DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Claims 13-16, 18-23 and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06 May 2026.
Claim Objections
Claim 3 is objected to because of the following informalities: “claim-1” in line 1 should be amended to --claim 1--. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-3, 5, 8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Vayser et al. (US 2016/0157920) in view of Lebouitz et al. (US 2002/0116022).
Regarding claim 1, Vayser discloses a monopolar electrosurgical electrode (see Figs. 16A-16D, the electrode is considered monopolar since there is a single electrode disclosed), comprising: an electrosurgical substrate comprising an electrically conductive material extending in an axial direction from a proximal end to a distal end (see 1612, see [0069]-[0070]), wherein the proximal end is configured to receive electrosurgical energy from an electrosurgical tool, wherein the electrosurgical substrate comprises an electrosurgical blade that is configured for at least one of cutting or coagulation of tissue by the electrosurgical energy received from the electrosurgical tool (see [0069]-[0070]), wherein the electrosurgical blade comprises: a first lateral surface, a second lateral surface opposite the first lateral surface, a first major surface extending between the first lateral surface and the second lateral surface on a first side of the electrosurgical blade; a second major surface extending between the first lateral surface and the second lateral surface on a second side of the electrosurgical blade that is opposite the first side (see lateral surfaces and major surfaces on each side of the electrode as shown in Figs. 16A-16D); and a first electrode sensor integrated in the blade (see sensor 1624; [0080], Fig. 16D). However, Vayser fails to further disclose the first electrode sensor being embedded between a plurality of electrical insulation layers on the first major surface of the electrosurgical blade.
Lebouitz teaches a surgical blade (see Figs. 1-5) comprising an electrode sensor disposed on a first major surface of the blade (see 40, 45, 50; Figs. 1-3) and embedded between a plurality of electrical insulation layers (see layer comprising 155 and 160, and layer 185; [0043], Fig. 11d). 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 the embedded sensor as disclosed by Vayser to be a first electrode sensor embedded between a plurality of electrical insulation layers on the first major surface of the electrosurgical blade in light of Lebouitz, the motivation being to provide the additional advantage of increased sensor density without sacrificing structural integrity for the application of surgical cutting (see Lebouitz [0011]-[0012] and [0034]).
Regarding claim 2, Vayser in view of Lebouitz further teaches wherein the first electrode sensor is a sensor selected from a group of sensors consisting of: (i) a temperature sensor, (iii) a force sensor, (iv) a mass loading sensor, (v) a dielectric sensor, (vi) a conductivity sensor, (vii) a metal detector sensor, (viii) a tracking sensor configured to sense at least one of: a location of the monopolar electrosurgical electrode and an orientation of the monopolar electrosurgical electrode, and a (ix) light sensor, and (x) a smoke detector sensor (see Vayser [0079]-[0080] and Lebouitz [0012]).
Regarding claim 3, Vayser in view of Lebouitz further teaches a second electrode sensor embedded between the plurality of electrical insulation layers on the second major surface of the electrosurgical blade (see Lebouitz: forming the sensor on both sides of the blade, [0021]).
Regarding claim 5, Lebouitz further teaches wherein the plurality of electrical insulation layers comprise: a first electrical insulation layer covering the first major surface of the electrosurgical blade (see layer comprising 155 and 160, [0043], Fig. 11d), wherein the first electrode sensor comprises a plurality of conductive traces on the first electrical insulation layer (see electrical traces 52, Fig. 2, [0036]); and a second electrical insulation layer covering the plurality of conductive traces of the first electrode sensor and the first electrical insulation layer (see layer 185).
Regarding claim 8, Lebouitz further teaches wherein the first electrode sensor comprises at least one sensing portion (see contacts 40, 45, 50; Figs. 1-3) and at least one connector portion (see electrical traces 52, Fig. 2, [0036]), wherein the at least one sensing portion is configured to sense one or more operational conditions during an electrosurgical procedure (see [0040]), and wherein the at least one connector portion is configured to transmit a sensor signal, which is indicative of the one or more operational conditions sensed by the at least one sensing portion, in a proximal direction along the electrosurgical blade (see [0040], proximal direction of traces 52 in Fig. 2).
Regarding claim 12, Lebouitz further teaches wherein the first electrode sensor comprises a depth sensor that is configured to sense a depth that the electrosurgical blade is inserted into tissue (see accelerometer and gyroscope that are configured for sensing a depth that the blade has been inserted, [0012]).
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Vayser in view of Lebouitz and in further view of Laufer et al. (US 2016/0206345).
Regarding claim 4, Vayser in view of Lebouitz teaches the limitations of claim 3 and further teaches wherein the first electrode sensor comprises a temperature sensor (see Lebouitz: [0012]), however Vayser in view of Lebouitz fails to further teach wherein the second electrode sensor comprises an electrochemical sensor.
Laufer teaches an electrosurgical blade (see Figs. 5A-5C) comprising an electrochemical sensor (see [0068]). 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 the sensor as taught by Vayser in view of Lebouitz to comprise an electrochemical sensor as the second electrode sensor in light of Laufer, the motivation being to provide the additional functionality of detecting that the blade is touching tissue through the voltage change generated (see Laufer [0068]).
Regarding claim 6, Vayser in view of Lebouitz teaches the limitations of claim 5, however Vayser in view of Lebouitz and Laufer further teaches wherein the first electrode sensor comprises an electrochemical sensor, wherein the electrochemical sensor comprises a plurality of electrodes, and wherein the plurality of electrodes comprise (i) a working electrode and (ii) at least one of a counter electrode or a reference electrode under the same rationale as that applied in the rejection of claim 4 above since detection of a voltage would require a working and counter/reference electrode to determine voltage.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Vayser in view of Lebouitz, Laufer, and in further view of Neale et al. (US 2010/0331644).
Regarding claim 7, Vayser in view of Lebouitz and Laufer teaches the limitations of claim 6, however Vayser in view of Lebouitz and Laufer fails to specifically teach wherein the second electrical insulation layer defines an aperture at the plurality of electrodes such that the plurality of electrodes are exposed.
Neale teaches an electrosurgical device (see Figs. 3B) comprising an electrochemical electrode sensor including working and reference electrodes, wherein the working electrode has a window formed in the insulation to expose the electrode (see [0148] and [0227]). 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 the second insulation layer as taught by Vayser in view of Lebouitz and Laufer such that the second electrical insulation layer defines an aperture at the plurality of electrodes such that the plurality of electrodes are exposed in light of Neale, the motivation being to expose the electrodes to the direct contact with the outside environment for an electrochemical reaction to occur thereon (see Neale [0227]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN W COLLINS whose telephone number is (408)918-7607. The examiner can normally be reached M-F 9:00 AM-5:00 PM ET.
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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