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 .
Claims 18-22 are withdrawn. A complete action on the merits of pending claims 1-17 appears herein.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/20/2025 has been entered.
Response to Arguments
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive.
Applicant argues “Applicant respectfully disagrees with the characterization of Aluru that electrode 104 is arranged so that the electrode "defines an opening to the evacuation lumen at an outermost edge of the distal end." Electrode 104 is not arranged on an edge as claimed, but rather on a planar surface - element 122.”
Examiner respectfully contends that, as seen in Fig 2B of Aluru and further discussed in the rejection to claim 1 below, Electrode 104 of Aluru defines openings to the evacuation lumen (Fig. 2B, Char. 130, 131, and 132: apertures) at an outermost edge of the distal end in at least the radial direction.
Applicant further argues “Further, electrode 104 and on shelf 122 are spaced proximally from the distal end 150/140, not at an outermost edge of the distal end.”
Examiner respectfully disagrees and contends that, as further discussed in the rejection to claim 1 below, given the term “distal end” broadest reasonable interpretation, the entirety of shaft distal portion (120) depicted in Fig. 2B of Aluru would be considered a “distal end” at least in that distal portion (120) is a portion of the distal half of the catheter shaft. Furthermore, as discussed above, electrode (104) and Shelf (122) of Aluru are disposed at an outermost edge in the radial direction.
Applicant further argues “Additionally, Aluru teaches it is desirable to space the shelf 122 and electrode away from the outermost surface 121 of the shaft. [0061].”
Examiner respectfully contends that, even if Aluru teaches it is desirable to space the shelf (122) and electrode (104) away from the shaft superior surface (121), one of ordinary skill in the art could make a similar spacing mechanism to space electrode (104) and the target tissue regardless of where electrode (104) is disposed on shaft distal portion (120), including if electrode (104) was disposed within plane (151) of Aluru.
Applicant further argues “The Office Action states it would have been obvious to modify Aluru to include the electrode 18 of Earley in place of the electrode 104 of Aluru such that the plate-like member 81 of Earley is disposed within plane 151 of Aluru. Applicant respectfully disagrees. A person of ordinary skill in the art would not be motivated to modify Aluru as suggested in the Action would impermissibly change the principle of operation of Aluru, or render Aluru unsatisfactory for its intended purpose, or both.”
Examiner respectfully disagrees and contends that, as further discussed in the rejection to claim 1 below, both Aluru and Earley are electrosurgical devices comprising planar electrode surfaces disposed on the distal ends of catheters, wherein said planar electrode surfaces comprise one or more openings/apertures connected to a suction lumen configured to collect/remove tissue/debris from the treatment zone; and wherein said planar electrode surfaces are configured to deliver electrosurgical energy to a target tissue such that said tissue is ablated. Therefore, as best understood by examiner, modifying Aluru as suggested in the final rejection to claim 1 dated 09/22/2025 would not impermissibly change the principle of operation of Aluru, or render Aluru unsatisfactory for its intended purpose, or both.”
Applicant further argues “First, Aluru describes the desirability of distal tip 140 being configured for the purpose of piercing or dissecting tissue. [0058]. In contrast, the distal tip arrangement of Earley is described as being configured for ablation, not piercing or dissecting tissue, and the projection 18 of Earley which are described as being "tissue-working" actually "have generally rounded tips." Earley [0039].
Examiner respectfully contends that distal tip (140) of Aluru is separate from plane (151) of Aluru and electrode (104) of Aluru. Therefore, Distal tip (140) would still be present in the proposed modification to Aluru discussed in the rejection to claim 1 below. Distal tip (140) would still be capable of piercing tissue regardless of projection (18) of Earley.
Applicant further argues “Second, rearranging the electrode structure as proposed would contradict the teaching in Aluru regarding relative positioning of the active electrode and the return electrode, as discussed in [0059]. The proposed modification would not position the active electrode "in such a way as to maintain a substantially uniform gap or dimension 106 between" the modified active electrode and return electrode 112, as depicted in Fig. 2B for example.
Examiner respectfully disagrees and contends that a substantially uniform gap or dimension (106) can be maintained by moving/shaping the tubular portion of return electrode (112) distally, such that the same gap is maintained at the new position.
Applicant’s arguments, see Remarks, filed 11/20/2025, with respect to the rejection(s) of claim(s) 1 under U.S.C. 103, regarding the amended claim limitations to claims 1 and 15 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Aluru (US 2014/0200581 A1) in view of Earley (US 2006/0235377 A1) in view of Bales (US 6,494,881 B1) in view of Tasto (US 2003/0055418 A1).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, 5, 12, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aluru (US 2014/0200581 A1) in view of Earley (US 2006/0235377 A1) in view of Bales (US 6,494,881 B1) in view of Tasto (US 2003/0055418 A1).
Regarding claim 1, Aluru teaches
an elongated body (Fig. 2A-E, Char. 112 and 100) extending from a proximal end to a distal end along a longitudinal axis (Fig. 2A-E) and defining an evacuation lumen configured to evacuate tissue from the distal end to the proximal end along the longitudinal axis; (Fig. 2E, Char. 135: suction lumen)
an irrigation channel carried by the elongated body, the irrigation channel configured to deliver a fluid to a target tissue adjacent to the distal end; (Fig. 2E, Char. 114: fluid supply lumen)
a coring electrode at the distal end of the elongated body, (Fig. 2C, Char. 104: active electrode) wherein the coring electrode defines an opening to the evacuation lumen (Fig. 2B, Char. 130, 131, 132) at an outermost edge of the distal end, (Fig. 2B: electrode (104) defines an outermost edge at least in that no portion of the device extends past the outermost top surface of electrode (104) in the section of support shelf (122) in which electrode (104) resides.), and wherein the coring electrode is configured to operate in a monopolar configuration to deliver radio frequency (RF) plasma energy to adjacent tissue to cut a volume of the target tissue; (Par. [0014]).
Aluru further teaches all surface areas, including the surface area of return electrode (112) may be altered or adjusted using coatings or electrical insulation so as to control the ratio between the wetted return electrode area and the active electrode surface area. (Par. [0070])
Aluru, as applied to claim 1 above, is silent regarding the opening to the evacuation lumen being coaxial with the longitudinal axis; and a dielectric coating on at least a distal portion of the elongated body, the dielectric coating electrically insulating the elongated body from target tissue and the volume of cut target tissue, wherein the dielectric coating comprises a ceramic material; and a depth gauge coupled to an exterior surface of the elongated body and configured to prevent further movement of the electrosurgical device after reaching a preset depth defined by the depth gauge, wherein the depth gauge comprises a disc shaped body orthogonal to the longitudinal axis.
Earley, in a similar field of endeavor, teaches an electrosurgical device comprising an elongated body extending from a proximal end to a distal end along a longitudinal axis (Fig. 6-7) and defining an evacuation lumen configured to evacuate tissue from the distal end to the proximal end along the longitudinal axis; (Fig. 7, Char. 73: suction tube) and an electrode at the distal end of the elongated body (Fig. 6-9, Char. 18: electrode), comprising a plate-like member configured to contact and ablate tissue. (Fig. 8-9, Char. 81: plate-like member; Par. [0039]: Projections (83) of plate-like member (81) define the tissue-working portions of electrode (18)) wherein the electrode defines an opening to the evacuation lumen at an outermost edge of the distal end, (Fig. 8-9, Char. 82: opening; Par. [0047]) wherein the opening to the evacuation lumen is coaxial with the longitudinal axis. (Fig. 8-9)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Aluru, as applied to claim 1 above, to incorporate the teachings of Earley, and reposition the electrode (104) of Aluru, such that electrode (104) is disposed within plane (151) of Aluru. Doing so would be a simple substitution of one electrode/suction lumen structure for another for the predictable result of ablating tissue and evacuating debris via an evacuation lumen, and would be a mere rearrangement of parts well within the ability of one of ordinary skill in the art.
The combination of Aluru/Earley, as applied to claim 1 above, is silent regarding a dielectric coating on at least a distal portion of the elongated body, the dielectric coating electrically insulating the elongated body from target tissue and the volume of cut target tissue, wherein the dielectric coating comprises a ceramic material; and a depth gauge coupled to an exterior surface of the elongated body and configured to prevent further movement of the electrosurgical device after reaching a preset depth defined by the depth gauge, wherein the depth gauge comprises a disc shaped body orthogonal to the longitudinal axis.
Bales, in a similar field of endeavor, teaches selectively coating an electrode surface with an insulative coating comprising ceramic materials. (Col. 1, Lines 53-65)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Aluru/Earley, as applied to claim 1 above, to incorporate the teachings of Bales, and selectively coat portions of return electrode (112) with insulative ceramic material in order to control the ratio of the wetted return electrode area and the active electrode surface area, as suggested in Aluru.
The combination of Aluru/Earley/Bales, as applied to claim 1 above, is silent regarding a depth gauge coupled to an exterior surface of the elongated body and configured to prevent further movement of the electrosurgical device after reaching a preset depth defined by the depth gauge, wherein the depth gauge comprises a disc shaped body orthogonal to the longitudinal axis.
Tasto, in a similar field of endeavor, teaches a depth gauge coupled (Fig. 11, Char. 352: mechanical stop) to an exterior surface of an elongated body (Fig. 11, Char. 200: catheter) and configured to prevent further movement of a surgical device after reaching a preset depth defined by the depth gauge, (Fig. 11 and Par. [0126]: The surgeon can adjust the maximum travel distance of catheter (200) using mechanical stop (352); In this case, stop (352) would be considered a depth gauge at least in that stop (352) would determine when catheter has reached the predefined depth limit.) wherein the depth gauge comprises a disc shaped body orthogonal to the longitudinal axis. (Fig. 11)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Aluru/Earley/Bales, as applied to claim 1 above, to incorporate the teachings of Tasto, and configure the device of Aluru to include the mechanical stop (352) of Tasto, such that the user can set a maximum translation distance for the device of Aluru within a target treatment zone. Doing so would minimize the risk of accidentally hurting the patient by translating the distal portion (120) of the device of Aluru too far distally.
Regarding claim 2, the combination of Aluru/Earley/Bales/Tasto, as applied to claim 1 above, teaches the coring electrode is configured to provide RF plasma energy in the range of about 200KHz to about 3.3MHz. (Aluru: Par. [0045])
Regarding claim 5, the combination of Aluru/Earley/Bales/Tasto, as applied to claim 1 above, teaches the tubular body comprises an electrically conductive material, (Aluru: Par. [0015]: Electrical energy is applied between the active and return electrodes) and wherein exposure of the conductive material at the distal end defines the coring electrode. (Aluru: Fig. 2B)
The combination of Aluru/Earley/Bales/Tasto, as applied to claim 1 above, is silent regarding the electrically conductive material being an electrically conductive metal.
Earley further teaches forming an ablative electrode out of an electrically conductive metal. (Par. [0039]: electrode (18) is made of conductive metal)
It has been held that “the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination”- MPEP 2144.07 In the instant case, one of ordinary skill in the art would recognize the benefits or suitability of the disclosed materials (e.g. cost-effectiveness, manufacturing feasibility, etc.) It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Aluru/Earley/Bales/Tasto, as applied to claim 1 above, to further incorporate the teachings of Earley and have the electrode (104) of Aluru be/include an electrically conductive metal as taught by Earley since these materials offer the benefits of cost-effectiveness, manufacturing feasibility, etc, as stated above, and are recognized in Earley as being suitable for the intended purpose of ablating a target tissue.
Regarding claim 12, the combination of Aluru/Earley/Bales/Tasto, as applied to claim 1 above, teaches the coring electrode is set at a bevel angle as measured from the longitudinal axis of the elongated body, and wherein the bevel angle extends along the opening of the evacuation lumen. (In the rejection to claim 1 above, the electrode (104) of Aluru was repositioned to be disposed within the plane (151) of Aluru. Given that Plane (151) is at a bevel angle as measured from the longitudinal axis of the elongated body, electrode (104) and apertures (130-132) would also be at the same bevel angle in the combination of Aluru/Earley/Bales/Tasto, as applied to claim 1 above.)
The combination of Aluru/Earley/Bales, as applied to claim 1 above, is silent regarding the bevel angle as measured from the longitudinal axis of the elongated body being within the range of about 100 to about 450.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to configure the bevel angle of Electrode (104) and plane (151) of Aluru to be within the range of about 100 to about 450 as measured from the longitudinal axis of the elongated body, 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 13, the combination of Aluru/Earley/Bales/Tasto, as applied to claim 1 above, teaches the elongated body comprises a cutting edge that defines the coring electrode. (Aluru: Par. [0046]: Electrode (104) is configured to be used to produce cutting effects in a target tissue. Therefore, any edge of electrode (104) would be considered a “cutting edge” defining electrode (104))
Claim(s) 3, 4, 10, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aluru (US 2014/0200581 A1) in view of Earley (US 2006/0235377 A1) in view of Bales (US 6,494,881 B1), in view of Tasto (US 2003/0055418 A1), as applied to claim 1 above, and further in view of Bass (US 6,102,855).
Regarding claim 3, the combination of Aluru/Earley/Bales/Tasto, as applied to claim 1 above, teaches the elongated body comprises a tubular body having an external surface and an interior surface defining the evacuation lumen, (Aluru: Par. [0073] and Fig. 2E, Char. 109: aspiration element).
The combination of Aluru/Earley/Bales/Tasto, as applied to claim 1 above, is silent regarding wherein the dielectric coating is applied to both the external surface and the interior surface over a length of the elongated body.
Bass, in a similar field of endeavor, teaches a suction channel comprising a metal material having insulating coating operatively formed on both the inside and outside portions of the channel. (Col. 11, Lines 45-48)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Aluru/Earley/Bales/Tasto, as applied to claim 1 above, to incorporate the teachings of Bass, and configure the aspiration element (109) of Aluru to comprise a metal tube having the ceramic insulation of Bales disposed on the exterior and interior surface over a length of the elongated body. Doing so would be a simple substitution of one suction channel for another for the predictable results of transporting tissue debris from a target treatment site.
Regarding claim 4, the combination of Aluru/Earley/Bales/Tasto/Bass, as applied to claim 3 above, is silent regarding the length over which the dielectric coating is applied is between about 35 mm to about 50 mm from the distal end of the elongated body.
However, looking to applicant’s specification, it appears the claimed length of between 35 mm to 50 mm is merely to ensure proper insulation between the coring electrode (12) and excised tissue and may be any length, including the entire length of the elongate body. (Par. [0052]) Therefore, absent a statement of criticality AND unexpected results, the application length of the ceramic coating in the Aluru/Earley/Bales/Tasto/Bass along the entire length of aspiration element (109) is interpreted as reading on the claimed range of between 35 mm to 50 mm.
Regarding claims 10 and 11, the combination of Aluru/Earley/Bales/Tasto, as applied to claim 1 above, is silent regarding a second dielectric coating applied over an exterior surface of the elongated body, the second dialectic coating at least partially overlapping the dielectric coating on the portion of the elongated body; wherein the second dielectric coating affixes the irrigation channel to the elongated body.
Bass, in a similar field of endeavor, teaches a second dielectric coating applied over an exterior surface of an elongated body, (Fig. 1, and Col. 10, Lines 11-14: Irrigation channel (32) is coated with an insulating material) the second dialectic coating at least partially overlapping a first dielectric coating on the portion of the elongated body; (Col. 9, Lines 61-64: Insulation surrounds cannula (12)) wherein the second dielectric coating affixes one or more irrigation channels to the elongated body. (Fig. 1)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Aluru/Earley/Bales/Tasto, as applied to claim 1 above, to incorporate the teachings of Bass, and configure the irrigation channel of Aluru as a separate tubular structure surrounded by insulation, and attached to the exterior surface of the elongated body, such that the second dialectic coating at least partially overlapping a first dielectric coating on the portion of the elongated body and affixes the one or more irrigation channels to the elongated body. Doing so would be a simple substitution of one irrigation channel for another for the predictable result of delivering fluid to the target treatment zone.
Claim(s) 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Aluru (US 2014/0200581 A1) in view of Earley (US 2006/0235377 A1) in view of Bales (US 6,494,881 B1), in view of Tasto (US 2003/0055418 A1), as applied to claim 1 above, and further in view of nonpatent literature reference Elan (Borosilicate Glasses, 2017, Elan Technology).
Regarding claims 6-9, the combination of Aluru/Earley/Bales/Tasto, as applied to claim 1 above, is silent regarding wherein the dielectric coating has a coefficient of thermal expansion of about 8 ppm to about 15 ppm and a dielectric strength of at least about 1000V; wherein the dielectric coating has a coefficient of thermal expansion that is within ± 10% of a coefficient of thermal expansion of a metal substrate forming the elongated body; wherein the dielectric coating comprises alkaline earth borosilicate glass; and wherein the dielectric coating comprises a non-porous film configured to withstand temperatures of at least about 800 °C without melting.
Elan, in a similar field of endeavor relating to insulative materials, teaches Alkaline earth borosilicate glasses are thermally and electrically insulative. (Please see the second paragraph of attached NPL Reference Elan)
It has been held that “the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination”- MPEP 2144.07 In the instant case, one of ordinary skill in the art would recognize the benefits or suitability of the disclosed materials (e.g. cost-effectiveness, manufacturing feasibility, etc.) It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Aluru/Earley/Bales/Tasto, as applied to claim 1 above, to incorporate the teachings of Elan and have the dielectric coating of Bales be/include Alkaline earth borosilicate glass since these materials offer the benefits of cost-effectiveness, manufacturing feasibility, etc, as stated above.
The combination of Aluru/Earley/Bales/Tasto/Elan, as applied to claims 6-9 above, is silent regarding wherein the dielectric coating has a coefficient of thermal expansion of about 8 ppm to about 15 ppm and a dielectric strength of at least about 1000V; wherein the dielectric coating has a coefficient of thermal expansion that is within ± 10% of a coefficient of thermal expansion of a metal substrate forming the elongated body; and wherein the dielectric coating comprises a non-porous film configured to withstand temperatures of at least about 800 °C without melting.
However, looking to applicant’s specification, it appears the limitations of “wherein the dielectric coating has a coefficient of thermal expansion of about 8 ppm to about 15 ppm and a dielectric strength of at least about 1000V; wherein the dielectric coating has a coefficient of thermal expansion that is within ± 10% of a coefficient of thermal expansion of a metal substrate forming the elongated body; and wherein the dielectric coating comprises a non-porous film configured to withstand temperatures of at least about 800 °C without melting” are merely material properties of the dielectric coating. Given that the dielectric coating of the Aluru/Earley/Bales/Tasto/Elan combination, as applied to claims 6-9 above, is made from the same material as the dielectric coating of the present application (alkaline-earth borosilicate glass), one of ordinary art would expect the dielectric coating of the Aluru/Earley/Bales/Tasto/Elan combination, as applied to claims 6-9 above, to have the same material properties as the coating of the present invention. Therefore, absent a statement of criticality and unexpected results, the material properties of the alkaline earth borosilicate glass of Elan is interpreted as reading on the claimed material properties of claims 6, 7, and 9.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aluru (US 2014/0200581 A1) in view of Earley (US 2006/0235377 A1) in view of Bales (US 6,494,881 B1), in view of Tasto (US 2003/0055418 A1), as applied to claim 1 above, and further in view of Lau (US 2007/0088203 A1).
Regarding claim 14, the combination of Aluru/Earley/Bales/Tasto, as applied to claim 1 above, is silent regarding the elongated body is configured to receive a borescope through the evacuation lumen for visualization of the target treatment site.
Lau, in a similar field of endeavor, teaches an elongated body configured to receive a borescope through the evacuation lumen for visualization of the target treatment site. (Par. [0050]: Manipulator (10) includes an elongated member (13) including a lumen that functions as a suction conduit as well as receiving an endoscope therethrough)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Aluru/Earley/Bales/Tasto, as applied to claim 1 above, to incorporate the teachings of Lau, and configure aspiration element (109) of Aluru to receive an endoscope therethrough. Doing so would allow for a user to visualize the target location, as suggested in Lau. (Par. [0009])
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aluru (US 2014/0200581 A1) in view of Earley (US 2006/0235377 A1) in view of Bass (US 6,102,855) in view of Germain (US 2019/0321095 A1), in view of Tasto (US 2003/0055418 A1).
Regarding claim 15, Aluru teaches
an electrosurgical device (Fig. 2A) comprising:
an elongated body extending from a proximal end to a distal end along a longitudinal axis and defining an evacuation lumen configured to evacuate tissue from the distal end to the proximal end along the longitudinal axis; (Fig. 2E, Char. 109L: aspiration element)
an irrigation channel carried by the elongated body, (Fig. 2E, Char. 114: fluid supply lumen) the irrigation channel configured to deliver a fluid to a target tissue adjacent to the distal end; (Par. [0072])
a coring electrode at the distal end of the elongated body, (Fig. 2C, Char. 104: active electrode) wherein the coring electrode defines an opening to the evacuation lumen (Fig. 2B, Char. 130, 131, and 132) at an outermost edge of the distal end, (Fig. 2B: electrode (104) defines an outermost edge at least in that no portion of the device extends past the outermost top surface of electrode (104) in the section of support shelf (122) in which electrode (104) resides.), and wherein the coring electrode is configured to operate in a monopolar plasma configuration to cut a volume of the target tissue; (Par. [0014]);
a return electrode; (Fig. 2A-E, Char. 112: return electrode) and
a power supply coupled to the electrosurgical device and the return electrode, (Par. [0043]) wherein the power supply is configured to deliver radio frequency (RF) plasma energy of at least about 100V to the coring electrode to cut a volume of the target tissue. (Par. [0046])
Aluru, as applied to claim 15 above, is silent regarding the opening to the evacuation lumen being coaxial with the longitudinal axis; and a dielectric coating on at least a distal portion of the elongated body, the dielectric coating electrically insulating the elongated body from target tissue and the volume of cut target tissue, wherein the dielectric coating comprises a ceramic material; and a depth gauge coupled to an exterior surface of the elongated body and configured to prevent further movement of the electrosurgical device after reaching a preset depth defined by the depth gauge, wherein the depth gauge comprises a disc shaped body orthogonal to the longitudinal axis.
Earley, in a similar field of endeavor, teaches an electrosurgical device comprising an elongated body extending from a proximal end to a distal end along a longitudinal axis (Fig. 6-7) and defining an evacuation lumen configured to evacuate tissue from the distal end to the proximal end along the longitudinal axis; (Fig. 7, Char. 73: suction tube) and an electrode at the distal end of the elongated body (Fig. 6-9, Char. 18: electrode), comprising a plate-like member configured to contact and ablate tissue. (Fig. 8-9, Char. 81: plate-like member; Par. [0039]: Projections (83) of plate-like member (81) define the tissue-working portions of electrode (18)) wherein the electrode defines an opening to the evacuation lumen at an outermost edge of the distal end, (Fig. 8-9, Char. 82: opening; Par. [0047]) wherein the opening to the evacuation lumen is coaxial with the longitudinal axis. (Fig. 8-9)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Aluru, as applied to claim 15 above, to incorporate the teachings of Earley, and reposition the electrode (104) of Aluru, such that electrode (104) is disposed within plane (151) of Aluru. Doing so would be a simple substitution of one electrode/suction lumen structure for another for the predictable result of ablating tissue and evacuating debris via an evacuation lumen, and would be a mere rearrangement of parts well within the ability of one of ordinary skill in the art.
The combination of Aluru/Earley, as applied to claim 15 above, is silent regarding a dielectric coating on at least a distal portion of the elongated body, the dielectric coating electrically insulating the elongated body from target tissue and the volume of cut target tissue, wherein the dielectric coating comprises a ceramic material; and a depth gauge coupled to an exterior surface of the elongated body and configured to prevent further movement of the electrosurgical device after reaching a preset depth defined by the depth gauge, wherein the depth gauge comprises a disc shaped body orthogonal to the longitudinal axis.
Bass, in a similar field of endeavor, teaches a suction channel comprising a metal material having insulating coating operatively formed on both the inside and outside portions of the channel. (Col. 11, Lines 45-48)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Aluru/Earley, as applied to claim 15 above, to incorporate the teachings of Bass, and configure the aspiration element (109) of Aluru to comprise a metal tube having the ceramic insulation of Bales disposed on the exterior and interior surface over a length of the elongated body. Doing so would be a simple substitution of one suction channel for another for the predictable results of transporting tissue debris from a target treatment site.
The combination of Aluru/Earley/Bass, as applied to claim 15 above, is silent regarding the dielectric coating comprises a ceramic material; and a depth gauge coupled to an exterior surface of the elongated body and configured to prevent further movement of the electrosurgical device after reaching a preset depth defined by the depth gauge, wherein the depth gauge comprises a disc shaped body orthogonal to the longitudinal axis.
Germain, in a similar field of endeavor, teaches using ceramic material as an insulator. (Par. [0087])
It has been held that “the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination”- MPEP 2144.07 In the instant case, one of ordinary skill in the art would recognize the benefits or suitability of the disclosed materials (e.g. cost-effectiveness, manufacturing feasibility, etc.) It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Aluru/Earley/Bass, as applied to claim 15 above, to incorporate the teachings of Germain and have the dielectric coating of Bass be/include a ceramic material since these materials offer the benefits of cost-effectiveness, manufacturing feasibility, etc, as stated above.
The combination of Aluru/Earley/Bass/Germain, as applied to claim 15 above, is silent regarding a depth gauge coupled to an exterior surface of the elongated body and configured to prevent further movement of the electrosurgical device after reaching a preset depth defined by the depth gauge, wherein the depth gauge comprises a disc shaped body orthogonal to the longitudinal axis.
Tasto, in a similar field of endeavor, teaches a depth gauge coupled (Fig. 11, Char. 352: mechanical stop) to an exterior surface of an elongated body (Fig. 11, Char. 200: catheter) and configured to prevent further movement of a surgical device after reaching a preset depth defined by the depth gauge, (Fig. 11 and Par. [0126]: The surgeon can adjust the maximum travel distance of catheter (200) using mechanical stop (352); In this case, stop (352) would be considered a depth gauge at least in that stop (352) would determine when catheter has reached the predefined depth limit.) wherein the depth gauge comprises a disc shaped body orthogonal to the longitudinal axis. (Fig. 11)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Aluru/Earley/Bass/Germain, as applied to claim 15 above, to incorporate the teachings of Tasto, and configure the device of Aluru to include the mechanical stop (352) of Tasto, such that the user can set a maximum translation distance for the device of Aluru within a target treatment zone. Doing so would minimize the risk of accidentally hurting the patient by translating the distal portion (120) of the device of Aluru too far distally.
Regarding claim 16, the combination of Aluru/Earley/Bass/Germain/Tasto, as applied to claim 15 above, teaches a negative pressure source coupled to the electrosurgical device, the negative pressure source configured to draw and collect tissue from the distal end to the proximal end of the elongated body. (Aluru: Par. [0074])
Regarding claim 17, the combination of Aluru/Earley/Bass/Germain/Tasto, as applied to claim 15 above, teaches an irrigation system coupled to the electrosurgical device, the irrigation system configured to deliver a conductive fluid through the irrigation channel to saturate the target treatment site. (Aluru: Par. [0072])
Conclusion
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/N.S.B./ Examiner, Art Unit 3794