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 .
Response to Amendment
Examiner acknowledges the amendments made to the claims 1, 10 with claims 1-20 currently pending in prosecution.
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.
Claim(s) 1-5, 7-15, 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US Patent No 20190388133) in view of Rajagopalan (US Patent No 20160081745) further in view of Saadat (US Patent No 20150164571).
Regarding claim 1, Sharma teaches an ablation catheter configured to deliver an ablation fluid to a volume of fibroid tissue of a patient (ablation device 2000 with a catheter 2002 configured to deliver an ablation fluid to a prostate or uterine cavity, [0296]-[0297], thereby teaching fibroid tissue), comprising: a sheath having at least one lumen (sheath 2022 encompassing the lumen 2008, [0300]), wherein the lumen is configured to receive a volume of fluid (lumen 2008 configured to receive saline, [0298]); at least one needle positioned within a distal tip of the catheter and configured to be deployed from an opening on a surface of the distal tip (needle 2005 positioned at the distal tip of the catheter 2002 and configured to be retractable and protrude from the distal end 2011, [0297], see also fig 2A); at least one port positioned in the at least one needle (port 2007 on needle 2005, [0298]); at least one heating component positioned within the lumen and proximate the distal tip (see the heating chamber 4028 which contains RF electrode and proximate the distal end 2011, see fig 4A), wherein the at least one heating component is configured to receive the volume of fluid (saline enters the heating chamber 4028, [0304]); a handle coupled to a proximal end of the sheath (see handle 2010, fig 2A), wherein a value defining a maximum diameter of the catheter is equal to, or less than, 8 mm (wherein the catheter has a diameter of 2.6mm which falls less than 8mm, [0306]).
Sharma does not teach a camera positioned adjacent to the opening on the surface of the distal tip and configured to directly visualize deployment of the at least one needle from the distal tip during delivery of the ablation fluid and when the at least one needle is extended out from the surface of the distal tip; a light source positioned adjacent to the opening on the surface of distal tip and adjacent the camera, wherein the camera and the light source are physically coupled to the sheath; and optical data transmission circuitry coupled to the camera and extending proximally through the sheath to transmit real-time visual data during needle deployment, wherein the camera component is adapted to be exposed outside of any portion of the ablation catheter on an exterior surface of the distal tip of the ablation catheter such that the camera and light source are directly exposed to the patients anatomy without any intervening structure.
However, the analogous ablation visualization system taught by Rajagopalan does teach a camera positioned adjacent to the opening on the surface of the distal tip (see from fig 3 in which the endoscope system 350 contains a camera 352 positioned next to the treatment shaft or tip 11, [0316]) and configured to directly visualize deployment of the at least one needle from the distal tip during delivery of the ablation fluid and when the at least one needle is extended out from the surface of the distal tip (see in which the camera 352 is configured to provide direct visualization of the treatment shaft 11a and 11b, seen as the analogous deployable needle, as well as providing direct visualization of the internal body spaces and tissues, [0316]); a light source positioned adjacent to the opening on the surface of distal tip and adjacent the camera, wherein the camera and the light source are physically coupled to the sheath (see in which the treatment assembly 140 which is found on the endoscope system 350 contains a light source for light distribution adjacent to the camera 352, [0278]); and optical data transmission circuitry coupled to the camera and extending proximally through the sheath to transmit real-time visual data during needle deployment (see in which the camera 352 is configured to provide direct visualization of the treatment shaft 11a and 11b, and the light source is coupled to transmit data via one or more optical laser fibers seen in the ablation device 100, [0278]), wherein the camera component is adapted to be exposed outside of any portion of the ablation catheter on an exterior surface of the distal tip of the ablation catheter such that the camera and light source are directly exposed to the patients anatomy without any intervening structure (see from the fig 3 in which the camera 352 and light components in the treatment assembly 140 are found on the exterior surface of the endoscope system 350 and they do not interfere with other intervening structure such as the treatment tip shaft 11 or the balloon element 131).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the vapor ablation catheter system of Sharma with the camera and visualization system of Rajagopalan as an effective way to visualize and track the ablation needle during treatment to ensure the right treatment region is being operated on without interference as disclosed by Rajagopalan, [0316].
Furthermore, neither Sharma nor Rajagopalan explicitly teach wherein the light source is configured to illuminate a target tissue area and assist in visualization via the camera, and wherein the at least one needle and the camera are surrounded by the light source and positioned together at the distal tip to form a probe.
However, the analogous ablation treatment apparatus taught by Saadat does disclose, wherein the light source is configured to illuminate a target tissue area and assist in visualization via the camera, and wherein the at least one needle and the camera are surrounded by the light source and positioned together at the distal tip to form a probe (see from Saadat, [0151], in which the surgical device 29 may be configured with both an optical camera and a light source disposed in the distal end 21 of the probe shaft member 20. The light source and camera may be used to help identify and place the distal end effector in the correct anatomical landmark during treatment).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the ablation and optical systems taught by Sharma and Rajagopalan, with that of the specific distal end camera and light source configuration on the probe taught by Saadat, as it is another known structure in the art to help illuminate and guide the distal end probe during treatment as to result in accurate and effective treatment methods, as disclosed by Saadat, [0031].
Regarding claim 2, the combination teaches the ablation catheter of claim 1, wherein the at least one heating component is a flat electrode (Sharma, see fig 11A in which the heating element 1150 is comprised of flat electrodes, [0374]).
Regarding claim 3, the combination teaches the ablation catheter of claim 1, wherein the at least one needle is configured to be deployed at an angle relative to a longitudinal axis defining a direction of the distal tip (Sharma, the needle 2005 is configured to be deployed at an angle relative the longitudinal axis, [0297], see also fig 2A).
Regarding claim 4, the combination teaches the ablation catheter of claim 3, wherein the angle is in a range of 10 degrees to 90 degrees relative to the longitudinal axis defining the direction of the distal tip (Sharma, needle 3005 is capable of bending up to and angle of at least 45 degrees, [0302], falling within the claimed range).
Regarding claim 5, the combination teaches the ablation catheter of claim 1, wherein the camera and the light source are not positioned in a scope physically separate from the sheath (see from Saadat, [0151], in which the surgical device 29 may be configured with both an optical camera and a light source disposed in the distal end 21 of the probe shaft member 20, and thereby found on a scope on the same sheath).
Regarding claim 7, the combination teaches the ablation catheter of claim 1, wherein the at least one heating component comprises an electrode and wherein the electrode is tapered such that a distal tip of the electrode is thinner than a proximal portion of the electrode (Sharma, see the heating chamber 4028 which contains RF electrode and proximate the distal end 2011, see fig 4A, furthermore the electrode assembly comprises a taper portion 4027 such that the distal tip is thinner than the proximal portion 4026, [0304]).
Regarding claim 8, the combination teaches the ablation catheter of claim 1, wherein the fluid is saline (Sharma, lumen 2008 configured to receive saline, [0298]).
Regarding claim 9, the combination teaches the ablation catheter of claim 1, wherein the sheath comprises a second lumen running parallel to the at least one lumen and wherein the optical data transmission circuitry is positioned within the second lumen (Rajagopalan, see in which there are other lumens such as second lumen 351 which may contain the treatment shafts 11 which may contain the light source 140 and optical cable transmissions, [0282]).
Regarding claim 10, Sharma teaches an ablation system configured to deliver an ablation fluid to a volume of fibroid tissue (ablation device 2000 with a catheter 2002 configured to deliver an ablation fluid to a prostate or uterine cavity, [0296]-[0297], thereby teaching fibroid tissue), comprising: a catheter having: a sheath having at least one lumen (sheath 2022 encompassing the lumen 2008, [0300]), wherein the lumen is configured to receive a volume of fluid (lumen 2008 configured to receive saline, [0298]); at least one needle positioned within a distal tip of the catheter and configured to be deployed from an opening on a surface of the distal tip (needle 2005 positioned at the distal tip of the catheter 2002 and configured to be retractable and protrude from the distal end 2011, [0297], see also fig 2A); at least one port positioned in the at least one needle (port 2007 on needle 2005, [0298]); at least one heating component positioned within the lumen and proximate the distal tip (see the heating chamber 4028 which contains RF electrode and proximate the distal end 2011, see fig 4A), wherein the at least one heating component is configured to receive the volume of fluid (saline enters the heating chamber 4028, [0304]); a handle coupled to a proximal end of the sheath (see handle 2010, fig 2A); wherein a value defining a maximum diameter of the catheter is equal to, or less than, 8 mm (wherein the catheter has a diameter of 2.6mm which falls less than 8mm, [0306]); a fluid reservoir configured to contain the volume of fluid and coupled to the at least one lumen (saline reservoir 1802 which has tubing 1800 to connect the reservoir to the lumen 2008, [0408]); a pump in pressure communication with the fluid reservoir (pump in fluid communication with the reservoir, [0411]); and a controller coupled to the pump (pumps controlled via a thumb dial 1806 which is coupled to the pump, [0408]), wherein the controller is in electrical communication with the at least one heating component and programmed to deliver an electrical current to the at least one heating component and to cause the volume of fluid to pass into the lumen from the fluid reservoir when activated (the vapor generator device 2050 which contains the controller and the pump 2075 is in electrical communication with the heating chamber and would deliver electrical current to the induction unit and cause the volume of saline to pass through the fluid tubes 1803 from the saline reservoir 1802 when the pump 2075 is activated, [0411]).
Sharma does not teach a camera positioned adjacent to the opening on the surface of the distal tip and configured to directly visualize deployment of the at least one needle from the distal tip during delivery of the ablation fluid and when the at least one needle is extended out from the surface of the distal tip; a light source positioned adjacent to the opening on the surface of distal tip and adjacent the camera, wherein the camera and the light source are physically coupled to the sheath; and optical data transmission circuitry coupled to the camera and extending proximally through the sheath to transmit real-time visual data during needle deployment, wherein the camera component is adapted to be exposed outside of any portion of the ablation catheter on an exterior surface of the distal tip of the ablation catheter such that the camera and light source are directly exposed to the patients anatomy without any intervening structure.
However, the analogous ablation visualization system taught by Rajagopalan does teach a camera positioned adjacent to the opening on the surface of the distal tip (see from fig 3 in which the endoscope system 350 contains a camera 352 positioned next to the treatment shaft or tip 11, [0316]) and configured to directly visualize deployment of the at least one needle from the distal tip during delivery of the ablation fluid and when the at least one needle is extended out from the surface of the distal tip (see in which the camera 352 is configured to provide direct visualization of the treatment shaft 11a and 11b, seen as the analogous deployable needle, as well as providing direct visualization of the internal body spaces and tissues, [0316]); a light source positioned adjacent to the opening on the surface of distal tip and adjacent the camera, wherein the camera and the light source are physically coupled to the sheath (see in which the treatment assembly 140 which is found on the endoscope system 350 contains a light source for light distribution adjacent to the camera 352, [0278]); and optical data transmission circuitry coupled to the camera and extending proximally through the sheath to transmit real-time visual data during needle deployment (see in which the camera 352 is configured to provide direct visualization of the treatment shaft 11a and 11b, and the light source is coupled to transmit data via one or more optical laser fibers seen in the ablation device 100, [0278]), wherein the camera component is adapted to be exposed outside of any portion of the ablation catheter on an exterior surface of the distal tip of the ablation catheter such that the camera and light source are directly exposed to the patients anatomy without any intervening structure (see from the fig 3 in which the camera 352 and light components in the treatment assembly 140 are found on the exterior surface of the endoscope system 350 and they do not interfere with other intervening structure such as the treatment tip shaft 11 or the balloon element 131).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the vapor ablation catheter system of Sharma with the camera and visualization system of Rajagopalan as an effective way to visualize and track the ablation needle during treatment to ensure the right treatment region is being operated on without interference as disclosed by Rajagopalan, [0316].
Furthermore, neither Sharma nor Rajagopalan explicitly teach wherein the light source is configured to illuminate a target tissue area and assist in visualization via the camera, and wherein the at least one needle and the camera are surrounded by the light source and positioned together at the distal tip to form a probe.
However, the analogous ablation treatment apparatus taught by Saadat does disclose, wherein the light source is configured to illuminate a target tissue area and assist in visualization via the camera, and wherein the at least one needle and the camera are surrounded by the light source and positioned together at the distal tip to form a probe (see from Saadat, [0151], in which the surgical device 29 may be configured with both an optical camera and a light source disposed in the distal end 21 of the probe shaft member 20. The light source and camera may be used to help identify and place the distal end effector in the correct anatomical landmark during treatment).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the ablation and optical systems taught by Sharma and Rajagopalan, with that of the specific distal end camera and light source configuration on the probe taught by Saadat, as it is another known structure in the art to help illuminate and guide the distal end probe during treatment as to result in accurate and effective treatment methods, as disclosed by Saadat, [0031].
Regarding claim 11, the combination teaches the ablation system of claim 10, further comprising a power source positioned in the controller and coupled to the light source and the camera (Rajagopalan, see the controller 310 contains the system for energy and power delivery to the functional components such as the light and camera, [0320]).
Regarding claim 12, the combination teaches the ablation system of claim 10, wherein the at least one heating component is a flat electrode (Sharma, see fig 11A in which the heating element 1150 is comprised of flat electrodes, [0374]).
Regarding claim 13, the combination teaches the ablation system of claim 10, wherein the at least one needle is configured to be deployed at an angle relative to a longitudinal axis defining a direction of the distal tip (Sharma, the needle 2005 is configured to be deployed at an angle relative the longitudinal axis, [0297], see also fig 2A).
Regarding claim 14, the combination teaches the ablation system of claim 13, wherein the angle is in a range of 10 degrees to 90 degrees relative to the longitudinal axis defining the direction of the distal tip (Sharma, needle 3005 is capable of bending up to and angle of at least 45 degrees, [0302], falling within the claimed range).
Regarding claim 15, the combination teaches the ablation system of claim 10, wherein the camera and the light source are not positioned in a scope physically separate from the sheath (see from Saadat, [0151], in which the surgical device 29 may be configured with both an optical camera and a light source disposed in the distal end 21 of the probe shaft member 20, and thereby found on a scope on the same sheath).
Regarding claim 17, the combination teaches the ablation system of claim 10, wherein the at least one heating component is an electrode and wherein the electrode is tapered such that a distal tip of the electrode is thinner than a proximal portion of the electrode (Sharma, see the heating chamber 4028 which contains RF electrode and proximate the distal end 2011, see fig 4A, furthermore the electrode assembly comprises a taper portion 4027 such that the distal tip is thinner than the proximal portion 4026, [0304]).
Regarding claim 18, the combination teaches the ablation system of claim 10, wherein the controller is configured to deliver the electrical current to the at least one heating component for a continuous period of time that is equal to, or less than, one minute (Sharma, controller is programmed to deliver electrical energy to the electrode for a period of time ranging between 1-60 sec, [0343]).
Regarding claim 19, the combination teaches the ablation system of claim 10, wherein the sheath comprises a second lumen running parallel to the at least one lumen and wherein the optical data transmission circuitry is positioned within the second lumen (Rajagopalan, see in which there are other lumens such as second lumen 351 which may contain the treatment shafts 11 which may contain the light source 140 and optical cable transmissions, [0282]).
Regarding claim 20, the combination teaches the ablation system of claim 19, wherein the second lumen has a diameter that is equal to or less than 4mm and the at least one lumen has a diameter that is equal to or less than 4mm (Sharma, wherein the catheter has a diameter of 2.6mm which falls less than 4mm, and the outer catheter which defines a second lumen has a diameter of 3.3mm which falls less than 4mm, [0306]).
Claim(s) 6,16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US Patent No 20190388133) in view of Rajagopalan (US Patent No 20160081745) further in view of Saadat (US Patent No 20150164571) further in view of Mickelsen (US Patent No 20150182740).
Regarding claim 6 and 16, the previous combination of Sharma and Rajagopalan teach the ablation catheter system of claims 1 and 10.
The previous combination does not teach wherein the maximum diameter of the catheter is in a range of 4 mm to 5 mm.
However, the analogous catheter system taught by Mickelsen does teach wherein the maximum diameter of the catheter is in a range of 4 mm to 5 mm (catheter 100 has an outer diameter of 5mm, [0074]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the previous catheter ablation system of Sharma and Rajagopalan with the catheter size of Mickelsen in order to provide a thin catheter profile to allow for more precise use and effectiveness accessing smaller treatment areas as disclosed by Mickelsen, [0074].
Response to Arguments
Applicants’ arguments with respect to claim(s) 1 and 10, as well as dependent claims 5 and 15, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The examiner agrees with the applicant in which it is argued that the previous prior art of record does not solely teach the new amended limitation of claims 1 and 10 in which “the camera and light source are positioned together at the distal tip to form a probe member in which the light source is configured to illuminate the target area.” However, after further search and consideration necessitated by the new amended claim language, it has been found that the analogous access catheter for ablation and imagery taught by Saadat does disclose the deficiencies of the previous prior art in view of the newly amended claim language. Specifically, Saadat does disclose, wherein the light source is configured to illuminate a target tissue area and assist in visualization via the camera, and wherein the at least one needle and the camera are surrounded by the light source and positioned together at the distal tip to form a probe (see from Saadat, [0151], in which the surgical device 29 may be configured with both an optical camera and a light source disposed in the distal end 21 of the probe shaft member 20. The light source and camera may be used to help identify and place the distal end effector in the correct anatomical landmark during treatment). Therefore, as the new limitations remain taught by the new reference Saadat, the amended claims 1 and 10 remain rejected under the new prior art of record rejection set forth in the present office action of Sharma in view of Rajagopalan further in view of Saadat. Furthermore, the new prior art of record rejection of Saadat teaches the limitations of the dependent claims 5 and 15 and therefore claims 5 and 15 also remain rejected under the new prior art of record rejection of Saadat set forth in the present office action.
With regards to the arguments made about the claims 9 and 19, that the previous prior art of Rajagopalan does not reasonably teach that “the sheath comprises a second lumen running parallel to the at least one lumen and wherein the optical data transmission circuitry is positioned within the second lumen,” this argument has been considered but ultimately falls unpersuasive. With regards to claims 9 and 19, the examiner would like to remind the applicant that the claim language is analyzed under the broadest reasonable interpretation of the limitation. Therefore, looking at the claim language under the broadest reasonable interpretation, the prior art of Rajagopalan only needs to contain a parallel secondary lumen which is capable of holding the optical data transmission circuitry. In which, the prior art of Rajagopalan does disclose a secondary lumen 351 which runs parallel to the analogous first lumen space, and the secondary lumen 351 does contain the optical transmission elements 140 as seen in the specification [0282]. Therefore, as the prior art of Rajagopalan does disclose the claim limitations of claims 9 and 19 as analyzed under the broadest reasonable interpretation, claims 9 and 19 remain rejected under the previous prior art of record of Rajagopalan set forth in the present office action.
As no further remarks or amendments have been made in view of the dependent claim limitations, they too remain rejected under the prior art of record rejections set forth in the present office action.
Conclusion
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/KYLE M. BROWN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
