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 .
Status of Claims
Claims 1, 4-5, 7-11, 13-14, and 16-20 are rejected. Claims 2-3, 6, 12, and 15 are objected to.
Response to Arguments
Claim Rejections - 35 USC § 102
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
Applicant’s arguments with respect to claims 11 and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments, see Remarks, filed 5/6/26, with respect to claims 2-3, 6, 12, and 15 have been fully considered and are persuasive. The following arguments were found persuasive:
Machado does not teach a recess with slots extending from the recess as recited in claims 2 and 12;
The combination relied upon in claim 3 does not teach a recess with slots extending from the recess and the lack of rational underpinning for combining Olson with Bartels and Machado; and
The cited depressions in Steglich relied upon in claims 5 and 15 are not grooves of a shocking-electrode base structure and do not perform the claimed cable-receiving or support-wire-retaining functions.
The 103 rejection of claims 2-3, 6, 12, and 15 have been withdrawn.
Regarding claims 5 and 14, Applicant asserts that Steglich describes insulative, not conductive adapters. However, the Examiner disagrees. Steglich describes electrically conductive external faces of annular contacts 12 (¶39). Steglich further describes connecting the electrical supply lines 66 to the terminal lines 16 of the annular electrodes 12 (¶47; Fig. 2).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 11, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Honeck (US 20050113898 filed on 11/20/03) in view of De Kock (US 10391325 filed on 5/4/17 as cited in the IDS).
Regarding claim 1, Honeck teaches a lead, the lead comprising: a shocking electrode (¶15-defibrillation electrode 12) 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) (emphasis in original). 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 that has an oblong cross-sectional shape perpendicular to a length of the base structure with a first side and a second side that is opposite the first side (¶15-defibrillation electrode 12, to a conductive wire or cable, for example the conductor extending within lead body coupling electrode 12 to connector contact 30; Fig. 1-where defibrillation electrode extends along the body and the top of the body is the first side and the bottom of the body is the second side opposite the first side), wherein the base structure has a set of grooves defined along the first side (Fig. 3B-grooves 321 and 322 of piece 300; Fig. 4-shows the grooves along the first side), the grooves in the set configured to receive a cable assembly that is placed into the grooves in a side-loading direction that is perpendicular to the length of the base structure (¶18-assembling wire or cable 425 into a first groove of components 300, 405 (reference FIG. 3B, first groove 310) from first sides 301, 415, respectively; As shown in Fig. 5A, the cable is place perpendicular to the length of the body as shown in Fig. 4; Figs. 3B, 4, and 5A).
While Honeck discloses (¶2-cardiac stimulation systems commonly include a pulse-generating device, such as a pacemaker or implantable cardioverter/defibrillator that is electrically connected to the heart by at least one electrical lead), Honeck does not explicitly teach a lead of an implantable medical device (IMD).
De Kock relates to the S-ICD System™ from Cameron Health, Inc., and Boston Scientific Corporation presents a new opportunity in cardiac rhythm management to reduce the complications associated with transvenous defibrillator systems (col. 1 and lines 24-27). De Kock further teaches the invention using the following step:
a lead of an implantable medical device (IMD) (col. 5 and lines 55-57-lead and electrode assembly 300 for use with an implantable cardiac rhythm management system; col. 6 and line 1-an implantable pulse generator).
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 Honeck to include a lead of an implantable medical device (IMD) of De Kock in order to provide pacing and defibrillation therapy (De Kock, col. 5 and lines 36-37).
Regarding claim 11, Honeck teaches a method of producing a lead the method comprising: forming a set of grooves along a first side of a base structure (Fig. 3B-grooves 321 and 322 of piece 300; Fig. 4-shows the grooves along the first side) of a shocking electrode (¶15-defibrillation electrode 12), the base structure having an oblong cross-section shape perpendicular to a length of the base structure with a second side that is opposite the first side (¶15-defibrillation electrode 12, to a conductive wire or cable, for example the conductor extending within lead body coupling electrode 12 to connector contact 30; Fig. 1-where defibrillation electrode extends along the body and the top of the body is the first side and the bottom of the body is the second side opposite the first side); and depositing a portion of a cable assembly into the grooves of the set in a side-loading direction that is perpendicular to the length of the base structure (¶18-assembling wire or cable 425 into a first groove of components 300, 405 (reference FIG. 3B, first groove 310) from first sides 301, 415, respectively; As shown in Fig. 5A, the cable is place perpendicular to the length of the body as shown in Fig. 4; Figs. 3B, 4, and 5A).
While Honeck discloses (¶2-cardiac stimulation systems commonly include a pulse-generating device, such as a pacemaker or implantable cardioverter/defibrillator that is electrically connected to the heart by at least one electrical lead), Honeck does not explicitly teach an implantable medical device (IMD), configured to deliver high-voltage shocks for defibrillation therapy.
De Kock teaches for an implantable medical device (IMD) (col. 5 and lines 55-57-lead and electrode assembly 300 for use with an implantable cardiac rhythm management system; col. 6 and line 1-an implantable pulse generator), configured to deliver high-voltage shocks for defibrillation therapy (col. 39 and lines 12-15-an implantable defibrillator may comprise a canister housing a source of electrical energy, a capacitor, and operational circuitry that senses heart rhythms and an electrode and lead assembly; col. 5 and lines 43-44-deliver therapy).
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 Honeck to include an implantable medical device (IMD), configured to deliver high-voltage shocks for defibrillation therapy of De Kock in order for determining whether a treatable arrhythmia is occurring (De Kock, col. 5 and lines 31-32) and provide pacing and defibrillation therapy (De Kock, col. 5 and lines 36-37).
Regarding claim 20, Honeck teaches a device comprising: a lead comprising a lead body (¶15-lead 100 including a lead body 10), a cable assembly (¶18-assembling wire or cable 425 into a first groove of components 300, 405 (reference FIG. 3B, first groove 310) from first sides 301, 415, respectively; Fig. 5A), and a shocking electrode (¶15-defibrillation electrode 12), wherein the cable assembly electrically and mechanically connects the lead body to the shocking electrode (¶16-coil 27 and wire or cable 25 are electrically and mechanically coupled by means of such junctions, i.e. wire or cable 25 in first groove 210 and coil 27 in second groove 212, formed by conductive component 200; Figs. 2A-2B), wherein the shocking electrode includes a base structure that has an oblong cross-sectional shape perpendicular to a length of the base structure including a first side and a second side that is opposite the first side (¶15-defibrillation electrode 12, to a conductive wire or cable, for example the conductor extending within lead body coupling electrode 12 to connector contact 30; Fig. 1-where defibrillation electrode extends along the body and the top of the body is the first side and the bottom of the body is the second side opposite the first side), the base structure including a set of grooves defined along the first side (Fig. 3B-grooves 321 and 322 of piece 300; Fig. 4-shows the grooves along the first side), wherein a portion of the cable assembly is loaded into the grooves of the set in a side-loading direction that is perpendicular to the length of the base structure (¶18-assembling wire or cable 425 into a first groove of components 300, 405 (reference FIG. 3B, first groove 310) from first sides 301, 415, respectively; As shown in Fig. 5A, the cable is place perpendicular to the length of the body as shown in Fig. 4; Figs. 3B, 4, and 5A).
While Honeck discloses (¶2-cardiac stimulation systems commonly include a pulse-generating device, such as a pacemaker or implantable cardioverter/defibrillator that is electrically connected to the heart by at least one electrical lead), Honeck does not explicitly teach an implantable medical device (IMD) a pulse generator; 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.
De Kock teaches an implantable medical device (IMD) (col. 5 and lines 55-57-lead and electrode assembly 300 for use with an implantable cardiac rhythm management system; col. 6 and line 1-an implantable pulse generator) a pulse generator (col. 5 and lines 55-57-lead and electrode assembly 300 for use with an implantable cardiac rhythm management system; col. 6 and line 1-an implantable pulse generator); and the lead body extends to the pulse generator (col. 5 and lines 55-57-lead and electrode assembly 300 for use with an implantable cardiac rhythm management system; col. 6 and line 1-an implantable pulse generator), the pulse generator configured to power the shocking electrode, via the lead body and the cable assembly (col. 39 and lines 12-17-an implantable defibrillator may comprise a canister housing a source of electrical energy, a capacitor, and operational circuitry that senses heart rhythms and an electrode and lead assembly. The electrode and lead assembly may comprise a lead, at least one sensing electrode, and at least one shocking electrode; col. 5 and lines 55-57-lead and electrode assembly 300 for use with an implantable cardiac rhythm management system; col. 6 and line 1-an implantable pulse generator), to deliver high-voltage shocks for defibrillation therapy (col. 39 and lines 12-15-an implantable defibrillator may comprise a canister housing a source of electrical energy, a capacitor, and operational circuitry that senses heart rhythms and an electrode and lead assembly; col. 5 and lines 43-44-deliver therapy).
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 Honeck to include an implantable medical device (IMD) a pulse generator; 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 De Kock in order for determining whether a treatable arrhythmia is occurring (De Kock, col. 5 and lines 31-32) and provide pacing and defibrillation therapy (De Kock, col. 5 and lines 36-37).
Claims 4-5 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Honeck in view of De Kock as applied to claims 1 and 11 above, and further in view of Steglich (US 20080188919 filed on 1/30/08).
Regarding claim 4, the combination of Honeck and De Kock teaches the lead of claim 1. However, the combination of Honeck and De Kock 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 Honeck 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 Honeck, De Kock, 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 Honeck 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 13, the combination of Honeck and De Kock teaches the method of claim 11. However, the combination of Honeck and De Kock 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 Honeck 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 Honeck, De Kock, 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 Honeck 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).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Honeck in view of De Kock as applied to claim 1 above, and further in view of Jenney (US 20030139794 filed on 1/18/02).
Regarding claim 7, the combination of Honeck and De Kock teaches the lead of claim 1. However, the combination of Honeck and De Kock 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 Honeck 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 Honeck, De Kock, 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 Honeck 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 Honeck in view of De Kock as applied to claim 1 above, and further in view of Aron (US 20060282146 filed on 6/10/15).
Regarding claim 9, the combination of Honeck and De Kock teaches the lead of claim 1. However, the combination of Honeck and De Kock 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 Honeck 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 10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Honeck in view of De Kock as applied to claims 1 and 11 above, and further in view of Bartels (US 20080015643 filed on 5/24/07).
Regarding claim 10, the combination of Honeck and De Kock teaches the lead of claim 1. However, the combination of Honeck and De Kock does not teach wherein the shocking electrode includes an overmold material on the first side of the base structure 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 teaches 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).
Bartels relates to implantable electrode. In particular, the present invention relates to so-called ICD electrode probes for implantable defibrillators and cardioverters, which have at least one shock electrode (¶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 Honeck to include wherein the shocking electrode includes an overmold material on the first side of the base structure 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 of Bartels so that wire material is optimally enclosed by material which delivers active ingredient, so that a well-dosed medication delivery in immediate proximity to the traumatically problematic shock electrode is achieved (Bartels, ¶16).
Regarding claim 19, the combination of Honeck and De Kock teaches the method of claim 11. However, the combination of Honeck and De Kock does not teach applying an overmold material on the first side of the base structure 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 teaches 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).
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 Honeck to include applying an overmold material on the first side of the base structure 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 of Bartels so that wire material is optimally enclosed by material which delivers active ingredient, so that a well-dosed medication delivery in immediate proximity to the traumatically problematic shock electrode is achieved (Bartels, ¶16).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Honeck in view of De Kock as applied to claim 11 above, and further in view of Jenney (US 20030139794 filed on 1/18/02).
Regarding claim 16, the combination of Honeck and De Kock teaches the method of claim 11. However, the combination of Honeck and De Kock 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).
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 Honeck 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 Honeck, De Kock, 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 Honeck 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 Honeck in view of De Kock as applied to claim 11 above, and further in view of Aron (US 20060282146 filed on 6/10/15).
Regarding claim 18, the combination of Honeck and De Kock teaches the method of claim 11. However, the combination of Honeck and De Kock 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 Honeck 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).
Allowable Subject Matter
Claims 2-3, 6, 12-13, and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 8670828: relates to body implantable medical devices for sensing electrical impulses and/or delivering electrical stimulation in a body, and more particularly, to a connection body having a slot for coupling a conductor member to a functional component in such devices (col. 1 and lines 17-22).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/L.N.H./Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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