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 .
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.
Claims 1, 3-6, 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over KOBAYASHI et al. (US 2019/0336202) in view of AKAGANE et al. (US 2016/0374744).
Regarding claim 1, KOBAYASHI discloses an ultrasonic treatment tool (fig.1), comprising: a blade (fig.1; rod 5) including a treatment portion at a distal side of the blade (fig.1), the blade configured to transmit an ultrasonic vibration from a proximal side of the blade to the treatment portion and the treatment portion configured to treat a body tissue (fig.1); a grasper (grasping piece 7) movable relative to the treatment portion between an open position and a closed position to grasp the body tissue between the grasper and the treatment portion (fig.2); and pad/layer is provided on the grasper, wherein the coating is formed by a first resin [0025], and wherein, when the grasper is in the closed position [0025], the pad/layer contacts the treatment portion (fig.2); wherein the grasper includes a pad (fig.2). However, KOBAYASHI does not disclose coating provided on the grasper and the pad is formed by the coating or the coating is a layer on a surface of the pad; and includes a second resin component, and wherein the second resin component is the same as the first resin.
AKAGANE teaching a coating material and a medical device. The medical device having an end effector and a coating to cover the end effector (abstract). The coating is made of an electrically insulating resin material [0045]. The coating includes a plurality of layers (a first layer 51, a second layer 52 and a third layer 53) on a device. The layers are made of resin martials [0047]. The coating has an appropriate thickness depending on use in the range of 10 μm to 200 μm [0045]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was effectively filed to modify the device of KOBAYASHI with coating that is formed of resin as taught by AKAGANE for the purpose having proper layer of insulation.
Regarding claim 3, KOBAYASHI/AKAGANE teaches the ultrasonic treatment tool according to claim 1, wherein a thickness of the coating is greater than or equal to 10 µm and less than or equal to 300 µm ([0045] of AKAGANE).
Regarding claim 4, KOBAYASHI/AKAGANE teaches the ultrasonic treatment tool according to claim 2, wherein the grasper includes a plating layer (first layer 51) between the pad and a body portion of the grasper (fig.6; end effector 28).
Regarding claim 5, KOBAYASHI/AKAGANE teaches the ultrasonic treatment tool according to claim 4, wherein the plating layer includes a second resin component, and wherein the second resin component is the same as the first resin ([0047] of AKAGANE).
Regarding claim 6, KOBAYASHI/AKAGANE does not teach wherein the plating layer includes a eutectic alloy, and wherein a percentage of the resin component included in the plating layer is greater than or equal to 30% and less than or equal to 95% and wherein the plating layer includes Ni-PTFE. The specification does not disclose the criticality of this specific material and the range. It would have been obvious to one having ordinary skill in the art at the time and the Application was effectively filed to have the desired ratio including wherein a percentage of the resin component included in the plating layer is greater than or equal to 30% and less than or equal to 95% and wherein the plating layer includes Ni-PTFE, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 9, KOBAYASHI/AKAGANE does not teach wherein the plating layer includes Ni-PTFE. The specification does not disclose the criticality of this specific material. It would have been obvious to one having ordinary skill in the art at the time the Application was effectively filed to have any desired 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.
Regarding claim 12, KOBAYASHI/AKAGANE teaches the ultrasonic treatment tool according to claim 1, wherein, when the grasper is in the closed position, a high frequency current flows between the grasper and the treatment portion (fig.2, see also [0038] of KOBAYASHI).
Response to Arguments
Applicant's arguments filed on 10/17/2025 have been fully considered but they are not persuasive.
The Applicant has argued saying “the coating 31 of Akagane is made of an electrically insulating resin material (para. [0045] of Akagane) that is also thermally insulating (see, e.g., paras. [0058] and [0066] of Akagane), and this coating is applied to areas of the end effector 28, such as the jaw back (see, e.g., Fig. 13 of Akagane). Thus, modifying the device in Kobayashi with the coating that is formed of resin as taught by Akagane would result in a thermal/electrical insulating coating being applied to grasping piece 7 and/or treating portion 23 of Kobayashi, which would interrupt the electrical path in Kobayashi's device that is otherwise necessary for the grasping piece 7 and treating portion 23 to function as electrodes to apply the high frequency current to the treatment target as treatment energy. In other words, if the coating of Akagane were to be applied to the device in Kobayashi, then the device in Kobayashi would have an insulating layer preventing the application of treatment energy to a treatment target and Kobayashi's device would be incapable of functioning as intended.”
KOBAYASHI teaches the grasping piece 7, a pad member 55 is fixed to the electrode member 41. The pad member 55 is formed of a resin such as polytetrafluoroethylene (PTFE), and is formed of a material having electrical insulation [0025]. The only thing KOBAYASHI is missing is the teaching of having a coat layer. The examiner is only depending on Akagane to teach an electrically insulating coat being applied on a medical device. In this case, the insulating coat is modifying the electrical insulation layer of pad member 22.
KOBAYASHI already taught having a pad member 55 being fixed on an electrode member 41. For that reason, the argument is not persuasive. The combination device will not prevent application of treatment energy to a treatment target and Kobayashi's device would be capable of functioning as intended since the pad member is formed of resin which is electrical insulating material.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794