DETAILED ACTION
Notice of Pre-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 Interpretations
In re claim 1, the limitation “applying the regression model and a sub-perception dose level to a plurality of sub-perception therapy programs” will be interpreted predicting multiple models to figure out what stimulation therapy would be optimal for treating the patient.
In re claim 3, the limitation “receiving, via a user interface, patient input accounting for environmental factors that impact sensor readings” will be interpreted with respect to the specification as weather data, air quality information, location elevation data, heart rate, blood pressure, weight, and the like (Instant application: [0095]).
Claim Objections
Claims 5 and 6 are duplicate claims. Applicant is advised that should claim 5 be found allowable, claim 6 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections – 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-20 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p. 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, p. 50, January 7, 2019)
Step 1: Claim 1 is drawn to a method.
Step 2A - Prong 1: Claim 1 is drawn to an abstract idea, that under its broadest reasonable interpretation, covers a mathematical calculation but for the recitation of insignificant extra-solution activity of pre-solution data gathering and generic computer components. In particular, claim 1 recites the following abstract limitations:
A method for parameterizing a closed-loop algorithm for providing sub-perception therapy, the method comprising:
generating a regression model for mapping the accelerometer data to an optimal stimulation parameter to achieve consistent nerve activation (mathematical concept),
the mapping enabling closed-loop control of the sub-perception therapy (mathematical concept);
applying the regression model and a sub-perception dose level to a plurality of sub-perception therapy programs (mathematical concept); and
In re claim 13 and 20, see above (In re claim 1). Substantially, the same reasoning applies.
These limitations of claim 1 are drawn to an abstract idea because they are processes that, under their broadest reasonable interpretation, are steps merely comprised of mathematical calculations.
Step 2A - Prong Two: Claim 1 recites the following emphasized additional elements that are beyond the judicial exception:
delivering neurostimulation (insignificant pre-solution activity);
sensing a neural signal (insignificant pre-solution activity) indicative of neural responses,
the neural responses each being a response to the delivering of the neurostimulation;
controlling the delivering of the neurostimulation (insignificant pre-solution activity) using a plurality of stimulation parameters;
recording evoked compound action potential (ECAP) features (insignificant pre-solution activity) received from a sensing circuit (generic computer element);
adjusting stimulation parameters based, at least in part, on the recorded ECAP features (insignificant pre-solution activity) in order to maintain consistent neural activation;
recording accelerometer data;
deploying the regression model to a patient via a stimulation output circuit (generic computer element) to deliver the neurostimulation (insignificant extra-solution activity).
The additional elements do not integrate the exception into a practical application of the exception because the elements are directed to mere instructions to apply an exception and insignificant extra-solution activity. The delivery, control, and adjustment of neurostimulation and data sensing and recording amount to no more than pre-solution activity of data gathering to receive the physiological data. The sensing and stimulation output circuits are generic computer elements that carries out the abstract steps described in claim 1 (see 2106.05(g) and 2106.05(f)). Deploying the regression model does not integrate the exception into a practical application of the exception because the limitation does not positively recite providing treatment (see 2106.04(d)(2)) and is directed to insignificant extra solution activity. Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea. Further, the judicial exception does not integrate the claim as a whole into a practical application because the claimed invention does not improve another technology or technical field. The alleged improvement made by the claimed invention as argued by the application above sets forth the improvement in a conclusory manner and the claim does not include the components or steps of the invention that the improvement described.
In re claim 13 and 20, see above (In re claim 1). Substantially, the same reasoning applies. Claim 13 has an additional limitation of “a machine-storage medium embodying instructions that, when executed by a machine, cause the machine to perform operations comprising” subject to the same analysis of the generic computer elements discussed above In re claim 1. Claim 20 has additional limitations of “one or more hardware processors of a machine” and “at least one memory storing instructions that, when executed by the one or more hardware processors, cause the system to perform operations comprising” subject to the same analysis of the generic computer elements discussed above In re claim 1.
Step 2B:
Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well understood, routine, conventional activity. The delivery, control, and adjustment of neurostimulation and data sensing amount to no more than pre-solution activity of data gathering to receive the physiological data. The sensing and stimulation output circuits are generic computer elements that carries out the abstract steps described in claim 1. Deploying the regression model does not integrate the exception into a practical application of the exception because the limitation does not positively recite providing treatment and is directed to insignificant extra solution activity. Moreover, implementing an abstract idea on a generic computer, does not add significantly more. Reconsidering the claim limitations individually and as a combination, the claims fail to meet the requirements for eligibility under 35 U.S.C. 101. All uses of the recited abstract idea require the pre-solution data gathering.
Regarding the limitations “delivering neurostimulation” and “deploying the regression model to a patient via a stimulation output circuit to deliver the neurostimulation”, see Mercanzini (US 9072906) which discloses a method for stimulating a neurological target (abstract) that uses an implantable pulse generator/neurostimulator (Col. 16, ln. 23-25). Thus, the limitations directed to the wearable device and the one or more sensors are well-understood, routine, and conventional, as evidenced by the reference above.
Moreover, implementing an abstract idea on a generic computer does not add significantly more. Reconsidering the claim limitations individually and as a combination, the claims fail to meet the requirements for eligibility under 35 U.S.C. 101. All uses of the recited abstract idea require the pre-solution data gathering.
In re claim 13 and 20, see above (In re claim 1). Substantially, the same reasoning applies. Claim 13 has an additional limitation of “a machine-storage medium embodying instructions that, when executed by a machine, cause the machine to perform operations comprising” subject to the same analysis of the generic computer elements discussed above In re claim 1. Claim 20 has additional limitations of “one or more hardware processors of a machine” and “at least one memory storing instructions that, when executed by the one or more hardware processors, cause the system to perform operations comprising” subject to the same analysis of the generic computer elements discussed above In re claim 1.
Claims 2-12, 14-19 recite the same abstract idea as their respective parent claims. Furthermore, these claims only contain recitations that further limit the abstract idea.
Claim Rejections – 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4, 7, 9, 13-15, 16, 18, 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Esteller (US 20210252289).
In re claim 1, Esteller discloses a method (Fig. 6: 600; [0085-0096]) for parameterizing a closed-loop algorithm for providing sub-perception therapy (abstract), the method comprising:
delivering neurostimulation ([0087]: “the remaining Phase 1 steps are performed using stimulation intensities that are above the neural threshold such that ECAP signals and features are measurable”);
sensing a neural signal indicative of neural responses (604: “Neural Features”; [0038, 0087]),
the neural responses each being a response to the delivering of the neurostimulation ([0038]: “it can be beneficial to sense a neural response in neural tissue that has received stimulation from the IPG”);
controlling the delivering of the neurostimulation using a plurality of stimulation parameters ([0087-0088]: “Each observed instance of the neural feature is also associated with one or more values of the stimulation parameters ( e.g., stimulation intensity, pulse width, frequency, etc.) that were used when the observation was made”);
recording evoked compound action potential (ECAP) features received from a sensing circuit ([0025]: “recording an electrospinogram (ESG) of the patient while receiving the one or more accelerometer signals; processing the ESG to extract an evoked compound action potential (ECAP) signal from the ESG”; [0087]);
adjusting stimulation parameters based, at least in part, on the recorded ECAP features in order to maintain consistent neural activation (Fig. 7: 700; Fig. 6: 606; [0090]: “The control system is then used to adjust the stimulation settings to maintain the neural feature(s) with respect to the set-point/set-range”);
recording accelerometer data (604: “Corresponding Accelerometer Signals”; [0087]: “simultaneous recording of the accelerometer signals is conducted”);
generating a regression model for mapping the accelerometer data to an optimal stimulation parameter to achieve consistent nerve activation (610; [0091-0094]),
the mapping enabling closed-loop control of the sub-perception therapy [0091, 0095];
applying the regression model and a sub-perception dose level to a plurality of sub-perception therapy programs [0095-0097]; and
deploying the regression model to a patient via a stimulation output circuit to deliver the neurostimulation [0079, 0095-0096].
In re claim 2, Esteller discloses further comprising:
identifying a target range for the ECAP features, the target range including an upper value of an ECAP range and a lower value of the ECAP range ([0086, 0090-0091]: “determining one or more set-points, set-ranges, or maximum threshold values for the neural feature(s) that correspond to comfortable and effective stimulation therapy”); and
determining the consistent nerve activation by maintaining values of the ECAP features within the target range [0090-0091].
In re claim 4, Esteller discloses wherein the one or more physical movements include one or more of a plurality of postural changes performed by the patient, the plurality of postural changes including at least one of lying down, standing up, bending over, twisting sidewise, performing daily life activities, and reclining [0087].
In re claim 7, Esteller discloses further comprising:
providing a monitoring platform [0006, 0018]; and
receiving information on a plurality of accelerometer data [0026],
the plurality of accelerometer data representing an overall patient health [0084] based on a combination of neurostimulation parameters comprising:
an electrical waveform [0007]; and
a selection of electrodes through which the electrical waveform is delivered [0039].
In re claim 9, Esteller discloses
wherein the plurality of accelerometer data provides supplemental data to the ECAP features to optimize stimulation in a sub-perception domain [0082], and
further comprising:
analyzing data for neurostimulation programming [0050, 0086].
In re claim 13, see above 35 U.S.C. 102 Rejection, In re claim 1. Further, Esteller discloses a machine-storage medium embodying instructions that, when executed by a machine, cause the machine to perform operations comprising [0027].
In re claim 14, see above 35 U.S.C. 102 Rejection above, In re claim 2.
In re claim 16, see above 35 U.S.C. 102 Rejection above, In re claim 4.
In re claim 18, see above 35 U.S.C. 102 Rejection above, In re claim 7.
In re claim 20, see above 35 U.S.C. 102 Rejection, In re claim 1 and 13. Further, Esteller discloses the limitation of a system for parameterizing a model for providing sub-perception therapy [0080], the system comprising:
one or more hardware processors of a machine [0023]; and
at least one memory storing instructions that, when executed by the one or more hardware processors, cause the system to perform operations comprising [0027].
Claim Rejections – 35 USC § 102/103
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.
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 12 is rejected under 35 U.S.C. 103 as being unpatentable over Esteller (US 20210252289) [in further view of Single (US 20230398360)].
In re claim 12, Esteller discloses:
wherein the regression model is further configured to generate a customized mapping for each patient by collecting ECAP and accelerometer data *in a clinical setting [0017; 0087-0099, 0094], and
wherein the regression model collects ECAP factors during the mapping ([0086-0087, 0094]: “the regression model may be trained on data collected on a patient during prescribed postural changes or a continuous recording”),
the ECAP factors selected from at least one of an amplitude, a detection threshold, a perception level, a linearity with stimulation intensity, the stimulation parameters, an electrode location, or neural activation levels [0051, 0086-0087, 0092-0094].
*Regarding the limitation “in a clinical setting”, it is apparent that the ECAP and accelerometer data is collected in a clinical setting as Esteller discloses the patient being instructed to perform tasks for measuring the ECAP and accelerometer data [0087] and the data is communicated with a clinical programmer [0017, 0022-0024]. Insofar as the ECAP and accelerometer data are not collected in a clinical setting as it is not explicitly stated, Claim 12 is rejected in further view of Single (US 20230398360). Single discloses a feedback loop control of a neuromodulation device wherein a clinician measures a patient response to a plurality of stimulus currents, including the ECAP threshold point and storing the information in clinical settings (Single: [0173-0174]).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method as disclosed by Esteller by providing wherein the regression model is further configured to generate a customized mapping for each patient by collecting a measured response to a plurality of stimulus currents, including the ECAP threshold point because it allows for an activation profile for the patient to be determined by a clinician in a controlled environment, where the clinician can verify the posture/activity routine of the patient while the ECAP and accelerometer features are measured (Esteller: [0086-0087]).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Esteller (US 20210252289) in view of Bink (US 20230364427).
In re claim 3, Esteller discloses
prompting the patient to perform one or more physical movements ([0087]: “The patient may be instructed to perform a variety of tasks (e.g., laugh, cough, walk, march in place, etc.) and/or assume a variety of postures (e.g., standing, sitting, supine, prone, etc.)”); and
receiving, via a user interface, patient input [0018-0020].
Esteller lacks:
receiving, via a user interface, patient input accounting for environmental factors that impact sensor readings.
Bink discloses a method of using processing circuitry to control and deliver electrical stimulation as well as to determine posture and activity information about the environment of the patient (abstract) that, similar to the method disclosed by Esteller, used closed-loop algorithm to determine optimal therapy to the patient. In addition, Bink discloses receiving input indicative of the patient and their environment to determine therapy [0023, 0028] as well as a user interface to receive user input [0052, 0094-0094].
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method as disclosed by Esteller by receiving posture and activity information about the environment of the patient that impact sensor readings as taught by Bink because variables of a patient’s environment may affect the level of pain relief a patient experiences with a given stimulation setting, for example if the patient is sleeping, awake, or distracted (Bink: [0022-0023]). Such a combination would yield receiving, via a user interface, patient input accounting for environmental factors that impact sensor readings.
In re claim 15, see above 35 U.S.C. 102 Rejection above, In re claim 3.
Claims 5-6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Esteller (US 20210252289) in view of Hendrick (US 20240399154).
In re claim 5, Esteller lacks:
identifying one or more settings in which to suggest alterations for delivering the neurostimulation to the patient, the neurostimulation being at least partially defined based on the accelerometer data.
Hendrick discloses a method for planning, updating, and delivering AEF therapy (abstract), for example, spinal cord stimulation (i.e. neurostimulation, [0090]) that, like Esteller, determines a stimulation therapy based on feedback regarding the state of the patient [0099]. In addition, Hendrick discloses recommending stimulation parameters that at least partially define the AEF therapy to a user (i.e. patient) via a user interface, such as when non-target tissues are receiving stimulation [0098-0099].
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method as disclosed by Esteller by providing a method for suggesting alterations to neurostimulation to the patient as taught by Hendrick because it would allow the patient to change therapy if the neurostimulation is not functioning appropriately, such as stimulating non-target tissues (Hendrick: [0098]), or if the patient wishes to decline an alteration in therapy at the present time due to their current circumstance or activity. Such a combination would yield “identifying one or more settings in which to suggest alterations for delivering the neurostimulation to the patient, the neurostimulation being at least partially defined based on the accelerometer data”.
In re claim 6, see above 35 U.S.C. 102 Rejection above, In re claim 5.
In re claim 8, Esteller lacks:
generating a suggestion for one or more additional combinations of the neurostimulation parameters; and
providing the suggestion to the monitoring platform.
Hendrick discloses a method for planning, updating, and delivering AEF therapy (abstract), for example, spinal cord stimulation (i.e. neurostimulation, [0090]) that, like Esteller, determines a stimulation therapy based on feedback regarding the state of the patient [0099]. In addition, Hendrick discloses recommending one or more stimulation parameters that at least partially define the AEF therapy to a user (i.e. patient) via a user interface (i.e. monitoring platform) [0069, 0098-0099, 0129].
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method as disclosed by Esteller by providing a method for suggesting one or more stimulation parameters and providing the suggestion to a user interface as taught by Hendrick because it would allow the patient to alter the stimulation therapy to a desired neurostimulation and adjusting one or more parameters would allow for targeting the desired neurostimulation without exceeding safety thresholds for the parameters (Hendrick: [0202]). Such a combination would yield “generating a suggestion for one or more additional combinations of the neurostimulation parameters; and providing the suggestion to the monitoring platform”.
In re claim 17, see above 35 U.S.C. 103 Rejection above, In re claim 5.
In re claim 19, see above 35 U.S.C. 103 Rejection above, In re claim 8.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Esteller (US 20210252289) in view of Kent (US 20190262610).
In re claim 10, Esteller discloses:
adjusting the closed-loop algorithm using patient-specific data [0096-0097].
Esteller lacks:
initializing the closed-loop algorithm based at least in part on historical patient data.
Kent discloses a method for predicting beneficial spinal cord stimulation patterns [0001] wherein a computational model is initially input with historical patient data to assess stimulation patters [0059] where measured neural activity is not available and a feedback loop (Fig. 8) using measured neural activity as the feedback signal [0060].
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method as disclosed by Esteller by providing wherein a model is initially input with historical patient data as taught by Kent because it would provide a model with data indicitave of the patient’s average health when measured neural activity is not available. Such a combination would yield “initializing the closed-loop algorithm based at least in part on historical patient data”.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Esteller (US 20210252289) in view of Esteller (US 20190209844).
In re claim 11, Esteller (‘289) discloses:
rescaling the mapping to account for changes identified ([0097]: “the prediction model 800 provided to the controller 702 may be rescaled to account for the lower stimulation intensity used during sub-perception stimulation”) in an implantable pulse generator (IPG) (Fig. 5: 100; [0026]: “the prediction model is programmed into a control circuitry of the IPG”),
the IPG configured to deliver electrical stimulation through leads (14) and electrodes (electrode array 17 with electrodes E3-E9).
Esteller (‘289) lacks:
recalibrating the mapping to account for changes identified in an implantable pulse generator (IPG).
Esteller (‘844) discloses a method for providing spinal cord stimulation (abstract) that, similar to the method disclosed by Esteller (‘289), utilizes a closed loop approach to adjust stimulation [0097]. In addition, Esteller (‘844) discloses recalibrating an ECAP algorithm in response to changes in pain perception [0078, 0094].
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method as disclosed by Esteller (‘289) by providing wherein the mapping is recalibrated to account for identified changes as taught by Esteller (‘844) because it would allow for the therapy to be determined using updated data when the stimulation is not working as expected, for example if the implanted leads have shifted or if the patient’s response to the stimulation changes over time (Esteller (‘844): [0078]).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALLE M WELCH whose telephone number is (571)272-0168. The examiner can normally be reached Mon-Fri, 8:30 am to 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, David E 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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/HALLE MARGARET WELCH/
Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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