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.
Claim Rejections - 35 USC § 112
3. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
4. Claims 6 and 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
5. The term “generally rigid” in claims 6 and 7 is a relative term which renders the claim indefinite. The term “generally rigid” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear whether the shaft is meant to be flexible or rigid, or some degree between. Therefore, clarification is required. For examination purposes, any degree of rigidity or flexibility will be considered to read on the claim language.
Claim Rejections - 35 USC § 102
6. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
7. Claims 1, 2, 5-8, 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith U.S. 2020/0060756 (herein referred to as “Smith”).
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 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”).
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 generally 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 generally 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 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”), 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”).
15. 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”).
16. 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”).
Claim Rejections - 35 USC § 103
17. 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.
18. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Smith and in view of Woloszko U.S. 2003/0130655 (herein referred to as “Woloszko”).
19. 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.
20. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Smith and in view of Karwei U.S. 2023/0309993 (herein referred to as “Karwei”).
21. 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.
22. Claims 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Smith.
23. 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.
24. 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).
25. 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”).
26. 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.
27. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Smith and in view of Schuler U.S. 2021/0353355 (herein referred to as “Schuler”).
28. 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 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 the insulator is transitionable to a retracted position to a retracted position wherein a portion of the longitudinal surface is exposed, such that the insulator is slidable along the longitudinal surface
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.
Conclusion
30. 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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/ANNIE L SHOULDERS/Examiner, Art Unit 3794