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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 4th, 2024 has been entered.
Response to Amendment
The amendment filed August 4th, 2024 has been entered. Claims 1, 6, 9, 12, 19-22, & 24 are amended. Claims 2-3 , 10-11, & 23 are canceled. Claim 25 is new. Claims 1, 4-9, 12-22, & 24-25 remain pending.
Response to Arguments
Applicant’s arguments, with respect to claims 1, 4-9, & 15-18 have been fully considered and are persuasive, in light of the claim amendments, therefore the previous rejection has been withdrawn.
Applicant’s arguments with respect to claims 12-14, 19-22, & 24-25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument; as necessitate by amendment.
Claim 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 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over by Fischer et al. (previously presented-US 20200093537 A1), hereinafter “Fischer”, in view of Horner et al. (US 20120215217 A1), hereinafter “Horner”.
Regarding claims 12-14, Fischer discloses an electrosurgical electrode for conveying electrical energy ([0052]; Figure 3 & 4—element 13), the electrosurgical electrode comprising: a proximal electrode end configured to receive electrical energy from an electrosurgical tool([0052] & [0057]; Figure 4—element 28); a distal electrode end ([0057]; Figure 4—element 38); a working end portion between the proximal electrode end and the distal electrode end ([0052] & [0057]; Figure 4—element 13; the examiner is considering the working end portion to be the portion of electrode 13 that extends between the proximal end 28 and distal end 32), wherein the working end portion is configured for cutting or coagulation of tissue using the electrical energy that is received by the proximal electrode end ([0085] & [0095]); a first lateral surface ([0053]; Figure 4—element 23a); a second lateral surface opposite the first lateral surface ([0053]; Figure 4—element 23b); a first major face extending between the first lateral surface and the second lateral surface on a first side of the electrosurgical electrode ([0053]; Figure 4—element 22a); a second major face extending between the first lateral surface and the second lateral surface on a second side of the electrosurgical electrode that is opposite the first side ([0053]; Figure 4—element 22b); one or more apertures extending entirely through a thickness of the electrosurgical electrode between the first major face and the second major face ([0071]; Figure 4—element 52); and at least one layer of an insulation material is coupled to an outer surface of the working end portion so that a first portion of the outer surface is covered by the at least one layer of the insulation material and a second portion of the outer surface is not covered by the at least one layer of the insulation material ([0029] & [0052]; Figure 3—element 16; the insulating body 16 encloses a part of the electrode 13 and leaves part of the electrode 13 exposed), wherein the at least one layer of the insulation material is configured to prevent applying electric current from the first portion of the outer surface to a tissue of a patient ([0029] & [0052]), wherein the at least one layer of the insulation material is coupled to the outer surface at the one or more apertures ([0071]; Figure 3 & 4—elements 16 & 52; the holes 52 are filled with the insulating body material during the manufacture of the insulating body 16 in order to form a lock between the insulating body 16 and the electrode 13).
Fischer does not disclose wherein the second portion is covered by a layer of a material that is configured to provide for applying electric current from the second portion of the outer surface to a tissue of a patient, and wherein the layer of the material that covers the second portion of the outer surface is a different material than the at least one layer of the insulation material that covers the first portion of the outer surface (claim 12); wherein the layer of the material is a non-stick coating (claim 13); wherein the layer of the material has a thickness that is less than a thickness of the at least one layer of the insulation material (claim 14).
Horner teaches an electrosurgical electrode comprising a first portion and a second portion ([0069]; Figure 2—element 108) cand at least one layer of insulation material that covers the first portion of the outer surface ([0072]-[0073]; Figure 2—element 122), wherein the second portion is covered by a layer of a material that is configured to provide for applying electric current from the second portion of the outer surface to a tissue of a patient, and wherein the layer of the material that covers the second portion of the outer surface is a different material than the at least one layer of the insulation material that covers the first portion of the outer surface (claim 12); wherein the layer of the material is a non-stick coating (claim 13); wherein the layer of the material has a thickness that is less than a thickness of the at least one layer of the insulation material (claim 14) ([0071], [0072], & [0088], Figure 2—elements 114 & 122; the first portion of the electrode is covered by the insulative sheath 122 that provides an insulative barrier between the covered portion and the patients tissue to allow exposed portion 114 to be used to perform electrosurgery; the exposed portion may also comprise a coating on non-stick material to reduce clinging of charred tissue and facilitate capacitive coupled of the electrode to patients tissue; it is the examiners position that the non-stick coating would have a thickness that is less than a thickness of the at least one layer of the insulation material in order to facilitate capacitive coupling to the exposed portion to a patients tissue to allow the exposed portion of the electrode to perform electrosurgery).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the second portion of the electrosurgical electrode, as disclosed by Fischer, to include wherein the second portion is covered by a layer of a material that is configured to provide for applying electric current from the second portion of the outer surface to a tissue of a patient, and wherein the layer of the material that covers the second portion of the outer surface is a different material than the at least one layer of the insulation material that covers the first portion of the outer surface, as taught by Horner, as both references and the claimed invention are directed toward electrosurgical electrodes for cutting and coagulating tissue. As disclosed by Horner, the second portion of the electrode may include a non-stick coating that serves to eliminate or reduce clinging or charred tissue to the electrode tip and facilitates capacitive coupling of the electrode to the patient’s tissue ([0071] & [0072]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the second portion of the electrosurgical electrode, as disclosed by Fischer, to include wherein the second portion is covered by a layer of a material that is configured to provide for applying electric current from the second portion of the outer surface to a tissue of a patient, and wherein the layer of the material that covers the second portion of the outer surface is a different material than the at least one layer of the insulation material that covers the first portion of the outer surface, as taught by Horner, as such a modification would reduce clinging of charred tissue to the exposed portion of the electrode tip.
Claims 19-22 & 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Greep et al. (previously presented-US 8439910 B2), hereinafter “Greep”, in view of Billings et al. (US 5395363 A), hereinafter “Billings”.
Regarding claim 19, Greep discloses an electrosurgical blade for conveying electrical energy ([Col. 7, line 60 – Col. 8, line 12]; Figure 3—element 122), the electrosurgical blade comprising: a proximal electrode end configured to receive electrical energy from an electrosurgical tool ([Col. 7, line 60 – Col. 8, line 12]; Figure 3—element 124); a distal electrode end ([Col. 7, line 60 – Col. 8, line 12]; Figure 3—element 128; the distal electrode end being the distal end of the working end 128); a working end portion between the proximal electrode end and the distal electrode end ([Col. 7, line 60 – Col. 8, line 12]; Figure 3—element 128; the working end portion being the working end 128), wherein the working end portion is configured for cutting or coagulation of tissue using the electrical energy that is received by the proximal electrode end ([Col. 7, lines 34-49] & [Col. 7, line 60 – Col. 8, line 12]); a first lateral surface ([Col. 7, line 60 – Col. 8, line 12]; Figures 3A & 3B—element 132A); a second lateral surface opposite the first lateral surface ([Col. 7, line 60 – Col. 8, line 12]; Figures 3A & 3B—element 132B); a first face extending between the first lateral surface and the second lateral surface on a first side of the electrosurgical blade ([Col. 7, line 60 – Col. 8, line 12]; Figures 3A & 3B—element 130A); a second face extending between the first lateral surface and the second lateral surface on a second side of the electrosurgical blade that is opposite the first side ([Col. 7, line 60 – Col. 8, line 12]; Figures 3A & 3B—element 130B); a body portion extending between the first lateral surface and the second lateral surface, wherein the body portion defines the first face and the second face ([Col. 7, line 60 – Col. 8, line 12]; Figures 3A & 3B—element 128; the body portion being the body of the working end 128 extending between the first lateral surface 132A and the second lateral surface 132B and defining the first face 130A and the second face 130B); and a plurality of teeth on at least one of the first lateral surface or the second lateral surface ([Col. 7, line 60 – Col. 8, line 12], [Col. 8, lines 13-43], [Col. 12, line 57 – Col. 13, line 3], [Col. 15, lines 35-49], & [Col. 16, line 65 – Col. 17, line 64]; Figures 3 & 3A—elements 134A & 134B; Figure 17—element 346; the first lateral surface and the second lateral surface 132A & 132B each define a flash edge 134A & 134B; to enhance or alter the performance characteristics of the electrode tip the flash edges can be formed with dimensions that are non-uniform or change along the working surface for example the flash edges can comprise a saw-tooth configuration 346; “flash edge may take the form of any of the flash edges shown or described herein”), wherein the plurality of teeth can each taper from (i) a base extending from the at least one of the first lateral surface or the second lateral surface ([Col. 17, lines 22-49]; Figure 17—elements 348/352/356/360/364/368; with the base being the valleys of the plurality of teeth 348/352/356/360/364/368), to (ii) a respective tip point ([Col. 17, lines 22-49]; Figure 17—elements 350/354/358/362/366/370; with the respective tip point being the peaks of the plurality of teeth 350/354/358/362/366/370), at least one layer of an insulation material covering the body portion of the electrosurgical blade ([Col. 6, lines 49-54] & [Col. 8, lines 13-26]; Figure 3A—element 136), wherein the plurality of teeth on the at least one of the first lateral surface or the second lateral surface protrude through the at least one layer of the insulation material ([Col. 17, line 65 – Col. 18, lines 25] & [Col. 18, line 39 – Col. 19, line 4]; Figure 8A—element 284).
Greep does not disclose wherein the plurality of teeth protrude through the at least one layer of the insulation material such that (i) the tip points of the plurality of teeth are exposed and extend outwardly of the at least one layer of the insulation material and (ii) the respective bases of the plurality of teeth are covered by the at least one layer of the insulation material.
Billings teaches an electrosurgical electrode comprising a plurality of teeth ([Col. 6, lines 30-41]; Figure 4—elements 52 & 58) comprising at least one layer of insulation material ([Col. 6, lines 17-42]; Figure 4—element 56), wherein the plurality of teeth protrude through the at least one layer of the insulation material such that (i) the tip points of the plurality of teeth are exposed and extend outwardly of the at least one layer of the insulation material and (ii) the respective bases of the plurality of teeth are covered by the at least one layer of the insulation material ([Col. 6, lines 30-42]; Figure 4—elements 61; the tip points of the teeth can be exposed by sanding away portions of coating 56, such that coating 56 defines perforations 61 to expose tip points 60).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the at least one layer of the insulation material, as disclose by Greep, to include wherein the plurality of teeth protrude through the at least one layer of the insulation material such that (i) the tip points of the plurality of teeth are exposed and extend outwardly of the at least one layer of the insulation material and (ii) the respective bases of the plurality of teeth are covered by the at least one layer of the insulation material, as taught by Billings, as both references and the claimed invention are directed toward electrosurgical electrodes comprising a plurality of teeth and layers of insulation material. As disclosed by Greep, the lateral surfaces of the electrode may comprise a flash edge that may comprise a saw-tooth configuration, the entirety of the electrosurgical electrode including the flash edge may be coated with the insulation material, or alternatively the electrosurgical electrode may be partially coated with the including the flash edge such that the flash edges are not coated in order to produce a plurality of concentrated electrical discharge points on the electrosurgical electrode ([Col. 14, lines 41-64], [Col. 17, lines 22-49], [Col. 17, line 65 – Col. 18, line 25], & [Col. 18, line 39 – Col. 19, line 17]). As disclosed by Billings, the electrosurgical electrode may comprise a saw-tooth configuration, the entirety of the electrosurgical electrode including the saw-tooth portion may be coating with the insulation material, or alternatively the bases of the plurality of teeth may be covered with the insulation material while the tip points of the plurality of teeth are exposed from the at least one layer of the insulation material, in order to produce a plurality of concentrated electrical discharge points on the electrosurgical electrode ([Col. 6, lines 30-55]). 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 at least one layer of the insulation material, as disclose by Greep, to include wherein the plurality of teeth protrude through the at least one layer of the insulation material such that (i) the tip points of the plurality of teeth are exposed and extend outwardly of the at least one layer of the insulation material and (ii) the respective bases of the plurality of teeth are covered by the at least one layer of the insulation material, as taught by Billings, as such a modification would provide for a suitable and known configuration for a layer of the insulation material so as to produce the predictable result of providing a plurality of concentrated electrical discharge points on the electrosurgical electrode.
Regarding claim 20, Greep in view of Billings disclose all of the limitations of claim 19, as described above.
Greep further discloses wherein the plurality of teeth are on the first lateral surface and the second lateral surface ([Col. 7, line 60 – Col. 8, line 12], [Col. 8, lines 13-43], [Col. 12, line 57 – Col. 13, line 3], [Col. 15, lines 35-49], & [Col. 16, line 65 – Col. 17, line 64]; Figures 3 & 3A—elements 134A & 134B; Figure 17—element 346; the first lateral surface and the second lateral surface 132A & 132B each define a flash edge 134A & 134B; to enhance or alter the performance characteristics of the electrode tip the flash edges can be formed with dimensions that are non-uniform or change along the working surface for example the flash edges can comprise a saw-tooth configuration 346; “flash edge may take the form of any of the flash edges shown or described herein”).
Regarding claim 21, Greep in view of Billings disclose all of the limitations of claim 19, as described above.
Greep further discloses wherein the plurality of teeth are equally spaced along the at least the first lateral surface or the second lateral surface ([Col. 17, lines 22-57]; Figure 17—element 346; the heights, widths, and lengths of segments 348, 350, 352, 354, 356, 358, 360, 362, 364, 366, 368, & 370 can be uniform or constant).
Regarding claim 22, Greep in view of Billings disclose all of the limitations of claim 19, as described above.
Greep further discloses wherein a distance between a first pair of adjacent teeth of the plurality of teeth is different than a distance between a second pair of adjacent teeth of the plurality of teeth ([Col. 17, lines 22-57]; Figure 17—element 346; the heights, widths, and lengths of segments 348, 350, 352, 354, 356, 358, 360, 362, 364, 366, 368, & 370 may have dimensions that are different from one another).
Regarding claim 24, Greep in view of Billings disclose all of the limitations of claim 19, as described above.
Greep further discloses wherein the plurality of teeth are on the first lateral surface, the second lateral surface, and a distal-most end of the working end portion, and wherein the distal-most end of the working end portion extends between the first lateral surface, the second lateral surface, the first face, and the second face ([Col. 7, line 60 – Col. 8, line 12], [Col. 8, lines 13-43], [Col. 12, line 57 – Col. 13, line 3], [Col. 15, lines 35-49], & [Col. 16, line 65 – Col. 17, line 64]; Figures 3 & 3A—elements 134A, 134B, & 134C; Figure 17—element 346; the first lateral surface 132A, the second lateral surface 132B, and a distal-most end of the working end portion 132C each define a respective flash edge 134A, 134B, & 134C; to enhance or alter the performance characteristics of the electrode tip the flash edges can be formed with dimensions that are non-uniform or change along the working surface for example the flash edges can comprise a saw-tooth configuration 346; “flash edge may take the form of any of the flash edges shown or described herein”).
Regarding claim 25, Greep in view of Billings disclose all of the limitations of claim 19, as described above.
Greep further discloses wherein the plurality of teeth extend outwardly along a plane that is (i) parallel to a plane defined by a width and a length of the working end portion, and (ii) perpendicular to a thickness of the working end portion, wherein the width is defined between the first lateral surface and the second lateral surface, wherein the length is defined between the proximal electrode end and the distal electrode end, and wherein the thickness is defined between the first face and the second face ([Col. 7, line 60 – Col. 8, line 12], [Col. 8, lines 13-43], [Col. 12, line 57 – Col. 13, line 3], [Col. 15, lines 35-49], & [Col. 16, line 65 – Col. 17, line 64]; Figures 3 & 3A—elements 134A, 134B, & 134C; Figure 17—element 346; the first lateral surface 132A, the second lateral surface 132B, and a distal-most end of the working end portion 132C each define a respective flash edge 134A, 134B, & 134C; to enhance or alter the performance characteristics of the electrode tip the flash edges can be formed with dimensions that are non-uniform or change along the working surface for example the flash edges can comprise a saw-tooth configuration 346; “flash edge may take the form of any of the flash edges shown or described herein”).
Allowable Subject Matter
Claims 1, 4-9, & 15-18 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Independent claim 1, as amended, recites “an electrosurgical electrode for conveying electrical energy, the electrosurgical electrode comprising: a proximal electrode end configured to receive electrical energy from an electrosurgical tool; a distal electrode end; a working end portion between the proximal electrode end and the distal electrode end, wherein the working end portion is configured for cutting or coagulation of tissue using the electrical energy that is received by the proximal electrode end; a first lateral surface; a second lateral surface opposite the first lateral surface; a first major face extending between the first lateral surface and the second lateral surface on a first side of the electrosurgical electrode; a second major face extending between the first lateral surface and the second lateral surface on a second side of the electrosurgical electrode that is opposite the first side; one or more apertures extending entirely through a thickness of the electrosurgical electrode between the first major face and the second major face; and at least one layer of an insulation material disposed over an outer surface of the working end portion so that a first portion of the outer surface is covered by the at least one layer of the insulation material and a second portion of the outer surface is not covered by the at least one layer of the insulation material, wherein the at least one layer of the insulation material is configured to prevent applying electric current from the first portion of the outer surface to a tissue of a patient, wherein the at least one layer of the insulation material is coupled to the outer surface at the one or more apertures, wherein the at least one layer of the insulation material is a continuous loop extending through the one or more apertures from the first major face to the second major face, and wherein the at least one layer of the insulation material is a solid structure that allows for play between the at least one layer of the insulation material and the outer surface of the working end portion such that the at least one layer of the insulation material is movable relative to the outer surface of the working end portion”. The Fischer reference provides a teaching for an electrosurgical electrode for conveying electrical energy ([0052]; Figure 3 & 4—element 13), the electrosurgical electrode comprising: a proximal electrode end configured to receive electrical energy from an electrosurgical tool ([0052] & [0057]; Figure 4—element 28); a distal electrode end ([0057]; Figure 4—element 38); a working end portion between the proximal electrode end and the distal electrode end ([0052] & [0057]; Figure 4—element 13; the examiner is considering the working end portion to be the portion of electrode 13 that extends between the proximal end 28 and distal end 32), wherein the working end portion is configured for cutting or coagulation of tissue using the electrical energy that is received by the proximal electrode end ([0083] & [0095]); a first lateral surface ([0053]; Figure 4—element 23a); a second lateral surface opposite the first lateral surface ([0053]; Figure 4—element 23b); a first major face extending between the first lateral surface and the second lateral surface on a first side of the electrosurgical electrode ([0053]; Figure 4—element 22a); a second major face extending between the first lateral surface and the second lateral surface on a second side of the electrosurgical electrode that is opposite the first side ([0053]; Figure 4—element 22b); one or more apertures extending entirely through a thickness of the electrosurgical electrode between the first major face and the second major face ([0071]; Figure 4—element 52); and at least one layer of an insulation material disposed over an outer surface of the working end portion so that a first portion of the outer surface is covered by the at least one layer of the insulation material and a second portion of the outer surface is not covered by the at least one layer of the insulation material ([0029] & [0052]; Figure 3—element 16; the insulating body 16 encloses a part of the electrode 13 and leaves part of the electrode 13 exposed), wherein the at least one layer of the insulation material is configured to prevent applying electric current from the first portion of the outer surface to a tissue of a patient ([0029] & [0052]), wherein the at least one layer of the insulation material is coupled to the outer surface at the one or more apertures ([0071]; Figure 3 & 4—elements 16 & 52; the holes 52 are filled with the insulating body material during the manufacture of the insulating body 16 in order to form a lock between the insulating body 16 and the electrode 13), wherein the at least one layer of the insulation material is a continuous loop extending through the one or more apertures from the first major face to the second major face ([0032], [0035], [0052], [0057], & [0071]; Figure 3—element 16; the insulating body consists of a seamless single piece which encloses the electrode, the insulating body covers the upper and lower side of the electrode, and the insulating body is fabricated by casting such that the cast material penetrates through the electrode holes and solidifies in the electrode holes; as the insulating body appears to have a cylindrical shape (as shown in figure 3) wherein the insulating body is a single piece and is solidified in the electrode holes, the examiner is considering the insulation body to be a continuous loop); however, the Fischer reference does not provide a teaching for “wherein the at least one layer of the insulation material is a solid structure that allows for play between the at least one layer of the insulation material and the outer surface of the working end portion such that the at least one layer of the insulation material is movable relative to the outer surface of the working end portion”. The examiner notes that no other reference or combination of references have been found to disclose, fairly suggest, or make obvious each and every limitations set forth in independent claim 1. Dependent claims 4-9, & 15-18 are also allowed as they depend from independent claim 1.
Conclusion
Accordingly, claims 12-14, 19-22, & 24-25 are rejected. Claims 1, 4-9, & 15-18 are allowed.
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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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794