DETAILED ACTION
The amendment filed May 28, 2026, has been entered and fully considered. Claims 1-20 have been amended.
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 § 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.
Claims 1, 7-10 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Moss et al., (hereinafter ‘Moss,’ U.S. PGPub. No. 2011/0238057) in view of Pedersen et al., (hereinafter ‘Pedersen,’ U.S. PGPub. No. 2016/0278839).
Regarding claim 1, Moss (Fig. 1) discloses a system for destruction of tissue comprising: a cannula (probe 1) having a proximal end and a distal end and containing a plurality of tissue penetrating elongate electrodes (electrode array 21) therein, the tissue penetrating elongate electrodes (21) being extendible beyond the distal end of the cannula (Fig. 1; [0084], “Each array 21 has a distal tip 58. Each tip 58 can be sharpened to facilitate the ability of the array tip 58 to penetrate tissue.”); an inner shaft (trocar 9) formed from a dielectric polymer disposed over the cannula ([0078], “trocar 9 can be comprised of a non-conductive material such as, but not limited to, polyimide or PEEK (polyether ether ketone)”); electrical connectors including at least one electrical connector electrically coupled to at least one of the tissue penetrating elongate electrodes (21) ([0075]; [0120], generator 29 provides electrical energy to electrodes 21), and a sheath (insulation sleeve 45) movable relative to the shaft electrode and inner shaft, the sheath moveable in a first direction to cover, at least in part, the shaft electrode, and moveable in a second direction to expose, at least in part, the shaft electrode, the sheath adapted to control exposure of the shaft electrode to patient tissue ([0104], “The slide member 7 is capable of being actuated in either a proximal or distal direction along the longitudinal axis of the probe device 100. To retract the insulative sleeve 45, the slide member 7 can be manually proximally actuated. To advance the insulative sleeve 45, the slide member can be manually distally actuated.”).
Moss is silent regarding the inner shaft carrying a shaft electrode formed from a conductive metal, the shaft electrode disposed near the distal end of the cannula at a spacing distance from the distal end of the cannula, wherein the inner shaft is moveable relative to the cannula to adjust the spacing distance; and at least one electrical connector electrically coupled to the shaft electrode.
However, in the same field of endeavor, Pedersen teaches a similar system (Fig. 2) comprising a cannula (12) including an inner shaft (18) disposed within the lumen of the canula (12). Pedersen teaches the inner shaft (18) carries a shaft electrode formed from a conductive metal (first conductive electrical terminal 18), and the shaft electrode (18) is disposed near the distal end of the cannula (12) at a spacing distance from the distal end of the cannula (Fig. 2). Further, at least one electrical connector is electrically coupled to the shaft electrode ([0060], see feed wires 30, 32 for delivering current to the electrodes 18, 20). Pedersen teaches the inner shaft (18) is moveable relative to the cannula (12) to adjust the spacing distance ([0037], “Disposed within the lumen of the catheter 12 is a first conductive electrical terminal 18, and in the preferred embodiment is able to slide within the catheter 12 so as to adjust the exposed operative length of the first terminal 18”). Pedersen teaches, “[t]he arrangement and sizing of the electrical terminals causes heat concentration at the first terminal, or electrode, and as a result for ablation to occur at the first terminal.” ([0009]). As such, different exposure lengths of the electrode (18) will result in varying current density and fields of heating ([0052]-[0054]), thereby improving versatility and control of the system. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to have modified the system as taught by Moss to include the inner shaft carrying a shaft electrode formed from a conductive metal, the shaft electrode disposed near the distal end of the cannula at a spacing distance from the distal end of the cannula, wherein the inner shaft is moveable relative to the cannula to adjust the spacing distance; and at least one electrical connector electrically coupled to the shaft electrode, as taught by Pedersen, in order to provide particularized ablation at the shaft electrode having varying characteristics specific to the desired treatment, thereby improving versatility and control of the system.
In view of the prior modification of Moss in view of Pedersen, the combination teaches each and every structural limitation as claimed in claim 1. It naturally follows that the sheath (insulation sleeve 45), as taught in Moss, would necessarily cover and expose, at least in part, the shaft electrode, as taught by Pedersen, as the sheath (45) is advanced and retracted ([0104]) as taught by Moss, thereby meeting the limitations of claim 1.
Regarding claim 7, Moss in view of Pedersen teach all of the limitations of the system according to claim 1. In view of the prior modification of Moss in view of Pedersen, Pedersen teaches wherein the shaft electrode (18) is cylindrical and extends around the inner shaft (Fig. 2).
Regarding claim 8, Moss in view of Pedersen teach all of the limitations of the system according to claim 1. Moss discloses wherein the sheath (insulation sleeve 45) covers the inner shaft (trocar 9).
Regarding claim 9, Moss in view of Pedersen teach all of the limitations of the system according to claim 1. Moss discloses the sheath covers the inner shaft (trocar 9). In view of the prior modification of Moss in view of Pedersen, Pedersen (Fig. 2) teaches wherein the shaft electrode (18) has a proximal end on the inner shaft and a distal end on the inner shaft (Fig. 2; as broadly claimed, first conductive electrical terminal 18 extends the length of the entire inner shaft). Further, in view of the prior combination of Moss in view of Pedersen, the sheath as taught by Moss would necessarily cover the shaft electrode on the inner shaft.
Regarding claim 10, Moss (Fig. 1) discloses a system for destruction of tissue comprising: a cannula (probe 1) having a proximal end and a distal end and containing a plurality of tissue penetrating elongate electrodes (electrode array 21) therein, the tissue penetrating electrodes (electrode array 21) being extendible beyond the distal end of the cannula (Fig. 1; [0084], “Each array 21 has a distal tip 58. Each tip 58 can be sharpened to facilitate the ability of the array tip 58 to penetrate tissue.”); an inner shaft (trocar 9) formed from a dielectric polymer disposed over the cannula ([0078], “trocar 9 can be comprised of a non-conductive material such as, but not limited to, polyimide or PEEK (polyether ether ketone)”); a plurality of electrical connectors including at least one electrical connector electrically coupled to at least one of the tissue penetrating elongate electrodes (21) ([0075]; [0120], generator 29 provides electrical energy to electrodes 21); and a sheath (insulation sleeve 45) disposed over the inner shaft (trocar 9), the sheath (45) moveable in a first direction to cover, at least in part, the shaft electrode, and moveable in a second direction to expose, at least in part, the shaft electrode ([0104], “The slide member 7 is capable of being actuated in either a proximal or distal direction along the longitudinal axis of the probe device 100. To retract the insulative sleeve 45, the slide member 7 can be manually proximally actuated. To advance the insulative sleeve 45, the slide member can be manually distally actuated.”).
Moss is silent regarding the inner shaft carrying a shaft electrode formed from a conductive metal, the shaft electrode disposed near the distal end of the cannula, the inner shaft being moveable relative to the cannula to enable a distance from the shaft electrode to the distal end of the cannula to be adjustable, and at least one electrical connector electrically coupled to the shaft electrode; wherein the shaft electrode is disposed at a spacing distance from the distal end of the cannula, wherein the spacing distance is adjustable.
However, in the same field of endeavor, Pedersen teaches a similar system (Fig. 2) comprising a cannula (12) including an inner shaft (18) disposed within the lumen of the canula (12). Pedersen teaches the inner shaft (18) carries a shaft electrode formed from a conductive metal (first conductive electrical terminal 18), and the shaft electrode (18) is disposed near the distal end of the cannula (12). Further, at least one electrical connector is electrically coupled to the shaft electrode ([0060], see feed wires 30, 32 for delivering current to the electrodes 18, 20). Pedersen teaches the inner shaft (18) being moveable relative to the cannula (12) to enable a distance from the shaft electrode (18) to the distal end of the cannula to be adjustable ([0037], “Disposed within the lumen of the catheter 12 is a first conductive electrical terminal 18, and in the preferred embodiment is able to slide within the catheter 12 so as to adjust the exposed operative length of the first terminal 18”). The shaft electrode (18) is disposed at a spacing distance from the distal end of the cannula (12), wherein the spacing distance is adjustable ([0037]). Pedersen teaches, “[t]he arrangement and sizing of the electrical terminals causes heat concentration at the first terminal, or electrode, and as a result for ablation to occur at the first terminal.” ([0009]). As such, different exposure lengths of the electrode (18) will result in varying current density and fields of heating ([0052]-[0054]), thereby improving versatility and control of the system. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to have modified the system as taught by Moss to include the inner shaft carrying a shaft electrode formed from a conductive metal, the shaft electrode disposed near the distal end of the cannula, the inner shaft being moveable relative to the cannula to enable a distance from the shaft electrode to the distal end of the cannula to be adjustable, and at least one electrical connector electrically coupled to the shaft electrode; wherein the shaft electrode is disposed at a spacing distance from the distal end of the cannula, wherein the spacing distance is adjustable, as taught by Pedersen, in order to provide particularized ablation at the shaft electrode having varying characteristics specific to the desired treatment, thereby improving versatility and control of the system.
In view of the prior modification of Moss in view of Pedersen, the combination teaches each and every structural limitation as claimed in claim 1. It naturally follows that the sheath (insulation sleeve 45), as taught in Moss, would necessarily cover and expose, at least in part, the shaft electrode, as taught by Pedersen, as the sheath (45) is advanced and retracted ([0104]) as taught by Moss, thereby meeting the limitations of claim 10.
Regarding claim 17, Moss in view of Pedersen teach all of the limitations of the system according to claim 10. In view of the prior modification of Moss in view of Pedersen, Pedersen teaches wherein the shaft electrode (18) is cylindrical and extends around the inner shaft (Fig. 2).
Regarding claim 18, Moss in view of Pedersen teach all of the limitations of the system according to claim 10. Moss discloses wherein the sheath (insulation sleeve 45) covers the inner shaft (trocar 9) and is adjustable to cover all, a portion of, or none of the shaft electrode ([0104]).
Regarding claim 19, Moss in view of Pedersen teach all of the limitations of the system according to claim 10. Moss discloses the sheath covers the inner shaft (trocar 9). In view of the prior modification of Moss in view of Pedersen, Pedersen (Fig. 2) teaches wherein the shaft electrode (18) has a proximal end on the inner shaft and a distal end on the inner shaft (Fig. 2; as broadly claimed, first conductive electrical terminal 18 extends the length of the entire inner shaft). Further, in view of the prior combination of Moss in view of Pedersen, the sheath as taught by Moss would necessarily cover the shaft electrode on the inner shaft.
Regarding claim 20, Moss (Fig. 1) discloses a system for destruction of tissue comprising: a cannula (probe 1) having a proximal end and a distal end and containing a plurality of tissue penetrating elongate electrodes (electrode array 21) therein, the tissue penetrating elongate electrodes being extendible beyond the distal end of the cannula (Fig. 1; [0084], “Each array 21 has a distal tip 58. Each tip 58 can be sharpened to facilitate the ability of the array tip 58 to penetrate tissue.”); a plurality of electrical connectors including at least one electrical connector electrically coupled to at least one of the tissue penetrating elongate electrodes (21) ([0075]; [0120], generator 29 provides electrical energy to electrodes 21); and cover (45) means moveable in a first direction for adjustably covering all, a portion of, or none of the moveable electrode means and moveable in a second direction for adjustably exposing all, a portion of, or none of the moveable electrodes means ([0104], “The slide member 7 is capable of being actuated in either a proximal or distal direction along the longitudinal axis of the probe device 100. To retract the insulative sleeve 45, the slide member 7 can be manually proximally actuated. To advance the insulative sleeve 45, the slide member can be manually distally actuated.”).
Moss is silent regarding a moveable electrode means disposed over the cannula, the moveable electrode means being moveable relative to the cannula to enable a distance from the moveable electrode means to the distal end of the cannula to be adjustable; and at least one electrical connector electrically coupled to the moveable electrode means.
However, in the same field of endeavor, Pedersen teaches a similar system (Fig. 2) comprising a cannula (12) including an inner shaft (18) disposed within the lumen of the canula (12). Pedersen teaches the inner shaft (18) carries a ‘moveable electrode means’ formed from a conductive metal (first conductive electrical terminal 18). Further, at least one electrical connector is electrically coupled to the moveable electrode means ([0060], see feed wires 30, 32 for delivering current to the electrodes 18, 20). Pedersen teaches the inner shaft (18) being moveable relative to the cannula (12) to enable a distance from the moveable electrode means (18) to the distal end of the cannula to be adjustable ([0037], “Disposed within the lumen of the catheter 12 is a first conductive electrical terminal 18, and in the preferred embodiment is able to slide within the catheter 12 so as to adjust the exposed operative length of the first terminal 18”). Pedersen teaches, “[t]he arrangement and sizing of the electrical terminals causes heat concentration at the first terminal, or electrode, and as a result for ablation to occur at the first terminal.” ([0009]). As such, different exposure lengths of the moveable electrode means (18) will result in varying current density and fields of heating ([0052]-[0054]), thereby improving versatility and control of the system. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to have modified the system as taught by Moss to include a moveable electrode means disposed over the cannula, the moveable electrode means being moveable relative to the cannula to enable a distance from the moveable electrode means to the distal end of the cannula to be adjustable; and at least one electrical connector electrically coupled to the moveable electrode means, as taught by Pedersen, in order to provide particularized ablation at the shaft electrode having varying characteristics specific to the desired treatment, thereby improving versatility and control of the system.
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Moss in view of Pedersen as applied to claim 1 above, and further in view of Wang (hereinafter ‘Wang,’ U.S. PGPub. No. 2010/0137859).
Regarding claim 2, Moss in view of Pedersen teach all of the limitations of the system according to claim 1. Although Moss contemplates a cooling mechanism comprising the infusion of one or more liquids ([0089]), Moss in view of Pedersen are silent regarding wherein the cannula includes a fluid delivery lumen and a distal portion of the cannula comprises one or more apertures for fluid infusion, further wherein the one or more apertures for fluid infusion are located on a first side of the cannula, and the shaft electrode is located on a second side of the cannula, such that the apertures and the shaft electrode occupy opposing sides of the cannula within a single axial region of the cannula.
However, in the same field of endeavor, Wang teaches a similar system comprising a cannula (12) wherein the cannula includes a fluid delivery lumen (irrigation lumen 22) and a distal portion of the cannula comprises one or more apertures for fluid infusion (irrigation ports 44), further wherein the one or more apertures (44) for fluid infusion are located on a first side of the cannula (Figs. 2-3, see manifold 30 at proximal side of cannula). Further, the shaft electrode (28) is located on a second side of the cannula (12) (at the distal most side), such that the apertures and the shaft electrode occupy opposing sides of the cannula within a single axial region of the cannula (see Fig. 2). Wang teaches “the irrigation ports 44 are configured for fluid communication with the inner cavity 42 and extend from the inner cavity 42 to the outer surface 40 of the body 38. The irrigation ports 44 allow for irrigating fluid to be distributed from the manifold 30. More particularly, irrigating fluid flowing in the irrigation lumen 22 flows through the inner cavity 42, and then through the irrigation ports 44 where the fluid is then distributed to the outer surface of electrode 28 and the tissue proximate the irrigation ports 44.” ([0038]). This configuration provides irrigation and cooling to the electrode, such that any char or coagulated tissue may be flushed away and the electrode temperature maybe regulated, thereby improving efficiency and safety. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to have modified the system as taught by Moss in view of Pedersen to include wherein the cannula includes a fluid delivery lumen and a distal portion of the cannula comprises one or more apertures for fluid infusion, further wherein the one or more apertures for fluid infusion are located on a first side of the cannula, and the shaft electrode is located on a second side of the cannula, such that the apertures and the shaft electrode occupy opposing sides of the cannula within a single axial region of the cannula, as taught by Wang. Doing so provides irrigation and cooling to the electrode, such that any char or coagulated tissue may be flushed away and the electrode temperature maybe regulated, thereby improving efficiency and safety.
Regarding claim 12, Moss in view of Pedersen teach all of the limitations of the system according to claim 10. Although Moss contemplates a cooling mechanism comprising the infusion of one or more liquids ([0089]), Moss in view of Pedersen are silent regarding wherein the cannula includes a fluid delivery lumen and a distal portion of the cannula comprises one or more apertures for fluid infusion, further wherein the one or more apertures for fluid infusion are located on a first side of the cannula, and the shaft electrode is located on a second side of the cannula, such that the apertures and the shaft electrode occupy opposing sides of the cannula within a single axial region of the cannula.
However, in the same field of endeavor, Wang teaches a similar system comprising a cannula (12) wherein the cannula includes a fluid delivery lumen (irrigation lumen 22) and a distal portion of the cannula comprises one or more apertures for fluid infusion (irrigation ports 44), further wherein the one or more apertures (44) for fluid infusion are located on a first side of the cannula (Figs. 2-3, see manifold 30 at proximal side of cannula). Further, the shaft electrode (28) is located on a second side of the cannula (12) (at the distal most side), such that the apertures and the shaft electrode occupy opposing sides of the cannula within a single axial region of the cannula (see Fig. 2). Wang teaches “the irrigation ports 44 are configured for fluid communication with the inner cavity 42 and extend from the inner cavity 42 to the outer surface 40 of the body 38. The irrigation ports 44 allow for irrigating fluid to be distributed from the manifold 30. More particularly, irrigating fluid flowing in the irrigation lumen 22 flows through the inner cavity 42, and then through the irrigation ports 44 where the fluid is then distributed to the outer surface of electrode 28 and the tissue proximate the irrigation ports 44.” ([0038]). This configuration provides irrigation and cooling to the electrode, such that any char or coagulated tissue may be flushed away and the electrode temperature maybe regulated, thereby improving efficiency and safety. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to have modified the system as taught by Moss in view of Pedersen to include wherein the cannula includes a fluid delivery lumen and a distal portion of the cannula comprises one or more apertures for fluid infusion, further wherein the one or more apertures for fluid infusion are located on a first side of the cannula, and the shaft electrode is located on a second side of the cannula, such that the apertures and the shaft electrode occupy opposing sides of the cannula within a single axial region of the cannula, as taught by Wang. Doing so provides irrigation and cooling to the electrode, such that any char or coagulated tissue may be flushed away and the electrode temperature maybe regulated, thereby improving efficiency and safety.
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Moss in view of Pedersen as applied to claim 1 above, and further in view of McCullagh et al., (hereinafter ‘McCullagh,’ U.S. PGPub. No. 2007/0260234).
Regarding claim 3, Moss in view of Pedersen teach all of the limitations of system according to claim 1. Although Moss discloses wherein at least one of the tissue penetrating elongate electrodes (21) comprises an insulation layer (93) on a first side of a portion thereof (Fig. 1), Moss in view of Pedersen are silent regarding a dielectric coating.
However, in the same field of endeavor, McCullagh teaches a similar system comprising an array of tines (110) formed by coating a bare metal electrode (124) with a coating (120) ([0022]). McCullagh teaches “DLC is used to form a coating with properties which vary, for example, along the length of the ablation probe or electrode, to form insulated and conductive regions. A tough and lubricious coating is applied to the entire device with the process parameters being varied during deposition as described above so that preselected portions of the device are coated with thermally and/or electrically insulative DLC. Using the DLC coating to provide insulation is beneficial because it eliminates the need to add thick, bulky insulation to the device. In addition, or alternatively, semi-conductive portions of the electrodes and/or of the probe may be formed, for example by varying the process parameters during deposition to apply to these areas a coating of DLC with a dielectric constant lower than that of the insulative DLC and higher than that of the conductive DLC.” ([0027]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to have modified the system as taught by Moss in view of Pedersen to include a dielectric coating as taught by McCullagh in order to provide insulation to the device while eliminating the need to add thick, bulky insulation to the device, thereby minimizing the overall size of the device.
Regarding claim 13, Moss in view of Pedersen teach all of the limitations of system according to claim 10. Although Moss discloses wherein at least one of the tissue penetrating elongate electrodes (21) comprises an insulation layer (93) on a first side of a portion thereof (Fig. 1), Moss in view of Pedersen are silent regarding a dielectric coating.
However, in the same field of endeavor, McCullagh teaches a similar system comprising an array of tines (110) formed by coating a bare metal electrode (124) with a coating (120) ([0022]). McCullagh teaches “DLC is used to form a coating with properties which vary, for example, along the length of the ablation probe or electrode, to form insulated and conductive regions. A tough and lubricious coating is applied to the entire device with the process parameters being varied during deposition as described above so that preselected portions of the device are coated with thermally and/or electrically insulative DLC. Using the DLC coating to provide insulation is beneficial because it eliminates the need to add thick, bulky insulation to the device. In addition, or alternatively, semi-conductive portions of the electrodes and/or of the probe may be formed, for example by varying the process parameters during deposition to apply to these areas a coating of DLC with a dielectric constant lower than that of the insulative DLC and higher than that of the conductive DLC.” ([0027]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to have modified the system as taught by Moss in view of Pedersen to include a dielectric coating as taught by McCullagh in order to provide insulation to the device while eliminating the need to add thick, bulky insulation to the device, thereby minimizing the overall size of the device.
Claims 4-5 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Moss in view of Pedersen as applied to claim 1 above, and further in view of Azure (hereinafter ‘Azure,’ U.S. Pat. 8,915,911).
Regarding claim 4, Moss in view of Pedersen teach all of the limitations of system according to claim 1. Moss discloses wherein the plurality of tissue penetrating elongate electrodes (21) includes at least a first tissue penetrating elongate electrode having a first electrical connection and a second tissue penetrating elongate electrode having a second electrical connection (as broadly claimed, each electrode 21 has an electrical connection).
Moss in view of Pedersen are silent regarding wherein the first and second electrical connections are separately addressable.
However, in the same field of endeavor, Azure teaches a similar device (30) including a plurality of electrodes (32, 34, 36, 38). Azure teaches “[e]ach of the electrodes can play different roles in the ablation process. For example, there can be changes in polarity and/or polarity shifting between the different electrodes of the device. As with other devices of the invention, electrodes can be electrically independent and separately addressable electrically, or two or more electrodes can be electrically connected, for example, to effectively function as one unit.” (col. 7, ll. 16-50). This configuration is advantageous because it makes possible various electrode configurations and subsequent ablation patterns, thereby increasing versatility, control, and accuracy of the device. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to have modified the system as taught by Moss in view of Pedersen to include wherein the first and second electrical connections are separately addressable, as taught by Azure, in order to provide various electrode configurations and ablation patterns, thereby increasing versatility, control, and accuracy of the device.
Regarding claim 5, Moss in view of Pedersen and Azure teach all of the limitations of the system according to claim 4. In view of the prior modification of Moss in view of Pedersen and Azure, Pedersen (Fig. 2) teaches wherein the sheath (12) is adapted to cover a radial portion of the shaft electrode (18) to facilitate directional control of an output electrical field between a selected one or more of the first and second tissue penetrating elongate electrodes and a portion of the shaft electrode ([0037], “Disposed within the lumen of the catheter 12 is a first conductive electrical terminal 18, and in the preferred embodiment is able to slide within the catheter 12 so as to adjust the exposed operative length of the first terminal 18.” Also see [0052]-[0053] for varying energy characteristics).
Regarding claim 14, Moss in view of Pedersen teach all of the limitations of system according to claim 10. Moss discloses wherein the plurality of tissue penetrating electrodes (21) includes at least a first tissue penetrating electrode having a first electrical connection and a second tissue penetrating electrode having a second electrical connection (as broadly claimed, each electrode 21 has an electrical connection).
Moss in view of Pedersen are silent regarding, wherein the first and second electrical connections are separately addressable.
However, in the same field of endeavor, Azure teaches a similar device (30) including a plurality of electrodes (32, 34, 36, 38). Azure teaches “[e]ach of the electrodes can play different roles in the ablation process. For example, there can be changes in polarity and/or polarity shifting between the different electrodes of the device. As with other devices of the invention, electrodes can be electrically independent and separately addressable electrically, or two or more electrodes can be electrically connected, for example, to effectively function as one unit.” (col. 7, ll. 16-50). This configuration is advantageous because it makes possible various electrode configurations and subsequent ablation patterns, thereby increasing versatility, control, and accuracy of the device. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to have modified the system as taught by Moss in view of Pedersen to include wherein the first and second electrical connections are separately addressable, as taught by Azure, in order to provide various electrode configurations and ablation patterns, thereby increasing versatility, control, and accuracy of the device.
Regarding claim 15, Moss in view of Pedersen and Azure teach all of the limitations of the system according to claim 14. In view of the prior modification of Moss in view of Pedersen and Azure, Pedersen (Fig. 2) teaches wherein the sheath (12) is adapted to cover a radial portion of the shaft electrode (18) to facilitate directional control of an output electrical field between a selected one or more of the first and second tissue penetrating electrodes and a portion of the shaft electrode ([0037], “Disposed within the lumen of the catheter 12 is a first conductive electrical terminal 18, and in the preferred embodiment is able to slide within the catheter 12 so as to adjust the exposed operative length of the first terminal 18.” Also see [0052]-[0053] for varying energy characteristics).
Claims 6, 11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Moss in view of Pedersen as applied to claim 1 above, and further in view of Behl et al., (hereinafter ‘Behl,’ U.S. Pat. 7,195,629).
Regarding claim 6, Moss in view of Pedersen teach all of the limitations of the system according to claim 1. Moss discloses wherein the plurality of tissue penetrating elongate electrodes (21) includes at least a first tissue penetrating elongate electrode having a first mechanical coupling and a second tissue penetrating elongate electrode having a second mechanical coupling (see electrode arrays 21 in Fig. 1-2B; [0077], [0087]; as broadly claimed, the electrodes 21 are mechanically coupled to slide member 7 to deploy electrodes 21).
Moss in view of Pedersen are silent regarding wherein the first and second mechanical couplings are separately actuatable to allow the first and second tissue penetrating elongate electrodes to be advanced independent of one another.
However, in the same field of endeavor, Behl (Figs. 10-12C) teaches a similar electrode probe (300) comprising a distal electrode array (302) and a proximal electrode array (304) which may be separately deployed (col. 14, ll. 47-58). Behl teaches “[a]s shown in FIG. 12B, the distal array 302 is deployed by depressing the knob 326, i.e., axially translating the knob relative to the cylindrical body 312 in a distal direction so that the electrode array 302 is advanced distally from the distal end of the shaft 306. . . . The proximal array 306 is separately deployed by rotating the handle 316 as illustrated by the arrow 340 in FIG. 12C. Such rotation causes the proximal electrode array 304 to first advance proximally relative to the shaft 306 and then to diverge radially outwardly.” (Col. 15, ll. 21-46). This configuration allows for various patterns of electrode deployment including the deployment of the proximal electrode array (304), the distal electrode array (302), or both the proximal and distal electrode array (col. 14, ll. 47-58), thereby increasing versatility and control. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to have modified the system as taught by Moss in view of Pedersen to include wherein the first and second mechanical couplings are separately actuatable to allow the first and second tissue penetrating elongate electrodes to be advanced independent of one another, as taught by Behl, in order to provide various patterns of electrode deployment, thereby increasing versatility and control.
Regarding claims 11 and 16, Moss in view of Pedersen teach all of the limitations of the system according to claim 10. Moss discloses wherein the plurality of tissue penetrating electrodes (21) includes at least a first tissue penetrating electrode having a first mechanical coupling and a second tissue penetrating electrode having a second mechanical coupling (see electrode arrays 21 in Fig. 1-2B; [0077], [0087]; as broadly claimed, the electrodes 21 are mechanically coupled to slide member 7 to deploy electrodes 21).
Moss in view of Pedersen is silent regarding wherein the first and second mechanical couplings are separately actuatable to allow the first and second tissue penetrating electrodes to be advanced independent of one another.
However, in the same field of endeavor, Behl (Figs. 10-12C) teaches a similar electrode probe (300) comprising a distal electrode array (302) and a proximal electrode array (304) which may be separately deployed (col. 14, ll. 47-58). Behl teaches “[a]s shown in FIG. 12B, the distal array 302 is deployed by depressing the knob 326, i.e., axially translating the knob relative to the cylindrical body 312 in a distal direction so that the electrode array 302 is advanced distally from the distal end of the shaft 306. . . . The proximal array 306 is separately deployed by rotating the handle 316 as illustrated by the arrow 340 in FIG. 12C. Such rotation causes the proximal electrode array 304 to first advance proximally relative to the shaft 306 and then to diverge radially outwardly.” (Col. 15, ll. 21-46). This configuration allows for various patterns of electrode deployment including the deployment of the proximal electrode array (304), the distal electrode array (302), or both the proximal and distal electrode array (col. 14, ll. 47-58), thereby increasing versatility and control. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to have modified the system as taught by Moss in view of Pedersen to include wherein the first and second mechanical couplings are separately actuatable to allow the first and second tissue penetrating electrodes to be advanced independent of one another, as taught by Behl, in order to provide various patterns of electrode deployment, thereby increasing versatility and control.
Response to Arguments
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the amendment has necessitated a new ground of rejection.
The Claim Objections and 112 Claim Rejections have been overcome.
Applicant argument (p. 12) that “the Moss and Pedersen references, individually or in combination, do not teach or suggest each and every element and limitation of independent claims 1, 10, and 20, as currently amended” is not found persuasive. Applicant contends (p. 12), “[f]or example, the Moss and Pedersen references do not teach or suggest an inner shaft, disposed over the cannula and carrying a shaft electrode, the shaft electrode disposed near the distal end of the cannula, and a sheath, the sheath movable in a first direction to cover, at least in part, the shaft electrode, and movable in a second direction to expose, at least in part, the shaft electrode.”
However, as broadly claimed, Moss disclose an inner shaft (trocar 9) disposed over the cannula (probe 1) in Figure 1, and also provides a moveable sheath (insulative sleeve 45) configured to move forward and backwards to cover and expose the inner shaft (trocar 9) ([0104]). In doing so, the sheath would also cover and expose any component attached to or on the inner sheath. In view of the modification of Moss in view of Pedersen, Pedersen cures any perceived deficiencies in Moss by teaches a similar system (Fig. 2) comprising a cannula (12) including an inner shaft (18) disposed within the lumen of the canula (12). Pedersen teaches the inner shaft (18) carries a shaft electrode formed from a conductive metal (first conductive electrical terminal 18), and the shaft electrode (18) is disposed near the distal end of the cannula (12) at a spacing distance from the distal end of the cannula (Fig. 2). Pedersen teaches the inner shaft (18) is moveable relative to the cannula (12) to adjust the spacing distance ([0037], “Disposed within the lumen of the catheter 12 is a first conductive electrical terminal 18, and in the preferred embodiment is able to slide within the catheter 12 so as to adjust the exposed operative length of the first terminal 18”). Again it is noted that the language in claim 1 recites “wherein the inner shaft is moveable relative to the cannula to adjust the spacing distance.” Here, Pedersen teaches the inner shaft is moveable as claimed.
Applicant has argued (pp.13-14), “Pedersen reference does not disclose a inner shaft disposed over a catheter and carrying a second conductive terminal, the second conductive terminal around the outer surface near the distal of the catheter and a sheath, the sheath movable in a first direction to cover, at least in part, the second conductive terminal, and movable in a second direction to expose, at least in part, the second conductive terminal. That is, the Pedersen reference does not disclose a moveable sheath to cover, at least in part, and/or expose, at least in part, a second conductive terminal located on an outer surface and at a distal end of an inner shaft.” However, as discussed above, Moss discloses a moveable sheath as claimed, and Pedersen further teaches a configuration wherein a second conductive terminal located on an outer surface and at a distal end of an inner shaft, and is moveable relative to the sheath cover.
For the reasons stated above, Applicant’s argument that independent claims 1, 10, and 20, as currently amended are not taught by the current prior art is not found persuasive.
Regarding claim 2, Applicant has argued (p. 14), “the Wang reference appears to teach an electrode coupled to a distal end of a shaft of a manifold. However, Applicant respectfully submits that the Wang reference does not teach or suggest an inner shaft, disposed over the cannula and carrying a shaft electrode, the shaft electrode disposed near the distal end of the cannula, and a sheath, the sheath movable in a first direction to cover, at least in part, the shaft electrode, and movable in a second direction to expose, at least in part, the shaft electrode, as recited in independent claims 1 and 10, as currently amended, at least because the Wang reference does not disclose a shaft disposed over a manifold and carrying an electrode, the electrode disposed near the distal end of the shaft and the manifold and a sheath, the sheath movable in a first direction to cover, at least in part, the electrode, and moveable in a second direction to expose, at least in part, the electrode.” As discussed above, Moss in view of Pedersen teach the limitations of claim 1 and 10. Wang is not relied upon to teach the newly added amendments.
Regarding claims 2 and 12, (pp. 14-16), Applicant has argued “that the Moss, Pedersen, and Wang references do not teach or suggest each and every element and limitation of dependent claims 2 and 12, as originally presented. For example, the Moss, Pedersen, and Wang reference do not teach or suggest one or more apertures for fluid infusion located on a first side of the cannula, and the shaft electrode located on a second side of the cannula, such that the apertures and the shaft electrode occupy opposing sides of the cannula within a single axial region of the cannula.” This argument is not found persuasive as Wang clearly teaches a similar system comprising a cannula (12) wherein the cannula includes a fluid delivery lumen (irrigation lumen 22) and a distal portion of the cannula comprises one or more apertures for fluid infusion (irrigation ports 44), further wherein the one or more apertures (44) for fluid infusion are located on a first side of the cannula (Figs. 2-3, see manifold 30 at proximal side of cannula). Further, the shaft electrode (28) is located on a second side of the cannula (12) (at the distal most side), such that the apertures and the shaft electrode occupy opposing sides of the cannula within a single axial region of the cannula (see Fig. 2). Wang teaches “the irrigation ports 44 are configured for fluid communication with the inner cavity 42 and extend from the inner cavity 42 to the outer surface 40 of the body 38. The irrigation ports 44 allow for irrigating fluid to be distributed from the manifold 30. More particularly, irrigating fluid flowing in the irrigation lumen 22 flows through the inner cavity 42, and then through the irrigation ports 44 where the fluid is then distributed to the outer surface of electrode 28 and the tissue proximate the irrigation ports 44.” ([0038]).
Regarding claims 3 and 13, (pp. 17-18), Applicant argues, “the McCullagh reference appears to teach an ablation device including a cannula, an array of tines having electrodes coated in a conductive layer of DLC to form insulated and conductive regions of the electrodes, and a coating applied to the cannula. However, Applicant respectfully submits that the McCullagh reference does not teach or suggest an inner shaft, disposed over the cannula and carrying a shaft electrode, the shaft electrode disposed near the distal end of the cannula, and a sheath, the sheath movable in a first direction to cover, at least in part, the shaft electrode, and movable in a second direction to expose, at least in part, the shaft electrode, as recited in independent claims 1 and 10, as currently amended, at least because the McCullagh reference does not disclose a coating, disposed over a cannula and carrying a coating electrode, the coating electrode disposed near a distal end of the cannula, and a sheath, the sheath movable in a first direction to cover, at least in part, the coating electrode, and movable in a second direction to expose, at least in part, the coating electrode.” Applicant’s arguments are not found persuasive. As discussed above, Moss in view of Pedersen teach the amendments to independent claims 1 and 10.
Regarding claims 4-5 and 14-15, (pp. 18-19) Applicant further argues “the Azure reference appears to teach a device having independent and separately addressable electrically and/or electrically connected electrodes extending from a distal portion of the device. However, Applicant respectfully submits that the Azure reference does not teach or suggest an inner shaft, disposed over the cannula and carrying a shaft electrode, the shaft electrode disposed near the distal end of the cannula, and a sheath, the sheath movable in a first direction to cover, at least in part, the shaft electrode, and movable in a second direction to expose, at least in part, the shaft electrode, as recited in independent claims 1 and 10, as currently amended, at least because the Azure reference does not disclose an inner shaft disposed over a device and carrying a shaft electrode, the shaft electrode disposed near a distal portion of the device, and a sheath, the sheath movable in a first direction to cover, at least in part, the shaft electrode, and movable in a second direction to expose, at least in part, the shaft electrode.” Applicant’s arguments are not found persuasive. As discussed above, Moss in view of Pedersen teach the amendments to independent claims 1 and 10.
Regarding claims 6, 11 and 16, (pp. 19-20), Applicant has similarly argued “[t]he Behl reference does not cure the deficiencies of the Moss and Pedersen references.” Applicant’s arguments are not found persuasive. As discussed above, Moss in view of Pedersen teach the amendments to independent claims 1 and 10.
Applicant’s arguments (pp. 20-23) regarding Kirschenman are moot in view of the rejection.
It is the Examiner’s position that Moss in view of Pedersen teach each and every limitation of independent claims 1, 10 and 20.
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.
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/C.A.D./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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