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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. CN202111582620.7, filed on 12/22/2021.
Information Disclosure Statement
The information disclosure statement(s) filed 06/21/2024 and 04/30/2025 has/have been considered by the Examiner.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract recites, “Disclosed are…”, which is considered implied phraseology and should be avoided. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 non-statutory subject matter (abstract ideas) without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Step 1):
Claims 1-19 recite a nerve stimulation apparatus, which satisfies the 4 statutory categories (process, machine, manufacture, or composition of matter) of patent-eligible subject matter.
Claims 20 recite a method, which satisfies the 4 statutory categories (process, machine, manufacture, or composition of matter) of patent-eligible subject matter.
Step 2a) Prong One:
Independent claim 1 recites:
A nerve stimulation apparatus, comprising: a pulse generator, an evoked compound action potential (ECAP) sensor and a controller; wherein the pulse generator is configured to generate pulses according to an instruction from the controller; the ECAP sensor is configured to sense an evoked compound action potential according to an instruction from the controller; and the controller is configured to instruct the ECAP sensor to sense the evoked compound action potential after a pulse is generated within a current pulse generation cycle, to obtain a peak-to-peak ratio of the evoked compound action potential, and to adjust, based on a determination that the peak-to-peak ratio of the evoked compound action potential is not within a comfort range, the amplitude of the pulse to be generated within a subsequent pulse generation cycle iteratively until the peak-to-peak ratio of the evoked compound action potential is within the comfort range; wherein the comfort range includes a dimension of amplitude of the pulse and a dimension of peak-to-peak ratio of the evoked compound action potential.
Independent claim 20 recites:
A control method applied at a nerve stimulation apparatus, wherein the nerve stimulation apparatus includes a controller, a pulse generator and an ECAP sensor, the control method includes: the controller instructing the ECAP sensor to sense an evoked compound action potential after a pulse generator generating a pulse within a current pulse generation cycle; obtaining a peak-to-peak ratio of the evoked compound action potential; and adjusting, based on a determination that the peak-to-peak ratio of the evoked compound action potential is not within a comfort range, the amplitude of the pulse to be generated within a subsequent pulse generation cycle iteratively until the peak-to-peak ratio of the evoked compound action potential is within the comfort range; wherein the comfort range includes a dimension of amplitude of the pulse and a dimension of peak-to-peak ratio of the evoked compound action potential.
Independent claims 1 and 20 are all directed to MENTAL PROCESSES, where nothing in the claim elements precludes the steps from practically being performed in the human mind or by a human using pen and paper. In the instant case, the claims are directed to adjusting values based on sensed ECAP data, which could be just a mental step of identifying or determining the appropriate stimulation pulse parameters that is yet to be generated and delivered (“…to be generated…” in claims 1 and 20) in response to sensed data.
Dependent claims 2-19 contain no additional elements that integrate the abstract ideas into practical application, or amount to significantly more than the abstract idea itself. Dependent claims 2-3, 8-10, 13-16, and 18 are all further directed to mental processes (i.e. comparing, traversing, determine, etc.). Dependent claims 4-5 are directed to abstract ideas of mathematical concepts (equations and formulas). Dependent claims 2-19 also only further define the abstract ideas (mental processes) and do not amount to significantly more than the abstract idea itself. Accordingly, the dependent claims are also directed to non-statutory subject matter.
Step 2a) Prong Two:
This judicial exception is not integrated into a practical application because mere instruction to implement on a computer, or merely using a computer as a tool to perform the abstract idea, adding insignificant extra solution activity, and/or generally linking the use of the abstract idea to a technological environment or field of use is not considered integration into a practical application. The Court defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
This judicial exception is not integrated into a practical application because claims 1-20 do not disclose using the result of the mental process steps (i.e. adjusting), for prophylactic treatment of a particular medical condition under MPEP 2106.05(e). In the instant case, there is no specific treatment in the form of stimulation/pacing pulses, drug therapy, or other forms of treatment that is ultimately delivered to treat a particular condition as a result of the mental process steps of adjusting the amplitude of the pulse to be generated. There is no specific treatment delivered to treat a particular condition that is specified in the claims, but is only directed to a mental process of identifying and determining optimal stimulation parameters than can be performed by a human mind. Accordingly, claims 1-20 do not disclose using the result of the mental processes steps for prophylactic treatment of a particular medical condition under MPEP 2106.05(e).
This judicial exception is not integrated into a practical application because claims 1-20 do not provide improvements to the functioning of a computer or to any the technical field under MPEP 2106.05(a). Specifically, the claims recite the elements of a pulse generator, an evoked compound action potential (ECAP) sensor and a controller comprising generic computer elements, but these elements have not been described with sufficient detail to constitute an improvement in the tech field, and as such these features merely define the field of use for the current invention by generally linking mental processes to generic computer elements as a tool to execute the abstract ideas (mental processes). By failing to explain how these elements are different from conventional computer elements, it is reasonable that the broadest reasonable interpretation of the additional elements is just a conventional computer performing generic functions. Conventional computer elements performing basic data analysis is directed to the components of a system amounting to merely field of use type limitations and/or extra solution activity to implement the abstract idea as identified above, and merely including instructions to implement abstract ideas on a computer does not integrate the judicial exception into practical application, see MPEP 2106.04(d) Integration of a Judicial Exception into a Practical Application.
Additional elements further include steps of generating pulses according to instruction from the controller, and an ECAP sensor used to sense an evoked compound action potential, all of which can be considered insignificant extra-solution activities for data gathering. In the instant case, these can be considered pre-solution activity as data-gathering steps by administering the stimulation pulses to gather ECAP data by the ECAP sensor before performing the mental process step of adjusting pulse amplitude to be generated. As such, these additional elements do not impose any meaningful limits on the claim, and are merely nominal or tangential additions to the claims without practical application, see MPEP 2106.05(g) Insignificant Extra-Solution Activity.
Accordingly, dependent claims 2-19 do not recite additional elements which practically integrate the judicial exception(s) of the current invention.
Step 2b)
Step 2B in the analysis requires us to determine whether the claims do significantly more than
simply describe that abstract method. Mayo, 132 S. Ct. at 1297. We must examine the limitations of the
claims to determine whether the claims contain an "inventive concept" to "transform" the claimed
abstract idea into patent-eligible subject matter. Alice, 134 S. Ct. at 2357 (quoting Mayo, 132 S. Ct. at
1294, 1298). The transformation of an abstract idea into patent-eligible subject matter "requires 'more
than simply stat[ing] the [abstract idea] while adding the words 'apply it."' Id. (quoting Mayo, 132 S. Ct.
at 1294) (alterations in original). "A claim that recites an abstract idea must include 'additional features'
to ensure 'that the [claim] is more than a drafting effort designed to monopolize the [abstract idea].'" Id.
(quoting Mayo, 132 S. Ct. at 1297) (alterations in original). Those "additional features" must be more
than "well-understood, routine, conventional activity." Mayo, 132 S. Ct. at 1298.
The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the recited additional elements of a pulse generator, an evoked compound action potential (ECAP) sensor and a controller is/are recognized as generic computer interfaces and generic computers (or computer components), because the claims do not describe these features as having distinguishing element(s) over their generic counterparts, which are well-understood, routine and conventional activities previously known in the industry.
As shown in the reference as taught by Min (US 20170173335 A1 – hereinafter Min), Min teaches a similar neural stimulation device/system (abstract – “A computer implemented method and system is provided for managing neural stimulation therapy”) comprising a controller and stimulation generation circuitry (paragraph 0041 – “The IPG 150 typically comprises a metallic housing or can 159 that encloses a controller 151, pulse generating circuitry 152…”) and further teaches ECAP sensing (paragraph 0088 – “At 704, the controller 151 senses an ECAP signal at one or more sensing electrodes located proximate to the nervous tissue of interest).
Additionally, Hershey (US 20170296823 A1) further teaches a similar neural stimulation device (paragraph 0002 – “The present invention relates generally to medical device systems, and more particularly to a pulse generator system operable to promote desynchronized firing of recruited neural populations”) comprising a controller (figure 2, controller 50), stimulation generation circuitry (figure 1, IPG 10) and ECAP sensing (paragraph 0041 – “Any of the electrodes 16 can preferably be used to sense the ECAP described earlier, and thus each electrode is further coupleable to at least one sense amp 110”).
Thus, the present claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. When looked at individually and as a whole, the claim limitations are determined to be an abstract idea without significantly more, and thus claims 1-20 are not patent eligible under 35 USC § 101.
Claim Interpretation
The term(s) “for”, “to” and “configured to” in the claim(s) may be interpreted as intended use. Intended use/functional language does not require that references teach or disclose the intended use of an element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP section 2114. II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 6-8, 12, 16-17 and 19-20 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Dinsmoor (US 20190388692 A1 – hereinafter Dinsmoor).
Re. claim 1, Dinsmoor teaches a nerve stimulation apparatus (abstract – “Devices, systems, and techniques for controlling electrical stimulation therapy are described. In one example, a system may be configured to deliver electrical stimulation therapy to a patient…”; paragraph 0031), comprising:
a pulse generator (figure 2A, stimulation generator 211),
an evoked compound action potential (ECAP) sensor (figure 2A, sensing circuitry 212; paragraph 0082 – “In one example, an ECAP elicited from to a control pulse delivered during a time event may be recorded by sensing circuitry 212…”),
and a controller (figure 2A, IMD 200, including the processing circuitry 214 memory 215);
wherein the pulse generator is configured to generate pulses according to an instruction from the controller (paragraph 0065 – “…stimulation generator 211 may include circuitry configured to generate stimulation signals such as pulses or continuous waveforms on one or more channels…”);
the ECAP sensor is configured to sense an evoked compound action potential according to an instruction from the controller (paragraph 0077 – “Processing circuitry 214 may receive, via an electrical signal sensed by sensing circuitry 212, information indicative of an ECAP signal…”);
and the controller is configured to instruct the ECAP sensor to sense the evoked compound action potential after a pulse is generated within a current pulse generation cycle (paragraph 0124 – “Processing circuitry 920 then delivers an informed pulse and a control pulse and senses the resulting ECAP elicited by the control pulse (920)”; figure 9, step 920),
to obtain a peak-to-peak ratio of the evoked compound action potential (paragraph 0101 – “When detecting the ECAP of ECAP signal 394, different characteristics may be identified…In other examples, the characteristic of the ECAP may be a ratio of one of peaks P1, N1, or P2 to another one of the peaks”),
and to adjust, based on a determination that the peak-to-peak ratio of the evoked compound action potential is not within a comfort range, the amplitude of the pulse to be generated within a subsequent pulse generation cycle iteratively until the peak-to-peak ratio of the evoked compound action potential is within the comfort range (flowchart in figure 9, steps 950 and 970; paragraph 0125 – “If processing circuitry 214 determines that the representative amplitude of the one or more ECAPs is greater than the target ECAP amplitude value plus the adjustment window (“YES” branch of block 940), processing circuitry 214 decreases the amplitude of the informed pulses and the control pulses by respective values (950)”; paragraph 0126 – “If the representative amplitude of the one or more respective ECAP is less than the lower-bound of target ECAP adjustment window (a “YES” branch of block 960), processing circuitry 214 increases the amplitude of the informed pulses and the control pulses by respective values (970)”);
wherein the comfort range includes a dimension of amplitude of the pulse (paragraphs 0125-0126 described the pulse amplitude adjustment to fit a desired ECAP variance) and a dimension of peak-to-peak ratio of the evoked compound action potential (figure 9, block 940 represents the ECAP range, paragraph 0037 – “The target ECAP adjustment window may be a range of amplitudes around the target ECAP amplitude, including an upper-bound and a lower-bound”; paragraph 0125 – “Processing circuitry 214 then determines if the representative amplitude of the one or more respective ECAP is greater than the upper-bound of target ECAP adjustment window (940)”).
Re. claim 2, Dinsmoor further teaches wherein the controller is configured to compare the peak-to-peak ratio of the evoked compound action potential with an upper limit and a lower limit of peak-to-peak ratio of the evoked compound action potential in the comfort range based on a determination that the peak-to-peak ratio of the evoked compound action potential is not within the comfort range (figure 9, block 940 represents the ECAP range to be compared; paragraphs 0125-0126);
the amplitude of the pulse to be generated within the subsequent pulse generation cycle is adjusted downward according to a preset step length based on a determination that the peak-to-peak ratio of the evoked compound action potential is greater than the upper limit of peak-to-peak ratio of the evoked compound action potential in the comfort range (paragraph 0125 – “If processing circuitry 214 determines that the representative amplitude of the one or more ECAPs is greater than the target ECAP amplitude value plus the adjustment window (“YES” branch of block 940), processing circuitry 214 decreases the amplitude of the informed pulses and the control pulses by respective values (950)”; paragraph 0060 – “The control pulses may have pulse widths of less than approximately 300 μs, such as a bi-phasic pulse with each phase having a duration of approximately 100 μs. Since the control pulses may have shorter pulse widths than the informed pulses, the ECAP signal may be sensed and identified following each control pulse and used to inform IMD 110 about any changes that should be made to the informed pulses (and control pulses in some examples)”);
and the amplitude of the pulse to be generated within the subsequent pulse generation cycle is adjusted upward according to the preset step length based on a determination that the peak-to-peak ratio of the evoked compound action potential is less than the lower limit of peak-to-peak ratio of the evoked compound action potential in the comfort range paragraph 0126 – “If the representative amplitude of the one or more respective ECAP is less than the lower-bound of target ECAP adjustment window (a “YES” branch of block 960), processing circuitry 214 increases the amplitude of the informed pulses and the control pulses by respective values (970)”; paragraph 0060 – “The control pulses may have pulse widths of less than approximately 300 μs, such as a bi-phasic pulse with each phase having a duration of approximately 100 μs. Since the control pulses may have shorter pulse widths than the informed pulses, the ECAP signal may be sensed and identified following each control pulse and used to inform IMD 110 about any changes that should be made to the informed pulses (and control pulses in some examples)”).
Re. claim 3, Dinsmoor further teaches wherein the preset step length is determined according to upper and lower limits of the amplitude of the pulse (paragraph 0059 – “The amount of action potentials (e.g., number of neurons propagating action potential signals) that are evoked may be based on the various parameters of electrical stimulation pulses such as amplitude, pulse width, frequency, pulse shape (e.g., slew rate at the beginning and/or end of the pulse), etc”) in the comfort range (figure 9, steps 950 and 970) and a preset scaling factor (paragraph 0060 – “The control pulses may have pulse widths of less than approximately 300 μs, such as a bi-phasic pulse with each phase having a duration of approximately 100 μs. Since the control pulses may have shorter pulse widths than the informed pulses, the ECAP signal may be sensed and identified following each control pulse and used to inform IMD 110 about any changes that should be made to the informed pulses (and control pulses in some examples)”).
Re. claim 6, Dinsmoor further teaches wherein the controller is further configured to obtain different comfort ranges according to different body postures or different pulse frequencies (paragraph 0090 – “In one example, sensor 216 may detect a change in activity or a change in posture of the patient. Processing circuitry 214 may receive an indication from sensor 216 that the activity level or posture of the patient is changed, and processing circuitry 214 may be configured to initiate or change the delivery of the plurality of control pulses according to the ECAP test stimulation programs 218. For example, processing circuitry 214 may increase the frequency of control pulse delivery and respective ECAP sensing in response to receiving an indication that the patient activity has increased, which may indicate that the distance between electrodes and nerves will likely change”), OR to obtain, according to different body postures or different pulse frequencies, the upper and lower limits of the amplitude of the pulse and the upper and lower limits of the peak-to-peak ratio of the evoked compound action potential corresponding to the body posture or the frequency of the pulse in the comfort range.
Re. claim 7, Dinsmoor further teaches a body posture sensor (paragraph 0090 – “In one example, sensor 216 may detect a change in activity or a change in posture of the patient”);
wherein the body posture sensor is communicatively connected with the controller to sense a body posture (figure 2A, sensor 216 connected to the processing circuitry 214 and memory 215; paragraph 0090 – “In one example, sensor 216 may detect a change in activity or a change in posture of the patient”);
and the controller is further configured to obtain the body posture through the body posture sensor to obtain the comfort range corresponding to the body posture (paragraph 0061 – “For example, to measure a physiological effect of a compound action potential, the one or more sensors may be an accelerometer, a pressure sensor, a bending sensor, a sensor configured to detect a posture of patient 105…”), OR to obtain the body posture through the body posture sensor to obtain the upper and lower limits of the amplitude of the pulse and the upper and lower limits of the peak-to-peak ratio of the evoked compound action potential corresponding to the body posture in the comfort range.
Re. claim 8, Dinsmoor further teaches wherein the controller is further configured to:
store potential values and associated information of the evoked compound action potential obtained by sampling after instructing the ECAP sensor to sense the evoked compound action potential, wherein the associated information includes index information for indicating a sampling sequence (figure 2A, memory 215 containing ECAP characteristics 222; paragraph 0124 – “As illustrated in FIG. 9, processing circuitry 214 of IMD 200 may determine a target ECAP amplitude (910). The target ECAP amplitude may be indicated in patient ECAP characteristics 222 stored in IMD 200”; paragraph 0064 – “The maximum target ECAP characteristic value, the minimum target ECAP characteristic value, and the predetermined frequency may be stored in the memory of IMD 110”);
and obtain a potential value of a second peak P2 and a potential value of a third peak P3 according to the potential values and the associated information of the evoked compound action potential (figure 3 shows peaks P1 and P2, N1; paragraph 0140 – “In the example of FIG. 11, processing circuitry 214 determines the target ECAP amplitude (1102). The target ECAP amplitude may be determined based on sample stimulation initially delivered to the patient”).
Re. claim 12, Dinsmoor further teaches wherein the controller is further configured to obtain the potential value of the third peak and the potential value of the second peak according to the potential values of the evoked compound action potential obtained in real time after instructing the ECAP sensor to sense the evoked compound action potential (paragraphs 0100-0101 details second and third peaks P1-P2 of ECAP signal 394; paragraph 0066 – “Memory 215 also stores target ECAP feedback rules 221 and patient ECAP characteristics 222”; figure 3).
Re. claim 16, Dinsmoor further teaches wherein the controller is further configured to obtain a peak-to-peak value of ECAP (figure 3, ECAP peaks 396; figure 9, step 930 which measures peak ECAP values against a target adjustment window, or comfort range),
and to adjust, based on a determination that the peak-to-peak value of ECAP is not within the comfort range, the amplitude of the pulse to be generated within the subsequent pulse generation cycle iteratively until the peak-to-peak value of ECAP is within the comfort range (paragraph 0035 – “If the amplitude of the ECAP signal (e.g. a voltage amplitude of one or more peaks in the ECAP signal) is greater than a target ECAP amplitude, then the intensity of the control pulses may be too high because the stimulation electrodes have moved closer to the nerves. The medical device may responsively reduce the intensity (e.g., current amplitude, pulse width, pulse frequency, slew rate, or any combination thereof) of the informed pulses. Conversely, if the amplitude of the ECAP signal is less than the target ECAP amplitude, then the intensity of the control pulses may not be strong enough because the stimulation electrodes have moved farther from the nerves”; figure 9, step 940-970);
wherein the comfort range further includes a dimension of peak-to-peak value of ECAP (adjustment window defined by upper and lower bounds, or peaks, of the ECAP signal, paragraph 0037 – “The target ECAP adjustment window may be a range of amplitudes around the target ECAP amplitude, including an upper-bound and a lower-bound. In some examples, the target ECAP adjustment window may be defined by the target ECAP characteristic plus and minus a variance so that adjustments are not made to the one or more parameters of the informed pulses for minor oscillations in the ECAP signal”).
Re. claim 17, Dinsmoor further teaches wherein the nerve stimulation apparatus is applied to spinal cord electrical stimulation or dorsal root ganglion electrical stimulation (paragraph 0041 – “In the example shown in FIG. 1, IMD 110 is configured to deliver spinal cord stimulation (SCS) therapy according to the techniques of the disclosure”; paragraph 0111 – “In one example, the electrodes of third channel 430 may be located on the opposite side of the lead as the electrodes of first channel 410. ECAPs 436 may be sensed at electrodes 232, 234 from the spinal cord of the patient in response to control pulses 412”).
Re. claim 19, Dinsmoor teaches a nerve stimulation system, comprising:
the nerve stimulation apparatus according to claim 1 (see claim 1 rejection above),
and an electrode lead electrically connected with the nerve stimulation apparatus (figure 1, leads 130A-130B).
Re. claim 20, Dinsmoor teaches control method applied at a nerve stimulation apparatus, wherein the nerve stimulation apparatus includes
a controller (figure 2A, IMD 200, including the processing circuitry 214 memory 215),
a pulse generator (figure 2A, stimulation generator 211),
and an ECAP sensor (figure 2A, sensing circuitry 212; paragraph 0082 – “In one example, an ECAP elicited from to a control pulse delivered during a time event may be recorded by sensing circuitry 212…”),
the control method includes:
the controller instructing the ECAP sensor to sense an evoked compound action potential after a pulse generator generating a pulse within a current pulse generation cycle (paragraph 0124 – “Processing circuitry 920 then delivers an informed pulse and a control pulse and senses the resulting ECAP elicited by the control pulse (920)”; figure 9, step 920);
obtaining a peak-to-peak ratio of the evoked compound action potential (paragraph 0101 – “When detecting the ECAP of ECAP signal 394, different characteristics may be identified…In other examples, the characteristic of the ECAP may be a ratio of one of peaks P1, N1, or P2 to another one of the peaks”),
and adjusting, based on a determination that the peak-to-peak ratio of the evoked compound action potential is not within a comfort range, the amplitude of the pulse to be generated within a subsequent pulse generation cycle iteratively until the peak-to-peak ratio of the evoked compound action potential is within the comfort range (flowchart in figure 9, steps 950 and 970; paragraph 0125 – “If processing circuitry 214 determines that the representative amplitude of the one or more ECAPs is greater than the target ECAP amplitude value plus the adjustment window (“YES” branch of block 940), processing circuitry 214 decreases the amplitude of the informed pulses and the control pulses by respective values (950)”; paragraph 0126 – “If the representative amplitude of the one or more respective ECAP is less than the lower-bound of target ECAP adjustment window (a “YES” branch of block 960), processing circuitry 214 increases the amplitude of the informed pulses and the control pulses by respective values (970)”);
wherein the comfort range includes a dimension of amplitude of the pulse (paragraphs 0125-0126 described the pulse amplitude adjustment to fit a desired ECAP variance) and a dimension of peak-to-peak ratio of the evoked compound action potential (figure 9, block 940 represents the ECAP range, paragraph 0037 – “The target ECAP adjustment window may be a range of amplitudes around the target ECAP amplitude, including an upper-bound and a lower-bound”; paragraph 0125 – “Processing circuitry 214 then determines if the representative amplitude of the one or more respective ECAP is greater than the upper-bound of target ECAP adjustment window (940)”).
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.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor (US 20190388692 A1 – hereinafter Dinsmoor) in view of Hou (US 20160158550 A1 – hereinafter Hou).
Re. claim 18, Dinsmoor teaches the controller configured to instruct the ECAP sensor to sense the evoked compound action potential when instructing the pulse generator to generate a pulse (paragraph 0077 – “Stimulation generator 211 may receive, via telemetry circuitry 213, user instructions to deliver control stimulation to the patient according to ECAP test stimulation programs 218. Each pulse of a plurality of control pulses may elicit an ECAP that is sensed by sensing circuitry 212 via some of electrodes 232 and 234”),
to obtain the peak-to-peak ratio of the evoked compound action potential (paragraph 0101 – “When detecting the ECAP of ECAP signal 394, different characteristics may be identified… In other examples, the characteristic of the ECAP may be a ratio of one of peaks P1, N1, or P2 to another one of the peaks”),
and determine whether the peak-to-peak ratio of the evoked compound action potential is within the comfort range (paragraph 0101 – “When detecting the ECAP of ECAP signal 394, different characteristics may be identified… In other examples, the characteristic of the ECAP may be a ratio of one of peaks P1, N1, or P2 to another one of the peaks”; paragraph 0037 – “The medical device may then compare the representative amplitude to a target ECAP characteristic (e.g., a target ECAP amplitude or other characteristics such as frequency content, area under one or more peaks, or the timing of one or more peaks) and a target ECAP adjustment window”).
Dinsmoor does not teach wherein a pulse generation mode of the nerve stimulation apparatus is a tonic bursting mode as well as generating a last pulse in a cluster of pulses.
Hou teaches a similar nerve stimulation system (abstract – “A system and method for delivering coupled burst and tonic stimulation of nervous tissue is provided”), and further teaches the known technique of delivering tonic bursting mode stimulation and subsequently sensing resultant ECAPs (paragraph 0084 – “A tonic burst waveform is delivered in the first 0.8 ms, such as from a conventional SCS electrode into the dorsal column. The sensed ECAP signals are sensed between 0.8 ms to 3.0 ms”) and generate a last pulse in a cluster of pulses (figure 6 shows the cluster of tonic burst waveforms; paragraph 0085 – “FIG. 6 illustrates examples of coupled tonic/burst therapies implemented in accordance with embodiments herein. The coupled tonic/burst therapy 602 includes a tonic stimulation waveform 604 and a burst stimulation waveform 606”).
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 system of Dinsmoor, specifically the pulse generation mode of Dinsmoor, to incorporate the tonic burst stimulation mode as taught by Hou, since such modification would predictably result in increasing neural activity and improved neural signaling.
Allowable Subject Matter
No prior art could be found to anticipate and/or render obvious to claims 4-5, 9-11 and 13-15; therefore, claims 4-5, 9-11 and 13-15 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. Claims 4-5, 9-11 and 13-15 however remain rejected under 35 USC § 101 as stated above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796