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 § 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-7, 10-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over single reference US 20220134117 A1 to Woock et al. (hereinafter “Woock”).
Regarding claim 1. Woock discloses a neurostimulation trial system (para 0006, 0036, 0049) comprising: an external stimulation controller (para 0017, 0049 “EPG/patient device 80” or “CD 50”, fig. 1) comprising: a housing; a processor circuit within the housing (para 0017 “The patient device can include a portable housing, a communication module, a user interface and a processor module disposed within the housing.”); a signal generator circuit coupled to the processor circuit and configured to generate neurostimulation signals in response to instructions from the processor circuit (para 0017 “programming the implantable pulse generator by the remote device through the patient device”, fig. 1); and a transceiver circuit coupled to the processor circuit (fig. 1, para 0049 “IPG”); and an external wireless interface device configured to: receive first stimulation programming instructions from at least one of a clinician device or a patient device (fig. 1; IPG receiving signal from CP 60 or PD 80); and in response to the first stimulation programming instructions, communicate second stimulation programming instructions to the transceiver circuit of the external stimulation controller to initiate or adjust a neurostimulation therapy (para 0049, “control over stimulation (e.g., initiating a pre-set program, increasing or decreasing stimulation)”), wherein the neurostimulation therapy comprises the neurostimulation signals generated by the signal generator circuit (para 0049).
Regarding claim 2. Woock discloses the neurostimulation trial system of claim 1, comprising a ground pad configured to adhere the housing of the external stimulation controller directly to patient skin tissue (para 0042 “external pulse generator (EPG) taped onto the skin of the patient”; para 0058 “CD can either be patched to the patient's skin using an adhesive or can be held in place using a belt 53”).
Regarding claim 3. Woock discloses the neurostimulation trial system of claim 1, comprising at least one trial lead coupled to a lead interface of the external stimulation controller, and wherein the trial lead is configured for implantation at a neural target (para 0042 “temporary lead is then connected to an external pulse generator (EPG)”).
Regarding claim 4. Woock discloses the neurostimulation trial system of claim 1, wherein the external wireless interface device is configured to receive the first stimulation programming instructions via a first data communication protocol, and wherein the external wireless interface device is configured to provide the second stimulation programming instructions to the transceiver circuit of the external stimulation controller using a different second data communication protocol (para 0049, 0103 “communicates with the Patient Device 520 by either Bluetooth or NFC”).
Regarding claim 5. Woock discloses the neurostimulation trial system of claim 1, wherein the first and second stimulation programming instructions comprise the same instructions (para 0049, 0103 “communicates with the Patient Device 520 by either Bluetooth or NFC”).
Regarding claim 6. Woock discloses the neurostimulation trial system of claim 1, wherein the first and second stimulation programming instructions comprise different instructions (para 0049 “control over stimulation (e.g., initiating a pre-set program, increasing or decreasing stimulation)”).
Regarding claim 7. Woock discloses the neurostimulation trial system of claim 1, wherein the external stimulation controller comprises a battery, and wherein each of the processor circuit, the signal generator circuit, and the transceiver circuit is configured to receive power from the battery (para 0049, 0057-0058, etc.).
Regarding claim 10. Woock discloses the neurostimulation trial system of claim 1, wherein the external wireless interface device comprises wireless power transmission circuitry configured to communicate power to an implanted device, wherein the wireless power transmission circuitry is deactivated in a trial therapy mode, and wherein the wireless power transmission circuity is activated in a second therapy mode (para 0058-0059, 0090, 0096, etc.).
Regarding claim 11. Woock discloses a treatment system (para 0006, 0036, 0049) comprising: a neurostimulation trial system including a body-external stimulation controller and at least one lead configured to provide a first neurostimulation signal from the stimulation controller to a neural target inside a patient body (para 0017, 0049 “EPG/patient device 80” or “CD 50”, “The patient device can include a portable housing, a communication module, a user interface and a processor module disposed within the housing.” “IPG”, fig. 1); a wireless transmitter-receiver device configured to be positioned outside the patient body at a tissue interface (para 0017, 0049); and an implantable neurostimulation device configured for implantation inside the patient body near the tissue interface (para 0017, 0049 “IPG”), the neurostimulation device comprising a circuitry housing, a pulse generator circuit (para 0017 “The patient device can include a portable housing, a communication module, a user interface and a processor module disposed within the housing.”), and multiple electrodes (para 0042 “temporary lead is then connected to an external pulse generator (EPG)”), wherein the implantable neurostimulation device is configured to receive power wirelessly from the wireless transmitter-receiver device (para 0049), and wherein the implantable neurostimulation device is configured to use the wirelessly- received power to provide a second neurostimulation signal from the pulse generator circuit to the neural target inside the patient body (para 0049, 0058).
Regarding claim 12. Woock discloses the treatment system of claim 11, wherein the body-external stimulation controller includes a second pulse generator circuit that is configured substantially identically to the pulse generator circuit in the implantable neurostimulation device (para 0042 “external pulse generator”).
Regarding claim 13. Woock discloses the treatment system of claim 11, wherein the wireless transmitter-receiver device is configured to use a first wireless communication link to communicate with the body-external stimulation controller, and the wireless transmitter-receiver device is configured to use a different second wireless communication link to communicate with the implantable neurostimulation device (para 0049, 0103 “communicates with the Patient Device 520 by either Bluetooth or NFC”).
Regarding claim 14. Woock discloses the treatment system of claim 13, wherein the first wireless communication link comprises a nearfield or farfield communication link, and wherein the second wireless communication link comprises a midfield link (para 0049, 0103 “communicates with the Patient Device 520 by either Bluetooth or NFC”).
Regarding claim 15. Woock discloses the treatment system of claim 11, comprising a programmer device configured to communicate therapy configuration information to the body-external stimulation controller via the wireless transmitter-receiver device (para 0049 “clinician programmer 60”).
Regarding claim 16. Woock discloses the treatment system of claim 15, wherein the programmer device is configured to communicate the same therapy configuration information or other therapy configuration information to the implantable neurostimulation device (para 0049 “allows the patient at least some control over stimulation (e.g., initiating a pre-set program, increasing or decreasing stimulation)”).
Regarding claim 17. Woock discloses a neuromodulation trial system (para 0006, 0036, 0049) comprising: an external stimulator (para 0017, 0049 “EPG/patient device 80” or “CD 50”, fig. 1) configured to adhere to a patient's skin (para 0042 “external pulse generator (EPG) taped onto the skin of the patient”; para 0058 “CD can either be patched to the patient's skin using an adhesive or can be held in place using a belt 53”) and to generate neurostimulation signals (para 0017 0049), wherein the external stimulator includes circuitry that is identical or functionally equivalent to circuitry used in a corresponding permanent implantable neurostimulator (para 0017, 0049; it is noted that the claim does not provide any details regarding the circuitry, or what it considers to be identical or functionally equivalent. Under its BRI, any external and implantable circuitry that are compatible are understood to be at least functionally equivalent); wherein the external stimulator includes a wireless communication circuit configured to communicate with at least one external device (fig. 1; IPG receiving signal from CP 60 or PD 80); and wherein the external stimulator is configured to provide the generated neurostimulation signals to target neural tissue using an implantable lead (para 0042 “temporary lead is then connected to an external pulse generator (EPG)”).
Regarding claim 18. Woock discloses the neuromodulation trial system of claim 17, comprising a wireless interface device configured to receive programming instructions from a patient or clinician device and, in response, provide further programming instructions to the external stimulator using the wireless communication circuit (para 0049 “each of the IPG and the EPG allows the patient at least some control over stimulation (e.g., initiating a pre-set program, increasing or decreasing stimulation)”).
Regarding claim 19. Woock discloses the neuromodulation trial system of claim 18, wherein the wireless interface device is configured to provide the programming instructions to the external stimulator using a first communication link, and wherein the wireless interface device is configured to communicate with the implantable neurostimulator using a different second communication link (para 0049, 0103 “communicates with the Patient Device 520 by either Bluetooth or NFC”).
Regarding claim 20. Woock discloses the neuromodulation trial system of claim 17, wherein the external device comprises a user interface configured to receive input from the patient or a clinician to adjust the neurostimulation signals (para 0050 “CP generally includes a graphical user interface to facilitate clinician input for programming”), and wherein the external device is configured to communicate a power signal to the permanent implantable neurostimulator (para 0058, 0064).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woock as applied to claims above, and further in view of US 20140350635 A1 to Strother et al. (hereinafter “Strother”).
Regarding claim 8. Woock discloses the neurostimulation trial system of claim 1, comprising a magnetic switch, wherein at least one function of the stimulation controller is disabled in response to a state change of the magnetic switch (para 0051 “physical on/off button to turn the CP on and off”).
Strother, from a similar field of endeavor teaches that it is known to provide a magnetic reed switch or a hall effect sensor to suspend the operation of the neurostimulator (para 0057). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Woock with the known teachings of Strother to provide the predictable result of turning off/suspending the operation of the neurostimulator using a magnetic reed switch.
Regarding claim 9. Woock as modified by Strother renders obvious the neurostimulation trial system of claim 8, wherein the magnetic switch is configured to selectively enable or disable generation of the neurostimulation signals (para 0051 “physical on/off button to turn the CP on and off”; Strother para 0057).
Conclusion
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/SANA SAHAND/Examiner, Art Unit 3796
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