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 .
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1-13 in the reply filed on August 3, 2026 is acknowledged. Currently claims 1-20 are pending in this application, with claims 14-20 withdrawn from consideration.
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.
Claims1-8 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over John et al. (US 2022/0143394).
Regarding claim 1, John disclose a system comprising (e.g. Claim 1) a device comprising processing circuitry configured to:
deliver one or more electrical stimulation pulses to one or more nerves of a patient and prior to implantation of an implantable medical device, the one or more nerves being associated with stimulation therapy (e.g. steps (a) to (c) of claim 1 of John).
sense an evoked signal generated by one or more signal sources in response to delivery of the one or more electrical stimulation pulses (e.g. step (d) of claim 1 of John);
determine, based at least in part on the evoked signal, a therapy response group of a plurality of therapy response groups for the patient (e.g. step (e) of claim 1 of John)
wherein the therapy response group indicates whether implantation of the implantable medical device is recommended output information indicative of the determined therapy response group (e.g. step (f) of prescribing implantation of a neurostimulator if the response is positive which necessarily requires on output of information).
Claim 1 of John does not expressly disclose that the delivery of stimulation is via one or more inserted electrodes on a lead or via a conductive portion on an evaluation needle, but rather discloses transcutaneous stimulation. John does, also, however, disclose using percutaneous needle stimulation to determine more precise stimulation desires once stimulation is recommended (e.g. assessment of sites using a percutaneous needle as disclosed in [0054]). It would have been obvious to one having ordinary skill in the art to include the percutaneous needle of John in the screening setup of John, since such a modification would provide the system with the predicable results of a reliable means of determining whether stimulation would be beneficial.
Regarding claim 2, John additionally discloses wherein to determine the therapy response group for the patient, the processing circuitry is further configured to determine the therapy response group for the patient substantially coincident with the delivery of the one or more electrical stimulation pulses (e.g. results can be assessed after 1 treatment session as disclosed in [0041]).
Regarding claim 3, John additionally discloses 3. wherein to determine the therapy response group for the patient, the processing circuitry is further configured to determine the therapy response group for the patient within a time period after delivery of the one or more electrical stimulation pulses, wherein the time period includes one of: less than one day; less than one hour; less than one minute; or less than one second (e.g. results can be assessed after 1 treatment session as disclosed in [0041] which is less than 1 day).
Regarding claim 4, John additionally discloses wherein the one or more nerves include the sacral nerve (e.g. as disclosed in [0047]).
Regarding claim 5, John additionally discloses wherein the processing circuitry is further configured to: determine that the evoked signal satisfies one or more criteria (e.g. positive criteria as taught in claim 1); and wherein to determine the therapy response group for the patient, the processing circuitry is further configured to classify, responsive to determining that the evoked signal satisfies the one or more criteria, the patient into the therapy response group that indicates that implantation of the implantable medical device is recommended for delivering stimulation therapy to the patient (e.g. as shown in Claim 1).
Regarding claim 6, John additionally discloses 6. The system of claim 1, wherein the processing circuitry is further configured to: determine that the evoked signal does not satisfy one or more criteria (e.g. negative response as taught in Claim 1); and wherein to determine the therapy response group for the patient, the processing circuitry is further configured to classify, responsive to determining that the evoked signal does not satisfy the one or more criteria, the patient into the therapy response group that indicates that the patient is a candidate for longer term evaluation of whether to receive therapy with the implantable medical device (e.g. as disclosed in claim 5).
Regarding claim 7, John additionally discloses wherein the evoked signal comprises a second evoked signal and the one or more electrical stimulation pulses comprises a second set of one or more electrical stimulation pulses, and the processing circuitry is further configured to: determine that a first evoked signal, evoked prior to the second evoked signal from delivery of a first set of one or more electrical stimulation pulses delivered to a first location, does not satisfy one or more criteria; and wherein to deliver the second set of one or more electrical stimulation pulses the processing circuitry is further configured to deliver, responsive to the determination that the first evoked signal does not satisfy the one or more criteria, the second set of one or more electrical stimulation pulses at a second location different than the first location (e.g. second location as taught in Claim 6).
Regarding claim 8, John discloses that the evoked signal criteria can be determined by an algorithm, but does not disclose any of the specific criteria as disclosed in claim 8. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the algorithm as taught by John with the desired criteria, because Applicant has not disclosed that the listed criteria provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the algorithm as taught by John, because it provides a reliable means of determining successful stimulation and since it appears to be an arbitrary design consideration which fails to patentably distinguish over the prior art. Therefore, it would have been an obvious matter of design choice to modify John to obtain the invention as specified in the claims.
Regarding claim 12, John additionally discloses wherein the processing circuitry is further configured to: determine that the evoked signal satisfies one or more criteria; and wherein to determine the therapy response group for the patient, the processing circuitry is further configured to classify, based on the evoked signal satisfying the one or more criteria, the patient into the therapy response group that indicates that the implantable medical device is a non-rechargeable implantable medical device (e.g. non-rechargeable device as disclosed in [0157]).
Regarding claim 13, John additionally discloses wherein the evoked signal comprises a second evoked signal and the one or more electrical stimulation pulses comprises a second set of one or more electrical stimulation pulses, and the processing circuitry is further configured to: determine that a first evoked signal, evoked prior to the second evoked signal from delivery of a first set of one or more electrical stimulation pulses delivered with a first stimulation amplitude, does not satisfy one or more criteria; wherein to deliver the second set of one or more electrical stimulation pulses the processing circuitry is further configured to deliver, responsive to the determination that the first evoked signal does not satisfy the one or more criteria, the second set of one or more electrical stimulation pulses at a second stimulation amplitude different than the first stimulation amplitude; and output information indicative of the stimulation level at which the therapy response group was determined for the patient (e.g. stimulation of different amplitudes as taught in [0045])..
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over John in view of Choi et al. (US 2023/0123383).
Regarding claims 9-11, John discloses the claimed invention except the express mention of the use of a machine learning model to determine the criteria and the outcomes of the therapy. Choi discloses that it was well known in the in art of trialing neuromodulation therapies to Youse machine learning models to help determine therapeutic criteria (e.g. machine learning as disclosed in [0050], [0057] and [0115]). It would have been obvious to one having ordinary skill in the art to include the machine learning model of Choi in the device of John in order to provide the system with the predictable results of a reliable means of determining stimulation criteria.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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/Amanda K Hulbert/ Primary Examiner, Art Unit 3792
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