DETAILED ACTION
This action is responsive to the preliminary amendment filed 1/3/23.
Claims 16-19, 21-36 are rejected.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 34 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.
Regarding claim 34, the claim recites “The apparatus of claim 32, further comprising a plug positioned between the outer sheath and each electrode member of the pair of electrode members, the plug being configured to seal a proximal end.” The examiner notes that claim 32 from which claim 34 depends recites ‘wherein each electrode member of the pair of electrode members includes a distal tip positioned distally to the distal end of the outer sheath’. Therefore, for the recited plug to be ‘between the outer sheath and each electrode member’ it would necessarily be located at a distal end of the outer sheath. Yet, claim 34 also requires that the plug is ‘configured to seal a proximal end’ which necessitates the plug to be located at the proximal end. Therefore, claim 34 is indefinite since it is unclear how the recited plug could both be ‘between the outer sheath and each electrode member’, implying that it is distally located, and also ‘configured to seal a proximal end’, which implies that it is proximally located.
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.
Claim(s) 16-18 and 28-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barry et al. (US 20160038219, “Barry”).
Regarding claim 16, Barry teaches an apparatus (Abstract, “An electrosurgical device and methods of use thereof.”), comprising: (a) a shaft assembly (Fig. 5, electrically insulative 108), wherein the shaft assembly comprises an outer sheath having a distal end (Fig. 5, shaft body 106 having distal end 138); and (b) an end effector located at the distal end of the outer sheath (Fig. 4a, first and second electrodes 102a-b located at distal end 138), wherein the end effector comprises: (i) a first electrode extending distally relative to the distal end of the outer sheath (Fig. 4a, first electrode 102a extending distally from shaft sleeve 300), wherein the first electrode defines a first lateral recess (Fig. 4b, groove 440a), (ii) a second electrode extending distally relative to the distal end of the outer sheath (Fig. 4a, second electrode 102b extending distally from shaft sleeve 300), wherein the second electrode defines a second lateral recess (Fig. 4b, groove 440b), wherein the first and second electrodes are operable to apply bipolar RF energy to tissue (Par. 16, “The electrosurgical unit 10 may be configured to provide both monopolar and bipolar radio-frequency (RF) power output.”), (iii) a first irrigation tube (Fig. 5, fluid exit lumen 134a) positioned in the first lateral recess (Fig. 4b, showing outlet 136a of fluid exit lumen 134a positioned in groove 440a), wherein the first irrigation tube is configured to dispense irrigation fluid (Par. 41, “Fluid 12 may comprise a liquid saline solution or another electrically conductive material. Further, an electrically non-conductive fluid may also be used with embodiments of the present disclosure.”) adjacent to the first electrode (Par. 31, “Fluid can exit lumens 134a, 134b through outlets 136a, 136b and travel along a groove 440a, 440b on the underside 406a, 406b of each electrode 102a, 102b and may further flow adjacent electrodes 102a, 102b such as known in the art.”), and (iv) a second irrigation tube (Fig. 5, fluid exit lumen 134b) positioned in the first second lateral recess (Fig. 4b, showing outlet 136b of fluid exit lumen 134b positioned in groove 440b), wherein the second irrigation tube is configured to dispense irrigation fluid adjacent to the second electrode (Par. 31, “Fluid can exit lumens 134a, 134b through outlets 136a, 136b and travel along a groove 440a, 440b on the underside 406a, 406b of each electrode 102a, 102b and may further flow adjacent electrodes 102a, 102b such as known in the art.”).
Regarding claim 17, Barry further teaches wherein the outer sheath further comprises a proximal end (Fig. 6, proximal end of shaft body 106 connecting with handle 101), wherein the outer sheath defines a full length extending between the distal end and the proximal end (Fig. 6 length of shaft body 106), wherein the first and second irrigation tubes extend along the full length of the outer sheath (Fig. 5, fluid delivery lumens 134a-b extending through the entire length of shaft body 106 in the fully extended configuration shown in figs. 4a-b).
Regarding claim 18, Barry further teaches wherein the shaft assembly further comprises a first electrode rod and a second electrode rod (Fig. 5, electrically conductive shafts 103a-b), wherein the first electrode is formed at a distal end of the first electrode rod, wherein the second electrode is formed at a distal end of the second electrode rod (Par. 23, “A first electrode 102a and a second electrode 102b extend from a distal end 138 of the shaft 108 and are coupled to parallel, self-supporting, electrically conductive hollow fluid delivery shafts 103a, 103b which comprise metal such as stainless steel tubing. Shafts 103a, 103b are in turn coupled to a source of electrical energy (e.g., monopolar and/or bipolar power of electrosurgical units 10, 500). Shafts 103a, 103b extend through linear conduits provided by cylindrical through passages 104a, 104b of shaft 108.”), wherein the first and second electrode rods extend through the outer sheath (Fig. 5, shafts 103a-b extending through shaft body 106).
Regarding claim 28, Barry further teaches wherein each of the first and second electrodes includes a tip protruding distally from the outer sheath (Fig. 4a and par. 27, “Electrodes 102a, 102b further include a distal or distal-most end or tips 402a, 402b which may comprise a U-shaped portion.”)
Regarding claim 29, Barry further teaches wherein each of the first and second irrigation tubes are positioned laterally to the tip of their respective first and second electrodes (Figs. 4a-b, fluid outlets 136a-b are laterally offset from tips 402a-b of electrodes 102a-b).
Regarding claim 30, Barry further teaches wherein each of the first and second electrodes includes a pair of flat surfaces configured to taper toward each other along a distal direction (Fig. 4a and par. 26, “Lateral edges 420a, 420b may further include a bevel on either or both sides thereof to provide a single or double bevel lateral edge, respectively. A bevel 418a, 418b provided on the first side 404a, 404b is shown in FIG. 4 and a second bevel on side 406a, 406b (not pictured) creates a double bevel lateral edge 420a, 420b.”).
Claim(s) 16, 21 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Conley et al. (US 20110319889, “Conley”).
Regarding claim 16, Conley teaches an apparatus (Abstract, “This invention provides an electrosurgical device […]”), comprising: (a) a shaft assembly, wherein the shaft assembly comprises an outer sheath (Fig. 8, shaft member 50) having a distal end (Fig. 8, distal end 58 of shaft member 50); and (b) an end effector located at the distal end of the outer sheath (Figs. 7-10, electrodes 100/102 at distal end 58 of shaft member 50), wherein the end effector comprises: (i) a first electrode extending distally relative to the distal end of the outer sheath (Figs. 7-10, electrode 100 extending distally to the distal end 58 of sheath member 50), wherein the first electrode defines a first lateral recess (Fig. 10, exit aperture 108; par. 61, “ Furthermore, as shown, exit apertures 108, 110 are proximal to a distal end of electrodes 100, 102, as well as located on lateral portions of electrodes 100, 102.”), (ii) a second electrode extending distally relative to the distal end of the outer sheath (Figs. 7-10, electrode 102 extending distally to the distal end 58 of sheath member 50), wherein the second electrode defines a second lateral recess (Fig. 10, exit aperture 110; par. 61, “ Furthermore, as shown, exit apertures 108, 110 are proximal to a distal end of electrodes 100, 102, as well as located on lateral portions of electrodes 100, 102.”), wherein the first and second electrodes are operable to apply bipolar RF energy to tissue (Par. 46, “In the illustrated embodiment, the RF power is bipolar and set to 200 watts. ”), (iii) a first irrigation tube positioned in the first lateral recess (Fig. 10, fluid delivery passage 104 within exit aperture 108), wherein the first irrigation tube is configured to dispense irrigation fluid adjacent to the first electrode (Par. 62, “After flowing through tubular fluid delivery passages 104, 106 of electrodes 100, 102, fluid 22 may be expelled from fluid outlets 108, 110 onto electrodes 100, 102.”), and (iv) a second irrigation tube positioned in the second lateral recess (Fig. 10, fluid delivery passage 106 within exit aperture 110), wherein the second irrigation tube is configured to dispense irrigation fluid adjacent to the second electrode (Par. 62, “After flowing through tubular fluid delivery passages 104, 106 of electrodes 100, 102, fluid 22 may be expelled from fluid outlets 108, 110 onto electrodes 100, 102.”).
Regarding claim 21, Conley further teaches wherein a first electrode sheath is positioned about a portion of the first electrode and configured to insulate the portion of the first electrode sheath (Figs. 7-10 and par. 57, “] Outer (lateral) passages 64, 66 of shaft member 50 more particularly comprise electrical passages which are parallel and isolated from one another, and which contain planar electrical conductors 70, 72. Electrical conductors 70, 72 extend along the complete length of passages 64, 66, and extend from entrance apertures 74, 76, respectively, of passages 64, 66 at a proximal end 56 of shaft member 50, as well as extend from exit apertures 78, 80 of passages 64, 66 at a distal end 58 of shaft member 50.”).
Regarding claim 22, Conley further teaches a cap at the distal end of the outer sheath (Figs. 7 and 10, the cap can be considered electrode receptables 88 and 90 located at distal end 58 of shaft 50; par. 58, “As shown, electrodes 100, 102 are seated in distal end electrode receptacles 88, 90 and electrical conductors 70, 72 extend through apertures 78, 80 within the receptacles 88, 90 at the base thereof for the electrical conductors 70, 72 to make contact with electrodes 100, 102.”), the cap being configured to separate the first electrode and the second electrode by a gap (Figs. 7-10 and par. 64, “As shown, electrodes 100, 102 may be laterally and spatially separated (by empty space)”).
Claim(s) 32-33 and 35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Witt et al. (US 20180085156, “Witt”).
Regarding claim 32, Witt teaches an apparatus (Abstract, “An end effector of an electrosurgical device may include a discharge port in communication with a first fluid path, an aspiration port in communication with a second fluid path, a first and second electrode, and a diverter in mechanical communication with the two electrodes.”), comprising: (a) an outer sheath defining a central longitudinal axis (Figs. 48-49, shaft 135 having a central longitudinal axis), the outer sheath being configured to provide suction at a distal end (Fig. 49, shaft 135 comprises a fluid aspiration port 165; par. 76, “The second fluid path, such as an aspirated fluid path (see 210 in FIG. 9), may permit a liquid mixture generated at the surgical site to flow from the fluid aspiration port 165 to the fluid evacuation port 110. The liquid mixture may then be removed from the electrosurgical device 100 by the vacuum source and stored in the storage component for later removal.”); (b) a pair of electrode members extending throughout the outer sheath (Fig. 48, showing electrodes 145a-b extending through shaft 135; par. 79, “Additionally, electrodes 145a,b may extend from housing 105 through shaft 135 and extend distally and protrude from the end of shaft 135. Alternatively, electrodes 145a,b may extend only through the shaft 135 and extend distally and protrude from the end of shaft 135.”), wherein each electrode member of the pair of electrode members includes a distal tip positioned distally to the distal end of the outer sheath (Fig. 48, tips of electrodes 145a-b are positioned distally to the distal end of shaft 135), wherein each electrode member of the pair of electrode members is positioned opposite to each other about the central longitudinal axis (Fig. 49, showing electrodes 145a-b positioned opposite to each other about the central longitudinal axis), wherein the distal tips of the electrode members are operable to apply bipolar (Par. 75, “a first electrode 145a may receive electrical energy of a first polarity (such as a positive polarity) from the energy supply 120 and the second electrode 145b may receive electrical energy of a second and opposing polarity (such as a negative polarity) from the energy supply 120”) RF energy to tissue (Par. 73, “The energy source 120 may be configured to supply energy (for example RF or radiofrequency energy) to the electrodes 145a,b.”); and (c) an irrigation tube extending throughout the outer sheath (Fig. 22 and par. 79, “It may be understood from FIGS. 11-21 that source fluid path 315 extends from fluid source port 115 through the housing 105 and through shaft 135 to the distal fluid discharge port 150.”) and including a distal opening (Fig. 48, fluid discharge port 150), the distal opening being positioned distally to the distal end of the outer sheath but proximal to each distal tip of the pair of electrode members (Fig. 48, showing discharge port 150 extending distally to shaft 135 but proximally to the tips of electrodes 145a-b), wherein the irrigation tube is configured to provide irrigation fluid to the distal end of the outer sheath (Par. 76, “The first fluid path, such as a source fluid path (see 315 in FIG. 11), may permit the fluid to flow from the fluid source port 115 to the fluid discharge port 150.”).
Regarding claim 33, Witt further teaches a suction port at a proximal end of the outer sheath (Fig. 3, showing evacuation port 110 at a proximal end of shaft 135; par. 72, “In some electrosurgical device systems, the fluid evacuation port 110 may be placed in fluid communication with a vacuum source.”), wherein the suction port is in fluid communication with the distal end of the outer sheath (Figs. 48-49, showing aspiration port 165 at the distal end of shaft 135; par. 76, “The end effector may also include a fluid aspiration port 165 that may be in fluid communication with the fluid evacuation port 110 through a second fluid path.”).
Regarding claim 35, Witt further teaches wherein each electrode member of the pair of electrode members comprises a rod (Par. 79, “Additionally, electrodes 145a,b may extend from housing 105 through shaft 135 and extend distally and protrude from the end of shaft 135. Alternatively, electrodes 145a,b may extend only through the shaft 135 and extend distally and protrude from the end of shaft 135. Proximal ends 345a,b of the electrodes 145a,b, may receive connectors to place the electrodes 145a,b in electrical communication with energy source 120.”; fig. 17, showing the proximal ends of 345a-b of the electrode rod extending out of the proximal end of shaft 135).
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.
Claim(s) 19, 23-26, and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Conley in view of Rydell et al. (US 5071419, “Rydell”).
Regarding claim 19, Conley fails to teach a proximal suction port located at a proximal end of the shaft assembly, wherein the proximal suction port is configured to couple with a source of suction, wherein the end effector further includes at least one distal suction port, wherein the shaft assembly is configured to communicate suction from the proximal suction port to the distal suction port.
Rydell teaches an analogous electrosurgical apparatus (Abstract, “An instrument for performing a percutaneous laparoscopic cholecystectomy”), comprising: (a) a shaft assembly (Fig. 3, tube 12), wherein the shaft assembly comprises an outer sheath (Fig. 3, outer wall of tube 12) having a distal end (Fig. 3, distal end of tube 12); and (b) an end effector located at the distal end of the outer sheath (Fig. 4, electrodes 62 and 64), wherein the end effector comprises: (i) a first electrode extending distally relative to the distal end of the outer sheath (Figs. 3-4, electrode 62; col. 4, lines 41-44, “In the arrangement of FIG. 3, rather than including a slot as at 22 in FIG. 2, the plug 56 includes a pair of closely spaced apertures 58 and 60 through which J-shaped hook electrodes 62 and 64 project.”), (ii) a second electrode extending distally relative to the distal end of the outer sheath (Figs. 3-4, electrode 66; col. 4, lines 41-44, “In the arrangement of FIG. 3, rather than including a slot as at 22 in FIG. 2, the plug 56 includes a pair of closely spaced apertures 58 and 60 through which J-shaped hook electrodes 62 and 64 project.”), wherein the first and second electrodes are operable to apply bipolar RF energy to tissue (Abstract, “A pair of conductors, connected at one end to the bipolar electrodes and at their other end to a source of radio frequency voltage,”), and (iii) an irrigation tube, wherein the first irrigation tube is configured to dispense irrigation fluid adjacent to the first electrode (Col. 4, lines 6-10, “The barb coupler 52 is adapted to be coupled to a further tube (not shown) leading to a source of flushing liquid, e.g., saline, which allows the flushing liquid to be perfused through the instrument and out its distal port 28.”; fig. 3, flushing port 70); and a cap at the distal end of the outer sheath (Figs. 3-4, plug 56), the cap being configured to separate the first electrode and the second electrode by a gap (Col. 4, lines 41-57, “In the arrangement of FIG. 3, rather than including a slot as at 22 in FIG. 2, the plug 56 includes a pair of closely spaced apertures 58 and 60 through which J-shaped hook electrodes 62 and 64 project […] A preferred spacing for the gap, g, between the electrodes 62 and 64 may be 0.015 inches and can be maintained by utilizing a rigid ceramic spacer bar as at 66 positioned a short predetermined distance (0.020-0.030 inches) from the free ends of the hook electrode 62 and 64.”); and a proximal suction port located at a proximal end of the shaft assembly (Fig. 3, proximal end 14 of tube 12; col. 3, lines 65-66, “The barb coupler 50 is in fluid communication with the bore 38 and, hence, the lumen 18 of the tube 12.”), wherein the proximal suction port is configured to couple with a source of suction (Col. 3, line 67-col. 4, line 2, “When a source of vacuum is joined to the barb coupler 50, via appropriate tubing, fluids can be aspirated through the distal bore or port 26 formed in the plug 20.”), wherein the end effector further includes at least one distal suction port (Figs. 3-4, aspiration port 68), wherein the shaft assembly is configured to communicate suction from the proximal suction port to the distal suction port (Col. 3, line 67-col. 4, line 2,).
Rydell further teaches that the aspiration port allows for irrigation fluid and blood to be removed from the treatment site (Col. 4, lines 24-25, “while a vacuum is applied, via barbed coupler 50, to allow the flushing liquid and blood to be removed.”).
Therefore, in view of Rydell, it would have been obvious to POSITA at the time that the invention was filed to modify Conley by configuring the device to apply a suction to the treatment site through a proximal suction port and a distal aspiration port, in order to configure the device to remove irrigation fluid and blood from the treatment site, as taught by Rydell.
Regarding claim 23, Conley, as modified, further teaches wherein the cap includes an opening into the outer sheath (Conley has previously been modified in view of Rydell to comprise an aspiration port; see Rydell, aspiration port 68 in plug 56), wherein the opening is configured to apply suction at the distal end of the outer sheath (See Rydell, col. 3, line 67-col. 4, line 2, “When a source of vacuum is joined to the barb coupler 50, via appropriate tubing, fluids can be aspirated through the distal bore or port 26 formed in the plug 20.”).
Regarding claim 24, Conley, as modified, further teaches a body positioned around the outer sheath (Conley has previously been modified in view of Rydell to comprise a proximal suction port; see Rydell, fig. 3 and col. 3, lines 48-53, “With continued reference to FIG. 1, it can be seen that there is affixed to the proximal end 14 of the tube 12 a molded plastic hub 36 having a bore 38 formed longitudinally therethrough into which the proximal end portion 14 of the tube 12 is inserted and adhesively bonded. ”) and configured to provide suction to an inner lumen of the outer sheath (See Rydell, col. 3, line 65-col. 4, line 2, “The barb coupler 50 is in fluid communication with the bore 38 and, hence, the lumen 18 of the tube 12. When a source of vacuum is joined to the barb coupler 50, via appropriate tubing, fluids can be aspirated through the distal bore or port 26 formed in the plug 20.”).
Regarding claim 25, Conley, as modified, further teaches wherein the outer sheath includes an opening (Conley has previously been modified in view of Rydell to comprise a proximal suction port; see Rydell, fig. 3, proximal opening in tube 12), wherein the body is positioned over the opening (See Rydell, fig. 3, plastic hub disposed over proximal end 14 of tube 12), wherein a port of the body is configured to be in fluid communication with a suction source and with the opening to thereby provide suction to the inner lumen of the outer sheath (See Rydell, col. 3, line 65-col. 4, line 2, “The barb coupler 50 is in fluid communication with the bore 38 and, hence, the lumen 18 of the tube 12. When a source of vacuum is joined to the barb coupler 50, via appropriate tubing, fluids can be aspirated through the distal bore or port 26 formed in the plug 20.”).
Regarding claim 26, Conley, as modified, further teaches a plug positioned radially around each of the first and second electrodes (Conley has previously been modified in view of Rydell to comprise a proximal suction port; see Rydell, fig. 3, plug 48 is extends radially beyond bore 38 which contains conductors 42 and 44) and configured to seal the outer sheath at a proximal end (See Rydell, fig. 3, plug 48 seals bore 38 at its proximal end and thus tube 12).
Regarding claim 31, Conley, as modified, further teaches that the apparatus is configured to provide irrigation fluid to a surgical site through the first and second irrigation tubes (Fig. 10, fluid delivery passages 104 and 106) and for the outer sheath to then suction the irrigation fluid out of the surgical site (Conley has previously been modified in view of Rydell to configure the device with an aspiration port; see Rydell, col. 4, lines 24-25, “while a vacuum is applied, via barbed coupler 50, to allow the flushing liquid and blood to be removed.”).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Conley in view of Rydell, as applied to claims 19, 23-26, and 31, above, and further in view of Desai (US 20030130575).
Regarding claim 27, Conley, as modified, fails to teach a seal positioned between the plug and the body, wherein the seal is configured to seal the outer sheath at a proximal end.
However, Desai teaches an analogous device (Abstract, “A method and apparatus wherein an application of energy is limited to a specific diseased portion of body tissue”), which utilizes O-rings between different device elements to seal device elements in order to maintain a sufficient vacuum (Fig. 21 and par. 97, “Similarly, an O-ring 396 can be placed between the apparatus 392 and the plug bore 398 for providing the required seal to retain the vacuum in the vaginal cavity 372”).
Therefore, in view of Desai, it would have been obvious to POSITA at the time that the invention was filed to provide O-rings between the plug and the body, in order to properly seal bore 38 (See Rydell, fig. 3) so as to maintain a sufficient vacuum, as taught by Desai.
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Witt in view of Conley.
Regarding claim 36, Witt teaches an apparatus (Abstract, “An end effector of an electrosurgical device may include a discharge port in communication with a first fluid path, an aspiration port in communication with a second fluid path, a first and second electrode, and a diverter in mechanical communication with the two electrodes.”), comprising: (a) an outer sheath (Figs. 48-49, shaft 135) configured to provide suction at a distal end (Fig. 49, shaft 135 comprises a fluid aspiration port 165; par. 76, “The second fluid path, such as an aspirated fluid path (see 210 in FIG. 9), may permit a liquid mixture generated at the surgical site to flow from the fluid aspiration port 165 to the fluid evacuation port 110. The liquid mixture may then be removed from the electrosurgical device 100 by the vacuum source and stored in the storage component for later removal.”); (b) a pair of electrodes extending throughout the outer sheath (Fig. 48, showing electrodes 145a-b extending through shaft 135; par. 79, “Additionally, electrodes 145a,b may extend from housing 105 through shaft 135 and extend distally and protrude from the end of shaft 135. Alternatively, electrodes 145a,b may extend only through the shaft 135 and extend distally and protrude from the end of shaft 135.”), wherein each electrode of the pair of electrodes includes a distal tip positioned distally to the distal end of the outer sheath (Fig. 48, tips of electrodes 145a-b are positioned distally to the distal end of shaft 135), wherein the pair of electrodes are operable to apply bipolar (Par. 75, “a first electrode 145a may receive electrical energy of a first polarity (such as a positive polarity) from the energy supply 120 and the second electrode 145b may receive electrical energy of a second and opposing polarity (such as a negative polarity) from the energy supply 120”) RF energy to tissue (Par. 73, “The energy source 120 may be configured to supply energy (for example RF or radiofrequency energy) to the electrodes 145a,b.”); and (c) an irrigation tube extending throughout the outer sheath (Fig. 22 and par. 79, “It may be understood from FIGS. 11-21 that source fluid path 315 extends from fluid source port 115 through the housing 105 and through shaft 135 to the distal fluid discharge port 150.”) and including a distal opening (Fig. 48, fluid discharge port 150), the distal opening being positioned distally to the distal end of the outer sheath but proximal to each distal tip of the pair of electrodes (Fig. 48, showing discharge port 150 extending distally to shaft 135 but proximally to the tips of electrodes 145a-b), wherein the irrigation tube is configured to provide irrigation fluid to the distal end of the outer sheath (Par. 76, “The first fluid path, such as a source fluid path (see 315 in FIG. 11), may permit the fluid to flow from the fluid source port 115 to the fluid discharge port 150.”).
Witt fails to teach wherein each electrode of the pair of electrodes includes a sheath about a portion of the electrode and configured to insulate the portion of the electrode.
Conley teaches an analogous apparatus (Abstract, “This invention provides an electrosurgical device […]”), comprising: (a) an outer sheath (Fig. 8, shaft member 50); (b) a pair of electrodes extending throughout the outer sheath (Fig. 8, conductors 70/72 extending through shaft 50 having electrodes 100/102 at their distal ends), wherein each electrode of the pair of electrodes includes a distal tip positioned distally to the distal end of the outer sheath (Fig. 7, electrodes 100/102 extending distally from the distal end of shaft 50), wherein each electrode of the pair of electrodes includes a sheath about a portion of the electrode and configured to insulate the portion of the electrode (Figs. 7-10 and par. 57, “] Outer (lateral) passages 64, 66 of shaft member 50 more particularly comprise electrical passages which are parallel and isolated from one another, and which contain planar electrical conductors 70, 72. Electrical conductors 70, 72 extend along the complete length of passages 64, 66, and extend from entrance apertures 74, 76, respectively, of passages 64, 66 at a proximal end 56 of shaft member 50, as well as extend from exit apertures 78, 80 of passages 64, 66 at a distal end 58 of shaft member 50.”), wherein the pair of electrodes are operable to apply bipolar RF energy to tissue (Par. 46, “In the illustrated embodiment, the RF power is bipolar and set to 200 watts. ”).
Therefore, in view of Conley, it would have been obvious to POSITA at the time that the invention was filed to provide each electrode of the pair of electrodes with an insulating sheath, in order to isolate the electrodes from each so as to prevent short-circuiting, as taught by Conley.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM JOSEPH AVIGAN whose telephone number is (571)270-3953. The examiner can normally be reached Monday-Friday 9am-5pm.
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ADAM JOSEPH. AVIGAN
Examiner
Art Unit 3739
/ADAM J AVIGAN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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