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
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 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.
Claims 1, 2, 5-8, 11 and 13-14 are rejected under 35 U.S.C. 103 as being obvious over Feldman(US 20180140831 A1) in view of Bradley(US 20060195159 A1).
The applied reference has a common assignee and inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 1, Feldman(US 20180140831 A1) discloses an implantable stimulator for providing spinal cord stimulation (SCS) to a patient(The description that follows will generally focus on the use of the invention within a Spinal Cord Stimulation (SCS) system[0003]), comprising: a plurality of electrode nodes, each electrode node configured to be coupled to one of a plurality of electrodes configured to be inserted within the patient’s spinal column and to contact a patient’s spinal cord; control circuitry configured to: cause stimulation circuitry to provide actively-driven stimulation at the stimulation nodes, cause passive charge recovery circuitry to provide passively-driven passive charge recovery for a passive charge recovery duration at the stimulation nodes; and cause sensing circuitry to sense a neural response at the sensing nodes during the passive charge recovery duration, wherein the neural response is evoked by the actively-driven stimulation(The case 12 typically holds the circuitry and power source (e.g., battery) 14 (FIG. 1C) necessary for the IPG 10 to function, although IPGs can also be powered via external RF energy and without a battery. The IPG 10 is coupled to electrodes 16 via one or more electrode leads 18, such that the electrodes 16 form an electrode array 20. The electrodes 16 are carried on a flexible body 22, which also houses the individual signal wires 24 coupled to each electrode. In the illustrated embodiment, there are eight electrodes (Ex) on two leads 18 for a total of sixteen electrodes 16, although the number of leads and electrodes is application specific and therefore can vary.[0004]. While active recovery of charge using a biphasic pulse is beneficial, such active recovery may not be perfect, and hence some residual charge may remain on the DC-blocking capacitors 55 even after completion of the second phase 94b of the biphasic pulse. Thus, the art has recognized the utility of passive charge recovery not involving use of active currents provided by the DAC circuitry 172. Passive charge recovery is implemented within the stimulation circuitry block 170, and includes use of passive recovery switches (e.g., transistors) 96(x), each connected between one of the electrode nodes (Ex′ and Ec′) 61a and a common reference voltage, as shown in FIG. 3B. This common reference voltage as shown may simply comprise the voltage, Vbat, of the battery 14 (FIG. 1C), but another reference voltage could also be used, such as the compliance voltage VH described earlier, a midpoint voltage such as VH/2, ground (GND), or some other value[0021]). Feldman fails to explicitly state “select one or more of the plurality of electrode nodes as stimulating electrode nodes and to select one or more of the plurality of electrode nodes as sensing electrode nodes”.
However, Bradley teaches “.It is emphasized that the electrodes 106a-d may be dedicated exclusively to either stimulation or sensing and, in some instances, may function as both, in a time-multiplexed manner. Preferably, each electrode 106 in the IPG 100 can operate as either a stimulating or sensing electrode, with the mode being determined by switches capable of connecting the electrode to current generation circuitry or voltage sensing circuitry.[0060]. In the example shown, those electrodes in the middle of the lead generally more easily are able to evoke a nerve response, as reflected by the lower current values at which nerve response was detected.[0072]. At this point, and as noted above, the IPG 100 is ready to be optimized, and part of this procedure is to choose the electrodes that are most sensible to activate as part of the patient's therapy[0083]”.
It would be obvious to one of ordinary skill in the art to before the effective filing date to configure the passive charge recovery device of Feldman with the electrode selection stimulator of Bradley. Doing so would clarify the electrodes implanted are able to sense or stimulate based on patient therapy.
Regarding claim 2, Feldman in view of Bradley teaches the stimulator device of claim 1, wherein the passive charge recovery circuitry comprises programmable variable resistance circuitry(Within improved stimulation circuitry block 170 is a recovery control block 174. Recovery control block includes a mode/resistance select control module 175 that stores data used to select different passive recovery modes and different resistances Rx for the passive recovery resistors 97 (FIG. 3B)[0052]).
Regarding claim 5, Feldman in view of Bradley teaches the stimulator device of claim 1, but Feldman fails to explicitly teach wherein the programmable variable resistance circuitry comprises a plurality of switching circuits, wherein each of the plurality of switching circuits is coupled with a different one of the electrode nodes and is configured, when selected, to provide variable impedance between its respective electrode node and a common node.
However, Bradley teaches “It is emphasized that the electrodes 106a-d may be dedicated exclusively to either stimulation or sensing and, in some instances, may function as both, in a time-multiplexed manner. Preferably, each electrode 106 in the IPG 100 can operate as either a stimulating or sensing electrode, with the mode being determined by switches capable of connecting the electrode to current generation circuitry or voltage sensing circuitry.[0060]. The first electrode measurement is electrode impedance. In a preferred embodiment, such impedance is measured by running a constant current through a given electrode, and measuring the resulting voltage on that electrode while holding the IPG 100 case 116 (FIG. 3A) to ground as a reference potential. That is, the impedance measurement is preferably performed on each electrode as a monopolar measurement, although this is not strictly required, as other reference potentials could be used as well[0065]”.
It would be obvious to one of ordinary skill in the art before the effective date to configure the passive charge recovery device of Feldman with the impedance of the electrode selection stimulator of Bradley. Doing so would specify impedance as a measurement taken in the system for each electrode in the system.
Regarding claim 6, Feldman in view of Bradley teaches the stimulator device of claim 5, wherein the common node comprises a reference voltage selected from the group consisting of a battery voltage, a compliance voltage, a fraction of a compliance voltage, and ground(Passive charge recovery is implemented within the stimulation circuitry block 170, and includes use of passive recovery switches (e.g., transistors) 96(x), each connected between one of the electrode nodes (Ex′ and Ec′) 61a and a common reference voltage, as shown in FIG. 3B. This common reference voltage as shown may simply comprise the voltage, Vbat, of the battery 14 (FIG. 1C), but another reference voltage could also be used, such as the compliance voltage VH described earlier, a midpoint voltage such as VH/2, ground (GND), or some other value[0021]).
Regarding claim 7, Feldman in view of Bradley teaches the stimulator device of claim 5, wherein each of the plurality of switching circuits comprises a plurality of switches wherein the switches are selectable to vary the passive charge recovery impedance(The pulse generator of claim 16, further comprising a plurality of resistors, wherein each of the resistors is serially connected to one of the switches between one of the electrodes nodes and the reference voltage, wherein the control circuitry is further configured to vary a resistance of the plurality of resistors[claim 19]). Resistance is a component of impedance; therefore varying resistance would then vary the impedance.
Bradley further teaches “It is emphasized that the electrodes 106a-d may be dedicated exclusively to either stimulation or sensing and, in some instances, may function as both, in a time-multiplexed manner. Preferably, each electrode 106 in the IPG 100 can operate as either a stimulating or sensing electrode, with the mode being determined by switches capable of connecting the electrode to current generation circuitry or voltage sensing circuitry.[0060]. The first electrode measurement is electrode impedance. In a preferred embodiment, such impedance is measured by running a constant current through a given electrode, and measuring the resulting voltage on that electrode while holding the IPG 100 case 116 (FIG. 3A) to ground as a reference potential. That is, the impedance measurement is preferably performed on each electrode as a monopolar measurement, although this is not strictly required, as other reference potentials could be used as well[0065]”. This explicitly states switches in an electrode system measuring impedance.
It would be obvious to one of ordinary skill in the art before the effective date to configure the passive charge recovery device of Feldman with the impedance of the electrode selection stimulator of Bradley. Doing so would specify impedance as a measurement taken in the system for each electrode in the system.
Regarding claim 8, Feldman in view of Bradley teaches the stimulator device of claim 7, wherein the plurality of switches comprises a plurality of transistors in parallel(When the passive recovery switches 96(x) are closed during post-program recovery period 99 (RCVx=‘1’), the equivalent circuit 95 of FIG. 5 results. Equivalent circuit 95 includes the series connection of passive recovery resistor 97 Rx and DC-blocking capacitor 55 through each switch 96x for each electrode Ex. These series connections are coupled in parallel between the common reference voltage (e.g., Vbat) and the patient's tissue (e.g., Rt).[0046]).
Regarding claim 11, Feldman in view of Bradley teaches the stimulator device of claim 1, wherein the stimulation circuitry is further configured to provide actively-driven active charge recovery(As noted earlier, an IPG 10 may include circuitry and techniques designed to remove the charge from DC-blocking capacitors 55 in the electrode output paths that provide stimulation to a patient's tissue, Rt. An IPG 10 may issue biphasic pulses, with the second pulse phase 94b (FIG. 3A) designed to actively recover charge stored on the DC-blocking capacitors 55[0034]).
Regarding claim 13, Feldman in view of Bradley teaches the stimulator device of claim 1, wherein each electrode node is coupled to its associated electrode through a DC-blocking capacitor(The electrode nodes 61a connect to the electrodes 16 (E1-E16) on the lead(s) 18 outside of the case 12 by way of DC-blocking capacitors 55[0009]).
Regarding claim 14, Feldman discloses the method of providing spinal cord stimulation (SCS) to a patient using an implantable stimulator(The description that follows will generally focus on the use of the invention within a Spinal Cord Stimulation (SCS) system[0003]), wherein the implantable stimulator comprises a plurality of electrode nodes, each electrode node configured to be coupled to one of a plurality of electrodes configured to be inserted within the patient’s spinal column and to contact a patient’s spinal cord, the method comprising: using the implantable stimulator’s control circuitry to: cause stimulation circuitry to provide actively-driven stimulation at the stimulation nodes, cause passive charge recovery circuitry to provide passively-driven passive charge recovery for a passive charge recovery duration at the stimulation nodes; and cause sensing circuitry to sense a neural response at the sensing nodes during the passive charge recovery duration, wherein the neural response is evoked by the actively-driven stimulation(The case 12 typically holds the circuitry and power source (e.g., battery) 14 (FIG. 1C) necessary for the IPG 10 to function, although IPGs can also be powered via external RF energy and without a battery. The IPG 10 is coupled to electrodes 16 via one or more electrode leads 18, such that the electrodes 16 form an electrode array 20. The electrodes 16 are carried on a flexible body 22, which also houses the individual signal wires 24 coupled to each electrode. In the illustrated embodiment, there are eight electrodes (Ex) on two leads 18 for a total of sixteen electrodes 16, although the number of leads and electrodes is application specific and therefore can vary.[0004]. While active recovery of charge using a biphasic pulse is beneficial, such active recovery may not be perfect, and hence some residual charge may remain on the DC-blocking capacitors 55 even after completion of the second phase 94b of the biphasic pulse. Thus, the art has recognized the utility of passive charge recovery not involving use of active currents provided by the DAC circuitry 172. Passive charge recovery is implemented within the stimulation circuitry block 170, and includes use of passive recovery switches (e.g., transistors) 96(x), each connected between one of the electrode nodes (Ex′ and Ec′) 61a and a common reference voltage, as shown in FIG. 3B. This common reference voltage as shown may simply comprise the voltage, Vbat, of the battery 14 (FIG. 1C), but another reference voltage could also be used, such as the compliance voltage VH described earlier, a midpoint voltage such as VH/2, ground (GND), or some other value[0021]).
However, Bradley teaches “It is emphasized that the electrodes 106a-d may be dedicated exclusively to either stimulation or sensing and, in some instances, may function as both, in a time-multiplexed manner. Preferably, each electrode 106 in the IPG 100 can operate as either a stimulating or sensing electrode, with the mode being determined by switches capable of connecting the electrode to current generation circuitry or voltage sensing circuitry.[0060]. In the example shown, those electrodes in the middle of the lead generally more easily are able to evoke a nerve response, as reflected by the lower current values at which nerve response was detected.[0072]. At this point, and as noted above, the IPG 100 is ready to be optimized, and part of this procedure is to choose the electrodes that are most sensible to activate as part of the patient's therapy[0083]”.
It would be obvious to one of ordinary skill in the art to before the effective filing date to configure the passive charge recovery device of Feldman with the electrode selection stimulator of Bradley. Doing so would clarify the electrodes implanted are able to sense or stimulate based on patient therapy.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Feldman in view of Bradley and further in view of (JP 6096759 B2), herein after referred to as Ref C.
Regarding claim 12, Feldman in view of Bradley teaches the stimulation device of claim 1, but fails to disclose wherein the sensing circuitry comprises a differential amplifier, and wherein the differential amplifier receives a sensing electrode node at a first input, and wherein the differential amplifier receives a reference electrode node selected from one of the electrode nodes at a second input.
However, Ref C teaches “FIG. 5 shows a circuit of an alternative embodiment of the invention in which a differential measurement amplifier is used and charge recovery is due to the voltage rail V .sub.dd . Some embodiments of the present invention, such as the embodiment of FIG. 5, can use a differential amplifier to detect the voltage difference between two sensing electrodes(see attached translation, page 8, paragraph 3)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the passive charge recovery device of Feldman with the differential amplifier of the neural response measurement of Ref C. Doing so would specify a differential amplifier in the circuitry to receive the sensing signals.
Allowable Subject Matter
Claims 3, 4, 9, 10, and 15-18 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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