a corresponding stimulation signal (Para. 0060, “In this way, the example techniques may automatically titrate the therapy parameter value based on whether the difference in the present and previous power values is greater than a threshold value. The medical device may more quickly determine the therapy parameter value with limited to no clinician or patient involvement, as compared to a manual trial-and-error process”).
Regarding Claims 2 and 13, Xiao teaches the inventions according to claims 1 and 12, wherein the stimulation module is further configured to: before determining the threshold range in which the first energy value is, determine, based on a local field potential signal of a patient in at least one first state, a second energy value of the frequency band of interest in the local field potential signal in each of the at least one first state (Para. 0095, “Processing circuitry 210 may determine a power band difference value between the present power value and the previous power value 216, and compare the power band difference value to a threshold value (e.g., predefined or preconfigured threshold value stored in memory 211). If the power band difference value is less than the threshold, processing circuitry 210 may set a final therapy parameter value equal to the present therapy parameter value”); wherein the system further comprises a control terminal (Programmer 104), the control terminal is configured to: determine, according to at least one received second energy value corresponding to at least one first state, a plurality of threshold ranges; and determine, based on the plurality of threshold ranges, respective stimulation protocols (Para. 0062, “In the example shown in FIG. 2, memory 211 stores therapy programs 214, previous power value 216, and sense electrode combinations and associated stimulation electrode combinations 218, in separate memories within memory 211 or separate areas within memory 211. Each stored therapy program 214 defines a particular set of electrical stimulation parameters (e.g., a therapy parameter set), such as a stimulation electrode combination, electrode polarity, current or voltage amplitude, pulse width, and pulse rate. In some examples, individual therapy programs may be stored as a therapy group, which defines a set of therapy programs with which stimulation may be generated. The stimulation signals defined by the therapy programs of the therapy group may be delivered together on an overlapping or non-overlapping (e.g., time-interleaved) basis”, Paras. 0065-0069 shows various threshold ranges).
Regarding Claims 5 and 16, Xiao teaches the inventions according to claims 2 and 12, wherein the at least one first state comprises at least one of following: medicated and the neural stimulator being turned on for treatment (Para. 0024, “The suppression of pathological beta activity (e.g., suppression or squelching of the signal component of the bioelectric signals generated from the LFP source that is within the beta frequency band) by both medication and DBS may correlate with improvements in the motor symptoms of patients who have Parkinson's disease”).
Regarding Claim 10, Xiao teaches the system according to claim 1, further comprising: an electrode configured to collect the local field potential signal of the patient’s brain region and output a stimulation electrical pulse according to the received stimulation signal (Para. 0056, “As one example, in response to delivery of a present electrical stimulation (e.g., using electrodes 116, 118 selected based on the CSD values) having a present therapy parameter value, IMD 106 may determine a present power value of power in a frequency band (e.g., beta band) in the bioelectric signal generated by the LFP source and sensed by sense electrodes. Also assume that IMD 106 had determined, prior to determining the present power, a previous power value of power in the frequency band in response to delivery of a previous electrical stimulation having a previous therapy value different than the present therapy parameter value. In some cases, if the difference between the present power value and the previous power value is less than a threshold value (e.g., 0.5 uV/√{square root over (Hz)} as one non-limiting example), further adjustment of the therapy value may not provide noticeably more effective therapy. In other words, there may not be any further benefit of adjusting the therapy value if the delta (e.g., difference) between the present power value and the previous power value is less than the threshold value”); wherein the neural stimulator further comprises a collecting module, the collecting module is configured to receive the local field potential signal collected by the electrode and send the local field potential signal to the stimulation module (Para. 0079, “Telemetry circuitry 208 supports wireless communication between IMD 106 and an external programmer 104 or another computing device under the control of processing circuitry 210. Processing circuitry 210 of IMD 106 may receive, as updates to programs, values for various stimulation parameters such as magnitude and electrode combination, from programmer 104 via telemetry circuitry 208. The updates to the therapy programs may be stored within therapy programs 214 portion of memory 211. Telemetry circuitry 208 in IMD 106, as well as telemetry modules in other devices and systems described herein, such as programmer 104, may accomplish communication by radiofrequency (RF) communication techniques. In addition, telemetry circuitry 208 may communicate with external medical device programmer 104 via proximal inductive interaction of IMD 106 with programmer 104. Accordingly, telemetry circuitry 208 may send information to external programmer 104 on a continuous basis, at periodic intervals, or upon request from IMD 106 or programmer 104”).
Regarding Claim 11, Xiao teaches the system according to claim 2, wherein the neural stimulator further comprises: a first communication module, configured to send the second energy value (Para. 0079, “Telemetry circuitry 208 supports wireless communication between IMD 106 and an external programmer 104 or another computing device under the control of processing circuitry 210. Processing circuitry 210 of IMD 106 may receive, as updates to programs, values for various stimulation parameters such as magnitude and electrode combination, from programmer 104 via telemetry circuitry 208. The updates to the therapy programs may be stored within therapy programs 214 portion of memory 211. Telemetry circuitry 208 in IMD 106, as well as telemetry modules in other devices and systems described herein, such as programmer 104, may accomplish communication by radiofrequency (RF) communication techniques. In addition, telemetry circuitry 208 may communicate with external medical device programmer 104 via proximal inductive interaction of IMD 106 with programmer 104. Accordingly, telemetry circuitry 208 may send information to external programmer 104 on a continuous basis, at periodic intervals, or upon request from IMD 106 or programmer 104”); and a microcontroller unit, configured to control the stimulation module and the first communication module (Para. 0071, “Processing circuitry 210 may include fixed function processing circuitry and/or programmable processing circuitry, and may comprise, for example, any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), discrete logic circuitry, or any other processing circuitry configured to provide the functions attributed to processing circuitry 210 herein may be embodied as firmware, hardware, software or any combination thereof. Processing circuitry 210 may control stimulation generation circuitry 202 according to therapy programs 214 stored in memory 211 to apply particular stimulation parameter values specified by one or more of programs, such as voltage amplitude or current amplitude, pulse width, and/or pulse rate”); wherein the control terminal comprises: a second communication module, connected to the first communication module and configured to receive the second energy value, and to send the threshold ranges and corresponding stimulation protocols (Para. 0079 above states that there are duplicate telemetry modules in both the IMD 106 and programmer 104, though Fig. 3 labels this second telemetry unit 308)).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 3 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Xiao as applied to claim 1 and 12 above, and further in view of U.S. Patent Publication 20160175594 awarded to Min et al.
Regarding Claims 3 and 14, Xiao teaches the inventions of claims 2 and 12. Xiao does not teach wherein the control terminal is further configured to: determine, in response to receiving one second energy value, two threshold ranges by using the one second energy value as a division point.
However, in the art of neurostimulation (abstract), Min teaches determining, in response to receiving one second energy value, two threshold ranges by using the one second energy value as a division point to avoid improper nerve activation (Para. 0084, “For example, with reference to FIG. 5A, the method may analyze the frequency spectrum 502 and identify the upper and lower limits of each cluster 512-516. From the upper and lower limits, the method may determine an acceptable range associated with each frequency component 504-508. The method may further analyze the signal amplitude associated with each frequency bin within each cluster 512-516 to determine an amount of AP activity associated with each cluster 512-516. The amount of AP activity, frequency range and other characteristics defining each of the clusters 512-516 may be recorded and characterized in various manners. For example, the AP activity, frequency range and other characteristics associated with the clusters 512-516 may be recorded as thresholds associated with an excessive amount of AP activity for nerve fibers for which it is desirable to avoid activation (e.g. non-target nerve fibers). Hence, measurement recorded in connection with the frequency spectrum 502 may be utilized to define thresholds and criteria for activation levels that are not acceptable during operation and, when present, warrant changes in the stimulation waveform”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xiao by Min, i.e. by using the threshold system above of Min in the system of Xiao, for the predictable purpose of improving nerve targeting accuracy in Xiao as taught in Min.
Claims 4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Xiao as applied to claims 1 and 12 above, and further in view of U.S. Patent Publication 20110130797 awarded to Talathi et al.
Regarding Claims 4 and 15, Xiao teaches the inventions according to Claims 2 and 12. Xiao does not teach wherein the control terminal is further configured to: sort, in response to receiving second energy values in the at least one second energy value, the second energy values according to sizes of the second energy values; and determine, by using the sorted second energy values as endpoint values, the plurality of threshold ranges, but does teach determining what stimulation inhibits or excites the neurons at issue (Para. 0030).
However, in the art of neurostimulation (Para. 0070), Talathi teaches using multiple field potential readings to determine the thresholds for inhibitory and excitatory levels using amplitude data sorted by size (Para. 0070, “Data analyses for spike extraction. We analyzed single channel data from microwire electrode implanted in the hippocampal CA1 ipsilateral to the stimulation electrode. High amplitude local field activity corresponding to inhibitory and excitatory postsynaptic potentials were extracted using the following methodology: Complete data sets from each rat were divided into non-overlapping 1 hr time windows to ensure a lack of drift in the amplitude of the EEG signal. Candidate events, representing those events from the recorded data whose amplitude exceeds a threshold of five standard deviations (5.sigma.) from the median of the absolute value of the EEG signal in the 1 hr window were extracted. This multiple of the standard deviation used to establish the threshold for extracting candidate events was determined by measuring the multiple of the standard deviation where the numbers of events first plateau before decreasing again to zero from a random sampling of 1 hr windows over the entire experiment. The peak of each event was determined from a polynomial fit of a region around the maximum amplitude of the data in a window of 1.5 s duration centered on the threshold crossing. Data from the temporal window that best captured the entire profile of the candidate event was extracted. This consisted of a time window of 0.45 s centered on the event including 0.15 s before the fitted peak to 0.3 s after the fitted peak. Then these peak-aligned candidate events were sorted using a modification of a well-established clustering algorithm 6 to generate two primary clusters representing the excitatory and inhibitory field potential activities”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xiao by Talathi, i.e. by using the sorting system of Talathi to find the inhibitory and excitatory ranges of Xiao, for the predictable purpose of improving the similar system of Xiao in same way in Talathi.
Claims 6-8, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Xiao as applied to claims 1 and 12 above, and further in view of U.S. Patent Publication 20210196958 awarded to Schnell et al.
Regarding Claims 6-7 and 17, Xiao teaches the inventions according to claims 2 and 13. Xiao does not teach wherein the stimulation module is further configured to: before determining the first energy value, determine, based on local field potential signals of the patient in a plurality of second states, respective third energy values of a plurality of frequency bands in the local field potential signals in the second states; and wherein the control terminal is further configured to: determine, based on a change amount between the third energy values of the frequency bands in the plurality of second states, the frequency band of interest in the plurality of frequency bands, , wherein the plurality of second states comprises at least one of following: unmedicated with the neural stimulator being not turned on for treatment and medicated with the neural stimulator being not turned on for treatment; or medicated with the neural stimulator being not turned on for treatment and medicated with the neural stimulator being turned on for treatment.
However, in the art of neurostimulation using field potential signals (Para. 0167), Schnell teaches wherein the stimulation module is further configured to: before determining the first energy value, determine, based on local field potential signals of the patient in a plurality of second states, respective third energy values of a plurality of frequency bands in the local field potential signals in the second states; and wherein the control terminal is further configured to: determine, based on a change amount between the third energy values of the frequency bands in the plurality of second states (Para. 0135, “In some examples, programmer 104 may evaluate all constraints and known information of stimulation outcomes, such as electrode impedances, signal powers in one or more frequency bands, electrode combinations selected for therapy, or other such factors. For example, for each lead or hemisphere, programmer 104 may suggest a sensing electrode configuration based on one, some, or all of the following factors: electrodes available for sensing due to concurrent stimulation electrodes used, sensed signals of interest (e.g., one or more of a predetermined signal range or a peak power for a specific frequency band such as a Beta or Gamma band), previously collected information regarding effects and/or side effects for various electrodes at certain stimulation parameter values (e.g., as shown in FIGS. 8 and 9), or identified sources of artifacts due to other signals such as electrocardiogram (ECG) artifacts”), the frequency band of interest in the plurality of frequency bands (Para. 0199, “The brain signal information (e.g., spectral information for a brain signal) can be obtained by IMD 106 in response to the user providing input indicating that a patient event occurred. IMD 106 may capture Beta and/or Gamma band data for each event. The clinician can determine which bands or frequencies are good biomarkers for that type of event that happened based on the captured brain signal information for that event. This functionality may also be beneficial for the patient since medication takes a long time to wear off and may not occur during a clinic visit”), wherein the plurality of second states comprises at least one of following: or medicated with the neural stimulator being not turned on for treatment and medicated with the neural stimulator being turned on for treatment (Para. 0167, “Typically, to set the upper threshold and lower threshold for brain signal monitoring, the patient has been off medication, i.e., the upper and lower thresholds are set when the patient is not taking medication selected to reduce the symptoms. The patient may be considered to be not taking the medication when the patient, prior to the time the upper bound is set, has not taken the medication for at least approximately 72 hours for extended release forms of dopamine agonists, the patient has not taken the medication for at least approximately 24 hours for regular forms of dopamine agonists and controlled release forms of CD/LD, and the patient has not taken the medication for at least approximately 12 hours for regular forms of CD/LD, entacapone, rasagiline, selegiline, and amantadine. If only stimulation is suppressing brain signals (e.g., LFP signals), then the system can measure these brain signals for various values of stimulation parameters without outside inputs. Once the upper threshold and lower threshold is established, the system can identify when medication wears off because the brain signals will cross the lower or upper threshold. In response to identifying the brain signal crossing a threshold, the system may turn on electrical stimulation to bring back brain signal amplitudes back between the lower threshold and the upper threshold. Thresholds may be set for certain brain signals, such as signals within the Beta frequency band, when the patient is off medication. In some examples, such as when assessing signals within the Gamma frequency band, thresholds may be set when the patient is on medication”) to improve treatment effectiveness (Paras. 0167 and 0199).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xiao by Schnell, i.e. by using the state analysis system of Schnell above in the system of Xiao, for the predictable purpose of improving treatment efficacy as taught above in Paras. 0167 and 0199.
Regarding Claims 8 and 19, Xiao teaches the inventions according to claims 1 and 12. Xiao does not teach wherein the stimulation module is further configured to: perform discrete Fourier transform on a time sequence signal of the frequency band of interest; and determine the first energy value according to a ratio of a square of a result of the discrete Fourier transform to a quantity of signal points of the time sequence signal.
However, Schnell teaches wherein the stimulation module is further configured to: perform discrete Fourier transform on a time sequence signal of the frequency band of interest; and determine the first energy value according to a ratio of a square of a result of the discrete Fourier transform to a quantity of signal points of the time sequence signal to process and store data (Para. 0200, “The LFP information captured may include time domain information and/or an FFT transform of recorded LFP data. In some examples, processing circuitry 310 may select a certain number of power values across the frequency domain, such as 100 power values. However, more or less data may be stored for each sample of LFP information in other examples. The LFP data may be stored on the patient programmer or IMD 106. In other examples, the LFP information may be transmitted to the cloud or other device for storage. In some examples, the LFP information may be directly transmitted to a clinician”, the Examiner notes that Fourier transforms use the ratio of a square to the quantity of signal points to perform said processing).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xiao by Schnell, i.e. by using the FFT to process and store data in Xiao as taught in Schnell, for the predictable purpose of improving the processing and storing of data in Xiao as in the similar device of Schnell.
Allowable Subject Matter
Claims 9 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jess Mullins whose telephone number is (571)-272-8977. The examiner can normally be reached between the hours of 9:00 a.m. to 5:00 p.m. PST M-F.
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/JLM/
Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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