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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/6/24 is being considered by the examiner.
Claim Objections
Claim 11 is objected to because of the following informalities: Applicant is encouraged to change the last limitation of “selecting a therapy waveform type from the plurality of test waveform types, using the processor, using the response parameter” to recite --selecting a therapy waveform type from the plurality of test waveform types, using the processor and the response parameter-- for clarity purposes. 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 2-10 and 17-18 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.
Claim 2 recites the limitations "the delivery of electrical pulses" and "the electrical pulses" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the Examiner is interpreting the limitation of "the delivery of electrical pulses" in line 2 to recite –delivery of electrical pulses--. Dependent claims 3-10 are rejected for the same deficiency in claim 2.
In claims 8-9, the limitation of “the evoked responses” seems unclear. Claims 8-9 depend from claim 7 which recites “an evoked response” in line 2. However, there is no previous recitation of multiple evoked responses. Therefore, it remains unclear if “the evoked responses” in claims 8-9 include “an evoked response” in claim 7 or are different. For the purpose of examination, the Examiner is interpreting the limitation of “the evoked responses” in claims 8-9 to be different from “an evoked response” in claim 7.
In claims 8-9, the limitation of “the test waveform type” seems unclear. Claim 1 recites “a plurality of test waveform types” in lines 4-5. However, it remains unclear if “the test waveform type” in claims 8-9 are a part of “a plurality of test waveform types” in claim 1 or are different. For the purpose of examination, the Examiner is interpreting the limitation of “the test waveform type” to be different from “the plurality of test waveform types” in claim 1.
In claim 17, the limitation of “the test waveform type” seems unclear. Claim 16 recites “a plurality of test waveform types” in line 4. However, it remains unclear if “the test waveform type” in claim 17 is a part of “a plurality of test waveform types” in claim 16 or are different. For the purpose of examination, the Examiner is interpreting the limitation of “the test waveform type” to be different from “the plurality of test waveform types” in claim 16.
Claims 17-18 recite the limitation "the evoked responses" in line 3 of claim 17 and line 4 of claim 18. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the Examiner is interpreting the limitation of “the evoked responses” to recite –evoked responses--.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea.
Step 1
The claimed invention in claims 1-20 are directed to statutory subject matter as the claims recite a system, a method, and a non-transitory computer-readable storage medium for delivering neurostimulation to a patient having a spinal cord.
Step 2A, Prong One
Regarding claims 1, 11, and 19, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsection (III)).
Regarding claims 1, 11, and 19, the limitations of “receive an electrospinogram (ESG) signal recording electrical activity from the spinal cord; a measurement circuit configured to determine a response parameter for each test waveform type of the plurality of test waveform types using the received ESG signal, the response parameter characterizing a response of the patient to the delivery of the neurostimulation; and a selection circuit configured to select a therapy waveform type from the plurality of test waveform types using the response parameter” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional receiving a print out of an electrospinogram (ESG) signal, determining a response parameter for each test waveform type of the plurality of test waveform types using the print out, and selecting a therapy waveform type from the plurality of test waveform types using the response parameter.
Step 2A, Prong Two
For claims 1, 11, and 19, the judicial exception is not integrated into a practical application. In particular, claims 1, 11, and 19 recite “controlling the delivery of the neurostimulation according to each waveform type of a plurality of test waveform types, the neurostimulation delivered from a stimulation device.” Claim 1 also recites a stimulation control circuit and a sensing input. Claim 11 also recites a processor. The sensing input and delivery of the neurostimulation amount to nothing more than pre-solution activity of data gathering. The stimulation control circuit and processor for controlling the delivery of the neurostimulation are recited at a high-level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into
a practical application, the additional elements of the sensing input and delivery of the neurostimulation amount to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, the sensing input and delivery of the neurostimulation are recited at a high level of generality and are well-understood, routine, and conventional structures as evidenced by US 20150217117 (¶13-in both conventional neuromodulation therapy described above where the patient feels paresthesia (super-threshold neuromodulation therapy) and sub-threshold neuromodulation therapy, common complications, caused due to cellular and synaptic mechanisms, include neurological phenomena, such as accommodation, adaption, and habituation, all of which entail a diminished neural response over time when there exists continuous input (in this case, electrical stimulation)), US 20180178015 (¶53-conventional spinal cord neurostimulators), US 20110184486 (¶74-conventional neuromodulation devices typically include a microprocessor and a pulse generation module. The pulse generation module generates the electrical pulses according to a defined pulse width and pulse amplitude and applies the electrical pulses to defined electrodes), and US 20170348540 (¶107-a routine to confirm that the neuromodulation along the full lead is effective and then focus the neuromodulation along a portion of the lead). Further, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Regarding dependent claims 2-10, 12-18, and 20, the limitations of claims 1, 11, and 19 further define the limitations already indicated as being directed to the abstract idea.
Regarding claims 2, 12, and 20, the limitation of “wherein the stimulation circuit is configured to control the delivery of electrical pulses of the neurostimulation, the electrical pulses each having a stimulation waveform including a stimulation phase and a recharge phase, and the plurality of test waveform types are each defined by one or more attributes of the stimulation waveform” are recited at a high-level of generality and amount to nothing more than parts of a generic computer. In addition, as shown above in claims 1, 11, and 19, the delivery of electrical pulses of neurostimulation is well-understood, routine, and conventional activity.
Claims 3-6 and 8-9 further define the abstract idea in claim 1.
Regarding claim 7, the limitation of “wherein the measurement circuit is configured to determine the response parameter to characterize an evoked response being the response of the patient evoked by a pulse of the electrical pulses” is a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, this limitation is nothing more than a medical professional analyzing a print out of data to determine the response parameter to characterize an evoked response being the response of the patient evoked by a pulse of the electrical pulses.
Regarding claim 10 and 16, the limitation of “wherein the measurement circuit is configured to determine the response parameter to characterize a morphological feature of evoked compound action potentials (ECAPs) in the ESG signal” is a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, this limitation is nothing more than a medical professional analyzing a print out of data to determine the response parameter to characterize a morphological feature of evoked compound action potentials (ECAPs) in the ESG signal.
Claims 13-15 and 17-18 further defines the abstract idea in claim 11.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1, 11, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over King (US 20080004674 filed on 6/7/07 as cited in the IDS) in view of Minev (WO 2016110564 filed on 1/8/16).
Regarding claims 1, 11, and 19, King teaches a system, a method, and a non-transitory computer-readable storage medium including instructions, which when executed by a system, cause the system to perform a method for delivering neurostimulation to a patient having a spinal cord (¶98-clinician programmer 20 to program electrical stimulation therapy for a patient, e.g., to select electrode combinations and create programs; ¶25-neurostimulation therapy to a patient; ¶92-spinal cord of a patient), comprising: a stimulation control circuit configured to control the delivery of the neurostimulation according to each waveform type of a plurality of test waveform types (¶91-a medical device 14 that delivers stimulation to a patient (not shown). The medical device 14 may be an electrical stimulation generator, and may deliver stimulation to the patient in the form of electrical pulses or substantially continuous-time signals (e.g., sinusoidal signals); ¶95-the medical device 14 delivers stimulation therapy in the form of electrical pulses, the parameters may include pulse voltage or current amplitudes, pulse widths, pulse rates, duty cycles and the like. The pulses may be independently variable (e.g., programmable) so that the voltage or current of each active electrode can be independently controlled; ¶98-clinician programmer 20 to program electrical stimulation therapy for a patient, e.g., to select electrode combinations and create programs) using a processor (¶25-processor), the neurostimulation delivered from a stimulation device (¶25-the processor selects an electrode combination for delivery of neurostimulation therapy to a patient); the stimulation control circuit including: a sensing input configured to receive a signal recording electrical activity from the spinal cord (¶11-spinal cord stimulation (SCS); ¶94-medical device 14 may include sensing electrodes for sensing a patient physiological parameter; ¶84-a useful electrode combination for use in delivering electrical stimulation to a patient is identified by testing a patient response to electrode combinations within at least five groups of electrode combinations; ¶124-the patient response may, for example, indicate the area of paresthesia coverage, efficacy of the stimulation therapy delivered by the electrode combination or any side effects resulting from the stimulation. This response may be recorded within the stimulation device, via an external recording device, such as the patient programmer 26 or the clinician programmer 20 (FIG. 1); Figs. 14-18); a measurement circuit configured to determine a response parameter for each test waveform type of the plurality of test waveform types using the received signal (¶124-the programmer and/or medical device can implement each of the electrode combinations for a duration of time, and the patient response can be tested. The patient response may, for example, indicate the area of paresthesia coverage, efficacy of the stimulation therapy delivered by the electrode combination or any side effects resulting from the stimulation. This response may be recorded within the stimulation device, via an external recording device, such as the patient programmer 26 or the clinician programmer 20 (FIG. 1); ¶28-the therapy metric comprising a quantifiable result of delivery of stimulation, wherein the values of the therapy metric associated with the electrode combinations are generated by computer modeling of delivery of stimulation via the electrode combinations), the response parameter characterizing a response of the patient to the delivery of the neurostimulation (¶32-receive patient feedback to the therapy delivery via the baseline electrode combination, select a therapy metric based on the patient feedback, the therapy metric comprising a quantifiable result of delivery of stimulation; ¶25-delivery of neurostimulation therapy; ¶28); and a selection circuit configured to select a therapy waveform type from the plurality of test waveform types using the response parameter (¶19-upon finding a best suited class, group or electrode combination, the clinician or patient may utilize programming methodologies to fine-tune (i.e., further optimize) the selected class, group or electrode combination. The methodologies may include, for example, steering stimulation along or between leads to help find a preferred locus for delivery of stimulation from the combination, optimizing stimulation parameters (e.g., stimulation amplitude, pulse width, pulse rate, etc.), or generating additional combinations based on the best suited class, group or electrode combination, such as permutations of combinations within the best suited class or group, or permutations of the best suited electrode combination; ¶28-selecting an additional electrode combination based on information associating a plurality of electrode combinations with a respective value of the therapy metric, wherein the values of the therapy metric associated with the electrode combinations are generated by computer modeling of delivery of stimulation via the electrode combinations; claim 23-selected type of therapy metric; ¶23).
While King teaches spinal cord stimulation (SCS) (¶11), King does not explicitly teach an electrospinogram (ESG) signal.
Minev relates to a device adapted to be implanted at the surface of electrically active biological tissues and organs for therapeutic and/or diagnostic purposes, and a method for producing same (page 1, lines 4-6). Minev further teaches the invention using the following step:
an electrospinogram (ESG) signal (page 22, line 6-chronic recordings of electrospinograms (Fig. 16C, Fig. 26); page 22, lines 10-12-both electrospinograms and muscle activity were recorded in response to stimulation delivered to peripheral nerve or motor cortex).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of King to include an electrospinogram (ESG) signal of Minev in order to analyze the latency, amplitude, and amplitude density spectrum of the recorded signals (Minev, page 22, lines 25-27) and detect peripheral sensory feedback (Minev, page 26, line 5).
Claims 2-3, 6, 12-13, 15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over King in view of Minev as applied to claims 1, 11, and 19 above, and further in view of Stanslaski (US 20180243564 filed on 2/28/17 as cited in the IDS).
Regarding claims 2, 12, and 20, the combination of King and Minev teaches the system, the method, and the non-transitory computer-readable storage medium of claims 1, 11, and 19, wherein the stimulation circuit is configured to control the delivery of electrical pulses of the neurostimulation (King, ¶95-where the medical device 14 delivers stimulation therapy in the form of electrical pulses, the parameters may include pulse voltage or current amplitudes, pulse widths, pulse rates, duty cycles and the like. The pulses may be independently variable (e.g., programmable) so that the voltage or current of each active electrode can be independently controlled; ¶99-control the delivery of therapy by the medical device 14). However, the combination of King and Minev does not explicitly teach the electrical pulses each having a stimulation waveform including a stimulation phase and a recharge phase, and the plurality of test waveform types are each defined by one or more attributes of the stimulation waveform.
Stanslaski teaches the electrical pulses each having a stimulation waveform including a stimulation phase and a recharge phase (¶7-the waveform including a stimulation pulse followed by an active recharge pulse), and the plurality of test waveform types are each defined by one or more attributes of the stimulation waveform (¶25-optimize the ratio of active recharge amplitude to stimulation pulse amplitude; ¶48-the duration of the passive recharge 410, T.sub.PR, may be set to a particular fixed value (e.g., 264-396 μs) and then allow the active recharge ratio to be adjusted, in light of that fixed duration of passive recharge, to effectively clear the capacitors and minimize signal artifacts; ¶29-providing the stimulation signals and for sensing the physiological signals may be of various types).
Stanslaski relates to sensing physiological signals while stimulation therapy is being conducted (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of King to include the electrical pulses each having a stimulation waveform including a stimulation phase and a recharge phase, and the plurality of test waveform types are each defined by one or more attributes of the stimulation waveform of Stanslaski in order to reduce the likelihood of non-neurological signals producing unwanted artifacts in the sensed physiological signals (Stanslaski, ¶5).
Regarding claim 3, the combination of King, Minev, and Stanslaski teaches the system of claim 2, wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by whether the recharge phase is actively or passively driven (Stanslaski, ¶25-determine whether there are non-neurological signal artifacts present in the sensed signal while using passive recharge without active recharge and then switch to using active recharge followed by passive recharge when non-neurological signal artifacts are present; ¶73-after the mode is selected at the operation 1310 or 1312, the controller 202 continues with the selected mode for a set period of time).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of King to include wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by whether the recharge phase is actively or passively driven of Stanslaski in order to determine whether there are non-neurological signal artifacts present in the sensed signal while using passive recharge without active recharge and then switch to using active recharge followed by passive recharge when non-neurological signal artifacts are present (Stanslaski, ¶25).
Regarding claim 6, the combination of King, Minev, and Stanslaski teaches the system of claim 2, wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by a polarity of the stimulation phase (King, ¶8-a selected subset of the electrodes located on one or more leads and the polarities of the electrodes of the subset collectively define an "electrode combination," which is also referred to as an "electrode pattern."; ¶95-the parameters for a program may include information identifying which electrodes have been selected for delivery of pulses according to the program, and the polarities of the selected electrodes).
Regarding claim 13, the combination of King, Minev, and Stanslaski teaches the method of claim 12, wherein selecting the therapy waveform type comprises selecting between an active recharge phase and a passive recharge phase (Stanslaski, ¶25-determine whether there are non-neurological signal artifacts present in the sensed signal while using passive recharge without active recharge and then switch to using active recharge followed by passive recharge when non-neurological signal artifacts are present; ¶73-after the mode is selected at the operation 1310 or 1312, the controller 202 continues with the selected mode for a set period of time).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of King to include wherein selecting the therapy waveform type comprises selecting between an active recharge phase and a passive recharge phase of Stanslaski in order to determine whether there are non-neurological signal artifacts present in the sensed signal while using passive recharge without active recharge and then switch to using active recharge followed by passive recharge when non-neurological signal artifacts are present (Stanslaski, ¶25).
Regarding claim 15, the combination of King, Minev, and Stanslaski teaches the method of claim 12, wherein selecting the therapy waveform type comprises selecting a polarity of the stimulation phase from multiple pluralities of the stimulation phase (King, ¶8-a selected subset of the electrodes located on one or more leads and the polarities of the electrodes of the subset collectively define an "electrode combination," which is also referred to as an "electrode pattern."; ¶95-the parameters for a program may include information identifying which electrodes have been selected for delivery of pulses according to the program, and the polarities of the selected electrodes).
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over King in view of Minev, and further in view of Stanslaski applied to claims 2-3, 6, 12-13, 15, and 20 above, and further in view of Parker ‘257 (US 20140236257 filed on 5/11/12 as cited in the IDS).
Regarding claim 4, the combination of King, Minev, and Stanslaski teaches the system of claim 2. However, the combination of King, Minev, and Stanslaski does not teach wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by a shape of the stimulation phase.
Parker ‘257 teaches wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by a shape of the stimulation phase (¶49-a selection of pulse shapes which may be tested to determine the most efficient at producing depolarization; Fig. 3).
Parker ‘257 relates to controlling a neural response to a stimulus, and in particular relates to measurement of a compound action potential by using one or more electrodes implanted proximal to the neural pathway, in order to provide feedback to control subsequently applied stimuli (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of King to include wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by a shape of the stimulation phase of Parker ‘257 in order to determine which is most efficient at producing depolarization (Parker ‘257, ¶172).
Regarding claim 14, the combination of King, Minev, and Stanslaski teaches the method of claim 12. However, the combination of King, Minev, and Stanslaski does not teach wherein selecting the therapy waveform type comprises selecting a shape of the stimulation waveform from multiple shapes of the stimulation waveform.
Parker ‘257 teaches wherein selecting the therapy waveform type comprises selecting a shape of the stimulation waveform from multiple shapes of the stimulation waveform (¶49-a selection of pulse shapes which may be tested to determine the most efficient at producing depolarization; Fig. 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of King to include wherein selecting the therapy waveform type comprises selecting a shape of the stimulation waveform from multiple shapes of the stimulation waveform of Parker ‘257 in order to determine which is most efficient at producing depolarization (Parker ‘257, ¶172).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over King in view of Minev, and further in view of Stanslaski as applied to claims 2-3, 6, 12-13, 15, and 20 above, and further in view of Zhang (US 20180214689 filed on 1/29/18 as cited in the IDS).
Regarding claim 5, the combination of King, Minev, and Stanslaski teaches the system of claim 2. However, the combination of King, Minev, and Stanslaski does not teach wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by a shape of the recharge phase.
Zhang teaches wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by a shape of the recharge phase (¶133-applied to different waveform shapes, strength-duration relationships may also differ by waveform shape, and separate strength-duration equations may be fit/saved for each waveform type (e.g. passive recharge vs. biphasic active recharge vs. sinusoidal, strength-duration curves from different waveforms may be displayed at the same time and compared, as shown, for user reference. A user may be presented with strength-duration curve corresponding to neural element being targeted that may adapt after user changes settings).
Zhang relates generally to medical devices, and more particularly, but not by way of limitation, to systems, devices, and methods to provide a neuromodulation field (¶3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of King to include wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by a shape of the recharge phase of Zhang in order to define electrode parameters for neuromodulation such as sub-perception SCS (Zhang, ¶6) and because scaling factors (i.e. by how much a given threshold and total electrode fractionalization is scaled by) may vary by various neuron-related and waveform-related variables (Zhang, ¶134).
Claims 7, 10, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over King in view of Minev, and further in view of Stanslaski as applied to claims 2-3, 6, 12-13, 15, and 20 above, and further in view of Parker ‘987 (US 20180110987 filed on 4/8/16 as cited in the IDS).
Regarding claim 7, the combination of King, Minev, and Stanslaski teaches the system of claim 2. However, the combination of King, Minev, and Stanslaski does not teach wherein the measurement circuit is configured to determine the response parameter to characterize an evoked response being the response of the patient evoked by a pulse of the electrical pulses.
Parker ‘987 teaches wherein the measurement circuit is configured to determine the response parameter to characterize an evoked response being the response of the patient evoked by a pulse of the electrical pulses (Abstract-neural measurements of at least one evoked compound action potential are obtained, and processed in order to estimate an originating state of stimulation exhibiting at least one characteristic defined by a single fibre size. A single fibre model is then applied to produce a measure of the nerve-to-electrode distance; ¶32-the neural measurements are then analysed specifically in relation to the portion of the observed measurement which corresponds with the response evoked by the probe stimulus; ¶91-the amplitude and morphology of an ECAP measurement; ¶20; ¶25; ¶93).
Parker ‘987 relates to neurostimulation, and in particular relates to observing evoked compound action potentials caused by electrical stimuli, in order to estimate a distance, or a change in distance, between a nerve and an electrode being used to stimulate the nerve (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of King to include wherein the measurement circuit is configured to determine the response parameter to characterize an evoked response being the response of the patient evoked by a pulse of the electrical pulses of Parker ‘987 in order to enable a single fibre model of recruitment to be applied, in order to estimate the nerve-to-electrode distance and eliminate complicating effects arising from propagation of a compound action potential along a group of neural fibres of distinct size (Parker ‘987, ¶20).
Regarding claims 10 and 16, the combination of King, Minev, and Stanslaski teaches the system and the method of claims 2 and 12, and the ESG signal (Minev, page 22, line 6-chronic recordings of electrospinograms (Fig. 16C, Fig. 26); page 22, lines 10-12-both electrospinograms and muscle activity were recorded in response to stimulation delivered to peripheral nerve or motor cortex).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of King to include the ESG signal of Minev in order to analyze the latency, amplitude, and amplitude density spectrum of the recorded signals (Minev, page 22, lines 25-27) and detect peripheral sensory feedback (Minev, page 26, line 5).
However, the combination of King, Minev, and Stanslaski does not teach wherein the measurement circuit is configured to determine the response parameter to characterize a morphological feature of evoked compound action potentials (ECAPs) in the signal.
Parker ‘987 teaches wherein the measurement circuit is configured to determine the response parameter to characterize a morphological feature of evoked compound action potentials (ECAPs) in the signal (¶25-an estimate of the ECAP peak width at the stimulus site; ¶91-the amplitude and morphology of an ECAP measurement; ¶20-estimating the originating state of stimulation, it is possible to isolate at least one characteristic which is defined by a single fibre size).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of King to include wherein the measurement circuit is configured to determine the response parameter to characterize a morphological feature of evoked compound action potentials (ECAPs) in the signal of Parker ‘987 in order to enable a single fibre model of recruitment to be applied, in order to estimate the nerve-to-electrode distance and eliminate complicating effects arising from propagation of a compound action potential along a group of neural fibres of distinct size (Parker ‘987, ¶20).
Claims 8-9 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over King in view of Minev and Stanslaski, and further in view of Parker ‘987 as applied to claims 7, 10, and 16 above, and further in view of Parker ‘257.
Regarding claim 8, the combination of King, Minev, Stanslaski, and Parker ‘987 teaches the system of claim 7. However, the combination of King, Minev, Stanslaski, and Parker ‘987 does not teach wherein the selection circuit is configured to select the therapy waveform type being the test waveform type associated with a maximum evoked response of the evoked responses resulting from the delivery of the neurostimulation according to each waveform type of the plurality of test waveform types.
Parker ‘257 teaches wherein the selection circuit is configured to select the therapy waveform type being the test waveform type associated with a maximum evoked response of the evoked responses resulting from the delivery of the neurostimulation according to each waveform type of the plurality of test waveform types (¶69-the maximum allowable measured evoked response strength and limited at high stimulus values by a maximum allowable stimulus intensity; ¶175-automated optimisation of the stimulus pulse parameters based on measurement of the evoked response arising from test stimuli having varied stimulus parameters; ¶35; ¶108; ¶172).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of King to include wherein the selection circuit is configured to select the therapy waveform type being the test waveform type associated with a maximum evoked response of the evoked responses resulting from the delivery of the neurostimulation according to each waveform type of the plurality of test waveform types of Parker ‘257 in order to provide feedback to control subsequently applied stimuli (Parker ‘257, ¶2).
Regarding claim 9, the combination of King, Minev, Stanslaski, and Parker ‘987 teaches the system of claim 7. However, the combination of King, Minev, Stanslaski, and Parker ‘987 does not teach wherein the selection circuit is configured to select the therapy waveform type for pain relief by selecting the therapy waveform type being the test waveform type associated with a maximum pain-paresthesia overlap identified from the evoked responses resulting from the delivery of the neurostimulation according to each waveform type of the plurality of test waveform types.
Parker ‘257 teaches wherein the selection circuit is configured to select the therapy waveform type for pain relief by selecting the therapy waveform type being the test waveform type associated with a maximum pain-paresthesia overlap identified from the evoked responses resulting from the delivery of the neurostimulation according to each waveform type of the plurality of test waveform types (¶36-maximally align induced paraesthesia with a preferred location, the therapy map may include or be derived from a body map setting out the location of effects of stimuli when applied by each electrode of an electrode array; ¶80- effective paraesthesia is present and there is good pain relief; ¶146-optimise the pain relief by selecting stimulus parameters and location to achieve coverage, i.e. matching the area of paraesthesia with the area over which the patient experiences pain; ¶175-provides for automated optimisation of the stimulus pulse parameters based on measurement of the evoked response arising from test stimuli having varied stimulus parameters; ¶77; ¶108).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of King to include wherein the selection circuit is configured to select the therapy waveform type for pain relief by selecting the therapy waveform type being the test waveform type associated with a maximum pain-paresthesia overlap identified from the evoked responses resulting from the delivery of the neurostimulation according to each waveform type of the plurality of test waveform types of Parker ‘257 in order to provide feedback to control subsequently applied stimuli (Parker ‘257, ¶2) and have good pain relief (Parker ‘257, ¶80).
Regarding claim 17, the combination of King, Minev, Stanslaski, and Parker ‘987 teaches the method of claim 16. However, the combination of King, Minev, Stanslaski, and Parker ‘987 does not teach wherein selecting the therapy waveform type comprises selecting the test waveform type associated with a maximum evoked response of the evoked responses resulting from the delivery of the neurostimulation according to each waveform type of the plurality of test waveform types.
Parker ‘257 teaches wherein selecting the therapy waveform type comprises selecting the test waveform type associated with a maximum evoked response of the evoked responses resulting from the delivery of the neurostimulation according to each waveform type of the plurality of test waveform types (¶69-the maximum allowable measured evoked response strength and limited at high stimulus values by a maximum allowable stimulus intensity; ¶175-automated optimisation of the stimulus pulse parameters based on measurement of the evoked response arising from test stimuli having varied stimulus parameters; ¶35; ¶108; ¶172).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of King to include wherein selecting the therapy waveform type comprises selecting the test waveform type associated with a maximum evoked response of the evoked responses resulting from the delivery of the neurostimulation according to each waveform type of the plurality of test waveform types of Parker ‘257 in order to provide feedback to control subsequently applied stimuli (Parker ‘257, ¶2).
Regarding claim 18, the combination of King, Minev, Stanslaski, and Parker ‘987 teaches the method of claim 16. However, the combination of King, Minev, Stanslaski, and Parker ‘987 does not teach wherein selecting the therapy waveform type comprises selecting the therapy waveform type for pain relief by selecting the therapy waveform type associated with a maximum pain-paresthesia overlap identified from the evoked responses resulting from the delivery of the neurostimulation according to each waveform type of the plurality of test waveform types.
Parker ‘257 teaches wherein selecting the therapy waveform type comprises selecting the therapy waveform type for pain relief by selecting the therapy waveform type associated with a maximum pain-paresthesia overlap identified from the evoked responses resulting from the delivery of the neurostimulation according to each waveform type of the plurality of test waveform types (¶36-maximally align induced paraesthesia with a preferred location, the therapy map may include or be derived from a body map setting out the location of effects of stimuli when applied by each electrode of an electrode array; ¶80- effective paraesthesia is present and there is good pain relief; ¶146-optimise the pain relief by selecting stimulus parameters and location to achieve coverage, i.e. matching the area of paraesthesia with the area over which the patient experiences pain; ¶175-provides for automated optimisation of the stimulus pulse parameters based on measurement of the evoked response arising from test stimuli having varied stimulus parameters; ¶77; ¶108).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of King to include wherein selecting the therapy waveform type comprises selecting the therapy waveform type for pain relief by selecting the therapy waveform type associated with a maximum pain-paresthesia overlap identified from the evoked responses resulting from the delivery of the neurostimulation according to each waveform type of the plurality of test waveform types of Parker ‘257 in order to provide feedback to control subsequently applied stimuli (Parker ‘257, ¶2) and have good pain relief (Parker ‘257, ¶80).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 11, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11383088. Although the claims at issue are not identical, they are not patentably distinct from each other. See the table below for a matching of the claims anticipated by the U.S. Patent.
Claims of the Present Application (18/939156)
Claims of US Patent No. 11383088
1, 11, and 19
1, 11, and 19
Claims 2-3, 7-9, 12-13, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11383088 in view of Stanslaski (US 20180243564).
This is a nonstatutory double patenting rejection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include the subject matter in Stanslaski as shown below.
Claims of the Present Application (18/939156)
Claims of US Patent No. 11383088
Secondary Reference Stanslaski (US 20180243564)
2, 12, and 20
1, 11, and 19
Stanslaski teaches wherein the stimulation circuit is configured to control the delivery of electrical pulses of the neurostimulation (¶41-the controller 202 orchestrates the operation of the sensing circuit 204 and the stimulation engine 206 . The controller 202 activates and deactivates various phases of operation of the stimulation that occur during stimulation therapy), the electrical pulses each having a stimulation waveform including a stimulation phase and a recharge phase (¶7-the waveform including a stimulation pulse followed by an active recharge pulse), and the plurality of test waveform types are each defined by one or more attributes of the stimulation waveform (¶25-optimize the ratio of active recharge amplitude to stimulation pulse amplitude; ¶48-the duration of the passive recharge 410, T.sub.PR, may be set to a particular fixed value (e.g., 264-396 μs) and then allow the active recharge ratio to be adjusted, in light of that fixed duration of passive recharge, to effectively clear the capacitors and minimize signal artifacts; ¶29-providing the stimulation signals and for sensing the physiological signals may be of various types). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the US Patent to include wherein the stimulation circuit is configured to control the delivery of electrical pulses of the neurostimulation, the electrical pulses each having a stimulation waveform including a stimulation phase and a recharge phase, and the plurality of test waveform types are each defined by one or more attributes of the stimulation waveform of Stanslaski in order to reduce the likelihood of non-neurological signals producing unwanted artifacts in the sensed physiological signals (Stanslaski, ¶5).
3
3, 13
Stanslaski teaches wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by whether the recharge phase is actively or passively driven (Stanslaski, ¶25-determine whether there are non-neurological signal artifacts present in the sensed signal while using passive recharge without active recharge and then switch to using active recharge followed by passive recharge when non-neurological signal artifacts are present; ¶73-after the mode is selected at the operation 1310 or 1312, the controller 202 continues with the selected mode for a set period of time). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the US Patent to include wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by whether the recharge phase is actively or passively driven of Stanslaski in order to determine whether there are non-neurological signal artifacts present in the sensed signal while using passive recharge without active recharge and then switch to using active recharge followed by passive recharge when non-neurological signal artifacts are present (Stanslaski, ¶25).
7
2, 12
8
1, 6, 11, 15, 19
9
1, 5,11, 17, 19
13
Stanslaski teaches wherein selecting the therapy waveform type comprises selecting between an active recharge phase and a passive recharge phase (Stanslaski, ¶25-determine whether there are non-neurological signal artifacts present in the sensed signal while using passive recharge without active recharge and then switch to using active recharge followed by passive recharge when non-neurological signal artifacts are present; ¶73-after the mode is selected at the operation 1310 or 1312, the controller 202 continues with the selected mode for a set period of time). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the US Patent to include wherein selecting the therapy waveform type comprises selecting between an active recharge phase and a passive recharge phase of Stanslaski in order to determine whether there are non-neurological signal artifacts present in the sensed signal while using passive recharge without active recharge and then switch to using active recharge followed by passive recharge when non-neurological signal artifacts are present (Stanslaski, ¶25).
Claims 4 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11383088 in view of Stanslaski and Parker ‘257 (US 20140236257).
This is a nonstatutory double patenting rejection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include the subject matter in Stanslaski and Parker ‘257 as shown below.
Claims of the Present Application (18/939156)
Claims of US Patent No. 11383088
Secondary Reference Stanslaski (US 20180243564)
Secondary Reference Parker ‘257 (US 20140236257)
4
Parker ‘257 teaches wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by a shape of the stimulation phase (¶49-a selection of pulse shapes which may be tested to determine the most efficient at producing depolarization; Fig. 3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the US Patent to include wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by a shape of the stimulation phase of Parker ‘257 in order to determine which is most efficient at producing depolarization (Parker ‘257, ¶172).
14
Parker ‘257 teaches wherein selecting the therapy waveform type comprises selecting a shape of the stimulation waveform from multiple shapes of the stimulation waveform (¶49-a selection of pulse shapes which may be tested to determine the most efficient at producing depolarization; Fig. 3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the US Patent to include wherein selecting the therapy waveform type comprises selecting a shape of the stimulation waveform from multiple shapes of the stimulation waveform of Parker ‘257 in order to determine which is most efficient at producing depolarization (Parker ‘257, ¶172).
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11383088 in view of Stanslaski and Zhang (US 20180214689).
This is a nonstatutory double patenting rejection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include the subject matter in Stanslaski and Zhang as shown below.
Claims of the Present Application (18/939156)
Claims of US Patent No. 11383088
Secondary Reference Stanslaski (US 20180243564)
Secondary Reference Zhang (US 20180214689)
5
Zhang teaches wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by a shape of the recharge phase (¶133-applied to different waveform shapes, strength-duration relationships may also differ by waveform shape, and separate strength-duration equations may be fit/saved for each waveform type (e.g. passive recharge vs. biphasic active recharge vs. sinusoidal, strength-duration curves from different waveforms may be displayed at the same time and compared, as shown, for user reference. A user may be presented with strength-duration curve corresponding to neural element being targeted that may adapt after user changes settings). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the US Patent to include wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by a shape of the recharge phase of Zhang in order to define electrode parameters for neuromodulation such as sub-perception SCS (Zhang, ¶6) and because scaling factors (i.e. by how much a given threshold and total electrode fractionalization is scaled by) may vary by various neuron-related and waveform-related variables (Zhang, ¶134).
Claims 6 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11383088 in view of Stanslaski and King (US 20080004674).
This is a nonstatutory double patenting rejection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include the subject matter in Stanslaski and King as shown below.
Claims of the Present Application (18/939156)
Claims of US Patent No. 11383088
Secondary Reference Stanslaski (US 20180243564)
Secondary Reference King (US 20080004674)
6
King teaches wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by a polarity of the stimulation phase (King, ¶8-a selected subset of the electrodes located on one or more leads and the polarities of the electrodes of the subset collectively define an "electrode combination," which is also referred to as an "electrode pattern."; ¶95-the parameters for a program may include information identifying which electrodes have been selected for delivery of pulses according to the program, and the polarities of the selected electrodes). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the US Patent to include wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by a polarity of the stimulation phase of King in order to determine of a class of electrode combinations that provide efficacious stimulation for the particular patient (King, ¶9).
15
King teaches wherein selecting the therapy waveform type comprises selecting a polarity of the stimulation phase from multiple pluralities of the stimulation phase (King, ¶8-a selected subset of the electrodes located on one or more leads and the polarities of the electrodes of the subset collectively define an "electrode combination," which is also referred to as an "electrode pattern."; ¶95-the parameters for a program may include information identifying which electrodes have been selected for delivery of pulses according to the program, and the polarities of the selected electrodes). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the US Patent to include wherein selecting the therapy waveform type comprises selecting a polarity of the stimulation phase from multiple pluralities of the stimulation phase of King in order to determine of a class of electrode combinations that provide efficacious stimulation for the particular patient (King, ¶9).
Claims 10 and 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11383088 in view of Stanslaski, Minev (WO 2016110564), and Parker ‘987 (US 20180110987).
This is a nonstatutory double patenting rejection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include the subject matter in Stanslaski, Minev, and Parker ‘987 as shown below.
Claims of the Present Application (18/939156)
Claims of US Patent No. 11383088
Secondary Reference Stanslaski (US 20180243564)
Secondary Reference Minev (WO 2016110564)
Secondary Reference Parker ‘987 (US 20180110987)
10 and 16
Minev teaches the ESG signal (Minev, page 22, line 6-chronic recordings of electrospinograms (Fig. 16C, Fig. 26); page 22, lines 10-12-both electrospinograms and muscle activity were recorded in response to stimulation delivered to peripheral nerve or motor cortex). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the US Patent to include the ESG signal of Minev in order to analyze the latency, amplitude, and amplitude density spectrum of the recorded signals (Minev, page 22, lines 25-27) and detect peripheral sensory feedback (Minev, page 26, line 5).
Parker ‘987 teaches wherein the measurement circuit is configured to determine the response parameter to characterize a morphological feature of evoked compound action potentials (ECAPs) in the signal (¶25-an estimate of the ECAP peak width at the stimulus site; ¶91-the amplitude and morphology of an ECAP measurement; ¶20-estimating the originating state of stimulation, it is possible to isolate at least one characteristic which is defined by a single fibre size). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the US Patent to include wherein the measurement circuit is configured to determine the response parameter to characterize a morphological feature of evoked compound action potentials (ECAPs) in the signal of Parker ‘987 in order to enable a single fibre model of recruitment to be applied, in order to estimate the nerve-to-electrode distance and eliminate complicating effects arising from propagation of a compound action potential along a group of neural fibres of distinct size (Parker ‘987, ¶20).
17
1, 6, 11, 15, 19
18
1, 5,11, 17, 19
Claims 1, 11, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12168132. Although the claims at issue are not identical, they are not patentably distinct from each other. See the table below for a matching of the claims anticipated by the U.S. Patent.
Claims of the Present Application (18/939156)
Claims of US Patent No. 12168132
1, 11, and 19
1, 10, 11, 19
Claims 2-3, 7-10, 12-13, 16-18, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12168132 in view of Stanslaski (US 20180243564).
This is a nonstatutory double patenting rejection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include the subject matter in Stanslaski as shown below.
Claims of the Present Application (18/939156)
Claims of US Patent No. 12168132
Secondary Reference Stanslaski (US 20180243564)
2, 12, and 20
1, 8, 9, 11, 19
Stanslaski teaches wherein the stimulation circuit is configured to control the delivery of electrical pulses of the neurostimulation (¶41-the controller 202 orchestrates the operation of the sensing circuit 204 and the stimulation engine 206 . The controller 202 activates and deactivates various phases of operation of the stimulation that occur during stimulation therapy), the electrical pulses each having a stimulation waveform including a stimulation phase and a recharge phase (¶7-the waveform including a stimulation pulse followed by an active recharge pulse), and the plurality of test waveform types are each defined by one or more attributes of the stimulation waveform (¶25-optimize the ratio of active recharge amplitude to stimulation pulse amplitude; ¶48-the duration of the passive recharge 410, T.sub.PR, may be set to a particular fixed value (e.g., 264-396 μs) and then allow the active recharge ratio to be adjusted, in light of that fixed duration of passive recharge, to effectively clear the capacitors and minimize signal artifacts; ¶29-providing the stimulation signals and for sensing the physiological signals may be of various types). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the US Patent to include wherein the stimulation circuit is configured to control the delivery of electrical pulses of the neurostimulation, the electrical pulses each having a stimulation waveform including a stimulation phase and a recharge phase, and the plurality of test waveform types are each defined by one or more attributes of the stimulation waveform of Stanslaski in order to reduce the likelihood of non-neurological signals producing unwanted artifacts in the sensed physiological signals (Stanslaski, ¶5).
3
10, 11
Stanslaski teaches wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by whether the recharge phase is actively or passively driven (Stanslaski, ¶25-determine whether there are non-neurological signal artifacts present in the sensed signal while using passive recharge without active recharge and then switch to using active recharge followed by passive recharge when non-neurological signal artifacts are present; ¶73-after the mode is selected at the operation 1310 or 1312, the controller 202 continues with the selected mode for a set period of time). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the US Patent to include wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by whether the recharge phase is actively or passively driven of Stanslaski in order to determine whether there are non-neurological signal artifacts present in the sensed signal while using passive recharge without active recharge and then switch to using active recharge followed by passive recharge when non-neurological signal artifacts are present (Stanslaski, ¶25).
7
1, 2, 5, 9, 10, 12, 19
8
1, 2, 9, 10, 12, 19, 20
9
1, 7, 9, 10, 13, 19, 20
10 and 16
1, 9, 19
13
Stanslaski teaches wherein selecting the therapy waveform type comprises selecting between an active recharge phase and a passive recharge phase (Stanslaski, ¶25-determine whether there are non-neurological signal artifacts present in the sensed signal while using passive recharge without active recharge and then switch to using active recharge followed by passive recharge when non-neurological signal artifacts are present; ¶73-after the mode is selected at the operation 1310 or 1312, the controller 202 continues with the selected mode for a set period of time). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the US Patent to include wherein selecting the therapy waveform type comprises selecting between an active recharge phase and a passive recharge phase of Stanslaski in order to determine whether there are non-neurological signal artifacts present in the sensed signal while using passive recharge without active recharge and then switch to using active recharge followed by passive recharge when non-neurological signal artifacts are present (Stanslaski, ¶25).
17
1, 2, 9, 10, 12, 19, 20
18
1, 7, 9, 10, 13, 19, 20
Claims 4 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12168132 in view of Stanslaski and Parker ‘257 (US 20140236257).
This is a nonstatutory double patenting rejection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include the subject matter in Stanslaski and Parker ‘257 as shown below.
Claims of the Present Application (18/939156)
Claims of US Patent No. 12168132
Secondary Reference Stanslaski (US 20180243564)
Secondary Reference Parker ‘257 (US 20140236257)
4
Parker ‘257 teaches wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by a shape of the stimulation phase (¶49-a selection of pulse shapes which may be tested to determine the most efficient at producing depolarization; Fig. 3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the US Patent to include wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by a shape of the stimulation phase of Parker ‘257 in order to determine which is most efficient at producing depolarization (Parker ‘257, ¶172).
14
Parker ‘257 teaches wherein selecting the therapy waveform type comprises selecting a shape of the stimulation waveform from multiple shapes of the stimulation waveform (¶49-a selection of pulse shapes which may be tested to determine the most efficient at producing depolarization; Fig. 3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the US Patent to include wherein selecting the therapy waveform type comprises selecting a shape of the stimulation waveform from multiple shapes of the stimulation waveform of Parker ‘257 in order to determine which is most efficient at producing depolarization (Parker ‘257, ¶172).
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12168132 in view of Stanslaski and Zhang (US 20180214689).
This is a nonstatutory double patenting rejection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include the subject matter in Stanslaski and Zhang as shown below.
Claims of the Present Application (18/939156)
Claims of US Patent No. 12168132
Secondary Reference Stanslaski (US 20180243564)
Secondary Reference Zhang (US 20180214689)
5
Zhang teaches wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by a shape of the recharge phase (¶133-applied to different waveform shapes, strength-duration relationships may also differ by waveform shape, and separate strength-duration equations may be fit/saved for each waveform type (e.g. passive recharge vs. biphasic active recharge vs. sinusoidal, strength-duration curves from different waveforms may be displayed at the same time and compared, as shown, for user reference. A user may be presented with strength-duration curve corresponding to neural element being targeted that may adapt after user changes settings). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the US Patent to include wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by a shape of the recharge phase of Zhang in order to define electrode parameters for neuromodulation such as sub-perception SCS (Zhang, ¶6) and because scaling factors (i.e. by how much a given threshold and total electrode fractionalization is scaled by) may vary by various neuron-related and waveform-related variables (Zhang, ¶134).
Claims 6 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12168132 in view of Stanslaski and King (US 20080004674).
This is a nonstatutory double patenting rejection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include the subject matter in Stanslaski and King as shown below.
Claims of the Present Application (18/939156)
Claims of US Patent No. 12168132
Secondary Reference Stanslaski (US 20180243564)
Secondary Reference King (US 20080004674)
6
King teaches wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by a polarity of the stimulation phase (King, ¶8-a selected subset of the electrodes located on one or more leads and the polarities of the electrodes of the subset collectively define an "electrode combination," which is also referred to as an "electrode pattern."; ¶95-the parameters for a program may include information identifying which electrodes have been selected for delivery of pulses according to the program, and the polarities of the selected electrodes). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the US Patent to include wherein the selection circuit is configured to select the therapy waveform type from test waveform types defined by a polarity of the stimulation phase of King in order to determine of a class of electrode combinations that provide efficacious stimulation for the particular patient (King, ¶9).
15
King teaches wherein selecting the therapy waveform type comprises selecting a polarity of the stimulation phase from multiple pluralities of the stimulation phase (King, ¶8-a selected subset of the electrodes located on one or more leads and the polarities of the electrodes of the subset collectively define an "electrode combination," which is also referred to as an "electrode pattern."; ¶95-the parameters for a program may include information identifying which electrodes have been selected for delivery of pulses according to the program, and the polarities of the selected electrodes). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the US Patent to include wherein selecting the therapy waveform type comprises selecting a polarity of the stimulation phase from multiple pluralities of the stimulation phase of King in order to determine of a class of electrode combinations that provide efficacious stimulation for the particular patient (King, ¶9).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 10096386: relates to biomedical systems and devices. Particularly, the presently disclosed subject matter relates to systems and methods for model-based optimization of spinal cord stimulation electrodes (col. 1 and lines 23-26).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA HODGE whose telephone number is (571) 272-7101. The examiner can normally be reached M-F: 8:00 am-5:00 pm.
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