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 .
Remarks
The claims being considered in this application are those submitted on 01/29/2024. Claims 1-20 are pending.
Priority
The applicant’s claim to priority of PRO63/237,550 on 08/27/2021 is acknowledged.
Information Disclosure Statement
The information disclosure statement(s) filed on 01/29/2024, 02/06/2024 (1), and 02/06/2024 (2) have been annotated and considered.
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.
Claims 1, 4-5, 9, 12, 16 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton, IV et. al. (WO 2020260999 A1, attached) in view of Monteverde et. al. (US 20210378746 A1).
Regarding Claim 1, Shelton, IV discloses:
A surgical robotic system, comprising: (See at least Figures 4-5 which depict a surgical robotic system)
a robotic arm configured to support an access port inserted within a patient and a surgical instrument inserted into the access port, (See at least Figures 4-5 and ¶0154 via "the robotic surgical system 13000 includes robotic arms 13002, 13003, a control device 13004, and a console 13005 coupled to the control device 13004" and also ¶0168 via "When the position of the instrument indicates that the instrument is outside of an access port, instructions are provided to open the jaw assembly.". Additionally see at least ¶0384 via "FIG. 37 illustrates a robotic surgical system 7030 and method for detecting a location 7032 of the distal end 7060 of a fixed shaft 7062 and a straight-line travel path 7064 to an intended position 7034 according to at least one aspect of the present disclosure. Here, a robotic arm 7066 is attached to a trocar 7068, which is shown inserted through the wall 7070 of a body cavity")
the robotic arm including at least one joint having a sensor; a surgeon console configured to receive user input; and (See at least Figures 4-5 and ¶0154 via "the robotic surgical system 13000 includes robotic arms 13002, 13003, a control device 13004, and a console 13005 coupled to the control device 13004" and ¶0155 via "Additional robotic arms are likewise connected to the control device 13004 and are telemanipulatable via the console 13005". Additionally, see ¶0351 via "…The torque T^ may be sensed by a torque sensor located at the articulation joint 6014…" )
a controller configured to: receive a measured torque of the at least one joint from the sensor; (See at least ¶0447 via "The torques T induced by the robotic surgical tool 7404 on the pliable anatomical structures 7412 could be measured by the reaction loads of the robotic surgical tool 7404 being compared to a relative ground based on the torques T measured on the patient 7400 or OR table 7402 by the load cells 7410.")
compare the measured torque to a predetermined threshold; (See at least ¶0489 via "In addition, while the motor is rotating, a reaction torque transducer measures 60220 torque applied by the motor. The reaction torque transducer generates 60222 a torque signal indicative of the measured torque and transmits 60224 the torque signal to the controller 60126." and ¶0490 via "The controller 60126 receives 60230 the verification signal and generates an acceptable range of torques which may be applied 60240 by the motor for the given verification signal. The controller 60126 then receives the torque signal from the reaction torque transducer and compares 60250 the torque signal to the acceptable range of torques." Additionally see at least ¶0448 via "Having determined the relative torques between the robotic surgical tool 7404 and the hard anatomic references (in this case the pelvis and the skeletal system) limits could be pre- defined to prevent the robotic surgical tool 7404 or robotic surgical tool driver 7410 from exceeding during the manipulation or insertion of the powered circular stapler robotic surgical tool 7404. As depicted in FIG. 65, when the torque induced on the robotic toll 7404 reaches a maximum torque T.sub.ZMax, the robotic surgical tool 7404 retracts slightly to be in ideal tissue tension.".)
determine a habitus of the patient based on the comparison; and (See at least ¶0567 via "the central control circuit is configured to control a rate of linear advancement of a knife coupled to the motor based on tissue thickness sensed based on differences in torque sensed by the tool driver.").
However, Shelton, IV does not explicitly disclose the outputting of the access port recommendation.
Nevertheless, Monteverde--who is directed towards port placement guidance--discloses: output a recommendation for the access port based on the determined habitus of the patient (See at least ¶0061 via "wherein each set of surgical target locations is inside a volume of a respective one of the plurality of reference patient sizes, and a plurality of sets of permissible port locations wherein each set of permissible port locations is on one of the plurality of reference patient sizes, wherein each permissible port location, of a set of permissible port locations, has been selected such that a surgical tool having specified reach characteristics and placed at the permissible port location, can reach all of the set of surgical target locations inside the reference patient size" as well as ¶0067 via "This set of permissible port locations may then be presented to a surgeon during surgery on the patient, based on which the surgeon can decide where on the patient's abdomen to place the port." and ¶0033 via "the abdominal wall thickness may be computed as a function of an input BMI.")
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the given invention to modify Shelton, IV in view of Monteverde's access port recommendation based on patient habitus in order to account for patients with different physiques/body types or sizes: "Reference port locations (expressed in normalized coordinates as defined above) are described that can be used as a guide when choosing port locations for patients of varying sizes." [Monteverde ¶0051] whilst ensuring the selected location of the port enables the surgical tool to reach the desired location: " the location of a port in terms of normalized coordinates {L, θ, R} as defined above needs to be determined that will allow the surgical tool (when inserted into that port) to reach the normalized surgical target location" [Monteverde ¶0049].
Regarding Claim 4, Modified Shelton, IV discloses the surgical robotic system according to Claim 1.
Furthermore, Shelton, IV discloses a display: (See at least Figure 2 and ¶0136 via " As illustrated in FIG. 2, a primary display 119 is positioned in the sterile field to be visible to an operator at the operating table 114" as well as ¶0125 via "The robotic hub 122 can be used to process the images of the surgical site for subsequent display to the surgeon through the surgeon’s console 1 18.").
However, Shelton, IV does not explicitly disclose, but Monteverde discloses: wherein the controller is configured to output the recommendation via a display (See at least ¶0067 via "This set of permissible port locations may then be presented to a surgeon during surgery on the patient, based on which the surgeon can decide where on the patient's abdomen to place the port.")
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the given invention to modify Modified Shelton, IV in view of outputting the recommendation in order to enable the surgeon/user to confirm the placement(s): "the surgeon can decide where on the patient's abdomen to place the port" [Monteverde ¶0067].
Regarding Clam 5, Modified Shelton, IV discloses the surgical robotic system according to Claim 1.
Furthermore, Shelton, IV discloses: wherein the sensor includes a strain gauge configured to convert a mechanical force into a sensor signal (See at least ¶0352 via " The forces F.sub.tiSSueA, F.sub.Ciam.sub.PA may be sensed by one or more than one strain gauge sensor located within the jaws 6018, 6020 of the end-effector 6016. The arm force F.sub.arm.sub.A may be sensed by a strain gauge sensor located either on the articulation joint 6014 or the arm 6024.").
Regarding Claim 9, Shelton, IV discloses:
A surgical robotic system, comprising: (See at least Figures 4-5 which depict a surgical robotic system)
a display; (See at least Figure 2 and ¶0136 via " As illustrated in FIG. 2, a primary display 119 is positioned in the sterile field to be visible to an operator at the operating table 114" as well as ¶0125 via "The robotic hub 122 can be used to process the images of the surgical site for subsequent display to the surgeon through the surgeon’s console 1 18.")
a robotic arm configured to support an access port inserted within a patient and an instrument having an end effector inserted into the access port, (See at least Figures 4-5 and ¶0154 via "the robotic surgical system 13000 includes robotic arms 13002, 13003, a control device 13004, and a console 13005 coupled to the control device 13004" and also ¶0168 via "When the position of the instrument indicates that the instrument is outside of an access port, instructions are provided to open the jaw assembly.". Additionally see at least ¶0384 via "FIG. 37 illustrates a robotic surgical system 7030 and method for detecting a location 7032 of the distal end 7060 of a fixed shaft 7062 and a straight-line travel path 7064 to an intended position 7034 according to at least one aspect of the present disclosure. Here, a robotic arm 7066 is attached to a trocar 7068, which is shown inserted through the wall 7070 of a body cavity")
the robotic arm including at least one joint having a sensor; a surgeon console configured to receive user input; and (See at least Figures 4-5 and ¶0154 via "the robotic surgical system 13000 includes robotic arms 13002, 13003, a control device 13004, and a console 13005 coupled to the control device 13004" and ¶0155 via "Additional robotic arms are likewise connected to the control device 13004 and are telemanipulatable via the console 13005". Additionally, see ¶0351 via "…The torque T^ may be sensed by a torque sensor located at the articulation joint 6014…" )
a controller configured to: receive a measured torque of the joint from the at least one sensor; and (See at least ¶0447 via "The torques T induced by the robotic surgical tool 7404 on the pliable anatomical structures 7412 could be measured by the reaction loads of the robotic surgical tool 7404 being compared to a relative ground based on the torques T measured on the patient 7400 or OR table 7402 by the load cells 7410.". Additionally see ¶0489-¶0490 which describe the comparison of torque to a threshold, as well as ¶0567.).
on the display (See at least Figure 2 and ¶0136 via " As illustrated in FIG. 2, a primary display 119 is positioned in the sterile field to be visible to an operator at the operating table 114" as well as ¶0125 via "The robotic hub 122 can be used to process the images of the surgical site for subsequent display to the surgeon through the surgeon’s console 1 18.")
However, Shelton, IV does not explicitly disclose the outputting of the access port recommendation.
Nevertheless, Monteverde discloses: output, (See at least ¶0061 via "wherein each set of surgical target locations is inside a volume of a respective one of the plurality of reference patient sizes, and a plurality of sets of permissible port locations wherein each set of permissible port locations is on one of the plurality of reference patient sizes, wherein each permissible port location, of a set of permissible port locations, has been selected such that a surgical tool having specified reach characteristics and placed at the permissible port location, can reach all of the set of surgical target locations inside the reference patient size" as well as ¶0067 via "This set of permissible port locations may then be presented to a surgeon during surgery on the patient, based on which the surgeon can decide where on the patient's abdomen to place the port." and ¶0033 via "the abdominal wall thickness may be computed as a function of an input BMI.")
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the given invention to modify Shelton, IV's torque based habitus determination (tissue thickness) in view of Monteverde's access port recommendation based on patient habitus in order to account for patients with different physiques/body types or sizes: "Reference port locations (expressed in normalized coordinates as defined above) are described that can be used as a guide when choosing port locations for patients of varying sizes." [Monteverde ¶0051] whilst ensuring the selected location of the port enables the surgical tool to reach the desired location: " the location of a port in terms of normalized coordinates {L, θ, R} as defined above needs to be determined that will allow the surgical tool (when inserted into that port) to reach the normalized surgical target location" [Monteverde ¶0049].
Regarding Clam 12, Modified Shelton, IV discloses the surgical robotic system according to Claim 9.
Furthermore, Shelton, IV discloses: wherein the sensor includes a strain gauge configured to convert a mechanical force into a sensor signal (See at least ¶0352 via " The forces F.sub.tiSSueA, F.sub.Ciam.sub.PA may be sensed by one or more than one strain gauge sensor located within the jaws 6018, 6020 of the end-effector 6016. The arm force F.sub.arm.sub.A may be sensed by a strain gauge sensor located either on the articulation joint 6014 or the arm 6024.")
Regarding Claim 16, Shelton, IV discloses:
A method for controlling a surgical robot, the method comprising: outputting a drive command at a main controller to actuate a robotic arm having at least one joint; (See at least Figure 32 via Step 6168 "Actuate drive motors" and also ¶0117 via "FIG. 107 illustrates a surgical instrument holder of a surgical assembly that functions both to actuate a rotation of a body of an instrument drive unit and to support a housing of a surgical instrument according to at least one aspect of the present disclosure.")
measuring torque of the at least one joint using a sensor during actuation of the robotic arm; receiving the measured torque of the joint from the sensor; (See at least Figures 4-5 as well as ¶0351 via "…The torque T^ may be sensed by a torque sensor located at the articulation joint 6014…" as well as Figure 32 via 6164-6168 and ¶0371 via "… torque sensors to sense the torque applied to the end-effector 6016 such as T.sub.jaw…")
comparing the measured torque to a predetermined threshold; (See at least Figure 32 and also ¶0489 via "In addition, while the motor is rotating, a reaction torque transducer measures 60220 torque applied by the motor. The reaction torque transducer generates 60222 a torque signal indicative of the measured torque and transmits 60224 the torque signal to the controller 60126." and ¶0490 via "The controller 60126 receives 60230 the verification signal and generates an acceptable range of torques which may be applied 60240 by the motor for the given verification signal. The controller 60126 then receives the torque signal from the reaction torque transducer and compares 60250 the torque signal to the acceptable range of torques." Additionally see at least ¶0448 via "Having determined the relative torques between the robotic surgical tool 7404 and the hard anatomic references (in this case the pelvis and the skeletal system) limits could be pre- defined to prevent the robotic surgical tool 7404 or robotic surgical tool driver 7410 from exceeding during the manipulation or insertion of the powered circular stapler robotic surgical tool 7404. As depicted in FIG. 65, when the torque induced on the robotic toll 7404 reaches a maximum torque T.sub.ZMax, the robotic surgical tool 7404 retracts slightly to be in ideal tissue tension.".)
determining a habitus of a patient based on the comparison; and (See at least ¶0567 via "the central control circuit is configured to control a rate of linear advancement of a knife coupled to the motor based on tissue thickness sensed based on differences in torque sensed by the tool driver.").
However, Shelton, IV does not explicitly disclose the outputting of the access port recommendation.
Nevertheless, Monteverde--who is directed towards port placement guidance--discloses: outputting a recommendation for an access port to be used with the robotic arm based on the determined habitus of the patient (See at least ¶0061 via "wherein each set of surgical target locations is inside a volume of a respective one of the plurality of reference patient sizes, and a plurality of sets of permissible port locations wherein each set of permissible port locations is on one of the plurality of reference patient sizes, wherein each permissible port location, of a set of permissible port locations, has been selected such that a surgical tool having specified reach characteristics and placed at the permissible port location, can reach all of the set of surgical target locations inside the reference patient size" as well as ¶0067 via "This set of permissible port locations may then be presented to a surgeon during surgery on the patient, based on which the surgeon can decide where on the patient's abdomen to place the port." and ¶0033 via "the abdominal wall thickness may be computed as a function of an input BMI.")
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the given invention to modify Shelton, IV in view of Monteverde's access port recommendation based on patient habitus in order to account for patients with different physiques/body types or sizes: "Reference port locations (expressed in normalized coordinates as defined above) are described that can be used as a guide when choosing port locations for patients of varying sizes." [Monteverde ¶0051] whilst ensuring the selected location of the port enables the surgical tool to reach the desired location: " the location of a port in terms of normalized coordinates {L, θ, R} as defined above needs to be determined that will allow the surgical tool (when inserted into that port) to reach the normalized surgical target location" [Monteverde ¶0049].
Claims 2-3, 10-11, 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton, IV et. al. (WO 2020260999 A1, attached) and Monteverde et. al. (US 20210378746 A1) in view of Weisbrod et. al. (US 20150216514 A1).
Regarding Claim 2, Modified Shelton, IV discloses the surgical robotic system according to Claim 1.
Furthermore, Shelton, IV discloses: wherein the controller is configured to output a request for a user input confirmation (See at least ¶0182 via "The surgeon 13371 at the remote command console 13370 can grant or deny the clinician’s request. For example, the surgeon can receive a pop-up or other notification indicating the permission is being requested by another clinician operating a handheld surgical instrument and/or interacting with an interactive secondary display 13362" as well as ¶0320).
However, although modified Shelton, IV discloses guidance for port selection based on various patient sizes (See Monteverde ¶0051), modified Shelton, IV does not explicitly disclose the length of the access port corresponding to the habitus of the patient.
Nevertheless, Weisbrod--who is directed towards a trocar and wound closure device--discloses: that a length of the access port corresponds to the determined habitus of the patient (See at least ¶0106 via "Various trocars may comprise narrow portions with different lengths. Optionally, a trocar having a certain narrow portion length is selected according to various parameters to be suited for the patient's needs, such as a size of an aperture in the tissue, a thickness of muscle layer, and/or the elasticity of the fascia layer. Optionally, one or more of the parameters described herein are correlated with the age of the treated patient." Additionally, see ¶0069).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the given invention to modify modified Shelton, IV's request/confirmation in view of Weisbrod's trocar length selection (corresponding to access port) that correspond to different patient's needs in order to confirm the ideal trocar/port length for the determined patient habitus/physique and to ensure that fascia/tissue layer can be entered in the desired manner: "a length of the narrow portion is long enough to allow a fascia having a certain thickness, such as 0.5 mm, 1 mm, 3, mm, 5 mm, 1 cm, 2 cm, or intermediate, larger or smaller thickness to at least partially enter one or more voids defined by the narrow portion" [Weisbrod ¶0069].
Regarding Claim 3, Modified Shelton, IV discloses the surgical robotic system according to Claim 2.
Furthermore, Shelton, IV discloses: wherein the controller is configured to: disable operation of the surgical instrument until the user input confirmation is received; and enable operation of the surgical instrument in response to receiving the user input confirmation (See at least ¶0181 via "For example, when a clinician input is received from the one or more interactive secondary displays 13362, 13364, a clinician positioned at the remote command console 13370 can either allow the command to be issued and the desired function performed or the clinician can override the command by interacting with the remote command console 13370 and prohibiting the command from being issued." as well as ¶0182 and ¶0319 via "For example, the Ul processor 836 may be programmed to monitor various aspects of user input and/or other inputs (e.g., touch screen inputs, foot switch inputs, temperature sensor inputs) and may disable the drive output of the generator 800 when an erroneous condition is detected.")
Regarding Claim 10, Modified Shelton, IV discloses the surgical robotic system according to Claim 9.
Furthermore, Shelton, IV discloses: wherein the controller is configured to output, on the display, a request for a user input confirmation (See at least ¶0182 via "The surgeon 13371 at the remote command console 13370 can grant or deny the clinician’s request. For example, the surgeon can receive a pop-up or other notification indicating the permission is being requested by another clinician operating a handheld surgical instrument and/or interacting with an interactive secondary display 13362" as well as ¶0320).
received measured torque (See at least ¶0447 via "The torques T induced by the robotic surgical tool 7404 on the pliable anatomical structures 7412 could be measured by the reaction loads of the robotic surgical tool 7404 being compared to a relative ground based on the torques T measured on the patient 7400 or OR table 7402 by the load cells 7410.". Additionally see ¶0489-¶0490 which describe the comparison of torque to a threshold, as well as ¶0567.)
However, although modified Shelton, IV discloses using torque to determine a patients habitus, such as tissue thickness (See Shelton, IV ¶0567) as well as guidance for port selection based on various patient sizes (See Monteverde ¶0051), modified Shelton, IV does not explicitly disclose the confirmation of the length of the access port corresponding to the received measured torque.
Nevertheless, Weisbrod discloses: of a length of the access port based on the (See at least ¶0106 via "Various trocars may comprise narrow portions with different lengths. Optionally, a trocar having a certain narrow portion length is selected according to various parameters to be suited for the patient's needs, such as a size of an aperture in the tissue, a thickness of muscle layer, and/or the elasticity of the fascia layer. Optionally, one or more of the parameters described herein are correlated with the age of the treated patient." Additionally, see ¶0069).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the given invention to modify modified Shelton, IV's torque based habitus determination and request/confirmation in view of Weisbrod's trocar length selection (corresponding to access port) that correspond to different patient's needs in order to confirm the ideal trocar/port length for the determined patient habitus/physique and to ensure that fascia/tissue layer can be entered in the desired manner: "a length of the narrow portion is long enough to allow a fascia having a certain thickness, such as 0.5 mm, 1 mm, 3, mm, 5 mm, 1 cm, 2 cm, or intermediate, larger or smaller thickness to at least partially enter one or more voids defined by the narrow portion" [Weisbrod ¶0069].
Regarding Claim 11, Modified Shelton, IV discloses the surgical robotic system according to Claim 10.
Furthermore, Shelton, IV discloses: wherein the controller is configured to: disable operation of the surgical instrument until the user input confirmation is received; and enable operation of the surgical instrument in response to receiving the user input confirmation (See at least ¶0181 via "For example, when a clinician input is received from the one or more interactive secondary displays 13362, 13364, a clinician positioned at the remote command console 13370 can either allow the command to be issued and the desired function performed or the clinician can override the command by interacting with the remote command console 13370 and prohibiting the command from being issued." as well as ¶0182 and ¶0319 via "For example, the Ul processor 836 may be programmed to monitor various aspects of user input and/or other inputs (e.g., touch screen inputs, foot switch inputs, temperature sensor inputs) and may disable the drive output of the generator 800 when an erroneous condition is detected.")
Regarding Claim 17, Modified Shelton, IV discloses the method according to Claim 16.
Furthermore, Shelton, IV discloses: further comprising outputting a request for a user input confirmation (See at least ¶0182 via "The surgeon 13371 at the remote command console 13370 can grant or deny the clinician’s request. For example, the surgeon can receive a pop-up or other notification indicating the permission is being requested by another clinician operating a handheld surgical instrument and/or interacting with an interactive secondary display 13362" as well as ¶0320).
However, although modified Shelton, IV discloses guidance for port selection based on various patient sizes (See Monteverde ¶0051), modified Shelton, IV does not explicitly disclose the length of the access port corresponding to the habitus of the patient.
Nevertheless, Weisbrod discloses: that a length of an access port supported by the robotic arm corresponds to the determined habitus of the patient (See at least ¶0106 via "Various trocars may comprise narrow portions with different lengths. Optionally, a trocar having a certain narrow portion length is selected according to various parameters to be suited for the patient's needs, such as a size of an aperture in the tissue, a thickness of muscle layer, and/or the elasticity of the fascia layer. Optionally, one or more of the parameters described herein are correlated with the age of the treated patient." Additionally, see ¶0069).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the given invention to modify modified Shelton, IV's user request/confirmation in view of Weisbrod's trocar length selection (corresponding to access port) that correspond to different patient's needs in order to confirm the ideal trocar/port length for the determined patient habitus/physique and to ensure that fascia/tissue layer can be entered in the desired manner: "a length of the narrow portion is long enough to allow a fascia having a certain thickness, such as 0.5 mm, 1 mm, 3, mm, 5 mm, 1 cm, 2 cm, or intermediate, larger or smaller thickness to at least partially enter one or more voids defined by the narrow portion" [Weisbrod ¶0069].
Regarding Claim 18, Modified Shelton, IV discloses the method according to Claim 17.
Furthermore, Shelton, IV discloses: further comprising: disabling operation of a surgical instrument supported by the robotic arm until the user input confirmation is received; and enabling operation of the surgical instrument in response to receiving the user input confirmation (See at least ¶0181 via "For example, when a clinician input is received from the one or more interactive secondary displays 13362, 13364, a clinician positioned at the remote command console 13370 can either allow the command to be issued and the desired function performed or the clinician can override the command by interacting with the remote command console 13370 and prohibiting the command from being issued." as well as ¶0182 and ¶0319 via "For example, the Ul processor 836 may be programmed to monitor various aspects of user input and/or other inputs (e.g., touch screen inputs, foot switch inputs, temperature sensor inputs) and may disable the drive output of the generator 800 when an erroneous condition is detected.")
Claims 6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton, IV et. al. (WO 2020260999 A1, attached) and Monteverde et. al. (US 20210378746 A1) in view of Pfotenhauer et. al. (US 20200054410 A1).
Regarding Claim 6, Modified Shelton, IV discloses the surgical robotic system according to Claim 1.
However, Modified Shelton, IV does not explicitly disclose the determination of patient habitus based on a number of times that measured torque exceeds the threshold.
Nevertheless, Pfotenhauer--who is directed towards torque-limiting devices, systems, and methods in surgical applications--discloses: wherein the controller is configured to determine the habitus of the patient based on a number of times the measured torque exceeds the predetermined threshold (See at least Figure 9 and ¶0074 via "As shown in block 216, if a given torque value is greater than or equal to the first threshold T.sub.Thresh1, the controller 20 can collect/store each of such occurrence as a “count,” the benefits of which are described further below. In some cases, the number of occurrences/times that measured torque values are greater than or equal to the first threshold T.sub.Thresh1 can provide an indication of the thickness of the bone 202.").
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the given invention to modify Modified Shelton, IV in view of determining patient habitus based on the number of times that measured torque exceeds a threshold such as in Pfotenhauer in order to provide an additional predictable means of measuring the patients habitus at a certain confidence level which is used to aid in determining robotic operations: "At block 226a, if the number of bone-engaging torque samples is greater than or equal to a threshold percentage P.sub.Thresh1 of the total number of torque values measured, a certain confidence level is achieved and the controller 20 continues with the analysis described below. Such threshold percentage P.sub.Thresh1 can be 60%, 70%, 80%, 90%, 95%, 96%, 97%, 98%, or 99%, for example" [Pfotenhauer ¶0091].
Regarding Claim 13, Modified Shelton, IV discloses the surgical robotic system according to Claim 9.
However, Modified Shelton, IV does not explicitly disclose the determination of patient habitus based on a number of times that measured torque exceeds the threshold.
Nevertheless, Pfotenhauer discloses: wherein the controller is configured to determine a habitus of the patient based on a number of times the measured torque exceeds the predetermined threshold (See at least Figure 9 and ¶0074 via "As shown in block 216, if a given torque value is greater than or equal to the first threshold T.sub.Thresh1, the controller 20 can collect/store each of such occurrence as a “count,” the benefits of which are described further below. In some cases, the number of occurrences/times that measured torque values are greater than or equal to the first threshold T.sub.Thresh1 can provide an indication of the thickness of the bone 202.").
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the given invention to modify Modified Shelton, IV in view of determining patient habitus based on the number of times that measured torque exceeds a threshold such as in Pfotenhauer in order to provide an additional predictable means of measuring the patients habitus at a certain confidence level which is used to aid in determining robotic operations: "At block 226a, if the number of bone-engaging torque samples is greater than or equal to a threshold percentage P.sub.Thresh1 of the total number of torque values measured, a certain confidence level is achieved and the controller 20 continues with the analysis described below. Such threshold percentage P.sub.Thresh1 can be 60%, 70%, 80%, 90%, 95%, 96%, 97%, 98%, or 99%, for example" [Pfotenhauer ¶0091].
Claims 7-8, 14-15, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton, IV et. al. (WO 2020260999 A1, attached) and Monteverde et. al. (US 20210378746 A1) in view of Sexson et. al. (US 20170348037 A1).
Regarding Claim 7, Modified Shelton, IV discloses the surgical robotic system according to Claim 1.
Furthermore, Shelton, IV discloses: wherein the robotic arm includes a plurality of joints and the controller is configured to: receive a measured torque of (See at least Figures 4-5 which depict the robot arm(s) with a plurality of joints, as well as ¶0447 via "The torques T induced by the robotic surgical tool 7404 on the pliable anatomical structures 7412 could be measured by the reaction loads of the robotic surgical tool 7404 being compared to a relative ground based on the torques T measured on the patient 7400 or OR table 7402 by the load cells 7410." and also ¶0560 via "…torque or resulting force within the robotic arm or any of its joints")
However, Modified Shelton, IV does not explicitly disclose the calculating of the mean of the measured torques.
Nevertheless, Sexson--who is directed towards torque limiting--discloses: calculate a mean of the measured torques received from (See at least ¶0166 via "a first average A.sub.l of N consecutive torque values over a period T.sub.1 can be determined and compared to a subsequently determined average A.sub.2 of N consecutive torque values over a later period T.sub.2. The sample number N can be any suitable number (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10)").
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the given invention to modify Modified Shelton, IV in view of the averaging of measured torques such as in Sexson in order to implement predictable sensor processing of averaging values to decrease noise and mitigate error: "The use of consecutive increasing or decreasing torque values can reduce the likelihood of a noise or error being detected as a tissue transition." [Sexson¶0239] as well as "A significant challenge of using torque analysis to manage drive velocity is properly sensitizing the readings, and/or extracting the signal from the noise. Various smoothing techniques can be used to help achieve this, and the particular smoothing procedure is not limiting. One method is to plot two moving averages of the torques, a faster and slower moving average, and looking at the relative values of each to make the determination about the material the screw is currently in" [Sexson ¶0257].
Regarding Claim 8, Modified Shelton, IV discloses the surgical robotic system according to Claim 7.
Furthermore, Shelton, IV discloses: wherein the controller is configured to determine the habitus of the patient based on a comparison of the (See at least ¶0489 via "In addition, while the motor is rotating, a reaction torque transducer measures 60220 torque applied by the motor. The reaction torque transducer generates 60222 a torque signal indicative of the measured torque and transmits 60224 the torque signal to the controller 60126." and ¶0490 via "The controller 60126 receives 60230 the verification signal and generates an acceptable range of torques which may be applied 60240 by the motor for the given verification signal. The controller 60126 then receives the torque signal from the reaction torque transducer and compares 60250 the torque signal to the acceptable range of torques." Additionally see at least ¶0448 via "Having determined the relative torques between the robotic surgical tool 7404 and the hard anatomic references (in this case the pelvis and the skeletal system) limits could be pre- defined to prevent the robotic surgical tool 7404 or robotic surgical tool driver 7410 from exceeding during the manipulation or insertion of the powered circular stapler robotic surgical tool 7404. As depicted in FIG. 65, when the torque induced on the robotic toll 7404 reaches a maximum torque T.sub.ZMax, the robotic surgical tool 7404 retracts slightly to be in ideal tissue tension."; and also see at least ¶0567 via "the central control circuit is configured to control a rate of linear advancement of a knife coupled to the motor based on tissue thickness sensed based on differences in torque sensed by the tool driver.")
However, Shelton, IV does not explicitly disclose the mean of the measured torques.
Nevertheless, Sexson discloses: mean of the measured torques (See at least ¶0166 via "a first average A.sub.l of N consecutive torque values over a period T.sub.1 can be determined and compared to a subsequently determined average A.sub.2 of N consecutive torque values over a later period T.sub.2. The sample number N can be any suitable number (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10)").
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the given invention to modify Modified Shelton, IV in view of the averaging of measured torques such as in Sexson in order to implement predictable sensor processing of averaging values to decrease noise and mitigate error: "The use of consecutive increasing or decreasing torque values can reduce the likelihood of a noise or error being detected as a tissue transition." [Sexson¶0239] as well as "A significant challenge of using torque analysis to manage drive velocity is properly sensitizing the readings, and/or extracting the signal from the noise. Various smoothing techniques can be used to help achieve this, and the particular smoothing procedure is not limiting. One method is to plot two moving averages of the torques, a faster and slower moving average, and looking at the relative values of each to make the determination about the material the screw is currently in" [Sexson ¶0257].
Regarding Claim 14, Modified Shelton, IV discloses the surgical robotic system according to Claim 9.
Furthermore, Shelton, IV discloses: wherein the robotic arm includes a plurality of joints and the controller is configured to: receive a measured torque of (See at least Figures 4-5 which depict the robot arm(s) with a plurality of joints, as well as ¶0447 via "The torques T induced by the robotic surgical tool 7404 on the pliable anatomical structures 7412 could be measured by the reaction loads of the robotic surgical tool 7404 being compared to a relative ground based on the torques T measured on the patient 7400 or OR table 7402 by the load cells 7410." and also ¶0560 via "…torque or resulting force within the robotic arm or any of its joints")
However, Modified Shelton, IV does not explicitly disclose the calculating of the mean of the measured torques.
Nevertheless, Sexson discloses: calculate a mean of the measured torques received from (See at least ¶0166 via "a first average A.sub.l of N consecutive torque values over a period T.sub.1 can be determined and compared to a subsequently determined average A.sub.2 of N consecutive torque values over a later period T.sub.2. The sample number N can be any suitable number (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10)").
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the given invention to modify Modified Shelton, IV in view of the averaging of measured torques such as in Sexson in order to implement predictable sensor processing of averaging values to decrease noise and mitigate error: "The use of consecutive increasing or decreasing torque values can reduce the likelihood of a noise or error being detected as a tissue transition." [Sexson¶0239] as well as "A significant challenge of using torque analysis to manage drive velocity is properly sensitizing the readings, and/or extracting the signal from the noise. Various smoothing techniques can be used to help achieve this, and the particular smoothing procedure is not limiting. One method is to plot two moving averages of the torques, a faster and slower moving average, and looking at the relative values of each to make the determination about the material the screw is currently in" [Sexson ¶0257].
Regarding Claim 15, Modified Shelton, IV discloses the surgical robotic system according to Claim 14.
Furthermore, Shelton, IV discloses: wherein the controller is configured to determine a habitus of the patient based on a comparison of the to the predetermined threshold (See at least ¶0489 via "In addition, while the motor is rotating, a reaction torque transducer measures 60220 torque applied by the motor. The reaction torque transducer generates 60222 a torque signal indicative of the measured torque and transmits 60224 the torque signal to the controller 60126." and ¶0490 via "The controller 60126 receives 60230 the verification signal and generates an acceptable range of torques which may be applied 60240 by the motor for the given verification signal. The controller 60126 then receives the torque signal from the reaction torque transducer and compares 60250 the torque signal to the acceptable range of torques." Additionally see at least ¶0448 via "Having determined the relative torques between the robotic surgical tool 7404 and the hard anatomic references (in this case the pelvis and the skeletal system) limits could be pre- defined to prevent the robotic surgical tool 7404 or robotic surgical tool driver 7410 from exceeding during the manipulation or insertion of the powered circular stapler robotic surgical tool 7404. As depicted in FIG. 65, when the torque induced on the robotic toll 7404 reaches a maximum torque T.sub.ZMax, the robotic surgical tool 7404 retracts slightly to be in ideal tissue tension."; and also see at least ¶0567 via "the central control circuit is configured to control a rate of linear advancement of a knife coupled to the motor based on tissue thickness sensed based on differences in torque sensed by the tool driver.")
However, Shelton, IV does not explicitly disclose the mean of the measured torques.
Nevertheless, Sexson discloses: the mean (See at least ¶0166 via "a first average A.sub.l of N consecutive torque values over a period T.sub.1 can be determined and compared to a subsequently determined average A.sub.2 of N consecutive torque values over a later period T.sub.2. The sample number N can be any suitable number (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10)").
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the given invention to modify Modified Shelton, IV in view of the averaging of measured torques such as in Sexson in order to implement predictable sensor processing of averaging values to decrease noise and mitigate error: "The use of consecutive increasing or decreasing torque values can reduce the likelihood of a noise or error being detected as a tissue transition." [Sexson¶0239] as well as "A significant challenge of using torque analysis to manage drive velocity is properly sensitizing the readings, and/or extracting the signal from the noise. Various smoothing techniques can be used to help achieve this, and the particular smoothing procedure is not limiting. One method is to plot two moving averages of the torques, a faster and slower moving average, and looking at the relative values of each to make the determination about the material the screw is currently in" [Sexson ¶0257].
Regarding Claim 19, Shelton, IV discloses the method according to Claim 16.
Furthermore, Shelton, IV discloses: further comprising: measuring torque of a plurality of joints; receiving the measured torques of the plurality of joints; and (See at least Figures 4-5 which depict the robot arm(s) with a plurality of joints, as well as ¶0447 via "The torques T induced by the robotic surgical tool 7404 on the pliable anatomical structures 7412 could be measured by the reaction loads of the robotic surgical tool 7404 being compared to a relative ground based on the torques T measured on the patient 7400 or OR table 7402 by the load cells 7410." and also ¶0560 via "…torque or resulting force within the robotic arm or any of its joints")
However, Modified Shelton, IV does not explicitly disclose the calculating of the mean of the measured torques.
Nevertheless, Sexson discloses: calculating a mean of the received measured torques (See at least ¶0166 via "a first average A.sub.l of N consecutive torque values over a period T.sub.1 can be determined and compared to a subsequently determined average A.sub.2 of N consecutive torque values over a later period T.sub.2. The sample number N can be any suitable number (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10)").
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the given invention to modify Modified Shelton, IV in view of the averaging of measured torques such as in Sexson in order to implement predictable sensor processing of averaging values to decrease noise and mitigate error: "The use of consecutive increasing or decreasing torque values can reduce the likelihood of a noise or error being detected as a tissue transition." [Sexson¶0239] as well as "A significant challenge of using torque analysis to manage drive velocity is properly sensitizing the readings, and/or extracting the signal from the noise. Various smoothing techniques can be used to help achieve this, and the particular smoothing procedure is not limiting. One method is to plot two moving averages of the torques, a faster and slower moving average, and looking at the relative values of each to make the determination about the material the screw is currently in" [Sexson ¶0257].
Regarding Claim 20, Modified Shelton, IV discloses the method according to Claim 19.
Furthermore, Shelton, IV discloses: further comprising determining the habitus of the patient based on a comparison of the(See at least ¶0489 via "In addition, while the motor is rotating, a reaction torque transducer measures 60220 torque applied by the motor. The reaction torque transducer generates 60222 a torque signal indicative of the measured torque and transmits 60224 the torque signal to the controller 60126." and ¶0490 via "The controller 60126 receives 60230 the verification signal and generates an acceptable range of torques which may be applied 60240 by the motor for the given verification signal. The controller 60126 then receives the torque signal from the reaction torque transducer and compares 60250 the torque signal to the acceptable range of torques." Additionally see at least ¶0448 via "Having determined the relative torques between the robotic surgical tool 7404 and the hard anatomic references (in this case the pelvis and the skeletal system) limits could be pre- defined to prevent the robotic surgical tool 7404 or robotic surgical tool driver 7410 from exceeding during the manipulation or insertion of the powered circular stapler robotic surgical tool 7404. As depicted in FIG. 65, when the torque induced on the robotic toll 7404 reaches a maximum torque T.sub.ZMax, the robotic surgical tool 7404 retracts slightly to be in ideal tissue tension."; and also see at least ¶0567 via "the central control circuit is configured to control a rate of linear advancement of a knife coupled to the motor based on tissue thickness sensed based on differences in torque sensed by the tool driver.")
However, Shelton, IV does not explicitly disclose the mean of the measured torques.
Nevertheless, Sexson discloses: mean of the measured torques (See at least ¶0166 via "a first average A.sub.l of N consecutive torque values over a period T.sub.1 can be determined and compared to a subsequently determined average A.sub.2 of N consecutive torque values over a later period T.sub.2. The sample number N can be any suitable number (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10)").
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the given invention to modify Modified Shelton, IV in view of the averaging of measured torques such as in Sexson in order to implement predictable sensor processing of averaging values to decrease noise and mitigate error: "The use of consecutive increasing or decreasing torque values can reduce the likelihood of a noise or error being detected as a tissue transition." [Sexson¶0239] as well as "A significant challenge of using torque analysis to manage drive velocity is properly sensitizing the readings, and/or extracting the signal from the noise. Various smoothing techniques can be used to help achieve this, and the particular smoothing procedure is not limiting. One method is to plot two moving averages of the torques, a faster and slower moving average, and looking at the relative values of each to make the determination about the material the screw is currently in" [Sexson ¶0257].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Meglan et. al. (US20180021058A1)
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/K.R.D./Examiner, Art Unit 3657
/ABBY LIN/ Supervisory Patent Examiner, Art Unit 3657