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
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 23-24 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being unpatentable by Molnar(CN 112839602 A).
Regarding claim 23, Molnar discloses an electrode comprising: an electrode body defining: a first fixation hole configured to receive a first projection of an expandable structure; a second fixation hole separate from the first fixation hole and configured to receive a second projection of the expandable structure; and at least one conductor hole configured to receive a conductor wire(The cutting pattern 2820 includes a tether 2808, an attachment point 2812, a proximal fixation mechanism including a hole 2816, 2804b fixation structure 2802, and a distal fixation mechanism 2804a. In addition to other means of the shape set described herein, the adjacent proximal end fixing mechanism 2804b the strut can be bent at a certain angle. 28H is a side view of the post 2824 of FIG. 28G. The proximal end 2826 of the proximal fixation mechanism 2804b and the distal end 2828 of the proximal fixation mechanism 2804b are shown as a dotted line after the post 2824(see attached translation, page 134, paragraph 4).The struts may be laser-cut struts. The hole can be cut by laser. The first side of the strut may include a channel. The conductor may be located in the channel. The assembly may further include an electrically insulating material over the swaging portion of the electrode. The assembly may further include a plurality of holes in the portion of the pillar and one electrode in each hole of the plurality of holes, and comprises a swaging portion on the first side of the pillar. The assembly may further include a plurality of strut portions, each strut portion comprises at least one electrode in the hole of one strut, and comprises a swaging portion on the first side of one strut(see attached translation, page 43, paragraph 7)); wherein the electrode body includes a first electrode surface, the first electrode surface being electrically conductive, wherein the electrode body includes a second electrode surface opposite the first electrode surface with an electrically insulative material applied to the second electrode surface, and wherein the electrode body defines a non-cylindrical shape(The device may include a plurality of electrodes comprising the electrodes. The plurality of electrodes may at least partially form an electrode matrix. Each of the plurality of electrodes may be electrically connected to one of the plurality of conductors. The electrode may have a dome shape(see attached translation, page 18, paragraph 2) The device may also include an insulating material between the plurality of conductors and the electrodes. The device may also include an insulating material between the plurality of conductors and the third side wall. The device may also include an insulating material extending at least over the bottom of the electrode. The insulating material may include a dome shape(see attached translation, page 18, paragraph 3)).
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Regarding claim 24, Molnar discloses the electrode of claim 23, wherein the at least one conductor hole is configured as a pass-through hole to facilitate electrical connection of the conductor wire to a different electrode(The conductor 5368 can be electrically coupled to the electrode 5366 without brazing, fusion welding or the like. For example, the electrode 5366 can pass through the hole of the strut 5362, and then the inner deformation (e.g., forging, crimping) to the electrode 5366 retained on the strut 5362, for example, as shown in FIG. 53G(see attached translation, page 204, paragraph 4)).
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.
Claim(s) 1, 2, 4, 5, 9, 11-13, 15, 16, 20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over John(US 11376138 B2) in view of Nguyen(CN 114786597 A).
Regarding claim 1, John discloses an endovascular medical device system comprising: an elongated body configured to be introduced in a blood vessel of a patient; an expandable structure at a distal portion of the elongated body, the expandable structure comprising: an expandable body portion including a plurality of interconnected struts, and a plurality of electrode attachment elements, each electrode attachment element of the plurality of electrode attachment, wherein each electrode of the one or more electrodes is configured to receive the first projection and the second projection of a respective electrode attachment element of the plurality of electrode attachment elements to couple the respective electrode to the expandable structure(The present disclosure further includes a medical device for use within a tubular body having a lumen, the medical device comprising: a frame structure forming a plurality of struts, where the frame structure is moveable between a reduce profile and an expanded profile in which a diameter of the frame structure increases; where at least one of the plurality of struts forming the frame structure comprises an electrically conductive material on a support material, the electrically conductive material extending along at least a portion of the strut and being covered with a non-conductive material; at least one electrode formed by an opening in the non-conductive material on the portion of the strut; and a lead located at an end of the frame structure and configured to be in electrical communication with the electrically conductive portion, the lead extending from the frame structure(Summary of the Invention, paragraph 6)). John fails to disclose the elements including a first projection and a second projection branching off of at least one strut of the plurality of interconnected struts; and one or more electrodes coupled to the expandable structure via the plurality of electrode attachment elements.
However, Nguyen teaches “.FIG. 3 A also shows a plurality of protrusions 318 on which an electrode 202 or a radiopaque marker may be mounted. Each protrusion 318 may be attached to a portion of the interventional component 100, which may contact thrombus during use of the intervening component In some embodiments, the protrusion 318 may be attached to the portion of the interventional component 100 in the working length WL. In the embodiment of the interventional component includes a strut 302, the protrusion 318 may be attached to the strut 302. If present, the projection 318 may be arranged in the unit 304, or arranged on the other surface of the interventional component In some embodiments, a plurality of projections 318 can respectively attached to a plurality of struts 302(see attached translation, page 22, paragraph 3)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the blood vessel stimulating and sensing device of John with the projections of the endovascular device of Nguyen. Doing so would specify projections attached to the struts if the vascular device for enhanced structural support.
Regarding claim 2, John in view of Nguyen teaches the endovascular medical device system of claim 1, wherein the expandable structure is configured to expand radially outwards from a relatively low-profile delivery configuration to a deployed configuration to position the one or more electrodes to deliver electrical stimulation to tissue of the patient or sense a patient parameter from a location within the blood vessel(John - For purposes of illustration, the stents 101 in FIGS. 46A-47F described above and FIGS. 48A-48B, 46B-46C, 51B, 52B, 53B-53C, 54A-57 and 58C described below are shown flat so that the cells, struts 108, electrodes 131, and/or electrode tracks 236 can be easily seen. However, the stents 101 are curved in practice (e.g., when in the compressed and/or expanded configuration). The top of the stents 101 can be directly joined to the bottom of the stents101 (the top and bottom as shown in FIGS. 46A-47F) to form cylindrical tube-like stent structures that can exert radial outward forces against a vessel wall(Detailed Description, paragraph 199). To optimize the ability of the electrodes 131 to stimulate or record from medium (including but not limited to neural tissue, vascular tissue, blood, bone, muscle, cerebrospinal fluid), the electrodes 131 may be positioned at pre-determined intervals based on the diameter of the target vessel 103 to allow each of the electrodes 131 to be in contact with the vessel 103 in the same orientation (ie, all electrodes facing to and in contact with the left vessel wall upon deposition). Electrodes 131 may be mounted such that recordings or stimulation can be directed to all 360 degrees of the vessel simultaneously(Detailed description, paragraph 26)).
Regarding claim 4, John in view of Nguyen teaches the endovascular medical device system of claim 1, wherein at least one electrode of the one or more electrodes defines at least one conductor hole configured to receive a conductor wire(John - Furthermore, the connection pads 132 can include one or more holes or openings that enable visual confirmation that the pads are aligned with contacts on the lead. These holes/openings also enables direct/laser welding or adhesion of the contact leads (inside tube 121) and the contact pads (on the inside of the tube spanning through the hole to the outside)( Detailed Description, paragraph 132). The pads of the stent can be electrically connected to the electrodes 131 (not shown) via the electrode tracks 236. The pads and openings 226, 228 can have the various dimensions shown. This design, and similar changes to the pads on the stent 101, can advantageously allow for linear attachment of the pads 226 to the wire bonding holes 228, which can make manufacturing the connection panel 220 easier than(Detailed Description, paragraph 174)).
Regarding claim 5, John in view of Nguyen teaches the endovascular medical device system of claim 4, wherein the at least one conductor hole is configured as a pass-through hole to facilitate electrical connection of the conductor wire to a second, different electrode of the one or more electrodes(John - The pads of the stent can be electrically connected to the electrodes 131 (not shown) via the electrode tracks 236. The pads and openings 226, 228 can have the various dimensions shown. This design, and similar changes to the pads on the stent 101, can advantageously allow for linear attachment of the pads 226 to the wire bonding holes 228, which can make manufacturing the connection panel 220 easier than( Detailed Description, paragraph 174)).
Regarding claim 9, John in view of Nguyen teaches the endovascular medical device system of claim 1, wherein at least one electrode of the one or more electrodes includes an electrically insulative material applied to an electrode surface facing radially inward toward a central longitudinal of the expandable structure(John - Electrical insulation of electrodes is achieved by RF sputtering and deposition of a non-conductive layer (52) (eg, SiO) onto the thin-film structure (54). Electrodes and electrode tracks (50) are sputter deposited onto the non-conductive layer (using conductive and biomedically acceptable materials including gold, Pt, Ti, NiTi, PtIr), with an additional non-conductive layer deposited over the conductive track for further electrical isolation and insulation. As shown, conducting path 50 is left exposed to form the electrode 138 (similarly, a contact pad area can remain exposed). Finally, the sacrificial layer 56 and substrate are removed leaving the stent structure 101 as shown in FIG. 39C.(Detailed Description, paragraph 140)).
Regarding claim 11, John in view of Nguyen teaches the endovascular medical device system of claim 1, but John fails to disclose wherein the first projection extends away from a first side of the at least one strut and the second projection extends away from a second side of the at least one strut opposite the first side.
However, Nguyen teaches “ The method according to any one of the preceding claims, wherein the conveying electrode coupling to extend from a projection extending from a strut of the expandable member(see attached translation, page 15, paragraph 9)[FIG. 11]).
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It would be obvious to one of ordinary skill in the art before the effective filing date to configure the blood vessel stimulating and sensing device of John with the projections of the endovascular device of Nguyen. Doing so would specify projections attached to the struts if the vascular device for enhanced structural support.
Regarding claim 12, John discloses a method of using a medical device system, the method comprising: introducing a medical device into vasculature of a patient, the medical device comprising: an elongated body configured to be introduced in a blood vessel of a patient; an expandable structure at a distal portion of the elongated body, the expandable structure comprising: an expandable body portion including a plurality interconnected struts, each electrode attachment element of the plurality of electrode attachment elements; and one or more electrodes coupled to the expandable structure via the plurality of electrode attachment elements, wherein each electrode of the one or more electrodes is configured to receive the first projection and the second projection of a respective electrode attachment element of the plurality of electrode attachment elements to couple the respective electrode to the expandable structure; and advancing the medical device until the one or more electrodes are at or near a target location in the vasculature of the patient(The present disclosure further includes a medical device for use within a tubular body having a lumen, the medical device comprising: a frame structure forming a plurality of struts, where the frame structure is moveable between a reduce profile and an expanded profile in which a diameter of the frame structure increases; where at least one of the plurality of struts forming the frame structure comprises an electrically conductive material on a support material, the electrically conductive material extending along at least a portion of the strut and being covered with a non-conductive material; at least one electrode formed by an opening in the non-conductive material on the portion of the strut; and a lead located at an end of the frame structure and configured to be in electrical communication with the electrically conductive portion, the lead extending from the frame structure(Summary of the Invention, paragraph 6). The first and second devices 100a, 100b can have any of the features disclosed, contemplated and/or illustrated herein. The first and second vessels 800a, 800b can be the same or a different vessel and can be any blood vessel in the body. The target location 802 can be any tissue location disclosed, contemplated and/or illustrated herein. The devices 100a and 100b can emit signals away from the devices 100a and 100b, respectively, for example, to stimulate tissue (e.g., tissue in the target area 802), the devices 100a and 100b can record signals received from the tissue (e.g., tissue in the target area 802), or both (e.g., the devices 100a and/or 100b can stimulate tissue and/or can record signals from tissue)(Detailed Description, paragraph 314)). John fails to disclose the elements including a first projection and a second projection branching off of at least one strut of the plurality of interconnected struts; and one or more electrodes coupled to the expandable structure via the plurality of electrode attachment elements.
However, Nguyen teaches “.FIG. 3 A also shows a plurality of protrusions 318 on which an electrode 202 or a radiopaque marker may be mounted. Each protrusion 318 may be attached to a portion of the interventional component 100, which may contact thrombus during use of the intervening component In some embodiments, the protrusion 318 may be attached to the portion of the interventional component 100 in the working length WL. In the embodiment of the interventional component includes a strut 302, the protrusion 318 may be attached to the strut 302. If present, the projection 318 may be arranged in the unit 304, or arranged on the other surface of the interventional component In some embodiments, a plurality of projections 318 can respectively attached to a plurality of struts 302(see attached translation, page 22, paragraph 3)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the blood vessel stimulating and sensing device of John with the projections of the endovascular device of Nguyen. Doing so would specify projections attached to the struts if the vascular device for enhanced structural support.
Regarding claim 13, John in view of Nguyen teaches the method of claim 12, wherein the expandable structure is configured to expand radially outwards from a relatively low-profile delivery configuration to a deployed configuration to position the one or more electrodes to deliver electrical stimulation to tissue of the patient or sense a patient parameter from a location within the blood vessel(John - For purposes of illustration, the stents 101 in FIGS. 46A-47F described above and FIGS. 48A-48B, 46B-46C, 51B, 52B, 53B-53C, 54A-57 and 58C described below are shown flat so that the cells, struts 108, electrodes 131, and/or electrode tracks 236 can be easily seen. However, the stents 101 are curved in practice (e.g., when in the compressed and/or expanded configuration). The top of the stents 101 can be directly joined to the bottom of the stents101 (the top and bottom as shown in FIGS. 46A-47F) to form cylindrical tube-like stent structures that can exert radial outward forces against a vessel wall(Detailed Description, paragraph 199). To optimize the ability of the electrodes 131 to stimulate or record from medium (including but not limited to neural tissue, vascular tissue, blood, bone, muscle, cerebrospinal fluid), the electrodes 131 may be positioned at pre-determined intervals based on the diameter of the target vessel 103 to allow each of the electrodes 131 to be in contact with the vessel 103 in the same orientation (ie, all electrodes facing to and in contact with the left vessel wall upon deposition). Electrodes 131 may be mounted such that recordings or stimulation can be directed to all 360 degrees of the vessel simultaneously(Detailed description, paragraph 26)).
Regarding claim 15, John in view of Nguyen teaches the method of claim 12, wherein at least one electrode of the one or more electrodes defines at least one conductor hole configured to receive a conductor wire(John - Furthermore, the connection pads 132 can include one or more holes or openings that enable visual confirmation that the pads are aligned with contacts on the lead. These holes/openings also enables direct/laser welding or adhesion of the contact leads (inside tube 121) and the contact pads (on the inside of the tube spanning through the hole to the outside)( Detailed Description, paragraph 132). The pads of the stent can be electrically connected to the electrodes 131 (not shown) via the electrode tracks 236. The pads and openings 226, 228 can have the various dimensions shown. This design, and similar changes to the pads on the stent 101, can advantageously allow for linear attachment of the pads 226 to the wire bonding holes 228, which can make manufacturing the connection panel 220 easier than(Detailed Description, paragraph 174)).
Regarding claim 16, John in view of Nguyen teaches the method of claim 15, wherein the at least one conductor hole is configured as a pass-through hole to facilitate electrical connection of the conductor wire to a second, different electrode of the one or more electrodes((John - The pads of the stent can be electrically connected to the electrodes 131 (not shown) via the electrode tracks 236. The pads and openings 226, 228 can have the various dimensions shown. This design, and similar changes to the pads on the stent 101, can advantageously allow for linear attachment of the pads 226 to the wire bonding holes 228, which can make manufacturing the connection panel 220 easier than( Detailed Description, paragraph 174)).
Regarding claim 20, John in view of Nguyen teaches the method of claim 12, wherein at least one electrode of the one or more electrodes includes an electrically insulative material applied to an electrode surface facing radially inward toward a central longitudinal of the expandable structure(John - Electrical insulation of electrodes is achieved by RF sputtering and deposition of a non-conductive layer (52) (eg, SiO) onto the thin-film structure (54). Electrodes and electrode tracks (50) are sputter deposited onto the non-conductive layer (using conductive and biomedically acceptable materials including gold, Pt, Ti, NiTi, PtIr), with an additional non-conductive layer deposited over the conductive track for further electrical isolation and insulation. As shown, conducting path 50 is left exposed to form the electrode 138 (similarly, a contact pad area can remain exposed). Finally, the sacrificial layer 56 and substrate are removed leaving the stent structure 101 as shown in FIG. 39C.(Detailed Description, paragraph 140)).
Regarding claim 22, John in view of Nguyen teaches the method of claim 12, but John fails to disclose wherein the first projection extends away from a first side of the at least one strut and the second projection extends away from a second side of the at least one strut opposite the first side.
However, Nguyen teaches “ The method according to any one of the preceding claims, wherein the conveying electrode coupling to extend from a projection extending from a strut of the expandable member(see attached translation, page 15, paragraph 9)[FIG. 11]).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the blood vessel stimulating and sensing device of John with the projections of the endovascular device of Nguyen. Doing so would specify projections attached to the struts if the vascular device for enhanced structural support.
Claim(s) 3, 6-8, 10, 14, 17-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over John in view of Nguyen, and further in view of Molnar(CN 112839602 A).
Regarding claim 3, John in view of Nguyen teaches the endovascular medical device system of claim 1, but fail to disclose wherein each electrode of the one or more electrodes defines at least a first fixation hole and a second fixation hole, the first fixation hole configured to receive the first projection of the respective electrode attachment element and the second fixation hole configured to receive the second projection of the respective electrode attachment.
However, Molnar teaches “The cutting pattern 2820 includes a tether 2808, an attachment point 2812, a proximal fixation mechanism including a hole 2816, 2804b fixation structure 2802, and a distal fixation mechanism 2804a. In addition to other means of the shape set described herein, the adjacent proximal end fixing mechanism 2804b the strut can be bent at a certain angle. 28H is a side view of the post 2824 of FIG. 28G. The proximal end 2826 of the proximal fixation mechanism 2804b and the distal end 2828 of the proximal fixation mechanism 2804b are shown as a dotted line after the post 2824(see attached translation, page 134, paragraph 4).The struts may be laser-cut struts. The hole can be cut by laser. The first side of the strut may include a channel. The conductor may be located in the channel. The assembly may further include an electrically insulating material over the swaging portion of the electrode. The assembly may further include a plurality of holes in the portion of the pillar and one electrode in each hole of the plurality of holes, and comprises a swaging portion on the first side of the pillar. The assembly may further include a plurality of strut portions, each strut portion comprises at least one electrode in the hole of one strut, and comprises a swaging portion on the first side of one strut(see attached translation, page 43, paragraph 7)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the blood vessel stimulating and sensing device of John with the fixation holes of the neural stimulation of Molnar. Doing so would specify holes for receiving projection elements or electrodes in order to maintain a strong structural device.
Regarding claim 6, John in view of Nguyen teaches the endovascular medical device system of claim 1, but fails to disclose wherein the one or more electrodes includes one or more machined electrodes. However, Molnar teaches “FIG 53Ci 2 schematically shows an example method for manufacturing an electrode assembly 5300a an electrode assembly 5300 such as FIG. 53A, 5300b shown in 53Ciii. 5300. 53Ci electrode 5306 is placed in the mold 5340. When the cylindrical electrode assembly 5300 is formed, the mold 5340 may have a cylindrical or annular shape. The electrode 5306 is coupled to the electrical connector 5307. FIG 53Cii 1 shows the use of a polyurethane, silicone, a combination of the biocompatible electric insulating material 5342 the mold 5340 in the electrode 5306 for coating and forming(see attached translation, page 202, paragraph 6)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the blood vessel stimulating and sensing device of John with the electrodes of the neural stimulation of Molnar. Doing so would the manufacturing or type of electrodes used in the system for proper stimulation.
Regarding claim 7, John in view of Nguyen teaches the endovascular medical device system of claim 1, but fails to disclose wherein the one or more electrodes includes one or more stamped electrodes. However, Molnar teaches “The hollow electrode 5810 may be more easily manufactured, for example by stamping a flat metal sheet(see attached translation, page 215, paragraph 3)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the blood vessel stimulating and sensing device of John with the electrodes of the neural stimulation of Molnar. Doing so would the manufacturing or type of electrodes used in the system for proper stimulation.
Regarding claim 8, John in view of Nguyen teaches the endovascular medical device system of claim 1, but fails to disclose wherein the one or more includes one or more machined electrodes and one or more stamped electrodes. However, Molnar teaches “FIG 53Ci 2 schematically shows an example method for manufacturing an electrode assembly 5300a an electrode assembly 5300 such as FIG. 53A, 5300b shown in 53Ciii. 5300. 53Ci electrode 5306 is placed in the mold 5340. When the cylindrical electrode assembly 5300 is formed, the mold 5340 may have a cylindrical or annular shape. The electrode 5306 is coupled to the electrical connector 5307. FIG 53Cii 1 shows the use of a polyurethane, silicone, a combination of the biocompatible electric insulating material 5342 the mold 5340 in the electrode 5306 for coating and forming(see attached translation, page 202, paragraph 6). The hollow electrode 5810 may be more easily manufactured, for example by stamping a flat metal sheet(see attached translation, page 215, paragraph 3)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the blood vessel stimulating and sensing device of John with the electrodes of the neural stimulation of Molnar. Doing so would the manufacturing or type of electrodes used in the system for proper stimulation.
Regarding claim 10, John in view of Nguyen teaches the endovascular medical device system of claim 1, to disclose wherein at least one electrode of the one or more electrodes defines an electrically conductive surface facing radially outward from a central longitudinal of the expandable structure(John - Alternatively, the electrodes 131 are made from electrically conductive material and attached to one or more stents, which form the device 100 and allow for multiple positions(Detailed Description, paragraph 26). The seven electrodes 131 can span radially across a length of the vessel with no electrode overlap. For example, the seven electrodes 131 can span radially across a length of an 8mm vessel with no electrode overlap. The seven electrodes 131 can be at different radial positions along a length of the stent 101 such that there is no overlap of electrodes 131 when the stent 101 is expanded in a vessel(Detailed Description, paragraph 185), but fails to disclose the electrically conductive surface defining an area of about 0.5 mm2 to about 10 mm2.
However, Molnar teaches “In some examples, the electrode 203 has a surface area of between about 0.5mm2 to about 5mm2 (e.g., about 0.5mm2, about 1mm2, about 1.5mm2, about 2mm2, about 2.5mm2, about 3mm2, about 3.5mm2, about 4mm2; about 4.5mm2 range of about 5mm2, such a range, etc.)(see attached translation, page 72, paragraph 4)[FIG 2G]).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the blood vessel stimulating and sensing device of John with the electrodes of the neural stimulation of Molnar. Doing so would specify the surface area of the electrode stimulation so the patient knows the how many electrodes to use in the system.
Regarding claim 14, John in view of Nguyen teaches the method of claim 12, but fails to disclose wherein each electrode of the one or more electrodes defines at least a first fixation hole and a second fixation hole, the first fixation hole configured to receive the first projection of the respective electrode attachment element and second fixation hole configured to receive the second projection of the respective electrode attachment.
However, Molnar teaches “The cutting pattern 2820 includes a tether 2808, an attachment point 2812, a proximal fixation mechanism including a hole 2816, 2804b fixation structure 2802, and a distal fixation mechanism 2804a. In addition to other means of the shape set described herein, the adjacent proximal end fixing mechanism 2804b the strut can be bent at a certain angle. 28H is a side view of the post 2824 of FIG. 28G. The proximal end 2826 of the proximal fixation mechanism 2804b and the distal end 2828 of the proximal fixation mechanism 2804b are shown as a dotted line after the post 2824(see attached translation, page 134, paragraph 4).The struts may be laser-cut struts. The hole can be cut by laser. The first side of the strut may include a channel. The conductor may be located in the channel. The assembly may further include an electrically insulating material over the swaging portion of the electrode. The assembly may further include a plurality of holes in the portion of the pillar and one electrode in each hole of the plurality of holes, and comprises a swaging portion on the first side of the pillar. The assembly may further include a plurality of strut portions, each strut portion comprises at least one electrode in the hole of one strut, and comprises a swaging portion on the first side of one strut(see attached translation, page 43, paragraph 7)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the blood vessel stimulating and sensing device of John with the fixation holes of the neural stimulation of Molnar. Doing so would specify holes for receiving projection elements or electrodes in order to maintain a strong structural device.
Regarding claim 17, John in view of Nguyen teaches the method of claim 12, fails to disclose wherein the one or more electrodes includes one or more machined electrodes. However, Molnar teaches “FIG 53Ci 2 schematically shows an example method for manufacturing an electrode assembly 5300a an electrode assembly 5300 such as FIG. 53A, 5300b shown in 53Ciii. 5300. 53Ci electrode 5306 is placed in the mold 5340. When the cylindrical electrode assembly 5300 is formed, the mold 5340 may have a cylindrical or annular shape. The electrode 5306 is coupled to the electrical connector 5307. FIG 53Cii 1 shows the use of a polyurethane, silicone, a combination of the biocompatible electric insulating material 5342 the mold 5340 in the electrode 5306 for coating and forming(see attached translation, page 202, paragraph 6)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the blood vessel stimulating and sensing device of John with the electrodes of the neural stimulation of Molnar. Doing so would the manufacturing or type of electrodes used in the system for proper stimulation.
Regarding claim 18, John in view of Nguyen teaches the method of claim 12, but fails to disclose wherein the one or more electrodes includes one or more stamped electrodes. However, Molnar teaches “The hollow electrode 5810 may be more easily manufactured, for example by stamping a flat metal sheet(see attached translation, page 215, paragraph 3)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the blood vessel stimulating and sensing device of John with the electrodes of the neural stimulation of Molnar. Doing so would the manufacturing or type of electrodes used in the system for proper stimulation.
Regarding claim 19, John in view of Nguyen teaches the method of claim 12, but fails to disclose wherein the one or more electrodes includes one or more machined electrodes and one or more stamped electrodes. However, Molnar teaches “FIG 53Ci 2 schematically shows an example method for manufacturing an electrode assembly 5300a an electrode assembly 5300 such as FIG. 53A, 5300b shown in 53Ciii. 5300. 53Ci electrode 5306 is placed in the mold 5340. When the cylindrical electrode assembly 5300 is formed, the mold 5340 may have a cylindrical or annular shape. The electrode 5306 is coupled to the electrical connector 5307. FIG 53Cii 1 shows the use of a polyurethane, silicone, a combination of the biocompatible electric insulating material 5342 the mold 5340 in the electrode 5306 for coating and forming(see attached translation, page 202, paragraph 6). The hollow electrode 5810 may be more easily manufactured, for example by stamping a flat metal sheet(see attached translation, page 215, paragraph 3)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the blood vessel stimulating and sensing device of John with the electrodes of the neural stimulation of Molnar. Doing so would enable the manufacturing or type of electrodes used in the system for proper stimulation.
Regarding claim 21, John in view of Nguyen teaches the method of claim 12, wherein at least one electrode of the one or more electrodes defines an electrically conductive surface facing radially outward from a central longitudinal of the expandable structure((John - Alternatively, the electrodes 131 are made from electrically conductive material and attached to one or more stents, which form the device 100 and allow for multiple positions(Detailed Description, paragraph 26). The seven electrodes 131 can span radially across a length of the vessel with no electrode overlap. For example, the seven electrodes 131 can span radially across a length of an 8mm vessel with no electrode overlap. The seven electrodes 131 can be at different radial positions along a length of the stent 101 such that there is no overlap of electrodes 131 when the stent 101 is expanded in a vessel(Detailed Description, paragraph 185), but fails to disclose the electrically conductive surface defining an area of about 0.5 mm2 to about 10 mm2.
However, Molnar teaches “In some examples, the electrode 203 has a surface area of between about 0.5mm2 to about 5mm2 (e.g., about 0.5mm2, about 1mm2, about 1.5mm2, about 2mm2, about 2.5mm2, about 3mm2, about 3.5mm2, about 4mm2; about 4.5mm2 range of about 5mm2, such a range, etc.)(see attached translation, page 72, paragraph 4)[FIG 2G]).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the blood vessel stimulating and sensing device of John with the electrodes of the neural stimulation of Molnar. Doing so would specify the surface area of the electrode stimulation so the patient knows the how many electrodes to use in the system.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CARL LAYNO can be reached at (571) 272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796