DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, filed April 6, 2026, with respect to the rejection(s) of claim(s) 1, 4, 9, and 13-20 under 35 U.S.C. 102(a)(1) and claims 2-3, 5-8, and 10-12 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of applicant’s amendments as can be further seen below.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-20 are rejected under 35 U.S.C. 101 due to the claims being directed to a mental process without significantly more.
Claims 1-20 are directed to a method, a system, and a non-transitory, computer readable medium for operating a stimulator device, which comprises providing stimulation to the patient via one or more electrode nodes, sensing the response via one or more second electrode nodes, determining a baseline voltage from the sensed response, and determining at least one feature of the response using the baseline voltage and the sensed response to identify at least one feature is indicative of an AC characteristic of the response, which could be performed by the human mind and/or by a human with a physical aid as with pen and paper. To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.05. The instant claims are evaluated according to such analysis.
Step 1:
Claims 1, 19, and 20 recite a method, a system, and a computer readable medium for operating a device, which comprises:
providing stimulation to the patient via one or more electrode nodes, sensing the response via one or more second electrode nodes, determining a baseline voltage from the sensed response, and determining at least one feature of the response using the baseline voltage and the sensed response to identify at least one feature is indicative of an AC characteristic of the response, and thus meet the requirements for step 1.
Step 2A (Prong 1):
Claims 1, 19, and 20 recite the steps of:
Providing stimulation to the patient’s tissue via one or more electrode nodes.
Sensing a response to the stimulation via one or more second electrode nodes.
Determining a singular baseline voltage from the sensed response.
Determining at least one feature of the response using the baseline voltage and the sensed response to identify at least one feature indicative of an AC characteristic of the response.
The steps above, under broadest reasonable interpretation, can be performed by mental process steps because they can be practically performed in the human mind (i.e. using a pen and paper). For instance, a baseline voltage can be determined from the sensed response, and following the determination, at least one feature can be identified to indicate the AC characteristic of the response as a result of the applied stimulation.
Step 2A, Prong 2:
Claims 1, 19, and 20 include the additional elements of:
A stimulator device comprising a plurality of electrode nodes, wherein the electrode nodes are associated with a different electrode configured to contact the patient’s tissue. This is generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP 2106.04 (d).
Stimulation circuitry comprising electrode nodes configured to provide stimulation to the patient’s tissue. This is generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP 2106.04 (d).
Sense amplifier circuitry and one or more second electrode nodes to sense the stimulation response from the patient’s tissue. This is generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP 2106.04 (d).
A non-transitory, computer readable medium comprising instructions executable in the stimulator device. This is generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP 2106.04 (d).
Linking the use of a judicial exception to another technological environment or field of use; generic computer implementation; and insignificant extra-solution activity do not provide integration into a practical application.
Step 2B:
Claims 1, 19, and 20 include the additional elements of:
A stimulator device comprising a plurality of electrode nodes, wherein the electrode nodes are associated with a different electrode configured to contact the patient’s tissue. This is generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP 2106.04 (d).
Stimulation circuitry comprising electrode nodes configured to provide stimulation to the patient’s tissue. This is generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP 2106.04 (d).
Sense amplifier circuitry and one or more second electrode nodes to sense the stimulation response from the patient’s tissue. This is generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP 2106.04 (d).
A non-transitory, computer readable medium comprising instructions executable in the stimulator device. This is generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP 2106.04 (d).
These additional elements in claims 1, 19, and 20 identified by the courts, either alone or in combination, have been found not to be enough to qualify as “significantly more” than the abstract idea itself when recited in a claim with a judicial exception.
Dependent Claims:
Claims 2-18 further define the mental process and abstract idea, therefore failing to amount to “significantly more” than the abstract ideas either alone or in combination as previously stated for the independent claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4, 9, and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0184399 A1 to Zhang et al. (hereinafter “Zhang”) in view of US 2022/0040485 A1 to Li et al. (hereinafter “Li”).
Regarding claim 1, Zhang teaches:
A method for operating a stimulator device comprising a plurality of electrode nodes (See abstract, lines 1-3, para 0008,0009-0010-specifically the discussion of the electrode nodes 39, and fig. 6, e1-e3),
wherein each of the electrode nodes is associated with a different electrode configured to contact a patient’s tissue (see fig. 6, para 0008 – “IPG 10 as mentioned includes stimulation circuitry 28 to form prescribed stimulation at a patient's tissue.”, and para 0047- “ The IPG 100 also includes stimulation circuitry 28 to produce stimulation at the electrodes 16, which may comprise the stimulation circuitry 28 shown earlier (FIG. 3). …..As noted earlier, but not shown in FIG. 6, a switch matrices could intervene between the PDACs and the electrode nodes 39, and between the NDACs and the electrode nodes, to route their outputs to one or more of the electrodes, including the conductive case electrode 12 (Ec). Control signals for switch matrices, if present, may also be carried by bus 118. Notice that the current paths to the electrodes 16 include the DC-blocking capacitors 38 described earlier, which provide safety by preventing the inadvertent supply of DC current to an electrode and to a patient's tissue.”),
the method comprising:
providing stimulation to the patient’s tissue via one or more first of the electrode nodes (see para 0008- “IPG 10 as mentioned includes stimulation circuitry 28 to form prescribed stimulation at a patient's tissue.”, para 0047- “The IPG 100 also includes stimulation circuitry 28 to produce stimulation at the electrodes 16, which may comprise the stimulation circuitry 28 shown earlier (FIG. 3). …..As noted earlier, but not shown in FIG. 6, a switch matrices could intervene between the PDACs and the electrode nodes 39, and between the NDACs and the electrode nodes, to route their outputs to one or more of the electrodes, including the conductive case electrode 12 (Ec). Control signals for switch matrices, if present, may also be carried by bus 118. Notice that the current paths to the electrodes 16 include the DC-blocking capacitors 38 described earlier, which provide safety by preventing the inadvertent supply of DC current to an electrode and to a patient's tissue.”);
sensing a response to the stimulation at one or more second of the electrode nodes (see para 0048 - “IPG 100 also includes sensing circuitry 115, and one or more of the electrodes 16 can be used to sense neural responses such as the ECAPs described earlier. In this regard, each electrode node 39 is further coupleable to a sense amp circuit 110. Under control by bus 114, a multiplexer 108 can select one or more electrodes to operate as sensing electrodes by coupling the electrode(s) to the sense amps circuit 110 at a given time, as explained further below.”), but does not explicitly disclose:
determining a singular baseline voltage from the sensed response;
and
determining at least one feature of the response using the baseline voltage and the sensed response, wherein the at least one feature is indicative of an AC characteristic of the response.
However, Li, who is in the same field of endeavor, teaches systems, devices, and methods for using ECAP signal to monitor lead position and/or lead migration (see abstract). The system (figs. 7A-7C) teaches determining a singular baseline voltage from the sensed response, and determining at least one feature of the response using the baseline voltage and the sensed response, wherein the at least one feature is indicative of an AC characteristic of the response (see figs. 7A-7C and para [0076]).
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 teachings of Zhang with the baseline and feature detection system of Li to arrive at the claimed invention. Such modification would improve the system by improving treatment efficiency for patients, ultimately providing more effective and personalized stimulation therapy for each patient.
Regarding Claim 4, Zhang as modified teaches:
The method of claim 1, further comprising determining one or more peaks in the response (See para 0045: “An ECAP comprises a cumulative response provided by neural fibers that are recruited by the stimulation, and essentially comprises the sum of the action potentials of recruited fibers when they “fire.” An ECAP is shown in FIG. 6, and comprises a number of peaks that are conventionally labeled with P for positive peaks and N for negative peaks, with P1 comprising a first positive peak, N1 a first negative peak, P2 a second positive peak and so on.”),
wherein the baseline voltage is determined relative to a voltage value of at least one of the peaks (see para [0076]).
Regarding claim 9, Zhang as modified teaches:
The method of claim 1, further comprising determining one or more segments in the response (any portion of the curve in the ECAP), wherein the baseline voltage is determined using at least one of the segments (segments = any portion of the curve of the ECAP. See fig. 6, para 0035, para 0038, para 0049-0057, and para 0070-0071).
Regarding claim 13, Zhang as modified teaches:
The method of claim 1, wherein the response comprises a stimulation artifact which results from an electromagnetic field/electric field that forms in the tissue as a result of the stimulation (see para 0069-“Choosing sensing electrodes Si at a sensibly far distance from the stimulating electrodes is desired to make sure that stimulation artifacts (i.e., the electric field produced in the tissue due to the stimulation) are not too large at the sensing electrodes, which artifacts might otherwise mask the small-signal ECAP signals. However, the sensing electrodes should also be suitably close to the stimulating electrodes such that the ECAP, which has an amplitude that attenuates with distance, is still large enough to be reliably sensed.”).
Regarding claim 14, Zhang as modified teaches:
The method of claim 1, wherein the response comprises a neural response evoked in the tissue in response to the stimulation (see abstract, lines 1-3 and para 0069: “ In a preferred example of the technique, one or more sensing electrodes are selected (e.g., by multiplexer 108, FIG. 6) to sense an ECAP in response to the prescribed stimulation. Three such sensing electrodes—S1, S2, and S3—are illustrated in FIGS. 7A and 7B. The sensing electrodes Si may be selected by the user (e.g., using GUI 82 of an external device), or may be selected by the ECAP algorithm 124 or the therapy adjustment algorithm 160 in the IPG”).
Regarding claim 15, Zhang as modified teaches:
The method of claim 1, wherein the stimulation is provided in a sequence of pulses (see para 0006, first sentence: “ Stimulation in IPG 10 is typically provided by a sequence of waveforms (e.g., pulses) each of which may include a number of phases such as 30a and 30b, as shown in the example of FIG. 2A.”).
Regarding claim 16, Zhang as modified teaches:
The method of claim 15, wherein a response to the stimulation is sensed for each pulse (see abstract, and para 0048- “IPG 100 also includes sensing circuitry 115, and one or more of the electrodes 16 can be used to sense neural responses such as the ECAPs described earlier. In this regard, each electrode node 39 is further coupleable to a sense amp circuit 110. Under control by bus 114, a multiplexer 108 can select one or more electrodes to operate as sensing electrodes by coupling the electrode(s) to the sense amps circuit 110 at a given time, as explained further below.”, para 0049- discusses receiving and analyzing digitized ECAPs following stimulation), para 0050-0061 -- determining one or more ECAP features following stimulation, and para 0062 – adjusting the stimulation the IPG provides following the collection of the ECAP features),
wherein a unique baseline voltage is determined for each of the responses (para 0070-0071 – the unique baseline voltage is determined from the features of the sensed ECAP response following stimulation),
and wherein the at least one feature of each response is determined using its baseline voltage (para 0049-0062 and para 0070-0071).
Regarding claim 17, Zhang as modified teaches:
The method of claim 15, wherein a response to the stimulation is sensed for each pulse (see abstract, and para 0048- “IPG 100 also includes sensing circuitry 115, and one or more of the electrodes 16 can be used to sense neural responses such as the ECAPs described earlier. In this regard, each electrode node 39 is further coupleable to a sense amp circuit 110. Under control by bus 114, a multiplexer 108 can select one or more electrodes to operate as sensing electrodes by coupling the electrode(s) to the sense amps circuit 110 at a given time, as explained further below.”, para 0049- discusses receiving and analyzing digitized ECAPs following stimulation), para 0050-0061 -- determining one or more ECAP features following stimulation, and para 0062 – adjusting the stimulation the IPG provides following the collection of the ECAP features),
wherein the baseline voltage is determined for a plurality of the responses, and wherein the at least one feature of the plurality of responses is determined using the baseline voltage (See Li - para [0076]).
Regarding claim 18, Zhang as modified teaches:
The method of claim 1, further comprising digitizing the sensed response (see para 0048, first sentence and last two sentences), wherein the baseline voltage is determined using the digitized sensed response (See Li – para [0048] and para [0076]).
Regarding claim 19, Zhang teaches:
A stimulator device (See abstract: “Systems and methods for providing stimulation and neural response sensing in an implantable stimulation device are disclosed.”),
comprising:
a plurality of electrode nodes (See abstract, lines 1-3, para 0008,0009-0010-specifically the discussion of the electrode nodes 39, and fig. 6, e1-e3),
wherein each of the electrode nodes is associated with a different electrode configured to contact a patient’s tissue (see fig. 6, para 0008 – “IPG 10 as mentioned includes stimulation circuitry 28 to form prescribed stimulation at a patient's tissue.”, and para 0047- “ The IPG 100 also includes stimulation circuitry 28 to produce stimulation at the electrodes 16, which may comprise the stimulation circuitry 28 shown earlier (FIG. 3). …..As noted earlier, but not shown in FIG. 6, a switch matrices could intervene between the PDACs and the electrode nodes 39, and between the NDACs and the electrode nodes, to route their outputs to one or more of the electrodes, including the conductive case electrode 12 (Ec). Control signals for switch matrices, if present, may also be carried by bus 118. Notice that the current paths to the electrodes 16 include the DC-blocking capacitors 38 described earlier, which provide safety by preventing the inadvertent supply of DC current to an electrode and to a patient's tissue.”);
stimulation circuitry configured to provide stimulation to the patient’s tissue via one or more first of the electrode nodes (para 0006 – “Stimulation in IPG 10 is typically provided by a sequence of waveforms (e.g., pulses) each of which may include a number of phases such as 30a and 30b, as shown in the example of FIG. 2A…..These and possibly other stimulation parameters taken together comprise a stimulation program that the stimulation circuitry 28 in the IPG 10 can execute to provide therapeutic stimulation to a patient.” , and para 0008: “IPG 10 as mentioned includes stimulation circuitry 28 to form prescribed stimulation at a patient's tissue. FIG. 3 shows an example of stimulation circuitry 28, which includes one or more current sources 40.sub.i and one or more current sinks 41.sub.i…….In the example shown, a NDAC/PDAC 40.sub.i/42.sub.i pair is dedicated (hardwired) to a particular electrode node ei 39. Each electrode node ei 39 is connected to an electrode Ei 16 via a DC-blocking capacitor Ci 38, for the reasons explained below. PDACs 40.sub.i and NDACs 42.sub.i can also comprise voltage sources.”);
sense amplifier circuitry configured to sense a response to the stimulation at one or more second of the electrode nodes (para 0048: “IPG 100 also includes sensing circuitry 115, and one or more of the electrodes 16 can be used to sense neural responses such as the ECAPs described earlier. In this regard, each electrode node 39 is further coupleable to a sense amp circuit 110. Under control by bus 114, a multiplexer 108 can select one or more electrodes to operate as sensing electrodes by coupling the electrode(s) to the sense amps circuit 110 at a given time, as explained further below.”), and control circuitry (see para [0047]), but does not explicitly disclose wherein the control circuitry is configured to:
determine a singular baseline voltage from the sensed response, and determine at least one feature of the response using the baseline voltage and the sensed response, wherein the at least one feature is indicative of an AC characteristic of the response.
However, Li, who is in the same field of endeavor, teaches systems, devices, and methods for using ECAP signal to monitor lead position and/or lead migration (see abstract). The system (figs. 7A-7C) teaches determining a singular baseline voltage from the sensed response, and determining at least one feature of the response using the baseline voltage and the sensed response, wherein the at least one feature is indicative of an AC characteristic of the response (see figs. 7A-7C and para [0076]).
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 teachings of Zhang with the baseline and feature detection system of Li to arrive at the claimed invention. Such modification would improve the system by improving treatment efficiency for patients, ultimately providing more effective and personalized stimulation therapy for each patient.
Regarding claim 20, Zhang teaches:
A non-transitory computer readable medium comprising instructions executable in a stimulator device comprising a plurality of electrode nodes (see fig. 6 below, 39 (e1-e3), para 0047-0049), wherein each of the electrode nodes is associated with a different electrode configured to contact a patient’s tissue (see fig. 6, para 0008 – “IPG 10 as mentioned includes stimulation circuitry 28 to form prescribed stimulation at a patient's tissue.”, and para 0047- “ The IPG 100 also includes stimulation circuitry 28 to produce stimulation at the electrodes 16, which may comprise the stimulation circuitry 28 shown earlier (FIG. 3). …..As noted earlier, but not shown in FIG. 6, a switch matrices could intervene between the PDACs and the electrode nodes 39, and between the NDACs and the electrode nodes, to route their outputs to one or more of the electrodes, including the conductive case electrode 12 (Ec). Control signals for switch matrices, if present, may also be carried by bus 118. Notice that the current paths to the electrodes 16 include the DC-blocking capacitors 38 described earlier, which provide safety by preventing the inadvertent supply of DC current to an electrode and to a patient's tissue.”),
wherein the stimulator device is configured to provide stimulation to the patient’s tissue via one or more first of the electrode nodes (see para 0008 - “IPG 10 as mentioned includes stimulation circuitry 28 to form prescribed stimulation at a patient's tissue.”, para 0047- “The IPG 100 also includes stimulation circuitry 28 to produce stimulation at the electrodes 16, which may comprise the stimulation circuitry 28 shown earlier (FIG. 3). …..As noted earlier, but not shown in FIG. 6, a switch matrices could intervene between the PDACs and the electrode nodes 39, and between the NDACs and the electrode nodes, to route their outputs to one or more of the electrodes, including the conductive case electrode 12 (Ec). Control signals for switch matrices, if present, may also be carried by bus 118. Notice that the current paths to the electrodes 16 include the DC-blocking capacitors 38 described earlier, which provide safety by preventing the inadvertent supply of DC current to an electrode and to a patient's tissue.”), but does not disclose wherein
the instructions when executed are configured to cause the stimulator device to:
sense a response to the stimulation at one or more second of the electrode nodes; determine a singular baseline voltage from the sensed response;
and
determine at least one feature of the response using the baseline voltage and the sensed response, wherein the at least one feature is indicative of an AC characteristic of the response.
However, Li, who is in the same field of endeavor, teaches systems, devices, and methods for using ECAP signal to monitor lead position and/or lead migration (see abstract). The system (figs. 7A-7C) teaches wherein the instructions when executed are configured to cause the stimulator device to:
determining a singular baseline voltage from the sensed response, and determining at least one feature of the response using the baseline voltage and the sensed response, wherein the at least one feature is indicative of an AC characteristic of the response (see figs. 7A-7C, para [0006], and para [0076]).
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 teachings of Zhang with the baseline and feature detection system of Li to arrive at the claimed invention. Such modification would improve the system by improving treatment efficiency for patients, ultimately providing more effective and personalized stimulation therapy for each patient.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Li, and further in view of US 2017/0296823 A1 to Hershey et al. (hereinafter “Hershey”).
Regarding claim 2, Zhang as modified teaches:
The method of claim 1, wherein the baseline is determined by assessing the entire waveform of the response in addition to one or more ECAP features (para 0070-0071), but does not disclose wherein the baseline is determined by assessing a shape of the response.
However, Hershey teaches wherein the baseline is determined by assessing a shape of the response (see para 0055 - “Once an original stimulation program is chosen, the ECAP algorithm 124 can choose one or more electrodes to act as a sense electrode (S) (step 142), as described above. Stimulation can then be provided using the original stimulation program (step 144), and one or more ECAP measured (step 146) at the sense electrode(s). As noted above, a plurality of ECAPs can be measured. For the ECAP(s), at least one ECAP shape parameter (e.g., H, FWHM) can be determined (step 148), and if necessary averaged from the plurality of ECAP(s). The ECAP algorithm 124 can then assess the shape parameter(s) to determine a degree of synchronicity of the firing of the recruited neurons (step 150), which may involve comparison of the parameters to one or more thresholds as described earlier.”).
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 modified teachings of Zhang with the teachings Hershey to arrive at the claimed invention. Such modification would improve the system by providing more accurate and precise stimulation therapy that is personalized to each patient.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Li, and further in view of US 2016/0213274 A1 to Cao et al. (hereinafter “Cao”).
Regarding claim 3, Zhang as modified teaches:
The method of claim 1, but does not explicitly disclose wherein the baseline voltage is determined as a first or last voltage value in the response.
However, Cao teaches a method for identifying a cardiac waveform that includes sensing cardiac signals (abstract). The system (fig. 1) teaches wherein the baseline voltage is determined as a first or last voltage value point in the response value of the P-wave (see abstract, annotated fig. 6B below, para 0058, and claim 3).
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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 modified system of Zhang with the teachings of Cao to arrive at the claimed invention. Such modification would improve the system by accurately adjusting the stimulation in order to provide more precise and personalized stimulation therapy to more effectively treat each patient.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view Li, and further in view of US 2018/0126169A1 to Hou et al. (hereinafter “Hou”).
Regarding claim 5, Zhang as modified teaches:
The method of claim 4, wherein the method further comprises determining peaks in the response (see fig. 6, N1 and P2), wherein the baseline voltage is determined relative to the voltage value of the peaks (see fig. 6, para 0049-0062 (emphasis on para 0052) and para 0070-0071), but does not explicitly disclose wherein the method further comprises determining either or both of a maximum peak or minimum peak in the response, wherein the baseline voltage is determined relative to the voltage value of either or both of the maximum peak and the minimum peak.
However, Hou teaches modifying a stimulation threshold/baseline voltage relative to the voltage value of either or both of the maximum peak and[/or] minimum peak (see para 0076– “At 910, the method 900 determines a time delay between the onset of SCS (e.g., a stimulation spike 1314) and above one or more fiducial points 1312 for each of the ECAP waveforms 1104-1112. FIG. 13 is a graphical representation 1300 of electrical potential measurements of the nerve tissue of interest at a lead electrode (e.g., one of the lead electrodes 311a-h) for an ECAP waveform 1310 representing one of the ECAP waveforms 1104-1112……. The ECAP waveform 1310 includes a stimulation spike 1314 corresponding to the onset of the SCS and a minimum peak of the ECAP waveform 1310. The minimum peak may be assigned by the controller as the fiducial point 1312 for determining the time delay. It should be noted that in other embodiments more than one fiducial point may be assigned based on a maximum peak, maximum or minimum slope, a morphology point of interest of the ECAP waveform 1310, or the like.” And para 0077 – “Next at 912, a stimulation threshold is defined based on a stimulation amplitude and at least one of an amplitude, the slope (ascending or descending), a maximum, a minimum, or time delay between the onset of the SCS and above one or more fiducial point of the ECAP waveforms.”).
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 modified system of Zhang with the teachings of Hou to arrive at the claimed invention. Such modification would improve the system by accurately adjusting the stimulation in order to provide more precise and personalized stimulation therapy to more effectively treat each patient.
Regarding claim 6, Zhang as modified teaches:
The method of claim 5, wherein the baseline voltage is determined between the voltage value of one or more peaks (See Li - para [0076]), but does not explicitly disclose wherein the baseline voltage is determined between the voltage value of the maximum peak and the voltage value of the minimum peak.
However, Hou teaches modifying a stimulation threshold/baseline voltage relative to the voltage value of either or both of the maximum peak and[/or] minimum peak (see para 0076 – “At 910, the method 900 determines a time delay between the onset of SCS (e.g., a stimulation spike 1314) and above one or more fiducial points 1312 for each of the ECAP waveforms 1104-1112. FIG. 13 is a graphical representation 1300 of electrical potential measurements of the nerve tissue of interest at a lead electrode (e.g., one of the lead electrodes 311a-h) for an ECAP waveform 1310 representing one of the ECAP waveforms 1104-1112……. The ECAP waveform 1310 includes a stimulation spike 1314 corresponding to the onset of the SCS and a minimum peak of the ECAP waveform 1310. The minimum peak may be assigned by the controller as the fiducial point 1312 for determining the time delay. It should be noted that in other embodiments more than one fiducial point may be assigned based on a maximum peak, maximum or minimum slope, a morphology point of interest of the ECAP waveform 1310, or the like.” And para 0077 – “Next at 912, a stimulation threshold is defined based on a stimulation amplitude and at least one of an amplitude, the slope (ascending or descending), a maximum, a minimum, or time delay between the onset of the SCS and above one or more fiducial point of the ECAP waveforms.”).
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 modified system of Zhang with the teachings of Hou to arrive at the claimed invention. Such modification would improve the system by accurately adjusting the stimulation in order to provide more precise and personalized stimulation therapy to more effectively treat each patient.
Regarding claim 7, Zhang as modified teaches:
The method of claim 1, but does not disclose further comprising determining a slope of the response, wherein the baseline voltage/stimulation threshold is determined relative to a voltage value corresponding to a maximum slope in the response.
However, Hou teaches systems and methods for determining a stimulation threshold for a closed loop stimulation system (abstract). The system (fig. 1) comprises determining a slope of the response (see para 0007, last two sentences: “The method includes measuring evoked compound action potential (ECAP) waveforms resulting from the plurality of stimulation waveforms. Further, the method includes defining a stimulation threshold based on at least one of an amplitude, a maximum, a minimum, a slope (ascending or descending), and time delay between onset of SCS and above fiducial points of the ECAP waveforms.” , and para 0076: “ At 910, the method 900 determines a time delay between the onset of SCS (e.g., a stimulation spike 1314) and above one or more fiducial points 1312 for each of the ECAP waveforms 1104-1112….. The ECAP waveform 1310 includes a stimulation spike 1314 corresponding to the onset of the SCS and a minimum peak of the ECAP waveform 1310. The minimum peak may be assigned by the controller as the fiducial point 1312 for determining the time delay. It should be noted that in other embodiments more than one fiducial point may be assigned based on a maximum peak, maximum or minimum slope, a morphology point of interest of the ECAP waveform 1310, or the like. The controller 151 may calculate the time delay 1306 between the stimulation spike 1314 and the fiducial point 1312 (e.g., the minimum peak) of the ECAP waveform 1310.”, and para 0077: “Next at 912, a stimulation threshold is defined based on a stimulation amplitude and at least one of an amplitude, the slope (ascending or descending), a maximum, a minimum, or time delay between the onset of the SCS and above one or more fiducial point of the ECAP waveforms.”), wherein the baseline voltage/stimulation threshold is determined relative to a voltage value corresponding to a maximum slope in the response (see para 0007, last two sentences above, claims 8-13 and para 0069-0071- discussion focusing on utilizing the ECAP waveforms to determine a stimulation threshold based on a maximum, a minimum, or a slope (ascending or descending), and para 0074-0078- determining slopes for multiple ECAP waveforms).
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 modified system of Zhang with the teachings of Hou to arrive at the claimed invention. Such modification would improve the system by providing more precise and accurate therapy by tuning (in real-time) the baseline voltage as needed to provide more personalized stimulation therapy in order to properly treat each patient.
Claims 8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Li, and further in view of US 2022/0218996 A1 to Dinsmoor et al. (hereinafter “Dinsmoor”).
Regarding claim 8, Zhang as modified teaches:
The method of claim 1, wherein the baseline is determined from the sensed ECAP response,
and determining at least one feature of the response using the baseline voltage, wherein the at least one feature is indicative of an AC characteristic of the response (See Li – figs. 7A-7C and para [0076]), but does not explicitly disclose wherein the method further comprises determining a curvature/amplitude (or peak) of the response, wherein the baseline voltage is determined relative to a voltage value corresponding to a maximum curvature/amplitude (or peak) in the response.
However, Dinsmoor teaches determining a curvature/amplitude (or peak) of the response (para 0059 – “In this disclosure, efficacy of electrical stimulation therapy may be indicated by one or more characteristics (e.g. an amplitude of or between one or more peaks or an area under the curve of one or more peaks) of an action potential that is evoked by a control pulse delivered by IMD 110 (i.e., a characteristic value of the ECAP signal). ”), wherein the baseline voltage (such as the baseline target ECAP characteristic value/target ECAP characteristic value) is determined relative to a voltage value corresponding to a maximum curvature/amplitude (or peak) in the response (see para 0059-identifying the one or more peaks (or characteristics) of the ECAP signal, para 0075- adjusting baseline target ECAP characteristic/ target ECAP characteristic value based on a maximum ECAP characteristic value, and para 0122-0123).
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 modified system of Zhang with the teachings of Dinsmoor to arrive at the claimed invention. Such modification would improve the system by providing more precise and accurate therapy by tuning (in real-time) the baseline voltage as needed to provide more personalized stimulation therapy in order to provide proper therapeutic treatment to the patient.
Regarding claim 12, Zhang as modified teaches:
The method of claim 1, but does not explicitly disclose whether the baseline voltage is determined at a voltage value that either maximizes or minimizes a value of the at least one feature.
However, Dinsmoor teaches systems and devices for adjusting electrical stimulation (see abstract, line 1). The system (figs. 1-2) teach wherein the baseline voltage is determined at a voltage value that either maximizes or minimizes a value of the at least one feature (see para 0075-programming the system to oscillate a target ECAP characteristic value between a maximum target ECAP characteristic value and a minimum target ECAP characteristic value, and para 0122-0123— ECAP amplitude variation).
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 modified system of Zhang with the teachings of Dinsmoor to arrive at the claimed invention. Such modification would improve the system by providing more precise and accurate therapy by tuning (in real-time) the baseline voltage as needed to provide more personalized stimulation therapy in order to provide proper therapeutic treatment to the patient.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Li, and further in view of US 9,314,180 B2 to India et al. (hereinafter “India”).
Regarding claim 10, Zhang as modified teaches:
The method of claim 9, but does not disclose wherein the method further comprises determining a longest of the one or more segments,
wherein the baseline voltage is determined relative to at least one voltage value in the longest segment.
However, India teaches a system for automatically detecting and measuring ST deviation from a cardiac wave ECG signal (see abstract, lines 1-3). The system (figs. 1-2 ) use a signal processor to determine a baseline by identifying the longest and flattest segment between the T peak and P peak in the cardiac wave signal (see col. 4, lines 19-29: “Signal processor 27 advantageously identifies a J point and computes an ECG signal baseline. Known systems typically determine a baseline by identifying the longest flattest segment between T and P peaks based on slope change. However, ECG signals (especially the region that qualifies to be the baseline) typically shows insignificant slope changes between neighbouring points. System 10 (FIG. 1) addresses these problems, by determining the exponential values of ECG signal values and by using the exponential values which exaggerate slope change between neighbouring points and make it easily observable.”).
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 modified system of Zhang with the teachings of India to arrive at the claimed invention. Such modification would improve the system by providing more precise and accurate therapy by tuning (in real-time) the baseline voltage as needed to provide more personalized stimulation therapy in order to properly treat each patient.
Regarding claim 11, Zhang as modified teaches:
The method of claim 10, but does not disclose wherein the baseline voltage is determined relative to either or both of a start voltage value and an end voltage value of the longest segment.
However, India teaches wherein the baseline voltage is determined relative to either or both of a start voltage value and an end voltage value of the longest segment (see fig. 2—P and T voltage peaks, col. 4, lines 19-29 (see what is stated above) and lines 65-67, and col. 5: “(19) Processor 27 in step 824 identifies a P peak point of a second heart cycle subsequent and successive to the first heart cycle in the electrical signal waveform and in step 827 determines exponential values of data samples of the electrical signal waveform lying between the identified T and P peak points. In step 830, processor 27 identifies particular samples having a derivative of the determined exponential values below a predetermined threshold value and in step 833 determines a baseline portion of the electrical signal waveform in response to the identified particular samples. Specifically, processor 27 processes data representing the electrical signal waveform by determining a baseline portion of the electrical signal waveform as a portion having the largest number of consecutive identified particular samples.”).
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 modified system of Zhang with the teachings of India to arrive at the claimed invention. Such modification would improve the system by providing more precise and accurate therapy by tuning (in real-time) the baseline voltage as needed to provide more personalized stimulation therapy in order to properly treat each patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bornzin et al. (US 9,302,112 B2) teaches a system of non-linear feedback control for spinal cord stimulation by sensing ECAP responses and obtaining baseline state changes based on the sensed ECAP response.
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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