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.
Claims 1-2, 4, 6-7, 10-12, 14, 16-17, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No 2019/0009094 granted to Zhang et al (hereinafter “Zhang”).
In reference to claims 1 and 11, Zhang discloses a device and method to generate recommendations [e.g. paragraph 0018] for neurostimulation device [e.g. neurostimulation device 212] configuration, the device comprising: one or more processors [e.g. paragraph 0074]; and one or more memory devices comprising instructions [e.g. paragraph 0082], which when executed by the one or more processors, cause the one or more processors to: identify, with a recommendation model, a programming setting [e.g. programming device 413] for use a neurostimulation device to control neurostimulation treatment of a patient; communicate, to a patient device, a command to present a recommendation to use the programming setting [e.g. paragraph 0073], wherein the recommendation is customized [e.g. modulation control circuitry 450] by another user, and wherein the patient device includes a patient user interface [e.g. user interface 214] to present the recommendation to the patient [e.g. paragraph 0073]; and communicate [e.g. Figure 14: external telemetry circuit 1357], to the patient device, data values associated with the programming setting, wherein the data values are used to reconfigure the neurostimulation device according to the programming setting [e.g. Figure 14: programming control circuit 1419].
In reference to claims 2 and 12, Zhang discloses wherein the another user is a medical user associated with care of the patient, and wherein the instructions further cause the one or more processors to: communicate, to a medical user device, the programming setting identified with the recommendation model; and receive, from the medical user device, a command to activate the recommendation for use of the programming setting, wherein the medical user device includes a medical user interface to enable the medical user to customize and activate the recommendation [e.g. paragraph 0073]; wherein operations to communicate the command and the data values to the patient device occur after customization and activation of the recommendation by the medical user [e.g. paragraph 0103].
In reference to claims 4 and 14, Zhang discloses wherein the patient device includes programming functionality to directly communicate the programming setting to the neurostimulation device [e.g. paragraph 0106].
In reference to claims 6 and 16, Zhang discloses wherein the recommendation to use the programming setting is associated with a recommended time of delivery or validity for the patient device [e.g. paragraph 0092].
In reference to claims 7 and 17, Zhang discloses wherein the instructions further cause the one or more processors to: receive, from the patient device, feedback relating to the recommendation, wherein subsequent recommendations to reconfigure the neurostimulation device are customized to the patient based on the feedback [e.g. paragraph 0067].
In reference to claims 10 and 20, Zhang discloses wherein the patient device is further configured to receive a user command to manually input or control the data values, to reconfigure a program in the neurostimulation device according to the programming setting; wherein the data values to reconfigure the neurostimulation device causes a change to one or more of: timing, amplitude, frequency, intensity, duration, pulse patterns, pulse shapes, a spatial location of pulses, waveform shapes, or a spatial location of waveform shapes, of modulated energy provided with a plurality of leads of the neurostimulation device [e.g. paragraph 0029].
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.
Claims 5, 8-9, 15, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of U.S. Patent Application Publication No 2019/0344080 granted to McDonald et al (hereinafter “McDonald”).
In reference to claims 5 and 15, Zhang discloses a patient device but fails to disclose where the device is a smartphone and where the user interface is presented a software app installed on the smartphone. McDonald discloses a method and apparatus for neurostimulation device therapy management and describes the patient being provided with an integrated application in a smartphone or smartwatch [e.g. paragraph 0054]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Zhang to include the smartphone as taught by McDonald, since such a modification would provide the predictable results of the patient interface being a compact, familiar device which would allow ease of use.
In reference to claims 8, 9, 18, and 19, Zhang discloses a patient device but fails to describe the model configured to evaluate data feedback during use of the neuromodulation treatment, wherein the feedback is obtained from the patient. McDonald discloses a method and apparatus for neurostimulation device therapy management and describes a sensing circuit 742 that senses one or more physiological signals for purposes of patient monitoring and/or feedback [e.g. paragraph 0079]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Zhang to include the patient feedback system as taught by McDonald, since such a modification would provide the predictable results of allowing for patient monitoring during the delivery of neurostimulation.
Allowable Subject Matter
Claims 3 and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The closest prior arts of Zhang and McDonald fail to disclose encoded data values that cause the patient programming device to reconfigure operation of the device. Rather, they disclose reconfiguration as a result of other factors such as patient feedback, but not encoded data values.
Conclusion
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/NADIA A MAHMOOD/Primary Examiner, Art Unit 3796