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.
Response to Arguments
3. 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.
Drawings
4. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: reference number ‘224’ found in paragraph 0071 of the specification, pointed to “insulator”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
5. Claims 6 and 7 were previously rejected under 35 U.S.C. 112(b) for indefiniteness. These claims have been amended to overcome the previous rejection. Therefore, the rejection has been withdrawn.
Claim Rejections - 35 USC § 103
6. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
7. Claims 1, 2, 5-13, 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Smith U.S. 2020/0060756 (herein referred to as “Smith”) and in view of Sutter U.S. 7,699,843 (herein referred to as “Sutter”).
8. Regarding Claim 1, Smith teaches an electrosurgical device (Fig. 1A), comprising:
a. a longitudinally extending shaft having a distal region (Fig. 1A, ref num 14, having distal region, ref num 16), the shaft defining an axis (see Fig. 1A, ref num 14 defines an axis);
b. an electrode disposed on the distal region (Fig. 1A, ref num 26 and Fig. 8C, ref num 726), the electrode having a longitudinal surface (see Fig. 8C) and a generally planar, exposed distalmost surface, the distalmost surface defining an edge (Fig. 8C, ref num 796); and
c. an insulator disposed on the longitudinal surface continuously extending to the edge (Fig. 8C, ref num 709), the insulator surrounding the electrode and flush with the distalmost surface (para 0065, “the outer wall of annular insulator 709 may be substantially aligned with (flush with) the outer surface of a distal end portion of electrode 726”).
Smith fails to teach the insulator terminates at a junction between the longitudinal surface and the distalmost surface, such that the distalmost surface is the only exposed conductive surface of the electrode.
Sutter teaches an electrosurgical device of analogous art (Fig. 1), wherein the device comprises an electrode disposed on the distal region (Fig. 1, ref num 14) and an insulator disposed on a longitudinal surface (Fig. 2, ref num 38 is disposed on longitudinal surface of electrode, ref num 28, as shown in Figs. 2 and 4). The insulator terminates at a junction between the longitudinal surface and the distalmost surface of the electrode (see Fig. 2, ref num 38 terminates at ref num 46), so that the distalmost surface of the electrode is the only exposed conductive surface (see Fig. 2, the distalmost surface of ref num 14 is exposed; Col. 3, lines 34-37, “With exception of the bare electrode tip, the shaft tube 20 and the electrode 14 are completely electrically insulated on their outside through the handle 12, the cladding 22 and the electrode ferrule 38”). This focuses the energy that is applied to the target tissue to the tip (Col. 3, lines 33-37). 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 Smith to have the insulator surround the electrode such that the distalmost surface is the only exposed conductive surface of the conductive electrode in order to focus the electrosurgical energy to the target tissue at the distalmost surface.
9. Regarding Claim 2, Smith teaches the insulator includes a distal side flush with the distalmost surface (para 0065, “the outer wall of annular insulator 709 may be substantially aligned with (flush with) the outer surface of a distal end portion of electrode 726”).
10. Regarding Claim 5, Smith teaches the shaft includes a proximal region (see Fig. 1A and 1B, ref num 14 has a proximal region) and further comprises a handle coupled to the proximal region (Fig. 1A, 1B, ref num 12 is coupled to the proximal region of ref num 14 via ref num 40; para 0038, “Shaft 14 may be coupled to handle 12 via a coupler 40”).
11. Regarding Claim 6, Smith teaches the shaft is one of flexible and rigid (para 0100, “the user may select between shafts and/or handles having different characteristics, including shapes, dimensions, material properties, level(s) of use, flexibility, operation, and/or any other characteristics”).
12. Regarding Claim 7, Smith teaches the shaft is rigid (para 0100) and the electrosurgical device is a handheld device (see Figs. 1A/1B, ref nums 38 are “finger holes”, therefore, the device, ref num 10, is handheld).
13. Regarding Claim 8, Smith teaches the electrode is cylindrical (see Fig. 8C, ref num 726 is cylindrical).
14. Regarding Claim 9, another embodiment of Smith teaches the electrode includes an outer puck disposed on a core mandrel (Fig. 12A, ref num 1025 disposed on ref num 1023). These various embodiments of Smith produce the same expected result of treating tissue; 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 embodiments.
15. Regarding Claim 10, the other embodiment of Smith teaches the shaft (Fig. 12B, ref num 1014) carries an electrical conductor (Fig. 12B, ref num 1029).
16. Regarding Claim 11, the other embodiment of Smith teaches the core mandrel (Fig. 12A, ref num 1023) is integrally formed with the electrical conductor (Fig. 12B, ref num 1023 is formed with ref num 1029; para 0080, “First conductor 1029 may be connected to first conductive member 1023”).
17. Regarding Claims 12 and 13, Smith teaches the outer puck (see Fig. 2A, ref num 26) is threaded on to the core mandrel (Fig. 2A, ref num 56 = core mandrel; para 0040, “electrode 26 and cylindrical extension 56 may be coupled via a snap fit, friction fit, threading, an elastomeric and/or adhesive material, or other suitable coupling”). While Smith does not explicitly teach that the outer puck is welded on to the core mandrel, Smith does discuss that they may be coupled by any suitable coupling, and one of ordinary skill in the art would know that welding is a common form of coupling. 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 Smith to weld the outer puck to the core mandrel.
18. Regarding Claim 15, Smith teaches an electrosurgical system (Fig. 1A), comprising:
a. an electrosurgical unit (Fig. 1A, ref num 24) configured to provide a source of radiofrequency energy (para 0035, “handle 12 may be coupled to an energy source through hub 24… the energy source may be… a radio frequency generator”);
b. an electrosurgical device operably coupled to the electrosurgical unit (Fig. 1A, ref num 10/12 is coupled to ref num 24), the electrosurgical device comprising:
b.1. a longitudinally extending shaft having a distal region (Fig. 1A, ref num 14, having distal region, ref num 16), the shaft defining an axis (see Fig. 1A, ref num 14 defines an axis);
b.2 an electrode disposed on the distal region (Fig. 1A, ref num 26 and Fig. 8C, ref num 726),the electrode configured to receive the source of radiofrequency energy from the electrosurgical unit (para 0035, “two conductive elements may run through shaft 14, where the conductive elements may be electrically isolated from each other, allowing one to conduct energy to the active electrode”) and to direct radiofrequency energy from the distalmost surface along the axis (para 0035), the electrode having a longitudinal surface (see Fig. 8C) and a generally planar, exposed distalmost surface, the distalmost surface defining an edge (Fig. 8C, ref num 796); and
c. an insulator disposed on the longitudinal surface continuously extending to the edge (Fig. 8C, ref num 709), the insulator surrounding the electrode and flush with the distalmost surface (para 0065, “the outer wall of annular insulator 709 may be substantially aligned with (flush with) the outer surface of a distal end portion of electrode 726”).
Smith fails to teach the insulator terminates at a junction between the longitudinal surface and the distalmost surface, such that the distalmost surface is the only exposed conductive surface of the electrode.
Sutter teaches an electrosurgical device of analogous art (Fig. 1), wherein the device comprises an electrode disposed on the distal region (Fig. 1, ref num 14) and an insulator disposed on a longitudinal surface (Fig. 2, ref num 38 is disposed on longitudinal surface of electrode, ref num 28, as shown in Figs. 2 and 4). The insulator terminates at a junction between the longitudinal surface and the distalmost surface of the electrode (see Fig. 2, ref num 38 terminates at ref num 46), so that the distalmost surface of the electrode is the only exposed conductive surface (see Fig. 2, the distalmost surface of ref num 14 is exposed; Col. 3, lines 34-37, “With exception of the bare electrode tip, the shaft tube 20 and the electrode 14 are completely electrically insulated on their outside through the handle 12, the cladding 22 and the electrode ferrule 38”). This focuses the energy that is applied to the target tissue to the tip (Col. 3, lines 33-37). 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 Smith to have the insulator surround the electrode such that the distalmost surface is the only exposed conductive surface of the conductive electrode in order to focus the electrosurgical energy to the target tissue at the distalmost surface.
19. Regarding Claim 16, Smith teaches the electrosurgical device is configurable in a plurality of functions including a cut function (para 0070, “The user may also position the uninsulated electrode shaft to abut or contact tissue and apply energy to cut, dissect, or ablate tissue”) and a coagulation function (para 0070, “The user may position the radial exterior of the distal portion to perform hemostasis to cauterize or coagulate tissue”).
20. Regarding Claim 17, Smith teaches the electrosurgical device is configurable in a monopolar mode (para 0035, “medical device 10 may be used for monopolar electrosurgery”).
21. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Smith and Sutter, and further in view of Woloszko U.S. 2003/0130655 (herein referred to as “Woloszko”).
22. Regarding Claim 3, Smith teaches the insulator comprises a heat shrink material (para 0066), but fails to specifically teach that the material is polytetrafluoroethylene.
Woloszko teaches a device of analogous art (Figs. 1 and 17), wherein the insulator comprises a material that is polytetrafluoroethylene (Fig. 17A, ref num 17; para 0138 , “an electrically insulative jacket 17, which is typically formed as one or more electrically insulative sheaths or coatings, such as polytetrafluoroethylene”). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the insulator made out of polytetrafluoroethylene, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
23. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Smith and Sutter, and further in view of Karwei U.S. 2023/0309993 (herein referred to as “Karwei”).
24. Regarding Claim 4, Smith fails to teach the electrode comprises nitinol.
Karwei teaches a device of analogous art (Fig. 1), wherein the device comprises an electrode (Fig. 3, ref num 22) and an insulator (Fig. 3, ref num 15), such that the electrode comprises nitinol (para 0024, “the thrust element forms or contains the electrode supply line for supply of the electrode with electrical power and is preferably made of flexible metal, e.g. nitinol”). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the electrode comprise of nitinol, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
25. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Smith and Sutter, and further in view of Schuler U.S. 2021/0353355 (herein referred to as “Schuler”).
26. Regarding Claim 14, Smith fails to teach the shaft is configured as a guidewire.
Schuler teaches a device of analogous art (Figs. 1 and 2A), wherein the device comprises a shaft (Fig. 2A, ref num 210) that is configured as a guidewire (para 0043, “guide wire 210”). The guidewire provides access to smaller structure for perform the desired treatment (para 0006, 0007, 0043). 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 Smith to have the shaft configured as a guidewire in order to provide access to smaller structures to perform the same function of treating the target area.
27. Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Smith and Sutter, and further in view of Johnson U.S. 2008/0281314 (herein referred to as “Johnson”).
28. Regarding Claim 18, Smith teaches the system further comprises a pump couplable to source of fluid via delivery tubing (Fig. 1A, ref num 28, 22; Fig. 1B, ref num 22A, 27; para 0034, “port 22 may include a one-way valve 28, a luer, a seal, threading 30, and/or any appropriate element to maintain a secure connection between handle 12 and the fluid source”) and the delivery tubing operably coupled to the electrosurgical device (see Fig. 1B, ref num 22A is coupled to ref num 10/12).
Smith fails to teach the electrosurgical unit configured to operate the pump.
Johnson teaches a system of analogous art (Fig. 14), wherein the system comprises an electrosurgical unit (Fig. 14, ref num 24), wherein the electrosurgical unit is configured to operate a pump (para 0088, “Handpiece 24 can be coupled to tissue aspiration/collection devices 26, fluid delivery devices 28 (e.g. infusion pumps), fluid reservoirs 30 (cooling, electrolytic, irrigation, etc.), or power source 20, through the use of ports 24'”). By controlling the pump, this controls the amount of fluid that that is introduced to the treatment site in order to enhance the electrodes (para 0096). 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 Smith to have the electrosurgical unit operate the pump in order to control the amount of fluid delivered to the target site.
29. Regarding Claims 19 and 20, Smith teaches an electrosurgical device (Fig. 1A), comprising:
a. a longitudinally extending shaft having a distal region (Fig. 1A, ref num 14, having distal region, ref num 16), the shaft defining an axis (see Fig. 1A, ref num 14 defines an axis);
b. an electrode disposed on the distal region (Fig. 1A, ref num 26 and Fig. 8C, ref num 726), the electrode having a longitudinal surface (see Fig. 8C) and a generally planar, exposed distalmost surface, the distalmost surface defining an edge (Fig. 8C, ref num 796); and
c. an insulator disposed on the longitudinal surface to the edge (Fig. 8C, ref num 709), the insulator surrounding the electrode and flush with the distalmost surface (para 0065, “the outer wall of annular insulator 709 may be substantially aligned with (flush with) the outer surface of a distal end portion of electrode 726”).
While Smith teaches extending and retraction of the electrode (Figs. 4 and 5A-5B), Smith fails to teach an axially movable insulator, such that the insulator is transitionable from the first position to a retracted second position to a retracted position wherein a portion of the longitudinal surface is exposed, such that the insulator is slidable along the longitudinal surface.
Smith also fails to teach the insulator terminates at a junction between the longitudinal surface and the distalmost surface, such that the distalmost surface is the only exposed conductive surface of the electrode.
Johnson teaches a device of analogous art (Figs. 1 and 19-22) wherein the device comprises an electrode (Fig. 20, ref num 18e) and an insulator (Fig. 20, ref num 36). The insulator is transitionable to a retracted position along the longitudinal surface wherein a portion of the longitudinal surface of the electrode is exposed (para 0098, “as might occur due to advancement or retraction of slidable insulation layer 36”). This controls the resistance of device (para 0098). 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 Smith to have the insulator be retractable in order to control the resistance and energy application of the device via the electrode.
Sutter teaches an electrosurgical device of analogous art (Fig. 1), wherein the device comprises an electrode disposed on the distal region (Fig. 1, ref num 14) and an insulator disposed on a longitudinal surface (Fig. 2, ref num 38 is disposed on longitudinal surface of electrode, ref num 28, as shown in Figs. 2 and 4). The insulator terminates at a junction between the longitudinal surface and the distalmost surface of the electrode (see Fig. 2, ref num 38 terminates at ref num 46), so that the distalmost surface of the electrode is the only exposed conductive surface (see Fig. 2, the distalmost surface of ref num 14 is exposed; Col. 3, lines 34-37, “With exception of the bare electrode tip, the shaft tube 20 and the electrode 14 are completely electrically insulated on their outside through the handle 12, the cladding 22 and the electrode ferrule 38”). This focuses the energy that is applied to the target tissue to the tip (Col. 3, lines 33-37). 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 Smith to have the insulator surround the electrode such that the distalmost surface is the only exposed conductive surface of the conductive electrode in order to focus the electrosurgical energy to the target tissue at the distalmost surface.
Conclusion
30. 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.
31. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
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