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 16th, 2025 has been entered. Claims 1, 3, 7, 16, 18, & 21 are amended. Claims 4, 15, & 20 are canceled. Claims 24-26 are new. Claims 1-3, 5-14, 16-19, & 21-26 remain pending.
Response to Arguments
Applicant's arguments filed October 16th, 2025 have been fully considered but they are not persuasive.
Regarding independent claims 1 & 18, Applicant argues that Howard does not disclose the amendment “wherein the profile shape forms an inner contour of the supply electrode having a first radius and an outer contour enclosing the inner contour having a second radius” and “wherein the profile shape forms an inner contour of the supply electrode having a first surface area and an outer contour enclosing the inner contour, the outer contour having a second surface area larger than the first surface area”, as the office action explains that the examiner is considering the inner contour to be disclosed by the electrode 66 and the outer contour to be the distal tip, and the distal most tip or edge 80 of the elongated body 22 does not form any portion of the electrode 66. The examiner respectfully disagrees, Hancock discloses the electrode forming a cavity having a profile shape recessed from the distal end portion toward the proximal end portion ([0121], [0126], & [0127]; Figure 32—element 66’ & 72; with said profile shape being defined by the concave surface 72 of concave electrode 66’)), and as stated in the non-final rejection mailed on 07/16/2025 “the examiner is considering the “inner contour” to be the proximal end of the profile/concave shape of the electrode 66’ and the “outer contour” to be the distal tip of the profile/concave shape of the electrode 66’”, the examiner is not considering the distal tip 80 of the insulating elongated body 22 to define the outer contour; more specifically, the examiner is considering the inner contour to be defined by a proximal contour portion of the profile shape 72 of the electrode 66’ and the outer contour to be defined by a distal contour portion of the profile shape 72 of the electrode 66’(see annotated figure in the 102 rejections of claims 1 & 18 below), therefore Howard does disclose the profile shape forms an inner contour of the supply electrode having a first radius and an outer contour enclosing the inner contour having a second radius.
Regarding Independent claim 21, Applicant argues that Melman does not disclose the amendment of “wherein the profile shape of the supply electrode forms a first concave region and a second concave region enclosing the first concave region about the longitudinal axis”; although the amendments overcome the previous interpretation of the art, the examiner respectfully disagrees that Melman does not disclose the amendment, as Melman discloses a supply electrode forming a cavity having a profile shape recessed from the distal end portion toward the proximal end portion ([0038]; Figure 3A & 3B—element 301 & 302), the examiner is considering a first concave region to be defined by a proximal portion of the profile shape of the electrode 302 and a second concave region to be defined by a distal portion of the profile shape of the electrode 302 (see annotated figures in the 102 rejections of claim 21 below in a first interpretation and a second interpretation).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6, 11, 13, & 16-19 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Howard et al. (previously presented-US 20180214202 A1), hereinafter “Howard”.
Regarding claim 1, Howard discloses an electrode assembly for a surgical ablator, the electrode assembly comprising: an insulator comprising a distal end portion and a proximal end portion ([0080], [0126], & [0128]; Figures 1 & 32-34—element 22; with said insulator being the elongate body 22 comprising proximal end portion 26 and distal end portion 28), the insulator comprising a rim forming a distal extent of the distal end portion ([0126] & [0127]; Figures 32-34—element 80; with said rim being the edge 80), the rim forming an aperture disposed in the distal end portion ([0126]-[0128]; Figures 32-34—element 80; with said aperture being the lumen of the rim 80); a supply electrode disposed in the aperture and forming a cavity having a profile shape recessed from the distal end portion toward the proximal end portion ([0127]; Figure 32—element 66’; with said cavity being defined by the supply electrode’s concave shape), wherein the profile shape forms an inner contour of the supply electrode having a first radius and an outer contour enclosing the inner contour having a second radius ([0126]-[0128]; Figure 32—element 66’; see figure below; under the broadest reasonable interpretation, the examiner is considering the “inner contour” to be the proximal end portion of the profile/concave shape of the electrode 66’ and the “outer contour” to be the distal end portion of the profile/concave shape of the electrode 66’; see figure below); and wherein the electrode assembly is configured to project a focal point of an ablation region emitted from the supply electrode through the aperture to a projection distance beyond the distal extent ([0121], [0127], & [0128]; Figure 32; the examiner is considering the focal point to be the concentrated electric field as shown in Figure 32).
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Regarding claim 2, Howard discloses all of the limitations of claim 1, as described above.
Howard further discloses wherein a projection axis extends centrally from the supply electrode through the focal point and the profile shape forms an electrode angle relative to the projection axis, wherein the projection distance of the focal point is a function of the electrode angle ([0121] & [0127]; Figures 31 & 32—element 66’; electric fields are projected perpendicular to the conductive surface; electric fields may be concentrated by using concave electrodes as compared to currently known flat electrodes; the examiner is considering the projection axis to be the axis defined by the middle portion of electrode 66’ which is shown in Figure 32 as extending through the focal point/concentrated electric field, and the electrode angle to be the angle of concavity/average slope of the electrode 66’ relative to the projection axis of the electrode; as electric fields are projected perpendicularly to the conductive surface of the electrode, it is the examiner’s position that the projection distance would be a function of the electrode angle/slope of the electrode relative to the projection axis).
Regarding claim 3, Howard discloses all of the limitations of claim 2, as described above.
Howard further discloses wherein the profile shape extends along a varying slope that changes from a central portion of the supply electrode to a perimeter of the supply electrode ([0126]-[0128]; Figure 32—element 66’; the concave electrode 66’ may comprise a hemispherical/bowl shaped configuration); wherein the electrode angle is an average of the varying slope of the profile shape ([0121] & [0127]; Figures 31 & 32—element 66’; electric fields are projected perpendicular to the conductive surface; electric fields may be concentrated by using concave electrodes as compared to currently known flat electrodes; the examiner is considering the projection axis to be the axis defined by the middle portion of electrode 66’ which is shown in Figure 32 as extending through the focal point/concentrated electric field, and the electrode angle to be the angle of concavity/average slope of the electrode 66’ relative to the projection axis of the electrode; as electric fields are projected perpendicularly to the conductive surface of the electrode, it is the examiner’s position that the projection distance would be a function of the average slope of the electrode relative to the projection axis).
Regarding claim 6, Howard discloses all of the limitations of claim 1, as described above.
Howard further discloses wherein the rim forms an interior wall of the aperture that extends a first distance from the supply electrode to the distal extent ([0128]; Figures 33 & 34—element 66’, 80, & “d”; the supply electrode 66’ may be recessed by a distance “d” from the distal most tip or edge 80).
Regarding claim 11, Howard discloses all of the limitations of claim 1, as described above.
Howard further discloses wherein the focal point is projected along a projection axis from a central portion of the supply electrode through the aperture of the rim to the projection distance ([0121], & [0126]-[0127]; Figure 32—element 66’).
Regarding claim 13, Howard discloses all of the limitations of claim 1, as described above.
Howard further discloses wherein the profile shape comprises a rounded concave shape ([0016] & [0128]; Figure 32—element 66’).
Regarding claim 16, Howard discloses all of the limitations of claim 1, as described above.
Howard further discloses wherein the first radius is smaller than the second radius (claim 16) ([0126]-[0128]; Figure 32—element 66’; see above figure in the rejection of claim 1; as the electrode comprises a hemispherical/bowl shape, it is the examiners position that the “inner contour”/proximal end of the profile shape of the electrode would have a smaller radius than the “outer contour”/distal tip of the profile shape of the electrode).
Regarding claim 17, Howard discloses all of the limitations of claim 1, as described above.
Howard further discloses a return electrode conductively separated from the supply electrode via the insulator and disposed adjacent to the proximal end portion ([0128]; Figure 33—element 38).
Regarding claim 18, Howard discloses a surgical ablation system comprising: an electrode assembly comprising a proximal end portion and a distal end portion ([0080]; Figure 1—element 12; with said proximal end portion being the proximal portion of medical device 12 and said distal end portion being the distal portion of medical device 12), the electrode assembly comprising: an insulator comprising a rim forming a distal extent of the distal end portion ([0080], & [0126]-[0128]; Figures 1 & 32-34—element 22; with said insulator being the elongate body 22 and said rim being the edge 80), the rim forming an aperture disposed in the distal end portion ([0126]-[0128]; Figures 32-34—element 80; with said aperture being the lumen of the rim 80); and a supply electrode disposed in the aperture and forming a cavity having a profile shape recessed from the distal end portion toward the proximal end portion ([0127]; Figure 32—element 66’; with said cavity being defined by the supply electrode’s concave shape), wherein the electrode assembly is configured to project a focal point of an ablation region along a projection direction, and the projection direction extends from the supply electrode through the aperture of the rim to a projection distance beyond the distal extent ([0121], [0127], & [0128]; Figure 32; the examiner is considering the focal point to be the concentrated electric field as shown in Figure 32), wherein the profile shape forms an inner contour of the supply electrode having a first surface area and an outer contour enclosing the inner contour, the outer contour having a second surface area larger than the first surface area ([0126]-[0128]; Figure 32—element 66’; see figure below; under the broadest reasonable interpretation, the examiner is considering the “inner contour” to be the proximal end portion of the profile/concave shape of the electrode 66’ and the “outer contour” to be the distal end portion of the profile/concave shape of the electrode 66’; as the electrode comprises a hemispherical/bowl shape, it is the examiners position that the “inner contour”/proximal end portion of the profile shape of the electrode would have a smaller surface area than the “outer contour”/distal end portion of the profile shape of the electrode; see figure below); and a controller comprising a signal generator and a processor ([0079] & [0086]; Figure 1—elements 14 & 20), wherein the controller is configured to control a radio frequency (RF) signal conducted to the supply electrode ([0079] & [0086]), wherein the supply electrode is configured to transmit RF energy to the focal point of the ablation region in response to the RF signal ([0121] & [0126]-[0128]).
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Regarding claim 19, Howard discloses all of the limitations of claim 18, as described above.
Howard further discloses wherein the ablation region is defined perpendicular to the projection direction ([0126] & [0127]; Figure 32; the ablation region is shown as extending perpendicular to the projection of the electric fields).
Claims 21-26 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Melman et al. (previously presented-US 20220354567 A1), hereinafter “Melman”.
Regarding claim 21, in a first interpretation, Melman discloses a surgical ablation apparatus comprising: an insulator comprising a proximal end portion and a distal end portion extending along a longitudinal axis ([0038]; Figure 3A—element 101 & 303), the insulator comprising a rim forming an aperture disposed in the distal end portion ([0038]; Figures 3A & 3B—element 304; said aperture being the lumen/opening defined by rim 304); a supply electrode disposed in the aperture and forming a cavity having a profile shape recessed from the distal end portion toward the proximal end portion ([0038]; Figure 3A & 3B—element 301 & 302), wherein the supply electrode is configured to project a focal point of an ablation region along a projection direction that extends from the supply electrode through the aperture of the rim to a projection distance beyond the distal end portion ([0010], [0012], [0021], [0035], [0043]-[0048], & [0052]; Figures 4B & 6), wherein the profile shape of the supply electrode forms a first concave region and a second concave region enclosing the first concave region about the longitudinal axis ([0038]; Figure 3A—element 302; see figure below; in the first interpretation, and under the broadest reasonable interpretation the examiner is considering the first concave region to be a proximal concave region of the supply electrode profile shape 302 extending distally of aspiration aperture 305 and the second concave region to be a distal concave region of the supply electrode profile shape 302 extending distally from the proximal concave region; see figure below); and at least one aspiration aperture extending through the supply electrode to a lumen, wherein the at least one aspiration aperture is aligned with the focal point ([0038]; Figures 3A & 3B—elements 305).
First interpretation annotated figure:
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Regarding claim 21, in a second interpretation, Melman discloses a surgical ablation apparatus comprising: an insulator comprising proximal end portion and a distal end portion extending along a longitudinal axis ([0038]; Figure 3A—element 101 & 303), the insulator comprising a rim forming an aperture disposed in the distal end portion ([0038]; Figures 3A & 3B—element 304; said aperture being the lumen/opening defined by rim 304); a supply electrode disposed in the aperture and forming a cavity having a profile shape recessed from the distal end portion toward the proximal end portion ([0038]; Figure 3A & 3B—element 301 & 302), wherein the supply electrode is configured to project a focal point of an ablation region along a projection direction that extends from the supply electrode through the aperture of the rim to a projection distance beyond the distal end portion ([0010], [0012], [0021], [0035], [0043]-[0048], & [0052]; Figures 4B & 6), wherein the profile shape of the supply electrode forms a first concave region and a second concave region enclosing the first concave region about the longitudinal axis ([0038]; Figure 3A—element 302; see figure below; in the second interpretation, and under the broadest reasonable interpretation the examiner is considering the first concave region to be a proximal concave region of the supply electrode profile shape 302 terminating proximally of aspiration aperture 305 and the second concave region to be a distal concave region of the supply electrode profile shape 302 extending distally from the proximal concave region; see figure below); and at least one aspiration aperture extending through the supply electrode to a lumen, wherein the at least one aspiration aperture is aligned with the focal point ([0038]; Figures 3A & 3B—elements 305).
Second interpretation annotated figure:
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Regarding claim 22, in the first and second interpretation, Melman discloses all of the limitations of claim 21, as described above.
Melman further discloses wherein the at least one aspiration aperture comprises a plurality of aspiration apertures formed through the supply electrode ([0038]; Figure 3A—elements 305; the tip may comprise one or more flow ports 305 for delivering or aspirating fluid).
Regarding claim 23, in the first and second interpretation, Melman discloses all of the limitations of claim 22, as described above.
Melman further discloses wherein the plurality of aspiration apertures are aligned with the focal point over the profile shape of the supply electrode ([0038] & [0043]-[0048]; Figure 3A—elements 305; as it is known that electric fields are projected perpendicularly to an electrode surface, and the plurality of aspiration apertures are aligned perpendicularly relative to the electrode surface; it is the examiner position that the plurality of aspiration apertures would be aligned with the focal point).
Regarding claim 24, in the first and second interpretation, Melman discloses all of the limitations of claim 21, as described above.
Melman further discloses wherein the second concave region is larger than the first concave region ([0038], [0040], & [0045]; Figures 3A, 4A, & 4B—element 302; the profile shape of the supply electrode comprises a hemispherical shape (as shown in Figures 3A, 4A, & 4B), as the examiner is considering the second concave region to be the distal concave region of the supply electrode profile shape 302, it is the examiners position that the distal concave region of the hemispherical profile shape is larger/has a larger diameter than the first concave region of the hemispherical profile shape; see figures in the above rejections of claim 21).
Regarding claim 25, in the second interpretation, Melman discloses all of the limitations of claim 21, as described above.
Melman further discloses wherein the at least one aspiration aperture extends through the second concave region ([0038]; Figures 3A & 3B—elements 302 & 305; in the second interpretation, the examiner is considering the second concave region to comprise the at least one aspiration aperture 305; see annotated Figure in the above rejection of claim 21 in the second interpretation).
Regarding claim 26, in the first interpretation, Melman discloses all of the limitations of claim 21, as described above.
Melman further discloses wherein the at least one aspiration aperture comprises a first aspiration aperture extending through the first concave region and a second aspiration aperture extending through the first concave region ([0038] & [0045]; Figures 3A, 3B, & 4B—elements 302 & 305; in the first interpretation, the examiner is considering the first concave region to comprise the at least one aspiration aperture 305, wherein the first aspiration aperture is the opening at the apex of the hemisphere that allows communication with aspiration or saline bath, and the second aspiration aperture to be the aperture 305 located near the distal end of the first concave region; see annotated Figure in the above rejection of claim 21 in the first interpretation).
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 5, 10, & 12 are rejected under 35 U.S.C. 103 as being unpatentable over Howard in view of Melman.
Regarding claim 5, Howard discloses all of the limitations of claim 1, as described above.
Howard further discloses wherein the profile shape of the supply electrode forms a depth (D) of the aperture ([0127]; Figure 32—element 66’; with said depth (D) being the depth of the concavity of the electrode 66’).
Howard does not explicitly disclose the projection distance extends to a distance of two times the depth (2D) from the distal end portion of the supply electrode.
Melman teaches a supply electrode disposed in the aperture and forming a cavity having a profile shape recessed from a distal end portion toward a proximal end portion ([0038]; Figure 3A & 3B—element 301 & 302), wherein the supply electrode projects a focal point of an ablation region along a projection direction that extends from the supply electrode to a projection distance beyond the distal end portion ([0010], [0012], [0021], [0035], [0043]-[0048], & [0052]; Figures 4B & 6); wherein the profile shape of the supply electrode forms a depth (D) of the aperture ([0038], [0040], & [0052]; Figure 5C; the hollow portion of the tip containing the hemispherical electrode may comprise a diameter of 3.8mm; it is the examiner position that the depth of the hollow electrode would be less than or equal to the radius of the hollow portion of the tip (e.g. ½ the diameter) and therefore would be no more than 1.9mm), and the projection distance extends to a distance of two times the depth (2D) from the distal end portion of the supply electrode ([0041], [0043]-[0048], & [0052]; Figure 6).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the projection distance relative to the depth of the supply electrode, as taught by Howard, to include wherein the projection distance extends to a distance of two times the depth (2D) from the distal end portion of the supply electrode, as taught by Melman, as both references and the claimed invention are directed toward ablation devices comprising concave electrodes for focusing electric fields. As disclosed by Melman, the concave tip containing the hollow hemispherical electrode may comprise a diameter of approximately 3.8mm, the electrical field of the FEF catheter increases to a peak at a depth around 3.2mm below the tissue surface and the energy falls off with depth at a much slower rate than that of a current art RF-electrode tip ([0041] & [0052]). It would have been obvious to one of ordinary skill in the art, before the effective filing date off the claimed invention, to modify the projection distance relative to the depth of the supply electrode, as taught by Howard, to include wherein the projection distance extends to a distance of two times the depth (2D) from the distal end portion of the supply electrode, as taught by Melman, as such a modification would provide for a known projection distance for a concave electrode which allows for the energy to fall off with depth at a much slower rate as compared to current art RF-electrode tips. Further, the examiner notes that it would have been obvious to one of ordinary skill in the art at the time the invention was made to include wherein the projection distance extends to a distance of two times the depth (2D) from the distal end portion of the supply electrode, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F. 2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 10, Howard discloses all of the limitations of claim 6, as described above.
Howard does not disclose wherein the supply electrode forms a perimeter defining a first area and the aperture of the rim forms an opening proximate to the distal extent defining a second area, wherein the first area is greater than the second area.
Melman discloses a surgical ablation apparatus comprising a rim forming an aperture disposed in the distal end portion ([0038]; Figures 3A & 3B—element 304; said aperture being the lumen/opening defined by rim 304); a supply electrode disposed in the aperture and forming a cavity having a profile shape recessed from the distal end portion toward the proximal end portion ([0038]; Figure 3A & 3B—element 301 & 302), wherein the supply electrode forms a perimeter defining a first area ([0038]; Figure 3A—element 302; with said perimeter being circumference of the distal most end of the electrode 302) and the aperture of the rim forms an opening proximate to the distal extent defining a second area, wherein the first area is greater than the second area ([0010] & [0038]; Figure 3A—element 304; with said second area being the circumference of the aperture/hole defined by rim 304; the second area is shown to be less than the first area, as the rim 304 is shown to extend inwardly relative to the electrode 302).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the rim and aperture, as disclosed Howard, to include wherein the supply electrode forms a perimeter defining a first area and the aperture of the rim forms an opening proximate to the distal extent defining a second area wherein the first area is greater than the second area, as taught by Melman, as both references and the claimed invention are directed toward ablation devices comprising insulating rims and concave electrodes for focusing electric fields. As disclosed by Melman, the insulating rim is applied around the concave electrode tip so as to eliminate sharp curvature where the electric field is highest and prevent current from flowing directly into the surrounding blood pool ([0053]). 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 rim and aperture, as disclosed Howard, to include wherein the supply electrode forms a perimeter defining a first area and the aperture of the rim forms an opening proximate to the distal extent defining a second area wherein the first area is greater than the second area, as taught by Melman, as such a modification would further eliminate sharp curvature where the electric field is highest and prevent current from flowing directly into the surrounding blood pool.
Regarding claim 12, Howard discloses all of the limitations of claim 1, as described above.
Howard further discloses wherein the profile shape of the cavity extends from a perimeter of the supply electrode to a base of a central portion of the supply electrode over a depth ([0127]; Figure 32—element 66’; with said depth being the depth of the concavity of the electrode 66’).
Howard does not disclose the depth ranging from 0.25 mm to 10 mm.
Melman teaches a supply electrode disposed in the aperture and forming a cavity having a profile shape recessed from a distal end portion toward a proximal end portion ([0038]; Figure 3A & 3B—element 301 & 302), wherein the profile shape of the cavity extends from a perimeter of the supply electrode to a base of a central portion of the supply electrode over a depth ranging from 0.25 mm to 10 mm ([0038] & [0052]; Figure 5C; the hollow portion of the tip containing the hemispherical electrode may comprise a diameter of 3.8mm; it is the examiner position that the depth of the hollow electrode would be less than or equal to the radius of the hollow portion of the tip (e.g. ½ the diameter) and therefore would be no more than 1.9mm).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the depth, as taught by Howard, to include the depth ranging from 0.25 mm to 10 mm, as taught by Melman, as both references and the claimed invention are directed toward ablation devices comprising concave electrodes for focusing electric fields. As disclosed by Howard, the concave hemispherical electrode is configured to concentrate/focus electric fields. As disclosed by Melman, the concave tip containing the hollow hemispherical electrode may comprise a diameter of approximately 3.8mmm the configuration of the electrode tip allows for focusing of the electric field ([0010], [0052], & [0079]). It would have been obvious to one of ordinary skill in the art, before the effective filing date off the claimed invention, to modify the depth, as taught by Howard, to include the depth ranging from 0.25 mm to 10 mm, as taught by Melman, as such a modification would provide for a suitable and known electrode depth that produces the predictable result of focusing electric fields. Further, the examiner notes that it would have been obvious to one having ordinary skill in the art at the time the invention was made to include the depth ranging from 0.25 mm to 10 mm, 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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Howard.
Regarding claim 7, Howard discloses all of the limitations of claim 1, as described above.
Howard is silent to wherein the first distance is between 5% of the depth D (0.05D) to 100% of the depth D. However, Howard discloses that the concave electrode comprising a depth D ([0126] & [0127]; Figure 32—element 66’) and the rim forming the interior wall of the aperture that extends a first distance from the supply electrode to the distal extent ([0128]; Figures 33 & 34—element 66’, 80, & “d”; the concave supply electrode 66’ may be recessed by a distance “d” from the distal most tip or edge 80), it would have been obvious to one having ordinary skill in the art at the time the invention was made to wherein the first distance is between 5% of the depth D (0.05D) to 100% of the depth D, 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.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Howard in view of Dickens et al. (previously presented-US 6120499 A), hereinafter “Dickens”.
Regarding claims 8-9, Howard discloses all of the limitations of claim 6, as described above.
Howard does not disclose wherein the interior wall defines a cross section of the aperture formed by the rim, wherein the cross section decreases at an aperture angle along the first distance from the supply electrode to the distal extent (claim 8), wherein the cross section decreases at an increasing rate along at least a portion of the first distance (claim 9).
Dickens teaches an insulator comprising a rim defining an interior wall ([Col. 5, line 58 – Col. 6, line 4]; Figures 6-8—element 54; with said rim being the distal portion of outer tubular member/insulator 54), a concave supply electrode configured to focus RF energy ([Col. 5, line 58 – Col. 6, line 4]; Figures 6-8—element 51/52), wherein the interior wall defines a cross section of the aperture formed by the rim, wherein the cross section decreases at an aperture angle along the first distance from the supply electrode to the distal extent, wherein the cross section decreases at an increasing rate along at least a portion of the first distance ([Col. 5, line 58 – Col. 6, line 26]; Figures 6-8—elements 51/52 & 54; the rim/distal portion of the insulator 54 is shaped about the edge of the distal face 52 of the electrode 51; the insulator/rim 54 is shown as comprising a decreasing diameter at an increasing rate from the proximal portion toward the distal-most tip of the insulator).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the cross-section of the aperture formed by the rim, as disclosed by Howard, to include wherein the cross section decreases at an aperture angle along the first distance from the supply electrode to the distal extent, as taught by Dickens, as both references and the claimed invention are directed toward concave electrodes for delivering focused RF energy to tissue. As disclosed by Dickens, the distal tip of the rim is shaped about the circular edge of the distal face of the electrode to avoid thrombus formation along the edges ([Col. 5, line 58 – Col. 6, line 4]). 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 cross-section of the aperture formed by the rim, as disclosed by Howard, to include wherein the cross section decreases at an aperture angle along the first distance from the supply electrode to the distal extent, as taught by Dickens, as such a modification would provide for a suitable and known insulative rim configuration that additionally prevents thrombus formations along the edges of the electrode.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Howard in view of Hovda et al. (previously presented-US 6053172 A), hereinafter “Hovda”.
Regarding claim 14, Howard discloses all of the limitations of claim 1, as described above.
Howard does not disclose wherein the profile shape comprises a conical shape.
Hovda teaches an ablation device comprising an electrode defining a concave profile shape, wherein the profile shape comprises a conical shape ([Col. 13, lines 5-11] & [Col. 13, lines 30-47]; the active electrode surface can assume a variety of geometries; the geometries can be concave, hemispherical, conical, or other irregular shapes).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the concave hemispherical electrode profile shape, as disclosed by Howard, to include wherein the profile shape comprises a conical shape, as taught by Hovda, as both references and the claimed invention are directed to ablation devices comprising electrodes with concave profile shapes. As disclosed by Howard, the concave electrode may comprise a hemispherical configuration ([0128]). As disclosed by Hovda, the electrode geometries can be the geometries can be concave and comprise hemispherical, conical, or other irregular shapes ([Col. 13, lines 30-47]). 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 concave hemispherical electrode profile shape, as disclosed by Howard, to include wherein the profile shape comprises a conical shape, as taught by Hovda, as providing an electrode with a concave conical profile shape is a known alternative to providing an electrode with a concave and hemispherical profile shape and would produce the predictable result of providing an electrode with a concave shape.
Conclusion
Accordingly, claims 1-3, 5-14, 16-19, & 21-26 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARINA D TEMPLETON whose telephone number is (571)272-7683. The examiner can normally be reached M-F 8:00am to 5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794