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.
Claims 11 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites a method for delivering neurostimulation to a patient using a stimulation device. However, the claims don’t actually recite using a neurostimulator to deliver therapy.
To start off, step 1 is covered as the claims recite a process.
Moving on to step 2A, this is a two-prong analysis. Under prong one, examiner is required to show the abstract idea, law of nature, or natural phenomenon. In this case, examiner points out that the steps of “determining a therapeutic effect threshold of an adjustable parameter of a set of stimulation parameters using the sensed information”, “determining the set of stimulation parameters for producing the therapeutic effect using the therapeutic effect threshold of the adjustable parameter”, and “programming the stimulation device to control the delivery of the neurostimulation according to the set of stimulation parameters” are the abstract idea directed to a mental process. These limitations, under broadest reasonable interpretation, can be done in the mind other than the recitation of the generic computer component. That is, other than reciting “a stimulation device” and “a non-transitory computer-readable storage medium” (claim 20) nothing in the claim precludes the step from practically being performed in the mind. The step of determining can simply mean calculating the threshold or simply comparing the adjustable parameter to a table to determine threshold and the step of programming can simply mean inputting stimulation parameters into a computer. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claims recites an abstract idea.
Under prong two, examiner is required to show that the judicial exception is not integrated into a practical application. In particular, the claims recites these additional elements including: “receiving sensed information indicative of a therapeutic effect improving a condition being treated using the neurostimulation”. In this case, all of the additional elements recited are being performed using a generic computer function such that it amounts no more than mere instructions to apply the exception using a generic computer component. The receiving is merely data gathering that a generic computer can perform. Accordingly, these additional element do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea (MPEP 2106.05F). The claims are directed to an abstract idea.
Lastly for step 2B, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of receiving amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claim is not patent eligible.
Examiner states that the claim recites a judicial exception, but is not integrated into a practical application (Step 2b of 2019 PEG). In particular the steps of the claim do not recite any additional element that is required for the claim to be performed, moreover the steps of the claim add insignificant extra-solution activity to the abstract idea. (See MPEP 2106.05 (g)). Therefore, the claim does not integrate the abstract idea into a practical application, because it does not impose any meaningful limits on practicing the abstract idea. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements recited. Dependent claims 12-19 do not integrate the abstract idea into a practical application.
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.
Claim(s) 1-4, 11-13, 15, and 19-20 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by WO 2023/186887 Riahi et al., hereinafter “Riahi”.
Regarding claim 1, Riahi discloses a system for delivering neurostimulation to a patient using a stimulation device (Abstract), the system comprising: a programming control circuit (Para 71; a control unit) configured to generate information for programming the stimulation device to control the delivery of the neurostimulation according to a set of stimulation parameters (Para 20 and 71; the set of parameters include the amplitude threshold that is set in Para 51); and a stimulation programming circuit configured to determine the set of stimulation parameters, the stimulation programming circuit including (Para 71; the stimulation programming circuit is interpreted to be the main unit that contains all the circuitries): a sensed signal input configured to receive sensed information indicative of a therapeutic effect improving a condition being treated using the neurostimulation (Figure 1, element 120 is the eCAP sensor that is the signal data relied on to determine perception, see Para 51; perception in this case is the desired therapeutic effect); threshold detection circuity configured to determine a therapeutic effect threshold of an adjustable parameter of the set of stimulation parameters using the sensed information, the therapeutic effect threshold being a minimum value of the adjustable parameter for the delivery of the neurostimulation according to the set of stimulation parameters to produce the therapeutic effect (Para 71 shows the microprocessor which in this case is the threshold detection circuity; Para 51 and 81-82; show how the threshold is set, Para 51 specifically discloses “the perception threshold (PT) may be understood as a measure of a minimum stimulation input (e.g. a lowest stimulation amplitude) by the neurostimulation device necessary to generate a perceptible sensation for the patient”); and parameter setting circuity configured to determine the set of stimulation parameters for producing the therapeutic effect using the therapeutic effect threshold of the adjustable parameter (Para 51; a minim stimulation input is determined and applied to the user and is updated regularly).
Regarding claim 2, Riahi discloses the parameter setting circuity is configured to determine the set of stimulation parameters for producing the therapeutic effect in the patient using a minimum effective amplitude of a stimulation amplitude of the set of stimulation parameters (Para 51 and 81-82), and the threshold detection circuity is configured to determine the minimum effective amplitude using the sensed information, the minimum effective amplitude being a minimum value of the stimulation amplitude for the delivery of the neurostimulation according to the set of stimulation parameters to produce the therapeutic effect in the patient (Para 51 and 81-82; minimum stimulation input required to cause perception by the user based on the eCAPS measured).
Regarding claim 3, Riahi discloses the threshold detection circuity is configured to determine the therapeutic effect threshold of the adjustable parameter using a physiological signal of the sensed information, the physiological signal sensed while the neurostimulation is delivered to the patient with the value of the adjustable parameter swept across a test range (Para 51 and 82; the perception threshold is set based on eCAP measurements, the value is set at a minim and is tested once every hour to readjust the parameters, therefore an initial test range must be set based on a preoperative value, see also Para 84).
Regarding claim 4, Riahi discloses the threshold detection circuity is configured to: measure a biomarker parameter from the physiological signal (Para 82; “eCAP feature (e.g. eCAP amplitude, eCAP duration, eCAP frequency component)”); compare the measured biomarker parameter to a sensed effect threshold (Para 82); and identify the therapeutic effect threshold of the adjustable parameter from the test range, the therapeutic effect threshold being a minimum value at which the measured biomarker parameter reaches or exceeds the sensed effect threshold (Para 82 and 51).
Regarding claim 11, Riahi discloses a method for delivering neurostimulation to a patient using a stimulation device (Abstract), the method comprising: receiving sensed information indicative of a therapeutic effect improving a condition being treated using the neurostimulation (Figure 1, element 120 is the eCAP sensor that is the signal data relied on to determine perception, see Para 51; perception in this case is the desired therapeutic effect); determining a therapeutic effect threshold of an adjustable parameter of a set of stimulation parameters using the sensed information, the therapeutic effect threshold being a minimum value of the adjustable parameter for the delivery of the neurostimulation according to the set of stimulation parameters to produce the therapeutic effect (Para 71 shows the microprocessor which in this case is the threshold detection circuity; Para 51 and 81-82; show how the threshold is set, Para 51 specifically discloses “the perception threshold (PT) may be understood as a measure of a minimum stimulation input (e.g. a lowest stimulation amplitude) by the neurostimulation device necessary to generate a perceptible sensation for the patient”); determining the set of stimulation parameters for producing the therapeutic effect using the therapeutic effect threshold of the adjustable parameter (Para 71; the stimulation programming circuit is interpreted to be the main unit that contains all the circuitries); and programming the stimulation device to control the delivery of the neurostimulation according to the set of stimulation parameters (Para 51; a minim stimulation input is determined and applied to the user and is updated regularly).
Regarding claim 12, Riahi discloses receiving stored sensed information including at least one of a previously sensed physiological signal or information derived from the previously sensed physiological signal (Para 39 and 91), and wherein determining the therapeutic effect threshold of the adjustable parameter comprises determining the therapeutic effect threshold of the adjustable parameter using the received stored sensed information (Para 39 and 51).
Regarding claim 13, Riahi discloses sensing a physiological signal from the patient in real time (Figure 1, element 120 is the eCAP sensor that is the signal data relied on to determine perception; Para 51 and 82; regularly determined), and wherein receiving the sensed information comprises receiving the physiological signal in real time (Para 51 and 82), and determining the therapeutic effect threshold of the adjustable parameter comprises determining the therapeutic effect threshold of the adjustable parameter in real time (Para 51 and 82).
Regarding claim 15, Riahi discloses determining the therapeutic effect threshold of the adjustable parameter comprises: measuring a biomarker parameter from the physiological signal (Para 82; “eCAP feature (e.g. eCAP amplitude, eCAP duration, eCAP frequency component)”) sensed while delivering the neurostimulation to the patient with the value of the adjustable parameter swept across a test range (Para 51 and 82; the perception threshold is set based on eCAP measurements, the value is set at a minim and is tested once every hour to readjust the parameters, therefore an initial test range must be set based on a preoperative value, see also Para 84); comparing the measured biomarker parameter to a sensed effect threshold; and identifying the therapeutic effect threshold of the adjustable parameter from the test range (Para 82), the therapeutic effect threshold being a minimum value at which the measured biomarker parameter reaches or exceeds the sensed effect threshold (Para 82 and 51).
Regarding claim 19, Riahi discloses monitoring the therapeutic effect threshold of the adjustable parameter over time (Para 51 and 82); detecting an unanticipated significant change of the therapeutic effect threshold of the adjustable parameter; and producing a notification in response to a detection of the unanticipated significant change (Para 82 and 84).
Regarding claim 20, Riahi discloses a non-transitory computer-readable storage medium including instructions (Para 53 and 56), which when executed by a system, cause the system to perform a method for delivering neurostimulation to a patient using a stimulation device (Abstract), the method comprising: receiving sensed information indicative of a therapeutic effect improving a condition being treated using the neurostimulation (Figure 1, element 120 is the eCAP sensor that is the signal data relied on to determine perception, see Para 51; perception in this case is the desired therapeutic effect); determining a therapeutic effect threshold of an adjustable parameter of a set of stimulation parameters using the sensed information, the therapeutic effect threshold being a minimum value of the adjustable parameter for the delivery of the neurostimulation according to the set of stimulation parameters to produce the therapeutic effect (Para 71 shows the microprocessor which in this case is the threshold detection circuity; Para 51 and 81-82; show how the threshold is set, Para 51 specifically discloses “the perception threshold (PT) may be understood as a measure of a minimum stimulation input (e.g. a lowest stimulation amplitude) by the neurostimulation device necessary to generate a perceptible sensation for the patient”); determining the set of stimulation parameters for producing the therapeutic effect using the therapeutic effect threshold of the adjustable parameter (Para 71; the stimulation programming circuit is interpreted to be the main unit that contains all the circuitries); and programming the stimulation device to control the delivery of the neurostimulation according to the set of stimulation parameters (Para 51; a minim stimulation input is determined and applied to the user and is updated regularly).
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) 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2023/186887 Riahi et al., hereinafter “Riahi”, in view of US 2022/0184401 Vaidyanathan, hereinafter “Vaidyanathan”.
Regarding claim 5, Riahi discloses all the limitations of claim 1.
Riahi does not disclose the set of stimulation parameters defines a pattern of neurostimulation including one or more stimulation waveforms and one or more stimulation fields, and the sensed signal input is configured to receive a neural signal including evoked resonant neural activity (ERNA).
However, Vaidyanathan discloses a system/method of electrical stimulation therapy (Abstract) and teaches the set of stimulation parameters defines a pattern of neurostimulation including one or more stimulation waveforms and one or more stimulation fields (Para 33 and 45), and the sensed signal input is configured to receive a neural signal including evoked resonant neural activity (ERNA) (Para 26 and 103).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed evoked resonant neural activity as taught by Vaidyanathan, in the invention of Riahi, in order to monitor neurological brain signals (Vaidyanathan; Para 26).
Regarding claim 14, Riahi discloses all the limitations of claim 13.
Riahi does not disclose the physiological signal comprises a neural signal including evoked resonant neural activity (ERNA).
However, Vaidyanathan discloses a system/method of electrical stimulation therapy (Abstract) and teaches the physiological signal comprises a neural signal including evoked resonant neural activity (ERNA) (Para 26 and 103).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed evoked resonant neural activity as taught by Vaidyanathan, in the invention of Riahi, in order to monitor neurological brain signals (Vaidyanathan; Para 26).
Claim(s) 6, 8-9, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2023/186887 Riahi et al., hereinafter “Riahi”, in view of WO 2020/036886 Molnar et al., hereinafter “Molnar”.
Regarding claim 6, Riahi discloses the parameter setting circuity is configured to set a value range of the adjustable parameter (Para 51).
Riahi does not disclose the adjustable parameter having a lower bound and an upper bound, the lower bound set based on the therapeutic effect threshold of the adjustable parameter.
However, Molnar discloses a neurostimulation method/device (Abstract) and teaches the adjustable parameter having a lower bound and an upper bound, the lower bound set based on the therapeutic effect threshold of the adjustable parameter (Para 1239; “Upper and lower limits for stimulation parameters may be set such that that those bounds are not exceeded”).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a lower bound and an upper bound as taught by Molnar, in the invention of Riahi, in order to ensure that safety boundaries are not exceeded (Molnar; Para 1239).
Regarding claim 8, Riahi discloses a user interface (figure 1, element 160) including a presentation device and a user input device (Para 76; manual input interface and the external input handheld display device), and wherein the parameter setting circuity is configured to set the value range of the adjustable parameter for identifying an optimal value of the adjustable parameter in a stimulation setting for the patient (Para 51), to present the therapeutic effect threshold of the adjustable parameter using the presentation device (Para 44 and 82), and to allow the lower bound to be set using the user input device (Para 51; “the system may be configured to determine the perception threshold based at least in part on a manual input to the system”).
Regarding claim 9, Riahi discloses the stimulation programming circuit further comprises a notification circuitry to detect a substantial change in the therapeutic effect threshold of the adjustable parameter and to present a notification using the presentation device in response to a detection of the substantial change (Para 82 and 84).
Regarding claim 16, Riahi discloses determining the set of stimulation parameters comprises determining a value range of the adjustable parameter (Para 51).
Riahi does not disclose the adjustable parameter having a lower bound and an upper bound, the lower bound set based on the therapeutic effect threshold of the adjustable parameter.
However, Molnar discloses a neurostimulation method/device (Abstract) and teaches the adjustable parameter having a lower bound and an upper bound, the lower bound set based on the therapeutic effect threshold of the adjustable parameter (Para 1239; “Upper and lower limits for stimulation parameters may be set such that that those bounds are not exceeded”).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a lower bound and an upper bound as taught by Molnar, in the invention of Riahi, in order to ensure that safety boundaries are not exceeded (Molnar; Para 1239).
Regarding claim 17, Riahi discloses setting the lower bound based on the therapeutic effect threshold of the adjustable parameter (Para 51 and 82) comprises: presenting the therapeutic effect threshold using a user interface (Para 44 and 82); and allowing a user to set the lower bound using the user interface (Para 51; “the system may be configured to determine the perception threshold based at least in part on a manual input to the system”).
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2023/186887 Riahi et al., hereinafter “Riahi”, in view of WO 2020/036886 Molnar et al., hereinafter “Molnar”, further in view of WO 2011/156287 Su et al., hereinafter “Su”.
Regarding claim 7, Riahi discloses all the limitations of claim 6.
Riahi does not disclose the parameter setting circuity is configured to set the value range of the adjustable parameter for identifying an optimal value of the adjustable parameter in a stimulation setting for the patient and to set the lower bound automatically to the therapeutic effect threshold of the adjustable parameter multiplied by a factor.
However, Su discloses an electrical stimulation device/method (Abstract) and teaches the parameter setting circuity is configured to set the value range of the adjustable parameter for identifying an optimal value of the adjustable parameter in a stimulation setting for the patient and to set the lower bound automatically to the therapeutic effect threshold of the adjustable parameter multiplied by a factor (Para 111; “the therapeutic threshold or physiological threshold may be determined, and then a lower intensity stimulation level may be selected as a percentage of a selected one of the thresholds, e.g., based on a percentage of the amplitude associated with the selected threshold, or one or more of amplitude, pulse width or pulse rate”).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a lower bound as taught by Su, in the invention of Riahi, in order to ensure a desired effect after the stimulation has ended (Su; Para 111).
Claim(s) 10 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2023/186887 Riahi et al., hereinafter “Riahi”, in view of US 2016/0361542 Kaula et al., hereinafter “Kaula”.
Regarding claim 10, Riahi discloses the parameter setting circuity is configured to determine values of the adjustable parameter in a stimulation program including a stimulation ramp during which the value of the adjustable parameter changes in increments from or to a bound or turning point and to set the bound or turning point based on the therapeutic effect threshold of the adjustable parameter (Para 51 and 84).
Even if Riahi does not disclose the parameter setting circuity is configured to determine values of the adjustable parameter in a stimulation program including a stimulation ramp during which the value of the adjustable parameter changes in increments from or to a bound or turning point and to set the bound or turning point based on the therapeutic effect threshold of the adjustable parameter.
Kaula discloses an electrical stimulation device/method (Abstract) and teaches the parameter setting circuity is configured to determine values of the adjustable parameter in a stimulation program including a stimulation ramp during which the value of the adjustable parameter changes in increments from or to a bound or turning point and to set the bound or turning point based on the therapeutic effect threshold of the adjustable parameter (Abstract and Para 14).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed stimulation ramping as taught by Kaula, in the invention of Riahi, in order to ensure the patient is feeling the electrical stimulation (Kaula; Para 14).
Regarding claim 18, Riahi discloses determining the set of stimulation parameters comprises: determining values of the adjustable parameter in a stimulation program including a stimulation ramp during which the value of the adjustable parameter changes in increments from or to a bound or turning point; and setting the bound or turning point based on the therapeutic effect threshold of the adjustable parameter (Para 51 and 84).
Even if Riahi does not disclose determining the set of stimulation parameters comprises: determining values of the adjustable parameter in a stimulation program including a stimulation ramp during which the value of the adjustable parameter changes in increments from or to a bound or turning point; and setting the bound or turning point based on the therapeutic effect threshold of the adjustable parameter.
Kaula discloses an electrical stimulation device/method (Abstract) and teaches determining the set of stimulation parameters comprises: determining values of the adjustable parameter in a stimulation program including a stimulation ramp during which the value of the adjustable parameter changes in increments from or to a bound or turning point; and setting the bound or turning point based on the therapeutic effect threshold of the adjustable parameter (Abstract and Para 14).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed stimulation ramping as taught by Kaula, in the invention of Riahi, in order to ensure the patient is feeling the electrical stimulation (Kaula; Para 14).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/ANKIT D TEJANI/Primary Examiner, Art Unit 3796
Prosecution Insights