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 .
Response to Amendment
This Office Action is responsive to the amendment filed 13 May 2025. As per the amendment: claims 1-6 and 8-20 have been amended and no claims have been added or cancelled. Thus, claims 1-20 are presently pending and under examination.
Response to Arguments
Applicant’s arguments, see pg. 8-9 of Remarks, filed May 13, 2025, with respect to the rejection(s) of claim(s) 1-20 under 35 U.S.C. 102(a)(2) in view of Brik et al. (US 2023/0013550 A1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Brierton et al. (US 2018/0228559 A1), hereinafter Brierton.
Applicant has amended the claim to specifically recite the limitation of “receive first information associated with an identification feature of the first surgical tool; identify, based on the first information, the first surgical tool and a first set of surgical operations supported by the first surgical tool; and control the robotic arm and the first surgical tool to perform at least one of the first surgical operations, wherein signals for controlling the first surgical tool are sent through the set of components” and further argues Brik is merely used for identifying end effectors in surgical robotic systems using data from the end effects but does not disclose or suggest that any signal is passed through the set of components that could be said to control a surgical instrument to perform a surgical operation instead Brik teaches surgical instruments mounted for manual operation.
Without acquiescing to applicant’s arguments, Examiner has instead used Brierton to teach the amended limitations, as described in detail below.
Thus, claims 1-20 are now rejected under 35 USC 103, as described in detail below.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brik et al. (US 2023/0013550 A1, previously cited), hereinafter Brik in view of Brierton et al. (US 2018/0228559 A1), hereinafter Brierton.
Regarding claim 1, Brik discloses a robotic surgical system, comprising:
a robotic arm (Figure 3, 320) comprising a proximal end and a distal end;
a plurality of surgical tools ([0030] The end effector 308 can retain a tool (e.g., used in association with instruments) (not numbered)). Brik additionally teaches that the end effector can also be a tool/instrument, see [0040] (FIG. 6 illustrates an oscillating saw end effector 608 that can be used, for example, in a surgical procedure on a shoulder or knee.)
an interface unit (Figure 3, [0028] An end effector 308 can be coupled to the robot arm 320.) disposed at the distal end of the robotic arm and coupled to the robotic arm, wherein the interface unit comprises a set of components (Figure 3, [0028] The system 300 can utilize end effectors of various shapes, sizes, and functionalities) configured to interchangeably couple any surgical tool of the plurality of surgical tools to the robotic arm; (Figure 3. [0028 and 0030]) A surgical robot base 302 supports a robot arm 320 . . . The joints 309 can be configured for incremental changes in each of the six degrees of freedom to ensure precision in operation of a plurality of different end effectors during surgery . . . An end effector 308 can be coupled to the robot arm 320. The system 300 can utilize end effectors of various shapes, sizes, and functionalities. In some embodiments, the robot arm 320 can have the end effector 308 on a distal end thereof, as shown, although the end effector can couple to the robot arm along a length thereof in other embodiments. The end effector 308 can retain a tool (e.g., used in association with instruments) (not numbered). The end effector can be a guide for retaining a surgical tool (Figure 5) or can itself be a surgical tool such as an oscillating saw (Figure 6). Additionally see paragraphs [0039 & 0040]).
a processor ([0027]After the system identifies the end effector (e.g., using data received from the end effector), the system can adjust operation of the system (e.g., based on data received from the end effector or on additional data retrieved by the system controller (e.g., a database) after receiving the initial data from the end effector). coupled with the robotic arm and the interface unit; and
a memory coupled with and readable by the processor and storing data for processing by the processor, [0027] At step 214, an update is performed, such as updating data stored in memory of the end effector. In embodiments where the end effector includes a memory to store data that can be communicated (e.g., to the system upon coupling), the memory can in some embodiments be writable such that the information stored on the memory can be updated following use during a procedure). Finally, Brik teaches, the data, when processed, causes the processor to:
determine that a first surgical tool of the plurality of surgical tools is coupled to the interface unit via the set of components; receive first information associated with an identification feature of the first surgical tool ([0039] “The end effector 508 can have a unique identifier, be recognized by a robotic surgical system, and/or can send data. The system can, e.g., automatically, identify the particular end effector 508 based on data received from or regarding the end effector. Such data can include general characteristics of the end effector 508, such as dimensions, shape, weight, center of mass, or other mechanical parameters or characteristics, as well as any of a variety of more specific data parameters, such as the location, function, manufacturing information, history (e.g., lifetime, service, and/or sterilization), and other parameters of the end effector. Data can be stored on the end effector 508 and communicated to the robotic surgical system automatically (e.g., such as in connection with coupling the end effector to a robot arm).”)
Brik further teaches where “after the system identifies the end effector (e.g., using data received from the end effector), the system can adjust operation of the system (e.g., based on data received from the end effector or on additional data retrieved by the system controller (e.g., a database) after receiving the initial data from the end effector)” ([0027]) and “ once an end effector 908 is connected to the system, the system can detect the end effector and activate the corresponding operative module. For example, when the system detects that an instrument is retained by the guide 912, a module that corresponds to the instrument can be activated to read the parameters associated with the instrument, such as distance (D) or angle (C). In some embodiments, this information can be used to adjust calibration data (e.g., using the position and tolerance information).”, but fails to explicitly disclose identify, based on the first information, the surgical tool and a first set of surgical operations supported by the first surgical tool; and control the robotic arm and the first surgical tool to perform at least one of the first set of surgical operations, wherein signals for controlling the first surgical tool are sent through the set of components.
However, Brierton teaches a surgical robot with an instrument engagement detector to detect an engaged instrument wherein the processor is configured to: determine that a first surgical tool of the plurality of surgical tools is coupled to the interface unit via the set of components ([0007], [0055] “the coupler 501 may be located on either the robot arm interface or a surgical drape. In all of these examples, the coupler 501 is used to couple the engagement source 401 to the engagement detector 402, thereby enabling the robot arm to detect that the instrument 306 is engaged on the robot arm”, Figure 6: 601); receive first information associated with an identification feature of the first surgical tool ([0067]-[0069] “step 606, the controller 405 may control the arm transceiver 414 to transmit a query to the instrument. The arm transceiver 414 responds by transmitting the query to the instrument. The instrument receiver 502 receives the query. At step 607, the instrument responds to receipt of the query by retrieving the requested data from the data store 504, and transmitting the requested data from the instrument transmitter 503 to the robot arm. The arm receiver 403 receives the requested data and outputs it to the controller 405. That query may be a request for the instrument to provide data indicative of the value of one or more parameters of the instrument. These parameters include one, more or all of the following: instrument type, instrument identity, instrument usage data, and control data.”); identify, based on the first information, the first surgical tool and a first set of surgical operations supported by the first surgical tool ([0067]-[0070] data that is received and determined from the surgical tool); and control the robotic arm and the first surgical tool to perform at least one of the first set of surgical operations, wherein signals for controlling the first surgical tool are sent through the set of components ([0072] “at step 609, the controller 405 may modify an operational mode of the robot arm in response to the data it has received from the instrument. For example, the controller may change the operational mode of the robot arm by: engaging a manipulative mode of the instrument (in which the robot arm is operable to control manipulation of the end effector of the instrument), disengaging a manipulative mode of the instrument, engaging a manipulative mode which is specific to the instrument type identified in the data received from the instrument (i.e. specific to the instrument being a pair of grippers, a pair of scissors, a scalpel, etc), enabling a communication link with the instrument, disabling a communication link with the instrument, engaging a compliant mode of the robot arm (in which the robot arm responds to a manually applied external force to a limb/joint of the robot arm by controlling that limb/joint to move in the direction of the applied external force), engaging a non-compliant mode of the robot arm.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brik to incorporate the teachings of Brierton to identify, based on the first information, the surgical tool and a first set of surgical operations supported by the first surgical tool; and control the robotic arm and the first surgical tool to perform at least one of the first set of surgical operations, wherein signals for controlling the first surgical tool are sent through the set of components, as these prior art references are directed to surgical robots used for identifying attached surgical tools. One would be motivated to do this to be able to control and identify the multitude of instruments that are used during a surgical procedure, as recognized by Brierton ([0003]).
Regarding claim 2, Brik in view of Brierton teaches the robotic system of claim 1 (as shown above). Brik further discloses wherein the set of components of the interface unit is configured to provide, mechanical coupling, pneumatic coupling, irrigation coupling, or a combination thereof, for coupling any surgical tool of the plurality of surgical tools to the robotic arm. ([0021] As shown with respect to FIG. 1, an end effector can (e.g., first) be coupled to a robot arm. Both the end effector and the robot arm can be part of a robotic surgical system. It is understood that at the coupling includes mechanical attachment, and can also include the system receiving input that the end effector is being attached (such as by sensing with peripheral devices, completion of an electrical circuit between the end effector and robot arm, or receiving instructions from the controller)).
Regarding claim 3, Brik in view of Brierton teaches the robotic surgical system of claim 1 (as shown above). Brik further disclose wherein the first information associated with the identification feature of the first surgical tool is extracted from a visual marker or visual code ([0036] The end effector 308 can include a unique identifier 324. The unique identifier can be passive, such as a QR code, bar code, serial number, ID number, or other marking or tag that uniquely identifies a particular end effector (e.g., or a particular group of end effectors). The unique identifier 324 can be active, such as an RFID tag readable by a sensor of the system 300 or another data transmission technique.code, bar code, serial number, ID number, or other marking or tag that uniquely identifies a particular end effector (e.g., or a particular group of end effectors). The unique identifier 324 can be active, such as an RFID tag readable by a sensor of the system 300 or another data transmission technique marking or tag that uniquely identifies a particular end effector (e.g., or a particular group of end effectors). The unique identifier 324 can be active, such as an RFID tag readable by a sensor of the system 300 or another data transmission technique.)
Regarding claim 4, Brik in view of Brierton teaches the robotic surgical system of claim 1 (As shown above), wherein the memory stores further data for processing by the processor that, when processed, causes the processor to:
determine that a second surgical tool of the plurality of surgical tools is coupled to the interface unit via the set of components; receive second information associated with an identification feature of the second ([0053] For example, the system can include one or more modules (not shown) thereon that correspond to each end effector, with the modules being configured to read end effector parameters.)
Brik fails to explicitly disclose identify, based on the second information, the second surgical tool and a second set of surgical operations supported by the second surgical tool.
However, Brierton teaches identify, based on the second information, the second surgical tool and a second set of surgical operations supported by the second surgical tool (Figure 6, [0072] “at step 609, the controller 405 may modify an operational mode of the robot arm in response to the data it has received from the instrument. For example, the controller may change the operational mode of the robot arm by: engaging a manipulative mode of the instrument (in which the robot arm is operable to control manipulation of the end effector of the instrument), disengaging a manipulative mode of the instrument, engaging a manipulative mode which is specific to the instrument type identified in the data received from the instrument (i.e. specific to the instrument being a pair of grippers, a pair of scissors, a scalpel, etc), enabling a communication link with the instrument, disabling a communication link with the instrument, engaging a compliant mode of the robot arm (in which the robot arm responds to a manually applied external force to a limb/joint of the robot arm by controlling that limb/joint to move in the direction of the applied external force), engaging a non-compliant mode of the robot arm.”, [0003).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brik to incorporate the teachings of Brierton to identify, based on the second information, the second surgical tool and a second set of surgical operations supported by the second surgical tool, as these prior art references are directed to surgical robots used for identifying attached surgical tools. One would be motivated to do this to be able to control and identify the multitude of instruments that are used during a surgical procedure, as recognized by Brierton ([0003]).
Regarding claim 5, Brik in view of Brierton teaches the robotic surgical system of claim 4 (as shown above). Brik further discloses “Once an end effector 908 is connected to the system, the system can detect the end effector and activate the corresponding operative module. For example, when the system detects that an instrument is retained by the guide 912, a module that corresponds to the instrument can be activated to read the parameters associated with the instrument, such as distance (D) or angle (C)).” ([0053]), but fails to explicitly teach wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: operate the robotic arm and the second surgical tool to perform at least one of the second set of surgical operations.
However, Brierton teaches “at step 609, the controller 405 may modify an operational mode of the robot arm in response to the data it has received from the instrument. For example, the controller may change the operational mode of the robot arm by: engaging a manipulative mode of the instrument (in which the robot arm is operable to control manipulation of the end effector of the instrument), disengaging a manipulative mode of the instrument, engaging a manipulative mode which is specific to the instrument type identified in the data received from the instrument (i.e. specific to the instrument being a pair of grippers, a pair of scissors, a scalpel, etc), enabling a communication link with the instrument, disabling a communication link with the instrument, engaging a compliant mode of the robot arm (in which the robot arm responds to a manually applied external force to a limb/joint of the robot arm by controlling that limb/joint to move in the direction of the applied external force), engaging a non-compliant mode of the robot arm.”([0072]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brik to incorporate the teachings of Brierton to wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: operate the robotic arm and the second surgical tool to perform at least one of the second set of surgical operations, as these prior art references are directed to surgical robots used for identifying attached surgical tools. One would be motivated to do this to be able to control and identify the multitude of instruments that are used during a surgical procedure, as recognized by Brierton ([0003]).
Regarding claim 6, Brik in view of Brierton teaches, the robotic surgical system of claim 5 (as shown above). Brik further discloses “the operation adjustment is at least one of an adjustment to the robot arm based on an estimated load and/or force exerted by the end effector weight or center of mass, an adjustment to the robot arm to allow for optimal joint configuration of the robot arm based on tool trajectory, or an adjustment to calibration data” ([0060]), but fails to explicitly teach wherein the second set of surgical operations is different than the first set of surgical operations.
However, Brierton teaches “at step 609, the controller 405 may modify an operational mode of the robot arm in response to the data it has received from the instrument. For example, the controller may change the operational mode of the robot arm by:… engaging a manipulative mode which is specific to the instrument type identified in the data received from the instrument (i.e. specific to the instrument being a pair of grippers, a pair of scissors, a scalpel, etc)”([0072]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brik to incorporate the teachings of Brierton to the second set of surgical operations is different than the first set of surgical operations., as these prior art references are directed to surgical robots used for identifying attached surgical tools. One would be motivated to do this to be able to control and identify the multitude of instruments that are used during a surgical procedure, as recognized by Brierton ([0003]).
Regarding claim 7, Brik in view of Brierton teaches the robotic surgical system of claim 5 (as shown above). Brik further discloses “a robotic surgical system comprises a robot arm; a controller operably connected to the robot arm for positioning a tool with respect to a patient, wherein the tool is retained by an end effector, the controller being configured to: determine whether the end effector is coupled to the robot arm; receive data from the end effector; identify the end effector; and adjust operation of the surgical system (for example, the robot arm) based on the data received from the end effector” ([0060]), but fails to explicitly teach wherein the second surgical tool replaces the first surgical tool being coupled to the interface unit via the set of components.
However, Brierton teaches “The arm terminates in an attachment 305 for interfacing with the instrument 306. Suitably, the instrument 306 takes the form described with respect to FIG. 2. The attachment 305 comprises a drive assembly for driving articulation of the instrument. Movable interface elements of the drive assembly interface mechanically engage corresponding movable interface elements of the instrument interface in order to transfer drive from the robot arm to the instrument. One instrument is exchanged for another several times during a typical operation. Thus, the instrument is attachable to and detachable from the robot arm during the operation. Features of the drive assembly interface and the instrument interface aid their alignment when brought into engagement with each other, so as to reduce the accuracy with which they need to be aligned by the user.” ([0048]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brik to incorporate the teachings of Brierton to the second surgical tool replaces the first surgical tool being coupled to the interface unit via the set of components, as these prior art references are directed to surgical robots used for identifying attached surgical tools. One would be motivated to do this to be able to attach and utilize multiple surgical instruments that are typically used in surgical procedures, as recognized by Brierton ([0003]).
Regarding claim 8, Brik in view of Brierton teaches, the robotic surgical system of claim 4 (as shown above). Brik fails to explicitly teach wherein the second information associated with the identification feature of the second surgical tool is received through the set of components.
However, Brierton teaches teach wherein the second information associated with the identification feature of the second surgical tool is received through the set of components ([0067]-[0069] “step 606, the controller 405 may control the arm transceiver 414 to transmit a query to the instrument. The arm transceiver 414 responds by transmitting the query to the instrument. The instrument receiver 502 receives the query. At step 607, the instrument responds to receipt of the query by retrieving the requested data from the data store 504, and transmitting the requested data from the instrument transmitter 503 to the robot arm. The arm receiver 403 receives the requested data and outputs it to the controller 405. That query may be a request for the instrument to provide data indicative of the value of one or more parameters of the instrument. These parameters include one, more or all of the following: instrument type, instrument identity, instrument usage data, and control data.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brik to incorporate the teachings of Brierton to have the second information associated with the identification feature of the second surgical tool is received through the set of components, as these prior art references are directed to surgical robots used for identifying attached surgical tools. One would be motivated to do this to be able to control and identify the multitude of instruments that are used during a surgical procedure, as recognized by Brierton ([0003]).
Regarding claim 9, Brik in view of Brierton teaches, the robotic surgical system of claim 8 (as shown above). Brik fails to explicitly disclose wherein the first information associated with the identification feature of the first surgical tool is received through the set of components.
However, Brierton teaches wherein the first information associated with the identification feature of the first surgical tool is received through the set of components ([0067]-[0069] “step 606, the controller 405 may control the arm transceiver 414 to transmit a query to the instrument. The arm transceiver 414 responds by transmitting the query to the instrument. The instrument receiver 502 receives the query. At step 607, the instrument responds to receipt of the query by retrieving the requested data from the data store 504, and transmitting the requested data from the instrument transmitter 503 to the robot arm. The arm receiver 403 receives the requested data and outputs it to the controller 405. That query may be a request for the instrument to provide data indicative of the value of one or more parameters of the instrument. These parameters include one, more or all of the following: instrument type, instrument identity, instrument usage data, and control data.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brik to incorporate the teachings of Brierton to have the first information associated with the identification feature of the first surgical tool is received through the set of components, as these prior art references are directed to surgical robots used for identifying attached surgical tools. One would be motivated to do this to be able to control and identify the multitude of instruments that are used during a surgical procedure, as recognized by Brierton ([0003]).
Regarding claim 10, Brik in view of Brierton teaches, the robotic surgical system of claim 1 (as shown above). Brik further discloses wherein the identification feature comprises a quick response (QR) code, a serial number, a barcode, an inner memory stored inside each surgical tool, a visual marker, a radio-frequency identification (RFID) system, a Near-Field Communication (NFC) connection, inner switching of an input/output (I/O) system, or a combination thereof. ([0036] The end effector 308 can include a unique identifier 324. The unique identifier can be passive, such as a QR code, bar code, serial number, ID number, or other marking or tag that uniquely identifies a particular end effector (e.g., or a particular group of end effectors). The unique identifier 324 can be active, such as an RFID tag readable by a sensor of the system 300 or another data transmission technique.code, bar code, serial number, ID number, or other marking or tag that uniquely identifies a particular end effector (e.g., or a particular group of end effectors). The unique identifier 324 can be active, such as an RFID tag readable by a sensor of the system 300 or another data transmission technique marking or tag that uniquely identifies a particular end effector (e.g., or a particular group of end effectors). The unique identifier 324 can be active, such as an RFID tag readable by a sensor of the system 300 or another data transmission technique.)
Regarding claim 11, Brik discloses a robotic surgical system, comprising:
a robotic arm (Figure 3, 320) comprising a proximal end and a distal end;
a plurality of surgical tools; (The end effector 308 can retain a tool (e.g., used in association with instruments) (not numbered). The end effector can be a guide for retaining a surgical tool (Figure 5) or can itself be a surgical tool such as an oscillating saw (Figure 6). additionally see paragraphs [0039 & 0040].) an interface unit disposed at the distal end of the robotic arm and coupled to the robotic arm (An end effector 308 can be coupled to the robot arm 320. An end effector 308 can be coupled to the robot arm 320.), wherein the interface unit comprises a set of components configured to interchangeably couple any surgical tool of the plurality of surgical tools to the robotic arm. ((Figure 3. [0028 and 0030]) A surgical robot base 302 supports a robot arm 320 . . . The joints 309 can be configured for incremental changes in each of the six degrees of freedom to ensure precision in operation of a plurality of different end effectors during surgery . . . The system 300 can utilize end effectors of various shapes, sizes, and functionalities. In some embodiments, the robot arm 320 can have the end effector 308 on a distal end thereof, as shown, although the end effector can couple to the robot arm along a length thereof in other embodiments.
a processor coupled with the robotic arm and the interface unit, wherein signals passed through the set of interface components ([0041] “FIG. 7 illustrates an end effector 708. The end effector 708 has a housing 709. An instrument mount 710 extends from the housing 709. A plurality of alignment markers (not depicted) can be disposed on the housing 709. Manufacturing information about the end effector 708 can include data about the pattern and tolerances associated with the alignment markers. In some embodiments, this information can be used to adjust calibration data (e.g., using the position and tolerance information). The instrument mount 710 can hold a guide cannula 712. The guide cannula 712 can receive a tool (not depicted) and/or an instrument (not depicted) and direct it toward a surgical site. The housing 709 retains a memory, processor, and/or other integrated electronics for communicating with a controller (not depicted), for example, after coupling to the robot arm. In some embodiments, the memory, processor, and/or other integrated electronics can include a wireless communication module to implement wireless communications between the end effector 708 and controller, e.g., for sending and receiving data.”) enable the processor to:
determine that a first surgical tool of the plurality of surgical tools is coupled to the interface unit via the set of components; receive first information associated with an identification feature of the first surgical tool ([0039] “The end effector 508 can have a unique identifier, be recognized by a robotic surgical system, and/or can send data. The system can, e.g., automatically, identify the particular end effector 508 based on data received from or regarding the end effector. Such data can include general characteristics of the end effector 508, such as dimensions, shape, weight, center of mass, or other mechanical parameters or characteristics, as well as any of a variety of more specific data parameters, such as the location, function, manufacturing information, history (e.g., lifetime, service, and/or sterilization), and other parameters of the end effector. Data can be stored on the end effector 508 and communicated to the robotic surgical system automatically (e.g., such as in connection with coupling the end effector to a robot arm).”)
Brik further teaches where “after the system identifies the end effector (e.g., using data received from the end effector), the system can adjust operation of the system (e.g., based on data received from the end effector or on additional data retrieved by the system controller (e.g., a database) after receiving the initial data from the end effector)” ([0027]) and “ once an end effector 908 is connected to the system, the system can detect the end effector and activate the corresponding operative module. For example, when the system detects that an instrument is retained by the guide 912, a module that corresponds to the instrument can be activated to read the parameters associated with the instrument, such as distance (D) or angle (C). In some embodiments, this information can be used to adjust calibration data (e.g., using the position and tolerance information).”, but fails to explicitly disclose identify, based on the first information, the surgical tool and a first set of surgical operations supported by the first surgical tool; and control the robotic arm and the first surgical tool to perform at least one of the first set of surgical operations, wherein signals for controlling the first surgical tool are sent through the set of components.
However, Brierton et al. (US 2018/0228559 A1) teaches a surgical robot with an instrument engagement detector to detect an engaged instrument wherein the processor is configured to: determine that a first surgical tool of the plurality of surgical tools is coupled to the interface unit via the set of components ([0007], [0055] “the coupler 501 may be located on either the robot arm interface or a surgical drape. In all of these examples, the coupler 501 is used to couple the engagement source 401 to the engagement detector 402, thereby enabling the robot arm to detect that the instrument 306 is engaged on the robot arm”, Figure 6: 601); receive first information associated with an identification feature of the first surgical tool ([0067]-[0069] “step 606, the controller 405 may control the arm transceiver 414 to transmit a query to the instrument. The arm transceiver 414 responds by transmitting the query to the instrument. The instrument receiver 502 receives the query. At step 607, the instrument responds to receipt of the query by retrieving the requested data from the data store 504, and transmitting the requested data from the instrument transmitter 503 to the robot arm. The arm receiver 403 receives the requested data and outputs it to the controller 405. That query may be a request for the instrument to provide data indicative of the value of one or more parameters of the instrument. These parameters include one, more or all of the following: instrument type, instrument identity, instrument usage data, and control data.”); identify, based on the first information, the first surgical tool and a first set of surgical operations supported by the first surgical tool ([0067]-[0070] data that is received and determined from the surgical tool); and control the robotic arm and the first surgical tool to perform at least one of the first set of surgical operations, wherein signals for controlling the first surgical tool are sent through the set of components ([0072] “at step 609, the controller 405 may modify an operational mode of the robot arm in response to the data it has received from the instrument. For example, the controller may change the operational mode of the robot arm by: engaging a manipulative mode of the instrument (in which the robot arm is operable to control manipulation of the end effector of the instrument), disengaging a manipulative mode of the instrument, engaging a manipulative mode which is specific to the instrument type identified in the data received from the instrument (i.e. specific to the instrument being a pair of grippers, a pair of scissors, a scalpel, etc), enabling a communication link with the instrument, disabling a communication link with the instrument, engaging a compliant mode of the robot arm (in which the robot arm responds to a manually applied external force to a limb/joint of the robot arm by controlling that limb/joint to move in the direction of the applied external force), engaging a non-compliant mode of the robot arm.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brik to incorporate the teachings of Brierton to identify, based on the first information, the surgical tool and a first set of surgical operations supported by the first surgical tool; and control the robotic arm and the first surgical tool to perform at least one of the first set of surgical operations, wherein signals for controlling the first surgical tool are sent through the set of components, as these prior art references are directed to surgical robots used for identifying attached surgical tools. One would be motivated to do this to be able to control and identify the multitude of instruments that are used during a surgical procedure, as recognized by Brierton ([0003]).
Regarding claim 12, Brik in view of Brierton teaches, the robotic surgical system of claim 11 (as shown above). Brik further discloses wherein the set of components of the interface unit is configured to provide mechanical coupling, pneumatic coupling, irrigation coupling, or a combination thereof, for coupling any surgical tool of the plurality of surgical tools to the robotic arm. ([0021] As shown with respect to FIG. 1, an end effector can (e.g., first) be coupled to a robot arm. Both the end effector and the robot arm can be part of a robotic surgical system. It is understood that at the coupling includes mechanical attachment, and can also include the system receiving input that the end effector is being attached (such as by sensing with peripheral devices, completion of an electrical circuit between the end effector and robot arm, or receiving instructions from the controller).)
Regarding claim 13, Brik in view of Brierton teaches the robotic surgical system of claim 11 (as shown above). Brik further discloses wherein each surgical tool of the plurality of surgical tools supports a specific set of surgical operations. ([0034] “The end effector 308 retains a tool (not numbered) that retains an instrument or surgical device, for example, a drill, scalpel, saw blade, burr, reamer, mill, knife, or any other implement that could cut or deform bone and is appropriate for use in a given operation.”)
Regarding claim 14, Brik in view of Brierton teaches the robotic surgical system of claim 11 (as shown above). Brik further discloses wherein the identification feature of the first surgical tool is stored in memory of the first surgical tool ([0038] “The system can, e.g., automatically, identify the particular end effector 408 based on data received from or regarding the end effector. Such data can include general characteristics of the end effector 408, such as dimensions, shape, weight, center of mass, or other mechanical parameters or characteristics, as well as any of a variety of more specific data parameters, such as the location, function, manufacturing information, history (e.g., lifetime, service, and/or sterilization), and other parameters of the end effector. Data can be stored on the end effector 408 and communicated to the robotic surgical system automatically (e.g., such as in connection with coupling the end effector to a robot arm).”)
Regarding claim 15, Brik in view of Brierton teaches, the robotic surgical system of claim 11 (as shown above), wherein the identification feature comprises a quick response (QR) code, a serial number, a barcode, an inner memory stored inside each surgical tool, a visual marker, a radio-frequency identification (RFID) system, a Near-Field Communication (NFC) connection, inner switching of an input/output (I/O) system, or a combination thereof. ([0036] The unique identifier can be passive, such as a QR code, bar code, serial number, ID number, or other marking or tag that uniquely identifies a particular end effector (e.g., or a particular group of end effectors). The unique identifier 324 can be active, such as an RFID tag readable by a sensor of the system 300 or another data transmission technique.)
Regarding claim 16, Brik discloses a robotic surgical system, comprising:
a robotic arm comprising a proximal end and a distal end; a plurality of surgical tools; an interface unit disposed at the distal end of the robotic arm and coupled to the robotic arm, comprising:
a body (See annotated figure 3);
a tool receiving element (See annotated figure 3); and
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a set of components configured to interchangeably couple any surgical tool of the plurality of surgical tools to the robotic arm. (Figure 3. [0028 and 0030]) A surgical robot base 302 supports a robot arm 320 . . . The joints 309 can be configured for incremental changes in each of the six degrees of freedom to ensure precision in operation of a plurality of different end effectors (tools) during surgery . . . An end effector 308 can be coupled to the robot arm 320. The system 300 can utilize end effectors of various shapes, sizes, and functionalities. In some embodiments, the robot arm 320 can have the end effector 308 on a distal end thereof, as shown, although the end effector can couple to the robot arm along a length thereof in other embodiments. The end effector 308 can retain a tool (e.g., used in association with instruments) (not numbered). The end effector can be a guide for retaining a surgical tool (Figure 5) or can itself be a surgical tool such as an oscillating saw (Figure 6). Additionally see paragraphs [0039 & 0040].); and
a processor coupled with the robotic arm and the interface unit, wherein signals passed through the set of interface components ([0041] “FIG. 7 illustrates an end effector 708. The end effector 708 has a housing 709. An instrument mount 710 extends from the housing 709. A plurality of alignment markers (not depicted) can be disposed on the housing 709. Manufacturing information about the end effector 708 can include data about the pattern and tolerances associated with the alignment markers. In some embodiments, this information can be used to adjust calibration data (e.g., using the position and tolerance information). The instrument mount 710 can hold a guide cannula 712. The guide cannula 712 can receive a tool (not depicted) and/or an instrument (not depicted) and direct it toward a surgical site. The housing 709 retains a memory, processor, and/or other integrated electronics for communicating with a controller (not depicted), for example, after coupling to the robot arm. In some embodiments, the memory, processor, and/or other integrated electronics can include a wireless communication module to implement wireless communications between the end effector 708 and controller, e.g., for sending and receiving data.”) enable the processor to:
determine that a first surgical tool of the plurality of surgical tools is coupled to the interface unit via the set of components; receive first information associated with an identification feature of the first surgical tool ([0039] “The end effector 508 can have a unique identifier, be recognized by a robotic surgical system, and/or can send data. The system can, e.g., automatically, identify the particular end effector 508 based on data received from or regarding the end effector. Such data can include general characteristics of the end effector 508, such as dimensions, shape, weight, center of mass, or other mechanical parameters or characteristics, as well as any of a variety of more specific data parameters, such as the location, function, manufacturing information, history (e.g., lifetime, service, and/or sterilization), and other parameters of the end effector. Data can be stored on the end effector 508 and communicated to the robotic surgical system automatically (e.g., such as in connection with coupling the end effector to a robot arm).”)
Brik further teaches where “after the system identifies the end effector (e.g., using data received from the end effector), the system can adjust operation of the system (e.g., based on data received from the end effector or on additional data retrieved by the system controller (e.g., a database) after receiving the initial data from the end effector)” ([0027]) and “ once an end effector 908 is connected to the system, the system can detect the end effector and activate the corresponding operative module. For example, when the system detects that an instrument is retained by the guide 912, a module that corresponds to the instrument can be activated to read the parameters associated with the instrument, such as distance (D) or angle (C). In some embodiments, this information can be used to adjust calibration data (e.g., using the position and tolerance information).”, but fails to explicitly disclose identify, based on the first information, the surgical tool and a first set of surgical operations supported by the first surgical tool; and control the robotic arm and the first surgical tool to perform at least one of the first set of surgical operations, wherein signals for controlling the first surgical tool are sent through the set of components.
However, Brierton et al. (US 2018/0228559 A1) teaches a surgical robot with an instrument engagement detector to detect an engaged instrument wherein the processor is configured to: determine that a first surgical tool of the plurality of surgical tools is coupled to the interface unit via the set of components ([0007], [0055] “the coupler 501 may be located on either the robot arm interface or a surgical drape. In all of these examples, the coupler 501 is used to couple the engagement source 401 to the engagement detector 402, thereby enabling the robot arm to detect that the instrument 306 is engaged on the robot arm”, Figure 6: 601); receive first information associated with an identification feature of the first surgical tool ([0067]-[0069] “step 606, the controller 405 may control the arm transceiver 414 to transmit a query to the instrument. The arm transceiver 414 responds by transmitting the query to the instrument. The instrument receiver 502 receives the query. At step 607, the instrument responds to receipt of the query by retrieving the requested data from the data store 504, and transmitting the requested data from the instrument transmitter 503 to the robot arm. The arm receiver 403 receives the requested data and outputs it to the controller 405. That query may be a request for the instrument to provide data indicative of the value of one or more parameters of the instrument. These parameters include one, more or all of the following: instrument type, instrument identity, instrument usage data, and control data.”); identify, based on the first information, the first surgical tool and a first set of surgical operations supported by the first surgical tool ([0067]-[0070] data that is received and determined from the surgical tool); and control the robotic arm and the first surgical tool to perform at least one of the first set of surgical operations, wherein signals for controlling the first surgical tool are sent through the set of components ([0072] “at step 609, the controller 405 may modify an operational mode of the robot arm in response to the data it has received from the instrument. For example, the controller may change the operational mode of the robot arm by: engaging a manipulative mode of the instrument (in which the robot arm is operable to control manipulation of the end effector of the instrument), disengaging a manipulative mode of the instrument, engaging a manipulative mode which is specific to the instrument type identified in the data received from the instrument (i.e. specific to the instrument being a pair of grippers, a pair of scissors, a scalpel, etc), enabling a communication link with the instrument, disabling a communication link with the instrument, engaging a compliant mode of the robot arm (in which the robot arm responds to a manually applied external force to a limb/joint of the robot arm by controlling that limb/joint to move in the direction of the applied external force), engaging a non-compliant mode of the robot arm.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brik to incorporate the teachings of Brierton to identify, based on the first information, the surgical tool and a first set of surgical operations supported by the first surgical tool; and control the robotic arm and the first surgical tool to perform at least one of the first set of surgical operations, wherein signals for controlling the first surgical tool are sent through the set of components, as these prior art references are directed to surgical robots used for identifying attached surgical tools. One would be motivated to do this to be able to control and identify the multitude of instruments that are used during a surgical procedure, as recognized by Brierton ([0003]).
Regarding claim 17, Brik in view of Brierton teaches the robotic surgical system of claim 16 (as shown above). Brik further discloses wherein the set of components of the interface unit is configured to provide mechanical coupling, pneumatic coupling, irrigation coupling, or a combination thereof, for coupling any surgical tool of the plurality of surgical tools to the robotic arm. ([0021] As shown with respect to FIG. 1, an end effector can (e.g., first) be coupled to a robot arm. Both the end effector and the robot arm can be part of a robotic surgical system. It is understood that at the coupling includes mechanical attachment, and can also include the system receiving input that the end effector is being attached (such as by sensing with peripheral devices, completion of an electrical circuit between the end effector and robot arm, or receiving instructions from the controller).)
Regarding claim 18, Brik in view of Brierton teaches the robotic surgical system of claim 16 (as shown above). Brik further discloses wherein each surgical tool of the plurality of surgical tools supports a specific set of surgical operations. ([0034] “The end effector 308 retains a tool (not numbered) that retains an instrument or surgical device, for example, a drill, scalpel, saw blade, burr, reamer, mill, knife, or any other implement that could cut or deform bone and is appropriate for use in a given operation.”)
Regarding claim 19, Brik in view of Brierton teaches the robotic surgical system of claim 16 (as shown above). Brik further discloses wherein the identification feature of the first surgical tool is stored in memory of the first surgical tool ([0038] “The system can, e.g., automatically, identify the particular end effector 408 based on data received from or regarding the end effector. Such data can include general characteristics of the end effector 408, such as dimensions, shape, weight, center of mass, or other mechanical parameters or characteristics, as well as any of a variety of more specific data parameters, such as the location, function, manufacturing information, history (e.g., lifetime, service, and/or sterilization), and other parameters of the end effector. Data can be stored on the end effector 408 and communicated to the robotic surgical system automatically (e.g., such as in connection with coupling the end effector to a robot arm).”)
Regarding claim 20, Brik in view of Brierton teaches the robotic surgical system of claim 11 (as shown above). Brik further discloses wherein the identification feature comprises a quick response (QR) code, a serial number, a barcode, an inner memory stored inside each surgical tool, a visual marker, a radio-frequency identification (RFID) system, a Near-Field Communication (NFC) connection, inner switching of an input/output (I/O) system, or a combination thereof. ([0036] The unique identifier can be passive, such as a QR code, bar code, serial number, ID number, or other marking or tag that uniquely identifies a particular end effector (e.g., or a particular group of end effectors). The unique identifier 324 can be active, such as an RFID tag readable by a sensor of the system 300 or another data transmission technique.)
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ATTIYA SAYYADA HUSSAINI whose telephone number is (703)756-5921. The examiner can normally be reached Monday-Friday 8:00 am - 5:00 pm.
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/ATTIYA SAYYADA HUSSAINI/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
