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 .
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-10, 21, and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rontal (US 20150038790 A1) in view of Knoll (WO 2016071680 A1) and Zaidi (US 20150366042 A1).
Regarding claim 1, Rontal teaches a plasma delivery tip of a medical-grade cold plasma generating device ([0013] the treatment of acute and chronic sinusitis through the use of a novel endoscope which may be passed into the sinus cavities and directs cold plasma or plasma-activated species (referred to as "active species") to the infected mucosal surface), sized for delivery through an endoscope working channel ([0015] [0015] The plasma may be generated by applying an RF alternating current of any frequency or a pulsed direct current to a flow of any useful gas, or gas mixture, such as noble plus oxygen. This may be done near the proximal end of the endoscope by applying the electrical power to spaced electrodes in the gas flow and allowing the gas flow to carry the resulting plasma to one or more outlets near the distal end of the endoscope, or by generating the plasma at the distal end either by the application of current or voltage between spaced electrodes or through a known technique of dielectric barrier discharge (DBD)), and comprising: a gas delivery lumen having a proximal-to-distal axis ([0015]) ([0036] The hand-held section also receives flexible tubing members 24 and 26 which are connected, respectively, to two gas sources 28 and 30 which may be alternatively or collectively used to create the plasma), sized to insert within the endoscope working channel ([0015]) (Fig 1, 4, 5, and 6; tube 18), and through which a flow of ionization gas flows to a distal aperture of the gas delivery lumen ([0015]) ([0043] The channel 62 may either carry the plasma generated within the hand-held section 14 by excitation of the gas entering there, which plasma then passes through the length of the tubes 62, or may carry a gas which is ignited by a suitable dielectric barrier discharge device (not shown) disposed at the distal end); a discharge electrode (Fig 4; pulsed electrode 86), which establishes a high voltage difference within the flow of ionization gas when attached to a high voltage source ([0045] A tubular high voltage RF or pulsed electrode 86, which terminates shortly before the channel 84, and has gas flowing through it and out the end, is disposed in the channel 84), the high voltage difference acting to generate free electrons alongside the discharge electrode and generate cold plasma within the flow of ionization gas while inside the gas delivery lumen ([0043] The channel 62 may either carry the plasma generated within the hand-held section 14 by excitation of the gas entering there), producing a plume of said cold plasma ([0045] A plasma stream 90 is generated at the end of the electrode 86 and flows out of the endoscope); a dielectric barrier layer ([0045] The channel 84 has a dielectric tubular liner 88, which covers the electrode 86) positioned between and electrically isolating from each other the discharge electrode and the flow of ionization gas ([0045] The channel 84 has a dielectric tubular liner 88, which covers the electrode 86) ([0043] The channel 62 may either carry the plasma generated within the hand-held section 14 by excitation of the gas entering there, which plasma then passes through the length of the tubes 62, or may carry a gas which is ignited by a suitable dielectric barrier discharge device (not shown) disposed at the distal end), along which said dielectric barrier layer the cold plasma is generated by dielectric barrier discharge when the discharge electrodes transmits the high voltage ([0045] FIG. 4 illustrates the distal end of an embodiment of the invention in which the plasma is generated at the distal end by a dielectric barrier discharge (DBD) or other conventional technique to form a plasma jet); and a control member (Fig 1; Trigger grip 17), attached to the plasma delivery tip ([0033) The hand-held section includes a trigger grip 17 which may be pivoted by the surgeon to control the curvature of the distal tube 18 forming part of the disposable section 12. This is done to manipulate the distal section through tortuous passages such as nasal cavities surrounding sinuses. The section 14 is one of many designs for the proximal end of the device that controls movement, holds the flexible and steerable tubing/conduit, joins the various gas lines to the device and encloses the chamber to produce the plasma) and long enough to reach a proximal side of the endoscope working channel, from which said side the control member is operable ([0035] The hand-held section 14 also includes a conventional gripping section 22 which the surgeon holds and uses to manipulate the distal end of the tube 18 into an operative position. While as illustrated the endoscope is only capable of bending the tube 18 in a single plane, by manual rotation of the hand-held section 14 through a plane transverse to the plane in which the tube section 18 may be bent, the distal end of the tube 18 may be moved in three dimensions. In other embodiments of the invention the trigger 17 may be replaced by a joystick type control that could manipulate the end section 18 in three dimensions); wherein a site of plasma generation of the plasma delivery tip is dynamically adjustable ([0039] The gas connections may be made through surgeon adjustable valves, which may be opened, closed, or adjusted to an intermediate flow rate. This allows the composition and flow rate of the plasma forming gases to be adjusted to optimize the phase of the operation that the surgeon deems appropriate and to change those variables for each phase of the procedure).
Rontal fails to fully teach using the control member, to produce a change in geometry of the site of plasma generation, the change in geometry modifying one or more properties of the generated cold plasma; wherein the geometry is adjusted by modifying at least one of: a shape of the gas delivery lumen, concomitant with adjustment of a shape of the discharge electrode, and a position of the discharge electrode within the flow of ionization gas; and wherein the modified one or more properties of the generated cold plasma are selected from the group consisting of: power output through the discharge electrode, ionizing effect, plasma temperature, and plasma concentration.
However, Knoll teaches using the control member ([0090] a user-controllable electrode geometry alteration mechanism may be provided in the plasma torch to allow the operator to adjust the spot size and shape of the plume. For example, a mechanism may be provided to allow the user to adjust the relative axial positioning of the front ends of the cathode 2 and grounded tube 3 so as to adjust the directionality of the focusing Lorentz force that acts on the thermal plasma, and so also the focal distance, spot size, and spot energy/fluence of the resulting plasma plume. This may be manipulatable directly on the plasma torch, for example by means of a mechanical scroll wheel, or by means of controls 151. Alternatively, the electrode geometry may be adjusted by providing interchangeable electrode tips or other structural adaptations), to produce a change in geometry of the site of plasma generation ([0024] In embodiments, the spot size and shape of the plume may be adjusted by, in embodiments, providing a plasma torch having an adjustable electrode geometry and adjusting the relative position thereof, increasing or decreasing the feed gas pressure, constricting or dilating the aperture of the open ends of the cavities, or increasing or decreasing or otherwise changing the power supply waveforms to the electrodes to generate the one or both of the two plasma stages. By providing an adjustable spot size and plume shape, the user can readily adapt the output plasma for different regions and conditions of the skin, like a palette of paintbrushes, allowing blending and bespoke treatments to be applied to small zones of the skin), the change in geometry modifying one or more properties of the generated cold plasma ([0090]); wherein the geometry is adjusted by modifying at least one of: a shape of the gas delivery lumen ([0090] Further controls may be provided in the plasma control system operable, for example, from control panel 151 which may allow the user to adjust the spot size or plume geometry by causing the feed gas pressure to be increased or decreased, providing one or more means for constricting or dilating the aperture of the open ends of the cavities, or providing a power supply unit operable in use to enable increasing or decreasing), concomitant with adjustment of a shape of the discharge electrode ([0090] he electrode geometry may be adjusted by providing interchangeable electrode tips or other structural adaptations), and a position of the discharge electrode within the flow of ionization gas ([0090] a mechanism may be provided to allow the user to adjust the relative axial positioning of the front ends of the cathode 2 and grounded tube 3 so as to adjust the directionality of the focusing Lorentz force that acts on the thermal plasma, and so also the focal distance, spot size, and spot energy/fluence of the resulting plasma plume); and wherein the modified one or more properties of the generated cold plasma are selected from the group consisting of: power output through the discharge electrode ([0090] providing a power supply unit operable in use to enable increasing or decreasing or otherwise changing the power supply waveforms to the electrodes to generate the one or both of the two plasma stages), and plasma concentration ([0034] the relative axial extent of the cathode and grounded tube at the open end of the plasma torch is configured such that the resulting plasma plume is concentrated a given focal distance in front of the open end of the torch). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Rontal to include the control member, to produce a change in geometry of the site of plasma generation, the change in geometry modifying one or more properties of the generated cold plasma; wherein the geometry is adjusted by modifying at least one of: a shape of the gas delivery lumen, concomitant with adjustment of a shape of the discharge electrode, and a position of the discharge electrode within the flow of ionization gas; and wherein the modified one or more properties of the generated cold plasma are selected from the group consisting of: power output through the discharge electrode. Doing so allows for the plasma delivered to be varied depending on the desired effect and type of tissue is being treated.
Further, Zaidi teaches ionizing effect ([0059] By varying the plasma production location, at least one property of the exiting plasma plume can be adjusted. By changing the axial location along the inner electrode 36 at which ionization occurs, the plume temperature, length, and degree of ionization of the exiting plasma plume 8 can be adjusted and controlled to suit a particular application), plasma temperature ([0059] By varying the plasma production location, at least one property of the exiting plasma plume can be adjusted. By changing the axial location along the inner electrode 36 at which ionization occurs, the plume temperature, length, and degree of ionization of the exiting plasma plume 8 can be adjusted and controlled to suit a particular application). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Rontal to include where the modified properties include ionizing effect, plasma temperature. Doing so allows for the plasma delivered to be varied depending on the desired effect and type of tissue is being treated.
Regarding claim 2, Rontal teaches the plasma delivery tip of claim 1, but fails to fully teach wherein the one or more properties of the generated cold plasma are dynamically adjustable by modifying a relative position of the dielectric barrier layer relative and at least one of the gas delivery lumen and the discharge electrode.
However, Zaidi teaches wherein the one or more properties of the generated cold plasma are dynamically adjustable by modifying a relative position of the dielectric barrier layer (Fig 4; dielectric ionization tube 132) relative and at least one of the gas delivery lumen and the discharge electrode ([0059] Because the axial location of the outer electrode 42 can be adjusted relative to the inner electrode 38, the location within the ionization conduit at which plasma is produced can also be adjusted. By varying the plasma production location, at least one property of the exiting plasma plume can be adjusted. By changing the axial location along the inner electrode 36 at which ionization occurs, the plume temperature, length, and degree of ionization of the exiting plasma plume 8 can be adjusted and controlled to suit a particular application. For example, when the outer electrode 42 is positioned very close to the exit port 20 in the housing 18, a very intense, relatively-high temperature plasma plume is produced. Conversely, when the outer electrode 42 is positioned far away from the exit port 20, a less intense, lower temperature plasma plume exits the probe 12) ([0070] These complimenting shapes and sizes allow the outer electrode 142 to slide axially along the length of the ionization conduit 132). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Rontal to include wherein the one or more properties of the generated cold plasma are dynamically adjustable by modifying a relative position of the dielectric barrier layer relative and at least one of the gas delivery lumen and the discharge electrode. Doing so creates a way for altering the temperature or another parameter of the plasma for a desired outcome.
Regarding claim 3, Rontal teaches the plasma delivery tip of claim 1, but fails to fully teach wherein the relative position of the gas delivery lumen and the discharge electrode is adjusted by moving the discharge electrode along the proximal-to-distal axis, relative to the gas delivery lumen.
However, Zaidi teaches wherein the relative position of the gas delivery lumen and the discharge electrode is adjusted by moving the discharge electrode along the proximal-to-distal axis, relative to the gas delivery lumen ([0059] Because the axial location of the outer electrode 42 can be adjusted relative to the inner electrode 38, the location within the ionization conduit at which plasma is produced can also be adjusted. By varying the plasma production location, at least one property of the exiting plasma plume can be adjusted. By changing the axial location along the inner electrode 36 at which ionization occurs, the plume temperature, length, and degree of ionization of the exiting plasma plume 8 can be adjusted and controlled to suit a particular application. For example, when the outer electrode 42 is positioned very close to the exit port 20 in the housing 18, a very intense, relatively-high temperature plasma plume is produced. Conversely, when the outer electrode 42 is positioned far away from the exit port 20, a less intense, lower temperature plasma plume exits the probe 12) ([0070] These complimenting shapes and sizes allow the outer electrode 142 to slide axially along the length of the ionization conduit 132). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Rontal to include wherein the relative position of the gas delivery lumen and the discharge electrode is adjusted by moving the discharge electrode along the proximal-to-distal axis, relative to the gas delivery lumen. Doing so creates a way for altering the temperature or another parameter of the plasma for a desired outcome.
Regarding claim 4, Rontal teaches the plasma delivery tip of claim 1, wherein the relative position of the gas delivery lumen and the discharge electrode is adjusted by offsetting the discharge electrode radially within the gas delivery lumen (Fig 6; gas delivery lumen radially expands in a balloon shape from the electrode).
Regarding claim 5, Rontal teaches the plasma delivery tip of claim 1, but fails to fully teach wherein the relative position of the gas delivery lumen and the discharge electrode is maintained by a positioning support positioned within the gas delivery lumen.
However, Knoll teaches wherein the relative position of the gas delivery lumen and the discharge electrode is maintained by a positioning support positioned within the gas delivery lumen ([0090] mechanism may be provided to allow the user to adjust the relative axial positioning of the front ends of the cathode 2 and grounded tube 3 so as to adjust the directionality of the focusing Lorentz force that acts on the thermal plasma, and so also the focal distance, spot size, and spot energy/fluence of the resulting plasma plume. This may be manipulatable directly on the plasma torch, for example by means of a mechanical scroll wheel, or by means of controls 151). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Rontal to include wherein the relative position of the gas delivery lumen and the discharge electrode is maintained by a positioning support positioned within the gas delivery lumen. Doing so creates a simplistic way of altering the position.
Regarding claim 6, Rontal teaches the plasma delivery tip of claim 5, but fails to fully teach wherein the relative position is adjustable by rotating the positioning support.
However, Knoll teaches wherein the relative position is adjustable by rotating the positioning support ([0090] mechanism may be provided to allow the user to adjust the relative axial positioning of the front ends of the cathode 2 and grounded tube 3 so as to adjust the directionality of the focusing Lorentz force that acts on the thermal plasma, and so also the focal distance, spot size, and spot energy/fluence of the resulting plasma plume. This may be manipulatable directly on the plasma torch, for example by means of a mechanical scroll wheel, or by means of controls 151). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Rontal to include wherein the relative position is adjustable by rotating the positioning support. Doing so creates a simplistic way of altering the position.
Regarding claim 7, Rontal teaches the plasma delivery tip of claim 5, but fails to fully teach wherein the relative position is adjustable by sliding the positioning support.
However, Zaidi teaches wherein the relative position is adjustable by sliding the positioning support ([0071] An outer electrode 142 is slideably arranged on the outer surface of the ionization tube 132 and connected to the power source 16 by a connector cable 126). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Rontal to include wherein the relative position is adjustable by sliding the positioning support. Doing so creates a simplistic way of altering the position.
Regarding claim 8, Rontal teaches the plasma delivery tip of claim 1, sized for insertion to a target region through an aperture or conduit 7 mm in diameter or less ([0042] The entire length of the tube 16 and its flexible extension 18 may be in the range of 13 centimeters and the diameters of the tubes are preferably 4 millimeters or less. This allows for maneuvering through the nasal passages).
Regarding claim 9, Rontal teaches the plasma delivery tip of claim 1, but fails to fully teach wherein the one or more properties of the generated cold plasma are dynamically adjustable by modifying a shape of the dielectric barrier layer.
However, Knoll teaches wherein the one or more properties of the generated cold plasma are dynamically adjustable by modifying a shape of the dielectric barrier layer ([0090] the electrode geometry may be adjusted by providing interchangeable electrode tips or other structural adaptations. Further controls may be provided in the plasma control system operable, for example, from control panel 151 which may allow the user to adjust the spot size or plume geometry by causing the feed gas pressure to be increased or decreased, providing one or more means for constricting or dilating the aperture of the open ends of the cavities). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Rontal to include wherein the one or more properties of the generated cold plasma are dynamically adjustable by modifying a shape of the dielectric barrier layer. Doing so allows for the shape of the dielectric barrier to be tailored for specific outcomes.
Regarding claim 10, Rontal teaches the plasma delivery tip of claim 1, but fails to fully teach wherein the adjusted shape of the gas delivery lumen comprises a changed diameter of the gas delivery lumen.
However, Knoll teaches wherein the adjusted shape of the gas delivery lumen comprises a changed diameter of the gas delivery lumen ([0090] the electrode geometry may be adjusted by providing interchangeable electrode tips or other structural adaptations. Further controls may be provided in the plasma control system operable, for example, from control panel 151 which may allow the user to adjust the spot size or plume geometry by causing the feed gas pressure to be increased or decreased, providing one or more means for constricting or dilating the aperture of the open ends of the cavities). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Rontal to include wherein the adjusted shape of the gas delivery lumen comprises a changed diameter of the gas delivery lumen. Doing so allows the pressure of the gas to be increase or decrease and thereby effecting the plasma generation.
Regarding claim 21, Rontal teaches the plasma delivery tip of claim 1, wherein the adjusted shape of the gas delivery lumen comprises a changed outer diameter of the gas delivery lumen (Fig 5; Balloon structure 90 filled with pressurized gas).
Regarding claim 34, Rontal teaches the plasma delivery tip of claim 1, wherein the dielectric barrier layer (Fig 5; inner balloon 90) ([0048] The effect of charging the conductive inner surface is to create charged particles which accumulate on the dielectric outer surface of this balloon) circumferentially surrounds the discharge electrode (Fig 5; high voltage RF power source 92), and the gas delivery lumen circumferentially surrounds the dielectric barrier layer ([0049] outer nonconductive balloon 94. The volume between the balloons is filled with the pressurized gas through passages in the inner balloon).
Claim(s) 11-14, 16, 50, and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rontal (US 20150038790 A1) in view of Knoll (WO 2016071680 A1) and Zaidi (US 20150366042 A1), further in view of Truckai (US 20130304060 A1).
Regarding claim 11, Rontal teaches the plasma delivery tip of claim 10, but fails to fully teach wherein adjustment of the diameter of the gas delivery lumen is actuated by advancing the gas delivery lumen from confinement within a sheath and allowing elasticity of the gas delivery lumen to expand it to a width greater than the sheath along at least one axis.
However, Truckai teaches wherein adjustment of the diameter of the gas delivery lumen is actuated by advancing the gas delivery lumen from confinement within a sheath (Fig 8c; introducer sleeve 110) and allowing elasticity of the gas delivery lumen to expand it to a width greater than the sheath along at least one axis ([0061] The physician can slightly rotate and move the expanding dielectric structure 150 back and forth as the structure is opened to insure it is opened to the desired extent. In performing this step, the physician can actuate handle portions, 114a and 114b, a selected degree which causes a select length of travel of sleeve 170 relative to sleeve 115 which in turn opens the frame 155 to a selected degree. The selected actuation of sleeve 170 relative to sleeve 115 also controls the length of dielectric structure deployed from sleeve 110 into the uterine cavity. Thus, the thin-wall structure 150 can be deployed in the uterine cavity with a selected length, and the spring force of the elements of frame 155 will open the structure 150 to a selected triangular shape to contact or engage the endometrium 306). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Rontal to include wherein adjustment of the diameter of the gas delivery lumen is actuated by advancing the gas delivery lumen from confinement within a sheath and allowing elasticity of the gas delivery lumen to expand it to a width greater than the sheath along at least one axis. Doing so allows for the device to be inserted and then deployed once in the cavity for simplicity of insertion.
Regarding claim 12, Rontal teaches the plasma delivery tip of claim 10, but fails to fully teach wherein adjustment of the diameter of the gas delivery lumen is actuated by forces exerted longitudinally along the proximal-to-distal axis.
However, Truckai teaches wherein adjustment of the diameter of the gas delivery lumen is actuated by forces exerted longitudinally along the proximal-to-distal axis ([0061] The physician can slightly rotate and move the expanding dielectric structure 150 back and forth as the structure is opened to insure it is opened to the desired extent. In performing this step, the physician can actuate handle portions, 114a and 114b, a selected degree which causes a select length of travel of sleeve 170 relative to sleeve 115 which in turn opens the frame 155 to a selected degree. The selected actuation of sleeve 170 relative to sleeve 115 also controls the length of dielectric structure deployed from sleeve 110 into the uterine cavity. Thus, the thin-wall structure 150 can be deployed in the uterine cavity with a selected length, and the spring force of the elements of frame 155 will open the structure 150 to a selected triangular shape to contact or engage the endometrium 306). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Rontal to include wherein adjustment of the diameter of the gas delivery lumen is actuated by forces exerted longitudinally along the proximal-to-distal axis. Doing so allows the device to be easily placed in an optimal position for the unique cavity space by means of a control device located outside the cavity.
Regarding claim 13, Rontal teaches the plasma delivery tip of claim 10, but fails to fully teach wherein the control member attached to the gas delivery lumen, and operable to adjust longitudinal compression of the gas delivery lumen along the proximal-to-distal axis, increasing the diameter of the gas delivery lumen as longitudinal compression along the proximal-to- distal axis is decreased.
However, Truckai teaches wherein the control member attached to the gas delivery lumen, and operable to adjust longitudinal compression of the gas delivery lumen along the proximal-to-distal axis, increasing the diameter of the gas delivery lumen as longitudinal compression along the proximal-to- distal axis is decreased ([0061] the physician can actuate handle portions, 114a and 114b, a selected degree which causes a select length of travel of sleeve 170 relative to sleeve 115 which in turn opens the frame 155 to a selected degree. The selected actuation of sleeve 170 relative to sleeve 115 also controls the length of dielectric structure deployed from sleeve 110 into the uterine cavity. Thus, the thin-wall structure 150 can be deployed in the uterine cavity with a selected length, and the spring force of the elements of frame 155 will open the structure 150 to a selected triangular shape to contact or engage the endometrium 306). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Rontal to include wherein the control member attached to the gas delivery lumen, and operable to adjust longitudinal compression of the gas delivery lumen along the proximal-to-distal axis, increasing the diameter of the gas delivery lumen as longitudinal compression along the proximal-to- distal axis is decreased. Doing so allows the device to be placed in an optimal position for the unique cavity space.
Regarding claim 14, Rontal teaches the plasma delivery tip of claim 10, but fails to fully teach wherein the control member attached to the gas delivery lumen, and operable to adjust longitudinal stretching of the gas delivery lumen along the proximal-to-distal axis, increasing the diameter of the gas delivery lumen as longitudinal stretching along the proximal-to- distal axis is decreased.
However, Truckai teaches wherein the control member attached to the gas delivery lumen, and operable to adjust longitudinal stretching of the gas delivery lumen along the proximal-to-distal axis, increasing the diameter of the gas delivery lumen as longitudinal stretching along the proximal-to- distal axis is decreased ([0061] the physician can actuate handle portions, 114a and 114b, a selected degree which causes a select length of travel of sleeve 170 relative to sleeve 115 which in turn opens the frame 155 to a selected degree. The selected actuation of sleeve 170 relative to sleeve 115 also controls the length of dielectric structure deployed from sleeve 110 into the uterine cavity. Thus, the thin-wall structure 150 can be deployed in the uterine cavity with a selected length, and the spring force of the elements of frame 155 will open the structure 150 to a selected triangular shape to contact or engage the endometrium 306). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Rontal to include wherein the control member attached to the gas delivery lumen, and operable to adjust longitudinal stretching of the gas delivery lumen along the proximal-to-distal axis, increasing the diameter of the gas delivery lumen as longitudinal stretching along the proximal-to- distal axis is decreased. Doing so allows for the device to be tailored to different cavities.
Regarding claim 16, Rontal teaches the plasma delivery tip of claim 10, but fails to fully teach wherein adjustment of the diameter of the gas delivery lumen is actuated by the control member actuated to exert force circumferentially around the proximal-to-distal axis.
However, Truckai teaches wherein adjustment of the diameter of the gas delivery lumen is actuated by the control member actuated to exert force circumferentially around the proximal-to-distal axis (Fig 2; [0046] By actuating the first and second handle portions, 114a and 114b, a working end 122 can be deployed from a first retracted position (FIG. 1) in the distal portion of bore 120 in introducer sleeve 110 to an extended position as shown in FIG. 2. In FIG. 2, it can be seen that the first and second handle portions, 114a and 114b, are in a second actuated position with the working end 122 deployed from the bore 120 in introducer sleeve 110) ([0060] In FIG. 8B, it can be understood that the spring frame elements 158a, 158b, 160a and 160b move the dielectric structure 150 from a non-expanded position to an expanded position in the uterine cavity as depicted by the profiles in dashed lines. The spring force of the frame 155 will expand the dielectric structure 150 until limited by the dimensions of the uterine cavity). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Rontal to include wherein adjustment of the diameter of the gas delivery lumen is actuated by the control member actuated to exert force circumferentially around the proximal-to-distal axis. Doing so allows for the device to be tailored to different cavities.
Regarding claim 50, Rontal teaches the plasma delivery tip of claim 1, but fails to fully teach comprising a sensor, configured to measure an effect of cold plasma generation, and communicate measurement as an indication of the modified one or more properties of the generated cold plasma.
However, Truckai teaches comprising a sensor, configured to measure an effect of cold plasma generation ([0056] The system can include feedback control systems that include signals relating to operating parameters of the plasma in interior chamber 152 of the dielectric structure 150. For example, feedback signals can be provided from at least one temperature sensor 240 in the interior chamber 152 of the dielectric structure 150, from a pressure sensor within, or in communication, with interior chamber 152, and/or from a gas flow rate sensor in an inflow or outflow channel of the system), and communicate measurement as an indication of the modified one or more properties of the generated cold plasma ([0066] FIG. 9 further shows an optional temperature sensor 390, such as a thermocouple, carried at an exterior of the dielectric structure 150. In one method of use, the control unit 135 can acquire temperature feedback signals from at least one temperature sensor 390 to modulate or terminate RF energy delivery, or to modulate gas flows within the system. In a related method of the invention, the control unit 135 can acquire temperature feedback signals from temperature sensor 240 in interior chamber 152 (FIG. 6 to modulate or terminate RF energy delivery or to modulate gas flows within the system)). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Rontal to include comprising a sensor, configured to measure an effect of cold plasma generation, and communicate measurement as an indication of the modified one or more properties of the generated cold plasma. Doing so allows for tailored feedback and application of the plasma based on the surrounding tissue environment.
Regarding claim 51, Rontal teaches the plasma delivery tip of claim 50, but fails to fully teach provided together with a controller, wherein the controller is configured to adjust geometry of the site of plasma generation based on feedback from the sensor.
However, Truckai teaches provided together with a controller (control unit 135), wherein the controller is configured to adjust geometry of the site of plasma generation based on feedback from the sensor ([0067] In another aspect of the invention, FIG. 11 is a graphic representation of an algorithm utilized by the RF source 130A and RF controller 130B of the system to controllably apply RF energy in an endometrial ablation procedure. In using the expandable dielectric structure 150 of the invention to apply RF energy in an endometrial ablation procedure as described above, the system is configured to allow the dielectric structure 150 to open to different expanded dimensions depending on the size and shape of the uterine cavity 302. The axial length of dielectric structure 150 also can be adjusted to have a predetermined axial length extended outward from the introducer sleeve 110 to match a measured length of a uterine cavity. In any case, the actual surface area of the expanded dielectric structure 150 within different uterine cavities will differ--and it would be optimal to vary total applied energy to correspond to the differing size uterine cavities) ([0080] FIGS. 13A-13B, the handle component 114b can include a electrical contact sensor 470 that detects the axial movement of sliding element 450 and sleeve 170 relative to sleeve 115 to thereby provide an electronic signal indicating the degree of expansion of the frame 155 and dielectric structure 150. In one embodiment, the electronic signal communicates with RF controller 130B to disable the system if the relative axial positions of sleeves 170 and 115 do not indicate a predetermined degree of expansion of the frame 155 and dielectric structure). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Rontal to include provided together with a controller, wherein the controller is configured to adjust geometry of the site of plasma generation based on feedback from the sensor. Doing so allows for the device to be tailored to different cavities.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rontal (US 20150038790 A1) in view of Knoll (WO 2016071680 A1) and Zaidi (US 20150366042 A1), further in view of Truckai (2) (US 20100100091 A1).
Regarding claim 30, Rontal teaches the plasma delivery tip of claim 9, but fails to fully teach wherein a distal tip of the gas delivery lumen is beveled to form a pointed tip.
However, Truckai (2) teaches wherein a distal tip of the gas delivery lumen is beveled to form a pointed tip (Fig 3; [0081] the working end 120 has a sharp tip 124 for penetrating tissue to perform an ablation procedure). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Rontal to include wherein a distal tip of the gas delivery lumen is beveled to form a pointed tip. Doing so allows for the tip to be more precise and to cut through targeted tissues.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794