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 .
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 1-43 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
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: Independent claims 1 and 24 recite a system and method for a mental process, and are therefore directed to statutory categories of the invention.
STEP 2A, PRONG 1:
Claims 1 and 24 recite the following limitations:
3a. Measuring an intensity of an evoked response in each capture signal window to form a plurality of (stimulus intensity parameter, response intensity) pairs for each stimulus electrode configuration.
3b. Estimating one or more key parameters of an activation plot at each electrode stimulus configuration using the plurality of pairs (described above) for each stimulus electrode configuration.
The following limitation, under broadest reasonable interpretation, cover concepts that can practically be performed in the human mind (i.e. through the use of a pen and paper). For example, following delivery of a plurality of neural stimuli (prompted by the clinician), and following the collection of the captured signal windows, an intensity of the evoked response can be captured to form a plurality of (stimulus intensity parameters, response intensity) pairs for each stimulus electrode configuration, and from the (stimulus intensity parameters, response intensity) pairs, one or more key parameters of an activation plot at each electrode configuration can be estimated.
STEP 2A, PRONG 2:
Claims 1 and 24 recite the following additional elements:
A neurostimulation device.
One or more stimulating electrodes.
One or more sensing electrodes.
A stimulus source.
Measurement Circuitry.
A control unit.
A processor.
The above-identified abstract idea in each of independent claims 1 and 24 is not integrated into a practical application because the additional elements either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use.
More specifically, the neurostimulation device containing stimulation/sensing electrodes and measurement circuitry is merely insignificant pre-solution activity and mere data gathering.
Furthermore, the additional elements of a control unit and a processor are generically recited computer elements in independent claims 1 and 24 which do not improve the functioning of a computer, or any other technology or technical field of use. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer.
STEP 2B:
None of the claims include additional elements that are sufficient to amount to significantly more than the judicial exception, since the neurostimulation device comprises:
One or more stimulating electrodes.
One or more sensing electrodes.
A stimulus source.
Measurement Circuitry.
A control unit.
A processor.
The elements above are well understood and conventional, as shown by Bourget et al. (US 2021/0387002 A1), which discloses a neurostimulation device (see fig. 1 – 110 and para [0053]) containing a plurality of stimulation electrodes and sensing electrodes ( see fig. 2, 232 and 234, and para [0094]-[0095]), a stimulus source/stimulation generation circuitry for delivering neural stimuli (see fig. 2 – 202, para [0092], and para [0094]), measurement circuitry/sensing circuitry configured to capture the signal windows/rolling buffer in response to a respective neural stimuli (see fig. 2 – 206 & 218, para [0018], para [0085]-[0089], para [0093], para [0190]), a control unit/controller (para [0097]), and a processor (see para [0097]). Hershey et al. (US 2017/0296823 A1) discloses an Implantable pulse generator/IPG configured to measure ECAPs (see abstract, fig. 9, and para [0054]-[0055]).
Furthermore, per applicant’s specification in para [0021]-[0022] and para [00024C], the processor is construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018).
For at least the above reasons, the system and method of Claims 1 and 24 are directed to applying an abstract idea (e.g., mental process or certain method of organizing human activity) on a general purpose computer without (i) improving the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) providing a technical solution to a problem in a technical field (as in DDR).
In other words, none of the claims provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1 and 24 (and their dependent claims) do not add significantly more because they are simply attempt to limit the abstract idea to a particular technological environment. That is, 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 1 and 24 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).
DEPENDENT CLAIMS:
Claims 2-23 and 25-43 merely further limit the abstract idea and mental process, therefore failing to amount to “significantly more” than the abstract idea either alone or in combination.
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.
(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, 8, 13-15, 17, 21-26, 31, and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2021/0387002 A1 to Bourget et al. (hereinafter “Bourget”).
Regarding claims 1 and 24, Bourget teaches a system and method (see abstract, line 1 and para [0239]) comprising:
A neural stimulation system (see fig. 1 – 100 and para [0053]) comprising:
a neural stimulation device/implantable medical device for controllably delivering a neural stimulus (see fig. 1 – 110 and para [0053])
the neural stimulation device comprising:
a plurality of implantable electrodes including one or more stimulus electrodes and one or more sense electrodes (see fig. 1 – 130A & 130B, FIG. 2 – 232 & 234, para [0054], and para [0094] – [0095] ),
wherein a stimulus electrode configuration comprises at least one stimulus electrode acting as an anode and at least one stimulus electrode acting as a cathode (biphasic pulse – see para [0072])
a stimulus source/stimulation generation circuitry configured to deliver neural stimuli via a stimulus electrode configuration to a neural pathway of a patient (see fig. 2-202, para [0092] and para [0094]-[0095]),
measurement circuitry/sensing circuitry and the processing circuitry configured to capture signal windows (sensed by the rolling buffer) sensed at a sense electrode of the one or more sense electrodes in response to respective neural stimuli (see fig. 2 - 206 & 218 and fig. 4, para [0018], para [0085]-[0089], para [0093], para [0190]);
and a control unit/processing circuitry (see fig. 2 -210) configured to control the stimulus source/stimulation generation circuitry to deliver each neural stimulus according to a stimulus intensity parameter (see para [0107-0110]);
and a processor configured to:
instruct the control unit/controller to control the stimulus source/stimulator to sequentially deliver a plurality of neural stimuli via respective stimulus electrode configurations of a plurality of stimulus electrode configurations according to respective values of the stimulus intensity parameter, wherein the value of the stimulus intensity parameter at each stimulus electrode configuration is different from a preceding value of the stimulus intensity parameter at that stimulus electrode configuration (due to the increment/decrement modes - see figs. 5A-5B, para [0129]-[0131], para [0107]-[0110]);
receive a captured signal window/rolling buffer corresponding to each delivered neural stimulus (see fig. 2 -218 , fig. 7, para [0133]-[0142], and para [0143]-[0144]),
measure an intensity of an evoked neural response in each captured signal window/rolling buffer thereby forming a plurality of (stimulus intensity parameter, response intensity) pairs for each stimulus electrode configuration (see figs. 9-12 and para [0161]-[0178]),
estimating one or more key parameters of an activation plot at each stimulus electrode configuration (see figs. 10 – 1002, 1004, and 1006, fig. 12 – 1202-1210, para [0153], para [0170] – [0171]), using the plurality of (stimulus intensity parameter, response intensity) pairs for each stimulus electrode configuration (see figs. 16-20 and para [0198]-[0204]).
Regarding claims 2 and 25, Bourget teaches:
The neural stimulation system of claim 1 and the method of claim 24, wherein the processor is configured to:
Control the stimulus source/stimulation generation circuitry to sequentially deliver a first plurality of control pulses,
instruct the control unit to control the stimulus source to sequentially deliver a first plurality of neural stimuli via a first stimulus electrode configuration according to respective values of the stimulus intensity parameter;
and
instruct the control unit to control the stimulus source to sequentially deliver, interleaved with the first plurality of neural stimuli, a second plurality of neural stimuli via a second stimulus electrode configuration according to respective values/characteristic values of the stimulus intensity parameter (informed pulse(s) interleaved with the control pulse(s) - see para [0042], [0050], [0065], [0076], [0097]-[0098], [0104], and emphasis on para [0106]-[0108]).
Regarding claims 3 and 26, Bourget teaches:
The neural stimulation system of claim 1 and method of claim 24, wherein the processor is configured to deliver the stimuli from the respective stimulus electrode configurations in an order which is the same when repeated (such as when the ECAP Amplitude is not lower than the lower threshold, but is lower than the upper threshold – see fig. 11 – 1114 & 1102, para [0027], para [0065]-[0066], and para [0162]-[0169]).
Regarding claims 8 and 31, Bourget teaches:
The neural stimulation system of claims 1 and the method of claim 24, wherein the processor is configured to choose the value of the stimulus intensity parameter between an ECAP threshold T/lower threshold and a discomfort threshold Max/upper threshold for the corresponding stimulus electrode configuration ( see fig. 11, para [0097], and para [0162] – [0169]).
Regarding claims 13 and 36, Bourget teaches:
The neural stimulation system of claims 8 and the method of claim 31, wherein the processor is further configured to estimate the discomfort threshold/upper threshold at each stimulus electrode configuration from the ECAP threshold/lower threshold at that stimulus electrode configuration (see fig. 11 and para [0162]-[0169]).
Regarding claims 14 and 37, Bourget teaches:
The neural stimulation system of claim 13 and the method of claim 36, wherein the processor is configured to estimate the discomfort threshold at each stimulus electrode configuration by applying a linear model to the ECAP threshold at that stimulus electrode configuration (see fig. 2 and para [0111]-[0113]).
Regarding claims 15 and 38, Bourget teaches:
The neural stimulation system of claim 8 and the method of claim 31, wherein the processor is configured to estimate the ECAP threshold at each stimulus electrode configuration (fig. 11 and para [0162]-[0169]).
Regarding claims 17 and 40, Bourget teaches:
The stimulation system of claim 1 and the method of claim 24, wherein the processor is configured to estimate the one or more key parameters at each stimulus electrode configuration by fitting an activation plot model to the plurality of (stimulus intensity parameter, response intensity) pairs for that stimulus electrode configuration (see figs. 10 – 1002, 1004, and 1006, fig. 12 – 1202-1210, figs. 16-20, para [0153], para [0170] – [0171], and para [0198]-[0204]).
Regarding claim 21, Bourget teaches:
The neural stimulation system claim 1, wherein the processor is part of the neural stimulation device (see para [0010]).
Regarding claim 22, Bourget teaches:
The neural stimulation system of claim 1, further comprising an external computing device in communication with the neural stimulation device (see para [0006] – last sentence, and para [0123]).
Regarding claim 23, Bourget teaches:
The neural stimulation system of claim 22, wherein the processor is part of the external computing device/external programmer (see para [0010], para [0117], and para [0123]).
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.
Claim(s) 5-6 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Bourget in view of US 2020/0197687 A1 to Asirvatham et al. (hereinafter “Asir”).
Regarding claims 5 and 28, Bourget teaches:
The neural stimulation system of claim 1 and the method of claim 25, but does not explicitly disclose wherein
the processor is configured to deliver the stimuli from the respective stimulus electrode configurations in an order which is permuted when repeated.
However, Asir teaches methods and materials for improving the treatment of hyperten sion (abstract). The system (fig. 5) teaches wherein the processor is configured to deliver the stimuli from the respective stimulus electrode configurations in an order which is permuted when repeated (see fig. 5, para [0007], and para [0037]-[0042]).
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 Bourget with the permuted electrode configuration system of Asir to arrive at the claimed invention, since such modification would improve the system by allowing for more precise and effective stimulation treatment for each patient based on their response to the stimulation, ultimately improving therapeutic efficacy.
Regarding claims 6 and 29, Bourget as modified teaches:
The neural stimulation system of claim 5 and the method of claim 28, wherein the processor is configured to use Markov sampling to permute the order (see Asir – para [0008] – “ In some cases, the physiologic response can be assessed by an output of a supervised or unsupervised artificially intelligent network that incorporates multiple physiologic inputs. In some cases, the artificially intelligent network can be at least one of a feature extraction model, a hidden Markov model, a support vector machine, a convolutional neural network or a recurrent neural network. In some cases, the method can include changing an electrode configuration when the physiological response is detected. In some cases, changing the electrode configuration can include changing at least one of a location of the first electrode or the second electrode, changing a polarity of the first electrode of the second electrode, and changing a parameter for the stimulation.”).
Claim(s) 9-10 and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Bourget in view of US 2014/0121725 A1 to Bahmer.
Regarding claims 9 and 32, Bourget teaches:
The neural stimulation system of claim 8 and the method of claim 31, wherein the processor is configured to sample the value of the stimulus intensity parameter between the ECAP lower threshold/threshold T and upper threshold/discomfort threshold (see fig. 11, para [0097], and para [0162] – [0169]), but does not disclose wherein the processor is configured to sample the value of the stimulus intensity parameter from a uniform distribution between the ECAP threshold T and the discomfort threshold Max for the corresponding stimulus electrode configuration.
However, Bahmer teaches a system and method for activating electrodes in a multi-channel electrode array that are spatially divided (abstract). The system (figs. 2-4) teaches wherein the processor is configured to sample the value of the stimulus intensity parameter from a uniform distribution between the Sub-threshold and the supra-threshold for the corresponding stimulus electrode configuration (para [0008]-[0012], [0030], [0032], para [0037] – [0038], and para [0040]-[0041]).
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 Bourget with the teachings of Bahmer to arrive at the claimed invention. Such modification would improve the system by allowing for more precise and controlled stimulation therapy for each patient.
Regarding claims 10 and 33, Bourget teaches the neural stimulation system of claim 8 and the method of claim 31, but does not explicitly disclose wherein the processor is configured to sample the value of the stimulus intensity parameter from respective normal/gaussian distributions each having parameters which, at a respective stimulus electrode configuration, depend dynamically on measurements from one or more preceding stimulus electrode configurations.
However, Bahmer teaches a system and method for activating electrodes in a multi-channel electrode array that are spatially divided (abstract). The system (figs. 2-4) teaches wherein the processor is configured to sample the value of the stimulus intensity parameter from respective normal distributions each having parameters which, at a respective stimulus electrode configuration, depend dynamically on measurements from one or more preceding stimulus electrode configurations (para [0008]-[0012], [0030], [0032], para [0037] – [0038], and para [0040]-[0041]).
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 Bourget with the teachings of Bahmer to arrive at the claimed invention. Such modification would improve the system by allowing for more precise and controlled stimulation therapy for each patient.
Claim(s) 16 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Bourget in view of US 2014/0148725 A1 to Cadwell.
Regarding claims 16 and 39, Bourget teaches:
The neural stimulation system of claim 15 and the method of claim 38, wherein the processor is configured to detect ECAPs in captured signal windows corresponding to multiple neural stimuli of different stimulus intensity parameters delivered via the stimulus electrode configuration (see para [0087] and para [0089]-[0090]), but does not explicitly disclose wherein the processor is configured to estimate the ECAP threshold at a stimulus electrode configuration by applying a noise departure detector to detect ECAPs.
However, Cadwell teaches systems and methods for neuromonitoring (see abstract). The system (figs. 3-4) teaches wherein the processor is configured to estimate the EMG threshold at a stimulus electrode configuration by applying a noise departure detector to detected EMG signals (see figs. 2 and 5, para [0075]-[0077], and para [0082]-[0083]).
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 Bourget with the teachings of Cadwell to arrive at the claimed invention. Such modification would improve the system by allowing for more precise interpretation of the ECAP signals and more accurate modification of the stimulation parameters needed to improve the stimulation therapy for each patient.
Claim(s) 18 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Bourget in view of US 2017/0216587 A1 to Parker.
Regarding claims 18 and 41, Bourget teaches:
The neural stimulation system of claim 17 and the method of claim 40, wherein and one of the one or more key parameters is a slope of the activation plot (see para [0077]), but does not explicitly disclose wherein
the activation plot model is a straight line, and one of the one or more key parameters is a slope of the fitted straight line.
However, Parker teaches a therapeutic monitoring device for a user (see abstract). The system (fig. 1) teaches wherein the activation plot model is a straight line (see fig. 6, para [0045], and para [0065]).
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 Bourget with the teachings of Parker to arrive at the claimed invention. Such modification would lead to a reasonable expectation for success, since the prior art reference of Parker teach a straight line representation of the activation plot that shows how significantly different postures modify the electrode configuration and overall stimulation effect intensity/effect, ultimately allowing for more precise tuning of stimulation therapy for the patient.
Claim(s) 19-20 and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Bourget in view of Parker, and further in view of US 2021/0187298 A1 to Dinsmoor et al. (hereinafter “Dinsmoor”).
Regarding claims 19 and 42, Bourget as modified teaches:
The neural stimulation system of claim 17 and the method of claim 40, but does not explicitly disclose wherein the activation plot model is a straight line, and one of the one or more key parameters is an intercept of the fitted straight line.
However, Parker teaches wherein the activation plot model is a straight line (see fig. 6, para [0045], and para [0065]), but does not explicitly disclose wherein and one of the one or more key parameters is an intercept of the fitted straight line.
However, Dinsmoor teaches systems and methods for adjusting stimulation based on ECAP signals (see abstract). The system (figs. 1-2) teaches and one of the one or more key parameters is an intercept of the growth curve (see para [0055]).
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 Bourget with the teachings of Parker and Dinsmoor to arrive at the claimed invention. Such modification would lead to a reasonable expectation for success, since the prior art reference of Parker teach a straight line representation of the activation plot that shows how significantly different postures modify the electrode configuration and overall stimulation effect intensity/effect, ultimately allowing for more precise tuning of stimulation therapy for the patient.
Regarding claims 20 and 43, Bourget teaches:
The neural stimulation system of claim 17 and the method of claim 40, wherein the activation plot model is a logistic growth curve (see para [0108] and [0111]), and one of the one or more key parameters is a slope of the fitted logistic growth curve at its midpoint (see para [0075], [0077], [0106], and [0108]).
Examiner’s Note
Although no prior art has been applied to claims 4, 7, 11-12, 27, 30, and 34-35, these claims are not indicated as allowable in view of the pending 101 rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 10, 118, 036 B2 teaches a system configured to stochastically modulate stimulation parameters (see title and abstract).
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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