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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 8-11, the phrases "particularly" and “more particularly” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of examination, as best understood, the limitations following the phrases "particularly" and “more particularly” have not been taken to be part of the claimed invention.
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.
Claim(s) 1, 3-7 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2005/0228469 to Zarembo et al. (Zarembo).
In reference to at least claim 1
Zarembo discloses a method for manufacturing an implantable lead (e.g. lead assembly 110), the method comprising: providing an annular first electrode (e.g. outer electrode 160) and an annular second electrode (e.g. inner electrode 150), a diameter of an inner surface of the first electrode being larger than a diameter of an outer surface of the second electrode (e.g. diameter inner surface of electrode 160 is larger than a diameter of an outer surface of electrode 150, Figs. 2-3); providing at least one wire (e.g. coil conductor 124) comprising an electrically conductive core the core being surrounded by an electrically insulating sheathing in a sheathed wire portion (e.g. “The coiled conductors 124 include at least one filar, and optionally at least a portion of each individual filar is insulated”, para. [0030]); aligning the first electrode relative to the second electrode so that their individual central axes form a common central axis (e.g. central axes of outer electrode 160 and inner electrode 150 are aligned, Figs. 2-3); positioning at least a part of the sheathed wire portion opposite to the inner surface of the first electrode and/or opposite to the outer surface of the second electrode (e.g. conductor portion 120 is positioned opposite the inner surface of electrode 160 and the outer surface of electrode 150, Figs. 2-3); and electrically and mechanically connecting the wire to the first electrode and the second electrode by pressing the first electrode and the second electrode together along the common central axis (e.g. “ the inner electrode 150 and/or the outer electrode 160 include features 180 that remove or disrupt a portion of insulation from the conductor 120, for example by splitting, cutting, or interrupting the insulation, to allow for an electrical connection to the conductive filar.”, para. [0039]-[0040]; “As the outer and inner electrodes are assembled together, the features 180 cut into, interrupt, or split the insulation away from the conductive portion of the conductor 120, allowing the conductor 120 to be electrically coupled with the outer and/or inner electrodes 160,150”, para. [0041], [0047]), wherein an axial force in a direction parallel to the common central axis is applied to the sheathed wire portion by the first electrode and the second electrode being pressed together so that at least a part of the sheathing is removed from the core to obtain an exposed wire portion (e.g. “ the inner electrode 150 and/or the outer electrode 160 include features 180 that remove or disrupt a portion of insulation from the conductor 120, for example by splitting, cutting, or interrupting the insulation, to allow for an electrical connection to the conductive filar.”, para. [0039]-[0040]; “As the outer and inner electrodes are assembled together, the features 180 cut into, interrupt, or split the insulation away from the conductive portion of the conductor 120, allowing the conductor 120 to be electrically coupled with the outer and/or inner electrodes 160,150”, para. [0041], [0047]).
In reference to at least claim 3
Zarembo discloses an implantable lead (e.g. lead assembly 110) comprising: providing an annular first electrode (e.g. outer electrode 160); an annular second electrode (e.g. inner electrode 150), a diameter of an inner surface of the first electrode being larger than a diameter of an outer surface of the second electrode (e.g. diameter inner surface of electrode 160 is larger than a diameter of an outer surface of electrode 150, Figs. 2-3); at least one wire (e.g. coil conductor 124) comprising an electrically conductive core (e.g. “The coiled conductors 124 include at least one filar, and optionally at least a portion of each individual filar is insulated”, para. [0030]), the core being exposed in an exposed wire portion (e.g. “for example by splitting, cutting, or interrupting the insulation, to allow for an electrical connection to the conductive filar.”, para. [0039]-[0040]; “the features 180 cut into, interrupt, or split the insulation away from the conductive portion of the conductor 120, allowing the conductor 120 to be electrically coupled with the outer and/or inner electrodes 160,150”, para. [0041], [0047], therefore a portion of the core that includes electrical conductor 120 is exposed), wherein the first electrode and the second electrode are arranged concentrically to each other so that the inner surface of the first electrode at least partially overlaps the outer surface of the second electrode in an overlap area (e.g. outer electrode 160 and inner electrode 150 are arranged concentrically so an inner surface of outer electrode 160 partially overlaps the outer surface of inner electrode 160, Figs. 2-3); wherein at least a part of the exposed wire portion is inserted into the overlap area and compressed therein by the first electrode and the second electrode (e.g. at least part of the exposed wire that includes electrical conductor 120 is within the overlap area and compressed by outer electrode 160 and inner electrode 150, Figs. 2-3, 6A-6D); wherein a free end of the wire protrudes from the overlap area in a direction parallel to a common central axis of the first electrode and the second electrode (e.g. a free end of coiled conductors 124 which includes conductor 120 protrudes from an overlap area parallel to a common central axis outer electrode 160 and inner electrode 150, Figs. 2-3, 6A-6D).
In reference to at least claim 4
Zarembo discloses wherein the compressed part of the exposed wire portion has a longitudinal axis parallel to the common central axis (e.g. conductor 120 has a longitudinal axis parallel to the common central axis of outer electrode 160 and inner electrode 150, Figs. 2-3, 6A-6D).
In reference to at least claim 5
Zarembo discloses wherein the core is surrounded by an electrically insulating sheathing in a sheathed wire portion (e.g. “The coiled conductors 124 include at least one filar, and optionally at least a portion of each individual filar is insulated”, para. [0030]), wherein at least a part of the sheathed wire portion protrudes as the free end of the wire from the overlap area (e.g. a free end of coiled conductors 124 which includes conductor 120 protrudes from an overlap area between outer electrode 160 and inner electrode 150, Figs. 2-3, 6A-6D).
In reference to at least claim 6
Zarembo discloses wherein a part of the sheathed wire portion is inserted into the overlap area and compressed therein by the first electrode and the second electrode (e.g. “ the inner electrode 150 and/or the outer electrode 160 include features 180 that remove or disrupt a portion of insulation from the conductor 120, for example by splitting, cutting, or interrupting the insulation, to allow for an electrical connection to the conductive filar.”, para. [0039]-[0040]; “As the outer and inner electrodes are assembled together, the features 180 cut into, interrupt, or split the insulation away from the conductive portion of the conductor 120, allowing the conductor 120 to be electrically coupled with the outer and/or inner electrodes 160,150”, para. [0041], [0047]).
In reference to at least claim 7
Zarembo discloses wherein a first free end of the wire protrudes from the overlap area in a first direction parallel to the common central axis and a second free end of the wire protrudes from the overlap area in a second direction opposite to the first direction (e.g. multiple ends of conductor 120 protrude from the overlap area in a first direction and a second direction opposite the first direction, Figs. 2-3, 6A-6D).
In reference to at least claim 14
Zarembo discloses wherein the first electrode and the second electrode are made of the same material (e.g. “For example, in one option, a portion of the inner electrode and the outer electrode are formed of shape memory material.”, para. [0008]. “In another option, the inner electrode and the outer electrode 160 is formed of shape memory material, such as nitinol”, para. [0037]).
Claim(s) 1, 3-13 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2008/0178449 to Huotari et al. (Huotari).
In reference to at least claim 1
Huotari discloses a method for manufacturing an implantable lead (e.g. electrical lead 100), the method comprising: providing an annular first electrode (e.g. electrode 17/47); and an annular second electrode (e.g. conductive ring 27 which is part of core component 175/475), a diameter of an inner surface of the first electrode being larger than a diameter of an outer surface of the second electrode (e.g. diameter inner surface of electrode 17 is larger than a diameter of an outer surface of conductive ring 27, Fig. 2B); providing at least one wire (e.g. first conductor 151/451) comprising an electrically conductive core the core (e.g. “first conductor 151 including a conductor wire or wire filar 25 surrounded by a layer of insulation 205”, para. [0015]) being surrounded by an electrically insulating sheathing in a sheathed wire portion(e.g. “first conductor 151 including a conductor wire or wire filar 25 surrounded by a layer of insulation 205,”, para. [0015]); aligning the first electrode relative to the second electrode so that their individual central axes form a common central axis (e.g. central axes of outer electrode 17 and conductive ring 27 are aligned, Figs. 2B, 4A-4D); positioning at least a part of the sheathed wire portion opposite to the inner surface of the first electrode and/or opposite to the outer surface of the second electrode (e.g. a portion of first conductor 151/451 is positioned opposite the inner surface of inner surface of electrode 17 and the outer surface conductive ring 27 which is part of core component 175/475, Figs. 2B, 4A-4D); and electrically and mechanically connecting the wire to the first electrode and the second electrode by pressing the first electrode and the second electrode together along the common central axis (e.g. Figs. 4A-4D, “in order to form the junction with electrode 17 for electrical coupling, insulation layer 205 needs to be displaced from at least a portion of the circumference of wire 25 at the junction”, para. [0015], “first conductor 451 includes an insulating layer, for example, layer 205 of first conductor 151 illustrated in FIG. 2A, which extends over conductor terminal portion 453, and the action of ring inner surface 472, riding over portion 453, displaces the insulation layer without significantly deforming portion 453”, para. [0018], “has prevented significant damage to wire filar 25 during the press fit method, while ring first diameter D1 riding over conductor portion 153/453 and core 175/475 (FIG. 4C), in an interference fit, has effectively displaced insulation layer 205 from about the circumference of wire filar 25, for electrical coupling, and deformed outer surface 207 of core 175”, para. [0021] therefore a portion of the first conductor wire 151/451 that includes is exposed), wherein an axial force in a direction parallel to the common central axis is applied to the sheathed wire portion by the first electrode and the second electrode being pressed together so that at least a part of the sheathing is removed from the core to obtain an exposed wire portion (e.g. Figs. 4A-4D, “in order to form the junction with electrode 17 for electrical coupling, insulation layer 205 needs to be displaced from at least a portion of the circumference of wire 25 at the junction”, para. [0015], “first conductor 451 includes an insulating layer, for example, layer 205 of first conductor 151 illustrated in FIG. 2A, which extends over conductor terminal portion 453, and the action of ring inner surface 472, riding over portion 453, displaces the insulation layer without significantly deforming portion 453”, para. [0018], “has prevented significant damage to wire filar 25 during the press fit method, while ring first diameter D1 riding over conductor portion 153/453 and core 175/475 (FIG. 4C), in an interference fit, has effectively displaced insulation layer 205 from about the circumference of wire filar 25, for electrical coupling, and deformed outer surface 207 of core 175”, para. [0021] therefore a portion of the first conductor wire 151/451 that includes is exposed)
In reference to at least claim 3
Huotari discloses an implantable lead (e.g. electrical lead 100) comprising: providing an annular first electrode (e.g. electrode 17/47); an annular second electrode (e.g. conductive ring 27 which is part of core component 175/475), a diameter of an inner surface of the first electrode being larger than a diameter of an outer surface of the second electrode (e.g. diameter inner surface of electrode 17 is larger than a diameter of an outer surface of conductive ring 27, Fig. 2B); at least one wire (e.g. first conductor 151/451) comprising an electrically conductive core (e.g. “first conductor 151 including a conductor wire or wire filar 25 surrounded by a layer of insulation 205”, para. [0015]), the core being exposed in an exposed wire portion (e.g. Figs. 4A-4D, “in order to form the junction with electrode 17 for electrical coupling, insulation layer 205 needs to be displaced from at least a portion of the circumference of wire 25 at the junction”, para. [0015], “first conductor 451 includes an insulating layer, for example, layer 205 of first conductor 151 illustrated in FIG. 2A, which extends over conductor terminal portion 453, and the action of ring inner surface 472, riding over portion 453, displaces the insulation layer without significantly deforming portion 453”, para. [0018], “has prevented significant damage to wire filar 25 during the press fit method, while ring first diameter D1 riding over conductor portion 153/453 and core 175/475 (FIG. 4C), in an interference fit, has effectively displaced insulation layer 205 from about the circumference of wire filar 25, for electrical coupling, and deformed outer surface 207 of core 175”, para. [0021] therefore a portion of the first conductor wire 151/451 that includes is exposed), wherein the first electrode and the second electrode are arranged concentrically to each other so that the inner surface of the first electrode at least partially overlaps the outer surface of the second electrode in an overlap area (e.g. electrode 17 and conductive ring 27are arranged concentrically so an inner surface of electrode 17 partially overlaps the outer surface of conductive ring 27, Fig. 2B); wherein at least a part of the exposed wire portion is inserted into the overlap area and compressed therein by the first electrode and the second electrode (e.g. at least part of the exposed wire that includes electrical conductor wire 151 is within the overlap area and compressed by electrode 17/47 and conductive ring 27 which is part of core component 175/475, Figs. 2B, 4A-4C); wherein a free end of the wire protrudes from the overlap area in a direction parallel to a common central axis of the first electrode and the second electrode (e.g. a free end of first conductor wire 151/451 protrudes from an overlap area parallel to a common central axis of electrode 17 and conductive ring 27, Figs. 1-2, 4A-4D).
In reference to at least claim 4
Huotari discloses wherein the compressed part of the exposed wire portion has a longitudinal axis parallel to the common central axis (e.g. conductor wire 151/451 has a longitudinal axis parallel to the common central axis of electrode 17 and conductive ring 27, Figs. 1-2, 4A-4D).
In reference to at least claim 5
Huotari discloses wherein the core is surrounded by an electrically insulating sheathing in a sheathed wire portion (e.g. “first conductor 151 including a conductor wire or wire filar 25 surrounded by a layer of insulation 205,”, para. [0015]), wherein at least a part of the sheathed wire portion protrudes as the free end of the wire from the overlap area (e.g. a free end of conductor wire 151/451 protrudes from an overlap area between electrode 17 and conductive ring 27, Figs. 1-2, 4A-4D).
In reference to at least claim 6
Huotari discloses wherein a part of the sheathed wire portion is inserted into the overlap area and compressed therein by the first electrode and the second electrode (e.g. Figs. 4A-4D, “in order to form the junction with electrode 17 for electrical coupling, insulation layer 205 needs to be displaced from at least a portion of the circumference of wire 25 at the junction”, para. [0015], “first conductor 451 includes an insulating layer, for example, layer 205 of first conductor 151 illustrated in FIG. 2A, which extends over conductor terminal portion 453, and the action of ring inner surface 472, riding over portion 453, displaces the insulation layer without significantly deforming portion 453”, para. [0018], “has prevented significant damage to wire filar 25 during the press fit method, while ring first diameter D1 riding over conductor portion 153/453 and core 175/475 (FIG. 4C), in an interference fit, has effectively displaced insulation layer 205 from about the circumference of wire filar 25, for electrical coupling, and deformed outer surface 207 of core 175”, para. [0021]).
In reference to at least claim 7
Huotari discloses wherein a first free end of the wire protrudes from the overlap area in a first direction parallel to the common central axis and a second free end of the wire protrudes from the overlap area in a second direction opposite to the first direction (e.g. multiple ends of conductor wire 151/451 protrude from the overlap area in a first direction and a second direction opposite the first direction, Figs. 1-2, 4A-4D).
In reference to at least claim 8
Huotari discloses wherein an outer diameter (ODW) of the wire is 0.5 mm or less, particularly 0.2 mm or less, more particularly 0.1 mm or less (e.g. “and a diameter of first conductor 151, extending to terminal end of first conductor portion 153, is approximately 0.005 inch, which diameter includes twice a thickness of insulation layer 205,”, para. [0020]).
In reference to at least claim 9
Huotari discloses wherein the diameter (OD) of the outer surface of the second electrode is 3 mm or less, particularly 2 mm or less, particularly 1 mm or less (e.g. “conductive ring 27 formed from titanium or a titanium alloy (i.e. Ti64Al4, CP Ti grade 2) and having an inner diameter of approximately 0.042 inch and an outer diameter of approximately 0.050 inch”, para. [0021]).
In reference to at least claim 10
Huotari discloses wherein the diameter (OD) of the outer surface of the second electrode differs from the diameter of the inner surface of the first electrode by 10% or less, particularly by 5% or less (e.g. “a conductive ring 27 formed from titanium or a titanium alloy (i.e. Ti64Al4, CP Ti grade 2) and having an inner diameter of approximately 0.042 inch and an outer diameter of approximately 0.050 inch; electrode ring 17 is formed of a platinum alloy (i.e. 90/10 platinum/iridium) and has a maximum outer diameter of approximately 0.067 inch, a minimum outer diameter, at either end 171, 172 of approximately 0.062 inch, a first inner diameter D1 of approximately 0.051 inch and a second inner diameter D2 of approximately 0.056 inch;”, para. [0021]).
In reference to at least claim 11
Huotari discloses wherein the diameter (OD) of the outer surface of the second electrode differs from the diameter of the inner surface of the first electrode (9) by 0.5 mm or less, particularly by 0.2 mm or less, more particularly by 0.1 mm or less (e.g. “a conductive ring 27 formed from titanium or a titanium alloy (i.e. Ti64Al4, CP Ti grade 2) and having an inner diameter of approximately 0.042 inch and an outer diameter of approximately 0.050 inch; electrode ring 17 is formed of a platinum alloy (i.e. 90/10 platinum/iridium) and has a maximum outer diameter of approximately 0.067 inch, a minimum outer diameter, at either end 171, 172 of approximately 0.062 inch, a first inner diameter D1 of approximately 0.051 inch and a second inner diameter D2 of approximately 0.056 inch;”, para. [0021]).
In reference to at least claim 12
Huotari discloses wherein the first electrode has a greater wall thickness than the second electrode (e.g. electrode 17 has a greater wall thickness than conductive ring 27, Fig. 2B, “a conductive ring 27 formed from titanium or a titanium alloy (i.e. Ti64Al4, CP Ti grade 2) and having an inner diameter of approximately 0.042 inch and an outer diameter of approximately 0.050 inch; electrode ring 17 is formed of a platinum alloy (i.e. 90/10 platinum/iridium) and has a maximum outer diameter of approximately 0.067 inch, a minimum outer diameter, at either end 171, 172 of approximately 0.062 inch, a first inner diameter D1 of approximately 0.051 inch and a second inner diameter D2 of approximately 0.056 inch;”, para. [0021]).
In reference to at least claim 13
Huotari discloses wherein a wall thickness of the first electrode (9) differs from a wall thickness of the second electrode by 10% to 35% (e.g. electrode 17 differs in wall thickness from conductive ring 27, Fig. 2B, “a conductive ring 27 formed from titanium or a titanium alloy (i.e. Ti64Al4, CP Ti grade 2) and having an inner diameter of approximately 0.042 inch and an outer diameter of approximately 0.050 inch; electrode ring 17 is formed of a platinum alloy (i.e. 90/10 platinum/iridium) and has a maximum outer diameter of approximately 0.067 inch, a minimum outer diameter, at either end 171, 172 of approximately 0.062 inch, a first inner diameter D1 of approximately 0.051 inch and a second inner diameter D2 of approximately 0.056 inch;”, para. [0021]).
In reference to at least claim 15
Huotari discloses wherein the wire is a stranded wire (e.g. “According to alternate embodiments, either, or both, of first and second conductors 151,152 are formed from a cabled plurality of wire strands, for example silver-cored MP35N alloy strands.”, para. [0015]).
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0228469 to Zarembo et al. (Zarembo) in view of US 2015/0306376 to Novotny et al. (Novotny).
In reference to at least claim 2
Zarembo discloses a lead according to claim 1. Zarembo further discloses providing an elongated lead body (e.g. 110) and at least one electrically conductive contact element (e.g. 116) for contacting body tissue; providing an elongated lead body However, Zarembo does not explicitly disclose electrically and mechanically connecting a free end of the wire to the contact element; attaching the contact element (4) to a distal end of the lead body ;attaching the second electrode, which is pressed together with the first electrode, to a proximal end of the lead body.
Novotny, within a similar field of endeavor of lead assemblies, discloses providing electrode sub-assemblies that include an outer conductive element and an inner element (e.g. Figs. 5A-10) that are attached on to an elongated lead body (e.g. Fig. 11) including electrically and mechanically connecting a free end of the wire to the contact element (e.g. “FIG. 11 also illustrates one or more elongated conductors 704 inserted through the lumens (not shown) of pre-molded cylindrical sub-assemblies 702. Pre-molded cylindrical sub-assemblies 702 are positioned at respective locations along the longitudinal axis of elongated conductors 704.”, para. and attaching the contact element to a distal end of the lead body”, para. [0099]-[0100]) and attaching to a proximal end the second electrode, which is pressed together with the first electrode (e.g. “The stimulation and signals may be conducted between the electrodes and IMD 14A by conductors within lead 16A, which are electrical connected to IMD 14A by connectors at proximal end 20A of lead 16A.”, para. [0032]; “as including proximal end 20 with connectors configured to electrically connect elongated conductors within the lead to an IMD, and distal end 22 with electrodes configured to electrically connect the conductors to patient tissue,”, para. [0040]), to a proximal end of the lead body. Novotny discloses that the method provides improved straightness (e.g. para. [0031]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Zarembo to include utilizing a manufacturing process that electrically and mechanically connects a free end of the wire to the contact element, attaching the contact element to a distal end of the lead body and attaching the second electrode, which is pressed together with the first electrode, to a proximal end of the lead body, as taught by Novotny, in order to provide a technique that improves straightness, protects the conductors, maximizes distance between the conductors and conductive elements and improves AC impedance performance (‘376, para. [0030]-[0031]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2005/0240252 to Boser et al. which discloses a novel medical device conductor junction. US Patent No. 4,590,950 to Iwaszkiewicz which discloses an electrical connection.
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