DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 15, 16, 18-26, and 28-34 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gillbe(US 20100152817 A1) in view of Wallace(US 20050137647 A1).
Regarding claim 15, Gillbe discloses a system comprising: comprising a plurality of first electrodes; comprising a plurality of second electrodes; and a controller configured to control an electrical generator to pass electrical currents both in a first direction from the first endovascular device to the second endovascular device and in a second direction from the second endovascular device to the first endovascular device along a plurality of pathways that intersect each other to establish a network of intersecting conduction pathways between the first electrodes and the second electrodes during a single treatment period(FIG. 3 shows an example application of two linear electrode arrays labelled 06 and 07 of the type shown in FIG. 2. Each of the electrode arrays is positioned either side of a limb, 08, such that the component waveforms, A to E, are applied across electrode pairs A1-A2 etc. The respective current path through the tissues for each of the electrode pairs is illustrated approximately by the dotted lines shown, such as current path E1-E2, shown in bold[0116]. FIG. 8 illustrates a typical configuration of an implanted stimulator. The implanted stimulator comprises the stimulator device, 18, which contains the electronics, battery, charging electronics and signal generator(s) contained within an enclosure, 19, which is typically a hermetically sealed titanium shell. On top of the device, a connector assembly provides connection to one or more leads, 21, (shown shortened in the drawing) which terminate in one or more electrode arrays, 22. The enclosure, 19, if made of conductive material may also be used as an electrode and optionally may form part of the available array of electrodes. A typical modern implanted stimulator will have provision for a number of electrode contacts, typically sixteen arranged as two sets of eight outputs. Applications of implanted stimulators include spinal cord stimulation, where the electrodes are implanted in the epidural space, and deep brain stimulation, where electrodes are implanted in the brain[0133]). Gillbe fails to explicitly disclose “a first endovascular device for placement in a first cerebral blood vessel of a patient” and “a second endovascular device for placement in a second cerebral blood vessel of the patient”.
However, Wallace teaches “The method comprises delivering a stimulation lead within a blood vessel, intralumenally puncturing a wall of the blood vessel to create an exit point, and then introducing the stimulation lead through the exit point into direct contact with tissue the stimulation of which treats the disorder[abstract]. As illustrated in FIGS. 3-5, the electrical path of the stimulation signals generated by the stimulation system 10 will depend on the manner in which the stimulation source 14 is connected to the signal wires 16 of the stimulation leads 12. For example, FIG. 3 illustrates a four-channel monopolar arrangement, wherein the positive terminal of the stimulation source 14 is coupled in parallel to signal wires 16 of four stimulation leads 12(1)-(4). In this case, the electrical stimulation signals will travel from the four electrodes 18 located on the respective stimulation leads 12, through the brain tissue, and back to the electrically conductive casing of the stimulation source 14 remotely implanted in the patient's body[0076]. Using a stimulation lead implantation process similar to that described above, respective electrodes 18 of three stimulation leads 12 can be implanted within the superior cerebral veins 206 branching from the superior sagittal sinus 204, and the respective electrodes 18 of three more stimulation leads 12 can be implanted within the inferior cerebral veins 214 branching from the inferior sagittal sinus 212, as illustrated in FIG. 16. The stimulation leads 12 can be routed into the inferior sagittal sinus 212 via the straight sinus 216 of the superior sagittal sinus 204. Again, the inner jugular vein or femoral vein can be used as the access point to the patient's vasculature. As illustrated, electrodes 18 of the stimulation leads 12 located in the superior cerebral veins 206 are coupled in parallel to the positive terminal of the stimulation source 14, and the electrodes of the stimulation leads 12 located in the inferior cerebral veins 214 are coupled in parallel to the negative terminal of the stimulation source 14[0108]”.
It would be obvious to one of ordinary skill in the art before the effective filling date to configure the array stimulator of Gillbe with the vascular implant of the stimulation leads of Wallace. Doing so would specify placement in the vasculature of the brain for optimal stimulation of tissue.
Regarding claim 16, Gillbe in view of Wallace teaches the system of claim 15, wherein the controller is configured to select a plurality of combinations of electrodes from the first electrodes and the second electrodes to form a plurality of electrode pairs, and wherein to control the electrical generator, the controller is configured to control the electrical generator to pass electrical currents via the plurality of electrode pairs(In one aspect, the invention is an apparatus for applying electrical pulses to a patient, the apparatus comprising a plurality of electrodes arranged in an array, and a signal generator for generating signals to said electrodes so as to form said electrical pulses, the signal generator being arranged to generate said signals such that the signals are either sequentially transmitted to said successive electrode pairs in a cycle so the respective electrode pairs receive the corresponding signals at different times, or alternatively so that the signals are received by the electrode pairs such that they do not all start and end at the same point in time[0036], Whatever the target tissue area, implantation is an inexact science and therefore a multiplicity of contacts allows the neurosurgeon to span a particular area of tissue and experiment with different combinations of electrodes in the array to produce a desired therapeutic effect. Migration of the lead over time or changes in the contact impedance due to the accumulation of scar tissue around the implanted electrodes may necessitate reprogramming of the electrode combination over time[0136]).
Regarding claim 18, Gillbe in view of Wallace teaches the system of claim 16, wherein to select the plurality of combinations of electrodes from the first electrodes and second electrodes to form the plurality of electrode pairs, the controller is configured to select, according to a preset pattern, the plurality of combinations of electrodes from the first electrodes and second electrodes to form the plurality of electrode pairs(An extension to the reference stimulation field method is to consider current paths from the electrodes in the array and arrive at combination of these paths that gives a best fit to the parameters input by the surgeon. Current paths may be calculated using a finite element model of the tissues, either in two or three dimensions[0176]).
Regarding claim 19, Gillbe in view of Wallace the system of claim 15, wherein the plurality of pathways comprises pathways between a plurality of electrode pairs, each of the electrode pairs of the plurality of electrode pairs including electrodes from each of the plurality of first electrodes and the plurality of second electrodes(The preceding figures deal with only one configuration of electrode array and a limited number of ways of pairing the electrodes within that array. Other combinations are possible, for example the current paths need not cross as in FIGS. 12 to 15, but might consist of a ladder arrangement of electrode pairs such as D1-D2, E1-E2, and F1-F2[0158]).
Regarding claim 20, Gillbe in view of Wallace the system of claim 19, wherein the plurality of electrode pairs include: a first pair including a distal-most electrode of the plurality of second electrodes and a proximal-most electrode of the plurality of first electrodes, wherein to pass electrical currents along the plurality of pathways, the controller is configured to control the electrical generator to pass electrical currents along a first pathway between electrodes of the first pair, the first pathway traversing both longitudinally and laterally through brain tissue from the second endovascular device to the first endovascular device; and a second pair including electrodes that are longitudinally closer to each other than the distal-most electrode of the plurality of second electrodes and the proximal-most electrode of the plurality of first electrodes, wherein to pass electrical currents along the plurality of pathways, the controller is configured to control the electrical generator to pass electrical currents along a second pathway between the electrodes of the second pair(FIG. 3 shows the current paths in tissues through a cross section of a notional homogenous limb wherein two linear electrode arrays according to FIG. 2 are applied transcutaneously on either side of the limb[0086].The diagram is of course an idealised case assuming that the limb is homogeneous in cross-section; in a clinical situation the current will follow a path dictated by the relative conductivity of different tissues and bone etc. In both cases, the current path spreads out as it transits between the two electrode pairs, with its start and end point defined by the arrangement of the electrode pairs. A crossing arrangement as shown provides a point of focus for the stimulating waveform in the deep tissues, whereas an alternative non-crossing arrangement (where each electrode pair is opposite each other analogous to rungs on a ladder) provides a more distributed region of stimulation. It is also possible to vary the shape of the region of stimulation and the centre of this region by varying the relative duty cycle of the component waveforms and the pairing of electrodes[0118]).
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Regarding claim 21, Gillbe in view of Wallace teaches the system of claim 15, wherein the plurality of first electrodes comprises X number of electrodes, the plurality of second electrodes comprises Y number of electrodes, and a number of available pathways between the plurality of first electrodes and the plurality of second electrodes is 2XY, and wherein to pass electrical currents along the plurality of pathways, the controller is configured to control the electrical generator to pass electrical currents along more than half of the 2XY available pathways during the single treatment period(The preceding figures deal with only one configuration of electrode array and a limited number of ways of pairing the electrodes within that array. Other combinations are possible, for example the current paths need not cross as in FIGS. 12 to 15, but might consist of a ladder arrangement of electrode pairs such as D1-D2, E1-E2, and F1-F2. Furthermore, it is preferable in some instances to use the enclosure of the stimulator (FIG. 8, 19) as one of the electrode pairs. This produces a stimulation field that tends to penetrate further from the site of the electrodes thereby allowing tissues some distance from the implanted array to be stimulated[0158]).
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Regarding claim 22, Gillbe in view of Wallace teaches the system of claim 21, wherein X and Y are each 5 to 10(Typical modern implanted stimulator will have provision for a number of electrode contacts, typically sixteen arranged as two sets of eight outputs[0133]).
Regarding claim 23, Gillbe in view of Wallace teaches the system of claim 15, wherein to pass electrical currents, the controller is configured to pass electrical currents in the first direction between at least an electrode pair that includes one electrode from the plurality of first electrodes and one electrode from the plurality of second electrodes, and wherein the controller is configured to control the electrical generator to switch, during the single treatment period, a polarity of the electrode pair such that currents pass in the second direction from the second endovascular device to the first endovascular device(An alternative approach is to use a bi-directional balanced waveform consisting of equal forward and reverse pulses as previously discussed and illustrated in FIGS. 1 and 6. In these cases the anodes and cathodes effectively reverse every half cycle. Preferably, the waveform has an inter-pulse spacing (t.sub.ip in FIG. 1) that is selected so that the reverse pulse and forward pulses are equally spaced in time. With a balanced bi-phasic waveform, the preferred method is also to couple pairs of electrodes, or small groups, rather than have a number of anodes connected in parallel at one time. This provides more precise definition of the current path between the electrodes and therefore better control of the location and coverage area of the composite waveform. FIGS. 12 to 15 show an example of such a system implemented in an array consisting of two rows of eight electrodes[0149]).
Regarding claim 24, Gillbe in view of Wallace teaches the system of claim 15, wherein to pass electrical currents both in the first direction from the first endovascular device to the second endovascular device and in the second direction from the second endovascular device to the first endovascular device, the controller is configured to: control the electrical generator to deliver electrical stimulation via at least one first electrode of the plurality of first electrodes; and after delivering the electrical stimulation, control the electrical generator to switch a polarity of the at least one first electrode and use the at least one first electrode as a ground electrode to deliver electrical stimulation(Similarly, in the fifth aspect, the relative pulse widths and polarity of the component pulses is varied with respect to each other and optionally the number of electrode pairs used is varied to change the location and the coverage area of the region of the tissues that are stimulated.[0060]. Equally, in the sixth aspect the maximum component pulse widths on any given pair of electrodes, or individual electrodes with respect to the case or ground electrode of an implanted stimulator is determined with respect to each other to normalize the sensation on each electrode such that the perceived stimulation at the amplitude limit on each electrode pair is the same.[0061]).
Regarding claim 25, Gillbe discloses a system comprising: comprising a plurality of first electrodes including X number of electrodes; and comprising a plurality of second electrodes including Y number of electrodes, wherein a number of available pathways of a plurality of pathways between the plurality of first electrodes and the plurality of second electrodes is 2XY; and a controller configured to control an electrical generator to pass electrical currents along more than half of the 2XY available pathways between the first electrodes and the second electrodes during a single treatment period(FIG. 3 shows an example application of two linear electrode arrays labelled 06 and 07 of the type shown in FIG. 2. Each of the electrode arrays is positioned either side of a limb, 08, such that the component waveforms, A to E, are applied across electrode pairs A1-A2 etc. The respective current path through the tissues for each of the electrode pairs is illustrated approximately by the dotted lines shown, such as current path E1-E2, shown in bold[0116]. FIG. 8 illustrates a typical configuration of an implanted stimulator. The implanted stimulator comprises the stimulator device, 18, which contains the electronics, battery, charging electronics and signal generator(s) contained within an enclosure, 19, which is typically a hermetically sealed titanium shell. On top of the device, a connector assembly provides connection to one or more leads, 21, (shown shortened in the drawing) which terminate in one or more electrode arrays, 22. The enclosure, 19, if made of conductive material may also be used as an electrode and optionally may form part of the available array of electrodes. A typical modern implanted stimulator will have provision for a number of electrode contacts, typically sixteen arranged as two sets of eight outputs. Applications of implanted stimulators include spinal cord stimulation, where the electrodes are implanted in the epidural space, and deep brain stimulation, where electrodes are implanted in the brain[0133]). Gillbe fails to explicitly disclose “a first endovascular device for placement in a first cerebral blood vessel of a patient” and “a second endovascular device for placement in a second cerebral blood vessel of the patient”.
However, Wallace teaches “The method comprises delivering a stimulation lead within a blood vessel, intralumenally puncturing a wall of the blood vessel to create an exit point, and then introducing the stimulation lead through the exit point into direct contact with tissue the stimulation of which treats the disorder[abstract]. As illustrated in FIGS. 3-5, the electrical path of the stimulation signals generated by the stimulation system 10 will depend on the manner in which the stimulation source 14 is connected to the signal wires 16 of the stimulation leads 12. For example, FIG. 3 illustrates a four-channel monopolar arrangement, wherein the positive terminal of the stimulation source 14 is coupled in parallel to signal wires 16 of four stimulation leads 12(1)-(4). In this case, the electrical stimulation signals will travel from the four electrodes 18 located on the respective stimulation leads 12, through the brain tissue, and back to the electrically conductive casing of the stimulation source 14 remotely implanted in the patient's body[0076]. Using a stimulation lead implantation process similar to that described above, respective electrodes 18 of three stimulation leads 12 can be implanted within the superior cerebral veins 206 branching from the superior sagittal sinus 204, and the respective electrodes 18 of three more stimulation leads 12 can be implanted within the inferior cerebral veins 214 branching from the inferior sagittal sinus 212, as illustrated in FIG. 16. The stimulation leads 12 can be routed into the inferior sagittal sinus 212 via the straight sinus 216 of the superior sagittal sinus 204. Again, the inner jugular vein or femoral vein can be used as the access point to the patient's vasculature. As illustrated, electrodes 18 of the stimulation leads 12 located in the superior cerebral veins 206 are coupled in parallel to the positive terminal of the stimulation source 14, and the electrodes of the stimulation leads 12 located in the inferior cerebral veins 214 are coupled in parallel to the negative terminal of the stimulation source 14[0108]”.
It would be obvious to one of ordinary skill in the art before the effective filling date to configure the array stimulator of Gillbe with the vascular implant of the stimulation leads of Wallace. Doing so would specify placement in the vasculature of the brain for optimal stimulation of tissue.
Regarding 26, Gillbe in view of Wallace teaches the system of claim 25, wherein the controller is configured to select a plurality of combinations of electrodes from the first electrodes and the second electrodes to form a plurality of electrode pairs, and wherein to control the electrical generator, the controller is configured to control the electrical generator to pass electrical currents via the plurality of electrode pairs(In one aspect, the invention is an apparatus for applying electrical pulses to a patient, the apparatus comprising a plurality of electrodes arranged in an array, and a signal generator for generating signals to said electrodes so as to form said electrical pulses, the signal generator being arranged to generate said signals such that the signals are either sequentially transmitted to said successive electrode pairs in a cycle so the respective electrode pairs receive the corresponding signals at different times, or alternatively so that the signals are received by the electrode pairs such that they do not all start and end at the same point in time[0036], Whatever the target tissue area, implantation is an inexact science and therefore a multiplicity of contacts allows the neurosurgeon to span a particular area of tissue and experiment with different combinations of electrodes in the array to produce a desired therapeutic effect. Migration of the lead over time or changes in the contact impedance due to the accumulation of scar tissue around the implanted electrodes may necessitate reprogramming of the electrode combination over time[0136]).
Regarding claim 28, Gillbe in view of Wallace teaches the system of claim 26, wherein to select the plurality of combinations of electrodes from the first electrodes and second electrodes to form the plurality of electrode pairs, the controller is configured to select, according to a preset pattern, the plurality of combinations of electrodes from the first electrodes and second electrodes to form the plurality of electrode pairs(An extension to the reference stimulation field method is to consider current paths from the electrodes in the array and arrive at combination of these paths that gives a best fit to the parameters input by the surgeon. Current paths may be calculated using a finite element model of the tissues, either in two or three dimensions[0176]).
Regarding claim 29, Gillbe in view of Wallace teaches the system of claim 25, wherein the plurality of pathways comprises pathways between a plurality of electrode pairs, each of the electrode pairs of the plurality of electrode pairs including electrodes from each of the plurality of first electrodes and the plurality of second electrodes(The preceding figures deal with only one configuration of electrode array and a limited number of ways of pairing the electrodes within that array. Other combinations are possible, for example the current paths need not cross as in FIGS. 12 to 15, but might consist of a ladder arrangement of electrode pairs such as D1-D2, E1-E2, and F1-F2[0158]).
Regarding claim 30, Gillbe in view of Wallace teaches the system of claim 25, wherein X and Y are each 5 to 10(A typical modern implanted stimulator will have provision for a number of electrode contacts, typically sixteen arranged as two sets of eight outputs[0133]).
Regarding claim 31, Gillbe in view of Wallace teaches the system of claim 25, wherein to pass electrical currents between the first electrodes and the second electrodes during the single treatment period, the controller is configured to control the electrical generator to pass electrical currents along a plurality of pathways that intersect each other to establish a network of intersecting conduction pathways between the first electrodes and the second electrodes during the single treatment period(Preferably, the waveform has an inter-pulse spacing (t.sub.ip in FIG. 1) that is selected so that the reverse pulse and forward pulses are equally spaced in time. With a balanced bi-phasic waveform, the preferred method is also to couple pairs of electrodes, or small groups, rather than have a number of anodes connected in parallel at one time. This provides more precise definition of the current path between the electrodes and therefore better control of the location and coverage area of the composite waveform. FIGS. 12 to 15 show an example of such a system implemented in an array consisting of two rows of eight electrodes[0149]).
Regarding claim 32, Gillbe in view of Wallace teaches the system of claim 25, wherein to pass electrical currents between the first electrodes and the second electrodes during the single treatment period, the controller is configured to control the electrical generator to pass electrical currents both in a first direction from the first endovascular device to the second endovascular device and in a second direction from the second endovascular device to the first endovascular device(FIG. 3 shows the current paths in tissues through a cross section of a notional homogenous limb wherein two linear electrode arrays according to FIG. 2 are applied transcutaneously on either side of the limb[0086]).
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Regarding claim 33, Gillbe in view of Wallace teaches the system of claim 32, wherein to pass electrical currents, the controller is configured to pass electrical currents in the first direction between at least an electrode pair that includes one electrode from the plurality of first electrodes and one electrode from the plurality of second electrodes, and wherein the controller is configured to control the electrical generator to switch, during the single treatment period, a polarity of the electrode pair such that currents pass in the second direction from the second endovascular device to the first endovascular device(An alternative approach is to use a bi-directional balanced waveform consisting of equal forward and reverse pulses as previously discussed and illustrated in FIGS. 1 and 6. In these cases the anodes and cathodes effectively reverse every half cycle. Preferably, the waveform has an inter-pulse spacing (t.sub.ip in FIG. 1) that is selected so that the reverse pulse and forward pulses are equally spaced in time. With a balanced bi-phasic waveform, the preferred method is also to couple pairs of electrodes, or small groups, rather than have a number of anodes connected in parallel at one time. This provides more precise definition of the current path between the electrodes and therefore better control of the location and coverage area of the composite waveform. FIGS. 12 to 15 show an example of such a system implemented in an array consisting of two rows of eight electrodes[0149]).
Regarding claim 34, Gillbe in view of Wallace teaches the system of claim 32, wherein to pass electrical currents both in the first direction from the first endovascular device to the second endovascular device and in the second direction from the second endovascular device to the first endovascular device, the controller is configured to: control the electrical generator to deliver electrical stimulation via at least one first electrode of the plurality of first electrodes; and after delivering the electrical stimulation, control the electrical generator to switch a polarity of the at least one first electrode and use the at least one first electrode as a ground electrode to deliver electrical stimulation(Similarly, in the fifth aspect, the relative pulse widths and polarity of the component pulses is varied with respect to each other and optionally the number of electrode pairs used is varied to change the location and the coverage area of the region of the tissues that are stimulated.[0060]. Equally, in the sixth aspect the maximum component pulse widths on any given pair of electrodes, or individual electrodes with respect to the case or ground electrode of an implanted stimulator is determined with respect to each other to normalize the sensation on each electrode such that the perceived stimulation at the amplitude limit on each electrode pair is the same[0061]).
Claims 17 and 27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gillbe in view of Wallace and further in view of Molnar(US 8538513 B2).
Regarding claim 17, Gillbe in view of Wallace teaches the system of claim 16, but fails to explicitly state wherein to select the plurality of combinations of electrodes from the first electrodes and second electrodes to form the plurality of electrode pairs, the controller is configured to randomly select the plurality of combinations of electrodes from the first electrodes and second electrodes to form the plurality of electrode pairs.
However, Molnar teaches “Selecting one or more stimulation electrode combinations for therapy system 10 based on sensed bioelectrical brain signals may be useful for minimizing the amount of time required to select efficacious stimulation electrode combinations. In the example shown in FIG. 1, therapy system 10 comprises eight electrodes 24, 26, whereby any combination of the eight electrodes 24, 26 may be selected to provide stimulation therapy to brain 28. In existing techniques, a clinician may randomly select and test stimulation electrode combinations in order to find an efficacious stimulation electrode combination(Detailed Description, paragraph 30)”.
It would be obvious to one of the ordinary skill in the art before the effective filing date to configure the array stimulator of Gillbe with the random electrode selection of stimulation electrode selection of Molnar. Doing so would specify ways for different electrode pair stimulation depending on the desired effect on target tissue.
Regarding claim 27, Gillbe in view of Wallace teaches the system of claim 26, but fails to disclose wherein to select the plurality of combinations of electrodes from the first electrodes and second electrodes to form the plurality of electrode pairs, the controller is configured to randomly select the plurality of combinations of electrodes from the first electrodes and second electrodes to form the plurality of electrode pairs.
However, Molnar teaches “Selecting one or more stimulation electrode combinations for therapy system 10 based on sensed bioelectrical brain signals may be useful for minimizing the amount of time required to select efficacious stimulation electrode combinations. In the example shown in FIG. 1, therapy system 10 comprises eight electrodes 24, 26, whereby any combination of the eight electrodes 24, 26 may be selected to provide stimulation therapy to brain 28. In existing techniques, a clinician may randomly select and test stimulation electrode combinations in order to find an efficacious stimulation electrode combination(Detailed Description, paragraph 30)”.
It would be obvious to one of the ordinary skill in the art before the effective filing date to configure the array stimulator of Gillbe with the random electrode selection of stimulation electrode selection of Molnar. Doing so would specify ways for different electrode pair stimulation depending on the desired effect on target tissue.
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
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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