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 argument regarding the 101 rejection of claim 21 is persuasive.
Applicant's arguments filed 5/8/2026 have been fully considered but they are not persuasive.
Applicant argues measurement circuitry and processor cannot be performed in the human mind. The examiner notes that “necessitation of physical electronics such as measurement circuitry or generic computer elements are merely additional elements that are simply used as an insignificant extra-solution activity used for data gathering according to MPEP 2106.05(g) and implementing the abstract idea on a computer according to MPEP 2106.05(f). The examiner notes that when presented with data a human can mentally determine an ECAP threshold of the patient from signal windows captured (by the measurement circuitry). Applicant argues the claims include additional elements to integrate the judicial exception into a practical application. The Applicant argues the claims recite a particular treatment or prophylaxis for a disease or medical condition. The examiner notes that claim 16 determines an ECAP threshold of the patient and predicts a perceptual marker of the patient, but does not utilize these determined values for treatment. Applicant points to control unit, processor, and stimulus source required for capturing a signal window used in determining an ECAP threshold as a treatment for a particular or prophylaxis for a disease or medical condition. However, this is not delivering neural stimulus for a particular treatment or prophylaxis. Which is different from Claim 21 that integrates the judicial exception into a practical application by using the predicted value of the perceptual marker to deliver stimulus to the patient.
Similar to above the Applicant argues the additional elements are significantly more than the recited judicial exception. The examiner respectfully disagrees as similar to above and as noted in the previous office action that using neurostimulation to obtain an ECAP is well understood routine and conventional and that the processor is generic computing device as identified in the instant specification of Paragraphs [0030]-[0031]. Regarding the prior art rejection the Applicant argues that the prior art does not predict a perceptual marker based on the determined ECAP and a discomfort threshold. Applicant disagree that perception threshold is the minimum stimulation perceptible by the patient and is different from the discomfort threshold. Applicant argues a stimulation level such as PT does not cause discomfort, does not make it a comfortable stimulus intensity. Applicant indicates that a comfortable stimulus intensity would have to be sufficiently large to provide pain relief (citing Applicant’s specification in which the patient was asked whether the sensation is too strong or too weak). Therefore, the Applicant opines that there would be no need to ask whether it was “too strong” because Esteller discloses that PT is the “minimum stimulation perceptible by the patient which cannot be too strong. The examiner respectfully disagrees as this is what Esteller discloses in Paragraph [0085] that “(3) the perception threshold (PT), which corresponds to the minimum stimulation perceptible by the patient; (4) the discomfort threshold, which corresponds to the minimum stimulation intensity”. The examiner notes that values greater than the perception thresholds can be too strong and cause discomfort and that is why there is another threshold identified as the “discomfort threshold”. Esteller identifies the two thresholds as being different intensities, the discomfort threshold is equivalent to the minimum stimulation intensity that causes discomfort and the perception threshold is equivalent to the minimum stimulation perceptible by the patient.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., asking the patient if the intensity is too strong or too weak) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The examiner notes that an intensity that is too strong is equal to or greater than a discomfort threshold while a perception threshold is the minimum value at which the patient perceived stimulation. Esteller at Paragraph [0087] discloses that the perception threshold is estimated based on the ECAP and identifies it as being different form the discomfort threshold.
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 16-20, and 22-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) a mental process of using collected neural responses to determine an ECAP threshold, and predicting a perpetual marker of the patient based on the determined ECAP threshold and a discomfort threshold of the patient. This judicial exception is not integrated into a practical application because the neurostimulation device comprising a stimulus source, measurement circuitry are a pre-solution activity required for data gathering neural responses and control unit/processor are generically recited computer elements which do not improve the functioning of a computer, or any other technology or technical field. These claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because neurostimulation device comprising a stimulus source, measurement circuitry and a processor is well understood routine and conventional as evidenced by Cholette (US Publication 2008/0300655) discloses a neurostimulation device with a stimulus source that delivers energy to the nerve (e.g. Figure2, element 242/244; Figure 3, Element 321 and Figure 7, element 633) and a measurement circuitry (e.g. Figure 3, Elements 322-326). Hershey et al (US Publication 2017/0296823) discloses an IPG which measures an evoked action potential (ECAP) (e.g. Figure 9). Carcieri (US Publication 20140243926) discloses a an IPG (14) which delivers stimulation pulses to the tissue and measures evoked action potentials (e.g. Paragraph [0013]).
With regards to the processor/control unit, per applicant’s specification in Paragraphs [0030]-[0031], the processor/control unit is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process. neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 16-20 and 22-28 are merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 16-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Esteller et al (US Publication 2019/0209844) in view of Dinsmoor et al (US Publication 2021/0187299).
Referring to Claim 16, Esteller et al teaches a neurostimulation system comprising: a neurostimulation device for controllably delivering a neural stimulus (e.g. Paragraph [0002] discloses a neurostimulator), the neurostimulation device comprising: a stimulus source configured to deliver a neural stimulus via one or more stimulus electrodes of a plurality of implantable electrodes to a neural pathway of a patient (e.g. Figure 12 and Paragraph [0078]-[0079] disclose delivering stimulation via the IPG); measurement circuitry configured to capture a signal window sensed at one or more sense electrodes of the plurality of implantable electrodes in response to the neural stimulus (e.g. Paragraph [0079] discloses sensing electrodes to obtain ECAP); a control unit configured to control the stimulus source to deliver the neural stimulus according to a stimulus intensity parameter (e.g. Paragraph [0078] discloses automatically changing the stimulation intensity to determine ECAP threshold); a processor configured to: instruct the control unit to control the stimulus source to deliver a plurality of neural stimuli according to respective values of the stimulus intensity parameter (e.g. Paragraph [0078]); determine an ECAP threshold of the patient from the signal windows captured in response to the respective neural stimuli, wherein the ECAP threshold is a value of the stimulus intensity parameter above which an intensity of neural responses evoked by the neural stimuli starts to increase with increasing stimulus intensity (e.g. Paragraphs [0078] and [0079] disclose the amplitude is progressively increased ECAPS are detected which is used to detect the ECAP threshold); predict a perceptual marker of the patient based on the determined ECAP threshold and a discomfort threshold of the patient (e.g. Paragraphs [0087] and [0092] discloses the PT is estimated based on the ECAP threshold and the ECAP algorithm adjusts therapy if the measured ECAP metrics approach the value of the determined discomfort threshold), wherein the perceptual marker is a comfortable stimulus intensity (e.g. Paragraph [0085] discloses PT is the minimum stimulation perceptible by the patient and is different from the discomfort threshold). However, Esteller et al does not explicitly disclose predict a discomfort threshold of the patient. Dinsmoor et al teaches that it is known to use growth curves of sensed ECAPS from stimulation pulses at various postures which exhibit discomfort thresholds that correspond to a stimulation amplitude at a level at which the patient experiences discomfort from the resulting ECAP response (e.g., as paresthesia, numbness, etc.). The discomfort thresholds may be different for each patient and is shown in relation to the perception threshold as set forth in Figure 5B, Paragraphs [0124] and [0128] to provide improving target ECAP determinations which vary based on posture for controlling the stimulation pulses delivered to the patient in order to avoid abrupt changes in sensation to the user. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Esteller et al, with predicting a discomfort threshold of the patient as taught by Dinsmoor et al, since such a modification would provide the predictable results of improving target ECAP determinations which vary based on posture for controlling the stimulation pulses delivered to the patient in order to avoid abrupt changes in sensation to the user.
Referring to Claim 17, Esteller et al in view of Dinsmoor et al teaches the neurostimulation system of claim 16, wherein the processor is configured to predict the comfortable stimulus intensity using a linear prediction model (e.g. Paragraph [0087]).
Referring to Claim 18, Esteller et al in view of Dinsmoor et al teaches the neurostimulation system of claim 17, wherein the processor is configured to predict the comfortable stimulus intensity as being at a fixed proportion of an interval between the ECAP threshold and the discomfort threshold (e.g. Paragraphs [0085] and [0087]).
Referring to Claim 19, Esteller et al in view of Dinsmoor et al teaches the neurostimulation system of claim 16, wherein the processor is configured to predict the discomfort threshold of the patient from the determined ECAP threshold (e.g. Paragraph [0087] discloses the relationship between ECAP threshold and perception threshold (PT) and Dinsmoor illustrates the relationship between PT and the discomfort threshold, which varies based on posture. Therefore predicting the discomfort threshold from the determined ECAP threshold).
Referring to Claim 20, Esteller et al in view of Dinsmoor et al teaches the neurostimulation system of claim 19, wherein the processor is configured to predict the discomfort threshold using a linear prediction model (e.g. Paragraph [0087]).
Referring to Claim 21, Esteller et al in view of Dinsmoor et al teaches the neurostimulation system of claim 16, wherein the processor is further configured to program, using the predicted value of the perceptual marker, the neurostimulation device to deliver neural stimulus to the patient (e.g. Paragraphs [0062] and [0090] discloses using the thresholds to maintain therapy that best alleviates a patient’s symptoms).
Referring to Claim 22, Esteller et al in view of Dinsmoor et al teaches the neurostimulation system of claim 16, wherein the processor is part of the control unit of the neurostimulation device (e.g. Figure 8, control circuitry 102 which includes ECAP algorithm 124a).
Referring to Claim 23, Esteller et al in view of Dinsmoor et al teaches the neurostimulation system of claim 16, wherein the processor is part of an external computing device in communication with the neurostimulation device (e.g. Paragraph [0078] discloses using a clinician or patient programmer to determine specific thresholds).
Referring to Claim 24, Esteller et al teaches an automated method of controlling a neurostimulation device to deliver neural stimuli to a patient, the method comprising: delivering the neural stimuli according to respective values of a stimulus intensity parameter (e.g. Paragraph [0078] discloses automatically changing the stimulation intensity to determine ECAP threshold)); determine an ECAP threshold of the patient from the signal windows captured in response to the respective neural stimuli, wherein the ECAP threshold is a value of the stimulus intensity parameter above which an intensity of neural responses evoked by the neural stimuli starts to increase with increasing stimulus intensity (e.g. Paragraphs [0078] and [0079] disclose the amplitude is progressively increased ECAPS are detected which is used to detect the ECAP threshold); predict a perceptual marker of the patient based on the determined ECAP threshold and a discomfort threshold of the patient (e.g. Paragraphs [0087] and [0092] discloses the PT is estimated based on the ECAP threshold and the ECAP algorithm adjusts therapy if the measured ECAP metrics approach the value of the determined discomfort threshold), wherein the perceptual marker is a comfortable stimulus intensity (e.g. Paragraph [0085] discloses PT is the minimum stimulation perceptible by the patient and is different from the discomfort threshold). However, Esteller et al does not explicitly disclose predict a discomfort threshold of the patient. Dinsmoor et al teaches that it is known to use growth curves of sensed ECAPS from stimulation pulses at various postures which exhibit discomfort thresholds that correspond to a stimulation amplitude at a level at which the patient experiences discomfort from the resulting ECAP response (e.g., as paresthesia, numbness, etc.). The discomfort thresholds may be different for each patient and is shown in relation to the perception threshold as set forth in Figure 5B, Paragraphs [0124] and [0128] to provide improving target ECAP determinations which vary based on posture for controlling the stimulation pulses delivered to the patient in order to avoid abrupt changes in sensation to the user. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Esteller et al, with predicting a discomfort threshold of the patient as taught by Dinsmoor et al, since such a modification would provide the predictable results of improving target ECAP determinations which vary based on posture for controlling the stimulation pulses delivered to the patient in order to avoid abrupt changes in sensation to the user.
Referring to Claim 25, Esteller et al in view of Dinsmoor et al teaches the method of claim 24, wherein the predicting the perceptual marker uses a linear prediction model (e.g. Paragraph [0087]).
Referring to Claim 26, Esteller et al in view of Dinsmoor et al teaches the method of claim 25, wherein the perceptual marker is predicted as being at a fixed proportion of an interval between the ECAP threshold and the discomfort threshold (e.g. Paragraphs [0085] and [0087]).
Referring to Claim 27, Esteller et al in view of Dinsmoor et al teaches the method of claim 24, further comprising predicting the discomfort threshold of the patient from the determined ECAP threshold (e.g. Paragraph [0087] discloses the relationship between ECAP threshold and perception threshold (PT) and Dinsmoor illustrates the relationship between PT and the discomfort threshold, which varies based on posture. Therefore predicting the discomfort threshold from the determined ECAP threshold).
Referring to Claim 28, Esteller et al in view of Dinsmoor et al teaches the method of claim 27, wherein the predicting the discomfort threshold uses a linear prediction model (e.g. Paragraph [0087]).
Referring to Claim 29, Esteller et al in view of Dinsmoor et al teaches the method of claim 24, further comprising programming, using the predicted value of the perceptual marker, the neurostimulation device to deliver neural stimulus to the patient (e.g. Paragraphs [0062] and [0090] discloses using the thresholds to maintain therapy that best alleviates a patient’s symptoms).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Johanek et al (US Publication 2016/0121124) discloses delivering electricals stimulation to the patient and sensing the evoked CAP to relieve pain.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William J Levicky/Primary Examiner, Art Unit 3796
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