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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1 September 2026 has been entered.
Formal Matters
Claims 4, 5, 12, 13 are cancelled. Claims 1, 6, 8, 14, and 15 are currently amended. Claims 1-3, 6-11, and 14-20 are pending and under examination.
Objections/Rejections Withdrawn
The rejection of claims 4, 5, 12, and 13 are withdrawn as moot in light of the cancellation of the claims. However, insofar as claims 4 and 5 have been amended into independent claim 1 and claims 12 and 13 have been amended into independent claim 8, the rejections of record are modified, as set forth below.
Response to Arguments
Applicant argues that the amendments to the claims overcome the rejection of claims 1-7 and 17-19 under 35 USC 103 over Horner et al.,, US 20150327913 (19 November 2015) and State et al., US 20180116731 (3 May 2018); the rejection of claims 8-16 over Horner in view of State and further in view of Shelton et al., US 20200405375 (31 December 2020); and the rejection of claim 20 over Horner, in view of State and Durant et al., US 9,043,027 (26 May 2015) because the references alone or in combination do not teach or suggest at least a controller configured to “analyze the video to identify a critical structure of the tissue and to output the virtual representation of the probe based on a distance of the probe to the critical structure” as recited in independent claims 1 and 8 and as similarly recited in independent claim 17 or “wherein the virtual representation is generated based on a three-dimensional model of the probe and a reference point of an end effector assembly of the surgical instrument, as recited in independent claims 1, 8, and 17 (Remarks, numbered p. 6 of 11). Applicant’s arguments have been fully considered, but they are not persuasive. State expressly teaches system 100 wherein the controller (processor, ¶41) is further configured to analyze (determining “emplacement”, “referring to position, orientation, or other location information”, ¶32) the video (“including video”, ¶31) to identify a critical structure (¶142) of the tissue (¶141) and wherein the controller (processor, ¶41) is further configured to output the virtual representation of the probe (medical device, ¶187) based on a distance of the probe to the critical structure (¶187). However, in light of Applicant’s amendments to the independent claims, further search and consideration of the amendments was undertaken over the claims as a whole. Additional prior art was identified, providing additional clarity to the rejections of record, and necessitating modified rejections, set forth below.
Modified Rejections 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 (i.e., changing from AIA to pre-AIA ) 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 6, 7, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Horner et al., US 20150327913 (19 November 2015) in view of State et al., US 20180116731 (3 May 2018) (both previously cited of record), and further in view of Shelton et al., US 20210196383 (1 July 2021) (hereinafter Shelton ‘383).
Regarding claim 1, Horner teaches a surgical system (FIG 1) comprising:
a surgical instrument (10) including: first (110) and second (120) jaw members,
at least one of the first (110) or second (120) jaw members movable relative to the other of the first (110) or second jaw members from a spaced apart position to an approximated position to grasp tissue therebetween (¶34),
at least one of the first (110) or second (120) jaw members adapted (¶33 wires; cable 8) to connect to a source of energy (generator “G”) for conducting energy (¶33) through tissue grasped between the first (110) and second (120) jaw members to treat the tissue (¶33); and
a probe (151) adapted to connect to a source of energy (¶49) and movable (¶44 slidably housed within end effector assembly 150); from a retracted position (FIGs 2 and 4) to a deployed position (FIGs 3 and 5).
Horner does not teach a camera configured to capture a video of a tissue and the surgical instrument; a controller configured to generate a virtual representation of the probe based on the video of the surgical instrument; and a monitor configured to display the video of the tissue and the surgical instrument, and the virtual representation of the probe in the deployed position. However, Horner also teach that the robotic surgical system is intended to for use in endoscopic surgical procedures (¶31) and the system comprises a controller system that controls the end effector assembly and other instrumentation parameters (¶¶59-60).
State teaches medical instrument navigation systems (FIG 1A, ¶26 and FIG 13, ¶149) comprising system (100) comprising a display unit (120) and a position sensing unit (140) communicatively coupled to an image guidance unit (130) (¶30). State teaches that the system comprises a camera (155) configured to capture a video (¶31) of a tissue and the surgical instrument (145). State teaches a controller (processor, ¶41) configured to generate a virtual representation (122) of the probe (155) based on the video (¶31) of the surgical instrument (145) (¶31), where the instrument includes jaws or a transecting knife (¶41). State teaches a monitor (120) configured to display the video (¶31) of the tissue and the surgical instrument (145), and the virtual representation of the probe (155) in the deployed position (¶31).
State teaches system 100 wherein the controller (processor, ¶41) is further configured to analyze (determining “emplacement”, “referring to position, orientation, or other location information” ¶32) the video (“including video”, ¶31) to identify a critical structure (¶142) of the tissue (¶141) and wherein the controller (processor, ¶41) is further configured to output the virtual representation of the probe (medical device, ¶187) based on a distance of the probe to the critical structure (¶187).
State also teaches that “3D graphics can be produced using underlying data models stored in the image guidance unit” (e.g., “generated”) (¶41). State teaches that “the underlying 3D model can be updated based on the relative emplacements of the various devices 145 and 155 as determined by the position sensing unit 140 and/or based on new data associated with the devices 145 and 155” (¶41). State teaches an example that if the first medical device 145 is a stapler, then the underlying model can be updated to reflect any changes related to the jaws [e.g., “end effector assembly of the surgical instrument”], such as information regarding the affected region or angles of the jaws and/or transecting knife” (¶41). State also discloses that any appropriate 3D graphics processing can be used for rendering (¶41). State also teaches that “the system 100 can concurrently determine the emplacement of the medical image and/or one or more virtual medical devices, etc.” (¶189).
Shelton ‘383 expressly teaches wherein the controller (FIGs 1, 11, “control system 600 for surgical visualization system 100”; ¶¶152, 171, 175) is further configured to analyze the video (FIG 11, ¶¶172, 175, 176) to identify a critical structure (FIG 11, ¶¶174, 180) of the tissue (FIG 11, ¶¶174, 179) and wherein the controller (FIG 11, “control system 600 including spectral control circuit 602”, ¶175) is further configured to output the virtual representation of the probe (FIG 1, “surgical visualization system 100 can be configured to achieve identification of one or more critical structures 101 and the proximity of the surgical device 102 to the critical structures 101”, ¶152) based on a distance of the probe to the critical structure (FIGs 1 and 11, ¶¶152, 180, 182).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Horner, State, and Shelton ‘383, given that the prior art included each element claimed, although not necessarily in a single reference. Horner, State, and Shelton ‘ 383 teach in the same field of endeavor, medical surgical systems comprising surgical tools with jaw members.
Although, Horner discloses the claimed base surgical system comprising jaw members adapted to treat tissue and a probe adapted to connect to an energy source and movably housed within an end effector assembly from a retracted to a deployed position, Horner does not teach a camera configured to capture a video of a tissue and the surgical instrument; a controller configured to generate a virtual representation of the probe based on the video of the surgical instrument; and a monitor configured to display the video of the tissue and the surgical instrument, and the virtual representation of the probe in the deployed position.
State specifically addressed the navigation system and provides image guidance for placement of one or more medical devices at a target location (Abstract). State’s system can cause one or more displays to display video perspectives of images as well as image guidance cues, including virtual representations of the devices in 3D space (Abstract). Similarly, the systems of State can concurrently determine the emplacement of the medical image and/or one or more virtual medical devices.
Because Horner medical surgical system is compatible with endoscopic surgical systems, comprising surgical tools with jaw members that are controllable by a controller, a person of ordinary skill in the art, seeking to more precisely control the end effector assembly tools and probe would reasonably consult State’s navigation and 3D virtual representation solution. State’s navigation and 3D virtual representation solution can be incorporated alongside Horner’s base surgical device (same general location and interaction with the surgical end effector assembly and probe, as well as endoscopic cameras and controls) using known assembly methods and known software without redesigning Horner’s core surgical device.
Additionally, Shelton ‘383 expressly discloses control system 600 for surgical visualization system 100 (FIGs 1, 11; ¶¶152, 171, 175) is further configured to analyze the video (FIG 11, ¶¶172, 175, 176) to identify a critical structure (FIG 11, ¶¶174, 180) of the tissue (FIG 11, ¶¶174, 179) and wherein the controller (FIG 11, “control system 600 including spectral control circuit 602”, ¶175) is further configured to output the virtual representation of the probe (FIG 1, “surgical visualization system 100 can be configured to achieve identification of one or more critical structures 101 and the proximity of the surgical device 102 to the critical structures 101”, ¶152) based on a distance of the probe to the critical structure (FIGs 1 and 11, ¶¶152, 180, 182). A person of ordinary skill in the art attempting to render Horner’s medical surgical system compatible with surgical visualization systems that are controllable by a controller and to more precisely employ and control an interactive visualization system in a surgical setting would look for established visualization system designs to avoid creating a novel visualization interface. Shelton ‘383’s control system 600 for surgical visualization system 100 is modular and can be adapted to the medical surgical system of Horner and medical instrument navigation systems of State, particularly given that Shelton ‘383 also teaches the generation of 3D imaging of the surgical site (like that of State), including determining one or more distances at the surgical site (¶¶153, 157).
Because the references address the same engineering problem (controlling and visualizing endoscopic and robotic medical surgical systems comprising end effector surgical tool assemblies with jaw members and probes) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a controller-based position and navigation system and a surgical visualization system, to correlate video with an overlying virtual representation model) to modularly adapt the base surgical system of Horner, a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 2, Horner modified by State and Shelton ‘383 teaches the surgical system according to claim 1, as set forth above, for the reasons set forth above.
Horner teaches the system further comprising a switch (monopolar activation switch 157) operable in a first stage in response to which the probe is moved to the deployed position (deployed position FIGs 3 and 5; ¶46).
Regarding claim 3, Horner modified by State and Shelton ‘383 teaches the surgical system according to claim 2, as set forth above, for the reasons set forth above.
Horner teaches wherein the switch (monopolar activation switch 157) is operable in a second stage (fully extended, ¶49) in response to which the probe is energized (electrical activation, ¶49).
Regarding claim 6, Horner modified by State and Shelton ‘383 teaches the surgical system according to claim 4, as set forth above, for the reasons set forth above.
State teaches wherein the controller (¶41, processor) is further configured to highlight the critical structure (¶203).
Regarding claim 7, Horner modified by State and Shelton ‘383 teaches the surgical system according to claim 1 as set forth above, for the reasons set forth above.
State teaches wherein the monitor (display unit 120) is configured to display the virtual representation in response to a user command (¶61).
Regarding independent claim 17, Horner teaches a method for controlling deployment of a probe of a surgical instrument (¶16), the method comprising:
a surgical instrument (10) including an end effector assembly (first (110) and second (120) jaw members) and a probe (151) adapted to connect to a source of energy (¶49),
the probe movable from a retracted position to a deployed position relative to the end effector assembly (¶44 slidably housed within end effector assembly 150); from a retracted position (FIGs 2 and 4) to a deployed position (FIGs 3 and 5);
Horner does not teach capturing a video of a tissue, generating, at a controller, a virtual representation of the probe based on the video of the surgical instrument, wherein the virtual representation of the probe is generated based on a three-dimensional model of the probe and a reference point of the end effector assembly; analyzing, at a controller, the video to identify a critical structure of the tissue; and displaying on a monitor the video of the tissue and the surgical instrument and the virtual representation deployed position based on a distance of the probe to the critical structure.
State teaches medical instrument navigation systems (FIG 1A, ¶26 and FIG 13, ¶149) comprising system (100) capturing a video (¶31) of a tissue, generating, at a controller (¶41, processor), a virtual representation (122) of the probe (155) based on the video of the surgical instrument (¶31); analyzing, at a controller (processor, ¶41), the video (“including video”, ¶31) to identify a critical structure of the tissue (¶203); and displaying on the monitor (120) the virtual representation of the probe in the deployed position based on a distance of the probe (medical device, ¶187) to the critical structure (¶187). States teaches wherein a monitor displays the video of the tissue (¶31) and the surgical instrument (145) and the virtual representation of the probe (155) in the deployed position based on a distance of the probe (medical device, ¶187) to the critical structure (¶¶187-189) and expressly discloses that “the system 100 can concurrently determine the emplacement of the medical image and/or one or more virtual medical devices, etc.” (¶189).
State also teaches that “3D graphics can be produced using underlying data models stored in the image guidance unit” (e.g., “generated”) (¶41). State teaches that “the underlying 3D model can be updated based on the relative emplacements of the various devices 145 and 155 as determined by the position sensing unit 140 and/or based on new data associated with the devices 145 and 155” (¶41). State teaches an example that if the first medical device 145 is a stapler, then the underlying model can be updated to reflect any changes related to the jaws [e.g., “end effector assembly of the surgical instrument”], such as information regarding the affected region or angles of the jaws and/or transecting knife” (¶41). State also discloses that any appropriate 3D graphics processing can be used for rendering (¶41). State also teaches that “the system 100 can concurrently determine the emplacement of the medical image and/or one or more virtual medical devices, etc.” (¶189).
Shelton ‘383 expressly teaches wherein the controller (FIGs 1, 11, “control system 600 for surgical visualization system 100”; ¶¶152, 171, 175) is further configured to analyze the video (FIG 11, ¶¶172, 175, 176) to identify a critical structure (FIG 11, ¶¶174, 180) of the tissue (FIG 11, ¶¶174, 179) and wherein the controller (FIG 11, “control system 600 including spectral control circuit 602”, ¶175) is further configured to output the virtual representation of the probe (FIG 1, “surgical visualization system 100 can be configured to achieve identification of one or more critical structures 101 and the proximity of the surgical device 102 to the critical structures 101”, ¶152) based on a distance of the probe to the critical structure (FIGs 1 and 11, ¶¶152, 180, 182).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Horner, State, and Shelton ‘383, given that the prior art included each element claimed, although not necessarily in a single reference. Horner, State, and Shelton ‘ 383 teach in the same field of endeavor, medical surgical systems comprising surgical tools with jaw members.
Although, Horner discloses the claimed base method for controlling deployment of a probe of a surgical instrument comprising jaw members adapted to treat tissue and a probe adapted to connect to an energy source and movably housed within an end effector assembly from a retracted to a deployed position, Horner does not teach a camera configured to capture a video of a tissue and the surgical instrument; a controller configured to generate a virtual representation of the probe based on the video of the surgical instrument; and a monitor configured to display the video of the tissue and the surgical instrument, and the virtual representation of the probe in the deployed position.
State specifically addressed the navigation system and provides image guidance for placement of one or more medical devices at a target location (Abstract). State’s system can cause one or more displays to display video perspectives of images as well as image guidance cues, including virtual representations of the devices in 3D space (Abstract). Similarly, the systems of State can concurrently determine the emplacement of the medical image and/or one or more virtual medical devices.
Because Horner’s method for controlling deployment of a probe of a surgical instrument is compatible with endoscopic surgical systems comprising surgical tools with jaw members that are controllable by a controller, a person of ordinary skill in the art, seeking to more precisely control the end effector assembly tools and probe would reasonably consult State’s navigation and 3D virtual representation solution. State’s navigation and 3D virtual representation solution can be incorporated alongside Horner’s base surgical device (same general location and interaction with the surgical end effector assembly and probe, as well as endoscopic cameras and controls) using known assembly methods and known software without redesigning Horner’s core surgical device.
Additionally, Shelton ‘383 expressly discloses control system 600 for surgical visualization system 100 (FIGs 1, 11; ¶¶152, 171, 175) is further configured to analyze the video (FIG 11, ¶¶172, 175, 176) to identify a critical structure (FIG 11, ¶¶174, 180) of the tissue (FIG 11, ¶¶174, 179) and wherein the controller (FIG 11, “control system 600 including spectral control circuit 602”, ¶175) is further configured to output the virtual representation of the probe (FIG 1, “surgical visualization system 100 can be configured to achieve identification of one or more critical structures 101 and the proximity of the surgical device 102 to the critical structures 101”, ¶152) based on a distance of the probe to the critical structure (FIGs 1 and 11, ¶¶152, 180, 182). A person of ordinary skill in the art attempting to render Horner’s medical surgical system compatible with surgical visualization systems that are controllable by a controller and to more precisely employ and control an interactive visualization system in a surgical setting would look for established visualization system designs to avoid creating a novel visualization interface. Shelton ‘383’s control system 600 for surgical visualization system 100 is modular and can be adapted to the medical surgical system of Horner and medical instrument navigation systems of State, particularly given that Shelton ‘383 also teaches the generation of 3D imaging of the surgical site (like that of State), including determining one or more distances at the surgical site (¶¶153, 157).
Because the references address the same engineering problem (controlling and visualizing endoscopic and robotic medical surgical systems comprising end effector surgical tool assemblies with jaw members and probes) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a controller-based position and navigation system and a surgical visualization system, to correlate video with an overlying virtual representation model) to modularly adapt the base surgical system of Horner, a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 18, Horner modified by State and Shelton ‘383 teaches the method according to claim 17, as set forth above, for the reasons set forth above.
Horner teaches the system further comprising receiving a first input from a switch (monopolar activation switch 157) operable to move the probe to the deployed position (deployed position FIGs 3 and 5; ¶46).
Regarding claim 19, Horner modified by State and Shelton ‘383 teaches the method according to claim 17, as set forth above, for the reasons set forth above.
Horner teaches the system further comprising receiving a second input from a switch (monopolar activation switch 157; fully extended, ¶49) to energize the probe (electrical activation, ¶49).
Claims 8-11 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Horner et al., US 20150327913 (19 November 2015), in view of State et al., US 20180116731 (3 May 2018) (both previously cited of record), and further in view of Shelton et al., US 20200405375 (31 December 2020) (hereinafter Shelton ‘375) and Shelton et al., US 20210196383 (1 July 2021) (hereinafter Shelton ‘383).
Regarding independent claim 8, Horner teaches a surgical robotic system (FIG 1) comprising:
a first robotic arm controlling a surgical instrument (¶60) including:
first (110) and second (120) jaw members, at least one of the first (110) and second (120) jaw members movable relative to the other of the first (110) and second (120) jaw members from a spaced apart position to an approximated position to grasp tissue therebetween (¶34), at least one of the first (110) or second (120) jaw members adapted (¶33 wires; cable 8) to connect to a source of energy (generator “G”) for conducting energy (¶33) through tissue grasped between the first (110) and second (120) jaw members to treat the tissue (¶33); and
a probe (151) adapted to connect to a source of energy (¶49),
and movable (¶44 slidably housed within end effector assembly 150); from a retracted position (FIGs 2 and 4) to a deployed position (FIGs 3 and 5)
Horner does not teach a second robotic arm controlling a camera configured to capture a video of a tissue and the surgical instrument; a controller configured to generate a virtual representation of the probe based on the video of the surgical instrument, wherein the virtual representation is generated based on a three-dimensional model of the probe and a reference point of an end effector assembly of the surgical instrument; and a monitor configured to display the video of the tissue and the surgical instrument, and the virtual representation of the probe in the deployed position.
Horner does not teach wherein the controller is further configured to analyze the video to identify a critical structure of the tissue or wherein the controller is further configured to output the virtual representation of the probe based on a distance of the probe to the critical structure.
However, Horner teaches that the robotic surgical system is intended to for use in endoscopic surgical procedures (¶31) and the system comprises a controller system that controls the end effector assembly and other instrumentation parameters (¶¶59-60).
State teaches medical instrument navigation systems (FIG 1A, ¶26 and FIG 13, ¶149) comprising system (100) capturing a video (¶31) of a tissue, generating, at a controller (¶41, processor), a virtual representation (122) of the probe (155) based on the video of the surgical instrument (¶31); analyzing, at a controller (¶41, processor), the video (¶31) to identify a critical structure of the tissue (¶203); and displaying on the monitor (120) the virtual representation of the probe in the deployed position based on a distance of the probe to the critical structure (¶187). States teaches wherein a monitor displays the video of the tissue (¶31) and the surgical instrument (145) and the virtual representation of the probe (155) in the deployed position based on a distance of the probe to the critical structure (¶¶187-189) and expressly discloses that “the system 100 can concurrently determine the emplacement of the medical image and/or one or more virtual medical devices, etc.” (¶189).
State also teaches that “3D graphics can be produced using underlying data models stored in the image guidance unit” (e.g., “generated”) (¶41). State teaches that “the underlying 3D model can be updated based on the relative emplacements of the various devices 145 and 155 as determined by the position sensing unit 140 and/or based on new data associated with the devices 145 and 155” (¶41). State teaches an example that if the first medical device 145 is a stapler, then the underlying model can be updated to reflect any changes related to the jaws [e.g., “end effector assembly of the surgical instrument”], such as information regarding the affected region or angles of the jaws and/or transecting knife” (¶41). State also discloses that any appropriate 3D graphics processing can be used for rendering (¶41). State also teaches that “the system 100 can concurrently determine the emplacement of the medical image and/or one or more virtual medical devices, etc.” (¶189).
Horner generically teaches robotic “arms” (¶58). State does not teach a second robotic arm.
Shelton ‘375 teaches a multi-arm robotic surgical system (FIG 2) with arm-to-arm correlation to provide close operational control of an end-effector (¶430) where a second arm comprises a camera to generate relative positions of the end effectors, thereby establishing coordinate systems for each robotic surgical tool (¶430).
Shelton ‘383 expressly teaches wherein the controller (FIGs 1, 11, “control system 600 for surgical visualization system 100”; ¶¶152, 171, 175) is further configured to analyze the video (FIG 11, ¶¶172, 175, 176) to identify a critical structure (FIG 11, ¶¶174, 180) of the tissue (FIG 11, ¶¶174, 179) and wherein the controller (FIG 11, “control system 600 including spectral control circuit 602”, ¶175) is further configured to output the virtual representation of the probe (FIG 1, “surgical visualization system 100 can be configured to achieve identification of one or more critical structures 101 and the proximity of the surgical device 102 to the critical structures 101”, ¶152) based on a distance of the probe to the critical structure (FIGs 1 and 11, ¶¶152, 180, 182).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Horner, State, Shelton ‘375, and Shelton ‘383, given that the prior art included each element claimed, although not necessarily in a single reference. Horner, State, Shelton ‘375, and Shelton ‘ 383 teach in the same field of endeavor, medical surgical systems comprising surgical tools with jaw members.
Although, Horner discloses the claimed base surgical system comprising jaw members adapted to treat tissue and a probe adapted to connect to an energy source and movably housed within an end effector assembly from a retracted to a deployed position, Horner does not teach a camera configured to capture a video of a tissue and the surgical instrument; a controller configured to generate a virtual representation of the probe based on the video of the surgical instrument; and a monitor configured to display the video of the tissue and the surgical instrument, and the virtual representation of the probe in the deployed position.
State specifically addressed the navigation system and provides image guidance for placement of one or more medical devices at a target location (Abstract). State’s system can cause one or more displays to display video perspectives of images as well as image guidance cues, including virtual representations of the devices in 3D space (Abstract). Similarly, the systems of State can concurrently determine the emplacement of the medical image and/or one or more virtual medical devices.
Because Horner medical surgical system is compatible with endoscopic surgical systems, comprising surgical tools with jaw members that are controllable by a controller, a person of ordinary skill in the art, seeking to more precisely control the end effector assembly tools and probe would reasonably consult State’s navigation and 3D virtual representation solution. State’s navigation and 3D virtual representation solution can be incorporated alongside Horner’s base surgical device (same general location and interaction with the surgical end effector assembly and probe, as well as endoscopic cameras and controls) using known assembly methods and known software without redesigning Horner’s core surgical device.
Additionally, because Shelton 375’s multi-arm robotic surgical system with arm-to-arm correlation provides a camera on a second arm to generate relative positions of the end effectors, establishing coordinate systems for each robotic surgical tool, and providing better control to compensate for arm-t0-arm variances, further refining the control of the system and the use of surgical tool assembly tools, jaw members, and probes.
Further, Shelton ‘383 expressly discloses control system 600 for surgical visualization system 100 (FIGs 1, 11; ¶¶152, 171, 175) is further configured to analyze the video (FIG 11, ¶¶172, 175, 176) to identify a critical structure (FIG 11, ¶¶174, 180) of the tissue (FIG 11, ¶¶174, 179) and wherein the controller (FIG 11, “control system 600 including spectral control circuit 602”, ¶175) is further configured to output the virtual representation of the probe (FIG 1, “surgical visualization system 100 can be configured to achieve identification of one or more critical structures 101 and the proximity of the surgical device 102 to the critical structures 101”, ¶152) based on a distance of the probe to the critical structure (FIGs 1 and 11, ¶¶152, 180, 182). A person of ordinary skill in the art attempting to render Horner’s medical surgical system compatible with surgical visualization systems that are controllable by a controller and to more precisely employ and control an interactive visualization system in a surgical setting would look for established visualization system designs to avoid creating a novel visualization interface. Shelton ‘383’s control system 600 for surgical visualization system 100 is modular and can be adapted to the medical surgical system of Horner and medical instrument navigation systems of State, particularly given that Shelton ‘383 also teaches the generation of 3D imaging of the surgical site (like that of State), including determining one or more distances at the surgical site (¶¶153, 157).
Because Horner based medical surgical system is compatible with endoscopic surgical systems, comprising surgical tools with jaw members that are controllable by a controller and is compatible with multiple robotic arms, a person of ordinary skill in the art, seeking to more precisely control the end effector assembly tools and probe would reasonably consult State’s navigation and 3D virtual representation solution. State’s navigation and 3D virtual representation solution can be incorporated alongside Horner’s base surgical device (same general location and interaction with the surgical end effector assembly and probe, as well as endoscopic cameras and controls) using known assembly methods and known software without redesigning Horner’s core surgical device.
Because the references address the same engineering problem (controlling and visualizing endoscopic and robotic medical surgical systems comprising end effector surgical tool assemblies with jaw members and probes) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a controller-based position and navigation system and known software to correlate video with an overlying virtual representation model and adding a second robotic arm and adding a controller-based position and navigation system and a surgical visualization system, to correlate video with an overlying virtual representation model) to the base surgical system of Horner, a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 9, Horner, modified by State, Shelton ‘375, and Shelton ‘383 teaches the surgical robotic system according to claim 8, as set forth above, for the reasons set forth above.
Horner teaches the system further comprising a surgical console including a foot pedal (foot switch, ¶33) operable in a first stage in response to which the probe is moved to the deployed position (deployed position FIGs 3 and 5; ¶46).
Regarding claim 10, Horner modified by State, Shelton ‘375, and Shelton ‘383, teaches the surgical robotic system according to claim 9, as set forth above, for the reasons set forth above.
Horner teaches the system wherein the foot pedal (foot switch, ¶33) is operable in a second stage in response to which the probe is energized (facilitate electrical application of the forceps 10, ¶33) .
Regarding claim 11, Horner, modified by State, Shelton ‘375, and Shelton ‘383, teaches the surgical robotic system according to claim 9, as set forth above, for the reasons set forth above.
Horner teaches the system wherein the foot pedal (foot switch, ¶33) includes at least one of a distance sensor or a contact sensor (jaw member activation switch 200, ¶33) to operate in the first stage (deployed position FIGs 3 and 5; ¶46).
Regarding claim 14, Horner, modified by State, Shelton ‘375, and Shelton ‘383, teaches the surgical robotic system according to claim 13, as set forth above, for the reasons set forth above.
State teaches wherein the controller (processor, ¶41) is further configured to output the virtual representation of the probe based on a distance of the probe to the critical structure (¶187).
Shelton ‘375 teaches that the controller is configured based on at least one of the video or kinematics data of the first robotic arm and the second robotic arm (“arm-to-arm correlation to provide close operational control of an end-effector” (¶430); “a second arm comprises a camera to generate relative positions of the end effectors, thereby establishing coordinate systems for each robotic surgical tool” (¶430)).
Shelton ‘383 expressly teaches wherein the controller (FIGs 1, 11, “control system 600 for surgical visualization system 100”; ¶¶152, 171, 175) is further configured to determine the distance of the probe to the critical structure (FIGs 1 and 11, ¶¶152, 180, 182) based on at least one of the video (FIG 11, ¶¶172, 175, 176) or kinematics data of the first robotic arm and the second robotic arm (¶168).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Horner, State, Shelton ‘375, and Shelton ‘383, given that the prior art included each element claimed, although not necessarily in a single reference. Horner, State, Shelton ‘375, and Shelton ‘383 teach in the same field of endeavor, medical surgical systems comprising surgical tools with jaw members.
Although, Horner discloses the claimed base surgical system comprising jaw members adapted to treat tissue and a probe adapted to connect to an energy source and movably housed within an end effector assembly from a retracted to a deployed position, Horner does not teach a camera configured to capture a video of a tissue and the surgical instrument; a controller configured to generate a virtual representation of the probe based on the video of the surgical instrument; and a monitor configured to display the video of the tissue and the surgical instrument, and the virtual representation of the probe in the deployed position.
State specifically addressed the navigation system and provides image guidance for placement of one or more medical devices at a target location (Abstract). State’s system can cause one or more displays to display video perspectives of images as well as image guidance cues, including virtual representations of the devices in 3D space (Abstract). Similarly, the systems of State can concurrently determine the emplacement of the medical image and/or one or more virtual medical devices.
Shelton 375’s multi-arm robotic surgical system with arm-to-arm correlation provides a camera on a second arm to generate relative positions of the end effectors, establishing coordinate systems for each robotic surgical tool, and providing better control to compensate for arm-t0-arm variances. Shelton ‘383 expressly discloses wherein the controller (FIGs 1, 11, “control system 600 for surgical visualization system 100”; ¶¶152, 171, 175) is further configured to determine the distance of the probe to the critical structure (FIGs 1 and 11, ¶¶152, 180, 182) based on at least one of the video (FIG 11, ¶¶172, 175, 176) or kinematics data of the first robotic arm and the second robotic arm (¶168).
Because Horner based medical surgical system is compatible with endoscopic surgical systems, comprising surgical tools with jaw members that are controllable by a controller and is compatible with multiple robotic arms, a person of ordinary skill in the art, seeking to more precisely control the end effector assembly tools and probe would reasonably consult State’s navigation and 3D virtual representation solution. State’s navigation and 3D virtual representation solution can be incorporated alongside Horner’s base surgical device (same general location and interaction with the surgical end effector assembly and probe, as well as endoscopic cameras and controls) using known assembly methods and known software without redesigning Horner’s core surgical device. Additionally, because Shelton 375’s multi-arm robotic surgical system with arm-to-arm correlation provides a camera on a second arm to generate relative positions of the end effectors, establishing coordinate systems for each robotic surgical tool, and providing better control to compensate for arm-t0-arm variances, and Shelton ‘383’s control system 600 for surgical visualization system 100 expressly provides a solution for calculating distance based on a triangulation algorithm using a robotic arm (¶168), further refinement of the control of the system and the use of surgical tool assembly tools, jaw members, and probes would be reasonably accomplished without undue experimentation.
Because the references address the same engineering problem (controlling and visualizing endoscopic and robotic medical surgical systems comprising end effector surgical tool assemblies with jaw members and probes) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a controller-based position and navigation system and known software to correlate video with an overlying virtual representation model and adding a second robotic arm) to the base surgical system of Horner, a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 15, Horner, modified by State, Shelton ‘375, and Shelton ‘383, teaches the surgical robotic system according to claim 12, as set forth above, for the reasons set forth above.
State teaches wherein the controller (processor, ¶41) is further configured to highlight the critical structure (¶203).
Regarding claim 16, Horner, modified by State, Shelton ‘375, and Shelton ‘383, teaches the surgical robotic system according to claim 8, as set forth above, for the reasons set forth above.
State teaches wherein the monitor (display unit 120) is configured to display the virtual representation in response to a user command (¶61).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Horner et al., US 20150327913 (19 November 2015) in view of State et al., US 20180116731 (3 May 2018) (both previously cited of record), and further in view of Shelton et al., US 20210196383 (1 July 2021) (hereinafter Shelton ‘383) and Durant et al., US 9,043,027 (26 May 2015).
Regarding claim 20, Horner modified by State and Shelton ‘383, teaches the method of claim 17 as set forth above, for the reasons set forth above.
Horner, State, and Shelton ‘383 do not expressly teach the method further comprising: displaying, on the monitor, a prompt to at least one of deploy or energize the probe based on the identity of the critical structure.
However, Horner teaches that the probe movable from a retracted position (FIGs 2 and 4) to a deployed position (FIGs 3 and 5) relative to the end effector assembly (slidably housed within end effector assembly 150; ¶44). Horner teaches a switch (monopolar activation switch 157) is operable in a second stage (fully extended, ¶49) in response to which the probe is energized (electrical activation, ¶49).
Shelton ‘383 expressly teaches wherein the controller (FIGs 1, 11, “control system 600 for surgical visualization system 100”; ¶¶152, 171, 175) is further configured to analyze the video (FIG 11, ¶¶172, 175, 176) to identify a critical structure (FIG 11, ¶¶174, 180) of the tissue (FIG 11, ¶¶174, 179) and wherein the controller (FIG 11, “control system 600 including spectral control circuit 602”, ¶175) is further configured to output the virtual representation of the probe (FIG 1, “surgical visualization system 100 can be configured to achieve identification of one or more critical structures 101 and the proximity of the surgical device 102 to the critical structures 101”, ¶152) based on a distance of the probe to the critical structure (FIGs 1 and 11, ¶¶152, 180, 182).
Additionally, Shelton ‘383 teaches that the system can provide data or prompts on a display screen that may be pertinent for a particular procedural step and adjust modular devices based on the context, including changing the energy level of an ultrasonic surgical instrument or an RF electrosurgical instrument (¶257).
Durant suggests methods of controlling surgical end effectors (Abstract) where the user may be prompted to provide secondary input, where the form of the prompt may be a visual image including text (col 11, lines 63-67). Durant teaches that after receiving the feedback the user can act to cause the end effector 20 of the surgical instrument 18 to perform the surgical procedure (col 11, line 67 to col 12, line 16).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Horner, State, Shelton ‘383, and Durant, given that the prior art included each element claimed, although not necessarily in a single reference. Horner, State, Shelton ‘383, and Durant teach in the same field of endeavor, medical surgical systems comprising surgical tools with end effectors.
Although, Horner discloses the claimed base method for controlling deployment of a probe of a surgical system comprising jaw members adapted to treat tissue and a probe adapted to connect to an energy source and movably housed within an end effector assembly from a retracted to a deployed position and State specifically addresses the navigation system and provides image guidance for placement of one or more medical devices at a target location (Abstract). Shelton ‘383 expressly discloses control system 600 for surgical visualization system 100 (FIGs 1, 11; ¶¶152, 171, 175) and also teaches that the system can provide data or prompts on a display screen that may be pertinent for a particular procedural step and adjust modular devices based on the context, including changing the energy level of an ultrasonic surgical instrument or an RF electrosurgical instrument (¶257). Durant specifically addresses a prompt method step that provides direct feedback in the form of visual images and texts for the express purpose of having the user act to cause the end effector of the surgical instrument to perform the surgical procedure (col 11, line 67 to col 12, line 16).
System feedback in the form of prompts displayed on a monitor that prompts a clinician or other individual or device to deploy or energize the probe based on the identity of the critical structure would have been obvious to a person of ordinary skill in the art in light of the teachings, suggestion, and motivations of Shelton ‘383 and Durant, with a reasonable expectation of success.
Because the references address the same engineering problem (controlling and visualizing endoscopic and robotic medical surgical systems comprising end effector surgical tool assemblies with jaw members and probes) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a controller-based position and navigation system and known software to correlate video with an overlying virtual representation model and prompting based on feedback) to the base surgical system of Horner, a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
It is well established that obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-F 9am-6pm (CST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHERIE M POLAND/Examiner, Art Unit 3771
Prosecution Insights