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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 20 of U.S. Patent No. 12,257,442. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present application and the ‘442 patent claim a system comprising a user inter-race device configured to initiate an information exchange session between the patient and a software-based virtual agent (SVA) regarding patient neurological status or feedback to the neuromodulation therapy, and generate a control signal to the neuromodulation device to deliver or adjust the neuromodulation therapy in accordance with the determined device setting. The ‘442 patent is further limiting by positively reciting the transceiver circuit. Therefore, the claims of the ‘442 patent anticipates the claims of the present application.
Claim 1 of present application
Claim 1 of Patent ‘442
A medical-device system, comprising:
a neuromodulation device configured to provide a neuromodulation therapy to a neural target of a patient; and
a user-interface device configured to:
initiate an information exchange session between the patient and a software-based virtual agent (SVA) regarding patient neurological status or feedback to the neuromodulation therapy;
in response to a trigger event or a request by the patient or the SVA, prompt a human assistant, other than the patient, to join an ongoing information exchange session between the patient and the SVA;
determine a device setting for the neuromodulation device based on information exchanged among the patient, the SVA, and the human assistant;
and generate a control signal to the neuromodulation device to deliver or adjust the neuromodulation therapy in accordance with the determined device setting.
A system for computer-assisted programming of a neuromodulation device for pain management in a patient, the system comprising:
a programming aid device operable by the patient, comprising:
a user interface;
a transceiver circuit configured to receive, from one or more of a software-based virtual agent (SVA) or a human assistant other than the patient, information about pain management for the patient; and a controller circuit configured to:
initiate and manage an information exchange session between the patient and the SVA, via the user interface, regarding pain or paresthesia perception and pain management of the patient;
in response to a trigger event detected by the programming aid device, generate an alert to invite the human assistant to join the information exchange session while it is going on;
based on the information exchange among the patient, the SVA, and the human assistant, determine a stimulation setting for the neuromodulation device;
and generate a therapy control signal to the neuromodulation device to initiate delivery of neuromodulation energy to the patient in accordance with the determined stimulation setting.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3 – 6, 10, 13 – 16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kozloski et al. (US PGPUB 2019/0358457 – previously cited) in view of Pless et al. (US PGPUB 2017/0203111 – in IDS).
Regarding claims 1, 5, 13, and 15, Kozloski discloses a system and method, , for computer- assisted programming of a neuromodulation device for pain management in a patient, comprising: a programming aid device operable by the patient, comprising: a user interface (e.g. 610); and a controller circuit configured to: initiate and manage an information exchange session between the patient and one or more of the SVA or the human assistant, via the user interface, regarding pain or paresthesia perception and pain management of the patient (e.g. para 83); based on the information exchange, determine a stimulation setting for the neuromodulation device (e.g. ¶ 87); and generate a therapy control signal to the neuromodulation device to initiate delivery of neuromodulation energy to the patient in accordance with the determined stimulation setting (e.g. para 87). Kozloski fails to teach in response to a trigger event detected by the programming aid device, generate an alert to invite the human assistant to join the information exchange session.
Pless teaches it is known to, in response to a trigger event detected by a programming aide device, generate an alert to invite a human assistant to join an information exchange session (e.g. paras 131 and 136). It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to modify the device as taught by Kozloski with the alert to invite a human assistant as taught by Pless, since such a modification would provide the predictable results of alerting a physician to communicate with the patient when necessary in order to better treat the patient.
Regarding claims 3 and 4, Kozloski discloses providing the therapy via one or more electrodes operably positioned at a spinal or brain target (e.g. ¶ 5)
Regarding, claims 6 and 16, Kozloski discloses the controller circuit is configured to generate an alert to invite the human assistant to join the information exchange session responsive to a request by the patient or the SVA (e.g. ¶ 125) and the trigger even includes an identification of a new pain or paresthesia site; a new stimulation setting suggested by the SVA; a frequent reprogramming of therapy exceeding a threshold; or an outlier event during programming of therapy (e.g. ¶ 83).
Regarding claims 10 and 19, Kozloski discloses the information exchange session includes messages about identifying one or more stimulation sites to apply the neuromodulation energy or modified neuromodulation energy, and wherein the controller circuit is configured to determine the stimulation setting based on the identified one or more stimulation sites; and/or wherein the controller circuit is configured to determine the stimulation setting based on suggested stimulation setting; and/or wherein the controller circuit is configured to determine the stimulation setting based on the confirmation, override, or modification of the stimulation setting (e.g. ¶ 65).
Claim(s) 2, 7 – 9, 11, 12, 17, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kozloski et al. in view of Pless et al, and further in view of Davis et al. (US PGPUB 2011/0270358).
Regarding claims 2, 7 – 9, 11, 12, 17, 18, and 20, Kozloski in view of Pless discloses the information exchange session includes messages about pain or paresthesia perception of the patient including identifying one or more pain or paresthesia sites (e.g. ¶ 83 and 109), but fails to explicitly teach that the controller circuit is configured to generate a pain or paresthesia map based on the identified one or more pain or paresthesia sites.
Davis teaches it is known to use pain or paresthesia maps on an interface in a pain management stimulation system (e.g. ¶ 83 and 129). It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to modify the invention as taught by Kozloski with the pain mapping as taught by Davis, since such a modification would provide the predictable results of allowing for better optimization of stimulation parameters in order to better treat pain.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached on 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3792
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