DETAILED ACTION
A complete action on the merits of pending claims 1-14 appears below.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Palmer US 20130345704 in view of Doll US 20220160425.
Regarding claim 1, Palmer teaches an electrode assembly for delivering a radio-frequency (RF) power signal to a surgical site (par. [0059]), the electrode assembly comprising an active electrode (par. [0059] blade 10) and a return electrode (par. [0059] electrodes 70 and 80), wherein the return electrode comprises: a distal region (Fig. 9 insulating layer 90), wherein a portion of the distal region comprises a sloped surface, the sloped surface forming a protruding edge at a first end of the distal region (Fig. 9 surfaces of 90), and the protruding edge having a first outer diameter; and a proximal region extending from the first end of the distal region, the proximal region having a second outer diameter (Fig. 9 80 inside of 140), the second outer diameter being smaller than the first outer diameter (Fig. 9 80 inside of 90); and an insulating sleeve configured to be received by the proximal region of the return electrode (Fig. 9 140).
Palmer does not explicitly teach the insulating sleeve having an outer diameter substantially the same as the first outer diameter.
Doll, in an analogous device, teaches where the protruding edge around the electrode can be off set from the tube (Fig. 5A), similar to Palmer, or generally flush with the tube (Fig. 3D).
It would have been an obvious matter of design choice to one of ordinary skill in the art at the time the invention effectively filed to have the edge diameter the same as the insulating sleeve outer diameter, since applicant has not disclosed that similar diameters solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with either configuration. To that end, having flush sleeves could help prevent snagging on tissue when going through the body.
Regarding claim 2, Palmer teaches wherein the protruding edge extends around at least a portion of a circumference of the return electrode (Fig. 9 90 goes around 80).
Regarding claim 3, Palmer teaches wherein the protruding edge extends around up to about 75% of the circumference of the return electrode (Fig. 9 90 goes about 75% around 80).
Regarding claim 4, the combination of Palmer and Doll teaches wherein an end of the insulating sleeve is configured to mate with a surface of the protruding edge (combination in claim 1).
Regarding claim 5, Palmer teaches wherein the electrode assembly further comprises an insulating element arranged between the active electrode and the return electrode (Fig. 9 insulating film 60).
Regarding claim 6, Doll teaches wherein the insulating element is formed of a ceramic or a polymer (par. [0031]).
Regarding claim 7, Palmer teaches further comprising a rotatory shaver arrangement (par. [0040] rotating blade 9).
Regarding claim 11, Palmer teaches wherein the active electrode comprises an aperture for providing access to a suction channel extending through the insulating element to a lumen configured to carry fluid from the surgical site (par. [0040] windows 30 and 40 allow access to vacuum bore 25).
Regarding claim 12, Palmer teaches wherein the lumen is connectable to a suction tube for connecting to a suction source (Fig. 2 suction source 28).
Regarding claim 13, Palmer teaches a hand-piece (Fig. 2 handle 2); one or more user-operable buttons on the handpiece for operably controlling the instrument (Fig. 2 switch 12); and an operative shaft (Fig. 2), having RF electrical connections, and drive componentry for an end effector, the electrosurgical instrument further comprising an end effector according to claim 1, the active electrode and the return electrode being connected to the RF electrical connections (par. [0041] electrical connections 70a and 80a).
Regarding claim 14, Palmer teaches an RF electrosurgical generator (Fig. 2 16); a suction source (Fig. 2 28); and an electrosurgical instrument according to claim 13, the arrangement being such that in use the RF electrosurgical generator supplies an RF coagulation or ablation signal via the RF electrical connections to the active electrode and the return electrode (par. [0049]).
Claims 8-10 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Palmer and Doll as applied to claim 1 above, and further in view of Wrublewski US 6193715.
Regarding claims 8-10, the combination of Palmer and Doll does not explicitly teach wherein the insulating sleeve is heat-shrink wrapped around the proximal region of the return electrode, wherein the insulating sleeve comprises a polymer material, and wherein the polymer material comprising polyvinylidene fluoride.
Wrublewski, in an analogous device, teaches the insulating material can be any biocompatible material including polyester shrink tubing, Kynar, polycarbonate, polyvinyl chloride, and polysulfones (col 5 lines 49-21 and 64-65).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the insulating materials of Palmer to be a shrink polymer, polyvinylidene fluoride, or any other biocompatible material, 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. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331. It would yield the result of providing electrical insulation while the device is in use.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN T. CLARK whose telephone number is (408)918-7606. The examiner can normally be reached on Monday-Friday 7AM-3PM MT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on (571)272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/R.T.C./Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794