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 .
Claim Objections
Claim 69 is objected to because of the following informalities: “electrode in on” should read “electrode is on” at line 1. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 65-68, 75-77, 81, 82, 84 and 86 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schomacker et al (2015/0201993).
Regarding claim 65, Schomacker et al provide an electrode apparatus configured to limit arcing comprising a first electrically insulative support (18), a first electrode (22) supported by the support and having a first electrode surface (Figure 7A) and a second electrode (26) supported by the support and having a second electrode surface. The first and second electrodes are inherently capable of delivering electrical pulses having an amplitude of at least 0.1kV. It is noted there is no claimed energy source providing the pulses, and any electrode may be capable of providing the pulses recited in the intended use limitation. There is a first mitigating layer (30, 38) provided between the first and second electrodes, the mitigating layer being a semi-conductive material having a conductivity less that the conductivity of the electrode surfaces (para. [0006], for example).
Regarding claim 66, see again paragraphs [0006] and [0055]. Regarding claim 67, see Figure 7A. Regarding claim 68, see paragraph [0050] which discloses the electrodes contacting (i.e. not penetrating) a skin surface. Regarding claim 75, the electrodes are separated by a fixed distance (Figure 7A). Regarding claims 76 and 77, see paragraph [0056], for example. Regarding claim 81, see Figure 7Bwhich shows the electrodes having an oval shape. Regarding claim 82, see paragraph [0048]. Regarding claim 84, see discussion of claim 66 above. Regarding claim 86, again, the electrodes are inherently configured to pass pulses of any duration, and there is no positive recitation of an energy source providing pulses in the intended use limitation.
Claims 65, 67-70, 72, 75-83 and 86-90 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Truckai et al (2003/0216732).
Regarding claim 1, Truckai at al provide an electrode apparatus to limit arcing (para. [0108], for example) comprising a first electrically insulative support (i.e. jaws 112A and 112B which have electrodes embedded therein, and which are providing with an insulating coating 159) and a first electrode (220 – Figure 13A) supported by the electrically insulated support. A second electrode (225) is also supported by the insulative support (Figure 13A) having an exposed surface. The electrodes are inherently configured to pass pulses of 0.1kV. As addressed previously, there is no positive recitation of an energy source, and any electrode is capable of passing any amount of energy. The device further comprises an arc mitigating layer (155) between the electrodes to reduce or eliminate arcing, the arc mitigating layer formed of a semi-conductive material comprising a silicone doped with carbon particles (para. [0099]), for example). It is noted, the semi-conductive layer (155) is made from the same material as applicant’s arc mitigating layer.
Regarding claim 67, the arc mitigating layer is secured to and partially covering the electrodes (see Figures). Regarding claim 68, the electrodes are plate electrodes for compressing tissue and do not penetrate tissue (see Figures). Regarding claims 69 and 70, the electrodes are provided at various locations on one or both jaws (see Figures 3B, 5, 10, and 12-24, for example). Regarding claim 72, see again Figures 3B, 5, 10 and 12-24 which show various different arrangements for the electrodes including multiple electrodes on one or both jaws. Regarding claim 75, the electrodes are separated by a fixed distance as seen in the Figures. Regarding claims 76 and 77, see paragraph [0099] which discloses the polymeric material made from silicone doped with carbon. Regarding claim 78, see, for example, Figure 5 which shows a first electrode (185) and a second electrode (165) with a mitigating layer (155A) between the first and second electrodes and separated from the first electrode in an unactuated state. Regarding claim 79, the arc mitigating layer (155) is compressible when the jaws are closed (para. [0132] and Figures 17, 19, 21, and 24 for example). Regarding claim 80, the jaws may be opened more than 0.5mm as evident from the figures and by virtue of the size of the tissue being grasped. Regarding claims 81 and 82, the electrodes may comprise rounded edges (Figure 3A, for example) and are greater than 5mm in length (para. [0089], for example). Regarding claim 83, the mitigating layer may be a flexible membrane (para. [0131], for example). Regarding claim 86, again, the electrodes may pass pulses of any nominal duration and there is no positive recitation of an energy source providing the intended use pulse durations. Regarding claim 87, each jaw may reasonably be considered a “paddle region” and Truckai et al have numerous embodiments with multiple electrodes on a jaw (i.e. paddle region). Regarding claim 88, there is an articulating region (144 - Figure 3A) connecting the elongate body (106) to the paddle region (i.e. jaws 112A and 112B) with the jaws articulating in a plane extending through the elongate body (i.e. open and close). Regarding claim 89, the paddle region (i.e. jaws 112A and 112B) are configured to expand in width (i.e. open) to increase spacing between the first and second electrodes, which may be located on the first and second jaws, respectively.
Regarding claim 90, Truckai et al provide an electrode apparatus configured to limit arcing as addressed previously, the device comprising first and second jaws (112A, 112B – Figure 3A) configured to open and close to secure tissue. There are first and second electrodes on the jaws (in various arrangements in the various embodiments as addressed previously). The electrodes are inherently configured to pass electrical pulses of 0.1kV as addressed previously. The apparatus provides multiple arc mitigating layers (155) as seen in the various embodiments that are configured to mitigate arcing. The mitigating layers are made from a semiconductive material that is the same as applicant’s claimed material (para. [0099]) with the conductivity being less than that of the electrodes.
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.
Claims 66 and 84 are rejected under 35 U.S.C. 103 as being unpatentable over Truckai et al (2003/0216732) in view of the teaching of Schomacker et al (2015/0201993).
Truckai et al disclose a similar material for the arc mitigating layer, but fail to disclose the specific conductivity for the layer. Schomacker et al, as addressed previously, provide a similar layer and specifically teach the semi-conductive region has a conductivity that is within the applicant’s claimed range. To have provided the Truckai et al layer with a conductivity within applicant’s claimed range would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Schomacker et al fairly teach it is known to provide a similar semi-conductive layer with that level of conductivity.
Claims 73 and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Truckai et al (2003/0216732) in view of the teaching of Hofmann (5,439,440).
Truckai et al fail to disclose the jaws open and close to maintain the electrodes in a parallel relationship. The examiner maintains that the various mechanisms and linkages to open and close forceps jaws are generally well-known in the art. Hofmann teach that it is known to provide an electrosurgical forceps with jaws that remain parallel during opening and closing to maintain a constant pressure during actuation. To have provided the Truckai et al forceps device with a means to open and close the jaws such that the jaws remain parallel would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Hofmann fairly teach it is known to provide such an actuation for forceps jaws. Regarding claim 74, the jaws move axially relative to each other during actuation.
Claim 85 is rejected under 35 U.S.C. 103 as being unpatentable over Truckai et al (2003/0216732) in view of the teaching of Roy (8,469,957).
Truckai et al fail to disclose suction ports on the jaw members to remove debris and draw tissue to the jaw members.
Roy discloses another electrosurgical forceps device and specifically teach that it is known to provide a plurality suction ports (Abstract and Figure 3A at 130) to remove debris and draw tissue to the jaw members. To have provided the Truckai et al device with suction apertures would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Roy fairly teaches it is known to provide such a suction means on an electrosurgical forceps device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Del Cid et al (2021/0145507), Eilers, Jr. (2020/0368401) and Keppel (7,033,354) disclose various other electrosurgical forceps that provide an “arc mitigating layer” over the electrodes. Weissberg et al (9,956,391) disclose another device having multiple electrodes with an arc mitigating layer provided on the electrodes.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/March 17, 2026