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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/11/2026 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 6/11/2025.
Response to Arguments
Applicant’s arguments with respect to claims 16 and 41 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, claim 16 was rejected under 35 U.S.C. 103 as being unpatentable over Allen in view of Shah and claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Allen in view of Sakaguchi. Now, based on amendments to the claim language, claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Allen in view of Schoettgen and claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Allen in view of Boudreaux and Sakaguchi.
Applicant's arguments filed 6/11/2026 regarding claim 37 have been fully considered but they are not persuasive. Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections. As seen below, Embodiment A of Allen in view of Embodiment B of Allen does disclose the claim language of claim 37. Additionally, applicant argues that there is no motivation to combine the references used in the rejection, but both the previous office action and this office action include a motivation to combine. Thus, applicant’s arguments are not persuasive and the previous rejection of claim 37 stands.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “224” has been used to designate both a clamp closure sensor and a pistol grip in Figures 6A-C. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 44 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 44, the claim recites the language “wherein the second clamp closure sensor is positioned in the pistol grip”. While the specification labels the second clamp closure sensor as clamp closure sensor 224 and Figures 6A-C label 224 as being positioned in the pistol grip, this is clearly an error as 224 is also labeled near the top right of the figures. Paragraph [0071] of applicant’s specification recites “Clamp closure sensor (224) may be coupled with handle assembly (220). Particularly in FIGS. 6A-7C, clamp closure sensor (224) is shown as being coupled to yoke assembly (199) within handle assembly (220).” The item labeled as 224 in the top right of Figures 6A-C is coupled to yoke assembly 199, thus this is considered the second clamp closure sensor. Since the pistol grip is labeled as 124 in other figures, the examiner assumes that the label 224 that is directed to the pistol grip is a typo that should read “124” instead. Thus, the second clamp closure sensor is not positioned in the pistol grip in any figures and is not described as being positioned in the pistol grip anywhere in the specification. Therefore, claim 44 fails to comply with the written description requirement as is rejected under 35 U.S.C. 112(a).
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 16, 19-21, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Allen, IV, US 20200297407, herein referred to as “Allen”, in view of Schoettgen et al., US 20190202022, herein referred to as “Schoettgen”.
Regarding claim 16, Allen discloses an electrosurgical instrument (Figure 1: surgical instrument 10), comprising: (a) a shaft assembly (Figure 1: elongated shaft 16); (b) an end effector that extends distally from the shaft assembly (Figure 1: end effector assembly 14 extends distally from elongated shaft 16), the end effector comprising: (i) an energized feature configured to apply energy to a tissue (Figure 2A: electrically-conductive plates 48 and 50 and [0033]), (ii) a first jaw (Figures 1 and 2A: first jaw member 30), and (iii) a second jaw (Figures 1 and 2A: second jaw member 32) configured to selectively move relative to the first jaw from an open configuration configured to receive the tissue to a closed configuration configured to clamp the tissue ([0034] and Figures 2A-B); (c) an input actuator (Figure 1: movable handle 22) operatively connected to the end effector and configured to selectively move from an unactuated position to an actuated position to thereby move the first and second jaws from the open configuration toward the closed configuration ([0031]: “Movable handle 22, as detailed below, is operable to move jaw members 30, 32 of end effector assembly 14 between an open configuration (FIG. 2A), wherein jaw members 30, 32 are disposed in spaced relation relative to one another, and a closed configuration (FIG. 2B), wherein jaw members 30, 32 are approximated relative to one another. More specifically, compression of movable handle 22 towards stationary handle 20 serves to move end effector assembly 14 to the closed configuration and return of movable handle 22 away from stationary handle 20 serves to move end effector assembly 14 back to the open configuration.”); (d) a biasing feature (Figure 3A: drive assembly 70) operatively connected between the input actuator and the end effector and configured to resiliently deflect for limiting force transmitted therethrough (Figures 3A-3B and [0035]); (e) a first clamp closure sensor (Figure 5: one of optical sensors 302) positioned entirely proximal to the end effector (Figures 3A-C: sensor module 200 is within housing 12, Figure 1: housing 12 is positioned entirely proximal to end effector assembly 14) and configured to produce first sensor information relating to movement of the input actuator in response to the input actuator being moved from the unactuated position to the actuated position ([0050]: “sensor module 300 (and/or sensor module 200 (FIG. 4)) may further be configured such that one or more of sensors 302 is capable of sensing the position of movable handle 22. This may be accomplished by sensing the position of jaw drive rod 80 or a component fixed thereto, e.g., proximal stop ring 81.”); (f) a second clamp closure sensor (Figure 5: one of optical sensors 302) positioned entirely proximal to the end effector (Figures 3A-C: sensor module 200 is within housing 12, Figure 1: housing 12 is positioned entirely proximal to end effector assembly 14) and configured to produce second sensor information relating to deflection of the biasing feature in response to a tissue load force between the first and second jaws (Figure 5 and [0048]); and (g) a control unit (Figure 5: processor 324) operatively connected with the first and second clamp closure sensors (Figure 5: processor 324 is part of sensor module 300), wherein, based on each of the first and second sensor information produced by the first and second clamp closure sensors positioned entirely proximal to the end effector, the control unit is configured to determine each of: (i) the tissue load force exerted on the end effector ([0015]: “The sensor module is configured to sense a property of the spring of the force regulating mechanism indicative of an amount the spring has been compressed and, based upon the sensed property, determine the clamping pressure applied to tissue” and [0016]), and (ii) a position of one of the first and second jaws relative to the other of the first and second jaws ([0050]). Allen does not explicitly disclose an electrosurgical instrument comprising a control unit configured to determine a jaw angle between the first and second jaws.
However, Schoettgen teaches an electrosurgical instrument (Figures 8-11) wherein, based on each of the sensor information produced by the clamp closure sensor positioned entirely proximal to the end effector (Figures 8-11: encoder sensor 98), the control unit is configured to determine a jaw angle between the first and second jaws ([0059]: “The control unit 94 processes the output signal from the encoder sensor 98 to monitor the current jaw angle 26 and control lighting of the feedback output lights 74, 76, 78 in accordance with the current jaw angle 26 similar to as described herein with respect to the surgical instrument 70.”).
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 instrument of Allen so that the control unit is configured to determine a jaw angle between the first and second jaws as taught by Schoettgen to provide feedback to an operator of the surgical instrument indicative of whether the tissue is suitable clamped for sealing and/or cutting (Schoettgen Abstract).
Regarding claim 19, Allen in view of Schoettgen discloses the electrosurgical instrument of claim 16, and Allen further discloses an electrosurgical instrument wherein the first clamp closure sensor ([0050]: “sensor module 300 (and/or sensor module 200 (FIG. 4)) may further be configured such that one or more of sensors 302 is capable of sensing the position of movable handle 22) includes at least one of an optical reflective sensor ([0049]: “sensor module 300 includes one or more optical sensors 302, e.g., one or more optical encoder sensors, configured to sense a spacing between the rungs of spring 86.”), an optical linear encoder, a magnetic sensor, or a capacitive sensor.
Regarding claim 20, Allen in view of Schoettgen discloses the electrosurgical instrument of claim 16, and Allen further discloses an electrosurgical instrument further comprising a clamping drive train (Figure 5: jaw drive rod 80) connected between the input actuator ([0037]: “Movable handle 22 is pivotably coupled within housing 12 via a pivot pin 75 and is operably coupled to jaw drive rod 80 by way of mandrel 84 such that movable handle 22 may be manipulated to impart longitudinal motion to jaw drive rod 80.”) and the end effector ([0035]: “The distal end of jaw drive rod 80 is operably coupled to jaw members 30, 32, e.g., via a pin (not shown) associated with jaw drive rod 80 and extending through oppositely-angled slots (not shown) defined within proximal flanges (not shown) of jaw members 30, 32”) and configured to operatively move the first and second jaws from the open configuration toward the closed configuration ([0035]: “The distal end of jaw drive rod 80 is operably coupled to jaw members 30, 32, e.g., via a pin (not shown) associated with jaw drive rod 80 and extending through oppositely-angled slots (not shown) defined within proximal flanges (not shown) of jaw members 30, 32, such that proximal sliding of jaw drive rod 80 through elongated shaft 16 moves end effector assembly 14 from the open configuration to the closed configuration. ”), wherein the first clamp closure sensor is configured to sense movement of the clamping drive train ([0050]: “sensor module 300 (and/or sensor module 200 (FIG. 4)) may further be configured such that one or more of sensors 302 is capable of sensing the position of movable handle 22. This may be accomplished by sensing the position of jaw drive rod 80 or a component fixed thereto, e.g., proximal stop ring 81.”).
Regarding claim 21, Allen in view of Schoettgen discloses the electrosurgical instrument of claim 20, and Allen further discloses an electrosurgical instrument further comprising a first sensor receiver mechanism (Figure 5: CPU 320) configured to be sensed by the first clamp closure sensor ([0050]), wherein the clamping drive train includes an actuation rod (Figure 5: jaw drive rod 80) configured to translate within the shaft assembly to move the first and second jaws from the open configuration toward the closed configuration ([0038]), wherein either the first clamp closure sensor or a first sensor receiver mechanism is operatively coupled with the actuation rod ([0050]: “sensor module 300 (and/or sensor module 200 (FIG. 4)) may further be configured such that one or more of sensors 302 is capable of sensing the position of movable handle 22. This may be accomplished by sensing the position of jaw drive rod 80 or a component fixed thereto, e.g., proximal stop ring 81.”).
Regarding claim 44, Allen in view of Schoettgen discloses the electrosurgical instrument of claim 16, and Allen further discloses an electrosurgical instrument further comprising a handle assembly extending proximally from the shaft assembly (Figure 1: stationary handle 20), wherein the handle assembly includes a pistol grip (Figure 1: stationary handle 20 includes a piston grip), wherein the input actuator is configured to selectively move toward the pistol grip from the unactuated position to the actuated position ([0031]: “More specifically, compression of movable handle 22 towards stationary handle 20 serves to move end effector assembly 14 to the closed configuration and return of movable handle 22 away from stationary handle 20 serves to move end effector assembly 14 back to the open configuration.”), wherein the second clamp closure sensor is positioned in the pistol grip (Figures 3A-C: sensor module 200).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Allen (Figure 5) in view of Schoettgen, further in view of Embodiment B of Allen (Figure 4).
Regarding claim 23, Embodiment A of Allen in view of Schoettgen discloses the electrosurgical instrument of claim 21, but does not explicitly disclose an electrosurgical instrument wherein the first sensor receiver mechanism is coupled with a proximal most end of the actuation rod.
However, Embodiment B of Allen teaches an electrosurgical instrument wherein the first sensor receiver mechanism is coupled with a proximal most end of the actuation rod (Figure 4: CPU 220 is coupled to the proximal most end of jaw drive rod 80 via lead wire 206).
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 instrument of Embodiment A of Allen so that the first sensor receiver mechanism is coupled with a proximal most end of the actuation rod as taught by Embodiment B of Allen to determine the clamping pressure applied to tissue by the amount of compression of a spring (Allen [0041]).
Claims 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Allen in view of Schoettgen, further in view of Scott et al., US 11224428, herein referred to as “Scott”.
Regarding claim 24, Allen in view of Schoettgen discloses the electrosurgical instrument of claim 21, but does not explicitly disclose an electrosurgical instrument further comprising a slip ring in electrical communication with the first clamp closure sensor, wherein the slip ring is configured to allow for rotation of the first clamp closure sensor or the first sensor receiver mechanism relative to the other of the first clamp closure sensor or the first sensor receiver mechanism.
However, Scott teaches an electrosurgical instrument (Col. 116, line 63 – Col. 117, line 5) further comprising a slip ring (Figure 4: slip ring assembly 1660) in electrical communication with the first clamp closure sensor (Col. 33, lines 56-61), wherein the slip ring is configured to allow for rotation of the first clamp closure sensor or the first sensor receiver mechanism relative to the other of the first clamp closure sensor or the first sensor receiver mechanism (Col. 33, line 56 – Col. 34, line 16).
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 instrument of Allen so that it comprises a slip ring in electrical communication with the first clamp closure sensor, wherein the slip ring is configured to allow for rotation of the first clamp closure sensor or the first sensor receiver mechanism relative to the other of the first clamp closure sensor or the first sensor receiver mechanism as taught by Scott so that the rotary position of elements of the instrument can be conveyed to a microcontroller, which can provide an indication to the user (Scott Col. 34, lines 9-16).
Regarding claim 25, Allen in view of Schoettgen discloses the electrosurgical instrument of claim 21, but does not explicitly disclose an electrosurgical instrument wherein the first sensor receiver mechanism comprises at least one of a magnet or a reflector.
However, Scott teaches an electrosurgical instrument (Col. 116, line 63 – Col. 117, line 5) wherein the first sensor receiver mechanism comprises at least one of a magnet or a reflector (Figure 5: magnet support arm 1665 and Col. 33, lines 56-61).
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 instrument of Allen so that the first sensor receiver mechanism comprises at least one of a magnet or a reflector as taught by Scott so that the position of an element measured by a Hall effect sensor can be indicated to a processor (Col. 36, lines 52-57).
Regarding claim 26, Allen in view of Schoettgen discloses the electrosurgical instrument of claim 21, but does not explicitly disclose an electrosurgical instrument wherein the first sensor receiver mechanism comprises a magnet, wherein the first clamp closure sensor comprises a Hall Effect sensor configured to sense the magnet.
However, Scott teaches an electrosurgical instrument (Col. 116, line 63 – Col. 117, line 5) wherein the first sensor receiver mechanism comprises a magnet (Figure 5: magnet support arm 1665 and Col. 33, lines 56-61), wherein the first clamp closure sensor comprises a Hall Effect sensor configured to sense the magnet (Figure 5: Hall effect sensor 1662).
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 instrument of Allen so that the first sensor receiver mechanism comprises a magnet and the first clamp closure sensor comprises a Hall Effect sensor configured to sense the magnet as taught by Scott so that the position of an element measured by a Hall effect sensor can be indicated to a processor (Col. 36, lines 52-57).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Allen in view of Schoettgen, further in view of Kelleher et al., US 20150057701, herein referred to as “Kelleher”.
Regarding claim 28, Allen in view of Schoettgen discloses the electrosurgical instrument of claim 16, with Allen disclosing an electrosurgical instrument including a first clamp closure sensor ([0050]: “sensor module 300 (and/or sensor module 200 (FIG. 4)) may further be configured such that one or more of sensors 302 is capable of sensing the position of movable handle 22. This may be accomplished by sensing the position of jaw drive rod 80 or a component fixed thereto, e.g., proximal stop ring 81.”) and a second clamp closure sensor (Figure 5: sensor module 300), but does not explicitly disclose a device wherein the first clamp closure sensor includes a first reflective optocoupler, wherein the second clamp closure sensor includes a second reflective optocoupler.
However, Kelleher teaches a device wherein the sensor is a reflective optocoupler (Figure 10 and [0203]: “Alternatively, a reflective optocoupler-type device can be used in which a light source is directed distally and is coupled with a sensor also aimed distally.”).
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 instrument of Allen so that the sensors are reflective optocouplers as taught by Kelleher so that the sensors can detect whether tissue is present and the distance to the tissue (Kelleher [0203]).
Claims 37 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Allen (Figure 5) in view of Embodiment B of Allen (Figure 4).
Regarding claim 37, Allen discloses an electrosurgical instrument (Figure 1: surgical instrument 10), comprising: (a) a shaft assembly (Figure 1: elongated shaft 16); (b) an end effector that extends distally from the shaft assembly (Figure 1: end effector assembly 14 extends distally from elongated shaft 16), the end effector comprising: (i) an energized feature configured to apply energy to a tissue (Figure 2A: electrically-conductive plates 48 and 50 and [0033]), (ii) a first jaw (Figures 1 and 2A: first jaw member 30), and (iii) a second jaw (Figures 1 and 2A: second jaw member 32) configured to selectively move relative to the first jaw from an open configuration configured to receive the tissue to a closed configuration configured to clamp the tissue ([0034] and Figures 2A-B); (c) an input actuator (Figure 1: movable handle 22) operatively connected to the end effector and configured to selectively move from an unactuated position to an actuated position to thereby move the first and second jaws from the open configuration toward the closed configuration ([0031]: “Movable handle 22, as detailed below, is operable to move jaw members 30, 32 of end effector assembly 14 between an open configuration (FIG. 2A), wherein jaw members 30, 32 are disposed in spaced relation relative to one another, and a closed configuration (FIG. 2B), wherein jaw members 30, 32 are approximated relative to one another. More specifically, compression of movable handle 22 towards stationary handle 20 serves to move end effector assembly 14 to the closed configuration and return of movable handle 22 away from stationary handle 20 serves to move end effector assembly 14 back to the open configuration.”); (d) a clamping drive train (Figure 5: jaw drive rod 80) connected between the input actuator ([0037]: “Movable handle 22 is pivotably coupled within housing 12 via a pivot pin 75 and is operably coupled to jaw drive rod 80 by way of mandrel 84 such that movable handle 22 may be manipulated to impart longitudinal motion to jaw drive rod 80.”) and the end effector ([0035]: “The distal end of jaw drive rod 80 is operably coupled to jaw members 30, 32, e.g., via a pin (not shown) associated with jaw drive rod 80 and extending through oppositely-angled slots (not shown) defined within proximal flanges (not shown) of jaw members 30, 32”), wherein the clamping drive train includes an actuation rod (Figure 5: jaw drive rod 80) configured to translate within the shaft assembly to move the first and second jaws from the open configuration toward the closed configuration ([0038]), wherein the actuation rod includes a proximal most end (Figure 5: jaw drive rod 80 has a proximal most end); (e) a biasing feature (Figure 3A: drive assembly 70) operatively connected between the input actuator and the end effector and configured to resiliently deflect for limiting force transmitted therethrough (Figures 3A-3B and [0035]); (f) a first clamp closure sensor configured to produce first sensor information relating to movement of the input actuator in response to the input actuator being moved from the unactuated position to the actuated position ([0050]: “sensor module 300 (and/or sensor module 200 (FIG. 4)) may further be configured such that one or more of sensors 302 is capable of sensing the position of movable handle 22. This may be accomplished by sensing the position of jaw drive rod 80 or a component fixed thereto, e.g., proximal stop ring 81.”); (g) a first sensor receiver mechanism (Figure 5: CPU 320) configured to be sensed by the first clamp closure sensor ([0050]) wherein the first sensor receiver mechanism is positioned entirely proximal to the biasing feature (Figures 3A-C: as spring 86 compresses and expands, sensor module 200 and proximal stop ring 81 stay in the same position; Figure 5: CPU 320 is entirely proximal to proximal stop ring 81 thus it is entirely proximal to the biasing feature, spring 86); (h) a second clamp closure sensor (Figure 5: sensor module 300) configured to produce second sensor information relating to deflection of the biasing feature in response to a tissue load force between the first and second jaws (Figure 5 and [0048]); and (i) a control unit (Figure 5: processor 324) operatively connected with the first and second clamp closure sensors (Figure 5: processor 324 is part of sensor module 300), wherein, based on each of the first and second sensor information produced by the first and second clamp closure sensors, the control unit is configured to determine each of: (i) the tissue load force exerted on the end effector ([0015]: “The sensor module is configured to sense a property of the spring of the force regulating mechanism indicative of an amount the spring has been compressed and, based upon the sensed property, determine the clamping pressure applied to tissue” and [0016]), and (ii) a position of one of the first and second jaws relative to the other of the first and second jaws ([0050]). Embodiment A of Allen does not explicitly disclose an electrosurgical instrument wherein the first sensor receiver mechanism is positioned at the proximal most end of the actuation rod.
However, Embodiment B of Allen teaches an electrosurgical instrument wherein the first sensor receiver mechanism is positioned at the proximal most end of the actuation rod (Figure 4: CPU 220 is coupled to the proximal most end of jaw drive rod 80 via lead wire 206 which is part of the first sensor receiver mechanism).
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 instrument of Embodiment A of Allen so that the first sensor receiver mechanism is positioned at the proximal most end of the actuation rod as taught by Embodiment B of Allen to determine the clamping pressure applied to tissue by the amount of compression of a spring (Allen [0041]).
Regarding claim 46, Embodiment A of Allen in view of Embodiment B of Allen discloses the electrosurgical instrument of claim 37, and Embodiment A of Allen further discloses an electrosurgical instrument further comprising a second sensor receiver mechanism configured to be sensed by the second clamp closure sensor to determine the second sensor information (Figure 5: sensor module 300 and processor 324).
Claims 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Allen (Figure 5) in view of Embodiment B of Allen (Figure 4), further in view of Scott.
Regarding claim 38, Embodiment A of Allen in view of Embodiment B of Allen discloses the electrosurgical instrument of claim 37, but does not explicitly disclose an electrosurgical instrument wherein the first clamp closure sensor includes a Hall Effect sensor, wherein the first sensor receiver mechanism includes a magnet, wherein the Hall Effect sensor is configured to sense the magnet as the actuation rod and the magnet are configured to translate within the shaft assembly to move the first and second jaws from the open configuration toward the closed configuration.
However, Scott teaches an electrosurgical instrument (Col. 116, line 63 – Col. 117, line 5) wherein the first clamp closure sensor includes a Hall Effect sensor magnet (Figure 5: Hall effect sensor 1662), wherein the first sensor receiver mechanism includes a magnet (Figure 5: magnet support arm 1665 and Col. 33, lines 56-61), wherein the Hall Effect sensor is configured to sense the magnet as the actuation rod and the magnet are configured to translate within the shaft assembly to move the first and second jaws from the open configuration toward the closed configuration (Col. 35, line 60 – Col. 36, line 25).
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 instrument of Allen so that the first clamp closure sensor includes a Hall Effect sensor, wherein the first sensor receiver mechanism includes a magnet, wherein the Hall Effect sensor is configured to sense the magnet as the actuation rod and the magnet are configured to translate within the shaft assembly to move the first and second jaws from the open configuration toward the closed configuration as taught by Scott so that the position of an element measured by a Hall effect sensor can be indicated to a processor (Col. 36, lines 52-57).
Regarding claim 39, Embodiment A of Allen in view of Embodiment B of Allen and Scott discloses the electrosurgical instrument of claim 38, and Scott further discloses an electrosurgical instrument further comprising a slip ring that is coupled with the Hall Effect sensor, wherein the slip ring is in electrical communication with the Hall Effect sensor.
However, Scott teaches an electrosurgical instrument (Col. 116, line 63 – Col. 117, line 5) further comprising a slip ring (Figure 4: slip ring assembly 1660) that is coupled with the Hall Effect sensor (Col. 33, lines 56-61), wherein the slip ring is in electrical communication with the Hall Effect sensor (Col. 33, line 56 – Col. 34, line 16).
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 instrument of Allen so that it comprises a slip ring that is coupled with the Hall Effect sensor, wherein the slip ring is in electrical communication with the Hall Effect sensor as taught by Scott so that the rotary position of elements of the instrument can be conveyed to a microcontroller, which can provide an indication to the user (Scott Col. 34, lines 9-16).
Claims 40 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Allen (Figure 5) in view of Embodiment B of Allen (Figure 4), further in view of Schoettner.
Regarding claim 40, Embodiment A of Allen in view of Embodiment B of Allen discloses the electrosurgical instrument of claim 37, but does not explicitly disclose an electrosurgical instrument wherein the control unit is further configured to use the first and second sensor information to determine a jaw angle between the first and second jaws.
However, Schoettner teaches an electrosurgical instrument (Figures 8-11) comprising a control unit (Figures 8-11: control unit 94) configured to use sensor information to determine a jaw angle between the first and second jaws ([0059]: “The control unit 94 processes the output signal from the encoder sensor 98 to monitor the current jaw angle 26 and control lighting of the feedback output lights 74, 76, 78 in accordance with the current jaw angle 26 similar to as described herein with respect to the surgical instrument 70.”). In combination with Allen, encoder sensor 98 of Schoettner is part of sensor module 300 of Allen, and thus the control unit uses the first and second sensor information to determine a jaw angle between the first and second 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 instrument of Allen so that the control unit is configured to determine a jaw angle between the first and second jaws as taught by Schoettgen to provide feedback to an operator of the surgical instrument indicative of whether the tissue is suitable clamped for sealing and/or cutting (Schoettgen Abstract).
Regarding claim 47, Embodiment A of Allen in view of Embodiment B of Allen discloses the electrosurgical instrument of claim 37, and Embodiment A of Allen further discloses an electrosurgical instrument further comprising wherein the first and second clamp closure sensors are positioned entirely proximal to the end effector (Figures 3A-C: sensor module 200 is within housing 12, Figure 1: housing 12 is positioned entirely proximal to end effector assembly 14; thus optical sensors 302 are positioned entirely proximal to end effector assembly 14), wherein, based on each of the first and second sensor information produced by the first and second clamp closure sensors positioned entirely proximal to the end effector (Figure 5: sensor module 300), the control unit is configured to determine each of: (i) the tissue load force exerted on the end effector ([0015]: “The sensor module is configured to sense a property of the spring of the force regulating mechanism indicative of an amount the spring has been compressed and, based upon the sensed property, determine the clamping pressure applied to tissue” and [0016]), and (ii) the position of one of the first and second jaws relative to the other of the first and second jaws ([0050]). Allen does not explicitly disclose an electrosurgical instrument comprising a control unit configured to determine a jaw angle between the first and second jaws.
However, Schoettgen teaches an electrosurgical instrument (Figures 8-11) wherein, based on each of the sensor information produced by the clamp closure sensor positioned entirely proximal to the end effector (Figures 8-11: encoder sensor 98), the control unit is configured to determine a jaw angle between the first and second jaws ([0059]: “The control unit 94 processes the output signal from the encoder sensor 98 to monitor the current jaw angle 26 and control lighting of the feedback output lights 74, 76, 78 in accordance with the current jaw angle 26 similar to as described herein with respect to the surgical instrument 70.”).
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 instrument of Allen so that the control unit is configured to determine a jaw angle between the first and second jaws as taught by Schoettgen to provide feedback to an operator of the surgical instrument indicative of whether the tissue is suitable clamped for sealing and/or cutting (Schoettgen Abstract).
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Allen in view of Boudreaux et al., US 20160120601, herein referred to as “Boudreaux”, further in view of Sakaguchi et al., US 20160022355, herein referred to as “Sakaguchi”.
Regarding claim 41, Allen discloses an electrosurgical instrument (Figure 1: surgical instrument 10), comprising: (a) a shaft assembly (Figure 1: elongated shaft 16); (b) an end effector that extends distally from the shaft assembly (Figure 1: end effector assembly 14 extends distally from elongated shaft 16), the end effector comprising: (i) an energized feature configured to apply energy to a tissue (Figure 2A: electrically-conductive plates 48 and 50 and [0033]), (ii) a first jaw (Figures 1 and 2A: first jaw member 30), and (iii) a second jaw (Figures 1 and 2A: second jaw member 32) configured to selectively move relative to the first jaw from an open configuration configured to receive the tissue to a closed configuration configured to clamp the tissue ([0034] and Figures 2A-B); (c) an input actuator (Figure 1: movable handle 22) operatively connected to the end effector and configured to selectively move from an unactuated position to an actuated position to thereby move the first and second jaws from the open configuration toward the closed configuration ([0031]: “Movable handle 22, as detailed below, is operable to move jaw members 30, 32 of end effector assembly 14 between an open configuration (FIG. 2A), wherein jaw members 30, 32 are disposed in spaced relation relative to one another, and a closed configuration (FIG. 2B), wherein jaw members 30, 32 are approximated relative to one another. More specifically, compression of movable handle 22 towards stationary handle 20 serves to move end effector assembly 14 to the closed configuration and return of movable handle 22 away from stationary handle 20 serves to move end effector assembly 14 back to the open configuration.”); (d) a clamping drive train (Figure 5: jaw drive rod 80) connected between the input actuator ([0037]: “Movable handle 22 is pivotably coupled within housing 12 via a pivot pin 75 and is operably coupled to jaw drive rod 80 by way of mandrel 84 such that movable handle 22 may be manipulated to impart longitudinal motion to jaw drive rod 80.”) and the end effector ([0035]: “The distal end of jaw drive rod 80 is operably coupled to jaw members 30, 32, e.g., via a pin (not shown) associated with jaw drive rod 80 and extending through oppositely-angled slots (not shown) defined within proximal flanges (not shown) of jaw members 30, 32”), wherein the clamping drive train includes a biasing feature (Figure 3A and 5: drive assembly 70) operatively connected between the input actuator and the end effector and configured to resiliently deflect for limiting force transmitted therethrough (Figures 3A-3B and 5 and [0035]); (e) a first clamp closure sensor configured to produce first sensor information relating to movement of the input actuator in response to the input actuator being moved from the unactuated position to the actuated position ([0050]: “sensor module 300 (and/or sensor module 200 (FIG. 4)) may further be configured such that one or more of sensors 302 is capable of sensing the position of movable handle 22. This may be accomplished by sensing the position of jaw drive rod 80 or a component fixed thereto, e.g., proximal stop ring 81.”); a (f) a first sensor receiver mechanism configured to be sensed by the first clamp closure sensor as the clamping drive train translates within the shaft assembly to move the first and second jaws from the open configuration toward the closed configuration ([0050]); and (h) a second clamp closure sensor (Figure 5: sensor module 300) configured to produce second sensor information relating to deflection of the biasing feature in response to a tissue load force between the first and second jaws (Figure 5 and [0048]); and (i) a control unit (Figure 5: processor 324) operatively connected with the first and second clamp closure sensors (Figure 5: processor 324 is part of sensor module 300), wherein, based on each of the first and second sensor information produced by the first and second clamp closure sensors, the control unit is configured to determine each of: (i) the tissue load force exerted on the end effector ([0015]: “The sensor module is configured to sense a property of the spring of the force regulating mechanism indicative of an amount the spring has been compressed and, based upon the sensed property, determine the clamping pressure applied to tissue” and [0016]), and (ii) a position of one of the first and second jaws relative to the other of the first and second jaws ([0050]). Allen does not explicitly disclose an electrosurgical instrument comprising a first sensor receiver mechanism configured to be sensed by the first clamp closure sensor as the clamping drive train and the first sensor receiver mechanism translate relative to the biasing feature within the shaft assembly to move the first and second jaws from the open configuration toward the closed configuration; and a slip ring in electrical communication with the first clamp closure sensor, wherein the slip ring includes a plurality of annular spaced contacts extending longitudinally relative to the longitudinal axis.
However, Boudreaux teaches an electrosurgical instrument (Figure 31) comprising a first sensor receiver mechanism (Figure 33: sensor rack 687) configured to be sensed by the first clamp closure sensor (Figure 33: jaw sensor circuitry 700 and [0135]-[0136]) as the clamping drive train and the first sensor receiver mechanism translate relative to the biasing feature within the shaft assembly to move the first and second jaws from the open configuration toward the closed configuration ([0135] and [0137]).
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 instrument of Allen so that It includes a first sensor receiver mechanism configured to be sensed by the first clamp closure sensor as the clamping drive train and the first sensor receiver mechanism translate relative to the biasing feature within the shaft assembly to move the first and second jaws from the open configuration toward the closed configuration as taught by Boudreaux so that a controller can identify that an end effector is in a closed state and thus modify the energy delivered to the end effector to ensure adequate sealing of tissue grasped by end effector (Boudreaux [0138]).
Further, Sakaguchi teaches an electrosurgical instrument (Figure 1) comprising a slip ring (Figure 5: slip ring mechanism 26) in electrical communication with the another element of the instrument ([0077]: “The slip ring mechanism 96 is a mechanism that maintains a conductive path in the interior of the handle 14, and carries out supply of electricity to the gripper 12”), wherein the slip ring includes a plurality of annular spaced contacts extending longitudinally relative to the longitudinal axis (Figure 5: two contact terminals 104a and 104b extend longitudinally relative to the longitudinal axis). In combination with Allen, the slip ring is in electrical communication with the first clamp closure sensor, which is part of the device’s conductive path.
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 instrument of Allen so that it includes a slip ring in electrical communication with the first clamp closure sensor, wherein the slip ring includes a plurality of annular spaced contacts extending longitudinally relative to the longitudinal axis as taught by Sakaguchi because a slip ring mechanism can easily be assembled without using a bonding means such as soldering, an adhesive, or the like (Sakaguchi [0009]).
Claims 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Allen in view of Boudreaux and Sakaguchi, further in view of Scott.
Regarding claim 42, Allen in view of Boudreaux and Sakaguchi discloses the electrosurgical instrument of claim 41, but does not explicitly disclose an electrosurgical instrument wherein the first clamp closure sensor comprises a Hall Effect sensor configured to produce first sensor information relating to movement of the input actuator in response to the input actuator being moved from the unactuated position to the actuated position, wherein the first sensor receiver mechanism comprises a magnet, wherein the Hall Effect sensor is configured to sense the magnet as the clamping drive train and the magnet translate within the shaft assembly to move the first and second jaws from the open configuration toward the closed configuration, wherein the slip ring is in electrical communication with the Hall Effect sensor.
However, Scott teaches an electrosurgical instrument (Col. 116, line 63 – Col. 117, line 5) wherein the first clamp closure sensor comprises a Hall Effect sensor (Figure 5: Hall effect sensor 1662) configured to produce first sensor information relating to movement of the input actuator in response to the input actuator being moved from the unactuated position to the actuated position (Col. 35, line 60 – Col. 36, line 25), wherein the first sensor receiver mechanism comprises a magnet (Figure 5: magnet support arm 1665 and Col. 33, lines 56-61), wherein the Hall Effect sensor is configured to sense the magnet as the clamping drive train and the magnet translate within the shaft assembly to move the first and second jaws from the open configuration toward the closed configuration (Col. 35, line 60 – Col. 36, line 25), wherein the slip ring (Figure 4: slip ring assembly 1660) is in electrical communication with the Hall Effect sensor (Col. 33, line 56 – Col. 34, line 16).
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 instrument of Allen so that the first clamp closure sensor comprises a Hall Effect sensor configured to produce first sensor information relating to movement of the input actuator in response to the input actuator being moved from the unactuated position to the actuated position, wherein the first sensor receiver mechanism comprises a magnet, wherein the Hall Effect sensor is configured to sense the magnet as the clamping drive train and the magnet translate within the shaft assembly to move the first and second jaws from the open configuration toward the closed configuration, wherein the slip ring is in electrical communication with the Hall Effect sensor as taught by Scott so that the rotary position of elements of the instrument can be conveyed to a microcontroller, which can provide an indication to the user (Scott Col. 34, lines 9-16).
Regarding claim 43, Allen in view of Boudreaux, Sakaguchi, and Scott discloses the electrosurgical instrument of claim 42, and Sakaguchi further discloses an electrosurgical instrument wherein the plurality of annular spaced contacts extending longitudinally relative to the longitudinal axis (Figure 5: two contact terminals 104a and 104b extend longitudinally relative to the longitudinal axis) are configured to allow for rotation of one element of the device relative to another element of the device (Abstract and [0079]). In combination with Scott, these elements are the magnet and the Hall Effect sensor.
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 instrument of Allen so that it includes a slip ring, wherein the slip ring includes a plurality of annular spaced contacts extending longitudinally relative to the longitudinal axis as taught by Sakaguchi because a slip ring mechanism can easily be assembled without using a bonding means such as soldering, an adhesive, or the like (Sakaguchi [0009]).
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Allen in view of Schoettgen, further in view of Boudreaux.
Regarding claim 45, Allen in view of Schoettgen discloses the electrosurgical instrument of claim 16, but does not explicitly disclose an electrosurgical instrument further comprising a first sensor receiver mechanism configured to be sensed by the first clamp closure sensor, wherein the first sensor receiver mechanism is configured to translate longitudinally relative to the biasing feature.
However, Boudreaux teaches an electrosurgical instrument (Figure 31) comprising a first sensor receiver mechanism (Figure 33: sensor rack 687) configured to be sensed by the first clamp closure sensor (Figure 33: jaw sensor circuitry 700 and [0135]-[0136]) as the clamping drive train and the first sensor receiver mechanism translate relative to the biasing feature within the shaft assembly to move the first and second jaws from the open configuration toward the closed configuration ([0135] and [0137]).
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 instrument of Allen so that It includes a first sensor receiver mechanism configured to be sensed by the first clamp closure sensor as the clamping drive train and the first sensor receiver mechanism translate relative to the biasing feature within the shaft assembly to move the first and second jaws from the open configuration toward the closed configuration as taught by Boudreaux so that a controller can identify that an end effector is in a closed state and thus modify the energy delivered to the end effector to ensure adequate sealing of tissue grasped by end effector (Boudreaux [0138]).
Conclusion
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/N.W.R./Examiner, Art Unit 3794 /SEAN W COLLINS/Primary Examiner, Art Unit 3794
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