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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/12/24 is being considered by the examiner.
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.
Claims 1 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bartels (US 20080015643 filed on 5/24/07).
Regarding claim 1, Bartels teaches a lead of an implantable medical device (IMD), the lead comprising: a shocking electrode (¶25-shock electrode 10) configured to deliver high-voltage shocks for defibrillation therapy (MPEP 2114: [A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987), the shocking electrode including a base structure (¶25-an elongate, tubular electrode body 1) that has an oblong cross-sectional shape with a first side and a second side that is opposite the first side (¶22-a cross-section of the electrode device along section line A-A in FIG. 1), wherein the base structure has a set of grooves defined along the first side (¶25-multiple lumens 3 run for the passage of the electric supply lines 4; Fig. 2), the grooves in the set configured to receive a cable assembly that is placed into the grooves in a side-loading direction (¶25-multiple lumens 3 run for the passage of the electric supply lines 4 for the shock and stimulation electrodes of the ICD electrode device; Figs. 1-2).
Regarding claim 10, Bartels teaches the lead of claim 1, wherein the shocking electrode includes an overmold material on the first side of the base structure (Bartels, ¶14-the medication depot is quasi-integrated in the electrode; ¶17-the plastic material of the medication depot filling is preferably a biocompatible polymer matrix material, such as silicone, polyurethane, or a composite made of these two materials; ¶26-shock electrode 10; ¶27; ¶31) and a portion of the cable assembly that is within the set of grooves, wherein the overmold material conforms to a contour of the portion of the cable assembly and encases the portion of the cable assembly between the base structure and the overmold material (Bartels, ¶14- medication depot filling in the undercuts and/or intermediate spaces of the wire material, The medication depot filling is thus simultaneously used for stabilization and fixing of the wire braid and/or the wire coil while simultaneously maintaining the flexibility of the electrode; ¶17-the plastic material of the medication depot filling is preferably a biocompatible polymer matrix material, such as silicone, polyurethane, or a composite made of these two materials; ¶16).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Bartels in view of Machado (US 20150343203 filed on 6/1/15).
Regarding claim 2, Bartels teaches the lead of claim 1, further comprising the cable assembly, the cable assembly comprising multiple cables (¶25-multiple lumens 3 run for the passage of the electric supply lines 4) and a tubular member that collectively surrounds the cables (¶25-an ICD electrode device, which is implantable in the heart, having an elongate, tubular electrode body 1; Figs. 1-2). However, Bartels does not teach wherein the set of grooves includes a recess configured to accommodate the tubular member and multiple slots extending from the recess and configured to accommodate the cables.
Machado teaches wherein the set of grooves includes a recess configured to accommodate the tubular member and multiple slots extending from the recess and configured to accommodate the cables (¶40-the lead assembly 20 can include a plurality of first slots corresponding to a plurality of second slots, housing an array of a plurality of moveable contacts 22 therein; ¶9-the lead assembly includes a first lead body including a first slot arranged in a first orientation and a second lead body including a second slot corresponding to the first slot and having a second orientation. The first lead body is slid ably coupled to the second lead body; Fig. 2).
Machado relates generally to lead assemblies having at least one contact whose position in the lead can be adjusted (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bartels to include wherein the set of grooves includes a recess configured to accommodate the tubular member and multiple slots extending from the recess and configured to accommodate the cables of Machado in order to have one or more contacts whose positions in the lead can be adjusted (Machado, ¶8).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Bartels in view of Machado as applied to claim 2 above, and further in view of Olson (WO 2010078400 filed on 12/30/09).
Regarding claim 3, Bartels in view of Machado teaches the lead of claim 2. However, the combination of Bartels and Machado does not teach wherein the tubular member includes a neck and a flange that has a greater diameter than the neck, the recess in the set of grooves including a narrow segment and a broad segment, with the narrow segment disposed between a proximal end of the base structure and the broad segment, wherein the narrow segment is configured to receive the neck of the tubular member and the broad segment is configured to receive the flange of the tubular member, and the flange has a greater diameter than the narrow segment to axially secure the cable assembly to the shocking electrode.
Olson teaches wherein the tubular member includes a neck and a flange that has a greater diameter than the neck (¶91-the projection 508 can also be annular and can have an outer diameter D1 that may be about 4 to 6 times smaller than an outer diameter D2 of the flange 506), the recess in the set of grooves including a narrow segment and a broad segment (Figs. 18A and 18C), with the narrow segment disposed between a proximal end of the base structure and the broad segment (¶98-the proximal end 178 of the first sleeve 172 can be coupled to the opposing end 190; ¶94-the first sleeve 172 can contact the flange 506 at the second end 520 of the projection 508; Figs. 8A and 16), wherein the narrow segment is configured to receive the neck of the tubular member (¶91-the receipt of the tooling rod through the throughbore 510 can enable the tool 500 to be positioned about the distal end 180 of the first sleeve 172) and the broad segment is configured to receive the flange of the tubular member (¶93- projection 508 and can have a diameter D4 that can generally be sized to enable the tool 500 to slidably receive the distal end 180 of the first sleeve 172), and the flange has a greater diameter than the narrow segment to axially secure the cable assembly to the shocking electrode (Fig. 16-electrode 132c in flange and passage for cables connecting to 132c; Fig. 18A).
Olson relates to an implantable medical device (¶6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bartels to include wherein the tubular member includes a neck and a flange that has a greater diameter than the neck, the recess in the set of grooves including a narrow segment and a broad segment, with the narrow segment disposed between a proximal end of the base structure and the broad segment, wherein the narrow segment is configured to receive the neck of the tubular member and the broad segment is configured to receive the flange of the tubular member, and the flange has a greater diameter than the narrow segment to axially secure the cable assembly to the shocking electrode of Machado in order to control and monitor the heart, such as, to pace the heart, defibrillate the heart, sense conditions of the heart, etc (Olson, ¶54).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Bartels as applied to claim 1 above, and further in view of Steglich (US 20080188919 filed on 1/30/08).
Regarding claim 4, Bartels teaches the lead of claim 1. However, Bartels does not teach wherein the base structure is defined by multiple brick segments that are discrete and mechanically connected to one another in a line, wherein the set of grooves is defined along the first side of at least two of the brick segments.
Steglich teaches wherein the base structure is defined by multiple brick segments that are discrete and mechanically connected to one another in a line, wherein the set of grooves is defined along the first side of at least two of the brick segments (¶43-depressions 34, 36, and 38 running in the longitudinal direction are provided on the exterior side of the longitudinal sections 24 and 26 of the adapters 14, the remaining depressions 36 on a particular distal longitudinal section 26 of an adapter 14; Fig. 2).
Steglich relates to an electrode line for connection to an implantable heart stimulator, such as a cardiac pacemaker or a cardioverter/defibrillator. In particular, the present invention relates to a terminal part for such an electrode line (¶3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bartels to include wherein the base structure is defined by multiple brick segments that are discrete and mechanically connected to one another in a line, wherein the set of grooves is defined along the first side of at least two of the brick segments of Steglich in order to have an electrode line having such a terminal part, which are independent of the type and number of the contacts of the electrode line, are to be produced at acceptable outlay, and have high reliability (Steglich, ¶9).
Regarding claim 5, the combination of Bartels and Steglich teaches the lead of claim 4, wherein the brick segments are electrically conductive and electrically connected to one another (Steglich, ¶39-electrically conductive external faces of annular contacts 12; ¶47-connecting the electrical supply lines 66 to the terminal lines 16 of the annular electrodes 12; Fig. 2), wherein a power cable of the cable assembly is welded to one of the brick segments to establish a conductive pathway from a pulse generator of the IMD to the shocking electrode (Steglich, ¶3-an electrode line for connection to an implantable heart stimulator, such as a cardiac pacemaker or a cardioverter/defibrillator; ¶29 a terminal line of an annular contact of the terminal part via a…welded connection; ¶30 Fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bartels to include wherein the brick segments are electrically conductive and electrically connected to one another, wherein a power cable of the cable assembly is welded to one of the brick segments to establish a conductive pathway from a pulse generator of the IMD to the shocking electrode of Steglich in order to have an electrode line having such a terminal part, which are independent of the type and number of the contacts of the electrode line, are to be produced at acceptable outlay, and have high reliability (Steglich, ¶9).
Regarding claim 6, the combination of Bartels and Steglich teaches the lead of claim 4, wherein the set of grooves is a first set of grooves and the base structure further includes a second set of one or more grooves defined along the first side and spaced apart from the first set of grooves (Steglich, ¶22-at least one depression running in the longitudinal direction on their exterior side, which is used to receive a particular terminal line of an annular contact; ¶25-the plugged-together adapters and the terminus part are preferably oriented to one another in such a way that the particular depressions on the exterior side of the adapters and the terminus part align with one another and allow a particular terminal line to be led stretched and parallel to the longitudinal axis of the terminal part in the depressions; ¶48-the silicone sleeve 50 and the terminus ring 52 are then brought over the transition points as connection elements), wherein the shocking electrode further comprises one or more support wires disposed within the second set of the one or more grooves and affixed to the brick segments to secure the brick segments to one another in the line (Steglich, ¶29-electrically connected at its proximal end to a terminal line of an annular contact of the terminal part via a crimped, welded, or soldered connection; ¶30-the crimped, welded, or soldered connection is preferably located in one of the depressions of the distal terminus part of the terminal part running in the longitudinal direction; Fig. 2; ¶3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bartels to include wherein the set of grooves is a first set of grooves and the base structure further includes a second set of one or more grooves defined along the first side and spaced apart from the first set of grooves, wherein the shocking electrode further comprises one or more support wires disposed within the second set of the one or more grooves and affixed to the brick segments to secure the brick segments to one another in the line of Steglich in order to have an electrode line having such a terminal part, which are independent of the type and number of the contacts of the electrode line, are to be produced at acceptable outlay, and have high reliability (Steglich, ¶9).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Bartels as applied to claim 1 above, and further in view of Jenney (US 20030139794 filed on 1/18/02).
Regarding claim 7, Bartels teaches the lead of claim 1. However, Bartels does not teach wherein the base structure is an insulative body that extends from a proximal end of the shocking electrode to a distal end of the shocking electrode, wherein the shocking electrode includes an electrically conductive layer disposed along the second side of the insulative body, the electrically conductive layer configured to be electrically connected to a power cable of the cable assembly to establish a conductive pathway from a pulse generator of the IMD to the electrically conductive layer to deliver the high-voltage shocks for the defibrillation therapy.
Jenney teaches wherein the base structure is an insulative body that extends from a proximal end of the shocking electrode to a distal end of the shocking electrode (¶57-the lead body includes an insulating sheath or housing 22 of a suitable insulative, biocompatible, biostable material such as, for example, silicone rubber or polyurethane, extending substantially the entire length of the lead body, the lead 10 includes a lead body 12 having a distal end portion 14 and a proximal end portion 16. The distal end portion 14 includes a tip electrode 18 and a conductive polymer cardioversion/defibrillating shocking electrode 20, hereinafter sometimes referred to simply as a defibrillating electrode), wherein the shocking electrode includes an electrically conductive layer disposed along the second side of the insulative body (¶57-the lead 10 includes a lead body 12 having a distal end portion 14, the distal end portion 14 includes a tip electrode 18 and a conductive polymer cardioversion/defibrillating shocking electrode 20, hereinafter sometimes referred to simply as a defibrillating electrode, the lead body includes an insulating sheath or housing 22 of a suitable insulative, biocompatible, biostable material such as, for example, silicone rubber or polyurethane, extending substantially the entire length of the lead body), the electrically conductive layer configured to be electrically connected to a power cable of the cable assembly to establish a conductive pathway from a pulse generator of the IMD to the electrically conductive layer to deliver the high-voltage shocks for the defibrillation therapy (¶12-a cable conductor is contained within the lead body, the cable conductor coupling the proximal end portion of the lead body with the conductive polymer electrode, the conductive polymer electrode encapsulating the cable conductor and being in electrical contact therewith along the length of the conductive polymer electrode; ¶70-one or more additional conductors may be carried by the tubular housing for conducting sensed electrical signals from the heart to the pulse generator; ¶13).
Jenney relates generally to body implantable leads. More particularly, the invention relates to body implantable, transvenous leads having one or more conductive polymer electrodes. The invention further relates to methods for fabricating such leads (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bartels to include wherein the base structure is an insulative body that extends from a proximal end of the shocking electrode to a distal end of the shocking electrode, wherein the shocking electrode includes an electrically conductive layer disposed along the second side of the insulative body, the electrically conductive layer configured to be electrically connected to a power cable of the cable assembly to establish a conductive pathway from a pulse generator of the IMD to the electrically conductive layer to deliver the high-voltage shocks for the defibrillation therapy of Jenney in order for delivering an electrical charge generated by the defibrillator to the defibrillating or shocking electrode (Jenney, ¶61) and having a thin flexible lead body that can be readily delivered to a left side coronary vessel in the coronary sinus region through the SVC and via the coronary os and sinus (Jenney, ¶92).
Regarding claim 8, the combination of Bartels and Jenney teaches the lead of claim 7, wherein the electrically conductive layer includes one or more metal plates affixed to the second side of the insulative body (Jenney, claim 21-conductive particles comprise particles selected from the group consisting of silver, stainless steel, iridium, silver-coated nickel, carbon black, graphite, tantalum, palladium, titanium, platinum, gold, MP35N, fullerines, and carbon nanotubes; ¶63- conductor-filled polymers may include presently available materials approved for implantation such as silicone rubber with embedded metallic, carbon or graphite particles or powder).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bartels to include wherein the electrically conductive layer includes one or more metal plates affixed to the second side of the insulative body of Jenney in order for delivering an electrical charge generated by the defibrillator to the defibrillating or shocking electrode (Jenney, ¶61) and having a thin flexible lead body that can be readily delivered to a left side coronary vessel in the coronary sinus region through the SVC and via the coronary os and sinus (Jenney, ¶92).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bartels as applied to claim 1 above, and further in view of Aron (US 20060282146 filed on 6/10/15).
Regarding claim 9, Bartels teaches the lead of claim 1. However, Bartels does not teach wherein the shocking electrode includes one or more cover plates that cover a portion of the cable assembly that is within the set of grooves, such that the portion of the cable assembly is disposed between the one or more cover plates and the second side of the base structure.
Aron teaches wherein the shocking electrode includes one or more cover plates that cover a portion of the cable assembly that is within the set of grooves (¶20-the lead assembly includes a first defibrillation electrode 230, a second defibrillation electrode 235, and a sensing/pacing electrode 240. A porous polyethylene covering 245 extends over at least one of the defibrillation electrodes), such that the portion of the cable assembly is disposed between the one or more cover plates and the second side of the base structure (¶20-the coverings are spaced apart on the lead assembly).
Aron relates generally to medical device lead assemblies, and more particularly, but not by way of limitation, to porous polyethylene covers for a medical device lead assembly (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bartels to include wherein the shocking electrode includes one or more cover plates that cover a portion of the cable assembly that is within the set of grooves, such that the portion of the cable assembly is disposed between the one or more cover plates and the second side of the base structure of Aron in order for limiting or preventing tissue ingrowth around portions of the lead (Aron, ¶26).
Claims 11 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bartels in view of Sanghera (US 20210370081 filed on 2/26/21 as cited in the IDS).
Regarding claim 11, Bartels teaches a method of producing a lead for an implantable medical device (IMD), the method comprising: forming a set of grooves along a first side of a base structure (¶25-multiple lumens 3 run for the passage of the electric supply lines 4; Fig. 2) of a shocking electrode (¶25-shock electrode 10), the base structure having an oblong cross-section shape with a second side that is opposite the first side (¶22-a cross-section of the electrode device along section line A-A in FIG. 1); and depositing a portion of a cable assembly into the grooves of the set in a side-loading direction (¶25-multiple lumens 3 run for the passage of the electric supply lines 4 for the shock and stimulation electrodes of the ICD electrode device; Figs. 1-2). While Bartels does teach defibrillation electrode in (¶31), Bartels does not explicitly teach being configured to deliver high-voltage shocks for defibrillation therapy.
Sanghera relates to facilitating insertion of certain leads with electrode(s) into patients for a variety of medical purposes (¶5). Sanghera further teaches the invention using the following step:
to deliver high-voltage shocks for defibrillation therapy (¶9-a defibrillation lead including more than two defibrillation electrodes, from which to deliver a defibrillation pulse; ¶5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bartels to include being configured to deliver high-voltage shocks for defibrillation therapy of Sanghera in order to provide therapeutic electrical stimulation to the heart of a patient (Sanghera, ¶75).
Regarding claim 19, the combination of Bartels and Sanghera teaches the method of claim 11, further comprising applying an overmold material on the first side of the base structure (Bartels, ¶14-the medication depot is quasi-integrated in the electrode; ¶17-the plastic material of the medication depot filling is preferably a biocompatible polymer matrix material, such as silicone, polyurethane, or a composite made of these two materials; ¶26-shock electrode 10; ¶27; ¶31)and the portion of the cable assembly that is within the set of grooves, wherein the overmold material conforms to a contour of the cable assembly and encases the cable assembly between the base structure and the overmold material (Bartels, ¶14- medication depot filling in the undercuts and/or intermediate spaces of the wire material, The medication depot filling is thus simultaneously used for stabilization and fixing of the wire braid and/or the wire coil while simultaneously maintaining the flexibility of the electrode; ¶17-the plastic material of the medication depot filling is preferably a biocompatible polymer matrix material, such as silicone, polyurethane, or a composite made of these two materials; ¶16).
Regarding claim 20, Bartels teaches an implantable medical device (IMD) comprising: wherein the shocking electrode (¶25-shock electrode 10) includes a base structure that has an oblong cross-sectional shape including a first side and a second side that is opposite the first side (¶22-a cross-section of the electrode device along section line A-A in FIG. 1), the base structure including a set of grooves defined along the first side (¶25-multiple lumens 3 run for the passage of the electric supply lines 4; Fig. 2), wherein a portion of the cable assembly is loaded into the grooves of the set in a side-loading direction (¶25-multiple lumens 3 run for the passage of the electric supply lines 4 for the shock and stimulation electrodes of the ICD electrode device; Figs. 1-2). However, Bartels does not teach a pulse generator; and a lead comprising a lead body, a cable assembly, and a shocking electrode, wherein the cable assembly electrically and mechanically connects the lead body to the shocking electrode, and the lead body extends to the pulse generator, the pulse generator configured to power the shocking electrode, via the lead body and the cable assembly, to deliver high-voltage shocks for defibrillation therapy.
Sanghera teaches a pulse generator (¶164-pulse generator); and a lead comprising a lead body, a cable assembly, and a shocking electrode (¶164-leads wires (2432a, 2434a, 2436a, 2438a, 2442a, 2444a, 2446a, 2448a, 2450a, 2452a) that extend through or along the lead body and connect to their respective electrodes), wherein the cable assembly electrically and mechanically connects the lead body to the shocking electrode (¶180-the electrodes can be connected via a single lead 2810 (e.g., a multi-wire cable) at the connector cable side of the junction box; ¶164-leads wires (2432a, 2434a, 2436a, 2438a, 2442a, 2444a, 2446a, 2448a, 2450a, 2452a) that extend through or along the lead body and connect to their respective electrodes), and the lead body extends to the pulse generator (¶164-the lead wires can conduct defibrillation and pacing pulses and/or sensing signals to and/or from a connected pulse generator), the pulse generator configured to power the shocking electrode via the lead body and the cable assembly (¶164-the lead wires can conduct defibrillation and pacing pulses and/or sensing signals to and/or from a connected pulse generator or computer that controls or processes signals), to deliver high-voltage shocks for defibrillation therapy (¶9-a defibrillation lead including more than two defibrillation electrodes, from which to deliver a defibrillation pulse; ¶5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bartels to include a pulse generator; and a lead comprising a lead body, a cable assembly, and a shocking electrode, wherein the cable assembly electrically and mechanically connects the lead body to the shocking electrode, and the lead body extends to the pulse generator, the pulse generator configured to power the shocking electrode, via the lead body and the cable assembly, to deliver high-voltage shocks for defibrillation therapy of Sanghera in order to provide therapeutic electrical stimulation to the heart of a patient (Sanghera, ¶75).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Bartels in view of Sanghera as applied to claim 11 above, and further in view of Machado.
Regarding claim 12, the combination of Bartels and Sanghera teaches the method of claim 11, wherein the cable assembly includes multiple cables (Bartels, ¶25-multiple lumens 3 run for the passage of the electric supply lines 4) and a tubular member that collectively surrounds the cables (Bartels, ¶25-an ICD electrode device, which is implantable in the heart, having an elongate, tubular electrode body 1; Figs. 1-2). However, Bartels does not teach the set of grooves includes a recess and multiple slots extending from the recess, wherein depositing the portion of the cable assembly into the grooves includes placing the tubular member into the recess and placing the cables into different corresponding slots of the set of grooves.
Machado teaches the set of grooves includes a recess and multiple slots extending from the recess (¶40-the lead assembly 20 can include a plurality of first slots corresponding to a plurality of second slots, housing an array of a plurality of moveable contacts 22 therein; Fig. 2), wherein depositing the portion of the cable assembly into the grooves includes placing the tubular member into the recess and placing the cables into different corresponding slots of the set of grooves (¶9-the lead assembly includes a first lead body including a first slot arranged in a first orientation and a second lead body including a second slot corresponding to the first slot and having a second orientation. The first lead body is slid ably coupled to the second lead body; Fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bartels to include the set of grooves includes a recess and multiple slots extending from the recess, wherein depositing the portion of the cable assembly into the grooves includes placing the tubular member into the recess and placing the cables into different corresponding slots of the set of grooves of Machado in order to have one or more contacts whose positions in the lead can be adjusted (Machado, ¶8).
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bartels in view of Sanghera as applied to claim 11 above, and further in view of Steglich (US 20080188919 filed on 1/30/08).
Regarding claim 13, the combination of Bartels and Sanghera teaches the method of claim 11. However, the combination of Bartels and Sanghera does not teach assembling the base structure by mechanically connecting a plurality of discrete brick segments together in a line, wherein the set of grooves is formed along the first side of at least two of the brick segments.
Steglich teaches assembling the base structure by mechanically connecting a plurality of discrete brick segments together in a line, wherein the set of grooves is formed along the first side of at least two of the brick segments (¶43-depressions 34, 36, and 38 running in the longitudinal direction are provided on the exterior side of the longitudinal sections 24 and 26 of the adapters 14, the remaining depressions 36 on a particular distal longitudinal section 26 of an adapter 14; Fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bartels to include assembling the base structure by mechanically connecting a plurality of discrete brick segments together in a line, wherein the set of grooves is formed along the first side of at least two of the brick segments of Steglich in order to have an electrode line having such a terminal part, which are independent of the type and number of the contacts of the electrode line, are to be produced at acceptable outlay, and have high reliability (Steglich, ¶9).
Regarding claim 14, the combination of Bartels, Sanghera, and Steglich teaches the method of claim 13, wherein the brick segments are electrically conductive and electrically connected to one another (Steglich, ¶39-electrically conductive external faces of annular contacts 12; ¶47-connecting the electrical supply lines 66 to the terminal lines 16 of the annular electrodes 12; Fig. 2), and the method further comprises welding a power cable of the cable assembly to one of the brick segments to establish a conductive pathway from a pulse generator of the IMD to the shocking electrode (Steglich, ¶3-an electrode line for connection to an implantable heart stimulator, such as a cardiac pacemaker or a cardioverter/defibrillator; ¶29 a terminal line of an annular contact of the terminal part via a…welded connection; ¶30 Fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bartels to include wherein the brick segments are electrically conductive and electrically connected to one another, and the method further comprises welding a power cable of the cable assembly to one of the brick segments to establish a conductive pathway from a pulse generator of the IMD to the shocking electrode of Steglich in order to have an electrode line having such a terminal part, which are independent of the type and number of the contacts of the electrode line, are to be produced at acceptable outlay, and have high reliability (Steglich, ¶9).
Regarding claim 15, the combination of Bartels, Sanghera, and Steglich teaches the method of claim 13, wherein the set of grooves is a first set of grooves and the base structure further includes a second set of one or more grooves defined along the first side and spaced apart from the first set of grooves (Steglich, ¶22-at least one depression running in the longitudinal direction on their exterior side, which is used to receive a particular terminal line of an annular contact; ¶25-the plugged-together adapters and the terminus part are preferably oriented to one another in such a way that the particular depressions on the exterior side of the adapters and the terminus part align with one another and allow a particular terminal line to be led stretched and parallel to the longitudinal axis of the terminal part in the depressions; ¶48-the silicone sleeve 50 and the terminus ring 52 are then brought over the transition points as connection elements), wherein the method further comprises depositing one or more support wires in the side-loading direction into the second set of the one or more grooves and affixing the one or more support wires to the brick segments to secure the brick segments to one another in the line (Steglich, ¶29-electrically connected at its proximal end to a terminal line of an annular contact of the terminal part via a crimped, welded, or soldered connection; ¶30-the crimped, welded, or soldered connection is preferably located in one of the depressions of the distal terminus part of the terminal part running in the longitudinal direction; Fig. 2; ¶3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bartels to include wherein the set of grooves is a first set of grooves and the base structure further includes a second set of one or more grooves defined along the first side and spaced apart from the first set of grooves, wherein the method further comprises depositing one or more support wires in the side-loading direction into the second set of the one or more grooves and affixing the one or more support wires to the brick segments to secure the brick segments to one another in the line of Steglich in order to have an electrode line having such a terminal part, which are independent of the type and number of the contacts of the electrode line, are to be produced at acceptable outlay, and have high reliability (Steglich, ¶9).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Bartels in view of Sanghera as applied to claim 11 above, and further in view of Jenney.
Regarding claim 16, the combination of Bartels and Sanghera teaches the method of claim 11. However, the combination of Bartels and Sanghera does not teach wherein the base structure is an insulative body that extends from a proximal end of the shocking electrode to a distal end of the shocking electrode, and the method further comprises: applying an electrically conductive layer along the second side of the insulative body; and affixing a power cable of the cable assembly to the electrically conductive layer to establish a conductive pathway from a pulse generator of the IMD to the electrically conductive layer to deliver the high-voltage shocks for the defibrillation therapy.
Jenney teaches wherein the base structure is an insulative body that extends from a proximal end of the shocking electrode to a distal end of the shocking electrode (¶57-the lead body includes an insulating sheath or housing 22 of a suitable insulative, biocompatible, biostable material such as, for example, silicone rubber or polyurethane, extending substantially the entire length of the lead body, the lead 10 includes a lead body 12 having a distal end portion 14 and a proximal end portion 16. The distal end portion 14 includes a tip electrode 18 and a conductive polymer cardioversion/defibrillating shocking electrode 20, hereinafter sometimes referred to simply as a defibrillating electrode), and the method further comprises: applying an electrically conductive layer along the second side of the insulative body (¶57-the lead 10 includes a lead body 12 having a distal end portion 14, the distal end portion 14 includes a tip electrode 18 and a conductive polymer cardioversion/defibrillating shocking electrode 20, hereinafter sometimes referred to simply as a defibrillating electrode, the lead body includes an insulating sheath or housing 22 of a suitable insulative, biocompatible, biostable material such as, for example, silicone rubber or polyurethane, extending substantially the entire length of the lead body); and affixing a power cable of the cable assembly to the electrically conductive layer to establish a conductive pathway from a pulse generator of the IMD to the electrically conductive layer to deliver the high-voltage shocks for the defibrillation therapy (¶12-a cable conductor is contained within the lead body, the cable conductor coupling the proximal end portion of the lead body with the conductive polymer electrode, the conductive polymer electrode encapsulating the cable conductor and being in electrical contact therewith along the length of the conductive polymer electrode; ¶70-one or more additional conductors may be carried by the tubular housing for conducting sensed electrical signals from the heart to the pulse generator; ¶13).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bartels to include wherein the base structure is an insulative body that extends from a proximal end of the shocking electrode to a distal end of the shocking electrode, and the method further comprises: applying an electrically conductive layer along the second side of the insulative body; and affixing a power cable of the cable assembly to the electrically conductive layer to establish a conductive pathway from a pulse generator of the IMD to the electrically conductive layer to deliver the high-voltage shocks for the defibrillation therapy of Jenney in order for delivering an electrical charge generated by the defibrillator to the defibrillating or shocking electrode (Jenney, ¶61) and having a thin flexible lead body that can be readily delivered to a left side coronary vessel in the coronary sinus region through the SVC and via the coronary os and sinus (Jenney, ¶92).
Regarding claim 17, the combination of Bartels, Sanghera, and Jenney teaches the method of claim 16, wherein applying the electrically conductive layer includes affixing one or more metal plates to the second side of the insulative body (Jenney, claim 21-conductive particles comprise particles selected from the group consisting of silver, stainless steel, iridium, silver-coated nickel, carbon black, graphite, tantalum, palladium, titanium, platinum, gold, MP35N, fullerines, and carbon nanotubes; ¶63- conductor-filled polymers may include presently available materials approved for implantation such as silicone rubber with embedded metallic, carbon or graphite particles or powder).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bartels to include wherein applying the electrically conductive layer includes affixing one or more metal plates to the second side of the insulative body of Jenney in order for delivering an electrical charge generated by the defibrillator to the defibrillating or shocking electrode (Jenney, ¶61) and having a thin flexible lead body that can be readily delivered to a left side coronary vessel in the coronary sinus region through the SVC and via the coronary os and sinus (Jenney, ¶92).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Bartels in view of Sanghera as applied to claim 11 above, and further in view of Aron.
Regarding claim 18, the combination of Bartels and Sanghera teaches the method of claim 11. However, the combination of Bartels and Sanghera does not teach covering the portion of the cable assembly that is within the set of grooves with one or more cover plates such that the portion of the cable assembly is disposed between the one or more cover plates and the second side of the base structure.
Aron teaches covering the portion of the cable assembly that is within the set of grooves with one or more cover plates (¶20-the lead assembly includes a first defibrillation electrode 230, a second defibrillation electrode 235, and a sensing/pacing electrode 240. A porous polyethylene covering 245 extends over at least one of the defibrillation electrodes) such that the portion of the cable assembly is disposed between the one or more cover plates and the second side of the base structure (¶20-the coverings are spaced apart on the lead assembly).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bartels to include covering the portion of the cable assembly that is within the set of grooves with one or more cover plates such that the portion of the cable assembly is disposed between the one or more cover plates and the second side of the base structure of Aron in order for limiting or preventing tissue ingrowth around portions of the lead (Aron, ¶26).
Conclusion
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/L.N.H./Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792