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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/10/2026 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 1/16/2026 and 2/10/2026.
Response to Arguments
Applicant’s arguments with respect to claims 1, 10, and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Previously, claims 1, 10, and 20 were rejected under 35 U.S.C. 103 as being unpatentable over Takashino, the embodiment depicted in Figures 5A-B, in view of Takashino 2 and Henderson. Now, based on amendments to the claim language, claims 1, 10, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Takashino, the embodiment depicted in Figure 12, in view of Takashino 2 and Henderson.
Claim Rejections - 35 USC § 103
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.
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.
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, 10-13, 20, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Takashino et al., US 20170245923, herein referred to as “Takashino”, in view of Takashino et al., US 20170014175, herein in referred to as "Takashino 2", further in view of Henderson et al., US 20200100839, herein referred to as "Henderson".
Regarding claim 1, Takashino discloses an electrosurgical system (Figure 1), comprising: an electrosurgical device (Figure 2A: treatment instrument 12 and [0006]) including: first (Figure 2A: first treatment piece 102) and second jaw members (Figure 2A: second treatment piece 104) each defining a tissue treating surface (Figure 12: electrode portions 134 and second holding surface 172), the first and second jaw members pivotably coupled to one another such that at least one of the first or second jaw members is movable relative to the other ([0042]: “As shown in FIGS. 2A and 2B, the treatment portion 26 includes a first treatment piece 102, a second treatment piece 104, and an opening-and-closing shaft 106 which opens and closes the first and second treatment pieces 102 and 104 relatively.”) from a spaced-apart position (Figure 2A) to an approximated position (Figure 2B) to grasp tissue between the tissue treating surfaces ([0006]); and a thermal cutting element (Figure 12: blade 136 and projected surface 136a and [0053]: “The projected surface 136a incises living tissue held between the first and second holding surfaces 132 and 172, by applying pressure and heat transferred from the heating element to the living tissue.”) coupled to the first jaw member and configured to cut tissue in contact with the thermal cutting element (Figure 12: blade 136 is coupled to first treatment piece 102 and [0053]: “The projected surface 136a incises living tissue held between the first and second holding surfaces 132 and 172, by applying pressure and heat transferred from the heating element to the living tissue.”), the thermal cutting element separate from and protruding beyond the tissue treating surface of the first jaw member toward the second jaw member (Figure 12: blade 136 and projected surface 136a is separate from and protrudes from electrodes 134 towards second treatment piece 104; blade 136 is separated from electrodes 134 by main body 122); and an electrosurgical generator (Figure 1: high frequency energy source 184) configured to deliver power to the tissue treating surfaces for sealing tissue grasped between the tissue treating surfaces and to the thermal cutting element for cutting tissue ([0074] and Figure 7), when the jaw members are in the approximated position, the electrosurgical generator is configured to deliver power to the thermal cutting element to maintain the temperature of the thermal cutting element at an operating temperature for cutting sealed tissue grasped between the tissue treating surfaces ([0091]: “Accordingly, if the footswitch 16 is stepped on while the treatment portion 26 of the treatment instrument 12 is holding living tissue, a series of operations of sealing (coagulating) of the living tissue to be treated and incising the sealed portion is realized by one action.” And Figure 6) and when the jaw members are in the spaced-apart position ([0074]: energy output occurs whether the jaw members are spaced apart or they are closed; either way, the energy output is based on the settings in setting portion 188), the electrosurgical generator is configured to: deliver power to the thermal cutting element to warm the thermal cutting element to a standby setpoint temperature (Figure 6: T0); cause power to be delivered to the thermal cutting element to maintain the temperature of the thermal cutting element at the standby setpoint temperature (Figure 6: t11 to t12); deliver power to the thermal cutting element to increase the temperature of the thermal cutting element from the standby setpoint temperature to a cutting setpoint temperature (Figure 6: T2); and deliver power to the thermal cutting element to maintain the temperature of the thermal cutting element at the cutting setpoint temperature to dissect tissue in contact with the thermal cutting element (Figure 6: t21 to t22). Takashino does not explicitly disclose an electrosurgical system comprising an electrosurgical device including an electrosurgical generator configured to deliver power directly to the thermal cutting element via at least one conductive trace disposed within the thermal cutting element for heating the thermal cutting element via resistive heating and cutting tissue in contact with the thermal cutting element, the at least one conductive trace electrically coupling the thermal cutting element to the electrosurgical generator and to terminate delivery of power to the tissue treating surfaces and deliver power to the thermal cutting element without delivery of power to the tissue treating surfaces or an electrosurgical device wherein power is delivered to the thermal cutting element to increase the temperature of the thermal cutting element from the standby setpoint temperature to a cutting setpoint temperature in response to a determination of contact between tissue and the thermal cutting element.
However, Takashino 2 teaches an electrosurgical system (Figure 1) comprising an electrosurgical device (Figure 1: grasping treatment instrument 2) including an electrosurgical generator (Figure 1: energy source unit 10) configured to deliver power directly ([0030] and [0048]) to the thermal cutting element (Figure 4: blade 43 and heating insulating member 42 disclose the thermal cutting element; and electric power supply lines 58A and 58B deliver power) via at least one conductive trace (Figure 4: heating wire 50) disposed within the thermal cutting element (Figure 4: heating wire 50 is within blade 43) for heating the thermal cutting element via resistive heating ([0048]: “When the electric current flows through the heating wire 50, heat is generated due to thermal resistance of the heating wire 50.”) and cutting tissue in contact with the thermal cutting element ([0057]), the at least one conductive trace electrically coupling the thermal cutting element to the electrosurgical generator ([0048] and Figure 4: electric power supply lines 58A and 58B) and to terminate delivery of power to the tissue treating surfaces and deliver power to the thermal cutting element without delivery of power to the tissue treating surfaces ([0055]-[0056]: in paragraph [0056], energy is delivered to both the tissue treating surfaces and thermal cutting element and in paragraph [0055], energy is only delivered to the thermal cutting element).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrosurgical system of Takashino so that so that the generator delivers power directly to the thermal cutting element via at least one conductive trace disposed within the thermal cutting element and so that it prevents delivery of power to the tissue treating surfaces as taught by Takashino 2 so that the temperature of the distal portion can be easily adjusted to a desired temperature suited to the treatment (Takashino 2 [0061]).
Further, Henderson teaches an electrosurgical system (Figure 142) comprising an electrosurgical device (Figure 142: ultrasonic instrument 17602) configured to deliver power to the thermal cutting element (Figure 142: ultrasonic blade 17630) to increase the temperature of the thermal cutting element from the standby setpoint temperature to a cutting setpoint temperature in response to a determination of contact between tissue and the thermal cutting element ([1039]: “When a conductive medium such as tissue 17635 contacts both the conductive pad 17710 and the electrically conductive ultrasonic blade 17630, the capacitive touch sensor 17620 detects the presence of the tissue 17635 and provides a signal to the control circuit 17615 to indicate the presence of tissue 17635. The control circuit 17615 may then determine to activate the generator 17605 to supply electrical energy to an ultrasonic transducer 17604 to activate the ultrasonic blade 17630 of the end effector to apply therapeutic energy to the tissue 17635 clamped between the ultrasonic blade 17630 and the jaw 17625 of the end effector. The ultrasonic blade 17630 delivers the therapeutic ultrasonic energy after the capacitive touch sensor 17620 is appropriately triggered by the presence of tissue 17635.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrosurgical system of Takashino so that the temperature of the thermal cutting element is increased in response to a determination of contact between tissue and the thermal cutting element as taught by Henderson so that the timing of activating the instrument may correspond precisely to when it is needed (Henderson [1037]), which increases the effectiveness of the device.
Regarding claim 2, Takashino in view of Takashino 2 and Henderson discloses the electrosurgical system according to claim 1, and Takashino further discloses an electrosurgical system wherein the cutting setpoint temperature is between about 350° C and about 550° C ([0067]: “When energy is supplied to the heating element 126 from the heat energy source 186, the temperature T2 of the heating element 126 is set by the setting portion 188 to be within a range from 220° C. to 400° C.”).
Regarding claim 3, Takashino in view of Takashino 2 and Henderson discloses the electrosurgical system according to claim 1, and Takashino further discloses an electrosurgical system wherein the standby setpoint temperature is between about 20° C and about 60° C ([0064]: “A temperature T0 (<T2) immediately before allowing the heating element 126 to generate heat may be room temperature or a temperature which is increased from room temperature to a degree not affecting living tissue (for example, 60° C. or lower), based on a monitor output.”).
Regarding claim 10, Takashino discloses an electrosurgical system (Figure 1: treatment system 10), comprising: an electrosurgical device (Figure 2A: treatment instrument 12 and [0006]) including first (Figure 2A: first treatment piece 102) and second jaw members (Figure 2A: second treatment piece 104) each defining a tissue treating surface (Figure 12: electrode 134 and second holding surface 172), the first and second jaw members pivotably coupled to one another such that at least one of the first or second jaw members is movable relative to the other ([0042]: “As shown in FIGS. 2A and 2B, the treatment portion 26 includes a first treatment piece 102, a second treatment piece 104, and an opening-and-closing shaft 106 which opens and closes the first and second treatment pieces 102 and 104 relatively.”) from a spaced-apart position (Figure 2A) to an approximated position (Figure 2B) to grasp tissue between the tissue treating surfaces ([0006]); the first jaw member (Figure 12A: first treatment piece 102) including a thermal cutting element (Figure 12A: blade 136 and projected surface 136a and [0053]: “The projected surface 136a incises living tissue held between the first and second holding surfaces 132 and 172, by applying pressure and heat transferred from the heating element to the living tissue.”) configured to cut tissue in contact with the thermal cutting element ([0053]: “The projected surface 136a incises living tissue held between the first and second holding surfaces 132 and 172, by applying pressure and heat transferred from the heating element to the living tissue.”), the thermal cutting element protruding beyond the tissue treating surface of the first jaw member toward the second jaw member (Figure 12: blade 136 and projected surface 136a is separate from and protrudes from electrodes 134 towards second treatment piece 104; blade 136 is separated from electrodes 134 by main body 122); and an electrosurgical generator (Figure 1: high frequency energy source 184) electrically coupled to the first and second jaw members (Figure 1: high frequency energy source 184 is electrically coupled to first and second treatment pieces 102 and 104) and configured to: deliver power to the tissue treating surfaces to seal tissue grasped between the tissue treating surfaces when the jaw members are in the approximated position ([0075]: “As shown in FIG. 6, if a signal is input from the footswitch 16, the controller 182 controls the high frequency energy source 184 to output high frequency energy to the living tissue through the first and second electrodes 134 and 174 with a constant power P1 from t11 seconds after the receipt of the signal (Step S2 in FIG. 7)… The temperature T1 is a temperature sufficient at least to denature protein (structural change of secondary, tertiary combination of protein), to dehydrate tissue, and to seal the tissue.”); deliver power to the thermal cutting element ([0077]: “The blade 136 also functions as part of the electrode portion 134.”) to maintain a temperature of the thermal cutting element at an operating temperature (Figure 6: T2) for cutting sealed tissue in contact with the thermal cutting element and grasped between the tissue treating surfaces when the jaw members are in the approximated position ([0084]: “The temperature T2 is a temperature sufficient for advanced denaturation of protein (structural change in a linear combination of protein). Accordingly, the projected surface 136a of the blade 136 applies pressure to the living tissue held between the first and second holding surfaces 132 and 172, and incises the living tissue.”); deliver power to the thermal cutting element when the jaw members are in the spaced apart position ([0074]: energy output occurs whether the jaw members are spaced apart or they are closed; either way, the energy output is based on the settings in setting portion 188) to warm the thermal cutting element to a standby setpoint temperature (Figure 6: T0); control delivery of power to the thermal cutting element to maintain the temperature of the thermal cutting element at the standby setpoint temperature when the jaw members are in the spaced apart position (Figure 6: t11 to t12); control delivery of power to the thermal cutting element to increase the temperature of the thermal cutting element from the standby setpoint temperature to a cutting setpoint temperature (Figure 6: T2) for dissecting tissue when the jaw members are in the spaced apart position ([0084]: “The temperature T2 is a temperature sufficient for advanced denaturation of protein (structural change in a linear combination of protein). Accordingly, the projected surface 136a of the blade 136 applies pressure to the living tissue held between the first and second holding surfaces 132 and 172, and incises the living tissue.”); control delivery of power to the thermal cutting element to maintain the temperature of the thermal cutting element at the cutting setpoint temperature to dissect tissue in contact with the thermal cutting element when the jaw members are in the spaced apart position (Figure 6: t21 to t22); and terminate delivery of power to the thermal cutting element to decrease the temperature of the thermal cutting element (Figure 6: energy is not delivered after t12, which is equivalent to t21-, so after t-22, the temperature of the cutting element decreases). Takashino does not explicitly disclose an electrosurgical system comprising an electrosurgical generator configured to deliver power to at least one conductive trace disposed within the thermal cutting element to heat the thermal cutting element via resistive heating, the at least one conductive trace electrically coupling the thermal cutting element to the electrosurgical generator; configured to terminate delivery of power to the tissue treating surfaces when the jaw members are in a spaced apart position and control delivery of power to the thermal cutting element to maintain the temperature of the thermal cutting element at the cutting setpoint temperature to dissect tissue in contact with the thermal cutting element while delivery of power to the tissue treating surfaces is terminated when the jaw members are in the spaced apart position or a system wherein power is delivered to the thermal cutting element to increase the temperature of the thermal cutting element from the standby setpoint temperature to a cutting setpoint temperature for dissecting tissue in response to a determination of contact between tissue and the thermal cutting element.
However, Takashino 2 teaches an electrosurgical system (Figure 1) comprising an electrosurgical generator (Figure 1: energy source unit 10) configured to deliver power ([0030] and [0048]) to at least one conductive trace (Figure 4: heating wire 50) disposed within the thermal cutting element to heat the thermal cutting element (Figure 4: blade 43 and heating insulating member 42 disclose the thermal cutting element; and electric power supply lines 58A and 58B deliver power) via resistive heating ([0048]: “When the electric current flows through the heating wire 50, heat is generated due to thermal resistance of the heating wire 50.”), the at least one conductive trace electrically coupling the thermal cutting element to the electrosurgical generator ([0048] and Figure 4: electric power supply lines 58A and 58B); configured to terminate delivery of power to the tissue treating surfaces when the jaw members are in a spaced apart position ([0054]: “The movable handle 8 is then moved to close relative to the fixed handle 7, and an open-or-close operation of the grasping treatment unit 20 is input. As a result, the space between the first jaw 21 and the second jaw 22 is closed, and the treated target is grasped between the first jaw 21 and the second jaw 22. In a state where the treated target is grasped, an energy operation is input in the energy operation input portion 16. Accordingly, under the control of the control section 15, electric power (heat electric energy) is output from the heat energy source 12, and high-frequency electric power (high-frequency electric energy) is output from the high-frequency energy source 13.”) and control delivery of power to the thermal cutting element to maintain the temperature of the thermal cutting element at the cutting setpoint temperature to dissect tissue in contact with the thermal cutting element while delivery of power to the tissue treating surfaces is terminated when the jaw members are in the spaced apart position ([0054]-[0056]: in paragraph [0056], energy is delivered to both the tissue treating surfaces and thermal cutting element and in paragraph [0055], energy is only delivered to the thermal cutting element; thus the system is capable of delivering power only to the thermal cutting element while the jaws are spaced apart).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrosurgical system of Takashino so that so that the generator delivers power directly to the thermal cutting element via at least one conductive trace disposed within the thermal cutting element and so that it prevents delivery of power to the tissue treating surfaces as taught by Takashino 2 so that the temperature of the distal portion can be easily adjusted to a desired temperature suited to the treatment (Takashino 2 [0061]).
Further, Henderson teaches an electrosurgical system (Figure 142) wherein power is delivered to the thermal cutting element (Figure 142: ultrasonic blade 17630) to increase the temperature of the thermal cutting element from the standby setpoint temperature to a cutting setpoint temperature for dissecting tissue (Figure 142: ultrasonic blade 17630 and [0276]: “One energy type may be more beneficial for cutting the tissue, while another different energy type may be more beneficial for sealing the tissue.”) in response to a determination of contact between tissue and the thermal cutting element ([1039]: “When a conductive medium such as tissue 17635 contacts both the conductive pad 17710 and the electrically conductive ultrasonic blade 17630, the capacitive touch sensor 17620 detects the presence of the tissue 17635 and provides a signal to the control circuit 17615 to indicate the presence of tissue 17635. The control circuit 17615 may then determine to activate the generator 17605 to supply electrical energy to an ultrasonic transducer 17604 to activate the ultrasonic blade 17630 of the end effector to apply therapeutic energy to the tissue 17635 clamped between the ultrasonic blade 17630 and the jaw 17625 of the end effector. The ultrasonic blade 17630 delivers the therapeutic ultrasonic energy after the capacitive touch sensor 17620 is appropriately triggered by the presence of tissue 17635.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrosurgical system of Takashino so that the temperature of the thermal cutting element is increased in response to a determination of contact between tissue and the thermal cutting element as taught by Henderson so that the timing of activating the instrument may correspond precisely to when it is needed (Henderson [1037]), which increases the effectiveness of the device.
Regarding claim 11, Takashino in view of Takashino 2 and Henderson discloses the electrosurgical system according to claim 10, and Takashino further discloses an electrosurgical system wherein the operating temperature of the thermal cutting element for cutting sealed tissue grasped between the tissue treating surfaces is between about 350° C and about 550° C ([0067]: “When energy is supplied to the heating element 126 from the heat energy source 186, the temperature T2 of the heating element 126 is set by the setting portion 188 to be within a range from 220° C. to 400° C.”).
Regarding claim 12, Takashino in view of Takashino 2 and Henderson discloses the electrosurgical system according to claim 10, and Takashino further discloses an electrosurgical system wherein the cutting setpoint temperature of the thermal cutting element for dissecting tissue when the jaw members are in the spaced apart position ([0074]: energy output occurs whether the jaw members are spaced apart or they are closed; either way, the energy output is based on the settings in setting portion 188) is between about 350° C and about 550° C ([0067]: “When energy is supplied to the heating element 126 from the heat energy source 186, the temperature T2 of the heating element 126 is set by the setting portion 188 to be within a range from 220° C. to 400° C.”).
Regarding claim 13, Takashino in view of Takashino 2 and Henderson discloses the electrosurgical system according to claim 10, and Takashino further discloses an electrosurgical system wherein the standby setpoint temperature of the thermal cutting element when the jaw members are in the spaced apart position ([0074]: energy output occurs whether the jaw members are spaced apart or they are closed; either way, the energy output is based on the settings in setting portion 188) is between about 20° C and about 60° C ([0064]: “A temperature T0 (<T2) immediately before allowing the heating element 126 to generate heat may be room temperature or a temperature which is increased from room temperature to a degree not affecting living tissue (for example, 60° C. or lower), based on a monitor output.”).
Regarding claim 20, Takashino discloses an electrosurgical system (Figure 1: treatment system 10), comprising: an electrosurgical device (Figure 2A: treatment instrument 12 and [0006]) including first (Figure 2A: first treatment piece 102) and second jaw members (Figure 2A: second treatment piece 104) each defining a tissue treating surface (Figure 12: electrode 134 and second holding surface 172), the first and second jaw members pivotably coupled to one another such that at least one of the first or second jaw members is movable relative to the other ([0042]: “As shown in FIGS. 2A and 2B, the treatment portion 26 includes a first treatment piece 102, a second treatment piece 104, and an opening-and-closing shaft 106 which opens and closes the first and second treatment pieces 102 and 104 relatively.”) from a spaced-apart position (Figure 2A) to an approximated position (Figure 2B) to grasp tissue between the tissue treating surfaces ([0006]); the first jaw member (Figure 2A: first treatment piece 102) including a thermal cutting element (Figure 12: blade 136 and projected surface 136a and [0053]: “The projected surface 136a incises living tissue held between the first and second holding surfaces 132 and 172, by applying pressure and heat transferred from the heating element to the living tissue.”) configured to cut tissue in contact with the thermal cutting element ([0053]: “The projected surface 136a incises living tissue held between the first and second holding surfaces 132 and 172, by applying pressure and heat transferred from the heating element to the living tissue.”), the thermal cutting element protruding beyond the tissue treating surface of the first jaw member toward the second jaw member (Figure 12: blade 136 and projected surface 136a is separate from and protrudes from electrodes 134 towards second treatment piece 104; blade 136 is separated from electrodes 134 by main body 122); and an electrosurgical generator (Figure 1: high frequency energy source 184) electrically coupled to the first and second jaw members (Figure 1: high frequency energy source 184 is electrically coupled to first and second treatment pieces 102 and 104) and configured to: deliver power to the tissue treating surfaces to seal tissue grasped between the tissue treating surfaces when the jaw members are in the approximated position ([0075]: “As shown in FIG. 6, if a signal is input from the footswitch 16, the controller 182 controls the high frequency energy source 184 to output high frequency energy to the living tissue through the first and second electrodes 134 and 174 with a constant power P1 from t11 seconds after the receipt of the signal (Step S2 in FIG. 7)… The temperature T1 is a temperature sufficient at least to denature protein (structural change of secondary, tertiary combination of protein), to dehydrate tissue, and to seal the tissue.”); deliver power to the thermal cutting element ([0077]: “The blade 136 also functions as part of the electrode portion 134.”) to one of cut sealed tissue in contact with the thermal cutting element and grasped between the tissue treating surfaces when the jaw members are in the approximated position or dissect tissue determined to be in contact with the thermal cutting element when the jaw members are in the spaced apart position ([0084]: “The temperature T2 is a temperature sufficient for advanced denaturation of protein (structural change in a linear combination of protein). Accordingly, the projected surface 136a of the blade 136 applies pressure to the living tissue held between the first and second holding surfaces 132 and 172, and incises the living tissue.”); terminate delivery of power to the thermal cutting element upon detection of completion of the cutting of the sealed tissue when the jaw members are in the approximated position (Figure 6: energy is not delivered after t12, which is equivalent to t21-, so after t-22, the temperature of the cutting element decreases); operate in a low-temperature standby mode (Figure 6: T0) to deliver power to the thermal cutting element to maintain the temperature of the thermal cutting element at a standby setpoint temperature between about 20° C and about 60° C ([0064]: “A temperature T0 (<T2) immediately before allowing the heating element 126 to generate heat may be room temperature or a temperature which is increased from room temperature to a degree not affecting living tissue (for example, 60° C. or lower), based on a monitor output.”) when the jaw members are in the spaced apart position ([0074]: energy output occurs whether the jaw members are spaced apart or they are closed; either way, the energy output is based on the settings in setting portion 188); operate in a high-temperature cut mode (Figure 6: T2) to deliver power to the thermal cutting element ([0084]: “The temperature T2 is a temperature sufficient for advanced denaturation of protein (structural change in a linear combination of protein). Accordingly, the projected surface 136a of the blade 136 applies pressure to the living tissue held between the first and second holding surfaces 132 and 172, and incises the living tissue.”) when the jaw members are in the spaced apart position ([0074]: energy output occurs whether the jaw members are spaced apart or they are closed; either way, the energy output is based on the settings in setting portion 188) to increase the temperature of the thermal cutting element from the standby setpoint temperature to a cutting setpoint temperature between about 350° C and about 550° C for dissecting tissue ([0067]: “When energy is supplied to the heating element 126 from the heat energy source 186, the temperature T2 of the heating element 126 is set by the setting portion 188 to be within a range from 220° C. to 400° C.”); control delivery of power to the thermal cutting element during operation in the high-temperature cut mode to maintain the temperature of the thermal cutting element at the cutting setpoint temperature for dissecting tissue in contact with the thermal cutting element (Figure 6: T2 is maintained between t21 and t22); and terminate delivery of power to the thermal cutting element to decrease the temperature of the thermal cutting element (Figure 6: energy is not delivered after t12, which is equivalent to t21-, so after t-22, the temperature of the cutting element decreases).Takashino does not explicitly disclose an electrosurgical system comprising an electrosurgical generator configured to deliver power to the thermal cutting element via at least one conductive trace disposed within the thermal cutting element to heat the thermal cutting element via resistive heating, the at least one conductive trace electrically coupling the thermal cutting element to the electrosurgical generator; configured to terminate delivery of power to the tissue treating surfaces when the jaw members are in a spaced apart position and control delivery of power to the thermal cutting element during operation in the high-temperature cut mode to maintain the temperature of the thermal cutting element at the cutting setpoint temperature for dissecting tissue in contact with the thermal cutting element while delivery of power to the tissue treating surfaces is terminated or a system that operates in a mode to deliver power to the thermal cutting element in response to sensed contact between tissue and the thermal cutting element to increase the temperature of the thermal cutting element from the standby setpoint temperature to a cutting setpoint temperature for dissecting tissue.
However, Takashino 2 teaches an electrosurgical system (Figure 1) comprising an electrosurgical generator (Figure 1: energy source unit 10) configured to deliver power ([0030] and [0048]) to the thermal cutting element (Figure 4: blade 43 and heating insulating member 42 disclose the thermal cutting element; and electric power supply lines 58A and 58B deliver power) via at least one conductive trace (Figure 4: heating wire 50) disposed within the thermal cutting element (Figure 4) to heat the thermal cutting element via resistive heating ([0048]: “When the electric current flows through the heating wire 50, heat is generated due to thermal resistance of the heating wire 50.”), the at least one conductive trace electrically coupling the thermal cutting element to the electrosurgical generator ([0048] and Figure 4: electric power supply lines 58A and 58B); configured to terminate delivery of power to the tissue treating surfaces when the jaw members are in a spaced apart position ([0054]: “The movable handle 8 is then moved to close relative to the fixed handle 7, and an open-or-close operation of the grasping treatment unit 20 is input. As a result, the space between the first jaw 21 and the second jaw 22 is closed, and the treated target is grasped between the first jaw 21 and the second jaw 22. In a state where the treated target is grasped, an energy operation is input in the energy operation input portion 16. Accordingly, under the control of the control section 15, electric power (heat electric energy) is output from the heat energy source 12, and high-frequency electric power (high-frequency electric energy) is output from the high-frequency energy source 13.”) and control delivery of power to the thermal cutting element during operation in the high-temperature cut mode to maintain the temperature of the thermal cutting element at the cutting setpoint temperature for dissecting tissue in contact with the thermal cutting element while delivery of power to the tissue treating surfaces is terminated ([0054]-[0056]: in paragraph [0056], energy is delivered to both the tissue treating surfaces and thermal cutting element and in paragraph [0055], energy is only delivered to the thermal cutting element; thus the system is capable of delivering power only to the thermal cutting element while the jaws are spaced apart).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrosurgical system of Takashino so that so that the generator delivers power directly to the thermal cutting element via at least one conductive trace disposed within the thermal cutting element and so that it prevents delivery of power to the tissue treating surfaces as taught by Takashino 2 so that the temperature of the distal portion can be easily adjusted to a desired temperature suited to the treatment (Takashino 2 [0061]).
Further, Henderson teaches an electrosurgical system (Figure 142) comprising an electrosurgical generator (Figure 142: generator 17605) configured to deliver power to the thermal cutting element (Figure 142: ultrasonic blade 17630) in response to sensed contact between tissue and the thermal cutting element ([1039]: “When a conductive medium such as tissue 17635 contacts both the conductive pad 17710 and the electrically conductive ultrasonic blade 17630, the capacitive touch sensor 17620 detects the presence of the tissue 17635 and provides a signal to the control circuit 17615 to indicate the presence of tissue 17635. The control circuit 17615 may then determine to activate the generator 17605 to supply electrical energy to an ultrasonic transducer 17604 to activate the ultrasonic blade 17630 of the end effector to apply therapeutic energy to the tissue 17635 clamped between the ultrasonic blade 17630 and the jaw 17625 of the end effector. The ultrasonic blade 17630 delivers the therapeutic ultrasonic energy after the capacitive touch sensor 17620 is appropriately triggered by the presence of tissue 17635.”) to increase the temperature of the thermal cutting element from the standby setpoint temperature to a cutting setpoint temperature for dissecting tissue (Figure 142: ultrasonic blade 17630 and [0276]: “One energy type may be more beneficial for cutting the tissue, while another different energy type may be more beneficial for sealing the tissue.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrosurgical system of Takashino so that the generator operates in a mode to deliver power to the thermal cutting element in response to sensed contact between tissue and the thermal cutting element to increase the temperature of the thermal cutting element as taught by Henderson so that the timing of activating the instrument may correspond precisely to when it is needed (Henderson [1037]), which increases the effectiveness of the device.
Regarding claim 25, Takashino in view of Takashino 2 and Henderson discloses the electrosurgical system according to claim 1, and Takashino further discloses an electrosurgical system wherein the thermal cutting element is at least partially located in a longitudinally extending slot (Figure 12: recesses 128a and [0123]: “As shown in FIG. 12, a main body 122 includes a plurality of recesses 128a. The recesses 128a respectively include electrode portions 134, a blade 136, and a heating element 126 inside thereof. ”), wherein the thermal cutting element includes an upper surface (Figure 12: projected surface 136a of blade 136), and wherein the upper surface protrudes beyond the slot and the first treating surface towards the second treating surface (Figure 12: projected surface 136a protrudes beyond recess 128a and electrode 134 towards second holding surface 172).
Regarding claim 26, Takashino in view of Takashino 2 and Henderson discloses the electrosurgical system according to claim 1, wherein the thermal cutting element includes a base substate having an upper surface that extends beyond the first treating surface towards the second treating surface (Figure 12: projected surface 136a extends beyond electrode 134 towards second holding surface 172), wherein the upper surface is coupled to at least two sides (Figure 12: projected surface 136a of blade 136 is coupled to at least two sides), and wherein an insulating layer is on at least one side of at least two sides of the base substrate ([0107]: “a coating 136b which has electrical insulation properties and heat resistance” and [0126]), and wherein the conductive heater trace is on the insulated layer on the at least one side (Figure 12: heating element 126 is on the insulated layer on one side).
Claims 6-8 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Takashino in view of Takashino 2 and Henderson, further in view of Messerly et al., US 20130282003, herein referred to as "Messerly".
Regarding claim 6, Takashino in view of Takashino 2 and Henderson discloses the electrosurgical system according to claim 1, but does not explicitly disclose an electrosurgical system wherein the determination of contact between tissue and the thermal cutting element is based on the power delivered to the thermal cutting element to maintain the thermal cutting element at the standby setpoint temperature exceeding a threshold power level.
However, Messerly teaches an electrosurgical system (Figure 1: ultrasonic surgical instrument 100) wherein the determination of contact between tissue and the thermal cutting element is based on the power delivered to the thermal cutting element ([0441]: “Similarly, where current is substantially constant, power or energy delivered to the blade will also be proportional to ultrasonic impedance and corresponding changes in power, energy, changes in voltage, power or energy with respect to time, etc., may also indicate clamp arm closure.”) to maintain the thermal cutting element at the standby setpoint temperature exceeding a threshold power level ([0441]: “Also, as illustrated herein, when the clamp arm initially closes, the temperature of the ultrasonic blade may drop as it comes into contact with cool tissue. Accordingly, blade closure may alternately be detected by monitoring for a drop in blade temperature, indicated either by a rise in the resonant frequency of the blade and/or one of the other methods described herein. Also, in some forms, closure of the clamp arm may be determined based on detecting activation of a closure trigger and/or closure control. Various forms may detect clamp arm closure utilizing combinations of some or all of the electrical signal properties described.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrosurgical system of Takashino so that the determination of contact between tissue and the thermal cutting element is based on the power delivered to the thermal cutting element to maintain the thermal cutting element at the standby setpoint temperature exceeding a threshold power level as taught by Messerly so that contact between tissue and the thermal cutting element can be accurately determined in procedures where the current is substantially constant (Messerly [0441]).
Regarding claim 7, Takashino in view of Takashino 2, Henderson, and Messerly discloses the electrosurgical system according to claim 6, and Henderson further discloses an electrosurgical system (Figure 142: ultrasonic instrument 17602) wherein the electrosurgical generator (Figure 142: generator 17605) is configured to deliver power to the thermal cutting element to decrease the temperature of the thermal cutting element from the cutting setpoint temperature to the standby setpoint temperature in response to a determination that the thermal cutting element is not in contact with tissue ([1037]: “As such, it would be desirable to automatically activate ultrasonic therapeutic energy at the appropriate time, as well as automatically turn off the ultrasonic energy correctly. Thus, in some aspects, a sensor coupled to the end effector may provide accurate feedback for precisely when the ultrasonic energy should be applied or turned off.” And [1047]: “Once one activation signal no longer is transmitting to the control circuit, then the control circuit may automatically stop delivering the therapeutic energy.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrosurgical system of Takashino so that the temperature of the thermal cutting element is decreased in response to a determination that the thermal cutting element is not in contact with tissue as taught by Henderson so that the timing of activating the instrument may correspond precisely to when it is needed (Henderson [1037]), which increases the effectiveness of the device.
Regarding claim 8, Takashino in view of Takashino 2, Henderson, and Messerly discloses the electrosurgical system according to claim 7, and Messerly further discloses an electrosurgical system (Figure 1: ultrasonic surgical instrument 100) wherein the determination that the thermal cutting element is not in contact with tissue is based on the power delivered to the thermal cutting element ([0441]: “Similarly, where current is substantially constant, power or energy delivered to the blade will also be proportional to ultrasonic impedance and corresponding changes in power, energy, changes in voltage, power or energy with respect to time, etc., may also indicate clamp arm closure.”) to maintain the thermal cutting element at the standby setpoint temperature decreasing to a level below a threshold power level ([0441]: “Also, as illustrated herein, when the clamp arm initially closes, the temperature of the ultrasonic blade may drop as it comes into contact with cool tissue. Accordingly, blade closure may alternately be detected by monitoring for a drop in blade temperature, indicated either by a rise in the resonant frequency of the blade and/or one of the other methods described herein. Also, in some forms, closure of the clamp arm may be determined based on detecting activation of a closure trigger and/or closure control. Various forms may detect clamp arm closure utilizing combinations of some or all of the electrical signal properties described.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrosurgical system of Takashino so that the determination that the thermal cutting element is not in contact with tissue is based on the power delivered to the thermal cutting element to maintain the thermal cutting element at the standby setpoint temperature decreasing to a level below a threshold power level as taught by Messerly so that contact between tissue and the thermal cutting element can be accurately determined in procedures where the current is substantially constant (Messerly [0441]).
Regarding claim 16, Takashino in view of Takashino 2 and Henderson discloses the electrosurgical system according to claim 10, but does not explicitly disclose an electrosurgical system wherein the determination of contact between tissue and the thermal cutting element is based on the power delivered to the thermal cutting element to maintain the thermal cutting element at the standby setpoint temperature exceeding a threshold power level.
However, Messerly teaches an electrosurgical system (Figure 1: surgical system 19) wherein the determination of contact between tissue and the thermal cutting element is based on the power delivered to the thermal cutting element ([0441]: “Similarly, where current is substantially constant, power or energy delivered to the blade will also be proportional to ultrasonic impedance and corresponding changes in power, energy, changes in voltage, power or energy with respect to time, etc., may also indicate clamp arm closure.”) to maintain the thermal cutting element at the standby setpoint temperature exceeding a threshold power level ([0441]: “Also, as illustrated herein, when the clamp arm initially closes, the temperature of the ultrasonic blade may drop as it comes into contact with cool tissue. Accordingly, blade closure may alternately be detected by monitoring for a drop in blade temperature, indicated either by a rise in the resonant frequency of the blade and/or one of the other methods described herein. Also, in some forms, closure of the clamp arm may be determined based on detecting activation of a closure trigger and/or closure control. Various forms may detect clamp arm closure utilizing combinations of some or all of the electrical signal properties described.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrosurgical system of Takashino so that the determination of contact between tissue and the thermal cutting element is based on the power delivered to the thermal cutting element to maintain the thermal cutting element at the standby setpoint temperature exceeding a threshold power level as taught by Messerly so that contact between tissue and the thermal cutting element can be accurately determined in procedures where the current is substantially constant (Messerly [0441]).
Regarding claim 17, Takashino in view of Takashino 2, Henderson, and Messerly discloses the electrosurgical system according to claim 16, and Henderson further discloses an electrosurgical system (Figure 142) wherein the electrosurgical generator (Figure 142: generator 17605) is configured to control delivery of power to the thermal cutting element to decrease the temperature of the thermal cutting element from the cutting setpoint temperature to the standby setpoint temperature in response to a determination that the thermal cutting element is not in contact with tissue ([1037]: “As such, it would be desirable to automatically activate ultrasonic therapeutic energy at the appropriate time, as well as automatically turn off the ultrasonic energy correctly. Thus, in some aspects, a sensor coupled to the end effector may provide accurate feedback for precisely when the ultrasonic energy should be applied or turned off.” And [1047]: “Once one activation signal no longer is transmitting to the control circuit, then the control circuit may automatically stop delivering the therapeutic energy.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrosurgical system of Takashino so that the temperature of the thermal cutting element is decreased in response to a determination that the thermal cutting element is not in contact with tissue as taught by Henderson so that the timing of activating the instrument may correspond precisely to when it is needed (Henderson [1037]), which increases the effectiveness of the device.
Regarding claim 18, Takashino in view of Takashino 2, Henderson, and Messerly discloses the electrosurgical system according to claim 17, and Messerly further discloses an electrosurgical system (Figure 1: surgical system 19) wherein the determination that the thermal cutting element is not in contact with tissue is based on the power delivered to the thermal cutting element ([0441]: “Similarly, where current is substantially constant, power or energy delivered to the blade will also be proportional to ultrasonic impedance and corresponding changes in power, energy, changes in voltage, power or energy with respect to time, etc., may also indicate clamp arm closure.”) to maintain the thermal cutting element at the standby setpoint temperature decreasing to a level below a threshold power level ([0441]: “Also, as illustrated herein, when the clamp arm initially closes, the temperature of the ultrasonic blade may drop as it comes into contact with cool tissue. Accordingly, blade closure may alternately be detected by monitoring for a drop in blade temperature, indicated either by a rise in the resonant frequency of the blade and/or one of the other methods described herein. Also, in some forms, closure of the clamp arm may be determined based on detecting activation of a closure trigger and/or closure control. Various forms may detect clamp arm closure utilizing combinations of some or all of the electrical signal properties described.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrosurgical system of Takashino so that the determination that the thermal cutting element is not in contact with tissue is based on the power delivered to the thermal cutting element to maintain the thermal cutting element at the standby setpoint temperature decreasing to a level below a threshold power level as taught by Messerly so that contact between tissue and the thermal cutting element can be accurately determined in procedures where the current is substantially constant (Messerly [0441]).
Claim 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Takashino in view of Takashino 2 and Henderson, further in view of Nott et al., US 20190274717, herein referred to as "Nott".
Regarding claim 9, Takashino in view of Takashino 2 and Henderson discloses the electrosurgical system according to claim 1, but does not explicitly disclose an electrosurgical system wherein completion of cutting of the tissue grasped between the tissue treating surfaces is determined based on a decrease of the power delivered to the thermal cutting element to maintain the temperature of the thermal cutting element at the operating temperature.
However, Nott teaches an electrosurgical system (Figure 5) wherein completion of cutting of the tissue grasped between the tissue treating surfaces (Figure 30: 133128) is determined based on a decrease of the power delivered to the thermal cutting element ([0409]: “According to the frequency-temperature feedback control algorithm, a processor or control circuit of the generator or instrument or both maintains the ultrasonic blade temperature at the first target temperature T.sub.1 until the transection is completed. The frequency-temperature feedback control algorithm may be employed to detect the completion of the vessel transection process.”) to maintain the temperature of the thermal cutting element at the operating temperature ([0391]: “Once the temperature of the smart ultrasonic blade under the control of the CTM algorithm exceeds the desired temperature threshold (˜340° C.), the CTM algorithm takes control and regulates the temperature of the smart ultrasonic blade to match the threshold as closely as possible until the transection procedure is completed and the power to the ultrasonic transducer is deactivated or cut off.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrosurgical system of Takashino so that completion of cutting of the tissue grasped between the tissue treating surfaces is determined based on a decrease of the power delivered to the thermal cutting element to maintain the temperature of the thermal cutting element at the operating temperature as taught by Nott to match the temperature threshold as closely as possible until the transection procedure is complete (Nott [0391]), which increases the safety of the procedure.
Regarding claim 19, Takashino in view of Takashino 2and Henderson discloses the electrosurgical system according to claim 10, but does not explicitly disclose an electrosurgical system wherein completion of cutting of the tissue grasped between the tissue treating surfaces is determined based on a decrease of the power delivered to the thermal cutting element to maintain the temperature of the thermal cutting element at the operating temperature.
However, Nott teaches an electrosurgical system (Figure 5) wherein completion of cutting of the tissue grasped between the tissue treating surfaces (Figure 30: 133128) is determined based on a decrease of the power delivered to the thermal cutting element ([0409]: “According to the frequency-temperature feedback control algorithm, a processor or control circuit of the generator or instrument or both maintains the ultrasonic blade temperature at the first target temperature T.sub.1 until the transection is completed. The frequency-temperature feedback control algorithm may be employed to detect the completion of the vessel transection process.”) to maintain the temperature of the thermal cutting element at the operating temperature ([0391]: “Once the temperature of the smart ultrasonic blade under the control of the CTM algorithm exceeds the desired temperature threshold (˜340° C.), the CTM algorithm takes control and regulates the temperature of the smart ultrasonic blade to match the threshold as closely as possible until the transection procedure is completed and the power to the ultrasonic transducer is deactivated or cut off.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrosurgical system of Takashino so that completion of cutting of the tissue grasped between the tissue treating surfaces is determined based on a decrease of the power delivered to the thermal cutting element to maintain the temperature of the thermal cutting element at the operating temperature as taught by Nott to match the temperature threshold as closely as possible until the transection procedure is complete (Nott [0391]), which increases the safety of the procedure.
Claim 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Takashino in view of Takashino 2 and Henderson, further in view of Weiler et al., US 20150374430, herein referred to as "Weiler".
Regarding claim 22, Takashino in view of Takashino 2 and Henderson discloses the electrosurgical system according to claim 1, and Takashino further discloses an electrosurgical system wherein the electrosurgical generator (Figure 1: high frequency energy source 184) when the jaw members are in the approximated position, is configured to: deliver power to the tissue treating surfaces for sealing tissue grasped between the tissue treating surfaces ([0091]: “Accordingly, if the footswitch 16 is stepped on while the treatment portion 26 of the treatment instrument 12 is holding living tissue, a series of operations of sealing (coagulating) of the living tissue to be treated and incising the sealed portion is realized by one action.” And Figure 6); and deliver power to the thermal cutting element for cutting the sealed tissue grasped between the tissue treating surfaces ([0091]: “Accordingly, if the footswitch 16 is stepped on while the treatment portion 26 of the treatment instrument 12 is holding living tissue, a series of operations of sealing (coagulating) of the living tissue to be treated and incising the sealed portion is realized by one action.” And Figure 6). Takashino in view of Takashino 2 and Henderson does not explicitly disclose a system configured to deliver power to the thermal cutting element while delivery of power to the tissue treating surfaces is terminated.
However, Weiler discloses an electrosurgical system (Figure 1) configured to deliver power to the thermal cutting element while delivery of power to the tissue treating surfaces is terminated ([0013]: “The tissue can be severed by the cutting electrode before the sealing between the sealing jaws is complete. The simultaneous action of cutting electrode and sealing jaws on the tissue is not compulsory, but possible. The chronological sequence of cutting and sealing is preferably set by the voltages applied to the cutting electrode and to the sealing jaws”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrosurgical system of Takashino so that it prevents delivery of power to the tissue treating surfaces when the jaw members are in the approximated position as taught by Weiler so that the sealing and separation time can be reduced and the working process can be simplified (Weiler [0013]).
Regarding claim 24, Takashino in view of Takashino 2 and Henderson discloses the electrosurgical system according to claim 10, and Takashino further discloses an electrosurgical system wherein activation of the switch (Figure 1: footswitch 16) when the jaw members are in the approximated position is configured to: cause delivery of power to the tissue treating surfaces for sealing tissue grasped between the tissue treating surfaces ([0091]: “Accordingly, if the footswitch 16 is stepped on while the treatment portion 26 of the treatment instrument 12 is holding living tissue, a series of operations of sealing (coagulating) of the living tissue to be treated and incising the sealed portion is realized by one action.” And Figure 6); and cause delivery of power to the thermal cutting element for cutting the sealed tissue grasped between the tissue treating surfaces ([0091]: “Accordingly, if the footswitch 16 is stepped on while the treatment portion 26 of the treatment instrument 12 is holding living tissue, a series of operations of sealing (coagulating) of the living tissue to be treated and incising the sealed portion is realized by one action.” And Figure 6). Takashino in view of Takashino 2 and Henderson does not explicitly disclose a system configured to deliver power to the thermal cutting element while delivery of power to the tissue treating surfaces is terminated.
However, Weiler discloses an electrosurgical system (Figure 1) configured to deliver power to the thermal cutting element while delivery of power to the tissue treating surfaces is terminated ([0013]: “The tissue can be severed by the cutting electrode before the sealing between the sealing jaws is complete. The simultaneous action of cutting electrode and sealing jaws on the tissue is not compulsory, but possible. The chronological sequence of cutting and sealing is preferably set by the voltages applied to the cutting electrode and to the sealing jaws”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrosurgical system of Takashino so that it prevents delivery of power to the tissue treating surfaces when the jaw members are in the approximated position as taught by Weiler so that the sealing and separation time can be reduced and the working process can be simplified (Weiler [0013]).
Conclusion
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/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794