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.
Claim(s) 1-3, 16, 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Doerr (US Pre Grant Publication 2013/0023944 A1).
Regarding claims 1-3, & 16, Doerr teaches an implantable medical system comprising:
an implantable medical lead comprising:
a lead body (521, Fig. 5);
a plurality of conductors disposed within the lead body ([0037]; plurality of electrode feed lines), wherein:
a first conductor (571, Fig. 5) of the plurality of conductors extends from a proximal end of the lead body to a first return electrode (555, Fig. 5) at a first neural interface (Fig. 5; position of electrode 555 at first neural interface) at a first distal end of the lead body (521, Fig. 5) ([0037]; electrode 555 at a first distal end of lead 521),
a second conductor (572, Fig. 5) of the plurality of conductors extends from the proximal end of the lead body to a second return electrode (553, Fig. 5) at a second neural interface (Fig. 5; position of electrode 553 at second neural interface) at a second distal end of the lead body (521, Fig. 5) ([0037]; electrode 553 at a second distal end of lead 521), and
a third conductor (570, Fig. 5) of the plurality of conductors extends from the proximal end of the lead body:
to a first working electrode (560a, Fig. 5) in the first neural interface (electrodes 560a & 555 at first neural interface) at the first distal end ([0037]; electrode 560a at a first distal end of lead 521); and
to a second working electrode (560b, Fig. 5) in the second neural interface (electrodes 560b & 553 at second neural interface) at the second distal end ([0037]; electrode 560b at a first distal end of lead 521).
Regarding claim 21, Doerr teaches a method for configuring an implantable medical lead, comprising:
providing a lead body (521, Fig. 5) extending between a proximal end and first and second neural interfaces at respective first ([0037]; electrode 555 at a first distal end of lead 521) and second distal ends;
providing a plurality of conductors disposed within the lead body ([0037]; plurality of electrode feed lines),
extending a first conductor (571, Fig. 5) of the plurality of conductors from the proximal end of the lead body to a first reference electrode (555, Fig. 5) ([0037]; ring electrode 555 includes stimulation and sensing functions) at the first neural interface (Fig. 5; position of electrode 555 at first neural interface);
extending a second conductor (572, Fig. 5) of the plurality of conductors from the proximal end of the lead body to a second reference electrode (553, Fig. 5) ([0037]; electrode 553 part of tripolar electrode system that necessitates stimulation and sensing functions) at the second neural interface (Fig. 5; position of electrode 553 at second neural interface);
and
extending a third conductor (570, Fig. 5) of the plurality of conductors from the proximal end of the lead body:
to a first working electrode (560a, Fig. 5) at the first neural interface (electrodes 560a & 555 at first neural interface); and
to a second working electrode (560b, Fig. 5) at the second neural interface (electrodes 560b & 553 at second neural interface).
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.
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) 4-15, 17-20, 22-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doerr (US Pre Grant Publication 2013/0023944 A1), in view of Meadows et al (US Patent 6,516,227).
Regarding claims 4-5, 10, 17, Doerr teaches the implantable medical system of claims 3 & 16, and Doerr further teaches comprising:
an implantable medical device (210, Fig. 2) configured to generate stimulation signals ([0032]; cardiac stimulation and defib device 210) at either the first (Fig. 5; electrodes 560a & 555 at first neural interface) or the second neural interface,
but does not disclose,
a stimulation system comprising:
a plurality of subsystems comprising:
a current source,
a current sink,
a voltage source, and
a ground;
a matrix switch configured to:
selectively couple any one of the first and second return electrodes to any one of the plurality of subsystems, and
selectively couple all the first and second working electrodes to any other one of the plurality of subsystems; and
a controller configured to control the operation of the matrix switch,
as claimed.
However, Meadows teaches a system and a method for a rechargeable spinal cord stimulator. Meadows is analogous to the claimed invention because it is reasonably pertinent to the problem of providing neurostimulation to multiple regions of the body using various control system.
Meadows further teaches,
a stimulation system comprising:
a plurality of subsystems comprising:
a current source (4C06, Fig. 4C-1) [22:37-38],
a current sink (4C06),
a voltage source ([22:30-33]; electrode 4C11 selectively connected to voltage source), and
a ground ([22:30-33]; electrode 4C11 selectively connected to ground);
a matrix switch (188, Fig. 4A) configured to:
selectively couple any one of the first (E1, Fig. 4C-1) and second (E2) return electrodes ([22:22-25]; NDAC 4C07 enables current source 4C06 to sink current i.e. allows electrode E1 to function as a return electrode) to any one of the plurality of subsystems ([22:37-38]; current sink NDAC 4C07 selectively coupled to E1), and
selectively couple all the first (E3) and second (E4) working electrodes ([22:17-20]; PDAC 4C05 enables current source 4C06 to source current i.e. allows electrode E1 to function as an active electrode) to any other one of the plurality of subsystems ([22:37-38]; current source PDAC 4C05 selectively coupled to E3 & E4); and
a controller (166, Fig. 4A) configured to control the operation of the matrix switch ([20:37-38]; microcontroller 160 controls switching matrix 188).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method, as taught by Doerr, with a stimulation system, comprising, a plurality of subsystems, comprising, a current source, a current sink, a voltage source, and a ground, a matrix switch configured to selectively couple any one of the first and second return electrodes to any one of the plurality of subsystems, and selectively couple all of the first and second working electrodes to any other one of the plurality of subsystems, and a controller configured to control the operation of the matrix switch, as taught by Meadows. One of ordinary skill in the art would have been motivated to make these modifications to improve neuromodulation treatment by using a switching matrix to create “virtual” electrodes and control stimulation current fields (Meadows, [27:9-13]).
Regarding claim 6, Doerr, in view of Meadows, teaches the medical system of claim 5, but does not disclose, wherein the controller is configured to not switchably couple the stimulation system to the second return electrode in the second neural interface when the implantable medical device generates the neurostimulation signals at the first neural interface.
However, Meadows further teaches wherein the controller is configured to not switchably couple the stimulation system ([18:54-57]; “off” polarity (no current)) to the second return electrode in the second neural interface when the implantable medical device generates the neurostimulation signals at the first neural interface ([12:48-65]; sum of current sourced from positive electrodes should be equal to sum of current returned through negative electrodes; a 2-electrode single conductor configuration paired with 2 return electrodes at each neural interface, necessitates the other one of the return electrodes to float when one of the 2-electrode single conductor electrodes is selected or current may split across both return electrodes and stimulate neural tissue along both return paths).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system, as taught by Doerr and Meadows, with a controller configured to not switchably couple the stimulation system to the second return electrode in the second neural interface when the implantable medical device generates the neurostimulation signals at the first neural interface. One of ordinary skill in the art would have been motivated to make these modifications to control which electrodes are selected to create an electric field by turning off electrodes (Meadows, [18:46-48], [18:54-57]).
Regarding claims 7-9, 18, Doerr, in view of Meadows, teaches the implantable medical system of claims 5 & 17, but does not disclose,
wherein the controller is configured to not switchably couple the stimulation system to the second return electrode in the second neural interface such that the second return electrode in the second neural interface is floating and is not coupled to ground or any power source, and
wherein the controller is configured to either:
switchably couple the current source to the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors, and
switchably couple the ground to the first return electrode in the first neural interface via the first conductor of the plurality of conductors;
or
switchably couple the voltage source to the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors, and
switchably couple the current sink to the first return electrode in the first neural interface via the first conductor of the plurality of conductors.
However, Meadows teaches further comprising:
wherein the controller is configured to not switchably couple the stimulation system to the second return electrode in the second neural interface such that the second return electrode in the second neural interface is floating and is not coupled to ground or any power source ([18:54-57]; electrode not selected necessitates “off” polarity (no current)), and
wherein the controller is configured to either:
switchably couple the current source to the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors ([22:17-20]; PDAC 4C05 enables current source 4C06 to source current i.e. allows electrode E1 to function as an active electrode), and
switchably couple the ground to the first return electrode in the first neural interface via the first conductor of the plurality of conductors ([22:30-33]; recharge switch 4C10 allows indifferent electrode to be selectively connected to ground, or another voltage source);
or
switchably couple the voltage source to the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors, and
switchably couple the current sink to the first return electrode in the first neural interface via the first conductor of the plurality of conductors.
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system, as taught by Doerr and Meadows, with a controller configured to not switchably couple the stimulation system to the second return electrode in the second neural interface such that the second return electrode in the second neural interface is floating and is not coupled to ground or any power source and switchably couple the current source to the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors, and switchably couple the ground to the first return electrode in the first neural interface via the first conductor of the plurality of conductors. One of ordinary skill in the art would have been motivated to make these modifications to control which electrodes are selected to create an electric field by turning off electrodes (Meadows, [18:46-48], [18:54-57]).
Regarding claim 11, Doerr, in view of Meadows, teaches the medical system of claim 10, but does not disclose, wherein the controller is configured to not switchably couple the stimulation system to the first return electrode in the first neural interface when the implantable medical device generates the neurostimulation signals at the second neural interface.
However, Meadows further teaches wherein the controller is configured to not switchably couple the stimulation system ([18:54-57]; “off” polarity (no current)) to the first return electrode in the first neural interface when the implantable medical device generates the neurostimulation signals at the second neural interface ([12:48-65]; sum of current sourced from positive electrodes should be equal to sum of current returned through negative electrodes; a 2-electrode single conductor configuration paired with 2 return electrodes at each neural interface, necessitates the other one of the return electrodes to float when one of the 2-electrode single conductor electrodes is selected or current may split across both return electrodes and stimulate neural tissue along both return paths).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system, as taught by Doerr and Meadows, with a controller configured to not switchably couple the stimulation system to the first return electrode in the first neural interface when the implantable medical device generates the neurostimulation signals at the second neural interface. One of ordinary skill in the art would have been motivated to make these modifications to control which electrodes are selected to create an electric field by turning off electrodes (Meadows, [18:46-48], [18:54-57]).
Regarding claims 12-14, 19, Doerr, in view of Meadows, teaches the implantable medical system of claims 10 & 17, but does not disclose,
wherein the controller is configured to not switchably couple the stimulation system to the first return electrode in the first neural interface such that the first return electrode in the first neural interface is floating and is not coupled to ground or any power source, and
wherein the controller is configured to either:
switchably couple the current source to the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors, and
switchably couple the ground to the second return electrode in the second neural interface via the second conductor of the plurality of conductors;
or
switchably couple the voltage source to the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors, and
switchably couple the current sink to the second return electrode in the second neural interface via the second conductor of the plurality of conductors.
However, Meadows further teaches,
wherein the controller is configured to not switchably couple the stimulation system to the first return electrode in the first neural interface such that the first return electrode in the first neural interface is floating and is not coupled to ground or any power source ([18:54-57]; electrode not selected necessitates “off” polarity (no current)), and
wherein the controller is configured to either:
switchably couple the current source to the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors ([22:17-20]; PDAC 4C05 enables current source 4C06 to source current i.e. allows electrode E1 to function as an active electrode), and
switchably couple the ground to the second return electrode in the second neural interface via the second conductor of the plurality of conductors ([22:30-33]; recharge switch 4C10 allows indifferent electrode to be selectively connected to ground, or another voltage source);
or
switchably couple the voltage source to the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors, and
switchably couple the current sink to the second return electrode in the second neural interface via the second conductor of the plurality of conductors.
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system, as taught by Doerr and Meadows, with a controller configured to not switchably couple the stimulation system to the first return electrode in the first neural interface such that the first return electrode in the first neural interface is floating and is not coupled to ground or any power source, switchably couple the current source to the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors, and switchably couple the ground to the second return electrode in the second neural interface via the second conductor of the plurality of conductors. One of ordinary skill in the art would have been motivated to make these modifications to control which electrodes are selected to create an electric field by turning off electrodes (Meadows, [18:46-48], [18:54-57]).
Regarding claims 15 & 20, Doerr, in view of Meadows, teaches the implantable medical lead of claim 3 & 16, and Doerr further teaches wherein the first neural interface comprises at least one of a nerve cuff, a helical cuff, paddle electrodes or an electrode array (Fig. 5; electrode array 560a & 555 at first neural interface); and the second neural interface comprises at least one of a nerve cuff, a helical cuff, paddle electrodes or an electrode array (Fig. 5; electrode array 560b & 553 at second neural interface).
Regarding claim 22, Doerr teaches a method for configuring an implantable medical system, the method comprising:
the method of claim 21;
and Doerr further teaches,
providing an implantable medical device (210, Fig. 2), the implantable medical device comprising,
but does not disclose,
a stimulation system for generating stimulation signals via the implantable medical lead, the stimulation system comprising:
a plurality of subsystems comprising:
a current source,
a current sink,
a voltage source, and
a ground;
a matrix switch configured to:
selectively couple any one of the first and second reference electrodes to any one of the plurality of subsystems, and
selectively couple all the first and second working electrodes to any other one of the plurality of subsystems; and
a controller configured to control the operation of the matrix switch;
and coupling the implantable medical lead to the implantable medical device.
However, Meadows teaches,
a stimulation system, comprising:
a plurality of subsystems, comprising:
a current source (4C06, Fig. 4C-1) [22:37-38],
a current sink (4C06),
a voltage source ([22:30-33]; electrode 4C11 selectively connected to voltage source), and
a ground ([22:30-33]; electrode 4C11 selectively connected to ground).
a matrix switch (188, Fig. 4A) configured to:
selectively couple any one of the first (E1, Fig. 4C-1) and second (E2) return electrodes ([42:22-25]; NDAC 4C07 enables current source 4C06 to sink current i.e. allows electrode E1 to function as a return electrode) to any one of the plurality of subsystems ([42:37-52]; current sink NDAC 4C07 selectively coupled to E1), and
selectively couple all of the first (E3) and second (E4) working electrodes ([42:22-25]; PDAC 4C05 enables current source 4C06 to source current i.e. allows electrode E1 to function as an active electrode) to any other one of the plurality of subsystems ([42:37-52]; current source PDAC 4C05 selectively coupled to E3 & E4);
a controller (166, Fig. 4A) configured to control the operation of the matrix switch ([20:37-38]; microcontroller 160 controls switching matrix 188).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method, as taught by Doerr, with a stimulation system, comprising, a plurality of subsystems, comprising, a current source, a current sink, a voltage source, and a ground, a matrix switch configured to selectively couple any one of the first and second return electrodes to any one of the plurality of subsystems, and selectively couple all of the first and second working electrodes to any other one of the plurality of subsystems, and a controller configured to control the operation of the matrix switch, as taught by Meadows. One of ordinary skill in the art would have been motivated to make these modifications to improve neuromodulation treatment by using a switching matrix to create “virtual” electrodes and control stimulation current fields (Meadows, [27:9-13]).
Regarding claim 23, Doerr, in view of Meadows, teaches the method of claim 22, but does not disclose,
selecting the first neural interface to receive stimulation signals from the stimulation system;
coupling the first reference electrode in the first neural interface via the first conductor of the plurality of conductors to the ground via the matrix switch;
selecting the second conductor of the plurality of conductors to be floating and not coupled to ground or any power source; and
coupling the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors to the current source via the matrix switch.
However, Meadows further teaches comprising:
selecting the first neural interface to receive stimulation signals from the stimulation system ([20:37-44]; microcontroller 160 groups electrodes with other electrodes to control current stimulus pulses; electrode pairs placed at first and second neural interfaces requires controller to select one of the first or second neural interfaces for neural stimulation when said electrode groups are selected),
but does not disclose,
coupling the first reference electrode (4C11, Fig. 4C) in the first neural interface via the first conductor of the plurality of conductors to the ground via the matrix switch ([22:30-33]; recharge switch 4C10 allows indifferent electrode 4C11 to be selectively connected to ground, or another voltage source);
selecting the second conductor of the plurality of conductors to be floating and not coupled to ground or any power source ([18:54-57]; electrode not selected necessitates “off” polarity (no current)); and
coupling the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors to the current source via the matrix switch ([22:17-20]; PDAC 4C05 enables current source 4C06 to source current i.e. allows electrode E1 to function as an active electrode).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the method, as taught by Doerr and Meadows, with selecting the first neural interface to receive stimulation signals from the stimulation system, coupling the first reference electrode in the first neural interface via the first conductor of the plurality of conductors to the ground via the matrix switch, selecting the second conductor of the plurality of conductors to be floating and not coupled to ground or any power source, and coupling the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors to the current source via the matrix switch. One of ordinary skill in the art would have been motivated to make these modifications to control which electrodes are selected to create an electric field by turning off electrodes (Meadows, [18:46-48], [18:54-57]).
Regarding claim 24, Doerr, in view of Meadows, teaches the method of claim 22, but does not disclose,
selecting the first neural interface to receive stimulation signals from the stimulation system;
coupling the first reference electrode in the first neural interface via the first conductor of the plurality of conductors to the current sink via the matrix switch;
coupling the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors to the voltage source via the matrix switch; and
selecting the second reference electrode of the second neural interface to be floating and not coupled to ground or any power source.
However, Meadows further teaches comprising:
selecting the first neural interface to receive stimulation signals from the stimulation system ([20:37-44]; microcontroller 160 groups electrodes with other electrodes to control current stimulus pulses; electrode pairs placed at first and second neural interfaces requires controller to select one of the first or second neural interfaces for neural stimulation when said electrode groups are selected),
coupling the first reference electrode in the first neural interface via the first conductor of the plurality of conductors to the current sink via the matrix switch ([22:22-25]; NDAC 4C07 enables current source 4C06 to sink current);
coupling the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors to the voltage source via the matrix switch ([22:30-33]; recharge switch 4C10 allows indifferent electrode to be selectively connected to ground, or another voltage source); and
selecting the second reference electrode of the second neural interface to be floating and not coupled to ground or any power source ([18:54-57]; electrode not selected necessitates “off” polarity (no current)).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the method, as taught by Doerr and Meadows, with selecting the first neural interface to receive stimulation signals from the stimulation system, coupling the first reference electrode in the first neural interface via the first conductor of the plurality of conductors to the current sink via the matrix switch, coupling the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors to the voltage source via the matrix switch, and selecting the second reference electrode of the second neural interface to be floating and not coupled to ground or any power source. One of ordinary skill in the art would have been motivated to make these modifications to control which electrodes are selected to create an electric field by turning off electrodes (Meadows, [18:46-48], [18:54-57]).
Regarding claim 25, Doerr, in view of Meadows, teaches the method of claim 22, but does not disclose,
selecting the second neural interface to receive stimulation signals from the stimulation system;
coupling the second reference electrode in the second neural interface via the second conductor of the plurality of conductors to the ground via the matrix switch;
coupling the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors to the current source via the matrix switch; and
selecting the first reference electrode of the first neural interface to be floating and not coupled to ground or any power source.
However, Meadows further teaches comprising:
selecting the second neural interface to receive stimulation signals from the stimulation system ([20:37-44]; microcontroller 160 groups electrodes with other electrodes to control current stimulus pulses; electrode pairs placed at first and second neural interfaces requires controller to select one of the first or second neural interfaces for neural stimulation when said electrode groups are selected),
coupling the second reference electrode (4C11, Fig. 4C; plurality of indifferent electrodes) in the second neural interface via the second conductor of the plurality of conductors to the ground via the matrix switch ([22:30-33]; recharge switch 4C10 allows indifferent electrode 4C11 to be selectively connected to ground, or another voltage source);
coupling the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors to the current source via the matrix switch ([22:17-20]; PDAC 4C05 enables current source 4C06 to source current i.e. allows electrode E1 to function as an active electrode); and
selecting the first reference electrode of the first neural interface to be floating and not coupled to ground or any power source ([18:54-57]; electrode not selected necessitates “off” polarity (no current)).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the method, as taught by Doerr and Meadows, with selecting the second neural interface to receive stimulation signals from the stimulation system, coupling the second reference electrode in the second neural interface via the second conductor of the plurality of conductors to the ground via the matrix switch, coupling the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors to the current source via the matrix switch, and selecting the first reference electrode of the first neural interface to be floating and not coupled to ground or any power source. One of ordinary skill in the art would have been motivated to make these modifications to control which electrodes are selected to create an electric field by turning off electrodes (Meadows, [18:46-48], [18:54-57]).
Regarding claim 26, Doerr, in view of Meadows, teaches the method of claim 22, but does not disclose,
selecting the second neural interface to receive stimulation signals from the stimulation system
coupling the second reference electrode in the second neural interface via the second conductor of the plurality of conductors to the current sink via the matrix switch;
coupling the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors to the voltage source via the matrix switch; and
selecting the first reference electrode of the first neural interface to be floating and not coupled to ground or any power source.
However, Meadows teaches further comprising:
selecting the second neural interface to receive stimulation signals from the stimulation system ([20:37-44]; microcontroller 160 groups electrodes with other electrodes to control current stimulus pulses; electrode pairs placed at first and second neural interfaces requires controller to select one of the first or second neural interfaces for neural stimulation when said electrode groups are selected),
coupling the second reference electrode in the second neural interface via the second conductor of the plurality of conductors to the current sink via the matrix switch ([22:22-25]; NDAC 4C07 enables current source 4C06 to sink current);
coupling the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors to the voltage source via the matrix switch ([22:30-33]; recharge switch 4C10 allows indifferent electrode to be selectively connected to ground, or another voltage source); and
selecting the first reference electrode of the first neural interface to be floating and not coupled to ground or any power source ([18:54-57]; electrode not selected necessitates “off” polarity (no current)).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the method, as taught by Doerr and Meadows, with selecting the second neural interface to receive stimulation signals from the stimulation system, coupling the second reference electrode in the second neural interface via the second conductor of the plurality of conductors to the current sink via the matrix switch, coupling the first and second working electrodes in the first and second neural interfaces via the third conductor of the plurality of conductors to the voltage source via the matrix switch, and selecting the first reference electrode of the first neural interface to be floating and not coupled to ground or any power source. One of ordinary skill in the art would have been motivated to make these modifications to control which electrodes are selected to create an electric field by turning off electrodes (Meadows, [18:46-48], [18:54-57]).
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 & 4, 16 & 17, and 21 & 22 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 & 16 of copending Application No. 19/093,157 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 & 16 of the instant application are anticipated by the reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant Application
19/093,145
Application
19/093,157
Claim 1
Claim 1
An implantable medical lead comprising:
a lead body extending between a proximal end and first and second distal ends;
and a plurality of conductors disposed within the lead body, wherein:
An implantable medical system comprising:
a medical lead comprising:
a first conductor of the plurality of conductors extends from the proximal end of the lead body to a first electrode at the first distal end,
a first return conductor extending from a proximal end of the medical lead to a first return electrode at a first neural interface at a first distal end of the medical lead
a second conductor of the plurality of conductors extends from the proximal end of the lead body to a first electrode at the second distal end, and
a second return conductor extending from the proximal end of the medical lead to a second return electrode at a second neural interface at a second distal end of the medical lead, and
a third conductor of the plurality of conductors extends from the proximal end of the lead body:
to a second electrode at the first distal end; and to a second electrode at the second distal end.
a working conductor extending from the proximal end of the medical lead to first and second working electrodes respectively in the first and second neural interfaces; and
Claim 4
a stimulation system (necessarily requires a signal processor that receives (input) and/or transmits (output) a signal), comprising:
a plurality of subsystems, comprising:
a current source, a current sink, a voltage source, and a ground;
a plurality of subsystems comprising a current source, a current sink, a signal processor, a voltage source, and a ground,
wherein the signal processor has at least one input and at least one output.
Instant Application
19/093,145
Application
19/093,157
Claim 16
Claim 1
An implantable medical system comprising:
an implantable medical lead comprising:
a lead body;
a plurality of conductors disposed within the lead body, wherein:
An implantable medical system comprising:
a medical lead comprising:
a first conductor of the plurality of conductors extends from a proximal end of the lead body to a first return electrode at a first neural interface at a first distal end of the lead body,
a first return conductor extending from a proximal end of the medical lead to a first return electrode at a first neural interface at a first distal end of the medical lead
a second conductor of the plurality of conductors extends from the proximal end of the lead body to a second return electrode at a second neural interface at a second distal end of the lead body, and
a second return conductor extending from the proximal end of the medical lead to a second return electrode at a second neural interface at a second distal end of the medical lead, and
a third conductor of the plurality of conductors extends from the proximal end of the lead body:
to a first working electrode in the first neural interface at the first distal end; and to a second working electrode in the second neural interface at the second distal end.
a working conductor extending from the proximal end of the medical lead to first and second working electrodes respectively in the first and second neural interfaces; and
Claim 17
a stimulation system (necessarily requires a signal processor that receives (input) and/or transmits (output) a signal) comprising:
a plurality of subsystems comprising: a current source, a current sink, a voltage source, and a ground;
a plurality of subsystems comprising a current source, a current sink, a signal processor, a voltage source, and a ground,
wherein the signal processor has at least one input and at least one output.
Instant Application
19/093,145
Application
19/093,157
Claim 21
Claim 16
A method for configuring an implantable medical lead, comprising:
providing a lead body extending between a proximal end and first and second neural interfaces at respective first and second distal ends;
providing a plurality of conductors disposed within the lead body;
A method for configuring an implantable medical system, comprising:
providing a medical lead extending between a proximal end and first and second neural interfaces at respective first and second distal ends, the medical lead comprising:
extending a first conductor of the plurality of conductors from the proximal end of the lead body to a first reference electrode at the first neural interface;
extending a second conductor of the plurality of conductors from the proximal end of the lead body to a second reference electrode at the second neural interface;
a first and a second return conductor respectively extending from the proximal end of the medical lead to first and second return electrodes at first and second neural interfaces, and
extending a third conductor of the plurality of conductors from the proximal end of the lead body:
to a first working electrode at the first neural interface; and
to a second working electrode at the second neural interface.
a working conductor respectively extending from the proximal end of the medical lead to first and second working electrodes in the first and second neural interfaces;
Claim 22
the stimulation system (necessarily requires a signal processor that receives (input) and/or transmits (output) a signal) comprising:
a plurality of subsystems comprising: a current source, a current sink, a voltage source, and a ground;
providing a plurality of subsystems comprising a current source, a current sink, a signal processor, a voltage source, and a ground, the signal processor having at least one input and at least one output; and
a matrix switch configured to:
selectively couple any one of the first and second reference electrodes to any one of the plurality of subsystems, and selectively couple all the first and second working electrodes to any other one of the plurality of subsystems; and a controller configured to control the operation of the matrix switch; and coupling the implantable medical lead to the implantable medical device.
providing a matrix switch configured to:
selectively couple any one of the first and second return electrodes to any one of the plurality of subsystems, and selectively couple all the first and second working electrodes to any other one of the plurality of subsystems.
Conclusion
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/DWANE COLLARD/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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