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 December 19th, 2025 has been entered. Claims 1, 9, 11-13, & 15 are amended. Claims 16-20 are canceled. Claims 21-25 are new. Claims 1-15 & 21-25 remain pending.
Response to Arguments
Applicant’s arguments with respect to claims 1-15 & 21-25 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.
Claim Objections
Claim 13 is objected to because of the following informalities: “a circumference of the electrode shaft”, should be –the circumference of the electrode shaft—; as introduced in claim 1. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: “wherein the insulative material includes a bend (115a)”, the reference character “(115a)” should be removed from the claim in order to be consistent with the other claims of the application, as no other claim contains reference characters. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 recites “wherein the first electrode extends around no more than 80% of a circumference of the electrode shaft”; Claim 12 depends from claim 11 which depends from independent claim 1; independent claim 1 introduces “wherein the first electrode extends around no more than 80% of the circumference of the electrode shaft”, as claim 12 recites the same limitation as introduced in independent claim 1, claim 12 fails to further limit the subject matter of the claim upon which it depends. The examiner further notes that ““a circumference of the electrode shaft”, should be –the circumference of the electrode shaft—; as introduced in claim 1. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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 1-4, 8, 10, & 15 are rejected under 35 U.S.C. 103 as being unpatentable over Krueger et al. (previously presented-US 20140236144 A1), hereinafter “Krueger”, in view of Ingle et al. (US 6091995 A), hereinafter “Ingle”.
Regarding claim 1, Krueger discloses a bipolar RF electrode ([0040] & [0059]), comprising: an electrode shaft having a circumference, a first end portion, and a second end portion opposite the first end portion ([0050]; Figure 3E—element 960; with the circumference being the circumference of the shaft 960, the first end portion being the proximal portion of shaft 960, and the second end portion being the distal portion of the shaft 960); a first electrode coupled to the second end portion of the electrode shaft, wherein the first electrode extends around no more than 80% of the circumference of the electrode shaft ([0021] & [0050]; Figure 3E—element 962; the first electrode 962 may cover a radial half of the shaft 960 while the other radial half is insulated 961 so as to provide a radially-directional field); a second electrode coupled to the second end portion of the electrode shaft ([0050]; Figure 3E—element 966); an insulative material coupled to, and disposed between, the first electrode and the second electrode ([0050]; Figure 3E—element 964); and an electrode hub attached to the first end portion of the electrode shaft ([0056] & [0058]-[0059]; Figures 4A & 4B—element 1041).
Krueger does not disclose the electrode hub comprising a marker is positioned on the electrode hub and circumferentially aligned with the first electrode to identify to a user a circumferential orientation of the first electrode.
Ingle teaches a bipolar RF electrode comprising a first electrode and a second electrode ([Col. 21, lines 30-54] & [Col. 21, line 54 – Col. 22, line 10]; Figure 28 & 28D—elements 218) and an electrode hub ([Col. 21, lines 30-40]; Figure 28—element 226); the electrode hub comprising a marker is positioned on the electrode hub and circumferentially aligned with the first electrode to identify to a user a circumferential orientation of the first electrode ([Col. 21, lines 30-40]; Figure 28—element 228).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the electrode hub, as disclosed by Krueger, to include the electrode hub comprising a marker positioned on the electrode hub and circumferentially aligned with the first electrode to identify to a user a circumferential orientation of the first electrode, as taught by Ingle, as both references and the claimed invention are directed toward bipolar RF electrode devices comprising electrodes that do not extend around the entire circumference of the electrode shaft. As disclosed by Ingle, the electrode hub may include an arrow that indicates the alignment of the electrode hub with the asymmetrically mounted electrode ([Col. 21, lines 30-40]). 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 electrode hub, as disclosed by Krueger, to include the electrode hub comprising a marker positioned on the electrode hub and circumferentially aligned with the first electrode to identify to a user a circumferential orientation of the first electrode, as taught by Ingle, as such a modification would provide for a visual cue on the electrode hub that allows for a user to determine the alignment of the electrode hub with the asymmetrically mounted electrode.
Regarding claim 2, Krueger in view of Ingle disclose all of the limitations of claim 1, as described above.
Kruger further discloses wherein the second electrode extends around no more than 80% of the circumference of the electrode shaft ([0021] & [0050]; Figure 3E—elements 961 & 966; the second electrode 966 may cover a radial half of the shaft 960 while the other radial half is insulated 961 so as to provide the radially-directional field).
Regarding claim 3, Krueger in view of Ingle disclose all of the limitations of claim 2, as described above.
Kruger further discloses wherein both the first electrode and the second electrode extend around no more than 50% of the circumference of the electrode shaft ([0021] & [0050]; Figure 3E—elements 961, 962, & 966; the first electrode 962 and the second electrode 966 may cover a radial half of the shaft 960 while the other radial half is insulated 961 so as to provide the radially-directional field).
Regarding claim 4, Krueger in view of Ingle disclose all of the limitations of claim 3, as described above.
Kruger further discloses wherein the first electrode and the second electrode are aligned on the circumference of the electrode shaft ([0050]; Figure 3E—elements 962 & 966).
Regarding claim 8, Krueger in view of Ingle disclose all of the limitations of claim 1, as described above.
Kruger further discloses a kit, comprising: the bipolar RF electrode of claim 1 (see above rejection of claim 1); and a cannula configured for insertion of the electrode shaft through the cannula ([0050]; Figure 3E—element 936).
Regarding claim 10, Krueger in view of Ingle disclose all of the limitations of claim 1, as described above.
Kruger further discloses a RF ablation system, comprising: the bipolar RF electrode of claim 1 (see above rejection of claim 1); a cannula configured for insertion of the electrode shaft through the cannula ([0050]; Figure 3E—element 936); and a RF generator configured for electrically coupling to the bipolar RF electrode and energizing at least one of the first electrode or the second electrode ([0040], [0045], [0056], & [0058]-[0059]).
Regarding claim 15, Krueger discloses a RF electrode ([0040] & [0059]), comprising: an electrode shaft having a circumference, a first end portion, and a second end portion opposite the first end portion ([0050]; Figure 3E—element 960; with the circumference being the circumference of the shaft 960, the first end portion being the proximal portion of shaft 960, and the second end portion being the distal portion of the shaft 960); at least one electrode coupled to the second end portion of the electrode shaft ([0021] & [0050]; Figure 3E—elements 962 & 966), wherein the at least one electrode comprises a first electrode that extends around no more than 80% of the circumference of the electrode shaft ([0021] & [0050]; Figure 3E—element 962; the first electrode 962 may cover a radial half of the shaft 960 while the other radial half is insulated 961 so as to provide a radially-directional field); and an electrode hub attached to the first end portion of the electrode shaft ([0056] & [0058]-[0059]; Figures 4A & 4B—element 1041).
Krueger does not disclose the electrode hub comprising a marker is positioned on the electrode hub and circumferentially aligned with the first electrode to identify to a user a circumferential orientation of the first electrode.
Ingle teaches an RF electrode comprising a at least one electrode ([Col. 21, lines 30-54] & [Col. 21, line 54 – Col. 22, line 10]; Figure 28 & 28D—elements 218) and an electrode hub ([Col. 21, lines 30-40]; Figure 28—element 226); the electrode hub comprising a marker is positioned on the electrode hub and circumferentially aligned with the first electrode to identify to a user a circumferential orientation of the first electrode ([Col. 21, lines 30-40]; Figure 28—element 228).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the electrode hub, as disclosed by Krueger, to include the electrode hub comprising a marker positioned on the electrode hub and circumferentially aligned with the first electrode to identify to a user a circumferential orientation of the first electrode, as taught by Ingle, as both references and the claimed invention are directed toward bipolar RF electrode devices comprising electrodes that do not extend around the entire circumference of the electrode shaft. As disclosed by Ingle, the electrode hub may include an arrow that indicates the alignment of the electrode hub with the asymmetrically mounted electrode ([Col. 21, lines 30-40]). 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 electrode hub, as disclosed by Krueger, to include the electrode hub comprising a marker positioned on the electrode hub and circumferentially aligned with the first electrode to identify to a user a circumferential orientation of the first electrode, as taught by Ingle, as such a modification would provide for a visual cue on the electrode hub that allows for a user to determine the alignment of the electrode hub with the asymmetrically mounted electrode.
Claims 1-7, 11-13, 15, & 23 are rejected under 35 U.S.C. 103 as being unpatentable over Juergens (previously presented-US 20180042664 A1), hereinafter “Juergens”, in view of Krueger and Ingle.
Regarding claim 1, Juergens discloses a bipolar RF electrode, comprising: an electrode shaft having a circumference ([0031]; Figure 2—element 214; with the circumference being the circumference of the shaft 214), a first end portion ([0031]; Figure 2—element 216; with said first portion being the proximal portion including proximal end 216), and a second end portion opposite the first end portion ([0031]; Figure 2—element 218; with said second portion being the distal portion including distal end 218 and electrodes 220 & 222); a first electrode coupled to the second end portion of the electrode shaft ([0031]; Figures 2 & 3—element 222); a second electrode coupled to the second end portion of the electrode shaft ([0031]; Figures 2 & 3—element 220); an insulative material coupled to, and disposed between, the first electrode and the second electrode ([0031] & [0032]; Figures 2 & 3—element 226); and an electrode hub attached to the first end portion of the electrode shaft ([0030]; Figure 2—element 202).
Juergens does not disclose wherein the first electrode extends around no more than 80% of the circumference of the electrode shaft; the electrode hub comprising a marker is positioned on the electrode hub and circumferentially aligned with the first electrode to identify to a user a circumferential orientation of the first electrode.
Krueger teaches a bipolar RF electrode comprising an electrode shaft ([0050]; Figure 3E—element 960), a first electrode ([0050]; Figure 3E—element 962), and a second electrode ([0050]; Figure 3E—element 966), wherein the first electrode extends around no more than 80% of the circumference of the electrode shaft ([0050]; Figure 3E—elements 961 & 962; the lower radial half of the electrode shaft is insulated while the other half contains the first electrode and second electrode to provide for a radially limited field).
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, as disclosed by Juergens, to include wherein the first electrode extends around no more than 80% of the circumference of the electrode shaft, as taught by Krueger, as both references and the claimed invention are directed toward bipolar electrodes comprising directional electrodes. As disclosed by Juergens, the first electrode does not extend around the entire circumference of the shaft so as to form a directional electrode that provides for controlled heating of only the target zone with a clear direction of treatment ([0009], [0022], & [0034]). As disclosed by Krueger, the first electrode is provided on a radial half of the electrode shaft while the lower radial half of the shaft is insulated so as to provide for a radially-directional ablation energy field ([0021] & [0050]). 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, as disclosed by Juergens, to include wherein the first electrode extends around no more than 80% of the circumference of the electrode shaft, as taught by Krueger, as such a modification would provide for a suitable and known circumference for a directional electrode that produces the predictable result of providing directional active heating for controlled heating of only the target zone with a clear direction of treatment; further, the examiner notes it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the first electrode extends around no more than 80% of the circumference of the electrode shaft, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Ingle teaches a bipolar RF electrode comprising a first electrode and a second electrode ([Col. 21, lines 30-54] & [Col. 21, line 54 – Col. 22, line 10]; Figure 28 & 28D—elements 218) and an electrode hub ([Col. 21, lines 30-40]; Figure 28—element 226); the electrode hub comprising a marker is positioned on the electrode hub and circumferentially aligned with the first electrode to identify to a user a circumferential orientation of the first electrode ([Col. 21, lines 30-40]; Figure 28—element 228).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the electrode hub, as disclosed by Juergens, to include the electrode hub comprising a marker positioned on the electrode hub and circumferentially aligned with the first electrode to identify to a user a circumferential orientation of the first electrode, as taught by Ingle, as both references and the claimed invention are directed toward bipolar RF electrode devices comprising electrodes that do not extend around the entire circumference of the electrode shaft. As disclosed by Ingle, the electrode hub may include an arrow that indicates the alignment of the electrode hub with the asymmetrically mounted electrode ([Col. 21, lines 30-40]). 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 electrode hub, as disclosed by Juergens, to include the electrode hub comprising a marker positioned on the electrode hub and circumferentially aligned with the first electrode to identify to a user a circumferential orientation of the first electrode, as taught by Ingle, as such a modification would provide for a visual cue on the electrode hub that allows for a user to determine the alignment of the electrode hub with the asymmetrically mounted electrode.
Regarding claim 2, Juergens in view of Krueger and Ingle disclose all of the limitations of claim 1, as described above.
Juergens does not disclose wherein the second electrode extends around no more than 80% of the circumference of the electrode shaft.
Krueger further teaches wherein the second electrode extends around no more than 80% of the circumference of the electrode shaft ([0050]; Figure 3E—elements 961 & 966; the lower radial half of the electrode shaft is insulated while the other half contains the first electrode and the second electrode to provide for a radially limited field).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the second electrode, as disclosed by Juergens, to include wherein the second electrode extends around no more than 80% of the circumference of the electrode shaft, as further taught by Krueger, as both references and the claimed invention are directed toward bipolar electrodes comprising directional electrodes. As disclosed by Juergens, the second electrode does not extend around the entire circumference of the shaft so as to form a directional electrode that provides for controlled heating of only the target zone with a clear direction of treatment ([0009], [0022], & [0034]). As disclosed by Krueger, the second electrode is provided on a radial half of the electrode shaft while the lower radial half of the shaft is insulated so as to provide for a radially-directional ablation energy field ([0021] & [0050]). 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 second electrode, as disclosed by Juergens, to include wherein the second electrode extends around no more than 80% of the circumference of the electrode shaft, as further taught by Krueger, as such a modification would provide for a suitable and known circumference for a directional electrode that produces the predictable result of providing directional active heating for controlled heating of only the target zone with a clear direction of treatment; further, the examiner notes it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the second electrode extends around no more than 80% of the circumference of the electrode shaft, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 3, Juergens in view of Krueger and Ingle disclose all of the limitations of claim 2, as described above.
Juergens does not disclose wherein both the first electrode and the second electrode extend around no more than 50% of the circumference of the electrode shaft.
Krueger further teaches wherein both the first electrode and the second electrode extend around no more than 50% of the circumference of the electrode shaft ([0050]; Figure 3E—elements 961, 962, & 966; the lower radial half of the electrode shaft is insulated while the other half contains the first electrode and second electrode to provide for a radially limited field).
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 second electrode, as disclosed by Juergens, to include wherein both the first electrode and the second electrode extend around no more than 50% of the circumference of the electrode shaft, as further taught by Krueger, as both references and the claimed invention are directed toward bipolar electrodes comprising directional electrodes. As disclosed by Juergens, the first electrode and the second electrode do not extend around the entire circumference of the shaft so as to form directional electrodes that provides for controlled heating of only the target zone with a clear direction of treatment ([0009], [0022], & [0034]). As disclosed by Krueger, the first electrode and the second electrode are provided on a radial half of the electrode shaft while the lower radial half of the shaft is insulated so as to provide for a radially-directional ablation energy field ([0021] & [0050]). 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 second electrode, as disclosed by Juergens, to include wherein both the first electrode and the second electrode extend around no more than 50% of the circumference of the electrode shaft, as further taught by Krueger, as such a modification would provide for a suitable and known circumference for directional electrodes that produce the predictable result of providing directional active heating for controlled heating of only the target zone with a clear direction of treatment; further, the examiner notes it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein both the first electrode and the second electrode extend around no more than 50% of the circumference of the electrode shaft, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 4, Juergens in view of Krueger and Ingle disclose all of the limitations of claim 3, as described above.
Juergens further discloses wherein the first electrode and the second electrode are aligned on the circumference of the electrode shaft ([0031]; Figures 2 & 3—elements 220 & 222).
Regarding claim 5, Juergens in view of Krueger and Ingle disclose all of the limitations of claim 1, as described above.
Juergens further discloses wherein the insulative material defines at least one fluid delivery port ([0032] & [0034]; Figures 2 & 3—element 236).
Regarding claim 6, Juergens in view of Krueger and Ingle disclose all of the limitations of claim 5, as described above.
Juergens further discloses wherein the electrode hub or the electrode shaft is configured for attachment of a fluid line ([0030] & [0037]; Figures 2-3—elements 202 & 210; the connector port 210 may couple to the electric cable and one or more tubing structures for introduction of liquid), wherein at least the electrode shaft, the second electrode, and the insulative material form a hollow interior for flow of fluid from the electrode hub or the electrode shaft to the at least one fluid delivery port defined by the insulative material and disposed between the first electrode and the second electrode ([0030]-[0032], [0037]; Figures 2, 3, & 8—elements 201, 214, 220, & 236).
Regarding claim 7, Juergens in view of Krueger and Ingle disclose all of the limitations of claim 5, as described above.
Juergens further discloses wherein the at least one fluid delivery port is a single fluid delivery port directionally aligned with the first electrode ([0032] & [0034]; Figures 2 & 3—element 222 & 236; the fluid delivery port 236 is shown as being directionally aligned with the first electrode 222; although the device is shown with three ports, the device may include just one port).
Regarding claim 11, Juergens in view of Krueger and Ingle disclose all of the limitations of claim 1, as described above.
Juergens further discloses the insulative material having a circumference ([0031] & [0032]; Figures 2 & 3—element 226; with the circumference being the circumference of the insulative material 226) and defining one or more fluid delivery ports, wherein, when the one or more fluid delivery ports is a single fluid delivery port, the single fluid delivery port extends around no more than 50% of the circumference of the insulative material and, when the one or more fluid delivery ports is at least two fluid delivery ports, all of the at least two fluid delivery ports are defined in a contiguous portion of the insulative material that extends around no more than 50% of the circumference of the insulative material ([0032] & [0034]; Figures 2—element 236; although three fluid ports are shown on the device the device may just include one port; the single fluid port 236 is shown as extending no more than 50% the circumference of the insulting material 226; the examiner notes the rest are in the alternative), wherein the electrode hub or the electrode shaft is configured for attachment of a fluid line ([0030] & [0037]; Figures 2-3—elements 202 & 210; the connector port 210 may couple to the electric cable and one or more tubing structures for introduction of liquid), wherein at least the electrode shaft, the second electrode, and the insulative material form a hollow interior for flow of fluid from the electrode hub or the electrode shaft to the at least one fluid delivery port defined by the insulative material and disposed between the first electrode and the second electrode ([0030]-[0032], [0037]; Figures 2, 3, & 8—elements 201, 214, 220, & 236).
Regarding claim 12, as best understood in view of the 112(d) rejection above, Juergens in view of Krueger and Ingle disclose all of the limitations of claim 11, as described above.
Krueger further teaches wherein the first electrode extends around no more than 80% of a circumference of the electrode shaft (see above rejection of claim 1).
Regarding claim 13, Juergens in view of Krueger and Ingle disclose all of the limitations of claim 11, as described above.
Juergens does not explicitly disclose wherein both the first electrode and the second electrode extend around no more than 50% of a circumference of the electrode shaft.
Krueger teaches a bipolar RF electrode comprising an electrode shaft ([0050]; Figure 3E—element 960), a first electrode ([0050]; Figure 3E—element 962), and a second electrode ([0050]; Figure 3E—element 966), wherein both the first electrode and the second electrode extend around no more than 50% of a circumference of the electrode shaft ([0050]; Figure 3E—elements 961, 962, & 966; the lower radial half of the electrode shaft is insulated while the other half contains the first electrode and second electrode to provide for a radially limited field).
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 second electrode, as disclosed by Juergens, to include wherein both the first electrode and the second electrode extend around no more than 50% of the circumference of the electrode shaft, as taught by Krueger, as both references and the claimed invention are directed toward bipolar electrodes comprising directional electrodes. As disclosed by Juergens, the first electrode and the second electrode do not extend around the entire circumference of the shaft so as to form directional electrodes that provides for controlled heating of only the target zone with a clear direction of treatment ([0009], [0022], & [0034]). As disclosed by Krueger, the first electrode and the second electrode are provided on a radial half of the electrode shaft while the lower radial half of the shaft is insulated so as to provide for a radially-directional ablation energy field ([0021] & [0050]). 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 second electrode, as disclosed by Juergens, to include wherein both the first electrode and the second electrode extend around no more than 50% of the circumference of the electrode shaft, as taught by Krueger, as such a modification would provide for a suitable and known circumference for directional electrodes that produce the predictable result of providing directional active heating for controlled heating of only the target zone with a clear direction of treatment; further, the examiner notes it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein both the first electrode and the second electrode extend around no more than 50% of the circumference of the electrode shaft, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 15, Juergens discloses a RF electrode, comprising: an electrode shaft having a circumference ([0031]; Figure 2—element 214; with the circumference being the circumference of the shaft 214), a first end portion ([0031]; Figure 2—element 216; with said first portion being the proximal portion including proximal end 216), and a second end portion opposite the first end portion ([0031]; Figure 2—element 218; with said second portion being the distal portion including distal end 218 and electrodes 220 & 222); at least one electrode coupled to the second end portion of the electrode shaft ([0031]; Figures 2 & 3—element 220 & 222), wherein the at least one electrode comprises a first electrode ([0031]; Figures 2 & 3—element 222); and an electrode hub attached to the first end portion of the electrode shaft ([0030]; Figure 2—element 202).
Juergens does not disclose wherein the first electrode extends around no more than 80% of the circumference of the electrode shaft; the electrode hub comprising a marker is positioned on the electrode hub and circumferentially aligned with the first electrode to identify to a user a circumferential orientation of the first electrode.
Krueger teaches a bipolar RF electrode comprising an electrode shaft ([0050]; Figure 3E—element 960), a first electrode ([0050]; Figure 3E—element 962), and a second electrode ([0050]; Figure 3E—element 966), wherein the first electrode extends around no more than 80% of the circumference of the electrode shaft ([0050]; Figure 3E—elements 961 & 962; the lower radial half of the electrode shaft is insulated while the other half contains the first electrode and second electrode to provide for a radially limited field).
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, as disclosed by Juergens, to include wherein the first electrode extends around no more than 80% of the circumference of the electrode shaft, as taught by Krueger, as both references and the claimed invention are directed toward bipolar electrodes comprising directional electrodes. As disclosed by Juergens, the first electrode does not extend around the entire circumference of the shaft so as to form a directional electrode that provides for controlled heating of only the target zone with a clear direction of treatment ([0009], [0022], & [0034]). As disclosed by Krueger, the first electrode is provided on a radial half of the electrode shaft while the lower radial half of the shaft is insulated so as to provide for a radially-directional ablation energy field ([0021] & [0050]). 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, as disclosed by Juergens, to include wherein the first electrode extends around no more than 80% of the circumference of the electrode shaft, as taught by Krueger, as such a modification would provide for a suitable and known circumference for a directional electrode that produces the predictable result of providing directional active heating for controlled heating of only the target zone with a clear direction of treatment; further, the examiner notes it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the first electrode extends around no more than 80% of the circumference of the electrode shaft, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Ingle teaches an RF electrode comprising a at least one electrode ([Col. 21, lines 30-54] & [Col. 21, line 54 – Col. 22, line 10]; Figure 28 & 28D—elements 218) and an electrode hub ([Col. 21, lines 30-40]; Figure 28—element 226); the electrode hub comprising a marker is positioned on the electrode hub and circumferentially aligned with the first electrode to identify to a user a circumferential orientation of the first electrode ([Col. 21, lines 30-40]; Figure 28—element 228).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the electrode hub, as disclosed by Juergens, to include the electrode hub comprising a marker positioned on the electrode hub and circumferentially aligned with the first electrode to identify to a user a circumferential orientation of the first electrode, as taught by Ingle, as both references and the claimed invention are directed toward bipolar RF electrode devices comprising electrodes that do not extend around the entire circumference of the electrode shaft. As disclosed by Ingle, the electrode hub may include an arrow that indicates the alignment of the electrode hub with the asymmetrically mounted electrode ([Col. 21, lines 30-40]). 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 electrode hub, as disclosed by Juergens, to include the electrode hub comprising a marker positioned on the electrode hub and circumferentially aligned with the first electrode to identify to a user a circumferential orientation of the first electrode, as taught by Ingle, as such a modification would provide for a visual cue on the electrode hub that allows for a user to determine the alignment of the electrode hub with the asymmetrically mounted electrode.
Regarding claim 23, Juergens in view of Krueger and Ingle disclose all of the limitations of claim 1, as described above.
Juergens further discloses wherein the insulative material includes a bend ([0036]; Figure 4—element 231).
Claims 8-10, & 14 are rejected under 35 U.S.C. 103 as being unpatentable over Juergens in view of Krueger, Ingle, and Houden et al. (previously presented-US 20200390496 A1), hereinafter “Houden”.
Regarding claim 8, Juergens in view of Krueger and Ingle disclose all of the limitations of claim 1, as described above.
Juergens further discloses a kit, comprising: the bipolar RF electrode of claim 1 (see above 103 rejection of claim 1).
Juergens does not disclose a cannula configured for insertion of the electrode shaft through the cannula.
Houden teaches a kit, comprising: a bipolar RF electrode including an electrode shaft ([0112], [0113], & [0151]; Figures 3A & 3B—elements 320 & 335); and a cannula configured for insertion of the electrode shaft through the cannula ([0008], [0013], [0112] & [0113]; Figures 3A & 3B—element 315).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the bipolar RF electrode, as disclosed by Juergens, to further include a cannula configured for insertion of the electrode shaft through the cannula, as taught by Houden, as both references and the claimed invention are directed toward kits comprising bipolar RF electrodes for ablating nerves to reduce pain. As disclosed by Juergens, the bipolar RF electrode is configured to be inserted into a patient’s knee at a desired site and advanced to at least one genicular nerve to create one or more lesions on the genicular nerves in order to provide pain relief ([0039]). As disclosed by Houden, the bipolar RF electrode is configured to be inserted into a patient’s knee at a desired site and advanced to the genicular nerve to ablate the genicular nerve to provide pain relief; the bipolar RF electrode kit may also include a cannula configured for insertion of the electrode shaft through the cannula, so as to further aid in delivering the bipolar RF electrode to the desired site and assist in puncturing hard tissue ([0008], [0013], [0078], [0112], [0113], & [0191]). 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 bipolar RF electrode, as disclosed by Juergens, to further include a cannula configured for insertion of the electrode shaft through the cannula, as taught by Houden, as such a modification would further aid in delivering the bipolar RF electrode to the desired treatment site, such as the genicular nerve, by assisting with puncturing hard tissue.
Regarding claim 9, Juergens in view of Krueger, Ingle, and Houden disclose all of the limitations of claim 8, as described above.
Juergens further discloses a fluid line coupled, or coupleable, to the electrode shaft or the electrode hub ([0030]).
Regarding claim 10, Juergens in view of Krueger and Ingle disclose all of the limitations of claim 1, as described above.
Juergens further discloses a RF ablation system, comprising: the bipolar RF electrode of claim 1 (see above 103 rejection of claim 1); and a RF generator configured for electrically coupling to the bipolar RF electrode and energizing at least one of the first electrode or the second electrode ([0029] & [0030]; Figure 1—element 136).
Juergens does not disclose a cannula configured for insertion of the electrode shaft through the cannula.
Houden teaches a RF ablation system, comprising: a bipolar RF electrode including an electrode shaft ([0112], [0113], & [0151]; Figures 3A & 3B—elements 320 & 335); and a cannula configured for insertion of the electrode shaft through the cannula ([0008], [0013], [0112] & [0113]; Figures 3A & 3B—element 315).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the bipolar RF electrode, as disclosed by Juergens, to further include a cannula configured for insertion of the electrode shaft through the cannula, as taught by Houden, as both references and the claimed invention are directed toward systems comprising bipolar RF electrodes for ablating nerves to reduce pain. As disclosed by Juergens, the bipolar RF electrode is configured to be inserted into a patient’s knee at a desired site and advanced to at least one genicular nerve to create one or more lesions on the genicular nerves in order to provide pain relief ([0039]). As disclosed by Houden, the bipolar RF electrode is configured to be inserted into a patient’s knee at a desired site and advanced to the genicular nerve to ablate the genicular nerve to provide pain relief; the bipolar RF electrode system may also include a cannula configured for insertion of the electrode shaft through the cannula, so as to further aid in delivering the bipolar RF electrode to the desired site and assist in puncturing hard tissue ([0008], [0013], [0078], [0112], [0113], & [0191]). 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 bipolar RF electrode, as disclosed by Juergens, to further include a cannula configured for insertion of the electrode shaft through the cannula, as taught by Houden, as such a modification would further aid in delivering the bipolar RF electrode to the desired treatment site, such as the genicular nerve, by assisting with puncturing hard tissue.
Regarding claim 14, Juergens in view of Krueger and Ingle disclose all of the limitations of claim 11, as described above.
Juergens further discloses a RF ablation system, comprising: the bipolar RF electrode of claim 11 (see above 102 rejection of claim 11); and a RF generator configured for electrically coupling to the bipolar RF electrode and energizing at least one of the first electrode or the second electrode ([0029] & [0030]; Figure 1—element 136).
Juergens does not disclose a cannula configured for insertion of the electrode shaft through the cannula.
Houden teaches a system, comprising: a bipolar RF electrode including an electrode shaft ([0112], [0113], & [0151]; Figures 3A & 3B—elements 320 & 335); and a cannula configured for insertion of the electrode shaft through the cannula ([0008], [0013], [0112] & [0113]; Figures 3A & 3B—element 315).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the bipolar RF electrode, as disclosed by Juergens, to further include a cannula configured for insertion of the electrode shaft through the cannula, as taught by Houden, as both references and the claimed invention are directed toward kits comprising bipolar RF electrodes for ablating nerves to reduce pain. As disclosed by Juergens, the bipolar RF electrode is configured to be inserted into a patient’s knee at a desired site and advanced to at least one genicular nerve to create one or more lesions on the genicular nerves in order to provide pain relief ([0039]). As disclosed by Houden, the bipolar RF electrode is configured to be inserted into a patient’s knee at a desired site and advanced to the genicular nerve to ablate the genicular nerve to provide pain relief; the bipolar RF electrode system may also include a cannula configured for insertion of the electrode shaft through the cannula, so as to further aid in delivering the bipolar RF electrode to the desired site and assist in puncturing hard tissue ([0008], [0013], [0078], [0112], [0113], & [0191]). 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 bipolar RF electrode, as disclosed by Juergens, to further include a cannula configured for insertion of the electrode shaft through the cannula, as taught by Houden, as such a modification would further aid in delivering the bipolar RF electrode to the desired treatment site, such as the genicular nerve, by assisting with puncturing hard tissue.
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Krueger in view of Ingle and Schmidt et al. (US 20190117970 A1), hereinafter “Schmidt”.
Regarding claims 21 & 22, Krueger in view of Ingle disclose all of the limitations of claim 2, as described above.
Krueger further discloses wherein the first electrode and second electrode extend at different longitudinal positions along the length of the electrode shaft (claim 21) ([0050]; Figure 3E—elements 962 & 966).
Krueger does not disclose wherein the first electrode and second electrode extend around different portions of the circumference of the electrode shaft (claim 21); wherein the first electrode and second electrode do not circumferentially overlap (claim 22).
Schmidt teaches a bipolar RF electrode ([0134]) comprising a first electrode and second electrode extending at different longitudinal positions along the length of the electrode shaft ([0105]; Figure 11—elements 1110 & 1112) wherein the first electrode and second electrode extend around different portions of the circumference of the electrode shaft (claim 21); wherein the first electrode and second electrode do not circumferentially overlap (claim 22) ([0105]-[0108]; the first electrode 1112 and the second electrode 1110 may be oriented at the same positions radially around the outside surface of the electrode shaft 1104 or may be oriented at different positions radially around the outside surface of the electrode shaft 1104 such that the electrodes point in different directions).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the orientation of the first electrode and second electrode, as disclosed by Krueger, to include wherein the first electrode and second electrode extend around different portions of the circumference of the electrode shaft such that the first electrode and second electrode do not circumferentially overlap, as taught by Schmidt, as both references and the claimed invention are directed toward bipolar RF electrodes comprising field shaping electrode configurations. As disclosed by Krueger, the first electrode and second electrode may be oriented at the same positions radially around the outside surface of the electrode shaft to generate an electric field toward the exposed side of the probe ([0050]). As disclosed by Schmidt, the first electrode and the second electrode may be oriented at the same positions radially around the outside surface of the electrode shaft such that they point in the same direction or may be oriented at different positions radially around the outside surface of the electrode shaft such that the electrodes point in different directions, the electrodes pointing in different directions can generate electric field vectors pointing in different directions and thus enabling the manipulation of the direction of the electric field to treat target tissue ([0105]-[0108]). 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 orientation of the first electrode and second electrode, as disclosed by Krueger, to include wherein the first electrode and second electrode extend around different portions of the circumference of the electrode shaft such that the first electrode and second electrode do not circumferentially overlap, as taught by Schmidt, as providing electrodes that are oriented at different positions radially around the outside surface of the electrode shaft is a known alternative to providing electrodes that are oriented at the same positions radially around the outside surface of the electrode shaft, and would manipulate the electric field such that the electrodes produce electric field vectors that point in different directions in order to treat desired tissue.
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Krueger in view of Ingle and Schepis et al. (US 20200038096 A1), hereinafter “Schepis”.
Regarding claim 24, Krueger in view of Ingle disclose all of the limitations of claim 1, as described above.
Krueger does not disclose wherein the first electrode includes a bend.
Schepis teaches a bipolar RF electrode comprising a first electrode and a second electrode ([0088] & [0089]; Figure 12A—elements 260), wherein the first electrode includes a bend ([0088] & [0089], & [0126]; Figure 12A—elements 260; the examiner is considering the first electrode to be the distal conductor 260; “electrodes may be straight or curved to accommodate various anatomical geometries”).
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, as disclosed by Krueger, to include wherein the first electrode includes a bend, as taught by Schepis, as both references and the claimed invention are directed toward bipolar RF electrodes for tissue ablation. As disclosed by Schepis, the electrodes may be straight or curved to accommodate various anatomical geometries ([0126]). 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, as disclosed by Krueger, to include wherein the first electrode includes a bend, as taught by Schepis, as such a modification of providing a bent/curved electrode is a known alternative in the art to providing a straight electrode and would provide for an electrode that accommodates various anatomical geometries.
Regarding claim 25, Krueger in view of Ingle disclose all of the limitations of claim 1, as described above.
Krueger does not disclose wherein the second electrode includes a bend.
Schepis teaches a bipolar RF electrode comprising a first electrode and a second electrode ([0088] & [0089]; Figure 12A—elements 260), wherein the second electrode includes a bend ([0088] & [0089], & [0126]; Figure 12A—elements 260; the examiner is considering the second electrode to be the proximal conductor 260; “electrodes may be straight or curved to accommodate various anatomical geometries”).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the second electrode, as disclosed by Krueger, to include wherein the second electrode includes a bend, as taught by Schepis, as both references and the claimed invention are directed toward bipolar RF electrodes for tissue ablation. As disclosed by Schepis, the electrodes may be straight or curved to accommodate various anatomical geometries ([0126]). 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 second electrode, as disclosed by Krueger, to include wherein the second electrode includes a bend, as taught by Schepis, as such a modification of providing a bent/curved electrode is a known alternative in the art to providing a straight electrode and would provide for an electrode that accommodates various anatomical geometries.
Conclusion
Accordingly, claims 1-15 & 21-25 are rejected.
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