Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 7 is objected to because of the following informalities: “corresponding the repeated” should be “corresponding to the repeated”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3, 6 and associated dependent claims are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 3, “using a relationship between a neural activation and at least one pulse parameter” does not have written description support to cover any mathematical or heuristic relationship across any parameter set.
Regarding claim 6, “automatically selecting multiple pulses” does not have written description support for the selection rules for every possible scenario.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 5-7, 11, 15-16 and associated dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 3, “using a relationship between a neural activation and at least one pulse parameter” is open-ended and not supported as discussed above.
Regarding claim 5, “largest pulse amplitude” is ambiguous with multiple pulses sharing the same maximum amplitude. Examiner suggests amending to “one or more pulses having the maximum amplitude” if there is proper written description support.
Regarding claim 6, “automatically selecting multiple pulses” does not have support as discussed above. Examiner notes there may be better support if the claim is tied to particular thresholding or extrema.
Regarding claim 7, “averaging … at least two instances” – does it work for any instance or are there weighting factors such as signal quality, time, amplitude, or occurrence count?
The term “desired” in claim 11 is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “meaningful” in claim 15 is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 16, “when an evoked potential or a local field potential change is expected” appears open-ended as “expected” is outcome oriented – leading to questions of: expected based on what, the model or criterion used, how determined?
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 5-7, 15-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Zhang”, US Publication 20230173277.
Regarding claim 1, Zhang discloses a method, comprising:
accessing a non-uniform waveform pattern for use to deliver neurostimulation [0083: waveform pattern 1500 includes multiple bursts… burst 1501… includes a delay between the first pulse and the second pulse that is longer than the delay between other pulses; FIG. 5 and FIG. 15; a burst stimulation pattern modified to include pinging-pulses or modified delays, creating a non-uniform pattern];
automatically assigning, based on the non-uniform waveform pattern, at least one sensing window for the non-uniform waveform pattern [0071: pinging-pulse trailing latency of at least 1.2 ms… is provided… to facilitate sufficient time for sensing responsive signals (e.g., ECAPs); 0083: longer delay facilitates the sensing of the ECAP response; system’s logic assigns a specific latency/delay window based on the pulse pattern to sense the signal];
delivering neurostimulation corresponding the non-uniform waveform pattern [0067: delivering the therapeutic pulses and pinging-pulses to the neural tissue];
sensing a neural signal during the at least one sensing window when the neurostimulation is being delivered [0086: sensing signals (e.g., ECAPs) elicited by a pinging-pulse… may be monitored, received, etc. by implantable pulse generator 12; sensing the ECAP signals during the provided latency/delay window]; and
controlling delivery of the neurostimulation based on the sensed neural signal [0096: detect a change in the evoked neural response… and automatically adjust one or more parameters for the stimulation program… in response to detecting the change; closed-loop control where the stimulation parameters are adjusted based on the sensed ECAPs].
Regarding claim 2, Zhang discloses wherein the non-uniform waveform pattern includes activation pulses that cause a neural response and sub-activation threshold pulses that do not cause the neural response [0061+: burst stimulation at clinical amplitudes may not activate a sufficient number of dorsal column fibers, and thus usually results in no measurable or no meaningful ECAP data; 0063: deliver one or more non-therapeutic pulses (‘pinging-pulses’) configured for evoking responsive signals (e.g., ECAPs)]. Zhang further discloses determining at least one pulse that corresponds to the neural response and assigning the window to sense it [0071: pinging-pulse trailing latency of at least 1.2 ms… is provided between a pinging-pulse… and the subsequent therapeutic pulses… to facilitate sufficient time for sensing responsive signals].
Regarding claim 5, Zhang discloses automatically determining a largest pulse amplitude in the non-uniform waveform pattern, and assigning the sensing window to sense a neural response to the largest pulse amplitude [0089: generating, by the IPG, pinging-pulses at amplitudes greater than pulse amplitudes of the therapeutic pulses of the stimulation program… measuring an evoked neural response in the patient in response to the pinging-pulses].
Regarding claim 6, Zhang discloses automatically selecting multiple pulses in the non-uniform waveform pattern, and assigning the sensing window to sense a neural response corresponding to the selected multiple pulses [0075: pinging-pulses of alternating polarity are provided… to improve the SNR of elicited sensing signals; FIG. 8 showing multiple pinging pulses 811 and 812].
Regarding claim 7, Zhang discloses repeating the pattern, sensing a first neural response, and averaging the first neural response to neurostimulation corresponding to at least two instances of the first selected pulse [0075: the opposite polarity of stim pulses can be added to zero, and the ECAPS themselves can be averaged].
Regarding claim 15, Zhang discloses identifying a meaningful epoch in the non-uniform waveform, wherein the at least one sensing window is automatically assigned during the identified meaningful epoch [0083: burst 1501… includes a delay between the first pulse and the second pulse that is longer than the delay between other pulses… This longer delay facilitates the sensing of the ECAP response].
Regarding claim 16, Zhang discloses identifying when an evoked potential or a local field potential change is expected, wherein the sensing window is automatically assigned during a quiescent period within the non-uniform waveform pattern when the evoked potential is expected (Zhang, paragraph [0061] “ECAPs usually arrive less than 1 ms (<1 ms) after a corresponding stimulation pulse”; paragraph [0071] “A pinging-pulse trailing latency of at least 1.2 ms… is provided… to facilitate sufficient time for sensing responsive signals”).
Regarding claim 17, Zhang discloses determining a quiescent period within the non-uniform waveform pattern that is longer than a threshold period of time, and assigning the window to this period, wherein the threshold period of time is a user-programmable period of time [0083: delay between the first pulse and the second pulse that is longer than the delay between other pulses… The delay between the first pulse and the second pulse may be a programmable setting to optimize ECAP sensing].
Regarding claim 18, Zhang discloses assigning first and second sensing windows in first and second patterns, delivering neurostimulation at first and second sites, sensing first and second responses, and controlling delivery based on both [0076: multi-stim set in which the implantable pulse generator operates to rapidly switch between two programs… pinging-pulses 911 and 912… are interleaved in the pulse train of a first electrode and pinging-pulses 913 and 914… are interleaved in the pulse train of a second electrode; 0118: two percutaneous leads are implanted… electrodes of the two leads are roughly placed in a linear, sequential order].
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) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang as applied to claims above, and further in view of “Tyler”, US Patent 11612741.
Regarding claim 3, Zhang discloses determining the at least one pulse in the non-uniform waveform pattern that corresponds to the neural response [0070: amplitude of the cathodic phase is selected and/or adjusted in operation… such that a single pinging-pulse evokes one or more sensing signals]. However, Zhang does not explicitly detail using a broad relationship between neural activation and various pulse parameters to make this determination.
Tyler discloses a similar neurostimulation systems using a relationship between a neural activation and at least one pulse parameter for the at least one pulse to determine the at least one pulse in the non-uniform waveform pattern that corresponds to the neural response [col.4, lines 3+: the intensity can correspond to the number of neural fibers that are recruited by a pulse and/or pattern of pulses; col.7, lines 13+: The modulation of the one or more pulse parameters of the stimulation signal (SS) related to intensity can recruit a different population of axons with each pulse].
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 teachings of Tyler -- utilizing the relationship between pulse parameters and neural activation [recruitment] as taught by Tyler would enhance the system of Zhang by allowing the system to more accurately select and modulate the specific pulses [e.g., pinging pulses] required to evoke a measurable ECAP response.
Regarding claim 4, Zhang discloses adjusting amplitude [e.g., 0070], but does not explicitly detail the relationship across other parameters. Tyler discloses wherein the relationship is between the neural activation and at least one of a pulse amplitude, a pulse frequency or a pulse width [col.7, lines 37+: Examples of stimulation parameters related to intensity can include amplitude, pulse width, interpulse interval… frequency]. 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 teachings of Tyler -- utilizing amplitude, frequency, or pulse width to control neural activation, as taught by Tyler, would enhance the system of Zhang by providing multiple programmable variables to optimize the non-uniform waveform for both patient comfort and ECAP sensing.
Claim(s) 8-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang as applied to claims above, and further in view of “Esteller”, WO Publication 2021080727.
Regarding claim 8, Zhang does not explicitly disclose wherein the averaging includes determining a weighted average of the first neural response corresponding to the at least two instances. Esteller discloses determining a weighted average of measurements derived from the neural responses [0023+: a plurality of measurements are obtained for each of the applied time-varying pulse waveforms, wherein each of the plurality of measurements are weighted when determining the score; 0071+: the three measurements are weighted by multiplying each by a weight w1, w2, and w3… the weighted measurements are then added].
Regarding claim 9, Zhang does not explicitly disclose determining a weighted average of the first and second neural responses and controlling the delivery based on the weighted average. Esteller discloses determining a weighted average of multiple measurements [which correspond to different neural responses or features] and controlling the stimulation based on the resulting weighted score [0071: the three measurements are weighted by multiplying each by a weight w1, w2, and w3… the weighted measurements are then added; 0077+: the algorithm 180 can be programmed with at least one threshold, and can determine if the current score for the TVP has gotten worse… proceed to step 188 where adjustments to the TVP can be made].
Regarding claim 10, Zhang does not explicitly disclose modulating a mean for at least one pulse parameter based on the sensed neural signal. Esteller discloses modulating a mean for at least one pulse parameter based on the sensed neural signal [0053: e.g., Amid can also be defined as the mean or the median of the distribution of amplitude values generated by the modulation function; paragraph 0079: Fmid (the mean frequency averaged over the period of modulation… can be adjusted in step 188 in the hope of maintaining the score within a threshold band].
Regarding claim 11, Zhang does not explicitly disclose sensing first and second extrema neural responses corresponding to minimum and maximum parameter values, determining a desired neural response based on the extrema, and using a deviation between the sensed and desired response to control delivery. Esteller discloses measuring extrema neural responses to minimum and maximum parameter values, determining a desired response, and using the deviation/spread to control delivery [0068: The difference between the maximum and minimum areas — the spread between the two — provides one such measurement. The spread of this feature… may be normalized using the average, i.e., (max - min)/avg; 0069: The TVP algorithm 170 may compute or determine a fit metric… that quantifies how well the resulting ECAP area matches such preferred regions or other desired ECAP area thresholds].
Regarding claim 12, Esteller explicitly discloses modulating at least one of a center, depth or period for the variable pulse parameter to provide the desired neural response [0079: Modulation parameters that can be adjusted at step 188 can comprise the spread of the modulation function (e.g., maximum-minimum) [depth] and the middle value of the modulation function (e.g., mid) [center]].
Regarding claim 13, Zhang does not explicitly disclose sweeping neurostimulation through a plurality of parameter values to collect threshold neural response data, designating threshold level specifications based on the data, and maintaining the neurostimulation within the specifications. Esteller discloses sweeping neurostimulation through parameter values to collect threshold data and designating threshold level specifications to guide the waveform pattern [0051: fitting process can involve… trying various simulation parameters on an implanted patient… to determine what parameters work best; 0066: during each TVP, the amplitude of the stimulation can be adjusted, with the paresthesia threshold comprising a lowest amplitude… The discomfort threshold can comprise a highest amplitude… Pth and Dth comprise stimulation thresholds… that are used to guide the selection of the modulation parameters for a TVP].
Regarding claim 14, Esteller explicitly discloses wherein the sweeping the neurostimulation includes sweeping past a perception threshold parameter value, a maximum comfort threshold parameter value, or a discomfort threshold parameter value [0066+: paresthesia threshold (Pth) at which stimulation can be felt by a patient (paresthesia), or a discomfort threshold (Dth) where the stimulation is too intense].
Zhang and Esteller are combinable because both are directed towards neurostimulation systems that utilize time-varying or non-uniform pulse patterns and rely on sensed neural responses (such as ECAPs) to optimize therapy. 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 teachings of Esteller -- incorporating the specific algorithmic controls taught by Esteller such as weighting measurements, modulating mean/center/spread parameters, and utilizing threshold sweeps during a fitting process would enhance the system of Zhang by providing a robust, closed-loop mathematical framework to automatically adjust the non-uniform waveforms to maintain optimal therapeutic efficacy and patient comfort over time.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tse Chen whose telephone number is (571)272-3672. The examiner can normally be reached M-F 7-3 EST.
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/TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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