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 § 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 and 11is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (US 2019009094).
Regarding claim 1, Zhang discloses a device to identify therapy and sensing capabilities of neurostimulation programming, the device comprising:
one or more processors (sections 0082, 0134); and
one or more memory devices comprising instructions, which when executed by the one or more processors (Section 0082), cause the one or more processors to:
identify an arrangement for a plurality of electrical contacts of one or more implanted leads (Section 0085, 0087);
identify neurostimulation parameters for delivering therapy to a neurostimulation location using a first set of electrical contacts of the arrangement (Section 0085);
determine a sensing capability for sensing an evoked response to the therapy delivered to the neurostimulation location, using a second set of electrical contacts of the arrangement, wherein the sensing capability is determined based on the arrangement and one or more of the neurostimulation parameters (section 0091); and
change at least a portion of the neurostimulation parameters for delivering the therapy, in response to a determination that the sensing capability is not available at the neurostimulation location, to provide changed neurostimulation parameters for delivering therapy to a changed neurostimulation location (section 0124, placement (e.g., rostral vs. caudal placement) of an electrode may determine which neural elements are activated at lowest stimulation intensities).
Regarding claim 11, Zhang discloses a method for identifying therapy and sensing capabilities of neurostimulation programming, comprising:
identifying an arrangement for a plurality of electrical contacts of one or more implanted leads (Section 0085, 0087);
identifying neurostimulation parameters for delivering therapy to a neurostimulation location using a first set of electrical contacts of the arrangement (Section 0085);
determining a sensing capability for sensing an evoked response to the therapy delivered to the neurostimulation location, using a second set of electrical contacts of the arrangement, wherein the sensing capability is determined based on the arrangement and one or more of the neurostimulation parameters (section 0091); and
changing at least a portion of the neurostimulation parameters for delivering the therapy, in response to a determination that the sensing capability is not available at the neurostimulation location, to provide changed neurostimulation parameters for delivering therapy to a changed neurostimulation location (section 0124, placement (e.g., rostral vs. caudal placement) of an electrode may determine which neural elements are activated at lowest stimulation intensities).
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rivera et al. (US 20220280789).
Regarding claim 1, Rivera discloses a device to identify therapy and sensing capabilities of neurostimulation programming, the device comprising:
one or more processors (sections 0063); and
one or more memory devices 311 comprising instructions, which when executed by the one or more processors (Fig. 3, section 0062), cause the one or more processors to:
identify an arrangement 316 for a plurality of electrical contacts of one or more implanted leads (Fig. 3, section 0063);
identify neurostimulation parameters 317 for delivering therapy to a neurostimulation location using a first set of electrical contacts of the arrangement (Fig. 3, section 0063);
determine a sensing capability for sensing an evoked response to the therapy delivered to the neurostimulation location, using a second set of electrical contacts of the arrangement, wherein the sensing capability is determined based on the arrangement and one or more of the neurostimulation parameters (Fig. 7, section 0074); and
change at least a portion of the neurostimulation parameters for delivering the therapy, in response to a determination that the sensing capability is not available at the neurostimulation location, to provide changed neurostimulation parameters for delivering therapy to a changed neurostimulation location (Fig. 3, section 0062).
Regarding claim 2, Rivera discloses the device of claim 1, wherein
the neurostimulation location corresponds to a central point of stimulation provided with the first set of electrical contacts, and wherein to determine the sensing capability at the neurostimulation location includes to determine whether an evoked compound action potential (ECAP) is observable (section 0057-0058).
Regarding claim 3, Rivera discloses the device of claim 1, wherein
operations to identify the neurostimulation parameters, to determine the sensing capability, and to change the neurostimulation parameters, are iteratively repeated to produce the changed neurostimulation parameters associated with changed neurostimulation locations, until an evoked compound action potential (ECAP) is observed from use of the changed neurostimulation parameters at one of the changed neurostimulation locations (section 0061).
Regarding claim 4, Rivera discloses the device of claim 1, wherein the instructions further cause the one or more processors to perform operations that:
determine that the sensing capability is available at the changed neurostimulation location (section 0065); and
enable use of the changed neurostimulation parameters within one or more programs of a neurostimulation device (section 0063).
Regarding claim 5, Rivera discloses the device of claim 4, wherein the instructions further cause the one or more processors to perform operations that:
receive an indication that the therapy remains effective for a patient at the changed neurostimulation location (section 0061);
wherein the changed neurostimulation parameters are enabled for use within the one or more programs in response to the indication that the therapy remains effective for the patient (section 0061).
Regarding claim 6, Rivera discloses the device of claim 5, wherein the instructions further cause the one or more processors to perform operations that:
determine that the sensing capability is available via the second set of electrical contacts of the arrangement, based on use of the changed neurostimulation parameters (Fig. 7, section 0061, 0074);
wherein the changed neurostimulation parameters are enabled for use within the one or more programs in response to a determination that both the sensing capability remains available and the therapy remains effective for the patient (section 0061).
Regarding claim 7, Rivera discloses the device of claim 6, wherein
the change to the neurostimulation parameters is based on a suggested sensing area or a sensing exclusion area (section 0065);
wherein a size and a location of the suggested sensing area or the sensing exclusion area is based on lead geometry and stimulation waveform characteristics (section 0062-0064).
Regarding claim 8, Rivera discloses the device of claim 1, wherein the instructions further cause the one or more processors to:
display, in a programming user interface 314, a representation of the neurostimulation location 320 and a representation of the plurality of electrical contacts 315 (Fig. 3, section 0062);
wherein the change to the neurostimulation parameters 317 is based on settings of the neurostimulation parameters that are modifiable in the programming user interface (Fig. 3, section 0062).
Regarding claim 9, Rivera discloses the device of claim 8, wherein the instructions further cause the one or more processors to:
display, in the programming user interface 314 , a representation of a suggested sensing area 320, relative to the area of the therapy (Fig. 3, section 0062);
display, in the programming user interface 314, a representation of a sensing 318 exclusion area, relative to the area of the therapy (Fig. 3, section 0065); and
receive user interaction in the programming user interface to change at least one value of the neurostimulation parameters 317 or the neurostimulation location, based on the suggested sensing area or the sensing exclusion area (Fig. 3, section 0062, 0065).
Regarding claim 10, Rivera discloses the device of claim 9, wherein
the user interaction to change the at least one value of the neurostimulation parameters relates to a change to amplitude, pulse width, frequency, and percentage, of modulated energy to be provided with a particular contact of the plurality of electrical contacts (Section 0077).
Regarding claim 11, Rivera discloses a method for identifying therapy and sensing capabilities of neurostimulation programming, comprising:
identifying an arrangement 316 for a plurality of electrical contacts of one or more implanted leads (Fig. 3, section 0063);
identifying neurostimulation parameters 317 for delivering therapy to a neurostimulation location using a first set of electrical contacts of the arrangement (Fig. 3, section 0063);
determining a sensing capability for sensing an evoked response to the therapy delivered to the neurostimulation location, using a second set of electrical contacts of the arrangement, wherein the sensing capability is determined based on the arrangement and one or more of the neurostimulation parameters (Fig. 7, section 0074); and
changing at least a portion of the neurostimulation parameters for delivering the therapy, in response to a determination that the sensing capability is not available at the neurostimulation location, to provide changed neurostimulation parameters for delivering therapy to a changed neurostimulation location (Fig. 3, section 0062).
Regarding claim 12, Rivera discloses the method of claim 11, wherein
the neurostimulation location corresponds to a central point of stimulation provided with the first set of electrical contacts, and wherein determining the sensing capability at the neurostimulation location includes determining whether an evoked compound action potential (ECAP) is observable (section 0057-0058).
Regarding claim 13, Rivera discloses the method of claim 11, wherein
identifying the neurostimulation parameters, determining the sensing capability, and changing the neurostimulation parameters, are iteratively repeated to produce the changed neurostimulation parameters associated with changed neurostimulation locations, until an evoked compound action potential (ECAP) is observed from use of the changed neurostimulation parameters at one of the changed neurostimulation locations (section 0061).
Regarding claim 14, Rivera discloses the method of claim 11, further comprising:
determining that the sensing capability is available at the changed neurostimulation location (section 0065); and
enabling use of the changed neurostimulation parameters within one or more programs of a neurostimulation device (Section 0063).
Regarding claim 15, Rivera discloses the method of claim 14, further comprising:
receiving an indication that the therapy remains effective for a patient at the changed neurostimulation location (section 0061);
wherein the changed neurostimulation parameters are enabled for use within the one or more programs in response to the indication that the therapy remains effective for the patient (section 0061).
Regarding claim 16, Rivera discloses the method of claim 15, further comprising:
determining that the sensing capability is available via the second set of electrical contacts of the arrangement, based on use of the changed neurostimulation parameters (Fig. 7, section 0061, 0074);
wherein the changed neurostimulation parameters are enabled for use within the one or more programs in response to determining that both the sensing capability remains available and the therapy remains effective for the patient (section 0061).
Regarding claim 17, Rivera discloses the method of claim 16, wherein
the change to the neurostimulation parameters is based on a suggested sensing area or a sensing exclusion area (Section 0065);
wherein a size and a location of the suggested sensing area or the sensing exclusion area is based on lead geometry and stimulation waveform characteristics (section 0062-0064).
Regarding claim 18, Rivera discloses the method of claim 11, further comprising:
displaying, in a programming user interface 314, a representation of the neurostimulation location 320 and a representation of the plurality of electrical contacts 315 (Fig. 3, section 0062);
wherein the change to the neurostimulation parameters is based on settings of the neurostimulation parameters that are modifiable 317 in the programming user interface (Fig. 3, section 0062).
Regarding claim 19, Rivera discloses the method of claim 18, further comprising:
displaying, in the programming user interface 314 , a representation of a suggested sensing area 320, relative to the area of the therapy (Fig. 3, section 0062);
displaying, in the programming user interface 314, a representation of a sensing 318 exclusion area, relative to the area of the therapy (Fig. 3, section 0065); and
receive user interaction in the programming user interface to change at least one value of the neurostimulation parameters 317 or the neurostimulation location, based on the suggested sensing area or the sensing exclusion area (Fig. 3, section 0062, 0065).
Regarding claim 20, Rivera discloses the method of claim 19, wherein
the user interaction to change the at least one value of the neurostimulation parameters relates to a change to amplitude, pulse width, frequency, and percentage, of modulated energy to be provided with a particular contact of the plurality of electrical contacts (Section 0077).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796
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