DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5, 6, 13, 15, 18, and 19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being unpatentable by Boogaard(7239922).
Regarding claim 1, Boogaard discloses a lead for a medical device comprising: a cable comprising: an outer insulation having at least one first opening near a distal end of the cable; and an inner lumen; wherein the inner lumen is arranged coaxially to the outer insulation and extends in a longitudinal direction from a proximal end to the distal end of the cable; at least one conducting channel; wherein the at least one conducting channel is arranged between the outer insulation and the inner lumen of the cable; wherein the at least one conducting channel is formed by at least one insulated conductor comprising a conductor and an insulation layer, and wherein the insulation layer of the at least one insulated conductor comprises a second opening, which is aligned with the at least one first opening; at least one ring electrode; wherein the at least one ring electrode surrounds the cable at a position of the at least one aligned first and second opening of the cable(A method of manufacturing a biological electrical stimulus cable assembly, comprising: a) providing a cable portion, including a plurality of first conductive wires set into a length of insulative material having a surface, wherein the plurality of conductive wires are disposed at substantially the same radial depth within the insulative material, wherein the wires are encapsulated within the insulative material that forms a body of the cable portion; b) removing a portion of said insulative material from said surface of said length of insulative material to only a first one of said first conductive wires at a first location, thereby creating a first exposed first wire surface and removing a portion of said insulative material from said surface of said length of insulative material, also only to said first one of said first conductive wires at a second location, thereby creating a second exposed first wire surface, wherein the removing is performed on the cable portion after the first conductive wires have been set within the insulative material of the body of the cable portion; c) electrically connecting a second conductive wire to said first exposed first wire surface; and d) wrapping said second conductive wire about said cable portion and connecting it to said second exposed first wire surface, thereby creating a circumscribing electrode[claim 1]); wherein the at least one ring electrode is selectively connected to the conductor of the at least one insulated conductor via a bendable bridging element extending through the at least one aligned first and second opening(Wire 16 serves as bendable bridging element as it wraps around(i.e. bends according to broadest reasonable interpretation) cable 10 to connect connective ring 18).
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Regarding claim 3, Boogaard discloses the lead according to claim 1, wherein the at least one conducting channel is formed by two or more insulated conductors, which are arranged adjacent to each other; wherein each one of the two or more insulated conductors comprises at least one second opening and wherein the second openings of the insulation layers of the two or more insulated conductors of the at least one conducting channel are aligned with the at least one first opening(Boogaard - Referring to FIGS. 1 3, a preferred method of practicing the present invention begins with a cable portion 10 having a set of first conductive wires 12 set into a double layered structure of insulative material 14 about a tube 13. In an alternative preferred embodiment a wire is placed in the center of cable portion 10 to impart longitudinal strength to cable portion 10.(Detailed description of the preferred embodiment, paragraph 1). A method of manufacturing a biological electrical stimulus cable assembly, comprising: a) providing a cable portion, including a plurality of first conductive wires set into a length of insulative material having a surface, wherein the plurality of conductive wires are disposed at substantially the same radial depth within the insulative material, wherein the wires are encapsulated within the insulative material that forms a body of the cable portion; b) removing a portion of said insulative material from said surface of said length of insulative material to only a first one of said first conductive wires at a first location, thereby creating a first exposed first wire surface and removing a portion of said insulative material from said surface of said length of insulative material, also only to said first one of said first conductive wires at a second location, thereby creating a second exposed first wire surface, wherein the removing is performed on the cable portion after the first conductive wires have been set within the insulative material of the body of the cable portion; c) electrically connecting a second conductive wire to said first exposed first wire surface; and d) wrapping said second conductive wire about said cable portion and connecting it to said second exposed first wire surface, thereby creating a circumscribing electrode,[claim ][Fig. 3]); wherein the at least one ring electrode is selectively connected to the conductors of the two or more insulated conductors via a bendable bridging element extending through the at least one aligned first and second openings(Wire 16 serves as bendable bridging element as it wraps around cable 10 to connect connective ring 18).
Regarding claim 5, Boogaard discloses the lead according to claim 1, but Boogaard fails to disclose wherein the bridging element is a wire extending essentially parallel to a longitudinal axis of the lead(coil 16 can be seen in Figure 4 as “extending essentially parallel to a longitudinal axis of the lead”, as from 15 to 20 as shown in Figure 4, the wire is extending longitudinally).
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Regarding claim 6, Boogaard discloses the lead according to claim 1, wherein the bridging element is a metal ribbon or wire extending radially outward from a center of the lead in at least in portion thereof(Boogaard - Wire 16 is then attached to wire 12 by way of aperture 15, wound about cable portion 10 and then attached again to wire 12 through aperture 20. This provides a particularly robust attachment for wire 16 and provides a good amount of surface area to form an excellent electrical connection with ring 18, which is threaded directly radially over wire 16(Detailed description of the preferred embodiment, paragraph 2)).
Regarding claim 13, Boogaard discloses the lead according to claim 1, wherein the outer insulation of the cable has one or more of an outer diameter in the range of 200 to 5000 µm, and a wall thickness in the range of 2 to 300 µm(Boogaard - In an additional alternative preferred embodiment, a partial ring, for example one that extends through three-quarters of a circle is used. In one preferred embodiment cable portion 10 has a diameter of 500 microns, wires 12 are 100 microns thick, wire 16 is 75 microns thick and ring 18 is 50 microns thick and 3,000 microns wide(Detailed Description of the Preferred Embodiment, paragraph 3).
Regarding claim 15, Boogaard discloses the lead according to claim 1, wherein the inner lumen is formed by an inner tube( Referring to FIGS. 1 3, a preferred method of practicing the present invention begins with a cable portion 10 having a set of first conductive wires 12 set into a double layered structure of insulative material 14 about a tube 13(Detailed description of the embodiments, paragraph 1).
Regarding claim 18, Boogaard discloses a process for preparing a lead, wherein the process comprises: a) providing a cable comprising an outer insulation, an inner lumen, wherein the inner lumen is arranged coaxially to the outer insulation and extends in a longitudinal direction from a proximal end to a distal end of the cable, at least one conducting channel, wherein the at least one conducting channel is arranged between the outer insulation and the inner lumen of the cable, wherein the at least one conducting channel is formed by at least one insulated conductor comprising a conductor and an insulation layer; b) providing at least one ring electrode; c) providing at least one bendable bridging element; d) removing parts of the outer insulation near the distal end of the cable to create at least one first opening; e) removing parts of the insulation layer of the at least one insulated conductor beneath the at least one first opening to create at least one second opening, wherein the at least one second opening is aligned with the at least one first opening near the distal end of the cable; f) positioning the at least one bridging element in the aligned first and second opening so that the bridging element is in electrical contact with the conductor; g) attaching the bridging element to the conductor; h) positioning the at least one ring electrode around the cable obtained in step g) at the position of the at least one aligned first and second opening; and i) attaching the at least one ring electrode to the bridging element thereby connecting the at least one ring electrode to the conductor(A method of manufacturing a biological electrical stimulus cable assembly, comprising: a) providing a cable portion, including a plurality of first conductive wires set into a length of insulative material having a surface, wherein the plurality of conductive wires are disposed at substantially the same radial depth within the insulative material, wherein the wires are encapsulated within the insulative material that forms a body of the cable portion; b) removing a portion of said insulative material from said surface of said length of insulative material to only a first one of said first conductive wires at a first location, thereby creating a first exposed first wire surface and removing a portion of said insulative material from said surface of said length of insulative material, also only to said first one of said first conductive wires at a second location, thereby creating a second exposed first wire surface, wherein the removing is performed on the cable portion after the first conductive wires have been set within the insulative material of the body of the cable portion; c) electrically connecting a second conductive wire to said first exposed first wire surface; and d) wrapping said second conductive wire about said cable portion and connecting it to said second exposed first wire surface, thereby creating a circumscribing electrode,(claim 1)[Fig. 3]. Wire 16 serves as bendable bridging element as it wraps around cable 10 to connect connective ring 18)).
Regarding claim 19, Boogaard discloses the process according to claim 18, wherein steps d) and e) are carried out by laser ablation or by cutting(Boogaard - A laser is used to ablate an aperture 15 (FIG. 2) through insulative material 14 and a second conductive wire 16 is threaded through this aperture 15 into contact with a first conductive wire 12, to which it is laser welded or otherwise attached. (Detailed Description of the Preferred Embodiment, paragraph 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.
Claim(s) 2 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Boogaard(7239922).
Regarding claim 2, Boogaard discloses the lead according to claim 1, wherein the lead is a multipolar lead comprising: a cable comprising an outer insulation having at least four first openings near a distal end of the cable; an inner lumen; wherein the inner lumen is arranged coaxially to the outer insulation and extends in a longitudinal direction from a proximal end to the distal end of the cable; at least four conducting channels; wherein the at least four conducting channels are arranged between the outer insulation and the inner lumen of the cable; wherein each one of the at least four conducting channels is formed by at least one insulated conductor comprising a conductor and an insulation layer; and wherein the insulation layer of the at least one insulated conductor of each one of the at least four conducting channels comprises a second opening, which is aligned with one of the at least four first openings; at least four ring electrodes; wherein each one of the at least four ring electrodes surrounds the cable at a position of one of at least four aligned first and second openings of the cable(Boogaard - Referring to FIGS. 1 3, a preferred method of practicing the present invention begins with a cable portion 10 having a set of first conductive wires 12 set into a double layered structure of insulative material 14 about a tube 13. In an alternative preferred embodiment a wire is placed in the center of cable portion 10 to impart longitudinal strength to cable portion 10.(Detailed description of the preferred embodiment, paragraph 1). A method of manufacturing a biological electrical stimulus cable assembly, comprising: a) providing a cable portion, including a plurality of first conductive wires set into a length of insulative material having a surface, wherein the plurality of conductive wires are disposed at substantially the same radial depth within the insulative material, wherein the wires are encapsulated within the insulative material that forms a body of the cable portion; b) removing a portion of said insulative material from said surface of said length of insulative material to only a first one of said first conductive wires at a first location, thereby creating a first exposed first wire surface and removing a portion of said insulative material from said surface of said length of insulative material, also only to said first one of said first conductive wires at a second location, thereby creating a second exposed first wire surface, wherein the removing is performed on the cable portion after the first conductive wires have been set within the insulative material of the body of the cable portion; c) electrically connecting a second conductive wire to said first exposed first wire surface; and d) wrapping said second conductive wire about said cable portion and connecting it to said second exposed first wire surface, thereby creating a circumscribing electrode,[claim 1][Fig. 3]).
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Boogaard fails to disclose wherein each one of the at least four ring electrodes is selectively connected to the conductor of the at least one insulated conductor via a bendable bridging element extending through each one of the at least four aligned first and second openings.
However, this limitation is a duplication of parts clause. It would be obvious to have an opening and associated electrode that corresponds to each of the conductive cables, as the purpose of the invention is an electrical stimulus cable and, thus, it would be obvious to connect each cable to a corresponding electrical stimulation electrode.
Regarding claim 14, Boogaard discloses the lead according to claim 1, wherein the inner lumen has a diameter in the range of 10 to 1000 µm((Boogaard - In an additional alternative preferred embodiment, a partial ring, for example one that extends through three-quarters of a circle is used. In one preferred embodiment cable portion 10 has a diameter of 500 microns, wires 12 are 100 microns thick, wire 16 is 75 microns thick and ring 18 is 50 microns thick and 3,000 microns wide(Detailed Description of the Preferred Embodiment, paragraph 3).
Boogaard does not describe the exact dimensions of the lumen, however, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). Furthermore, it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 7, 10, 12, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Boogaard(7239922) in view of Verness(US 20020099430 A1).
Regarding claim 7, Boogaard discloses teaches the lead according to claim 1, but Boogaard fails to disclose wherein the bridging element is a spring element. However, Verness teaches “Crimp sleeve 386 is coupled to coiled conductor 360 by crimps 388 and conductive spring 384.[0074]. Also located within lead body 310 is a stranded wire conductor which extends along a length of the coiled conductor and which serves a mechanism for bridging a fracture of the coiled conductor which occurs between the ends of the stranded conductor, as discussed above[0070]”.
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It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical cable of Boogaard with the medical electrical lead of Verness. Doing so would specify a spring element to form the bridge between the conductor and the electrode to allow electrical connection to remain through movement of the lead.
Regarding claim 10, Boogaard discloses teaches the lead according to claim 1, but Boogaard fails to disclose wherein the bridging element is a coil spring. However Verness teaches “FIG. 19 shows a side, cut-away view through the lead of FIG. 16 in the vicinity of bifurcation 320. In this view, coiled conductor 360 and stranded conductors 362 and 364 are visible, exiting from lead body 310 and entering into molded bifurcation 320[0074]. Spring 384 as shown in Fig. 19 is a coil”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical cable of Boogaard with the medical electrical lead of Verness. Doing so would specify a spring element as the bridge connection between the conductor and the electrode to allow electrical connection to remain through movement of the lead.
Regarding claim 12, Boogaard discloses the lead according to claim 1, but Boogaard fails to explicitly state wherein the lead comprises the same number of ring electrodes near the proximal end of the cable as it comprises ring electrodes near the distal end of the cable, and wherein each one of the ring electrodes near the proximal end of the cable is in communication with one of the ring electrodes near the distal end of the cable via one conducting channel of the lead.
However, Verness teaches “Spacer 204 is molded in situ between connector pin 36 and ring electrode 32, [0058]. In this view, the interconnection of conductor 116, conductor 118 and electrode 16 is visible. Extending distally from the defibrillation electrode 12, the lead takes the form of a molded piece part 228, which carries ring electrode 14, which is in turn coupled to stranded conductor 112 (not visible in this view).[0053][Fig. 1]”.
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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 lead of Boogaard to include the same number of ring electrodes near the proximal end of the cable as ring electrodes near the distal end of the cable, as taught by Verness, in order to have dedicated communication between the proximal and distal end electrodes.
Regarding claim 20, Boogaard discloses the process according to claim 18, but Boogaard fails to disclose wherein the at least one ring electrodes is attached in step i) by swaging or by swaging and laser welding. However, Verness teaches "Similarly, other mechanisms may be employed to interconnect conductors 118 and 116 and electrode 16, including welding, swaging, crimping and combinations thereof[0053]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical cable of Boogaard with the medical electrical lead of Verness. Doing so would specify the attaching process of the conductor and the electrode in the medical lead.
Claim(s) 11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Boogaard in view of Verness(US 6018683 A), herein after known as Verness B.
Regarding claim 11, Boogaard discloses the lead according to claim 1, but fails to disclose wherein the bridging element comprises a metal selected from the group consisting of platinum, iridium, tantalum, palladium, titanium, iron, gold, molybdenum, niob, tungsten, nickel chromium, cobalt, steel, nitinol, alloys of each one of these metals, and composite materials of each one of these metals.
However, Verness B teaches “A lead according to claim 5 wherein said stranded conductor is made of MP35N alloy[claim 6]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the medical cable of Boogaard with the medical electrical lead of Verness B. Doing so would specify the material of the conductor in the cable in order to ensure proper cable manufacturing.
Regarding claim 16, Boogaard discloses teaches the lead according to claim 1, but fails to disclose wherein the conductor of the at least one insulated conductor of the at least two conducting channels comprises a metal selected from the group consisting of platinum, iridium, tantalum, palladium, titanium, iron, gold, molybdenum, niob, tungsten, nickel, chromium, cobalt, steel, nitinol, alloys of each one of these metals, and composite materials of each one of these metals.
However, Verness B teaches “A lead according to claim 5 wherein said stranded conductor is made of MP35N alloy[claim 6]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the medical cable of Boogaard with the medical electrical lead of Verness B. It would be obvious to change the material for the wire 16 of Boogaard to be the same as the conductor 118 of Verness B, as conductor 118 of Verness B is used as a bridge between conductor 116 and the electrode, see col. 3, ln. 41-col. 4, ln. 4.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Boogaard in view of Morris(US 20110160830 A1).
Regarding claim 17, Boogaard in view of Verness teaches the lead according to claim 1, but fail to disclose wherein the at least two ring electrodes comprise a metal selected from the group consisting of platinum, iridium, tantalum, palladium, titanium, iron, gold, molybdenum, niob, tungsten, nickel, chromium, cobalt, steel, nitinol, alloys of each one of these metals, and composite materials of each one of these metals.
However, Morris teaches the “In various embodiments, the terminal pin 225 extends proximally from the connector body 220, and in some embodiments is coupled to an inner conductor coil that extends longitudinally through the lead body 160 to one or more pace/sense electrodes or ring electrodes 180a-180d[0039]. The pace/sense electrodes 180a-180d can be made of any suitable electrically conductive material such as ELGILOY, MP35N, tungsten, tantalum, iridium, platinum, titanium, palladium, stainless steel, as well as alloys of any of these materials[0040]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the medical cable of Boogaard with the implantable electrical lead of Morris. Doing so would specify the material of the electrodes in the cable in order to ensure proper cable manufacturing.
Allowable Subject Matter
Claims 4, 8, and 9 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796