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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 18/713,621, filed on 05/24/2024.
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) 1-2, 6-8, 13-27, 32, 34-37, 41, and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Panescu (US 20190343581 A1) in view of Sun et al. (Xuyang Sun, Zhi-Zhu He, Zhong-Shan Deng, Yi-Xin Zhou & Jing Liu (2018) Liquid metal bath as conformable soft electrodes for target tissue ablation in radio frequency ablation therapy, Minimally Invasive Therapy & Allied Technologies, 27:4, 233-241, DOI: 10.1080/13645706.2017.1393437).
Regarding claim 1, Panescu teaches a radiofrequency [RF] ablation catheter ([abstract] an ablation electrode attached to a distal portion of the flexible shaft and to deliver radiofrequency (RF) electrical current to the tissue and conductively connectable to an RF electrical energy source external to the patient) comprising: a flexible shaft extending between a distal end and a proximal end (Fig 4; Shaft 229) ([0067] The shaft may be a flexible shaft capable of turning such that a bend in the shaft has a radius of curvature of less than 2.5 cm); an inflatable balloon mounted on the shaft ([0068] FIGS. 3 and 4 the device 220 has an occlusion element such as an inflatable balloon or obturator 231); and an RF conductor element ([0071] The device 220 shown in FIGS. 3 and 4 further comprises a distal electrode 234 positioned on the distal region 215 of the device 220 and connected to a conductor 238 (e.g., copper wire 32 AWG) that runs through the shaft 229 of the device to the proximal region where it is connectable to an energy delivery console), wherein a portion of the flexible shaft is distal to the inflatable balloon (Fig 4; balloon 231) and is defined as a distal segment of the shaft (Fig 4; distal electrode 234), and wherein the RF conductor element is located on the distal segment (Fig 4; distal electrode 234) and is adapted to electrically contact and to deliver RF energy ([0075] While the targeted lung portion is occluded with the obturator 231, optionally collapsed, and infused with conductive liquid RF ablation energy may be delivered from an energy delivery console to the distal electrode 234) to a conductive liquid.
Panescu fails to fully teach to a liquid metal. However, Sun et al. teaches to a liquid metal ([Pg 234; Para 1] Here we propose for the first time an innovative method of conformable tumor hyperthermia therapy with liquid metal bath-electrodes, which could be attributed to its high adaptability to various shapes of superficial tumors. This new conceptual liquid metal bath-electrode can simply be used by immersing the object or the tumor tissue of any shapes directly in the container of liquid metal. Taking advantage of high conductivity and compliance, liquid metal electrodes will also increase the size of the contact area with the skin surface and decrease the possibility of thermal damage and energy loss). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Panescu to include a liquid metal. Doing so allows for treatment with high adaptability to various shapes of superficial tumors.
Regarding claim 2, Panescu teaches the RF ablation catheter according to claim 1, wherein the flexible shaft comprises an inner shaft (Fig 4; second shaft 230) and an outer shaft (Fig 4; first shaft 229), and wherein the outer shaft is arranged surrounding the inner shaft to cover at least a partial length of the inner shaft ([0026] FIG. 5B is a schematic illustration of a distal region of an ablation device, constructed with two occluding balloons, one of which is proximal to the electrodes and located on a first shaft, and the other is distal to the electrodes and located on a second shaft which is extended from the first shaft).
Regarding claim 6, Panescu teaches the RF ablation catheter according to claim 2, wherein the flexible shaft further comprises an inflation lumen defined by a space between the outer flexible shaft and the inner flexible shaft in communication with the inflatable balloon adapted to supply or discharge a fluid to/from the inflatable balloon (Fig 3; The elongated shaft 229 comprises a lumen 222 (e.g., a polyimide tube with an inner diameter of 0.015″ running through a lumen in the shaft 229) with a port 232 positioned in the obturator 231 for inflating and deflating the obturator).
Regarding claim 7, Panescu teaches the RF ablation catheter according to claim 2, wherein the inner shaft comprises a guidewire lumen (Fig 4; guidewire lumen 236) adapted for insertion of a guidewire (Fig 4; guidewire 227).
Regarding claim 8, Panescu teaches the RF ablation catheter according to claim 2, wherein the inflatable balloon is mounted on the outer shaft (FIGS. 3 and 4 the device 220 has an occlusion element such as an inflatable balloon or obturator 231 on the elongated shaft 229).
Regarding claim 13, Panescu teaches the RF ablation catheter according to claim 1, wherein the RF conductor element is formed by at least one electrically conductive metal element on the distal segment of the shaft ([0071] FIGS. 3 and 4 further comprises a distal electrode 234 positioned on the distal region 215 of the device 220 and connected to a conductor 238 (e.g., copper wire 32 AWG) that runs through the shaft 229 of the device to the proximal region where it is connectable to an energy delivery console).
Regarding claim 14, Panescu teaches the RF ablation catheter according to claim 1, wherein the at least one electrically conductive element is formed as a ring-segment to cover a proportion of the circumference of the surface area of the distal segment or is formed as ring to cover the circumference of a partial surface area of the distal segment (Fig 4; [0071] The distal electrode 234 may be cylindrical in shape and have a diameter in a range of 1 to 2 mm (e.g., about 1.5 mm) and a length in a range of 4 to 7 mm (e.g., about 5 mm)).
Regarding claim 15, Panescu teaches the RF ablation catheter according to claim 1, wherein the at least one electrically conductive element is formed pad shaped or formed by at least one conductive wire (Fig 3; electrode 237 and 235 rectangular pad shaped and wrapped around the shaft).
Regarding claim 16, Panescu teaches the RF ablation catheter according to claim1, wherein the RF conductor element is arranged at a proximal end of the distal segment directly neighboring the inflatable balloon (Fig 4; proximal electrode 237).
Regarding claim 17, Panescu teaches the RF ablation catheter according to claim1, wherein the flexible shaft further comprises a fluid channel adapted to instill a liquid ([0075] While the targeted lung portion is occluded with the obturator 231, optionally collapsed, and infused with conductive liquid RF ablation energy may be delivered from an energy delivery console to the distal electrode 234) into at least one passageway, preferably at a target site in a body organ ([0073] Conductive fluid (e.g., 5 to 20% hypertonic saline) may be delivered to the targeted lung portion through irrigation ports 235 in the electrode(s) 234 or additionally or alternatively through an infusion lumen (not shown) exiting the device 220 distal to the occlusion balloon 231 that may or may not exit through ports in an electrode. The infusion lumen runs from the irrigation ports (e.g., 235) through the shaft 229 to the proximal region of the device where it is connectable to a conductive fluid supply and optionally pump. Alternatively, the guidewire lumen 236 may be used to infuse the conductive fluid) ([0108] FIG. 8 conductive fluid may be delivered from either ports 251 or 263, preferably from both, into the lung parenchyma or tumor and/or into airways distal the obturator 231).
Panescu fails to fully teach to a liquid metal. However, Sun et al. teaches to a liquid metal ([Pg 234; Para 1] Here we propose for the first time an innovative method of conformable tumor hyperthermia therapy with liquid metal bath-electrodes, which could be attributed to its high adaptability to various shapes of superficial tumors. This new conceptual liquid metal bath-electrode can simply be used by immersing the object or the tumor tissue of any shapes directly in the container of liquid metal. Taking advantage of high conductivity and compliance, liquid metal electrodes will also increase the size of the contact area with the skin surface and decrease the possibility of thermal damage and energy loss). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Panescu to include a liquid metal. Doing so allows for treatment with high adaptability to various shapes of superficial tumors.
Regarding claim 18, Panescu teaches the RF ablation catheter according to claim 17, wherein the catheter further comprises an injection port in the area of the proximal end that is in communication with the fluid channel of the flexible shaft ([0108] The proximal electrode 237 may optionally have irrigation ports 263 in fluid communication with an irrigation lumen (not shown) that passes through the shaft 229 to the proximal region of the device 255 where the lumen is connectable to a conductive fluid source or pump. The irrigation ports 263 and 251 on the proximal electrode 237 and distal electrode 250 may be connected to the same irrigation lumen or separate lumens for delivery of conductive fluid).
Regarding claim 19, Panescu teaches the RF ablation catheter according to claim 17, wherein the fluid channel is adapted to instill a liquid supplied to the fluid channel (FIG. 8 conductive fluid may be delivered from either ports 251 or 263), preferably via an injection port into at least one passageway (Fig 8; irrigation ports 263 and 251).
Panescu fails to fully teach to a liquid metal. However, Sun et al. teaches to a liquid metal ([Pg 234; Para 1] Here we propose for the first time an innovative method of conformable tumor hyperthermia therapy with liquid metal bath-electrodes, which could be attributed to its high adaptability to various shapes of superficial tumors. This new conceptual liquid metal bath-electrode can simply be used by immersing the object or the tumor tissue of any shapes directly in the container of liquid metal. Taking advantage of high conductivity and compliance, liquid metal electrodes will also increase the size of the contact area with the skin surface and decrease the possibility of thermal damage and energy loss). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Panescu to include a liquid metal. Doing so allows for treatment with high adaptability to various shapes of superficial tumors.
Regarding claim 20, Panescu teaches the RF ablation catheter according to claim1, wherein the flexible shaft further comprises an inflation lumen in communication with the inflatable balloon adapted to supply or discharge a fluid to/from the inflatable balloon ([0068] The elongated shaft 229 comprises a lumen 222 (e.g., a polyimide tube with an inner diameter of 0.015″ running through a lumen in the shaft 229) with a port 232 positioned in the obturator 231 for inflating and deflating the obturator. The obturator 231 may be a balloon (e.g., compliant balloon) sized to occlude the airway or a range of airway diameters (e.g., diameters in a range of 3 mm to 10 mm). The obturator 231 may be inflated by injecting fluid (e.g., gas such as air, or liquid such as water or saline, or contrast solution) through the lumen 222 and into the obturator 231).
Regarding claim 21, Panescu teaches the RF ablation catheter according to claim 1, wherein the catheter further comprises a temperature sensor mounted on the distal segment of the shaft ([0075] temperature sensor 242 (e.g., T-Type thermocouple) may be positioned on or in the distal electrode 234).
Regarding claim 22, Panescu teaches the RF ablation catheter according to claim 21, wherein the temperature sensor is arranged in the cavity of the cover element (Fig 3; sensor 242).
Regarding claim 23, Panescu teaches the RF ablation catheter according to claim 21, wherein the temperature sensor is formed as a thermocouple embedded in the distal segment of the flexible shaft ([0075] temperature sensor 242 (e.g., T-Type thermocouple) may be positioned on or in the distal electrode 234), wherein a temperature sensing surface is formed at an end face of the distal end of the flexible shaft (Fig 7; sensor 262).
Regarding claim 24, Panescu teaches the RF ablation catheter claim 21, wherein the temperature sensor is formed as a thermocouple partially attached to the RF conductor element, to form a temperature sensing surface in the area of the RF conductor element ([0075] temperature sensor 242 (e.g., T-Type thermocouple) may be positioned on or in the distal electrode 234).
Regarding claim 25, Panescu teaches the RF ablation catheter according to claim 1, wherein the flexible shaft comprises a guidewire lumen (Fig 4; guidewire lumen 236) adapted to receive a guidewire (Fig 4; guidewire 227).
Regarding claim 26, Panescu teaches the RF ablation catheter according to claim 1, wherein the RF conductor element is adapted to be electrically connected to an RF generator and to pass the flow of the RF current from the RF generator ([0109] The electrodes may be connected to electrical conductors that pass through the catheter shafts to a proximal region of the catheter for example terminating in an electrical connector, which may be electrically connected to an RF generator for example using a connector cable) to the liquid.
Panescu fails to fully teach to a liquid metal. However, Sun et al. teaches to a liquid metal ([Pg 234; Para 1] Here we propose for the first time an innovative method of conformable tumor hyperthermia therapy with liquid metal bath-electrodes, which could be attributed to its high adaptability to various shapes of superficial tumors. This new conceptual liquid metal bath-electrode can simply be used by immersing the object or the tumor tissue of any shapes directly in the container of liquid metal. Taking advantage of high conductivity and compliance, liquid metal electrodes will also increase the size of the contact area with the skin surface and decrease the possibility of thermal damage and energy loss). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Panescu to include a liquid metal. Doing so allows for treatment with high adaptability to various shapes of superficial tumors.
Regarding claim 27, Panescu teaches the RF ablation catheter according to claim 1, wherein the catheter further comprises: an RF generator electrically coupled to the RF conductor element ([0109] The electrodes may be connected to electrical conductors that pass through the catheter shafts to a proximal region of the catheter for example terminating in an electrical connector, which may be electrically connected to an RF generator for example using a connector cable).
Regarding claim 32, Panescu teaches the RF ablation catheter according to claim 1, but fails to teach wherein the liquid metal comprises gallium.
However, Sun et al. teaches RF ablation catheter according to claim 1, wherein the liquid metal comprises gallium ([Pg 240; Para 3] Liquid metal composed of gallium and indium or gallium alone has been proven to possess good Biocompatibility to living tissues). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Panescu to include wherein the liquid metal comprises gallium. Doing so allows for treatment with high adaptability to various shapes of superficial tumors.
Regarding claim 34, Panescu teaches the ablation catheter assembly comprising: a flexible bronchoscope comprising an instrument channel ([0067] The distal region 215 is configured to be delivered through a working channel (e.g., working channel 225 of a bronchoscope 221 or a lumen of a sheath 213 that may be delivered through the working channel of a bronchoscope)); an RF ablation catheter according to claim 1 adapted to travel through the instrument channel (Fig 3).
Regarding claim 35, Panescu teaches the ablation catheter assembly according to claim 34, wherein the bronchoscope has a diameter of less than 4.0 mm ([0067] The distal region 215 is configured to be delivered through a working channel (e.g., working channel 225 of a bronchoscope 221 or a lumen of a sheath 213 that may be delivered through the working channel of a bronchoscope). In its delivery state the device has a maximum diameter smaller than the inner diameter of the working channel through which it is delivered (e.g., less than or equal to 2 mm, less than or equal to 1.5 mm)).
Regarding claim 36, Panescu teaches the ablation catheter assembly according to claim 34, wherein the bronchoscope further comprises a fluid channel adapted to instill or suction fluid, preferably into at least one passageway at a target site in a body organ ([0083] As shown the air removal port 435 is the same port through which a conductive fluid (e.g., hypertonic saline) may be delivered. Alternatively, air may be removed from the targeted portion of lung by applying suction to a different lumen such as guidewire lumen 436 or an additional lumen (not shown) having an exit port on the shaft 429 between the obturators 431, 481) ([0084] The infusion lumen runs from the irrigation ports (e.g., 435) through the shaft 429 to the proximal region of the device where it is connectable to a conductive fluid supply and optionally pump).
Regarding claim 37, Panescu teaches the ablation catheter assembly according to claim 34, wherein the assembly further comprises an amount of liquid metal in electrical contact with the RF conductor element ([0075] While the targeted lung portion is occluded with the obturator 231, optionally collapsed, and infused with conductive liquid RF ablation energy may be delivered from an energy delivery console to the distal electrode 234).
Regarding claim 41, Panescu teaches the liquid metal for use in the treatment of cancer, the treatment comprising: inserting an ablation catheter device of claim 1 into a body organ ([0078] As shown in FIG. 4 a bronchoscope 221 having a lens 224 and light 223 is positioned in a patient's airway and a catheter 220 configured for airway occlusion and tumor ablation is delivered through the bronchoscope's working channel 225 to a targeted portion of lung 226 (e.g., a lung portion, lobe, or segment)); advancing the ablation catheter device to a passageway at a target site in the body organ ([0078]); instilling a volume of the liquid into a passageway of the body organ ([0061] A desired ablation volume, which may be for example a function of tumor size, distance between the targeted tumor and RF electrodes, or proximity to vulnerable non-target structures, may determine if infusion of a conductive fluid is flowing or stagnant, wherein stagnant infusion may be used for smaller ablations and flowing infusion may be used for larger ablations and optionally a greater flow rate or cooling of injected liquid may be used for even larger ablations); and applying an RF current to the liquid ([0075] While the targeted lung portion is occluded with the obturator 231, optionally collapsed, and infused with conductive liquid RF ablation energy may be delivered from an energy delivery console to the distal electrode 234).
Panescu fails to fully teach a liquid metal. However, Sun et al. teaches to a liquid metal ([Pg 234; Para 1] Here we propose for the first time an innovative method of conformable tumor hyperthermia therapy with liquid metal bath-electrodes, which could be attributed to its high adaptability to various shapes of superficial tumors. This new conceptual liquid metal bath-electrode can simply be used by immersing the object or the tumor tissue of any shapes directly in the container of liquid metal. Taking advantage of high conductivity and compliance, liquid metal electrodes will also increase the size of the contact area with the skin surface and decrease the possibility of thermal damage and energy loss). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Panescu to include a liquid metal. Doing so allows for treatment with high adaptability to various shapes of superficial tumors.
Regarding claim 44, Panescu teaches the liquid metal for use of claim 41, wherein the cancer is a lung cancer ([0002] The present disclosure is directed generally to devices and methods for ablating malignant lung tumors and more particularly to ablating lung tumors with an approach through the patient's airway).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Panescu (US 20190343581 A1) in view of Sun, et al. (Xuyang Sun, Zhi-Zhu He, Zhong-Shan Deng, Yi-Xin Zhou & Jing Liu (2018) Liquid metal bath as conformable soft electrodes for target tissue ablation in radio frequency ablation therapy, Minimally Invasive Therapy & Allied Technologies, 27:4, 233-241, DOI: 10.1080/13645706.2017.1393437), further in view of Panescu (2) (US 5740808 A).
Regarding claim 3, Panescu teaches RF ablation catheter according to claim 2, wherein the RF conductor element is formed on the distal segment of the outer shaft (distal electrode (e.g., 234 of FIG. 3) and a proximal electrode (e.g., 237 of FIG. 3)).
Panescu fails to teach wherein the inner shaft and the outer shaft have the same length.
However, Panescu (2) teaches wherein the inner shaft and the outer shaft have the same length distal to the inflatable balloon to together from the distal end of the shaft ([46] The distal end 220 is embedded within an inner sheath 224, which is carried within an outer sheath 226). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Panescu to include wherein the inner shaft and the outer shaft have the same length. Doing so allows for the two shafts to overlap for possible extension of one shaft and to form a safe cavity for the electrode.
Claim(s) 4 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Panescu (US 20190343581 A1) in view of Sun, et al. (Xuyang Sun, Zhi-Zhu He, Zhong-Shan Deng, Yi-Xin Zhou & Jing Liu (2018) Liquid metal bath as conformable soft electrodes for target tissue ablation in radio frequency ablation therapy, Minimally Invasive Therapy & Allied Technologies, 27:4, 233-241, DOI: 10.1080/13645706.2017.1393437), further in view of Cao (US 20200155227 A1).
Regarding claim 4, Panescu teaches the RF ablation catheter according to claim 2, but fails to teach wherein the length of the inner shaft distal to the inflatable balloon is shorter than the length of the outer shaft distal to the balloon to from a cavity between the distal end of the outer shaft and the distal end of the inner shaft with a distal opening and wherein the RF conductor element is arranged in the cavity.
However, Cao teaches wherein the length of the inner shaft distal to the inflatable balloon is shorter than the length of the outer shaft (Fig 3; outer sheath 111, shaft 125) distal to the balloon to from a cavity between the distal end of the outer shaft and the distal end of the inner shaft with a distal opening and wherein the RF conductor element is arranged in the cavity (Fig 3; electrode elements 133 disposed between shaft 125 and outer sheath 111). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Panescu to include wherein the length of the inner shaft distal to the inflatable balloon is shorter than the length of the outer shaft distal to the balloon to from a cavity between the distal end of the outer shaft and the distal end of the inner shaft with a distal opening and wherein the RF conductor element is arranged in the cavity. Doing so allows for a safe cavity to be formed for the electrode where it can be insulated from outer interactions.
Regarding claim 9, Panescu teaches the RF ablation catheter according to claim 1, but fails to teach wherein the distal segment of the flexible shaft comprises a cover element to partially overlay a conductive surface of the RF conductor element, wherein the cover element is made of a non-conductive material.
However, Cao teaches wherein the distal segment of the flexible shaft comprises a cover element to partially overlay a conductive surface of the RF conductor element, wherein the cover element is made of a non-conductive material ([0035] In some examples, the sheath 111 includes an insulation layer to insulate it from the elongate electrode assembly 121. The insulation layer can be a polyimide insulation layer). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Panescu to include wherein the distal segment of the flexible shaft comprises a cover element to partially overlay a conductive surface of the RF conductor element, wherein the cover element is made of a non-conductive material. Doing so allows for the electrode to be protected and insulated from outer interactions.
Claim(s) 10-12, 29-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Panescu (US 20190343581 A1) in view of Sun, et al. (Xuyang Sun, Zhi-Zhu He, Zhong-Shan Deng, Yi-Xin Zhou & Jing Liu (2018) Liquid metal bath as conformable soft electrodes for target tissue ablation in radio frequency ablation therapy, Minimally Invasive Therapy & Allied Technologies, 27:4, 233-241, DOI: 10.1080/13645706.2017.1393437), further in view of Cao (US 20200155227 A1) and Morneau (US 20200155217 A1).
Regarding claim 10, Panescu teaches the RF ablation catheter according to claim 1, but fails to teach wherein the distal segment comprises a cover element which is attached to the distal segment of the shaft to form a cavity with at least one opening, wherein the conductor element is received in the cavity and wherein the cover element is made of a non-conductive element.
However, Morneau teaches wherein the distal segment comprises a cover element which is attached to the distal segment of the shaft to form a cavity with at least one opening ([0216] Functional assembly 500 can comprise one, two, three, or more tissue capture chambers 510, such as are described hereabove. Tissue capture chambers 510 can comprise one or more materials selected from the group consisting of: a plastic; a liquid crystal polymer; a metal; stainless steel; a thermally conductive material; and combinations of these), wherein the conductor element is received in the cavity ([0162] Alternatively or additionally, to initiate, increase and/or otherwise modify the treatment of tissue by one or more functional elements (e.g. a fluid delivery element delivering ablative fluid, a mechanically abrasive element, a hot or cold fluid balloon delivering thermal energy to or from tissue and/or an electrode delivering RF energy) ([0135] the delivery zone can comprise an area defined by the electrodes on the periphery of the array (e.g. a convex hull as described above), such as when the electrodes are positioned and energy is delivered to treat relatively the entire surface of tissue within the periphery) and wherein the cover element is made of a non-conductive element ([0216]). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Panescu to include wherein the distal segment comprises a cover element which is attached to the distal segment of the shaft to form a cavity with at least one opening, wherein the conductor element is received in the cavity and wherein the cover element is made of a non-conductive element. Doing so allows for the electrode to be protected and insulated from outer interactions.
Regarding claim 11, Panescu teaches the RF ablation catheter according to claim 9, but fails to teach wherein the cover element is formed as a hollow cylinder to surround a partial length of the distal segment of the shaft and to form a cavity with at least one opening, wherein the cavity extends from the distal end of the shaft.
However, Morneau teaches wherein the cover element is formed as a hollow cylinder to surround a partial length of the distal segment of the shaft (Fig 9) and to form a cavity with at least one opening (Fig 9; 512), wherein the cavity extends from the distal end of the shaft ([0216] Functional assembly 500 can comprise one, two, three, or more tissue capture chambers 510). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Panescu to include wherein the cover element is formed as a hollow cylinder to surround a partial length of the distal segment of the shaft and to form a cavity with at least one opening, wherein the cavity extends from the distal end of the shaft. Doing so allows for the electrode to be protected and insulated from outer interactions.
Regarding claim 12, Panescu teaches the RF ablation catheter according to claim 9, but fails to teach wherein the RF conductor element is arranged in a recessed manner in the cavity to cover a partial surface area of the cavity, or wherein the RF conductor element is arranged in the cavity and entirely covers the surface area of the cavity, or wherein the RF conductor element is arranged in the cavity and protrudes via the at least one opening to the outside of the cavity.
However, Morneau teaches wherein the RF conductor element is arranged in a recessed manner in the cavity to cover a partial surface area of the cavity, or wherein the RF conductor element is arranged in the cavity and entirely covers the surface area of the cavity, or wherein the RF conductor element is arranged in the cavity and protrudes via the at least one opening to the outside of the cavity ([0216] Functional assembly 500 can comprise one, two, three, or more tissue capture chambers 510) ([0135] where the treatment element is an array of electrodes configured to deliver electrical energy (e.g. RF energy) to tissue, the delivery zone can comprise an area defined by the electrodes on the periphery of the array (e.g. a convex hull as described above), such as when the electrodes are positioned and energy is delivered to treat relatively the entire surface of tissue within the periphery) ([0301] when tissue has been captured in opening 512, injectate can be delivered via needle 525 into the tissue, as described herein, such as to expand the tissue to create a restriction (e.g. a therapeutic restriction), and/or prepare the tissue (e.g. create a safety margin of tissue) for a subsequent tissue 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 Panescu to include wherein the RF conductor element is arranged in a recessed manner in the cavity to cover a partial surface area of the cavity, or wherein the RF conductor element is arranged in the cavity and entirely covers the surface area of the cavity, or wherein the RF conductor element is arranged in the cavity and protrudes via the at least one opening to the outside of the cavity. Doing so allows for the electrode to be protected and insulated from outer interactions.
Regarding claim 29, Panescu teaches the RF ablation catheter according claim 1, but fails to teach further comprising a handle portion arranged in the area of the proximal end of the flexible shaft.
However, Morneau teaches further comprising a handle portion arranged in the area of the proximal end of the flexible shaft ([0200] Handle assembly 300 comprises a handle for an operator to manipulate catheter 200, including housing 301). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Panescu to include further comprising a handle portion arranged in the area of the proximal end of the flexible shaft. Doing so allows for control by an operator of the catheter during operation.
Regarding claim 30, Panescu teaches the RF ablation catheter according to claim 29, wherein the electrical connection is adapted to connect the conductor element to an RF generator ([0075] While the targeted lung portion is occluded with the obturator 231, optionally collapsed, and infused with conductive liquid RF ablation energy may be delivered from an energy delivery console to the distal electrode 234) and wherein the injection port is connected to an injection lumen formed in the flexible shaft and adapted to instilling a liquid ([0075]).
Panescu fails to teach wherein the handle portion comprises a guidewire port, an electrical connection and an injection port, wherein the guidewire port is connected to a guidewire lumen adapted for insertion of a guidewire and formed in the flexible shaft, and wherein the injection port is connected to an injection lumen formed in the flexible shaft and adapted to instilling a liquid metal into a passageway.
However, Sun et al. teaches instilling a liquid metal ([Pg 234; Para 1] Here we propose for the first time an innovative method of conformable tumor hyperthermia therapy with liquid metal bath-electrodes, which could be attributed to its high adaptability to various shapes of superficial tumors. This new conceptual liquid metal bath-electrode can simply be used by immersing the object or the tumor tissue of any shapes directly in the container of liquid metal. Taking advantage of high conductivity and compliance, liquid metal electrodes will also increase the size of the contact area with the skin surface and decrease the possibility of thermal damage and energy loss). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Panescu to include instilling a liquid metal. Doing so allows for treatment with high adaptability to various shapes of superficial tumors.
Further, Morneau teaches wherein the handle portion comprises a guidewire port ([0263] Handle assembly 300 includes multiple tubes, guide tubes 3123 (3 shown)), an electrical connection and an injection port ([0251] n FIG. 3, portions of housing 301 and other components of handle assembly 300 have been removed for illustrative clarity. FDE control assembly 3100 can be configured to control multiple injectate delivery elements 520 (e.g. two, three, four or more injectate delivery elements 520) of functional assembly 500) , wherein the guidewire port is connected to a guidewire lumen adapted for insertion of a guidewire and formed in the flexible shaft ([0202] Handle assembly 300 can include an entry port, such as port 392, for passage of a guidewire or other filament, such as guidewire 60), instilling a liquid into a passageway ([0213] Injectate delivery elements 520 can comprise one or more needles or other fluid delivery elements as described hereabove. Injectate delivery elements 520 can comprise one or more needles or other fluid delivery elements that are configured to deliver fluid or other material to tissue to perform one or more functions, such as submucosal tissue expansion (e.g. duodenal submucosal tissue expansion), mucosal tissue treatment (e.g. duodenal mucosal tissue ablation or other treatment)). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Panescu to include wherein the handle portion comprises a guidewire port, an electrical connection and an injection port, wherein the guidewire port is connected to a guidewire lumen adapted for insertion of a guidewire and formed in the flexible shaft instilling a liquid into a passageway. Doing so allows for control over the movements of the catheter during operation.
Regarding claim 31, Panescu teaches the RF ablation catheter according to claim 30, wherein the injection port is adapted for attachment of a syringe ([0068] fluid may be injected manually with a syringe connected to a proximal region of the device 220 and fluid pressure may be contained by closing lock stop valve. The obturator may be deflated for removal by opening the lock stop valve and pulling the inflation fluid from the balloon using the syringe).
Claim(s) 33 and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Panescu (US 20190343581 A1) in view of Sun, et al. (Xuyang Sun, Zhi-Zhu He, Zhong-Shan Deng, Yi-Xin Zhou & Jing Liu (2018) Liquid metal bath as conformable soft electrodes for target tissue ablation in radio frequency ablation therapy, Minimally Invasive Therapy & Allied Technologies, 27:4, 233-241, DOI: 10.1080/13645706.2017.1393437), Further in view of Langberg (US 5248312 A).
Regarding claim 33, Panescu teaches the RF ablation catheter according to claim 1, but fails to teach wherein the liquid metal is liquid at 37C.
However, Langberg teaches wherein the liquid metal is liquid at 37C ([4] The melting point of gallium is 30.degree. C. (86.degree. F.) and so gallium can be frozen at ordinary refrigerator temperatures in a mold of the desired shape prior to insertion. Since body temperature is above the melting point of gallium, the solid gallium slug will melt after insertion into uterus 20 and fill the latex sheath 13 to conform to the uterine cavity 22). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Panescu to include wherein the liquid metal is liquid at 37C. Doing so allows for ease of manipulation. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the liquid metal is liquid at 37C, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 45, Panescu teaches the liquid metal for use of any one of claim 41, but fails to teach wherein the liquid metal is liquid at 37C.
However, Langberg teaches wherein the liquid metal is liquid at 37C ([4] The melting point of gallium is 30.degree. C. (86.degree. F.) and so gallium can be frozen at ordinary refrigerator temperatures in a mold of the desired shape prior to insertion. Since body temperature is above the melting point of gallium, the solid gallium slug will melt after insertion into uterus 20 and fill the latex sheath 13 to conform to the uterine cavity 22). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Panescu to include wherein the liquid metal is liquid at 37C. Doing so allows for ease of manipulation. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the liquid metal is liquid at 37C, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 38-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Panescu (US 20190343581 A1) in view of Sun, et al. (Xuyang Sun, Zhi-Zhu He, Zhong-Shan Deng, Yi-Xin Zhou & Jing Liu (2018) Liquid metal bath as conformable soft electrodes for target tissue ablation in radio frequency ablation therapy, Minimally Invasive Therapy & Allied Technologies, 27:4, 233-241, DOI: 10.1080/13645706.2017.1393437), further in view of Langberg (US 5248312 A) and Barry (US 20080110457 A1).
Regarding claim 38, Panescu teaches the RF ablation catheter according to claim 1 but fails to teach a kit comprising the RF ablation catheter according or the ablation catheter assembly and a container comprising a liquid metal.
However, Barry teaches a kit comprising the RF ablation catheter or the ablation catheter assembly and a container comprising a liquid metal ([0051] A medical kit for performing volumetric vapor heating of one or more target lung tissues which comprises a packaged, sterile liquid or liquid composition and a high temperature vapor delivery catheter. Other embodiments of said medical kits can comprise instructions of use, syringes, and the like). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Panescu to include a kit comprising the RF ablation catheter or the ablation catheter assembly and a container comprising a liquid metal. Doing so allows for ease of transportation and set up of the device.
Regarding claim 39, Panescu in combination with Barry teaches the kit of claim 38, but fails to teach wherein the liquid metal comprises gallium.
However, Sun et al teaches wherein the liquid metal comprises gallium ([Pg 240; Para 3] Liquid metal composed of gallium and indium or gallium alone has been proven to possess good Biocompatibility to living tissues). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Panescu to include wherein the liquid metal comprises gallium. Doing so allows the metal to be biocompatible to living tissue and therefore will not irritate the body when used.
Regarding claim 40, Panescu and Barry teaches the kit according to claim 38, but fails to teach wherein the liquid metal is liquid at 37C.
However, Langberg teaches kit according to claim 38, wherein the liquid metal is liquid at 37C ([4] The melting point of gallium is 30.degree. C. (86.degree. F.) and so gallium can be frozen at ordinary refrigerator temperatures in a mold of the desired shape prior to insertion. Since body temperature is above the melting point of gallium, the solid gallium slug will melt after insertion into uterus 20 and fill the latex sheath 13 to conform to the uterine cavity 22). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Panescu to include wherein the liquid metal is liquid at 37C. Doing so allows the metal to be liquid for ease of manipulation. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the liquid metal is liquid at 37C, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Panescu (US 20190343581 A1) in view of Sun, et al. (Xuyang Sun, Zhi-Zhu He, Zhong-Shan Deng, Yi-Xin Zhou & Jing Liu (2018) Liquid metal bath as conformable soft electrodes for target tissue ablation in radio frequency ablation therapy, Minimally Invasive Therapy & Allied Technologies, 27:4, 233-241, DOI: 10.1080/13645706.2017.1393437), further in view of Balbierz (US 6770070 B1).
Regarding claim 28, Panescu teaches the RF ablation catheter according to claim 1, but fails to teach wherein the RF power of the RF energy delivered to the liquid metal lies in the range of 40 to 180 watts.
However, Balbierz teaches wherein the RF power of the RF energy delivered to the liquid metal lies in the range of 40 to 180 watts ([25] the energy delivery device 18 is one or more RF electrodes 18 and the power source utilized is an RF power supply. For these and related embodiments RF power supply delivers 5 to 200 watts, preferably 5 to 100, and still more preferably 5 to 50 watts of electromagnetic energy is to the electrodes of energy delivery device 18 without impeding out). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Panescu to include wherein the RF power of the RF energy delivered to the liquid metal lies in the range of 40 to 180 watts. Doing so would allow for the metal to be heated to a preferred temperature for ease of manipulation. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the RF power of the RF energy delivered to the liquid metal lies in the range of 40 to 180 watts, 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.
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Panescu (US 20190343581 A1) in view of Sun, et al. (Xuyang Sun, Zhi-Zhu He, Zhong-Shan Deng, Yi-Xin Zhou & Jing Liu (2018) Liquid metal bath as conformable soft electrodes for target tissue ablation in radio frequency ablation therapy, Minimally Invasive Therapy & Allied Technologies, 27:4, 233-241, DOI: 10.1080/13645706.2017.1393437), further in view of Chieh (US 20190110829 A1).
Regarding claim 43, Panescu and the combination teaches the liquid metal for use of claim 41, but fails to teach wherein the liquid metal is heated to a range of 60C to 80C by applying RF.
However, Chieh teaches wherein the liquid metal is heated to a range of 60C to 80C by applying RF ([0047] As such, when the liquid metal LM is heated using the power supply 120 to kill tumor cells, the liquid metal LM can be controlled between 60 Celsius and 80 Celsius by controlling the AC frequency to achieve effective treatment and good treatment effect). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Panescu to include wherein the liquid metal is heated to a range of 60C to 80C by applying RF. Doing so would allow for the liquid metal to be easily controlled and manipulated ([0047]). Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the liquid metal is heated to a range of 60C to 80C by applying RF, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
Prosecution Insights