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 November 18th, 2025 has been entered. Claims 1 & 6 are amended. Claims 1-20 remain pending; claims 11-20 are withdrawn from consideration.
Response to Arguments
Applicant’s arguments with respect to claims 1-10 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 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, 4-6, & 8 are rejected under 35 U.S.C. 103 as being unpatentable over Sagon et al. (US 20040092806 A1), hereinafter “Sagon”, in view of Chou et al. (previously presented-US 20150366508 A1), hereinafter “Chou”.
Regarding claim 1, Sagon discloses an apparatus, comprising: a tube ([0050]; Figures 1, 2, 4, & 12—element 3); a tip electrode coupled to a distal end of the tube ([0058], [0069], & [0070]; Figure 12—element 57; distal cap 57 may be electrically conductive such that RF ablation energy can be delivered to the conductive distal cap 57) and comprising a cylindrical body and a dome section at a distal portion of the tip electrode, the dome section comprising a flat distal end and a curved portion that extends from the flat distal end to the cylindrical body, the flat distal end being positioned orthogonally with respect to an axis of the cylindrical body ([0058], [0069], & [0070]; Figure 12—elements 20, 22, 57; the examiner is considering the cylindrical body to be the cylindrically-shaped portion 22 of the distal cap, the curved portion to be the curved sides of the dome-shaped portion 20 of the distal cap 57, and the flat distal end to be the distal tip of the dome-shaped portion 20 which appears to be flat), the curved portion defining at least one cavity and facing outward from the tip electrode at an angle with respect to the axis ([0057] & [0058]; Figures 4 & 12—elements 20 & 47; the mapping electrodes 47 are disposed within apertures defined the dome-shaped portion 20 of the distal cap 57 and may be positioned at a 45 degree angle with respect to the axis extending the length of the catheter; the examiner is considering the at least one cavity to be the apertures in which the mapping electrodes 47 are disposed); a microelectrode disposed within the cavity and comprising an outer surface that is of lesser convexity than that of a portion of the tip electrode surrounding the cavity ([0055], [0057], & [0058]; Figure 4, 6, & 12—elements 47; although the mapping electrodes 47 as shown as dome-shaped, “the mapping electrodes of any of the illustrated embodiments may alternatively be flat”, as the portion of the tip electrode surrounding the cavity is dome-shaped (e.g. curved) and the microelectrodes 47 may be flat, it is the examiners position that the flat microelectrode surface would be of lesser convexity than the dome-shaped (e.g. curved) surface of the tip electrode surrounding the cavity).
Sagon does not disclose a conductive polymeric coating that coats the outer surface.
Chou teaches an electrosurgical device comprising a microelectrode comprising an outer surface ([0151]; Figure 7A—element 152), and a conductive polymeric coating that coats the outer surface ([0020], [0096], [0101]; the microelectrode may comprise a conductive coating such as PEDOT).
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 surface of the microelectrode, as disclosed by Sagon, to include a conductive polymeric coating that coats the outer surface, as taught by Chou, as both references and the claimed invention are directed toward catheters comprising a plurality of microelectrodes for mapping. As disclosed by Chou, the electrodes can be coated with a conductive polymer, such as PEDOT, in order to reduce impedance at one or more frequencies and therefore allowing the mapping electrodes to achieve high-fidelity recording of signal frequencies greater than or equal to 0.1Hz ([0020], [0096], & [0161]). 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 surface of the microelectrode, as disclosed by Sagon, to include a conductive polymeric coating that coats the outer surface, as taught by Chou, as such a modification would reduce impedance at one or more frequencies and therefore allow the mapping electrodes to achieve high-fidelity recording of signal frequencies greater than or equal to 0.1Hz.
Regarding claim 4, Sagon in view of Chou disclose all of the limitations of claim 1, as described above.
Sagon in view of Chou disclose the outer surface comprising the conductive polymeric coating (as described in the above rejection of claim 1).
Sagon further discloses an electrically-insulative rim surrounding the microelectrode and protruding beyond the outer surface ([0070]; Figure 12—element 77; the insulating sleeve 77 may extend beyond mapping electrodes 47 over the surface of the distal cap 57 in a gasket like formation in order to insulate the mapping electrodes from the conductive distal cap 57 and prevent the delivery of excess ablation energy to tissue from the edges of the cavities); the examiner is considering the electrically-insulative rim to be the portion of insulation sleeve 77 that extends “beyond mapping electrodes 47”; it is the examiners position that the rim would still protrude beyond the outer surface containing the conductive polymeric coating (as described in the above rejection of claim 1) by the same distance so as to insulate the mapping electrodes from the conductive distal cap 57 and prevent the delivery of excess ablation energy to tissue from the edges of the apertures).
Regarding claim 5, Sagon in view of Chou disclose all of the limitations of claim 4, as described above.
Sagon further discloses an electrical insulator surrounding the microelectrode within the cavity, wherein the electrical insulator comprises the electrically- insulative rim ([0070]; Figure 12—element 77; the examiner is considering the electrical insulator to be the portion of insulator 77 extending within the cavity formed in the conductive distal cap 57 and the electrically insulative rim to be the portion of insulator that extends “beyond mapping electrodes 47”).
Regarding claim 6, Sagon discloses an apparatus, comprising: a tube ([0050]; Figures 1, 2, 4, & 12—element 3); a tip electrode coupled to a distal end of the tube ([0058], [0069], & [0070]; Figure 12—element 57; distal cap 57 may be electrically conductive such that RF ablation energy can be delivered to the conductive distal cap 57) and comprising a cylindrical body and a dome section at a distal portion of the tip electrode, the dome section comprising a flat distal end and curved portion that extends from the flat distal end to the cylindrical body, the flat distal end being positioned orthogonally with respect to an axis of the cylindrical body ([0058], [0069], & [0070]; Figure 12—elements 20, 22, 57; the examiner is considering the cylindrical body to be the cylindrically-shaped portion 22 of the distal cap, the curved portion to be the curved sides of the dome-shaped portion 20 of the distal cap 57, and the flat distal end to be the distal tip of the dome-shaped portion 20 that appears to be flat), the curved portion defining at least one cavity and facing outward from the tip electrode at an angle with respect to the axis ([0057] & [0058]; Figures 4 & 12—elements 47; the mapping electrodes 47 are disposed within apertures on the dome-shaped portion 20 of the distal cap 57and may be positioned at a 45 degree angle with respect to the axis extending the length of the catheter; the examiner is considering the at least one cavity to be the apertures in which the mapping electrodes 47 are disposed); a microelectrode disposed within the cavity and comprising an outer surface ([0055], [0057], & [0058]; Figure 4, 6, & 12—elements 47); and an electrically-insulative rim surrounding the microelectrode and protruding beyond the outer surface ([0070]; Figure 12—element 77; the insulating sleeve 77 may extend beyond mapping electrodes 47 over the surface of the distal cap 57 in a gasket like formation in order to insulate the mapping electrodes from the conductive distal cap 57 and prevent the delivery of excess ablation energy to tissue from the edges of the cavities); the examiner is considering the electrically-insulative rim to be the portion of insulation sleeve 77 that extends “beyond mapping electrodes 47”).
Sagon does not disclose a conductive polymeric coating that coats the outer surface.
Chou teaches an electrosurgical device comprising a microelectrode comprising an outer surface ([0151]; Figure 7A—element 152), and a conductive polymeric coating that coats the outer surface ([0020], [0096], [0101]; the microelectrode may comprise a conductive coating such as PEDOT).
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 surface of the microelectrode, as disclosed by Sagon, to include a conductive polymeric coating that coats the outer surface, as taught by Chou, as both references and the claimed invention are directed toward catheters comprising a plurality of microelectrodes for mapping. As disclosed by Chou, the electrodes can be coated with a conductive polymer, such as PEDOT, in order to reduce impedance at one or more frequencies and therefore allowing the mapping electrodes to achieve high-fidelity recording of signal frequencies greater than or equal to 0.1Hz ([0020], [0096], & [0161]). 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 surface of the microelectrode, as disclosed by Sagon, to include a conductive polymeric coating that coats the outer surface, as taught by Chou, as such a modification would reduce impedance at one or more frequencies and therefore allow the mapping electrodes to achieve high-fidelity recording of signal frequencies greater than or equal to 0.1Hz.
Regarding claim 8, Sagon in view of Chou disclose all of the limitations of claim 6, as described above.
Sagon further discloses an electrical insulator surrounding the microelectrode within the cavity, wherein the electrical insulator comprises the electrically-insulative rim ([0070]; Figure 12—element 77; the examiner is considering the electrical insulator to be the portion of insulator 77 extending within the cavity formed in the conductive distal cap 57 and the electrically insulative rim to be the portion of insulator that extends “beyond mapping electrodes 47”).
Claims 2 & 7 are rejected under 35 U.S.C. 103 as being unpatentable over Sagon in view of Chou and Rogers et al. (previously presented-US 20150141767 A1), hereinafter “Rogers”.
Regarding claim 2, Sagon in view of Chou disclose all of the limitations of claim 1, as described above.
Sagon in view of Chou do not explicitly disclose wherein the conductive polymeric coating comprises poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS).
Rogers teaches an electrode for mapping tissue electrical activity ([0027]), the outer surface of the electrode is coated with a conductive polymeric coating, wherein the conductive polymeric coating comprises poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS) ([0076] & [0493]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the conductive polymeric coating material, as disclosed by Sagon in view of Chou, to include the conductive polymeric coating comprising the material poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS), as taught by Rogers, as all references and the claimed invention are directed toward mapping electrodes. As disclosed by Chou, and as described in the above rejection of claim 1, the electrodes can be coated with a conductive polymer, such as PEDOT, in order to reduce impedance at one or more frequencies and therefore allowing the mapping electrodes to achieve high-fidelity recording of signal frequencies greater than or equal to 0.1Hz ([0020], [0096], & [0161]). As disclosed by Rogers, the electrodes can be coated with a low impedance material such as poly(3,4-ethylenedioxythiophene)polystyrene sulfonate (PEDOT:PSS) ([0076] & [0493]). 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 conductive polymeric coating material, as disclosed by Sagon in view of Chou, to include the conductive polymeric coating comprising the material poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS), as taught by Rogers, as such a modification would produce the predictable result of providing a known low-impedance conductive polymeric coating material suitable for use on a mapping electrode; 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 modify the conductive polymeric coating, as disclosed by Sagon in view of Chou, to include the conductive polymeric coating comprising the material poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS), 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 7, Sagon in view of Chou disclose all of the limitations of claim 6, as described above.
Sagon in view of Chou do not explicitly disclose wherein the conductive polymeric coating comprises poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS).
Rogers teaches an electrode for mapping tissue electrical activity ([0027]), the outer surface of the electrode is coated with a conductive polymeric coating, wherein the conductive polymeric coating comprises poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS) ([0076] & [0493]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the conductive polymeric coating material, as disclosed by Sagon in view of Chou, to include the conductive polymeric coating comprising the material poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS), as taught by Rogers, as all references and the claimed invention are directed toward mapping electrodes. As disclosed by Chou, and as described in the above rejection of claim 6, the electrodes can be coated with a conductive polymer, such as PEDOT, in order to reduce impedance at one or more frequencies and therefore allowing the mapping electrodes to achieve high-fidelity recording of signal frequencies greater than or equal to 0.1Hz ([0020], [0096], & [0161]). As disclosed by Rogers, the electrodes can be coated with a low impedance material such as poly(3,4-ethylenedioxythiophene)polystyrene sulfonate (PEDOT:PSS) ([0076] & [0493]). 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 conductive polymeric coating material, as disclosed by Sagon in view of Chou, to include the conductive polymeric coating comprising the material poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS), as taught by Rogers, as such a modification would produce the predictable result of providing a known low-impedance conductive polymeric coating material suitable for use on a mapping electrode; 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 modify the conductive polymeric coating, as disclosed by Sagon in view of Chou, to include the conductive polymeric coating comprising the material poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS), 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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Sagon in view of Chou and Sharkey et al. (previously presented-US 6168593 B1), hereinafter “Sharkey”.
Regarding claim 3, Sagon in view of Chou disclose all of the limitations of claim 1, as described above.
Sagon does not disclose wherein the outer surface comprises a concave surface.
Sharkey teaches an electrosurgical device for ablation and sensing ([Col. 4, lines 5-20]), comprising an electrode with an outer surface ([Col. 6, line 60 – Col. 7, line 12]; Figures 4B-4E—element 420), wherein the outer surface comprises a concave surface ([Col. 7, lines 45-58]; electrode surfaces can be flat, convex, or concave; concave surfaces allow better thermal conductivity and reduced thermal fluctuation).
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 surface shape, as disclosed by Sagon, to include wherein the outer surface comprises a concave surface, as taught by Sharkey, as both references and the claimed invention are directed toward electrosurgical devices for sensing and ablating tissue. As disclosed by Sagon, the mapping electrodes may have any numerous shapes, for example the mapping electrodes may be square, oval, hexagonal, octagonal, dome-shaped, flat, or any other shape that may be readily imagined by one skilled in the art ([0055]). As disclosed by Sharkey, electrode surfaces can be flat, convex, or concave, the choice of surface profiles depend on the surgical environment, a concave surface has the advantage of isolating the surgical site which allows better thermal conductivity and reduced thermal fluctuation ([Col. 7, lines 45-58]). 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 surface shape, as disclosed by Sagon, to include wherein the outer surface comprises a concave surface, as taught by Sharkey, as such a modification would provide for a suitable and known electrode shape in the art and further would provide the advantage of isolating the surgical site which allows better thermal conductivity and reduced thermal fluctuation.
Claims 9 & 10 is rejected under 35 U.S.C. 103 as being unpatentable over Sagon in view of Chou and Kim et al. (previously presented-US 20100331658 A1), hereinafter “Kim”.
Regarding claim 9, Sagon in view of Chou disclose all of the limitations of claim 6, as described above.
Sagon does not disclose wherein a height of the electrically-insulative rim is at least approximately 0.1 mm.
Kim teaches a tip electrode comprising at least one cavity ([0023] & [0025]; Figure 1A—element 102), a microelectrode disposed within the cavity and comprising an outer surface ([0004], [0005], [0023], & [0024]; Figure 1A & 1B—element 103; with said outer surface being the exterior surface of electrode 103 facing away from insert 104 & tip 102), an electrically-insulative rim surrounding the microelectrode and protruding beyond the outer surface ([0024] & [0028];Figure 1A & 1C—element 108; Figure 3C—element 308 & 316; the examiner is considering the “rim” to be the lip 316 of the noise artifact isolator 108/308) wherein a height of the electrically-insulative rim is at least approximately 0.1 mm ([0028]; the lip/rim extends a distance in a range of 0.002 to 0.020 inches past the surface of the 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 electrically-insulative rim, as disclosed by Sagon, to include wherein a height of the electrically-insulative rim is at least approximately 0.1 mm, as taught by Kim, as both references and the claimed invention are directed toward ablation catheter comprising microelectrodes with electrically-insulative rims. As disclosed by Sagon, the electrically-insulative rim may extend beyond the microelectrode so as to electrically isolate the microelectrodes from the ablation electrode ([0070]). As disclosed by Kim, the electrically insulative rim may extend beyond the microelectrode by a distance within the range of 0.002 to 0.020 inches past the surface of the microelectrode so as to electrically isolate the microelectrode from the ablation electrode ([0028]). 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 electrically-insulative rim, as disclosed by Sagon, to include wherein a height of the electrically-insulative rim is at least approximately 0.1 mm, as taught by Kim, as such a modification would provide for a known and suitable distance for the electrically insulative rim to extend beyond the surface of the microelectrode in order to produce the predictable result of electrically isolating the microelectrode from the ablation electrode. The examiner further notes it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein a height of the electrically-insulative rim is at least approximately 0.1 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.
Regarding claim 10, Sagon in view of Chou disclose all of the limitations of claim 6, as described above.
Sagon does not disclose wherein a height of the electrically-insulative rim is less than approximately 0.5 mm.
Kim teaches a tip electrode comprising at least one cavity ([0023] & [0025]; Figure 1A—element 102), a microelectrode disposed within the cavity and comprising an outer surface ([0004], [0005], [0023], & [0024]; Figure 1A & 1B—element 103; with said outer surface being the exterior surface of electrode 103 facing away from insert 104 & tip 102), an electrically-insulative rim surrounding the microelectrode and protruding beyond the outer surface ([0024] & [0028];Figure 1A & 1C—element 108; Figure 3C—element 308 & 316; the examiner is considering the “rim” to be the lip 316 of the noise artifact isolator 108/308) wherein a height of the electrically-insulative rim is less than approximately 0.5 mm ([0028]; the lip/rim extends a distance in a range of 0.002 to 0.020 inches past the surface of the 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 electrically-insulative rim, as disclosed by Sagon, to include wherein a height of the electrically-insulative rim is less than approximately 0.5 mm, as taught by Kim, as both references and the claimed invention are directed toward ablation catheter comprising microelectrodes with electrically-insulative rims. As disclosed by Sagon, the electrically-insulative rim may extend beyond the microelectrode so as to electrically isolate the microelectrodes from the ablation electrode ([0070]). As disclosed by Kim, the electrically insulative rim may extend beyond the microelectrode by a distance within the range of 0.002 to 0.020 inches past the surface of the microelectrode so as to electrically isolate the microelectrode from the ablation electrode ([0028]). 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 electrically-insulative rim, as disclosed by Sagon, to include wherein a height of the electrically-insulative rim is less than approximately 0.5 mm, as taught by Kim, as such a modification would provide for a known and suitable distance for the electrically insulative rim to extend beyond the surface of the microelectrode in order to produce the predictable result of electrically isolating the microelectrode from the ablation electrode. The examiner further notes it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein a height of the electrically-insulative rim is less than approximately 0.5 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.
Conclusion
Accordingly, claims 1-10 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