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 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.
Response to Amendment
Acknowledgement is made to the amendment received 09/18/2025.
Acknowledgement is made to the amendment of claims 19, 22, 32, 34, and 36-38.
Acknowledgement is made to the cancellation of claims 1-18.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.
Claims 19-38 are pending. A complete action on the merits appears below.
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 19-21 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Livneh (US 20080004656 A1) in view of King (US 20180098771 A1).
Regarding claim 19, Livneh teaches a method (Abstract), comprising:
coupling a first electrode with a first structure (Fig. 38-40; electrode 158) to a distal end of a medical device shaft ([0082] teaches the electrode as being detachably connected to the distal end of the housing of the surgical instrument), wherein the coupling includes releasably coupling an internal component of the medical device shaft to a reception portion of the first electrode ([0062] teaches the detachable tool assembly as being operably connected to the shaft; Fig. 38-40; shows shaft 52 as being located within the housing 58 [0082] teaches the electrode as being connected in a similar fashion as the first embodiment), wherein the first electrode is a singular, unitary component ([0079]), wherein the reception portion of the first electrode includes a radially inward indentation (Fig. 38-60; teaches the electrode as having a rod 166 which indents from the ball-shaped end 166), wherein the distal end of the medical device shaft includes one or more arms ([0069]- [0070] and [0082] teach the distal end of the surgical instrument 50 as containing a collet 116 having a plurality of fingers 120), wherein the one or more arms are biased radially outwardly ([0070] teaches the fingers of the collet as each including a stem which allows the fingers to flare apart when not compressed), wherein the distal end of the medical device shaft includes a central passage formed by a shaft wall ([0071]- [0072], [0082] teach the housing 58 as defining a central opening 126 and a cavity 128), wherein an inner portion of the shaft wall includes an angled portion ([0071]- [0072], [0082] teach the cavity and the central opening as being connected at an angled cross-section), and wherein the one or more arms are longitudinally movable within the distal end of the medical device shaft to couple and uncouple the first electrode from the distal end of the medical device shaft ([0071]-[0072], [0082] teach the fingers of the collet as being disposed within the central opening such that the fingers are collapsed to capture the ball-shaped proximal end of the connection rod), and wherein movement of the one or more arms causes the one or more arms to interact with the angled portion of the inner portion of the shaft wall such that the one or more arms are forced radially inward to releasably couple the one or more arms to the portion of the first electrode ([0070]- [0072]);
uncoupling the first electrode from the distal end of the medical device shaft by longitudinally moving the one or more arms such that the one or more arms are moved and move radially outward ([0063], [0072], [0082]); and
coupling a second electrode ([0061]- [0062] teach the surgical instrument including the detachable tool assembly as being easily separable from the shaft and housing to allow a user of the surgical instrument to quickly change the desired tool, Abstract teaches the exemplary tool as being an electrode, such as either of the electrodes which are taught as being attachable in the third or fourth embodiments of Fig. 38-40 and Fig. 44, as is discussed in [0079]- [0082]) with a second structure to the distal end of the medical device shaft by again moving the one or more arms such that the one or more arms interact with the angled portion of the inner portion of the shaft wall such that the one or more arms are forced radially inward to releasably couple the one or more arms to a reception portion of the second electrode ([0071]- [0072] and [0082]), wherein the second electrode is a singular, unitary component ([0079]), wherein the reception portion of the second electrode includes a radially inward indentation, and wherein the second structure is different than the first structure ([0079]- [0082]).
However, Livneh fails to teach the movement which forces the arms radially inward as being a distal movement and the arms moving radially outward by proximal retraction.
Livneh instead teaches the device as being comprised of two sections, a distal end and a proximal portion, wherein the distal end is referred to as the detachable tool assembly containing a connection rod and the proximal portion is referred to as the housing containing a shaft including a plurality expandable elements, referred to as expandable fingers. These expandable fingers are taught as being used to grasp and couple the connection rod ([0069]- [0072], [0082]).
King teaches a medical device comprised of two sections, a distal end and a proximal portion, wherein the distal end is referred to as a clipping assembly and the proximal portion is referred to as the applicator. This device provides the method of the clipping assembly to be loaded onto the applicator, utilized for treating a patient, and removed from the applicator, followed by a second separate clipping assembly which is attached to the applicator, so that the second clipping assembly may be used to treat the patient and then removed from the applicator in a similar fashion to the first applicator ([0023]).
King further teaches the distal end as being the portion of the device which contains expandable elements which are permitted to spread and receive an enlarged distal end of a control member of the applicator, such that that longitudinal movement of the control member relative to the outer portion of the applicator, referred to herein as the capsule, provides for an attachment between the inner proximal member and the expandable elements of the distal end ([0023]).
Therefore, while Livneh does not explicitly teach the distal movement as being the movement which forces the arms inward and the arms moving radially outwardly by proximal movement, there is no evidence that the direction which causes this inward and outward movement of the arms as making a meaningful difference to the function of the device and/or producing an unexpected result and it has been held that the reversal of parts is an obvious modification (MPEP 2144.04(VI)(A)). For this reason, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have reversed any functional elements of the shaft which produce the arms coupling and uncoupling the distal end effector of King into the portion of Livneh which causes the arms to couple and uncouple the electrode as long as each functional element retains its ability to function in a desired and/or predictable manner.
Regarding claim 20, Livneh teaches the method of claim 19, wherein uncoupling the first electrode includes an action on a medical device handle coupled to a proximal end of the shaft, wherein the action on the medical device handle moves the one or more arms causing the one or more arms to expand and uncouple the arms from a proximal portion of the first electrode ([0070]).
In accordance with the above rejection of claim 19, King further teaches this movement as being a proximal retraction ([0023]).
Regarding claim 21, Livneh teaches the method of claim 20, wherein the one or more arms include a plurality of arms ([0070]- [0072]).
Regarding claim 28, Livneh teaches the method of claim 19, further comprising, before uncoupling the first electrode from the distal end, energizing at least a portion of the first electrode ([0079]).
Claim 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Livneh (US 20080004656 A1) in view of King (US 20180098771 A1) and Klein (US 20080243157 A1).
Regarding claim 22, Livneh as modified fails to teach the method of claim 21.
However, Livneh as modified fails to teach the method wherein the first electrode includes a first fluid flow path, and wherein the second electrode includes a second fluid flow path having a shape different from a shape of the first fluid flow path, and wherein the first fluid flow path and the second fluid flow path each include receiving fluid from a lumen within a proximal support coupled to proximal ends of the plurality of arms.
Klein teaches an applicator for providing water-jet surgery comprising a handle, a pressure conduit, a nozzle, and an electrode, wherein the distal portion, referred to as a molded part, can be connected detachably to the handle based on the necessity for the operating step being performed (Abstract, [0042], [0043]).
Klein further teaches the molded part as being able to be constructed with different lengths and being able to be bent into various lengths and shapes ([0035]- 0037]). These size and shape distinctions are provided so as to allow for a shape which is suitable based on the momentary operating step and the alteration based on this step is performed simply by changing to another molded part during the operation ([0007]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the surgical device having detachable distal elements for use in performing surgical procedure with an electrode as having a variety of sizes and shape for delivering fluid, as is taught by Klein, into the surgical instrument having a detachable tool assembly as is taught by Livneh as modified, to produce the predictable result of providing the desired fluid delivery based on the current operating step, as is taught by Klein, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 23, Klein further teaches the method of claim 22, wherein the first fluid flow path includes a radial flow path, and wherein the second fluid flow path extends at an acute angle relative a central longitudinal axis of the distal end of the medical device shaft ([0035]).
Claim 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Livneh (US 20080004656 A1) in view of King (US 20180098771 A1) and Okada (US 20040210215 A1).
Regarding claim 24, Livneh as modified teaches the method of claim 19.
However, Livneh as modified fails to teach the method wherein the first electrode includes a first insulation pattern, and wherein the second electrode includes a second insulation pattern different from the first insulation pattern.
Okada teaches a cutting device having a main body member and a tip end portion having an electrode to treat tissue (Abstract).
Okada further teaches the device having multiple electrodes with insulation patterns which differ from one another ([0023], [0026]- [0028]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the teachings of utilizing different distal insulation patterns, as is taught by Okada, into the modified method as is taught by Livneh as modified, to produce the predictable result of providing a desired treatment surface based on a desired outcome of a specific surgical procedure, as is taught by Okada, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 25, Okada further teaches the method of claim 24, wherein the first insulation pattern includes a rounded annular insulation pattern on a distal end face of the first electrode ([0023]), and wherein the second insulation pattern includes a dotted insulation pattern on a distal end face of the second electrode ([0028]).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Livneh (US 20080004656 A1) in view of King (US 20180098771 A1) and Schaller (US 5810864 A).
Regarding claim 26, Livneh as modified teaches the method of claim 19, wherein uncoupling the first electrode from the distal end includes an action on a medical device handle ([0070]- [0072]).
However, Livneh as modified fails to teach the method wherein coupling the second electrode to the distal end includes inserting the distal end of the medical device shaft into an opening of a cartridge, wherein the opening of the cartridge retains the second electrode.
Schaller teaches a surgical instrument system for use in minimally invasive surgery having interchangeable instrument heads with different surgical tools (Abstract).
Schaller further teaches a magazine having plug-in receptacles, wherein an instrument head is fixed in the receptable, and an insertion funnel guides a distal tie-in point of a shaft to the instrument head for coupling (Col. 5, Lines 19-25).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the surgical tools being contained within a holder and attached from a point within said holder, as is taught by Schaller, into the modified method as is taught by Livneh as modified, to produce the predictable result of containing multiple interchangeable surgical tools for use during a surgical procedure as is taught by Schaller, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Livneh (US 20080004656 A1) in view of King (US 20180098771 A1) and Schaller (US 5810864 A) in view of Okada (US 20040210215 A1).
Regarding claim 27, Schaller further teaches the method of claim 26, wherein the cartridge (Fig. 13; magazine 8) includes a plurality of openings (Fig. 13; insertion funnel 96), with each opening retaining a different tool (Fig. 13; surgical tools 7).
In accordance with the above rejection of claim 19, Livneh further teaches the tools as comprising electrodes ([0079]- [0084]).
Klein teaches an applicator for providing water-jet surgery comprising a handle, a pressure conduit, a nozzle, and an electrode, wherein the distal portion, referred to as a molded part, can be connected detachably to the handle based on the necessity for the operating step being performed (Abstract, [0042], [0043]).
Klein further teaches the molded part as being able to be constructed with different lengths and being able to be bent into various lengths and shapes ([0035]- 0037]). These size and shape distinctions are provided so as to allow for a shape which is suitable based on the momentary operating step and the alteration based on this step is performed simply by changing to another molded part during the operation ([0007]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the surgical device having detachable distal elements for use in performing surgical procedure with an electrode as having a variety of sizes and shape for delivering fluid, as is taught by Klein, into the surgical instrument having a detachable tool assembly as is taught by Livneh as modified, to produce the predictable result of providing the desired fluid delivery based on the current operating step, as is taught by Klein, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
However, Livneh as modified fails to teach the method wherein the each of the different electrodes having a different fluid flow path and/or a different insulation pattern.
Okada teaches a cutting device having a main body member and a tip end portion having an electrode to treat tissue (Abstract).
Okada further teaches the device having multiple electrodes with insulation patterns which differ from one another ([0023], [0026]- [0028]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the teachings of utilizing different distal insulation patterns, as is taught by Okada, into the modified method as is taught by Livneh as modified, to produce the predictable result of providing a desired treatment surface based on a desired outcome of a specific surgical procedure, as is taught by Okada, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claims 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Livneh (US 20080004656 A1) in view of King (US 20180098771 A1) and Weber (US 4919129 A).
Regarding claim 29, Livneh as modified teaches the method of claim 28.
However, Livneh as modified fails to teach the method wherein energizing at least a portion of the first electrode includes an action on a switch of a handle.
Weber teaches an electrocautery method and instrument which can be controlled through a slide element, control buttons, and an interlock switch positioned on the instrument (Abstract). The safety switching is included within the instrument to control the application of high-voltage electrical signals to the electrode and to permit the user to establish electrically inactive conditions during attachment and removal of extension units (Col. 1, Lines 50-63).
Weber further teaches the energizing a portion of the electrode including an action of a switch on a handle (Col. 3, Line 67- Col. 4, Line 20).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the switching action on a handle to control electrode energization, as is taught by Weber, into the modified method as is taught by Livneh, to produce the predictable result of providing safety control of the application and inactivity of high-voltage electrical signals during attachment and removal of extension units, as is taught by Weber, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 30, Weber further teaches the method of claim 29, wherein the switch is a slide switch that is movable between different positions, wherein the different positions of the slide switch correspond to different operational states of the first electrode (Col. 3, Line 60- Col. 4, Line 55 teaches the switches as being activated when the slide element is positioned in the forward location).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Livneh (US 20080004656 A1) in view of King (US 20180098771 A1) and Weber (US-4919129-A) further in view of Stockert (US 6592580 B1).
Regarding claim 31, Livneh as modified teaches the method of claim 30.
However, Livneh as modified fails to teach the method wherein the first electrode includes a first conductive member and a second conductive member, wherein the different operational states include a first operational state in which neither the first conductive member nor the second conductive member of the first electrode is energized, a second operational state in which the first conductive member of the first electrode is energized and the second conductive member of the first electrode is not energized, a third operational state in which the second conductive member of the first electrode is energized and the first conductive member of the first electrode is not energized, and a fourth operational state in which both the first conductive member and the second conductive member of the first electrode are energized.
Stockert teaches a high-frequency treatment of body tissue comprising a head which is provided with at least one HR electrode which can be brough into contact with tissue to be treated and electrically activated (Abstract).
Stockert further teaches the several HF electrode at the distal end of the head as being controlled individually or in combination (Col. 3, Lines 35-55). This allows only the HF electrodes which are actually positioned with respect to the tissue to be treated in such a manner that the energy emitted by then has the desired effect, while those electrodes which would cause an undesired heating are not activated (Col. 3, Lines 35-55).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the teachings of having the electrodes be energizable in any desired configuration, as is taught by Stockert, into the method of Livneh, to produce the predictable result of only activating those electrodes which produce the desired result as is taught by Stockert, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claim 32-38 are rejected under 35 U.S.C. 103 as being unpatentable over Livneh (US 20080004656 A1) in view of King (US 20180098771 A1), Klein (US 20080243157 A1), and Okada (US 20040210215 A1).
Regarding claim 32, Livneh teaches a method (Abstract), comprising:
coupling a first electrode with a first structure (Fig. 38-40; electrode 158) to a distal end of a medical device shaft ([0082] teaches the electrode as being detachably connected to the distal end of the housing of the surgical instrument), wherein the coupling includes releasably coupling a plurality of radially biased arms of the medical device shaft to a portion of the first electrode ([0062] teaches the detachable tool assembly as being operably connected to the shaft; Fig. 38-40; shows shaft 52 as being located within the housing 58 [0082] teaches the electrode as being connected in a similar fashion as the first embodiment [0069]- [0070] and [0082] teach the distal end of the surgical instrument 50 as containing a collet 116 having a plurality of fingers 120), and wherein the plurality of radially biased arms extend distally from a proximal support and are longitudinally movable within the distal end of the medical device shaft, wherein the distal end of the medical device shaft includes a central passage formed by an inner portion of a shaft wall ([0071]-[0072], [0082] teach the fingers of the collet as being disposed within the central opening such that the fingers are collapsed to capture the ball-shaped proximal end of the connection rod), wherein the inner portion of the shaft wall includes an angled portion, and wherein movement of the plurality of arms and the proximal support causes the plurality of arms to interact with the angled portion of the inner portion of the shaft wall such that the plurality of arms are forced radially inward to releasably couple the plurality of arms to the portion of the first electrode ([0070]- [0072]);
uncoupling the first electrode from the distal end by longitudinally moving the plurality of radially biased arms ([0063], [0072], [0082]); and
coupling a second electrode ([0061]- [0062] teach the surgical instrument including the detachable tool assembly as being easily separable from the shaft and housing to allow a user of the surgical instrument to quickly change the desired tool, Abstract teaches the exemplary tool as being an electrode, such as [0079]- [0082] either of the electrodes which are taught as being attachable in the third or fourth embodiments of Fig. 38-40 and Fig. 44) with a second structure to the distal end of the medical device shaft by again moving the plurality of arms such that the plurality of arms interact with the angled portion of the shaft wall such that the plurality of arms are forced radially inward ([0071]- [0072] and [0082]) to releasably couple the plurality of arms to a portion of the second electrode ([0079]- [0082]).
However, Livneh fails to teach the movement which forces the arms radially inward as being a distal movement and the arms moving radially outward by proximal retraction.
Livneh instead teaches the device as being comprised of two sections, a distal end and a proximal portion, wherein the distal end is referred to as the detachable tool assembly containing a connection rod and the proximal portion is referred to as the housing containing a shaft including a plurality expandable elements, referred to as expandable fingers. These expandable fingers are taught as being used to grasp and couple the connection rod ([0069]- [0072], [0082]).
King teaches a medical device comprised of two sections, a distal end and a proximal portion, wherein the distal end is referred to as a clipping assembly and the proximal portion is referred to as the applicator. This device provides the method of the clipping assembly to be loaded onto the applicator, utilized for treating a patient, and removed from the applicator, followed by a second separate clipping assembly which is attached to the applicator, so that the second clipping assembly may be used to treat the patient and then removed from the applicator in a similar fashion to the first applicator ([0023]).
King further teaches the distal end as being the portion of the device which contains expandable elements which are permitted to spread and receive an enlarged distal end of a control member of the applicator, such that that longitudinal movement of the control member relative to the outer portion of the applicator, referred to herein as the capsule, provides for an attachment between the inner proximal member and the expandable elements of the distal end ([0023]).
Therefore, while Livneh does not explicitly teach the distal movement as being the movement which forces the arms inward and the arms moving radially outwardly by proximal movement, there is no evidence that the direction which causes this inward and outward movement of the arms as making a meaningful difference to the function of the device and/or producing an unexpected result and it has been held that the reversal of parts is an obvious modification (MPEP 2144.04(VI)(A)). For this reason, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have reversed any functional elements of the shaft which produce the arms coupling and uncoupling the distal end effector of King into the portion of Livneh which causes the arms to couple and uncouple the electrode as long as each functional element retains its ability to function in a desired and/or predictable manner.
Livneh further fails to teach the method wherein the proximal support including a lumen to convey fluid, wherein the first electrode includes a first electrode lumen, and wherein coupling the proximal portion to the portion of the first electrode fluidly couples the lumen of the proximal support to the first electrode lumen, wherein the second electrode includes a second electrode lumen, and wherein coupling the plurality of arms to the portion of the second electrode fluidly couples the lumen of the proximal support to the second electrode lumen, and wherein the second structure includes a shape of a fluid flow path that is different from a shape of a fluid flow path pattern of the first structure.
Klein teaches an applicator for providing water-jet surgery comprising a handle, a pressure conduit, a nozzle, and an electrode, wherein the distal portion, referred to as a molded part, can be connected detachably to the handle based on the necessity for the operating step being performed (Abstract, [0042], [0043]).
Klein further teaches the molded part as being able to be constructed with different lengths and being able to be bent into various lengths and shapes ([0035]- 0037]). These size and shape distinctions are provided so as to allow for a shape which is suitable based on the momentary operating step and the alteration based on this step is performed simply by changing to another molded part during the operation ([0007]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the surgical device having detachable distal elements for use in performing surgical procedure with an electrode as having a variety of sizes and shape for delivering fluid, as is taught by Klein, into the surgical instrument having a detachable tool assembly as is taught by Livneh as modified, to produce the predictable result of providing the desired fluid delivery based on the current operating step, as is taught by Klein, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Livneh further fails to teach the method wherein the second structure includes an insulation pattern that is different from an insulation pattern of the first structure.
Okada teaches a cutting device having a main body member and a tip end portion having an electrode to treat tissue (Abstract).
Okada further teaches the device having multiple electrodes with insulation patterns which differ from one another ([0023], [0026]- [0028]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the teachings of utilizing different distal insulation patterns, as is taught by Okada, into the modified method as is taught by Livneh as modified, to produce the predictable result of providing a desired treatment surface based on a desired outcome of a specific surgical procedure, as is taught by Okada, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 33, Livneh teaches the method of claim 32, wherein uncoupling the first electrode includes an action on a medical device handle coupled to a proximal end of the medical device shaft ([0070]- [0072]), wherein the action on the medical device handle moves the plurality of arms causing the plurality of arms to expand and uncouple the plurality of arms from a proximal portion of the first electrode ([0061]- [0063]).
In accordance with the above rejection of claim 32, King further teaches this movement as being a proximal retraction ([0023]).
Regarding claim 34, Livneh teaches the method of claim 32, wherein the first electrode is a singular, unitary component, wherein the second electrode is a singular, unitary component ([0079]).
In accordance with the above rejection of claim 32, Klein further teaches the first electrode as including a radial flow path and the second electrode including a fluid flow path that extends at an acute angle relative a central longitudinal axis of the distal end of the medical device shaft ([0035]).
Regarding claim 35, in accordance with the above rejection of claim 32, Okada further teaches the method of claim 34, wherein the first electrode includes a rounded annular insulation pattern on a distal end face of the first electrode ([0023]), and wherein the second electrode includes a dotted insulation pattern on a distal end face of the second electrode ([0028]).
Regarding claim 36, Livneh teaches the method of claim 35, further comprising, before uncoupling the first electrode from the distal end, energizing at least a portion of the first electrode to deliver a first treatment to a target site ([0069]- [0072], [0079]- [0084]), and
after coupling the second electrode to the distal end, energizing at least a portion of the second electrode to deliver a second treatment different from the first treatment to the target site ([0069]- [0072], [0079]- [0084]).
Regarding claim 37, Livneh teaches a method (Abstract), comprising:
coupling a first electrode (Fig. 38-40; electrode 158) to a distal end of a medical device shaft ([0082] teaches the electrode as being detachably connected to the distal end of the housing of the surgical instrument), wherein the coupling includes releasably coupling one or more radially biased arms of the medical device shaft to a reception portion of the first electrode ([0062] teaches the detachable tool assembly as being operably connected to the shaft; Fig. 38-40; shows shaft 52 as being located within the housing 58 [0082] teaches the electrode as being connected in a similar fashion as the first embodiment), wherein the reception portion of the first electrode includes a radially inward indentation (Fig. 38-60; teaches the electrode as having a rod 166 which indents from the ball-shaped end 166), wherein the one or more radially biased arms extend distally from a proximal support ([0069]- [0070] and [0082] teach the distal end of the surgical instrument 50 as containing a collet 116 having a plurality of fingers 120), and wherein the one or more arms are longitudinally movable within the distal end ([0070]- [0072]);
delivering the first electrode and the distal end of the medical device shaft to a target site ([0005]- [0010], [0079]);
energizing at least a portion of the first electrode ([0079]- [0082]);
removing the first electrode and the distal end of the medical device shaft from the target site ([0005]- [0010], [0079]);
uncoupling the first electrode from the distal end by longitudinally retracting the one or more radially biased arms ([0063], [0070]- [0072], [0082]);
coupling a second electrode ([0061]- [0062] teach the surgical instrument including the detachable tool assembly as being easily separable from the shaft and housing to allow a user of the surgical instrument to quickly change the desired tool, Abstract teaches the exemplary tool as being an electrode, such as [0079]- [0082] either of the electrodes which are taught as being attachable in the third or fourth embodiments of Fig. 38-40 and Fig. 44) to the distal end of the medical device shaft, wherein the coupling includes releasably coupling the one or more radially biased arms of the medical device shaft to a reception portion of the second electrode ([0071]- [0072], and [0082]), wherein the reception portion of the second electrode includes a radially inward indentation ([0079]- [0082]);
delivering the second electrode and the distal end of the medical device shaft to the target site ([0079]- [0082]); and
energizing at least a portion of the second electrode ([0079]- [0082]).
However, Livneh fails to teach the arms moving radially outward by proximal retraction.
Livneh instead teaches the device as being comprised of two sections, a distal end and a proximal portion, wherein the distal end is referred to as the detachable tool assembly containing a connection rod and the proximal portion is referred to as the housing containing a shaft including a plurality expandable elements, referred to as expandable fingers. These expandable fingers are taught as being used to grasp and couple the connection rod ([0069]- [0072], [0082]).
King teaches a medical device comprised of two sections, a distal end and a proximal portion, wherein the distal end is referred to as a clipping assembly and the proximal portion is referred to as the applicator. This device provides the method of the clipping assembly to be loaded onto the applicator, utilized for treating a patient, and removed from the applicator, followed by a second separate clipping assembly which is attached to the applicator, so that the second clipping assembly may be used to treat the patient and then removed from the applicator in a similar fashion to the first applicator ([0023]).
King further teaches the distal end as being the portion of the device which contains expandable elements which are permitted to spread and receive an enlarged distal end of a control member of the applicator, such that that longitudinal movement of the control member relative to the outer portion of the applicator, referred to herein as the capsule, provides for an attachment between the inner proximal member and the expandable elements of the distal end ([0023]).
Therefore, while Livneh does not explicitly teach the distal movement as being the movement which forces the arms inward and the arms moving radially outwardly by proximal movement, there is no evidence that the direction which causes this inward and outward movement of the arms as making a meaningful difference to the function of the device and/or producing an unexpected result and it has been held that the reversal of parts is an obvious modification (MPEP 2144.04(VI)(A)). For this reason, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have reversed any functional elements of the shaft which produce the arms coupling and uncoupling the distal end effector of King into the portion of Livneh which causes the arms to couple and uncouple the electrode as long as each functional element retains its ability to function in a desired and/or predictable manner.
Livneh further fails teach the method wherein the first electrode includes a first electrode lumen with a first fluid flow, the proximal support includes a lumen to direct fluid toward the first electrode lumen, delivering fluid through the distal end of the medical device shaft and the first electrode to the target site, wherein the medical device shaft includes one or more seals between the one or more radially biased arms and the reception portion of the first electrode such that fluid delivered through the medical device shaft is delivered through the lumen of the proximal support and into the first electrode lumen, the second electrode including a second electrode lumen and a second fluid flow which is different from the first flow wherein the one or more seals are positioned between the one or more radially biased arms and the reception portion of the second electrode, and delivering fluid through the distal end of the medical device shaft and the second electrode to the target site, wherein fluid delivered through the medical device shaft is delivered through the lumen of the proximal support and into the second electrode lumen.
Klein teaches an applicator for providing water-jet surgery comprising a handle, a pressure conduit, a nozzle, and an electrode, wherein the distal portion, referred to as a molded part, can be connected detachably to the handle by a pressure-proof screw thread based on the necessity for the operating step being performed (Abstract, [0033], [0040]- [0043]).
Klein further teaches the molded part as being able to be constructed with different lengths and being able to be bent into various lengths and shapes ([0035]- 0037]). These size and shape distinctions are provided so as to allow for a shape which is suitable based on the momentary operating step and the alteration based on this step is performed simply by changing to another molded part during the operation ([0007]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the surgical device having detachable distal elements for use in performing surgical procedure with an electrode as having a variety of sizes and shape for delivering fluid, as is taught by Klein, into the surgical instrument having a detachable tool assembly as is taught by Livneh as modified, to produce the predictable result of providing the desired fluid delivery based on the current operating step, as is taught by Klein, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Livneh further fails to teach the method wherein the second structure includes an insulation pattern that is different from an insulation pattern of the first structure.
Okada teaches a cutting device having a main body member and a tip end portion having an electrode to treat tissue (Abstract).
Okada further teaches the device having multiple electrodes with insulation patterns which differ from one another ([0023], [0026]- [0028]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the teachings of utilizing different distal insulation patterns, as is taught by Okada, into the modified method as is taught by Livneh as modified, to produce the predictable result of providing a desired treatment surface based on a desired outcome of a specific surgical procedure, as is taught by Okada, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 38, Livneh teaches the method of claim 37, each of the first electrode and the second electrode is a singular, unitary component, such that extension or retraction of the first electrode or the second electrode moves an entirety of the first electrode or the second electrode distally or proximally ([0079]).
In accordance with the above rejection of claim 37, Okada teaches the first electrode includes a rounded annular insulation pattern on a distal end face of the first electrode ([0023]), wherein the second electrode includes a dotted insulation pattern on a distal end face of the second electrode ([0028]).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the amendments have necessitated new grounds of rejection.
Specifically, applicant’s arguments of the limitations that art not taught by the Livneh/Rollins reference are moot in view of the new rejections under Livneh and King.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794