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).
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].
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 (from Rajagopalan, camera 352 and light source 140 are both physically coupled to the endoscope 350 which equates to the sheath containing the ablation treatment, [0361], see also fig 3).
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].
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 (from Rajagopalan, camera 352 and light source 140 are both physically coupled to the endoscope 350 which equates to the sheath containing the ablation treatment, [0361], see also fig 3).
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 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
Applicant’s arguments with respect to claim(s) 1 and 10 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 directly exposed to the patient’s anatomy without intervening structure as well as using the camera to directly visualize the treatment needle at the distal tip.” 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 Rajagopalan does disclose the teachings from the previous prior art of record of Amirana and Lee as well as the deficiencies of the prior art in view of the newly amended claim language. Specifically, Rajagopalan teaches where the system is 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]) as well as 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, as the new limitations remain taught by the new reference Rajagopalan, 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.
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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/KYLE M. BROWN/Examiner, Art Unit 3794
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