DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Continued Examination Under 37 CFR 1.114
3. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/02/2026 has been entered.
Response to Arguments
4. Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference or combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
5. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
6. Claims 1, 2, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Nolan U.S. 2024/0307105 (herein referred to as “Nolan”) and in view of Young U.S. 2014/0336639 (herein referred to as “Young”) and Devries U.S. 11,534,233 (herein referred to as “Devries”).
7. Regarding Claim 1, Nolan teaches an ablation system (Fig. 10A-10G; para 0129, “used for neuromodulation (e.g., ablation)…”) comprising:
a. a sheath (Fig. 10A, ref num 1003) including a lumen (Fig. 10A, ref num 1001/1002 extends through lumen of ref num 1003, also see Fig. 10E);
b. a first electrode in the lumen that defines a tip of the ablation system (Fig. 10A, 10E, ref num 1004; para 0121 “the tip 1004 comprises a first electrode”); and
c. a bendable telescopic tube (Fig. 10A, ref num 1012; para 0122, “a stylet 1012 configured to exit the aperture 1007 and curve radially away from the needle body 1002”; para 0124, “deflect stylet 1012 proximally and distally”) extendable from the lumen (see Fig. 10A, ref num 1012 is extendable from ref num 1001/1002; para 0122, “a stylet 1012 configured to exit the aperture 1007”) and including a second electrode (Fig. 10A, ref num 1006; para 0122, “the tip 1006 comprises a second electrode”),
d. wherein the first electrode and the second electrode are configured to deliver an electric field energy to target tissue in a patient (para 0121, “the device 1000 may share features with the device 600, the device 900…connection to a tissue treatment”; para 0006, “applying bipolar radiofrequency energy to the first electrode and the second electrode to ablate first tissue between the first point and the second point”; para 0094, “The energy extends between the first electrode 604 and the second electrode 614 to create a line of ablation”; device 1000 embodiment includes teachings from device 600 embodiment, such as the teaching of energy being delivered to the first and second electrodes and to the tissue); and,
e. the bendable telescopic tube extends through an opening in a direction perpendicular to a direction in which the first electrode extends (Fig. 10A, ref num 1012 extends through opening, ref num 1007, which is found perpendicular to where ref num 1004 extends; para 0129, “The steerable stylet 1012 preferably extends out of a lateral side of the needle body 1002”).
Nolan fails to teach the sheath is retractable and the opening is defined at least in part by the first electrode and is exposed to allow the bendable telescopic tube to extend therethrough when the retractable sheath is in a retracted position
Young teaches a device of analogous art (Figs. 11 and 14A-14D), wherein the device comprises a sheath (Figs. 11 and 14A-14D, ref num 312) including a lumen (Fig. 11, ref num 318; para 000, “central lumen 318 extending through the cannula 312”) and a tube (Figs. 11 and 14A-14D, ref num 320) extendable from said lumen (para 001, “the second shaft 320 is slidably disposed within the lumen 318 of the cannula 312”). Young also teaches that the sheath is retractable (para 0016, “retracting the cannula 312 proximally relative to the second shaft 320”) in order to expose an electrode (Fig. 11, ref num 350; para 0061, “the second array 350 can be deployed by… retracting the cannula 312 proximally”; para 0060, “second array 350 of electrodes 356”). When the sheath is retractable, a tube is advanceable therethrough (para 0061, “the second shaft 320 is slidably disposed within the lumen 318 of the cannula 312”). The sheath being retractable is advantageous when controlling the distance and deployment of the first electrode relative to the second electrode (para 0061, “Such configuration is beneficial because it allows a distance between the first and the second arrays to be adjusted during use”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nolan to have the sheath be retractable in order to control the deployment of the first electrode relative to the deployment of the second electrode.
Devries teaches a device of analogous art (Fig. 1A; Col. 1, lines 30-33, “additional treatment of the tissue (e.g., ablation, cutting) may be necessary to treat the target site so that physicians may be required to use different devices to treat the target site as desired”), the device comprising an extendable tube (Fig. 1A, ref num 116) that extends through an opening (Fig. 1A, ref num 120; Col. 4, lines 31-35), such that the opening is defined at least in part by a first electrode (Fig. 2, ref num 108 is the first electrode that defines ref num 120; Col. 4, lines 39-41, “the first (e.g., positive) electrode 108 is structured so that it extends to the distal opening 120 of the lumen 104”; Col. 5, lines 22-24, “first electrode 108, however, may extend to the distal end of the distal tip 106 to at least partially surround the distal opening 120”). This allows the device to act in a bipolar configuration when applying energy to the target tissue (Col. 4, lines 19-59). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nolan to have the opening defined at least in part by the first electrode as this produces the same expected result of applying bipolar energy to treat the target tissue.
8. Regarding Claim 2, Nolan teaches the first electrode is exposed (see Fig. 10A, ref num 1004 is exposed), but fails to teach that it is exposed when the retractable sheath is retracted.
Young teaches a device of analogous art (Figs. 11 and 14A-14D), wherein the device comprises a sheath (Figs. 11 and 14A-14D, ref num 312) including a lumen (Fig. 11, ref num 318; para 000, “central lumen 318 extending through the cannula 312”) and a tube (Figs. 11 and 14A-14D, ref num 320) extendable from said lumen (para 001, “the second shaft 320 is slidably disposed within the lumen 318 of the cannula 312”). Young also teaches that the sheath is retractable (para 0016, “retracting the cannula 312 proximally relative to the second shaft 320”) in order to expose an electrode (Fig. 11, ref num 350; para 0061, “the second array 350 can be deployed by… retracting the cannula 312 proximally”; para 0060, “second array 350 of electrodes 356”). The sheath being retractable is advantageous when controlling the distance and deployment of the first electrode relative to the second electrode (para 0061, “Such configuration is beneficial because it allows a distance between the first and the second arrays to be adjusted during use”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nolan to have the sheath be retractable in order to control the deployment of the first electrode relative to the deployment of the second electrode.
9. Regarding Claim 7, Nolan teaches in another embodiment a device of analogous art (para 0006; Figs. 6A, 6B, and 7), wherein the device comprises a plurality of electrodes (Fig. 6A, ref num 604 and 614). The device also comprises an imaging sensor positioned to obtain imaging data of the target tissue (Fig. 7, ref num 712 which is disposed through ref num 654, Fig. 6B; para 0092, “The second electrode 614 may comprise radiopaque material. The stylet 612 may comprise a radiopaque marker…the tip 606 may comprise radiopaque material for visualization under fluoroscopy… fluoroscopy may be used to view radiopaque markers of the device 600 during and/or after insertion of the subject”). The imaging sensor confirms the placement of the system in regards to the target tissue (para 0092). Nolan also explains that device (ref num 1000) may include teachings from another embodiment of the device (such as ref num 600; para 0121, “the device 1000 may share features with the device 600, the device 900”), these teachings including imaging sensors (para 0121, “may share features… [such as] radiopaque markers… sensors”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined these teachings of Nolan to include an imaging sensor in order to properly place the system at the target site.
10. Regarding Claim 8, Nolan teaches in another embodiment a device of analogous art (para 0006; Figs. 6A, 6b, AND 7), wherein the device comprises a plurality of electrodes (Fig. 6A, ref num 604 and 614). The device also comprises an imaging sensor positioned to obtain imaging data of the target tissue (Fig. 7, ref num 712 which is disposed through ref num 654, Fig. 6B; para 0092, “The second electrode 614 may comprise radiopaque material. The stylet 612 may comprise a radiopaque marker…the tip 606 may comprise radiopaque material for visualization under fluoroscopy… fluoroscopy may be used to view radiopaque markers of the device 600 during and/or after insertion of the subject”). The imaging sensor is configured to operate simultaneously with the electrodes (para 0102; para 0092, “fluoroscopy may be used to view radiopaque markers of the device 600 during and/or after insertion into the subjection, for example to confirm position”; para 0006, “method comprises imaging using at least one of ultrasound or fluoroscopy to confirm a second location of the first electrode and the second electrode…and applying bipolar radiofrequency energy to the first electrode and the second electrode to ablate second tissue between the first point and the third point”). This allows for confirmation of the placement of the system in regards to the target tissue (para 0092). Nolan also explains that device (ref num 1000) may include teachings from another embodiment of the device (such as ref num 600; para 0121, “the device 1000 may share features with the device 600, the device 900”), these teachings including imaging sensors (para 0121, “may share features… [such as] radiopaque markers… sensors”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined these teachings of Nolan to include an imaging sensor in order to properly place the system at the target site.
11. Claims 3 are rejected under 35 U.S.C. 103 as being unpatentable over Nolan Young, and Devries, and further in view of Lenker U.S. 2018/0289388 (herein referred to as “Lenker”).
12. Regarding Claim 3, Nolan fails to teach the bendable telescopic tube is pre-bent with two opposing 90-degree bends.
Lenker teaches a bendable tube (Fig. 29A, ref nums 2906 and 2904; para 0222, “bi-directionally deflectable region 2900…comprises a first outer tube region 2906…a second outer tube region 2904”), such that the tube is pre-bent with a 90-degree bend (see Fig. 36A, needle, ref num 3600, is bent at 90 degrees; para 0248). While Lenker fails to specifically teach two opposing 90 degree bends, Lenker does teach that the system is bi-directionally bendable (para 0222). This indicates that the tube may bend in two opposing directions (para 0222). Since the tube is capable of bending at least one time in a 90 degree angle (see Fig. 36A, para 0248) and teaches that the two opposing bends may be of the same degree (para 0219, 0223), then the device is capable of being bent with two opposing 90-degree bends. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nolan and have the telescopic tube pre-bent with two opposing 90-degree bends.
13. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Nolan, Young, and Devries, and further in view of Paskar U.S. 2014/0088684 (herein referred to as “Paskar”).
14. Regarding Claim 4, Nolan fails to teach the bendable telescopic tube is pre-bent with a 180-degree bend.
Paskar teaches a steerable system of analogous art (para 0121, Fig. 6-F), wherein the system comprises a sheath (Fig. 6-F, ref num 23F) and a bendable tube extendable from the sheath (Fig. 6-F, ref num 27F; para 0155). The bendable tube (ref num 27F) is pre-bent with a 180-degree bend (para 0156, “when the curves of the outer tube and the inner curved element are at 0 degrees or 180 degrees with respect to each other”; see Fig. 6-F, ref num 27F is pictured with a 180-degree bend/u-shape bend). This bending allows for the desirable shape to be achieved by the system in order to achieve the expected result (para 0142). Therefore, It would have been an obvious matter of design choice to make the different portions of the bendable telescopic tube whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
15. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Nolan, Young, and Devries, and further in view of Gough U.S. 5,672,173 (herein referred to as “Gough”).
16. Regarding Claim 5, Nolan fails to teach the second electrode is extendable from the bendable telescopic tube.
Gough teaches an ablation system of analogous art (Figs. 1 and 2), wherein the system comprises a first electrode that defines a tip of the ablation system (Fig. 2, ref num 14; Col. 4, lines 4-5, “a primary antenna 14, and one or more secondary antennas 16, which are typically electrodes”) and a bendable tube extendable from a lumen (Fig. 2, ref num 18 that is associated with ref num 16 extends from lumen 18 via, ref num 26; Col. 6, lines 53-56, “secondary antenna distal end 16' is advanced out of aperture 26 and into selected tissue mass 28. Insulation sleeves 18 are adjusted for primary and secondary antennas 14 and 16 respectively”; Col. 6, lines 38-39, “There is wide variation in the amount of deflection of secondary antenna 16”). A second electrode is extendable from the bendable telescopic tube (see Fig. 2, ref num 16 extends from ref num 18). This permits repositioning of the sheath and first electrode as needed (Col. 3, lines 17-19) in order to create the desired ablation geometry for the target tissue (Col. 7, lines 25-31). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nolan to have the second electrode extendable from the bendable tube in order to facilitate the positioning and repositioning of the first and second electrodes for an optimal ablation pattern.
17. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Nolan, Young, Devries, and Gough, and further in view of Long U.S. 2017/0049508 (herein referred to as “Long”).
18. Regarding Claim 6, Forsyth as modified by Gough teaches the bendable telescopic tube is extended from the lumen and the second electrode is extended from the bendable telescopic tube (see Claim 5 rejection above; Gough: Fig. 2, ref num 18 that is associated with ref num 16 extends from lumen 18 via, ref num 26; Col. 6, lines 53-56, “secondary antenna distal end 16' is advanced out of aperture 26 and into selected tissue mass 28. Insulation sleeves 18 are adjusted for primary and secondary antennas 14 and 16 respectively”; Col. 6, lines 38-39, “There is wide variation in the amount of deflection of secondary antenna 16; Fig. 2, ref num 16 extends from ref num 18).
However, Nolan as modified fails to teach that the first electrode and the second electrode are arranged parallel to each other.
Long teaches a system of analogous art (Fig. 1), wherein the system comprises a first and second electrodes (Fig. 2A, ref nums 24 and 25 AND Fig. 8, ref nums 424 and 427), wherein the first and second electrodes are arranged parallel to each other (Fig. 8, see that ref nums 424 and 427 are parallel to one another; para 0060). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the first and second electrodes parallel to one another, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
19. Claims 9, 11, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Gough and in view of Nolan, Young, and Devries.
20. Regarding Claim 9, Gough teaches an ablation system (Figs. 1 and 8) comprising:
a. a sheath (Fig. 8, ref num 18) including a lumen (Fig. 8, understood there is a lumen in ref num 18);
b. a tip within the lumen (Figs. 2 and 8, ref num 26) and including a first opening and a second opening (Col. 8, lines 3-5, “two secondary antennas 16 introduced through apertures 26 formed in primary antenna 14”; the second opening is hidden from view in Fig. 8);
c. a first bendable telescopic tube (Fig. 8, ref num 16 on the right is understood to have a bendable telescopic tube, ref num 18, of its own; see Fig. 2 for reference) extendable from the lumen through the first opening (see Fig. 8, ref num 16 on either the right or left side at the distal end of ref num 14, contains ref num 18 that extends through the respective ref num 26) and including a first electrode (Fig. 8, ref num 16 is an electrode; Col. 4, lines 4-5, “a primary antenna 14, and one or more secondary antennas 16, which are typically electrodes); and
d. a second bendable telescopic tube (Fig. 8, ref num 16 on the left is understood to have a bendable telescopic tube, ref num 18, of its own; see Fig. 2 for reference) extendable from the lumen through the second opening (see Fig. 8, ref num 16 on either the right or left side at the distal end of ref num 14, contains ref num 18 that extends through the respective ref num 26) and including a second electrode (Fig. 8, ref num 16 is an electrode; Col. 4, lines 4-5, “a primary antenna 14, and one or more secondary antennas 16, which are typically electrodes), wherein the first electrode and the second electrode are configured to deliver an electric field energy to target tissue in a patient (Col. 6, lines 58-59, “multiple antenna device 12 can be operated in a bipolar mode (RF)”; Col. 8, lines 11-19, “primary and secondary antennas 14 and 16 and energy source 20 to provide an output for delivering and maintaining a selected energy at primary and secondary antennas 14 and 16, e.g., feedback control. Further, the resources provides an output that maintains a selected energy at primary and secondary antennas for a selected length of time. The following discussion pertains particularly to the use of an RF energy source and RF multiple antenna device 12”).
Gough fails to teach the sheath is retractable and that the first and second bendable tubes extend in directions perpendicular to the direction in which the tip extends and the second opening is defined at least in part by the tip and is exposed to allow the second bendable telescopic tube to extend therethrough when the retractable sheath is in a retracted position.
Nolan teaches an ablation system (Fig. 10A-10G; para 0129, “used for neuromodulation (e.g., ablation)…”) comprising a bendable telescopic tube (Fig. 10A, ref num 1012; para 0122, “a stylet 1012 configured to exit the aperture 1007 and curve radially away from the needle body 1002”; para 0124, “deflect stylet 1012 proximally and distally”) extendable from a lumen of a sheath (see Fig. 10A, ref num 1012 is extendable from ref num 1001/1002; para 0122, “a stylet 1012 configured to exit the aperture 1007”). The bendable telescopic tube extends through an opening in a direction perpendicular to a direction in which the first electrode extends (Fig. 10A, ref num 1012 extends through opening, ref num 1007, which is found perpendicular to where ref num 1004 extends; para 0129, “The steerable stylet 1012 preferably extends out of a lateral side of the needle body 1002”). By extending perpendicular to the tip of the ablation system, this allows the tube to navigate the tissue in order to capture the target area for ablation (para 0129; para 0126, “The adjustability provided by a steerable stylet 1012 can allow a user to articulate/steer the electrode around curved structures. Steering the stylet 1012 can allow the tip 1006 to be navigated to a desired position that the stylet 1012 may not otherwise achieve upon deployment”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gough to have the first and second bendable tubes extend perpendicular to the tip of the ablation system in order to capture the target area for ablation more effectively.
Young teaches a device of analogous art (Figs. 11 and 14A-14D), wherein the device comprises a sheath (Figs. 11 and 14A-14D, ref num 312) including a lumen (Fig. 11, ref num 318; para 000, “central lumen 318 extending through the cannula 312”) and a tube (Figs. 11 and 14A-14D, ref num 320) extendable from said lumen (para 001, “the second shaft 320 is slidably disposed within the lumen 318 of the cannula 312”). Young also teaches that the sheath is retractable (para 0016, “retracting the cannula 312 proximally relative to the second shaft 320”) in order to expose an electrode (Fig. 11, ref num 350; para 0061, “the second array 350 can be deployed by… retracting the cannula 312 proximally”; para 0060, “second array 350 of electrodes 356”). The sheath being retractable is advantageous when controlling the distance and deployment of the first electrode relative to the second electrode (para 0061, “Such configuration is beneficial because it allows a distance between the first and the second arrays to be adjusted during use”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gough to have the sheath be retractable in order to control the deployment of the first electrode relative to the deployment of the second electrode.
Devries teaches a device of analogous art (Fig. 1A; Col. 1, lines 30-33, “additional treatment of the tissue (e.g., ablation, cutting) may be necessary to treat the target site so that physicians may be required to use different devices to treat the target site as desired”), the device comprising an extendable tube (Fig. 1A, ref num 116) that extends through an opening (Fig. 1A, ref num 120; Col. 4, lines 31-35), such that the opening is defined at least in part by a first electrode (Fig. 2, ref num 108 is the first electrode that defines ref num 120; Col. 4, lines 39-41, “the first (e.g., positive) electrode 108 is structured so that it extends to the distal opening 120 of the lumen 104”; Col. 5, lines 22-24, “first electrode 108, however, may extend to the distal end of the distal tip 106 to at least partially surround the distal opening 120”). This allows the device to act in a bipolar configuration when applying energy to the target tissue (Col. 4, lines 19-59). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nolan to have the opening defined at least in part by the first electrode as this produces the same expected result of applying bipolar energy to treat the target tissue.
21. Regarding Claim 11, Gough teaches the first electrode is extendable from the first bendable telescopic tube and the second electrode is extendable from the second bendable telescopic tube (Fig. 8 shows a plurality of ref nums 16, i.e., the first and second electrodes; Col. 4, lines 4-5, “a primary antenna 14, and one or more secondary antennas 16, which are typically electrodes; Fig. 2, ref num 18 that is associated with ref num 16 extends from lumen 18 via, ref num 26; Col. 6, lines 53-56, “secondary antenna distal end 16' is advanced out of aperture 26 and into selected tissue mass 28. Insulation sleeves 18 are adjusted for primary and secondary antennas 14 and 16 respectively”; Col. 6, lines 38-39, “There is wide variation in the amount of deflection of secondary antenna 16”).
22. Regarding Claim 13, Gough teaches obtaining imaging data of the target tissue (Col. 8, lines 60-65, “User interface and display 36 includes operator controls and a display. Controller 38 can be coupled to imaging systems, including but not limited to ultrasound, CT scanners, X-ray, MRI, mammographic X-ray and the like. Further, direct visualization and tactile imaging can be utilized”), but fails to explicitly teach an imaging sensor.
Nolan teaches a device of analogous art (para 0006; Figs. 6A, 6B, and 7), wherein the device comprises a plurality of electrodes (Fig. 6A, ref num 604 and 614). The device also comprises an imaging sensor positioned to obtain imaging data of the target tissue (Fig. 7, ref num 712 which is disposed through ref num 654, Fig. 6B; para 0092, “The second electrode 614 may comprise radiopaque material. The stylet 612 may comprise a radiopaque marker…the tip 606 may comprise radiopaque material for visualization under fluoroscopy… fluoroscopy may be used to view radiopaque markers of the device 600 during and/or after insertion of the subject”). The imaging sensor confirms the placement of the system in regards to the target tissue (para 0092). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gough to include an imaging sensor in order to properly place the system at the target site.
23. Regarding Claim 14, Gough teaches obtaining imaging data of the target tissue (Col. 8, lines 60-65, “User interface and display 36 includes operator controls and a display. Controller 38 can be coupled to imaging systems, including but not limited to ultrasound, CT scanners, X-ray, MRI, mammographic X-ray and the like. Further, direct visualization and tactile imaging can be utilized”), but fails to explicitly teach an imaging sensor configured to operate simultaneously with operation of the first and second electrodes.
Nolan teaches (para 0006; Figs. 6A, 6b, AND 7), wherein the device comprises a plurality of electrodes (Fig. 6A, ref num 604 and 614). The device also comprises an imaging sensor positioned to obtain imaging data of the target tissue (Fig. 7, ref num 712 which is disposed through ref num 654, Fig. 6B; para 0092, “The second electrode 614 may comprise radiopaque material. The stylet 612 may comprise a radiopaque marker…the tip 606 may comprise radiopaque material for visualization under fluoroscopy… fluoroscopy may be used to view radiopaque markers of the device 600 during and/or after insertion of the subject”). The imaging sensor is configured to operate simultaneously with the electrodes (para 0102; para 0092, “fluoroscopy may be used to view radiopaque markers of the device 600 during and/or after insertion into the subjection, for example to confirm position”; para 0006, “method comprises imaging using at least one of ultrasound or fluoroscopy to confirm a second location of the first electrode and the second electrode…and applying bipolar radiofrequency energy to the first electrode and the second electrode to ablate second tissue between the first point and the third point”). This allows for confirmation of the placement of the system in regards to the target tissue (para 0092). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gough with the teachings of Nolan to include an imaging sensor in order to properly place the system at the target site.
24. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Gough, Nolan, Young, and Devries, and further in view of Lenker
25. Regarding Claim 10, Gough fails to teach the first bendable telescopic tube and second bendable telescopic tube are each pre-bent with a 90-degree bends.
Lenker teaches a bendable tube (Fig. 29A, ref nums 2906 and 2904; para 0222, “bi-directionally deflectable region 2900…comprises a first outer tube region 2906…a second outer tube region 2904”), such that the tube is pre-bent with a 90-degree bend (see Fig. 36A, needle, ref num 3600, is bent at 90 degrees; para 0248) as this is a feature of steering the tube within the tissue (para 0248). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nolan and have the first bendable telescopic tube and second bendable telescopic tube each pre-bent with a 90-degree bend
26. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gough, Nolan, Young, and Devries, and further in view of Long
27. Regarding Claim 12, Gough teaches the first and second bendable telescopic tubes are extended from the lumen and the first and second electrodes are extended from respective bendable telescopic tubes (see Claim 11 rejection above; Gough: Fig. 2, ref num 18 that is associated with ref num 16 extends from lumen 18 via, ref num 26; Col. 6, lines 53-56, “secondary antenna distal end 16' is advanced out of aperture 26 and into selected tissue mass 28. Insulation sleeves 18 are adjusted for primary and secondary antennas 14 and 16 respectively”; Col. 6, lines 38-39, “There is wide variation in the amount of deflection of secondary antenna 16; Fig. 2, ref num 16 extends from ref num 18).
However, Gough as modified fails to teach that the first electrode and the second electrode are arranged parallel to each other.
Long teaches a system of analogous art (Fig. 1), wherein the system comprises a first and second electrodes (Fig. 2A, ref nums 24 and 25 AND Fig. 8, ref nums 424 and 427), wherein the first and second electrodes are arranged parallel to each other (Fig. 8, see that ref nums 424 and 427 are parallel to one another; para 0060). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the first and second electrodes parallel to one another, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
28. Claims 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gough and in view of Young, Devries, Gough, and Long.
29. Regarding Claim 15, Nolan teaches a method of performing irreversible electroporation therapy (para 0005, 0096) comprising:
a. a sheath of an IRE probe system that is located at or near target tissue in a patient to expose a tip of the IRE probe system (Fig. 10A, ref num 1003 = sheath; ref num 1004 = tip; para 0121, “tissue-penetrating tip 1004”
b. extending a first bendable telescopic tube from a lumen of the IRE probe system (Fig. 10A, ref num 1012; para 0122, “a stylet 1012 configured to exit the aperture 1007 and curve radially away from the needle body 1002”; para 0124, “deflect stylet 1012 proximally and distally”; see Fig. 10A, ref num 1012 is extendable from ref num 1001/1002; para 0122, “a stylet 1012 configured to exit the aperture 1007”) through a first opening in of the tip (Fig. 10D, ref num 1007 is the opening) in a direction perpendicular to a direction in which the tip extends (Fig. 10A, ref num 1012 extends through opening, ref num 1007, which is found perpendicular to where ref num 1004 extends; para 0129, “The steerable stylet 1012 preferably extends out of a lateral side of the needle body 1002”);
c. a first electrode on the first bendable telescopic tube (Fig. 10A, ref num 1006; para 0122, “the tip 1006 comprises a second electrode”);
d. energizing an electrical field between the first electrode and a second electrode of the IRE probe system to ablate the target tissue in a first orientation (para 0121, “the device 1000 may share features with the device 600, the device 900…connection to a tissue treatment”; para 0006, “applying bipolar radiofrequency energy to the first electrode and the second electrode to ablate first tissue between the first point and the second point”; para 0094, “The energy extends between the first electrode 604 and the second electrode 614 to create a line of ablation”; device 1000 embodiment includes teachings from device 600 embodiment, such as the teaching of energy being delivered to the first and second electrodes and to the tissue).
Nolan fails to teach (a) retracting the sheath; (c) extending the first electrode from the first bendable telescopic tube; and (d) the first and second electrodes being parallel to one another; and extending a second bendable telescopic tube from the lumen of the IRE probe system through a second opening that is defined at least in part by the tip and is exposed to allow the second bendable telescopic tube to extend therethrough when the sheath is in a retracted position.
Young teaches a method of analogous art comprising a device (Figs. 11 and 14A-14D), wherein the device comprises a sheath (Figs. 11 and 14A-14D, ref num 312) including a lumen (Fig. 11, ref num 318; para 000, “central lumen 318 extending through the cannula 312”) and a tube (Figs. 11 and 14A-14D, ref num 320) extendable from said lumen (para 001, “the second shaft 320 is slidably disposed within the lumen 318 of the cannula 312”). Young also teaches that the sheath is retractable (para 0016, “retracting the cannula 312 proximally relative to the second shaft 320”) in order to expose an electrode (Fig. 11, ref num 350; para 0061, “the second array 350 can be deployed by… retracting the cannula 312 proximally”; para 0060, “second array 350 of electrodes 356”). The sheath being retractable is advantageous when controlling the distance and deployment of the first electrode relative to the second electrode (para 0061, “Such configuration is beneficial because it allows a distance between the first and the second arrays to be adjusted during use”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nolan to have the sheath be retractable in order to control the deployment of the first electrode relative to the deployment of the second electrode.
Devries teaches a device of analogous art (Fig. 1A; Col. 1, lines 30-33, “additional treatment of the tissue (e.g., ablation, cutting) may be necessary to treat the target site so that physicians may be required to use different devices to treat the target site as desired”), the device comprising an extendable tube (Fig. 1A, ref num 116) that extends through an opening (Fig. 1A, ref num 120; Col. 4, lines 31-35), such that the opening is defined at least in part by a first electrode (Fig. 2, ref num 108 is the first electrode that defines ref num 120; Col. 4, lines 39-41, “the first (e.g., positive) electrode 108 is structured so that it extends to the distal opening 120 of the lumen 104”; Col. 5, lines 22-24, “first electrode 108, however, may extend to the distal end of the distal tip 106 to at least partially surround the distal opening 120”). This allows the device to act in a bipolar configuration when applying energy to the target tissue (Col. 4, lines 19-59). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nolan to have the opening defined at least in part by the first electrode as this produces the same expected result of applying bipolar energy to treat the target tissue.
Gough teaches an ablation system of analogous art (Figs. 1 and 2), wherein the system comprises a bendable tube extendable from a lumen (Fig. 2, ref num 18 that is associated with ref num 16 extends from lumen 18 via, ref num 26; Col. 6, lines 53-56, “secondary antenna distal end 16' is advanced out of aperture 26 and into selected tissue mass 28. Insulation sleeves 18 are adjusted for primary and secondary antennas 14 and 16 respectively”; Col. 6, lines 38-39, “There is wide variation in the amount of deflection of secondary antenna 16”). An electrode is extendable from the bendable telescopic tube (see Fig. 2, ref num 16 extends from ref num 18). Gough also teaches a second bendable telescopic tube (Fig. 8, ref num 16 on the left is understood to have a bendable telescopic tube, ref num 18, of its own; see Fig. 2 for reference) extendable from the lumen through the second opening (see Fig. 8, ref num 16 on either the right or left side at the distal end of ref num 14, contains ref num 18 that extends through the respective ref num 26) and including a second electrode (Fig. 8, ref num 16 is an electrode; Col. 4, lines 4-5, “a primary antenna 14, and one or more secondary antennas 16, which are typically electrodes), wherein the first electrode and the second electrode are configured to deliver an electric field energy to target tissue in a patient (Col. 6, lines 58-59, “multiple antenna device 12 can be operated in a bipolar mode (RF)”; Col. 8, lines 11-19, “primary and secondary antennas 14 and 16 and energy source 20 to provide an output for delivering and maintaining a selected energy at primary and secondary antennas 14 and 16, e.g., feedback control. Further, the resources provides an output that maintains a selected energy at primary and secondary antennas for a selected length of time. The following discussion pertains particularly to the use of an RF energy source and RF multiple antenna device 12”). This permits repositioning of the sheath and electrode as needed (Col. 3, lines 17-19) in order to create the desired ablation geometry for the target tissue (Col. 7, lines 25-31). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nolan to have the first electrode extendable from the bendable tube in order to facilitate the positioning and repositioning of the electrode for an optimal ablation pattern.
Long teaches a system of analogous art (Fig. 1), wherein the system comprises a first and second electrodes (Fig. 2A, ref nums 24 and 25 AND Fig. 8, ref nums 424 and 427), wherein the first and second electrodes are arranged parallel to each other (Fig. 8, see that ref nums 424 and 427 are parallel to one another; para 0060). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the first and second electrodes parallel to one another, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
30. Regarding Claim 16, Nolan fails to teach retracting the first electrode; retracting the first bendable telescopic tube; extending the sheath; rotating the IRE probe system; re-extending the first bendable telescopic tube from the lumen of the IRE probe system; re-extending the first electrode from the first bendable telescopic tube; and energizing an electrical field between the first electrode and the second electrode to ablate the target tissue in a second orientation.
Gough teaches retracting the first electrode and first bendable telescopic tube (Col. 6, lines 61-63, “Secondary antenna distal end 16' is retracted back into primary antenna 14”; understood tube 18 would also be retracted); rotating the IRE probe system (Col. 6, line 63, “primary antenna is then rotated”); re-extending the first bendable telescopic tube from the lumen and the first electrode from the tube (Col. 6, lines 63-37 – Col. 7, lines 1-7); and energizing an electrical field between the first and second electrode to ablate the target tissue in a second orientation (Col. 6, lines 63-37 – Col. 7, lines 1-12). This permits repositioning of the sheath first electrode as needed (Col. 3, lines 17-19) in order to create the desired ablation geometry for the target tissue (Col. 7, lines 25-31). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nolan to have the first electrode extendable from the bendable tube and rotating the probe system in order to facilitate the positioning and repositioning of the first and second electrodes for an optimal ablation pattern.
31. Regarding Claim 17, Nolan fails to teach extending a second bendable telescopic tube from the lumen of the IRE probe system; extending the second electrode from the second bendable telescopic tube.
Gough teaches a second bendable telescopic tube (Fig. 8, ref num 16 on the left is understood to have a bendable telescopic tube, ref num 18, of its own; see Fig. 2 for reference) extendable from the lumen through the second opening (see Fig. 8, ref num 16 on either the right or left side at the distal end of ref num 14, contains ref num 18 that extends through the respective ref num 26) and including a second electrode (Fig. 8, ref num 16 is an electrode; Col. 4, lines 4-5, “a primary antenna 14, and one or more secondary antennas 16, which are typically electrodes) extendable from the bendable telescopic tube (see Fig. 2, ref num 16 extends from ref num 18). This permits repositioning of the sheath and plurality of electrodes as needed (Col. 3, lines 17-19) in order to create the desired ablation geometry for the target tissue (Col. 7, lines 25-31). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nolan to have a second electrode extendable from the bendable tube in order to facilitate the positioning and repositioning of the first and second electrodes for an optimal ablation pattern.
32. Regarding Claim 18, Nolan fails to teach retracting the first electrode and the second electrode; retracting the first bendable telescopic tube and the second bendable telescopic tube; extending the sheath; rotating the IRE probe system; re-extending the first bendable telescopic tube from the lumen of the IRE probe system; re-extending the first electrode from the first bendable telescopic tube; re-extending the second bendable telescopic tube from the lumen of the IRE probe system; re-extending the second electrode from the second bendable telescopic tube; and energizing an electrical field between the first electrode and the second electrode to ablate the target tissue in a second orientation.
Gough teaches the retraction of the electrode into the lumen, rotating the probe system, and reextending the electrode to ablate target tissue in an alternative orientation (see Claim 16 rejection above). Gough also teaches this may be done with a plurality of bendable tubes/electrodes (see Fig. 8, plurality of electrodes, ref nums 16; Col. 7, lines 66-67 – Col. 8, lines 1-9; Col. 7, lines 21-25, “Primary antenna 14 can be rotated, with secondary antennas 16 retracted into a central lumen of primary antenna 14, and another ablation volume defined between the two secondary antennas 16 is created”). This permits repositioning of the sheath and first and second electrodes as needed (Col. 3, lines 17-19) in order to create the desired ablation geometry for the target tissue (Col. 7, lines 25-31). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nolan to have the first and second electrodes retracted from the first and second bendable tubes and rotating the probe system in order to facilitate the positioning and repositioning of the first and second electrodes for an optimal ablation pattern.
33. Regarding Claim 19, Nolan teaches in another embodiment a device of analogous art (para 0006; Figs. 6A, 6B, and 7), wherein the device comprises a plurality of electrodes (Fig. 6A, ref num 604 and 614). The device also comprises an imaging sensor positioned to obtain imaging data of the target tissue (Fig. 7, ref num 712 which is disposed through ref num 654, Fig. 6B; para 0092, “The second electrode 614 may comprise radiopaque material. The stylet 612 may comprise a radiopaque marker…the tip 606 may comprise radiopaque material for visualization under fluoroscopy… fluoroscopy may be used to view radiopaque markers of the device 600 during and/or after insertion of the subject”). The imaging sensor confirms the placement of the system in regards to the target tissue (para 0092). Nolan also explains that device (ref num 1000) may include teachings from another embodiment of the device (such as ref num 600; para 0121, “the device 1000 may share features with the device 600, the device 900”), these teachings including imaging sensors (para 0121, “may share features… [such as] radiopaque markers… sensors”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined these teachings of Nolan to include an imaging sensor in order to properly place the system at the target site.
34. Regarding Claim 20, Nolan teaches in another embodiment a device of analogous art (para 0006; Figs. 6A, 6b, AND 7), wherein the device comprises a plurality of electrodes (Fig. 6A, ref num 604 and 614). The device also comprises an imaging sensor positioned to obtain imaging data of the target tissue (Fig. 7, ref num 712 which is disposed through ref num 654, Fig. 6B; para 0092, “The second electrode 614 may comprise radiopaque material. The stylet 612 may comprise a radiopaque marker…the tip 606 may comprise radiopaque material for visualization under fluoroscopy… fluoroscopy may be used to view radiopaque markers of the device 600 during and/or after insertion of the subject”). The imaging sensor is configured to operate simultaneously with the electrodes (para 0102; para 0092, “fluoroscopy may be used to view radiopaque markers of the device 600 during and/or after insertion into the subjection, for example to confirm position”; para 0006, “method comprises imaging using at least one of ultrasound or fluoroscopy to confirm a second location of the first electrode and the second electrode…and applying bipolar radiofrequency energy to the first electrode and the second electrode to ablate second tissue between the first point and the third point”). This allows for confirmation of the placement of the system in regards to the target tissue (para 0092). Nolan also explains that device (ref num 1000) may include teachings from another embodiment of the device (such as ref num 600; para 0121, “the device 1000 may share features with the device 600, the device 900”), these teachings including imaging sensors (para 0121, “may share features… [such as] radiopaque markers… sensors”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined these teachings of Nolan to include an imaging sensor in order to properly place the system at the target site.
Conclusion
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
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