DETAILED ACTION
A complete action on the merits of pending claims 1-16 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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 102
Claims 1-4, 7, 8, 10, and 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20190167338.
Regarding claims 1, 8, and 14, Yasunaga teaches a treatment instrument (Fig. 1) configured to perform treatment on a living tissue; and a control device configured to control an operation of the treatment instrument (Fig. 1 control device 3), wherein the treatment instrument includes a sheath extending along a central axis from a distal end to a proximal end (Fig. 1 6), and an end effector that is provided at the distal end of the sheath (Fig. 1 7), the end effector being configured to grip the living tissue and apply high frequency energy to the living tissue in accordance with electrical power that is supplied from the control device to perform treatment on the living tissue (par. [0008]), the end effector includes a pair of electrodes that are opposed to each other in a direction transverse to the central axis (Figs. 9A/B, 12A/B, 13A/B and 14A/B shows many electrode configurations where the electrical conductivity of each area is different because of the resistance of the pattern and they can stretch different distances in each region, additionally due to the breath of the claim the electrode pairs can be on the same or different jaws and on the left or right as long as it’s across the center axis) and are configured to apply the high frequency energy to the living tissue, the pair of electrodes are configured to apply, to the living tissue, high frequency energy that is higher on a distal end side along the central axis than high frequency energy applied by the pair of electrodes on a proximal end side along the central axis (par. [0009] high temperatures at higher resistance pattern, par. [0204] high frequency applicators can take over the resistance pattern regions), and a first one of the pair of electrodes includes a distal end portion that is located in the distal end side and a proximal end portion that is located on the proximal end side (Figs. 9A/B, 12A/B, 13A/B and 14A/B).
Regarding claims 2 and 13, Yasunaga teaches wherein the distal end portion is formed of a material having an electric conductivity that is higher than an electric conductivity of the proximal end portion (par. [0179] and Fig. 13B).
Regarding claims 3 and 12, Yasunaga teaches wherein the coating layer is formed of one of a fluorine coat, a fluorine coat including electric conductive fillers, a polyether ether ketone (PEEK) coat, and a polyimide (PI) coat (par. [0068]).
Regarding claim 4, Yasunaga teaches wherein, in a state in which the living tissue is gripped by the end effector, a separation distance between the pair of electrodes in the other area is larger than a separation distance between the pair of electrodes in the distal end area (Figs. 9A/B, 12A/B, 13A/B and 14A/B shows many electrode configurations where the electrical conductivity of each area is different).
Regarding claim 7, Yasunaga teaches wherein the end effector is provided with a cutter configured to make an incision in the living tissue gripped by the end effector (par. [0031] the device separates tissue).
Regarding claims 10 and 15, Yasunaga teaches wherein the control device is configured to cause the high frequency energy that is applied to the living tissue to be further increased in a specific period of time after the treatment on the living tissue is started relative to another period of time (par. [0134] and Fig. 11).
Claim Rejections - 35 USC § 103
Claims 5, 6, 9, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Yasunaga in view of Shelton US 20170202595.
Regarding claims 5, 6, 9, and 16, Yasunaga does not explicitly teach wherein the first one of the pair of electrodes further protrudes toward a distal end relative to the second one of the pair of electrodes in a state in which the pair of electrodes grip the living tissue and wherein the end effector is configured to supply, to a second one of the pair of electrodes included in the end effector, vibration due to ultrasound energy, and the applying includes simultaneously applying the ultrasound energy and the high frequency energy to the living tissue gripped by the end effector, and increasing the high frequency energy that is applied to the living tissue gripped by the distal end portion in a specific period of time after the ultrasound energy and the high frequency energy have started to be applied, to perform the treatment on the living tissue.
However, Yasunaga teaches increasing the energy to the electrodes (par. [0134] and Fig. 11) and the device can use ultrasonic treatment (par. [0204]).
Shelton, in an analogous device, teaches where the electrode surface protrudes down to the blade (Fig. 38). Shelton also teaches an ultrasonic output can occur with high-frequency output (par. [0254]). The RF energy is able to be increased during the surgical procedure (par. [0397]).
It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to modify the control of the device of Yasunaga to have a period where the RF is increased, as in Shelton. The increase in RF energy allows for an improved level of precision and control of the treatment (par. [0397]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Yasunaga in view of Takashino US 20170042602.
Regarding claim 11, Yasunaga does not explicitly teach wherein the distal end portion is formed of aluminum, and the proximal end portion is formed of stainless steel.
However, Yasunaga teaches that the distal or proximal end can have a higher conductivity (par. [0179]).
Takashino teaches where the different portions of the electrode have different conductivities (par. [0006]). The materials used can be stainless steel and aluminum (claim 3).
It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to use stainless steel and aluminum for different conductivity, since it has been held to be within the general skill of one of ordinary skill 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. The predictable result would be different jaw regions of different conductivities.
Response to Arguments
Applicant's arguments filed 9/15/25 have been fully considered but they are not persuasive. The applicant argues that Yasunaga does not teach applying high frequency energy. The examiner disagrees with this assertion. Pars. [0204] states that the regions of resistance pattern can be changed out for high frequency electrodes. Par. [0009] states that the higher resistance areas create higher temperatures. Figs. 9A/B, 12A/B, 13A/B and 14A/B shows that the higher and lower resistance areas can be on the proximal or distal side of the jaws. The patterns are on both the left and right of the middle channel. Thus, the high frequency applicators would have different outputs in the proximal and distal areas and the right and left sides would make pairs. Therefore, the arguments presented by the applicant are not persuasive.
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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/R.T.C./Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794