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 .
Response to Amendment
The amendment filed October 2nd, 2025 has been entered. Claims 50-51, & 53-77 are amended. Claims 1-49 & 52 are cancelled. Claims 78 is new. Claims 50-51, & 53-78 remain pending.
Response to Arguments
Applicant's arguments, with respect to claims 50-51, 53-61, 62-68, & 75, over McLawhorn, have been fully considered but they are not persuasive. Applicant argues, that claim 50 as amended to include “wherein the second electrode is at a distal end region of the inner deployment member” overcomes the previous rejection as McLawhorn do not teach the second electrode positioned at least partially with an opening of the funnel shape when the braided or woven body is inverted wherein the second electrode is at a distal region of the inner deployment member. The examiner respectfully disagrees that the limitation “wherein the second electrode is at a distal end region of the inner deployment member” requires for the second electrode to be attached or affixed to a distalmost tip of the inner deployment member, rather “at” is only limiting the position of the second electrode relative to the inner deployment member, as discussed in the examiner interview held on September 25th, 2025. McLawhorn discloses the second electrode 906 located centrally relative to the first electrode 904 ([0042]; Figures 9 & 9A), and further discloses that the braided or woven body can be inverted to formed a funnel shape, wherein the centrally located portion is positioned at least partially with an opening of the funnel shape, and as the second electrode is located on the centrally located portion of the braided or woven body relative to the first electrode, it is the examiners position that the second electrode would be positioned at least partially within an opening of the funnel shape ([0039] & [0042]), further the examiner is considering the distal end region of the inner deployment member 406 to be the portion of the inner deployment member 406 extending within and distally of the braided or woven body 402 ([0031], [0034], [0035], & [0039]), under the broadest under the broadest reasonable interpretation the examiner is considering the second electrode 906 to be “at” a distal end region of the inner deployment member 406 as the second electrode 906 is located at/surrounding a distal end region of the inner deployment member 406 and contacts the distal end region of the inner deployment member 406, as shown in figures 9 & 9a.
Applicant’s arguments with respect to claims 50, 69-74, & 76, over Latterell, 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; as necessitate by amendment.
Applicant’s arguments with respect to claim 77 has been fully considered and are persuasive; in light of the claim amendment; Therefore the previous rejection of has been withdrawn.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 50-51, 53-54, 57-61, 63-65, & 68 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McLawhorn et al. (previously presented-US 20150066010 A1), hereinafter “McLawhorn”.
Regarding claim 50, McLawhorn discloses an electrical applicator device, comprising: a braided or woven body having a distal end and a proximal end ([0031] & [0035]; Figures 4, 5, & 9—element 402; with said distal end being the distal end of body 402 coupled to the distal end of inner shaft 406 and said proximal end being the proximal end of body 402 coupled to outer shaft 404); an inner deployment member extending within the braided or woven body and coupled to a distal attachment site of the braided or woven body ([0031], [0034], [0035], & [0039]; Figures 4, 5, & 9—element 406), wherein the inner deployment member is configured to be movable to invert a distal end region of the braided or woven body to form a funnel shape having a distal-facing outer region ([0035], [0039], & [0051]; Figure 7—elements 704 & 708; said distal-facing outer region being the base 708 of inverted funnel); a first electrode formed at least partially around the distal-facing outer region of the inverted funnel shape ([0039], [0042] & [0051]; Figure 7—element 706; Figures 9 & 9a—element 904); and a second electrode configured to contact tissue to be ablated, wherein the second electrode is positioned at least partially within an opening of the funnel shape when the braided or woven body is inverted, further wherein the second electrode is at a distal end region of the inner deployment member ([0042] & [0051]; Figure 9 & 9a—elements 406 & 906; the examiner is considering the distal end region of the inner deployment member to be the portion of the inner deployment member 406 extending within and distally of the braided or woven body 402; under the broadest reasonable interpretation the examiner is considering the second electrode 906 to be “at” a distal end region of the inner deployment member 406 as the second electrode 906 is located at/surrounding a distal end region of the inner deployment member 406 and contacts the distal end region of the inner deployment member 406, as shown in figures 9 & 9a).
Regarding claim 51, McLawhorn discloses all of the limitations of claim 50, as described above.
McLawhorn further discloses wherein the first electrode and the second electrode are configured to be both positioned in contact with the tissue to be ablated when the braided or woven body is inverted ([0039], [0042], [0044], & [0051]; Figures 9 & 9a—elements 904 & 906; the braided or woven body 402 is pressed against the wall of the heart and energy is delivered to the first and second electrode 904 & 906; it is the examiners position that the first and second electrode would be capable of contacting tissue to be ablated when the body is inverted and pressed against tissue).
Regarding claim 53, McLawhorn discloses all of the limitations of claim 50, as described above.
McLawhorn further discloses wherein the electrical applicator device is configured as a bipolar electrical applicator ([0042]).
Regarding claim 54, McLawhorn discloses all of the limitations of claim 50, as described above.
McLawhorn further discloses further comprising an elongate proximal body extending proximally from the funnel shape ([0035] & [0042]; Figure 9—element 404) and one or more electrical connectors at a proximal end region of the elongate proximal body in electrical communication with the first and second electrodes ([0042], & [0047]-[0049]; Figure 12—element 1204).
Regarding claim 57, McLawhorn discloses all of the limitations of claim 50, as described above.
McLawhorn further discloses wherein a portion of the braided or woven body proximal to the distal-facing outer region is electrically insulated ([0031], [0033], & [0042]; the braided or woven body comprises a plurality of nonconductive filaments woven together).
Regarding claim 58, McLawhorn discloses all of the limitations of claim 50, as described above.
McLawhorn further discloses wherein the second electrode is distal to the distal attachment site of the braided or woven body ([0036] & [0042]; Figures 9 & 9a—elements 402 & 906; the second electrode 906 is shown as coating the distal surface of the braided or woven body 402, therefore it is the examiners position that the coating would be located distal relative to the distal attachment site of the braided or woven body 402 to the inner deployment member 406).
Regarding claim 59, McLawhorn discloses all of the limitations of claim 50, as described above.
McLawhorn further discloses wherein the second electrode comprises a solid material or body or comprises braided or woven material that is similar or different than a material of the braided or woven body ([0033] & [0042]; Figures 9 & 9a—element 906; the second electrode 906 comprises a conductive coating and the braided or woven body 402 comprises a nonconductive material; therefore, the examiner is considering the second electrode comprising a solid material that is different than a material of the braided or woven body; the examiner notes the rest are in the alternative).
Regarding claim 60, McLawhorn discloses all of the limitations of claim 50, as described above.
McLawhorn further discloses wherein the second electrode is configured to radially expand and/or longitudinally flatten when the inner deployment member or a separate inner deployment member is withdrawn proximally ([0032], [0034], [0035], & [0042]; Figures 4, 5, & 9—elements 402 & 906; the braided or woven body 402 expands as the inner deployment member 406 is withdrawn proximally relative to the outer shaft; as the second electrode 906 is positioned on the expandable body 402 it is the examiners position that the second electrode 906 also expands as the inner deployment member is withdrawn proximally).
Regarding claim 61, McLawhorn discloses all of the limitations of claim 50, as described above.
McLawhorn further discloses wherein the second electrode is configured to radially expand when the braided or woven body expands into the funnel shape ([0034], [0035], [0039], [0042], & [0051]; Figures 4, 5, 7, & 9—elements 402 & 906; the braided or woven body 402 expands and can form an inverted cone like shape as the inner deployment member 406 is withdrawn proximally relative to the outer shaft; as the second electrode 906 is positioned on the expandable body 402 it is the examiners position that the second electrode 906 also expands as the inner deployment member is withdrawn proximally).
Regarding claim 63, McLawhorn discloses all of the limitations of claim 50, as described above.
McLawhorn further discloses wherein a size, outer diameter and/or shape of either one or both of the first electrode and the second electrode is adjustable ([0034], [0035], [0039], [0042], & [0051]; Figures 4, 5, 7, & 9—elements 402, 904, & 906; the braided or woven body 402 expands from a collapsed configuration and can form an inverted cone like shape as the inner deployment member 406 is withdrawn proximally relative to the outer shaft; as the first electrode 904 and the second electrode 906 are positioned on the expandable body 402 it is the examiners position that the first electrode and the second electrode 906 also expand and therefore comprise a change in size, outer diameter, and shape as the inner deployment member is withdrawn proximally).
Regarding claim 64, McLawhorn discloses all of the limitations of claim 50, as described above.
McLawhorn further discloses wherein the device is configured for point-by-point ablation ([0003], [0042], & [0044]).
Regarding claim 65, McLawhorn discloses all of the limitations of claim 50, as described above.
McLawhorn further discloses wherein the first electrode and the second electrode are coplanar when deployed ([0034], [0036], & [0042]; Figure 6 & 9—element 402; the braided or woven body 402 is configured to expand into a shape that varies depending on the amount of movement of the inner deployment member 406; it is the examiner position that the first electrode and second electrode 904 & 906 located on the distal portion of the braided or woven body 402 would be capable of assuming a substantially coplanar configuration when deployed) .
Regarding claim 68, McLawhorn discloses all of the limitations of claim 50, as described above.
McLawhorn further discloses wherein the inner deployment member is configured to engage a releasable stop to prevent the distal end region of the braided or woven body to invert ([0039], & [0049]-[0050]; Figure 12—element 1220; the handle may include a lock 1220 that releasably locks the position of the inner deployment member to lock the braided or woven body 402 in a desired position and shape; it is the examiners position that the lock 1220 would be capable of preventing the braided or woven body 402 from inverting when the braided or woven body is locked in a different non-inverted position).
Claim 76 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Waldstreicher et al. (US 20190201089 A1), hereinafter “Waldstreicher”.
Regarding claim 76, Waldstreicher discloses an electrical applicator device, comprising: a braided or woven body ([0387] & [0388]; Figure 27—elements 108 & 108’); a first region of the braided or woven body configured to form a first funnel shape, the first funnel shape having a first distal-facing outer region ([0386]-[0389]; Figure 27—element 108, 122, & 124; the examiner is considering the first region to be region 108; an inner deployment member/pull wire (not shown) is configured to pull the distal end 124 of the first region 108 toward the proximal end 122 of the first region; it is the examiners position that the first region 108 would be capable of at least partially forming a first funnel shape when the inner deployment member is moved proximally enough such that the distal end 124 is moved toward the proximal end 122 of the first region 108), a second region of the braided or woven body configured to form a second funnel shape, the second funnel shape having a second distal-facing outer region, wherein the second region is distal to the first region when the electrical applicator device is in an undeployed configuration ([0386]-[0389]; Figure 27—elements 108’, 122’, & 124’; the examiner is considering the second region to be region 108’; an inner deployment member/pull wire (not shown) is configured to pull the distal end 124’ of the second region 108’ toward the proximal end 122’ of the second region; it is the examiners position that the second region 108’ would be capable of at least partially forming a second funnel shape when the inner deployment member is moved proximally enough such that the distal end 124’ is moved toward the proximal end 122’ of the second region 108); a first electrode formed at least partially around the first distal-facing outer region; a second electrode formed at least partially around the second distal-facing outer region ([0322] & [0383]; Figures 24-27—elements 108 & 108’; the first region 108 and the second region 108’ are each made up of an electrode 107 in the form of wires 120; the first region 108 and the second region 108’ are configured to be operated in a monopolar or bipolar fashion); and an inner deployment member extending within the braided or woven body and coupled to a distal end of the braided or woven body, wherein the inner deployment member is configured to be withdrawn proximally to invert the braided or woven body to form at least one of the first funnel shape and the second funnel shape, or both the first funnel shape and the second funnel shape ([0386] & [0389]; Figure 27—element 124’; the examiner is considering the inner deployment member to be the pull wire (not shown) that is attached to the distal end 124’ of the braided or woven body 108/108’; the inner deployment member/pull wire (not shown) is configured to pull the distal ends 124’ & 124 of the first portion and the second portion 108 & 108’ toward the proximal end 122 & 122’ of the of the first portion and the second portion 108 & 108’; it is the examiners position that of the first portion and the second portion 108 & 108’ would be capable of at least partially inverting to form the first funnel shape and the second funnel shape when the inner deployment member is moved proximally enough such that the distal ends 124 & 124’ are moved toward the proximal ends 122 & 122’ of the braided or woven body).
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.
Claims 50, 53, 55, 58-59, 67, 69, 71-75, & 78 are rejected under 35 U.S.C. 103 as being unpatentable over Waldstreicher in view of Viswanathan et al. (US 10130423 B1), hereinafter “Viswanathan”.
Regarding claim 50, Waldstreicher discloses an electrical applicator device, comprising: a braided or woven body having a distal end and a proximal end ([0387] & [0388]; Figure 27—element 108’, 122’, & 124’; with the proximal end being the proximal end 122’ of the braided or woven body 108’ and the distal end being the distal end 124’ of the braided or woven body 108’); an inner deployment member extending within the braided or woven body and coupled to a distal attachment site of the braided or woven body ([0386] & [0389]; Figure 27—element 124’; the examiner is considering the inner deployment member to be the pull wire (not shown) that is attached to the distal end 124’ of the braided or woven body 108’), wherein the inner deployment member is configured to be movable to invert a distal end region of the braided or woven body to form a funnel shape having a distal-facing outer region ([0386] & [0389]; Figure 27—element 108’; the inner deployment member/pull wire (not shown) is configured to pull the distal end 124’ of the braided or woven body 108’ toward the proximal end 122’ of the braided or woven body; it is the examiners position that a distal end region of the braided or woven body 108’ would be capable of at least partially inverting when the inner deployment member is moved proximally enough such that the distal end 124’ is moved toward the proximal end 122’ of the braided or woven body); a first electrode formed at least partially around the distal-facing outer region of the inverted funnel shape ([0383]; Figure 24-27—elements 107 & 108’; the braided or woven body 108’ is made up of an electrode 107 in the form of wires 120).
Waldstreicher does not disclose a second electrode configured to contact tissue to be ablated, wherein the second electrode is positioned at least partially within an opening of the funnel shape when the braided or woven body is inverted, further wherein the second electrode is at a distal end region of the inner deployment member.
Viswanathan discloses an ablation device comprising a body configured to be inverted ([Col. 37, line 56 – Col. 38, line 15]; Figure 33A—element 3330), an inner deployment member ([Col. 37, line 56 – Col. 38, line 15]; Figure 33A—element 3320), a first electrode ([Col. 38, lines 16-39]; Figure 33A—elements 3332; it is the examiners position that the body 3330 would be capable of inverting when the inner deployment member 3320 is retracted relative to the outer shaft 3310), and a second electrode configured to contact tissue to be ablated, wherein the second electrode is positioned at least partially within an opening of the funnel shape when the braided or woven body is inverted, further wherein the second electrode is at a distal end region of the inner deployment member ([Col. 37, line 56 – Col. 38, line 39]; Figure 33A—element 3332).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the inner deployment member, as disclosed by Waldstreicher, to include a second electrode, as taught by Viswanathan, as both references and the claimed invention are directed toward expandable ablation devices. As disclosed by Viswanathan, the inner deployment member may include a second electrode configured as a cap electrode, providing a cap electrode allows the distal end of the ablation device to generate and project a stronger electric field to thereby more effectively generate focal ablation lesions of tissue at a desired depth compared to any one electrode alone ([Col. 38, lines 16-39]). 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 inner deployment member, as disclosed by Waldstreicher, to include a second electrode, as taught by Viswanathan, as such a modification would allow the distal end of the ablation device to generate and project a stronger electric field to thereby more effectively generate focal ablation lesions of tissue at a desired depth compared to any one electrode alone.
Regarding claim 53, Waldstreicher in view of Viswanathan disclose all of the limitations of claim 50, as described above.
Waldstreicher further discloses wherein the electrical applicator device is configured as a bipolar electrical applicator ([0322] & [0383]).
Regarding claim 55, Waldstreicher in view of Viswanathan disclose all of the limitations of claim 50, as described above.
Waldstreicher further discloses wherein the braided or woven body comprises a conductive wire ([0383]; Figure 24-27—elements 107 & 120).
Regarding claim 58, Waldstreicher in view of Viswanathan disclose all of the limitations of claim 50, as described above.
Waldstreicher does not disclose wherein the second electrode is distal to the distal attachment site of the braided or woven body.
Viswanathan further teaches wherein the second electrode is distal to the distal attachment site of the braided or woven body ([Col. 37, line 56 – Col. 38, line 39]; Figure 33A—elements 3320, 3330, & 3332).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the inner deployment member, as disclosed by Waldstreicher, to include a second electrode wherein the second electrode is distal to the distal attachment site of the braided or woven body, as further taught by Viswanathan, as both references and the claimed invention are directed toward expandable ablation devices. As disclosed by Viswanathan, the inner deployment member may include a second electrode configured as a cap electrode, providing a cap electrode allows the distal end of the ablation device to generate and project a stronger electric field to thereby more effectively generate focal ablation lesions of tissue at a desired depth compared to any one electrode alone ([Col. 38, lines 16-39]). 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 inner deployment member, as disclosed by Waldstreicher, to include a second electrode wherein the second electrode is distal to the distal attachment site of the braided or woven body, as further taught by Viswanathan, as such a modification would allow the distal end of the ablation device to generate and project a stronger electric field to thereby more effectively generate focal ablation lesions of tissue at a desired depth compared to any one electrode alone.
Regarding claim 59, Waldstreicher in view of Viswanathan disclose all of the limitations of claim 50, as described above.
Waldstreicher does not disclose wherein the second electrode comprises a solid material or body or comprises braided or woven material that is similar or different than a material of the braided or woven body.
Viswanathan further teaches wherein the second electrode comprises a solid material or body or comprises braided or woven material that is similar or different than a material of the braided or woven body ([Col. 37, line 56 – Col. 38, line 39]; Figure 33A—element 3332; the cap electrode 3322 may have a flat, circular shape and/or a rounded and blunt profile; the examiner is considering the second electrode 3322 to be a solid material or body; the examiner notes the rest are in the alternative).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the inner deployment member, as disclosed by Waldstreicher, to include a second electrode wherein the second electrode comprises a solid material or body, as further taught by Viswanathan, as both references and the claimed invention are directed toward expandable ablation devices. As disclosed by Viswanathan, the inner deployment member may include a second electrode configured as a cap electrode, providing a cap electrode allows the distal end of the ablation device to generate and project a stronger electric field to thereby more effectively generate focal ablation lesions of tissue at a desired depth compared to any one electrode alone ([Col. 38, lines 16-39]). 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 inner deployment member, as disclosed by Waldstreicher, to include a second electrode wherein the second electrode comprises a solid material or body, as further taught by Viswanathan, as such a modification would allow the distal end of the ablation device to generate and project a stronger electric field to thereby more effectively generate focal ablation lesions of tissue at a desired depth compared to any one electrode alone.
Regarding claim 67, Waldstreicher in view of Viswanathan disclose all of the limitations of claim 50, as described above.
Waldstreicher further discloses wherein the electrical applicator device is further configured to detect electrical signals from the tissue to determine a region to ablate or to further ablate ([0339], [0341], & [0342]).
Regarding claim 69, Waldstreicher in view of Viswanathan disclose all of the limitations of claim 50, as described above.
Waldstreicher further discloses a second region of the braided or woven body forming or configured to form a second funnel shape, the second funnel shape having a second distal-facing outer region ([0387] & [0388]; Figure 27—element 108; the examiner is considering the second region of the braided or woven body to be the braided or woven body 108; the inner deployment member/pull wire (not shown) is configured to pull the distal end 124 of the braided or woven body 108 toward the proximal end 122 of the braided or woven body 108; it is the examiners position that the distal end region of the braided or woven body 108 would be capable of forming a second funnel shape when the inner deployment member is moved proximally enough such that the distal end 124 is moved toward the proximal end 122 of the braided or woven body).
Regarding claim 71, Waldstreicher in view of Viswanathan disclose all of the limitations of claim 69, as described above.
Latterell further discloses the electrical applicator device configured to circumferentially ablate the tissue between the funnel shape and the second funnel shape ([0322] & [0383]; Figure 27—elements 108’ & 108; the funnel shape 108’ and the second funnel shape 108 are configured to be activated in a bipolar fashion).
Regarding claim 72, Waldstreicher in view of Viswanathan disclose all of the limitations of claim 69, as described above.
Latterell further discloses wherein the inner deployment member is configured to be withdrawn proximally to invert the braided or woven body to form at least one of the funnel shape and the second funnel shape, or both the funnel shape and the second funnel shape ([0386] & [0389]; Figure 27—elements 108’ & 108; the inner deployment member/pull wire (not shown) is configured to pull the distal ends 124’ & 124 of the braided or woven body 108’ & 108 toward the proximal end 122’ & 122 of the braided or woven body 108’ & 108; it is the examiners position that a distal end regions of the braided or woven body 108’ & 108 would be capable of at least partially inverting to form the funnel shape and the second funnel shape when the inner deployment member is moved proximally enough such that the distal ends 124’ & 124 are moved toward the proximal ends 122’ & 122 of the braided or woven body).
Regarding claim 73, Waldstreicher in view of Viswanathan disclose all of the limitations of claim 69, as described above.
Waldstreicher further discloses a neck member on the braided or woven body between a first region of the braided or woven body and the second region of the braided or woven body ([0388]; Figure 27—element 800).
Regarding claim 74, Waldstreicher in view of Viswanathan disclose all of the limitations of claim 69, as described above.
Waldstreicher does not disclose wherein the distal end region of the braided or woven body is continuous with the second region of the braided or woven body and/or wherein the first electrode and the second electrode are electrically coupled.
Viswanathan further teaches wherein the distal end region of the braided or woven body is continuous with the second region of the braided or woven body and/or wherein the first electrode and the second electrode are electrically coupled ([Col. 38, lines 16-39]; the examiner notes the rest “wherein the distal end region of the braided or woven body is continuous with the second region of the braided or woven body” are in the alternative).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the inner deployment member, as disclosed by Waldstreicher, to include a second electrode wherein the first electrode and the second electrode are electrically coupled, as further taught by Viswanathan, as both references and the claimed invention are directed toward expandable ablation devices. As disclosed by Viswanathan, the inner deployment member may include a second electrode configured as a cap electrode, the first electrode and the cap electrode may collectively have the same polarity during use, this combination allows the distal end of the ablation device to generate and project a stronger electric field to thereby more effectively generate focal ablation lesions of tissue at a desired depth compared to any one electrode alone ([Col. 38, lines 16-39]). 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 inner deployment member, as disclosed by Waldstreicher, to include a second electrode wherein the first electrode and the second electrode are electrically coupled, as further taught by Viswanathan, as such a modification would allow the distal end of the ablation device to generate and project a stronger electric field to thereby more effectively generate focal ablation lesions of tissue at a desired depth compared to any one electrode alone.
Regarding claim 75, Waldstreicher in view of Viswanathan disclose all of the limitations of claim 50, as described above.
Viswanathan further discloses a pulse generator configured to generate a plurality of electrical pulses having amplitude of at least 0.1 kV ([0286] & [0287]; each pulse is in the range of approximately 100V to 999V) and a duration of less than 1000 nanoseconds ([0290] & [0291]; the packet duration may be in the range of approximately 50 to 100 microseconds and may comprise up to 5 pulses, up to 10 pulses, up to 25 pulses, up to 40 pulses, up to 60 pulses, up to 80 pulses, up to 100 pulses, up to 1,000 pulses or up to 2,000 pulses, including all values and subranges in between; it is the examiners position that the pulse generator would be capable of delivering 1000 nanosecond pulses based on the ranges above), the electrical applicator device configured to electrically couple to the pulse generator ([0250]; Figure 7—element 104).
Regarding claim 78, Waldstreicher in view of Viswanathan disclose all of the limitations of claim 50, as described above.
Waldstreicher in view of Viswanathan disclose the first electrode and the second electrode.
Waldstreicher further discloses wherein the electrodes are configured to deliver microsecond, nanosecond, or picosecond electric pulses ([0290] & [0291]; the electrodes are configured to deliver energy packets each having a packet duration in the range of approximately 50 to 100 microseconds, each energy packet comprising up to 5 pulses, up to 10 pulses, up to 25 pulses, up to 40 pulses, up to 60 pulses, up to 80 pulses, up to 100 pulses, up to 1,000 pulses or up to 2,000 including all values an subranges in between; therefore as the packet duration is between 50 to 100 microseconds and includes up to 2,000 pulses it is the examiners position that the pulses can be either microsecond or nanosecond pulses; the examiner notes the rest are in the alternative).
Claims 55-56 & 66-67 are rejected under 35 U.S.C. 103 as being unpatentable over McLawhorn in view of MacAdam et al. (previously presented-US 20080058794 A1), hereinafter “MacAdam”.
Regarding claims 55-56, McLawhorn discloses all of the limitations of claim 50, as described above.
McLawhorn does not explicitly disclose wherein the braided or woven body comprises a conductive wire (claim 55); wherein the first electrode is formed of an uninsulated portion of the conductive wire (claim 56).
MacAdam teaches an electrical applicator device comprising a braided or woven body ([0037]; Figures 1-3—element 28) configured to be inverted to form a funnel shape having a distal-facing outer region ([0042]-[0045] & [0047]; Figures 2-5—elements 28 & 30; with said distal facing outer region being the annular surface 30) and comprising a first electrode formed at least partially around a distal-facing outer region of the inverted funnel shape ([0049]; Figures 4 & 5—element 30; the annular surface/distal-facing outer region 30 formed by inverting the braided or woven body 28 may have electrodes spaced around the entire annular surface); wherein the braided or woven body comprises a conductive wire; wherein the first electrode is formed of an uninsulated portion of the conductive wire ([0053] & [0054]; Figures 2-3—element 34; the filaments 34 of the braided or woven body 28 may be electrically conductive and comprise an insulative coating; the electrode may be formed by removing a portion of the insulation on a filament).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the first electrode and the braided or woven body, as disclosed by McLawhorn to include, wherein the braided or woven body comprises a conductive wire and the first electrode is formed of an uninsulated portion of the conductive wire, as taught by MacAdam, as both references and the claimed invention are directed toward deployable ablation devices comprising braided or woven assemblies and electrodes. As disclosed by McLawhorn, the braided or woven body may be formed of non-conductive filaments and each electrode may be formed from a conductive coating applied to the filaments ([0031], [0033], & [0042]). As disclosed by MacAdam, the braided or woven body may be formed of conductive filaments that are covered in insulation and each electrode may be formed by removing a portion of the insulation of the conductive filaments ([0053] & [0054]). 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 first electrode and the braided or woven body, as disclosed by McLawhorn to include, wherein the braided or woven body comprises a conductive wire and the first electrode is formed of an uninsulated portion of the conductive wire, as taught by MacAdam, as such a modification would provide for a suitable and known manufacture of an electrode for an ablation device and would produce the predictable result of providing an electrode for ablating tissue.
Regarding claim 66, McLawhorn discloses all of the limitations of claim 50, as described above.
McLawhorn further discloses the device configured to steer the funnel shape ([0029]; Figures 1 & 2; the device may be delivered into the right atrium of a patent via the vascular system; it is the examiners position that the device would be sufficiently steerable and flexible in order to be delivered into the right atrium via vascular system from an incision made in a vein of a lower extremity of a patient).
McLawhorn does not explicitly disclose a bending region proximal to the funnel shape and configured to be bent to steer the funnel shape.
MacAdam teaches an electrical applicator device comprising a braided or woven body ([0037]; Figures 1-3—element 28) configured to be inverted to form a funnel shape having a distal-facing outer region ([0042]-[0045] & [0047]; Figures 2-5—elements 28 & 30; with said distal facing outer region being the annular surface 30) and a bending region proximal to the funnel shape and configured to be bent to steer the funnel shape ([0059]; Figures 4 & 5—element 26).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the steerable outer shaft proximal to the funnel shape, as disclosed by McLawhorn, to include a bending region proximal to the funnel shape and configured to be bent to steer the funnel shape, as taught by MacAdam, as both references and the claimed invention are directed toward steerable ablation devices comprising expandable assemblies. As disclosed by MacAdam, the distal end of the outer shaft, proximal to the braided or woven body, may be deflectable so as to assist in steering the ablation device and allow the braided or woven body to curve in predetermined directions ([0059] & [0070]). 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 steerable outer shaft proximal to the funnel shape, as disclosed by McLawhorn, to include a bending region proximal to the funnel shape and configured to be bent to steer the funnel shape, as taught by MacAdam, as such a modification would further assist in steering and navigating the ablation device through a patient’s vasculature to a target treatment site by allowing the distal end of the device by to curved in a predetermined direction.
Regarding claim 67, McLawhorn discloses all of the limitations of claim 50, as described above.
McLawhorn does not disclose wherein the device is further configured to detect electrical signals from the tissue to determine a region to ablate or to further ablate.
MacAdam teaches an electrical applicator device comprising a braided or woven body ([0037]; Figures 1-3—element 28) configured to be inverted to form a funnel shape having a distal-facing outer region ([0042]-[0045] & [0047]; Figures 2-5—elements 28 & 30; with said distal facing outer region being the annular surface 30) comprising a first electrode and a second electrode configured to ablate tissue ([0049] & [0058]); wherein the device is further configured to detect electrical signals from the tissue to determine a region to ablate or to further ablate ([0007], [0055], & [0056]; the device may comprise electrodes for ablating tissue and detecting electrical activity during mapping procedures to measure the quality of the lesion and determine regions of tissue to be ablated).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the electrical applicator device, as disclosed by McLawhorn, to include the device is configured to detect electrical signals from the tissue to determine a region to ablate or to further ablate, as taught by MacAdam, as both references and the claimed invention are directed toward ablation devices comprising expandable assemblies. As disclosed by MacAdam, the device may be used to perform both ablation and mapping procedures, mapping techniques allow the device to determine regions to be ablated and lesion quality ([0007], [0055], & [0056]). 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 electrical applicator device, as disclosed by McLawhorn, to include the device is configured to detect electrical signals from the tissue to determine a region to ablate or to further ablate, as taught by MacAdam, as such a modification would provide a user feedback regarding lesion quality and would assist in determined regions of the heart to be ablated.
Claim 62 is rejected under 35 U.S.C. 103 as being unpatentable over McLawhorn in view of Farley et al. (previously presented-US 6152899 A), hereinafter “Farley”.
Regarding claim 62, McLawhorn discloses all of the limitations of claim 50, as described above.
McLawhorn further discloses the device configured to allow an adjustment of a longitudinal position of the second electrode relative to the distal-facing outer region of the funnel shape ([0039], [0042], & [0051]).
McLawhorn does not disclose a positioning member extending within the braided or woven body proximally from the second electrode and configured to allow the adjustment.
Farley teaches an expandable body ([Col. 6, lines 14-34]; Figures 2 & 3—elements 26) a positioning member extending within body proximally from the second electrode and configured to allow the adjustment a longitudinal position of the second electrode ([Col. 8, line 58 – Col. 9, line 10; Figures 2 & 3—elements 54 & 56).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the braided or woven body, as disclosed by McLawhorn, to include the positioning member/inner stop tube, as disclosed by Farley, as both references and the claimed invention are directed toward electrosurgical expandable assemblies comprising mechanisms for changing the shape of the expandable bodies. As disclosed by Farley, the expandable member may comprise an inner stop tube to limit the expansion of the expandable assembly ([Col. 8, line 58 – Col. 9, line 10; Figures 2 & 3—elements 54 & 56). It is the examiner position that providing a positioning member/stop member, of Farley, would aid in allowing an adjustment of a longitudinal position of the second electrode relative to the distal-facing outer region of the funnel shape, of McLawhorn, as the second electrode is provided on the distal region of the braided or woven body, and therefore a stop member would be capable of controlling the longitudinal positioning of the second electrode relative to the distal distal-facing outer region of the funnel shape. 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 braided or woven body, as disclosed by McLawhorn, to include the positioning member/inner stop tube, as disclosed by Farley, as such a modification would limit and control the amount of expansion and geometric change of the braided or woven body.
Claim 75 is rejected under 35 U.S.C. 103 as being unpatentable over McLawhorn in view of Forsyth et al. (previously presented-US 20200289827 A1), hereinafter “Forsyth”.
Regarding claim 75, McLawhorn discloses all of the limitations of claim 50, as described above.
McLawhorn further discloses a system comprising a generator ([0047] & [0048]).
McLawhorn does not disclose the generator comprising a pulse generator configured to generate a plurality of electrical pulses having amplitude of at least 0.1 kV and a duration of less than 1000 nanoseconds, the electrical applicator configured to electrically couple to the pulse generator.
Forsyth teaches an ablation system comprising an electrical applicator and a pulse generator configured to generate a plurality of electrical pulses ([0016] & [0076]; Figure 9—element 200) having amplitude of at least 0.1 kV and a duration of less than 1000 nanoseconds ([0094]-[0095]), the electrical applicator device configured to electrically couple to the pulse generator ([0016] & [0078]; Figure 9—element 220).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the generator, as disclosed by McLawhorn, to include the pulsed generator, as taught by Forsyth, as both references and the claimed invention are directed toward ablation devices and systems. As disclosed by Forsyth, ablation may be thermal or non-thermal, thermal ablation techniques have little ability to spare normal structures in the treatment zone, non-thermal ablation techniques allow for better selectivity in the treatment zone than thermal techniques ([0002], [0005], & [0006]). 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 generator, as disclosed by McLawhorn, to include the pulsed generator, as taught by Forsyth, as such a modification would allow for non-thermal ablation which allows for better selectivity in the treatment zone than thermal ablation.
Allowable Subject Matter
Claim 70 is 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. Claim 77 is allowed.
Conclusion
Accordingly, claims 50-51, & 53-69, 71-76, & 78 are rejected. Claim 70 is objected to as being dependent upon a rejected base claim. Claim 77 is allowed.
THIS ACTION IS MADE FINAL. 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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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794