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 .
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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-7, 11, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burbank et al., (US 20020193705; hereinafter Burbank).
Regarding claim 1, Burbank (Figures 1-2 and 9-14) discloses an electrosurgical device (100), comprising: a handle (104) coupled to an introducer member (102) extending about a central axis to a working end (distal end of element 152), wherein the introducer member (102) has an outer surface that defines an introducer envelope (channel within introducer 102) extending axially from the introducer member (102), ([0044]-[0046]); an electrode shaft (140) moveably located within the introducer member (102), ([0049]); an RF loop electrode (138) carried by the electrode shaft (140) and positioned at the working end (distal end of element 152) extending in a transverse plane that is from 45 to 90 degrees transverse to the central axis (as shown in Figure 10; [0049]-[0050]); a drive assembly (motors within handle 104 connecting the motor driver 112 to the electrode shaft 140 for movement of the loop electrode 138) within the handle (104) and coupled to the electrode shaft (140), ([0044]-[0045], [0049]), where the drive assembly is configured to move the RF loop electrode between a first position (shown within the introducer in Figure 10) within the introducer (102) envelope for introduction into a working space and a second position (shown outside the introducer in phantom in Figure 10) radially outward from the introducer (102) envelope for resecting tissue ([0051], [0073]-[0074]), the second position selectable to define a selected cutting depth (as shown in Figure 10, the electrode 138 is rotated in the perpendicular plane to move it from within the introducer to the fully exposed position shown in phantom; therefore, the cutting depth defined by the fully exposed position is the selected cutting depth in that moment); wherein the tissue is resected by translating the working end (in any configuration in which the RF loop electrode 138 is exposed from within the introducer, the RF loop electrode 138 is deployed to a desired rotational position/cutting depth and configured for cutting/resection; therefore, translation/movement of the entire device 100 including the working end would resect tissue using the deployed RF loop electrode 138) over the target tissue while the RF loop electrode (138) remains in the second position (shown in Figure 11) such that the RF electrode (138) cuts a tissue strip at the selected cutting depth (as shown in Figures 11-14; [0075]-[0078]).
Regarding claim 2, Burbank (Figures 1-2 and 9-14) further discloses wherein the RF loop electrode (138) is carried at a distal end of the electrode shaft (140), ([0049]-[0050]).
Regarding claim 3, Burbank (Figures 1-2 and 9-14) further discloses wherein the drive assembly (motors within handle 104 connecting the motor driver 112 to the electrode shaft 140 for movement of the loop electrode 138) is adapted to move the RF loop electrode (138) between the first position (within the introducer) and the second position (outside of the introducer) by at least one of rotation of the electrode shaft (140) and lateral movement of the electrode shaft ([0044]-[0045], [0049], [0051], [0073]-[0078]).
Regarding claim 4, Burbank (Figures 1-2 and 9-14) further discloses wherein the drive assembly (motors within handle 104 connecting the motor driver 112 to the electrode shaft 140 for movement of the loop electrode 138) is further adapted to move the RF loop electrode (138) axially between a distal position and a proximal position relative to the introducer member ([0044]-[0045], [0049], [0051], [0073]-[0078]).
Regarding claim 5, Burbank (Figures 1-2 and 9-14) further discloses wherein the drive assembly (motors within handle 104 connecting the motor driver 112 to the electrode shaft 140 for movement of the loop electrode 138) is actuated by at least one of a motor drive (112) and manual actuation ([0044]-[0045], [0049], [0051], [0073]-[0078]).
Regarding claim 6, Burbank (Figures 1-2 and 9-14) further discloses wherein the drive assembly (motors within handle 104 connecting the motor driver 112 to the electrode shaft 140 for movement of the loop electrode 138) is selected by at least one of an actuator in the handle and an icon on a touch screen ([0044]-[0045], [0049], [0051], [0073]-[0078]).
Regarding claim 7, Burbank (Figures 1-2 and 9-14) further discloses wherein the RF loop electrode (138) comprises an inflexible wire ([0049]-[0050]).
Regarding claim 11, Burbank (Figures 1-2 and 9-14) further discloses an RF source (106) coupled to the RF loop electrode (138) and where the drive assembly (motors within handle 104 connecting the motor driver 112 to the electrode shaft 140 for movement of the loop electrode 138) includes a motor drive (112), and a controller (programmable logic controller not illustrated) configured to control operating parameters of the RF source and motor drive ([0044]-[0045], [0084]).
Regarding claim 17, Burbank (Figures 1-2 and 9-14) further discloses an extension-retraction mechanism for extending and retracting the RF loop electrode (138) relative to a passageway (channel) in the introducer member (102), wherein an outer surface of the RF loop electrode (138) is dimensioned to match a surface of the passageway (channel) wherein retraction of the RF loop electrode (138) scrapes eschar from the RF loop electrode (138) when retracted into the passageway (channel), ([0044]-[0045], [0049], [0051], [0073]-[0078]).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burbank, as applied to claim 1, and further in view of Hsu et al., (US 20220039640; hereinafter Hsu).
Regarding claim 14, Burbank discloses the electrosurgical device of claim 1, but fails to disclose wherein the introducer member includes an articulating section in the working end that is actuatable from the handle. However, Hsu (Figure 17) teaches an electrosurgical device, wherein an introducer member (1145) includes an articulating section (1144) in the working end (1140) that is actuatable from a handle through a pull wire (1148), ([0094]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burbank to include an articulating section in the working end of the introducer member, as taught by Hsu, because the modification would provide flexible functionality to the working end (Hsu; [0094]) to direct the working end as needed in the target area.
Claim(s) 18-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burbank in view of Eliachar et al., (US 20080188711; hereinafter Eliachar).
Regarding claim 18, Burbank (Figures 1-2 and 9-14) discloses a method of resecting tissue in a working space in a patient, comprising: providing an introducer (102) having an outer surface that defines an introducer envelope (channel within introducer 102) extending axially from the introducer (102), ([0044]-[0046]), the introducer (102) extending about a central axis to a working end (distal end of element 152) carrying an RF loop electrode (138), ([0049]-[0050]) that is moveable between a first position within the introducer envelope (shown in Figure 10 within introducer 102) and a second position radially outward from the introducer envelope (shown in phantom in Figure 10), the second position selectable to define a selected cutting depth (as shown in Figure 10, the electrode 138 is rotated in the perpendicular plane to move it from within the introducer to the fully exposed position shown in phantom; therefore, the cutting depth defined by the fully exposed position is the selected cutting depth in that moment); ([0049], [0051], [0073]-[0074]); introducing the working end (distal end of element 152) in the first position ([0073]); moving the RF loop electrode (138) to the second position (the position along the perpendicular plane to which the electrode 138 is rotated such that the cutting depth defined by the level of exposure of the electrode 138 from within the introducer is selected to define the selected cutting depth ([0074]); resecting the tissue by activating the RF loop electrode (138) and translating the working end (in any configuration in which the RF loop electrode 138 is exposed from within the introducer, the RF loop electrode 138 is deployed to a desired rotational position/cutting depth and configured for cutting/resection; therefore, translation/movement of the entire device 100 including the working end would resect tissue using the deployed RF loop electrode 138) over the tissue while the RF loop electrode (138) remains in the second position such that the RF electrode (138) cuts a tissue strip at the selected cutting depth; and moving the RF loop electrode (138) from the second position to the first position thereby mobilizing the tissue strip (shown in Figures 11-14; [0075]-[0078]).
Burbank fails to disclose introducing the working end in the first position through a working channel of an endoscope into the working space. However, Eliachar (Figure 1a) teaches a method of resecting tissue in a working space in a patient, comprising introducing a working end (distal end) in the first position through a working channel of an endoscope (10) into the working space ([0037]-[0039]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burbank to include introducing the working end in the first position through a working channel of an endoscope into the working space, as taught by Eliachar, because the modification would provide a protected maneuverable effecter adapted to maneuver adjacent or inside a target tissue or organ (Burbank; [0037]).
Regarding claim 19, Burbank (Figures 1-2 and 9-14) further discloses wherein the RF loop electrode (138) extends in a transverse plane that is from 45 to 90 degrees transverse to a central axis of the introducer (102) in the second position ([0049]-[0050]).
Regarding claim 20, Burbank (Figures 1-2 and 9-14) further discloses wherein the selected cutting depth is selected by a mechanism in a handle portion (104) of the introducer (102), ([0044]-[0045], [0049], [0051], [0073]-[0078]).
Regarding claim 21, Burbank (Figures 1-2 and 9-14) further discloses wherein the RF loop electrode (138) is moved between the first position and the second position in a rotational direction relative to the central axis of the introducer (102), ([0044]-[0045], [0049], [0051], [0073]-[0078]).
Regarding claim 22, Burbank (Figures 1-2 and 9-14) further discloses wherein the RF loop electrode (138) is moved between the first position and the second position in a transverse direction relative to the central axis of the introducer (102), ([0044]-[0045], [0049], [0051], [0073]-[0078]).
Regarding claim 23, Burbank (Figures 1-2 and 9-14) further discloses wherein the RF loop electrode (138) is moved between the first position and the second position by at least one of a motor drive (112) and manual actuation ([0044]-[0045], [0049], [0051], [0073]-[0078]).
Regarding claim 24, Burbank (Figures 1-2 and 9-14) further discloses wherein the working end (distal end of element 152) is translated over tissue by at least one of a motor drive (112) and manual actuation ([0044]-[0045], [0049], [0051], [0073]-[0078]: distal end of element 152 is translated into open and closed positioned in order to use the loop electrode 138 to cut over the selected cutting depth in the second position).
Regarding claim 25, Burbank (Figures 1-2 and 9-14) further discloses wherein a controller is configured to control movement of the RF loop electrode (programmable logic controller not illustrated), ([0044]-[0045], [0084]).
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burbank as applied to claim 1 above.
Regarding claim 8, Burbank discloses the electrosurgical device of claim 1, but fails to disclose wherein the outer surface of the RF loop electrode in the second position is positioned outward of the introducer envelope by at least 0.5 mm. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burbank to include the outer surface of the RF loop electrode in the second position positioned outward of the introducer envelope by at least 0.5 mm 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. MPEP 2144.05(I).
Regarding claim 9, Burbank discloses the electrosurgical device of claim 1, but fails to disclose wherein the outer surface of the RF loop electrode in the second position is positioned outward of the introducer envelope by at least 2 mm. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burbank to include the outer surface of the RF loop electrode in the second position positioned outward of the introducer envelope by at least 2 mm 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. MPEP 2144.05(I).
Regarding claim 10, Burbank discloses the electrosurgical device of claim 1, but fails to disclose wherein the outer surface of the RF loop electrode in the second position is positioned outward of the introducer envelope by at least 4 mm. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burbank to include the outer surface of the RF loop electrode in the second position positioned outward of the introducer envelope by at least 4 mm 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. MPEP 2144.05(I).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burbank as applied to claim 11 above, and further in view of Shelton, IV et al., (US 20210196425; hereinafter Shelton).
Regarding claims 12-13, Burbank discloses the electrosurgical device of claim 11, but fails to teach wherein the motor drive comprises an encoder motor configured to send signals to the controller for determining the degree of rotation and corresponding cutting depth of the RF loop electrode when deployed, further comprising an accelerometer carried by the electrosurgical device and configured to send signals to the controller relating to movement of the electrosurgical device. However, Shelton teaches an electrosurgical device (4600) in which the kinematics of the electrosurgical device (4600) can also instruct instrument operation, wherein the kinematics can be ascertained via accelerometers and motor encoders ([0354]). A control circuit executing one or more aspects of the process (4030) may receive instrument data indicative of the movement of an internal component of an end effector (4642) during a firing sequence thereof. The movement of the internal component can be tracked using conventional rotary encoders of the firing motor (4602), for example, and by a tracking system that employs an absolute positioning system using accelerometers ([0365], [0503], [0644]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burbank to include an encoder motor and accelerometer, as taught by Shelton, because the modification would correlate the relative positions and functions of the surgical devices to positive surgical outcomes to help surgeons improve technique or provide more precise information to study and improve surgical device functions (Shelton; [0591]). Furthermore, since the teachings of Shelton would be incorporated with the rotational motor teachings of Burbank in the modified device, the motor drive would comprise an encoder motor configured to send signals to the controller for determining the degree of rotation and corresponding cutting depth of the RF loop electrode when deployed, further comprising an accelerometer carried by the electrosurgical device and configured to send signals to the controller relating to movement of the electrosurgical device in the modified device.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eliachar as applied to claim 2 above, and further in view of Ward, (US 20140236143).
Regarding claim 15, Eliachar (Figures 1a-4) further discloses wherein the RF loop electrode (4) comprises an active electrode ([0039]), but fails to disclose that a distal circumferential band of the working end comprises an insulative material, and an outer surface of the working end proximal to the distal circumferential band comprises a return electrode. However, Ward (Figures 1-2 and 4C) teaches a resectoscope device (20) in which an RF loop electrode (302) comprises an active electrode ([0045]), a distal circumferential band (116) of the working end comprises an insulative material ([0039]), and an outer surface (304a, 304b) of the working end proximal to the distal circumferential band comprises a return electrode ([0045]-[0046]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the electrode structure disclosed by Eliachar with the active electrode + insulative material + return electrode structure taught by Ward because both electrode structures perform the same function of generating a current at a target tissue resection site, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burbank/Ward as applied to claim 15 above.
Regarding claim 16, Burbank/Ward teaches the electrosurgical device of claim 15, but fails to teach wherein a dimension of insulative material between the electrode shaft and the return electrode is at least 0.003”. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burbank/Ward to include a dimension of insulative material between the electrode shaft and the return electrode being at least 0.003” 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. MPEP 2144.05(I).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burbank/Eliachar as applied to claim 25 above, and further in view of Shelton.
Regarding claim 26, Burbank/Eliachar teaches the method of claim 24, but fails to disclose sending signals of movement of the introducer or the RF loop electrode to the controller using an accelerometer, controlling movement of the RF loop electrode responsive to the signals using the controller. However, Shelton teaches an electrosurgical device (4600) in which the kinematics of the electrosurgical device (4600) can also instruct instrument operation, wherein the kinematics can be ascertained via accelerometers and motor encoders ([0354]). A control circuit executing one or more aspects of the process (4030) may receive instrument data indicative of the movement of an internal component of an end effector (4642) during a firing sequence thereof. The movement of the internal component can be tracked using conventional rotary encoders of the firing motor (4602), for example, and by a tracking system that employs an absolute positioning system using accelerometers ([0365], [0503], [0644]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burbank/Eliachar to include a controller configured to control movement of the RF loop electrode, wherein the method further comprises sending signals of movement of the introducer or the RF loop electrode to the controller using an accelerometer, controlling movement of the RF loop electrode responsive to the signals using the controller, as taught by Shelton, because the modification would correlate the relative positions and functions of the surgical devices to positive surgical outcomes to help surgeons improve technique or provide more precise information to study and improve surgical device functions (Shelton; [0591]). Therefore, the modified device would include a controller configured to control movement of the RF loop electrode, and the method would further comprise sending signals of movement of the introducer or the RF loop electrode to the controller using an accelerometer, controlling movement of the RF loop electrode responsive to the signals using the controller.
Response to Arguments
Applicant's arguments found in the Pre-Appeal Conference Request filed 01/16/2026 have been fully considered.
In response to Applicant’s first argument that Burbank fails to disclose the limitation “the second position selectable to define a selected cutting depth” in independent claims 1 and 18, Examiner respectfully disagrees. As shown in Figure 10 of Burbank, the RF loop electrode 138 is rotated in the perpendicular plane to move it from within the introducer to the fully exposed position shown in phantom. Accordingly, the cutting depth defined by the fully exposed position is the selected cutting depth in that moment. Therefore, Examiner maintains that Burbank discloses claim 1 and Burbank/Eliachar teaches newly amended claim 18. However, Examiner suggests further defining how the cutting depth is selectable during treatment such that different cutting depths may be selectable by that same device during one treatment.
Applicant’s argument that Burbank fails to disclose the limitation(s) of claim 14 is found to be persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art reference Hsu, which teaches an electrosurgical device including an articulating section in the working end of the introducer member. In combination with Burbank, the modified device teaches the invention as recited at least in claim 14.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794