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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-19 in the reply filed on May 22nd, 2026, is acknowledged; Group II, claim 20, is withdrawn from further consideration.
Claim Objections
Claim 3 objected to because of the following informalities: “the C-shape electrode” should be – the C-shape electrode profile—; as introduced in claim 2. Appropriate correction is required.
Claim 8 objected to because of the following informalities: “the outer insulation” should be – the outer insulation layer—; as introduced in claim 1. Appropriate correction is required.
Claim 9 objected to because of the following informalities: “the inner insulation” should be – the inner insulation layer—; as introduced in claim 1. Appropriate correction is required.
Claim 13 objected to because of the following informalities: “the C-shape electrode” should be – the C-shape electrode profile—; as introduced in claim 12. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation "the C-shape electrode profile" in line 2. There is insufficient antecedent basis for this limitation in the claim; for examination purposes the examiner is considering “the C-shape electrode profile” to be –a C-shape electrode profile—. The examiner further notes that “the outer insulation” should be – the outer insulation layer—, as introduced in claim 1.
Claim 15 recites the limitation "the C-shape electrode profile" in line 2. There is insufficient antecedent basis for this limitation in the claim; for examination purposes the examiner is considering “the C-shape electrode profile” to be –a C-shape electrode profile—. The examiner further notes that “the outer insulation” should be – the outer insulation layer—, as introduced in claim 11.
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 1-6, 8-16, & 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (US 20160374751 A1), hereinafter “Davies”, in view of Yokoyama (US 20170303993 A1), hereinafter “Yokoyama”.
Regarding claim 1, Davies discloses a radiofrequency perforation device comprising: an elongate member defining a lumen ([0037] & [0040]; Figures 1-2C—elements 102 & 109) and extending from a proximal portion including a hub ([0037]; Figure 1—element 101) to a distal portion including a distal tip electrode ([0037]; Figures 1-2C—element 103) having a distal face ([0037]; Figures 1-2C—element 104) defining a distal opening ([0040]; Figure 2A—element 107) and a slot ([0055]; the distal face of the electrically conductive tubular member has a step recess; the examiner is considering the slot to be the step recess); an outer insulation layer covering a portion of an outer surface of the elongate member and leaving the distal tip electrode uncovered ([0037]-[0038] & [0052]; Figures 1-2C—element 105).
Davies does not disclose an inner insulation layer covering at least the distal portion of the lumen.
Yokoyama teaches an electrosurgical device comprising an elongate member including a lumen, a distal tip electrode ([0049] & [0057]; Figure 4—element 28) having a distal face ([0060] & [0061]; Figures 7B—element 56a) and a slot ([0057], [0060], & [0061]; Figure 7B—elements 56ab/57; the examiner is considering the slot to be the cutout/recessed portion 57 defining face 56ab of distal face 56a) an outer insulation layer covering a portion of an outer surface of the elongate member and leaving the distal tip electrode uncovered ([0049], [0060], & [0061]; Figures 4 & 7B—elements 28 & 33) and an inner insulation layer covering at least the distal portion of the lumen ([0049]; Figures 4 & 7B—element 32).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the elongate member lumen, as disclosed by Davies, to include an inner insulation layer covering at least the distal portion of the lumen, as taught by Yokoyama, as both references and the claimed invention are directed toward electrosurgical devices comprising hollow electrodes with distal electrode faces that comprise a semi-circular shape. As disclosed by Yokoyama, an inner insulation layer may be provided to cover the inner peripheral surface of the hollow elongate member, the inner insulation layer insulates the lumen of elongate member and, in combination with an outer insulation layer, aids to only expose a portion of the distal end face of the electrode to tissue which increases the density of high-frequency current ([0049], [0060], [0061], & [0073]). 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 elongate member lumen, as disclosed by Davies, to include an inner insulation layer covering at least the distal portion of the lumen, as taught by Yokoyama, as such a modification would insulate the inner peripheral surface of the hollow elongate member in order to only expose the electrode distal end which increases the density of high-frequency current.
Regarding claim 2, Davies in view of Yokoyama disclose all of the limitations of claim 1, as described above.
Davies further discloses wherein the distal face is a C-shape electrode profile ([0053] & [0054]; Figure 2B—element 103a).
Regarding claim 3, Davies in view of Yokoyama disclose all of the limitations of claim 2, as described above.
Davies further discloses wherein the C-shape electrode is adapted to create a C-shape incision into a tissue at a target site ([0054] & [0058]; Figure 2B—element 103a).
Regarding claims 4-5, as best understood in view of the 112(b) rejection above (for claim 5), Davies in view of Yokoyama disclose all of the limitations of claim 1, as described above.
Davies does not disclose wherein the inner insulation layer extends through the slot and couples to the outer insulation layer.
Yokoyama further teaches wherein the inner insulation layer extends through the slot and couples to the outer insulation layer (claim 4) ([0057] & [0061]; Figure 7B—elements 32 & 33; the examiner is considering the slot to be the cutout 57 defining face portion 56ab of face 56a; the slot face 56ab may be covered with the inner insulation layer 32); wherein the inner insulation layer extends under the outer insulation to create the C-shape electrode profile (claim 5) ([0060] & [0061];Figure 7B—elements 32 & 33; the examiner is considering the inner insulation layer 32 to be under the outer insulation 33 as it is positioned coaxially below/under the outer insulation relative to the central axis).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the outer insulation layer extending through the slot, as disclosed by Davies, to include wherein the inner insulation layer extends through the slot and couples to the outer insulation layer and wherein the inner insulation layer extends under the outer insulation, as further taught by Yokoyama, as both references and the claimed invention are directed toward electrosurgical devices comprising hollow electrodes with distal electrode faces that comprise a semi-circular shape. As disclosed by Davies, the outer insulation layer may cover the slot of the electrode face so as to provide a generally C-shaped or arcuate shaped electrode face ([0054] & [0055]). As disclosed by Yokoyama, an inner insulation layer may be provided to cover the inner peripheral surface of the hollow elongate member, the inner insulation layer insulates the lumen of elongate member and, in combination with an outer insulation layer, aids to only expose a portion of the distal end face of the electrode to tissue which increases the density of high-frequency current, the slot of the electrode face may be covered by either the inner insulation layer or the outer insulation layer ([0049], [0060], [0061], & [0073]). 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 outer insulation layer extending through the slot, as disclosed by Davies, to include wherein the inner insulation layer extends through the slot and couples to the outer insulation layer and wherein the inner insulation layer extends under the outer insulation, as further taught by Yokoyama, as such a modification would provide for a known and suitable insulation extending through the slot of the electrode face so as to produce the predictable result of only exposing a portion of the electrode face to tissue and further would aid in increasing the density of high-frequency current.
Regarding claim 6, Davies in view of Yokoyama disclose all of the limitations of claim 1, as described above.
Davies in view of Yokoyama disclose the inner insulation layer surrounding the lumen (as described in the above rejection of claim 1).
Davies further discloses wherein fluorinated ethylenepropylene (FEP) is disposed in the slot between lumen and the outer insulation layer ([0071] & [0119]; Figures 5A-5C—element 144).
Regarding claim 8, Davies in view of Yokoyama disclose all of the limitations of claim 1, as described above.
Davies further discloses wherein the outer insulation is made of a heat shrink material ([0055]).
Regarding claim 9, Davies in view of Yokoyama disclose all of the limitations of claim 1, as described above.
Davies in view of Yokoyama do not disclose wherein the inner insulation is made of fluorinated ethylene propylene (FEP); however Davies discloses a suitable insulation material comprising fluorinated ethylene propylene (FEP) ([0071]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the material of the inner insulation layer, as taught by Kadowaki, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 10, Davies in view of Yokoyama disclose all of the limitations of claim 1, as described above.
Davies further discloses wherein the distal opening is a forward-facing port opening ([0040] & [0058]; Figures 2A-B—element 107).
Regarding claim 11, Davies discloses an epicardial or transseptal crossing system comprising: a dilator having a dilator body defining a dilator lumen and a tapered distal tip ([0107]; Figure 13A—element 128); an elongate member defining a lumen ([0037] & [0040]; Figures 1-2C—elements 102 & 109) and extending from a proximal portion including a hub ([0037]; Figure 1—element 101) to a distal portion including a distal tip electrode ([0037]; Figures 1-2C—element 103) having a distal face ([0037]; Figures 1-2C—element 104) defining a distal opening ([0040]; Figure 2A—element 107) and a slot ([0055]; the distal face of the electrically conductive tubular member has a step recess; the examiner is considering the slot to be the step recess); an outer insulation layer covering a portion of an outer surface of the elongate member and leaving the distal tip electrode uncovered ([0037]-[0038] & [0052]; Figures 1-2C—element 105); wherein the elongate member is adapted to advance through the dilator lumen ([0107]; Figure 13A—elements 120 & 128) and to deliver RF energy to the distal tip electrode ([0112]).
Davies does not disclose an inner insulation layer covering at least the distal portion of the lumen.
Yokoyama teaches an electrosurgical device comprising an elongate member including a lumen, a distal tip electrode ([0049] & [0057]; Figure 4—element 28) having a distal face ([0060] & [0061]; Figures 7B—element 56a) and a slot ([0057], [0060], & [0061]; Figure 7B—elements 56ab/57; the examiner is considering the slot to be the cutout/recessed portion 57 defining face 56ab of distal face 56a) an outer insulation layer covering a portion of an outer surface of the elongate member and leaving the distal tip electrode uncovered ([0049], [0060], & [0061]; Figures 4 & 7B—elements 28 & 33) and an inner insulation layer covering at least the distal portion of the lumen ([0049]; Figures 4 & 7B—element 32).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the elongate member lumen, as disclosed by Davies, to include an inner insulation layer covering at least the distal portion of the lumen, as taught by Yokoyama, as both references and the claimed invention are directed toward electrosurgical devices comprising hollow electrodes with distal electrode faces that comprise a semi-circular shape. As disclosed by Yokoyama, an inner insulation layer may be provided to cover the inner peripheral surface of the hollow elongate member, the inner insulation layer insulates the lumen of elongate member and, in combination with an outer insulation layer, aids to only expose a portion of the distal end face of the electrode to tissue which increases the density of high-frequency current ([0049], [0060], [0061], & [0073]). 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 elongate member lumen, as disclosed by Davies, to include an inner insulation layer covering at least the distal portion of the lumen, as taught by Yokoyama, as such a modification would insulate the inner peripheral surface of the hollow elongate member in order to only expose the electrode distal end which increases the density of high-frequency current.
Regarding claim 12, Davies in view of Yokoyama disclose all of the limitations of claim 11, as described above.
Davies further discloses wherein the distal face is a C-shape electrode profile ([0053] & [0054]; Figure 2B—element 103a).
Regarding claim 13, Davies in view of Yokoyama disclose all of the limitations of claim 12, as described above.
Davies further discloses wherein the C-shape electrode is adapted to create a C-shape incision into a tissue at a target site ([0054] & [0058]; Figure 2B—element 103a).
Regarding claims 14-15, as best understood in view of the 112(b) rejection above (for claim 15), Davies in view of Yokoyama disclose all of the limitations of claim 11, as described above.
Davies does not disclose wherein the inner insulation layer extends through the slot and couples to the outer insulation layer.
Yokoyama further teaches wherein the inner insulation layer extends through the slot and couples to the outer insulation layer (claim 14) ([0057] & [0061]; Figure 7B—elements 32 & 33; the examiner is considering the slot to be the cutout 57 defining face portion 56ab of face 56a; the slot face 56ab may be covered with the inner insulation layer 32); wherein the inner insulation layer extends under the outer insulation to create the C-shape electrode profile (claim 15) ([0060] & [0061]; Figure 7B—elements 32 & 33; the examiner is considering the inner insulation layer 32 to be under the outer insulation 33 as it is positioned coaxially below/under the outer insulation relative to the central axis).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the outer insulation layer extending through the slot, as disclosed by Davies, to include wherein the inner insulation layer extends through the slot and couples to the outer insulation layer and wherein the inner insulation layer extends under the outer insulation, as further taught by Yokoyama, as both references and the claimed invention are directed toward electrosurgical devices comprising hollow electrodes with distal electrode faces that comprise a semi-circular shape. As disclosed by Davies, the outer insulation layer may cover the slot of the electrode face so as to provide a generally C-shaped or arcuate shaped electrode face ([0054] & [0055]). As disclosed by Yokoyama, an inner insulation layer may be provided to cover the inner peripheral surface of the hollow elongate member, the inner insulation layer insulates the lumen of elongate member and, in combination with an outer insulation layer, aids to only expose a portion of the distal end face of the electrode to tissue which increases the density of high-frequency current, the slot of the electrode face may be covered by either the inner insulation layer or the outer insulation layer ([0049], [0060], [0061], & [0073]). 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 outer insulation layer extending through the slot, as disclosed by Davies, to include wherein the inner insulation layer extends through the slot and couples to the outer insulation layer and wherein the inner insulation layer extends under the outer insulation, as further taught by Yokoyama, as such a modification would provide for a known and suitable insulation extending through the slot of the electrode face so as to produce the predictable result of only exposing a portion of the electrode face to tissue and further would aid in increasing the density of high-frequency current.
Regarding claim 16, Davies in view of Yokoyama disclose all of the limitations of claim 11, as described above.
Davies in view of Yokoyama disclose the inner insulation layer surrounding the lumen (as described in the above rejection of claim 1).
Davies further discloses wherein fluorinated ethylenepropylene (FEP) is disposed in the slot between lumen and the outer insulation layer ([0071] & [0119]; Figures 5A-5C—element 144).
Regarding claim 18, Davies in view of Yokoyama disclose all of the limitations of claim 11, as described above.
Davies further discloses wherein the distal tip electrode is a dome shape tip ([0057], [0092], & [0119]; the distal tip may be rounded or domed in order to reduce the risk of accidental puncture).
Regarding claim 19, Davies in view of Yokoyama disclose all of the limitations of claim 11, as described above.
Davies further discloses wherein the distal tip electrode is a bevel shape tip ([0054]).
Claims 1-3, 6-13, 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Davies in view of Kadowaki et al. (US 20220183742 A1), hereinafter “Kadowaki”.
Regarding claim 1, Davies discloses a radiofrequency perforation device comprising: an elongate member defining a lumen ([0037] & [0040]; Figures 1-2C—elements 102 & 109) and extending from a proximal portion including a hub ([0037]; Figure 1—element 101) to a distal portion including a distal tip electrode ([0037]; Figures 1-2C—element 103) having a distal face ([0037]; Figures 1-2C—element 104) defining a distal opening ([0040]; Figure 2A—element 107) and a slot ([0055]; the distal face of the electrically conductive tubular member has a step recess; the examiner is considering the slot to be the step recess); an outer insulation layer covering a portion of an outer surface of the elongate member and leaving the distal tip electrode uncovered ([0037]-[0038] & [0052]; Figures 1-2C—element 105).
Davies does not disclose an inner insulation layer covering at least the distal portion of the lumen.
Kadowaki teaches an electrosurgical device comprising an elongate member including a lumen, a distal tip electrode having a distal face and a slot ([0041], [0042], & [0044]; Figure 5—element 8; the distal face being the distal face of tubular portion 8 and the slot being defined by the recessed portion of the angled tip about opening OP), an outer insulation layer covering a portion of an outer surface of the elongate member and leaving the distal tip electrode uncovered ([0050] & [0051]; Figure 5—element CO; the outer insulation layer being the coating CO provided on the outer surface of electrode), and an inner insulation layer covering at least the distal portion of the lumen ([0050] & [0051]; Figure 5—element CO; the inner insulation layer being the coating CO provided on the inner surface of electrode).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the elongate member lumen, as disclosed by Davies, to include an inner insulation layer covering at least the distal portion of the lumen, as taught by Kadowaki, as both references and the claimed invention are directed toward electrosurgical devices comprising hollow electrodes with distal electrode faces that comprise a semi-circular shape. As disclosed by Kadowaki an insulation layer may be position on the inner surface of the electrode so as to prevent tissue that has entered inside of the opening of the electrode from adhering to the inner surface ([0064]). 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 elongate member lumen, as disclosed by Davies, to include an inner insulation layer covering at least the distal portion of the lumen, as taught by Kadowaki, as such a modification would prevent tissue from adhering to the inner surface of the electrode.
Regarding claim 2, Davies in view of Kadowaki disclose all of the limitations of claim 1, as described above.
Davies further discloses wherein the distal face is a C-shape electrode profile ([0053] & [0054]; Figure 2B—element 103a).
Regarding claim 3, Davies in view of Kadowaki disclose all of the limitations of claim 2, as described above.
Davies further discloses wherein the C-shape electrode is adapted to create a C-shape incision into a tissue at a target site ([0054] & [0058]; Figure 2B—element 103a).
Regarding claim 6, Davies in view of Kadowaki disclose all of the limitations of claim 1, as described above.
Davies in view of Kadowaki disclose the inner insulation layer surrounding the lumen (as described in the above rejection of claim 1).
Davies further discloses wherein fluorinated ethylenepropylene (FEP) is disposed in the slot between lumen and the outer insulation layer ([0071] & [0119]; Figures 5A-5C—element 144).
Regarding claim 7, Davies in view of Kadowaki disclose all of the limitations of claim 1, as described above.
Davies further discloses wherein the outer insulation layer extends into and couple in the slot ([0054] & [0055]; Figures 2A-2C—element 105a).
Davies does not disclose wherein the inner insulation layer extend into and couple in the slot.
Kadowaki further teaches wherein the outer insulation layer and the inner insulation layer extend into and couple in the slot ([0050] & [0051]; Figure 5—elements “CO”; Figure 5 portrays the inner insulation coating CO and the outer insulation coating CO extending into and coupling within the slot (e.g. the recessed side of the electrode 8)).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the outer insulation layer extending into the slot, as disclosed by Davies, to include both the outer insulation layer and the inner insulation layer extending into and coupling in the slot, as taught by Kadowaki, as both references and the claimed invention are directed towards electrosurgical devices comprising hollow electrodes with distal electrode faces that comprise a semi-circular shape. As disclosed by Davies, the outer insulation layer may cover the slot of the electrode face so as to provide a generally C-shaped or arcuate shaped electrode face ([0054] & [0055]). As disclosed by Kadowaki an insulation layer coating and an outer insulation coating are provided on the surfaces of the electrode except for the distal end electrode face such that only an arc shape portion of the electrode face is exposed ([0049], [0050], & [0051]). 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 outer insulation layer extending into the slot, as disclosed by Davies, to include both the outer insulation layer and the inner insulation layer extending into and coupling in the slot, as taught by Kadowaki, as such a modification would provide for a known and suitable insulation extending through the slot of the electrode face so as to produce the predictable result of only exposing an arc shape portion of the electrode face to tissue.
Regarding claim 8, Davies in view of Kadowaki disclose all of the limitations of claim 1, as described above.
Davies further discloses wherein the outer insulation is made of a heat shrink material ([0055]).
Regarding claim 9, Davies in view of Kadowaki disclose all of the limitations of claim 1, as described above.
Davies in view of Kadowaki do not disclose wherein the inner insulation is made of fluorinated ethylene propylene (FEP); however Davies discloses a suitable insulation material comprising fluorinated ethylene propylene (FEP) ([0071]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the material of the inner insulation layer, as taught by Kadowaki, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 10, Davies in view of Kadowaki disclose all of the limitations of claim 1, as described above.
Davies further discloses wherein the distal opening is a forward-facing port opening ([0040] & [0058]; Figures 2A-B—element 107).
Regarding claim 11, Davies discloses an epicardial or transseptal crossing system comprising: a dilator having a dilator body defining a dilator lumen and a tapered distal tip ([0107]; Figure 13A—element 128); an elongate member defining a lumen ([0037] & [0040]; Figures 1-2C—elements 102 & 109) and extending from a proximal portion including a hub ([0037]; Figure 1—element 101) to a distal portion including a distal tip electrode ([0037]; Figures 1-2C—element 103) having a distal face ([0037]; Figures 1-2C—element 104) defining a distal opening ([0040]; Figure 2A—element 107) and a slot ([0055]; the distal face of the electrically conductive tubular member has a step recess; the examiner is considering the slot to be the step recess); an outer insulation layer covering a portion of an outer surface of the elongate member and leaving the distal tip electrode uncovered ([0037]-[0038] & [0052]; Figures 1-2C—element 105); wherein the elongate member is adapted to advance through the dilator lumen ([0107]; Figure 13A—elements 120 & 128) and to deliver RF energy to the distal tip electrode ([0112]).
Davies does not disclose an inner insulation layer covering at least the distal portion of the lumen.
Kadowaki teaches an electrosurgical device comprising an elongate member including a lumen, a distal tip electrode having a distal face and a slot ([0041], [0042], & [0044]; Figure 5—element 8; the distal face being the distal face of tubular portion 8 and the slot being defined by the recessed portion of the angled tip about opening OP), an outer insulation layer covering a portion of an outer surface of the elongate member and leaving the distal tip electrode uncovered ([0050] & [0051]; Figure 5—element CO; the outer insulation layer being the coating CO provided on the outer surface of electrode), and an inner insulation layer covering at least the distal portion of the lumen ([0050] & [0051]; Figure 5—element CO; the inner insulation layer being the coating CO provided on the inner surface of electrode).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the elongate member lumen, as disclosed by Davies, to include an inner insulation layer covering at least the distal portion of the lumen, as taught by Kadowaki, as both references and the claimed invention are directed toward electrosurgical devices comprising hollow electrodes with distal electrode faces that comprise a semi-circular shape. As disclosed by Kadowaki an insulation layer may be position on the inner surface of the electrode so as to prevent tissue that has entered inside of the opening of the electrode from adhering to the inner surface ([0064]). 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 elongate member lumen, as disclosed by Davies, to include an inner insulation layer covering at least the distal portion of the lumen, as taught by Kadowaki, as such a modification would prevent tissue from adhering to the inner surface of the electrode.
Regarding claim 12, Davies in view of Kadowaki disclose all of the limitations of claim 11, as described above.
Davies further discloses wherein the distal face is a C-shape electrode profile ([0053] & [0054]; Figure 2B—element 103a).
Regarding claim 13, Davies in view of Kadowaki disclose all of the limitations of claim 12, as described above.
Davies further discloses wherein the C-shape electrode is adapted to create a C-shape incision into a tissue at a target site ([0054] & [0058]; Figure 2B—element 103a).
Regarding claim 16, Davies in view of Kadowaki disclose all of the limitations of claim 11, as described above.
Davies in view of Kadowaki disclose the inner insulation layer surrounding the lumen (as described in the above rejection of claim 1).
Davies further discloses wherein fluorinated ethylenepropylene (FEP) is disposed in the slot between lumen and the outer insulation layer ([0071] & [0119]; Figures 5A-5C—element 144).
Regarding claim 17, Davies in view of Kadowaki disclose all of the limitations of claim 11, as described above.
Davies further discloses wherein the outer insulation layer extends into and couple in the slot ([0054] & [0055]; Figures 2A-2C—element 105a).
Davies does not disclose wherein the inner insulation layer extend into and couple in the slot.
Kadowaki further teaches wherein the outer insulation layer and the inner insulation layer extend into and couple in the slot ([0050] & [0051]; Figure 5—elements “CO”; Figure 5 portrays the inner insulation coating CO and the outer insulation coating CO extending into and coupling within the slot (e.g. the recessed side of the electrode 8)).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the outer insulation layer extending into the slot, as disclosed by Davies, to include both the outer insulation layer and the inner insulation layer extending into and coupling in the slot, as taught by Kadowaki, as both references and the claimed invention are directed towards electrosurgical devices comprising hollow electrodes with distal electrode faces that comprise a semi-circular shape. As disclosed by Davies, the outer insulation layer may cover the slot of the electrode face so as to provide a generally C-shaped or arcuate shaped electrode face ([0054] & [0055]). As disclosed by Kadowaki an insulation layer coating and an outer insulation coating are provided on the surfaces of the electrode except for the distal end electrode face such that only an arc shape portion of the electrode face is exposed ([0049], [0050], & [0051]). 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 outer insulation layer extending into the slot, as disclosed by Davies, to include both the outer insulation layer and the inner insulation layer extending into and coupling in the slot, as taught by Kadowaki, as such a modification would provide for a known and suitable insulation extending through the slot of the electrode face so as to produce the predictable result of only exposing an arc shape portion of the electrode face to tissue.
Regarding claim 18, Davies in view of Kadowaki disclose all of the limitations of claim 11, as described above.
Davies further discloses wherein the distal tip electrode is a dome shape tip ([0057], [0092], & [0119]; the distal tip may be rounded or domed in order to reduce the risk of accidental puncture).
Regarding claim 19, Davies in view of Kadowaki disclose all of the limitations of claim 11, as described above.
Davies further discloses wherein the distal tip electrode is a bevel shape tip ([0054]).
Conclusion
Accordingly, claims 1-19 are rejected.
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.
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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
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