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 Arguments
Applicant’s arguments, filed November 5, 2025, with respect to the rejection(s) of claim(s)1-14 and 16-21 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further search and consideration, a new ground(s) of rejection have been made as can be further seen 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.
Claims 1-2, 8, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over US 11,406,472 B2 to Mata in view of US 2010/0198402 A1 to Greer et al. (hereinafter “Greer”).
Regarding claim 1, Mata teaches:
A device/surgical instrument assembly (see fig. 2A-2B), comprising:
a tool portion (see annotated fig. 2B below, col. 11, lines 57-67, and col. 12, lines 1-6) configured to be inserted into a target location in a patient during a procedure (col. 11, lines 57-67, and col. 12, lines 1-6 and fig. 4A-4C);
a display assembly mounted on the device and comprising a display (see annotated fig. 2A and col. 12, lines 56-57), the display configured to display prompts/options (such as the fig. 14A, 622 and 646) for an operator of the device to guide the tool portion to the first target location (point of entry) in the patient (such as the anatomical structure inside the patient) (see col. 18, lines 33-43);
and a computing device having one or more processors coupled to memory (see annotated fig. 2A below, col. 7, lines 29-41 &61-67, col. 8, lines 1-3, col. 24, lines 49-67, and col. 25, lines 1-8), the computing device mounted on the device/surgical instrument assembly (see annotated fig. 2A below),
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and wherein the computing device is controlled via buttons, keys, etc. located on a user interface portion (see col. 7, lines 42-49: “The computing device 204 also can contain the user interface portion 216 allowing a user to communicate with the computing device 204. The user interface 216 can include inputs that provide the ability to control the computing device 204, via, for example, buttons, soft keys, a mouse, voice actuated controls, a touch screen, movement of the computing device 204, visual cues (e.g., moving a hand in front of a camera on the computing device 204), or the like.”),
but does not disclose wherein the computing device is configured to:
receive, from the controller computing device/robotic control component, instructions to present a change in a position of the device to bring the tool portion closer to the first target location in the patient;
and present, based on the instructions, a guidance prompt for the operator that indicates the change in the position of the device responsive to a button push on the tool portion,
transmit a signal to the controller computing device to switch from the first target location to a second target location;
receive, from the controller computing device, updated instructions to present a change in a position of the surgical tool to bring the surgical tool closer to the second target location in the patient;
and
present, based on the updated instructions, the guidance prompt for the operator that indicates the change in position of the surgical tool to approximate the surgical tool to the second target location.
However, Greer teaches systems, methods, and devices for moving the tool of a medical robot along a single axis (see abstract, lines 1-7 (first sentence)). The system (figs. 1A, 2C, and 3C) teaches wherein the computing device is configured to:
receive, from the controller computing device/computer system, instructions to present a change in a position of the device to bring the tool portion closer to the first target location in the patient by actuating a button located on the user input device (see para 0010, first sentence , para 0012, and para 0013: In some embodiments, the computer system may also be configured to receive a command (e.g., after the command identifying the starting location) indicating a new (e.g., a second) target location. In some embodiments, the computer system may also be configured to receive a command (e.g., after the command identifying the starting location) indicating a new (e.g., a second) starting location……… “In some embodiments, the computer system may also be configured to receive a command (e.g., after the command identifying the starting location) indicating a new (e.g., a second) target location. In some embodiments, the computer system may also be configured to receive a command (e.g., after the command identifying the starting location) indicating a new (e.g., a second) starting location.”);
and present, based on the instructions, a guidance prompt (located on the GUI) for the operator that indicates the change in the position of the device responsive to a button push on the tool portion/input device (see para 0012),
transmit a signal to the controller computing device to switch from the first target location to a second target location (see para 0012—the computer system is configured to move the biopsy tool from one starting location to the target location along a single axis for an automated biopsy and is prompted through the executing function to begin when a button is pressed on the user’s input device in order to move the tool portion);
receive, from the controller computing device, updated instructions to present a change in a position of the surgical tool to bring the surgical tool closer to the second target location in the patient (target location for entering the patient during the biopsy – see para 0012, para 0013: “ Thus, in some embodiments, the computer system may be configured to perform at least the following functions: receive a command (e.g., through a user's touch of the screen displaying the relevant GUI) identifying a target location for a tool used in an automated movement by a robotic arm; receive a command identifying a starting location for the tool; receive a command to execute an automated move along a path (e.g., a line) defined at least in part by the starting location and the target location; and execute the automated move such that the tool, which may have a longitudinal axis, travels along the path (e.g., along a single axis). That path also may be aligned with the tools longitudinal axis.”, and para 0059-0060);
and
present, based on the updated instructions, the guidance prompt for the operator that indicates the change in position of the surgical tool to approximate the surgical tool to the second target location (see para 0047, last two sentences, para 0059-0061, and para 0064 – because the change in position of the surgical tool is occurring in a 2D or 3D virtual environment on the MRID (magnetic resonance display screen), the position of the surgical tool is approximated at the second target location prior to executing the automated biopsy surgical procedure).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Mata with the teachings of Greer to arrive at the claimed invention. Such modification would improve the system by providing a compact hand-held device used to ensure the tool position and alignment is optimal for each stage of the surgical procedure, ultimately ensuring control for the instruments when performing the surgical procedure is conducted in a smooth and effective manner for both the surgeon and patient.
Regarding claim 2, Mata as modified teaches the device of claim 1, wherein the device further comprises a grip portion that allows the operator to hold and position (operate) the device/medical instrument (abstract, col. 4, lines 54-67, col. 5, lines 1-11, see annotated fig. 2A-2B below).
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Regarding claim 8, Mata as modified teaches the device of claim 1, wherein the tool portion is one of a catheter device, a drill device, a biopsy needle, or a cannula needle (see fig. 2B, col. 11, lines 57-67, and col. 12, lines 1-6).
Regarding claim 11, Mata teaches a system (col. 2, lines 55-58), comprising:
a connector/arm configured to couple to a body (205) of a surgical tool (see fig. 2A, 205 and 205 and col. 9, lines 33-55);
a display assembly/ display coupled to the connector and comprising a display (see annotated fig. 2A-2B below and col. 9: “The mount 228 can further include an arm 232 attached to the support surface 230 and the body 205 of the surgical instrument 203, such that the display 212 is in a fixed position relative to the body 205 of the surgical instrument 203. The arm 232 or the support surface 230 can be configured to rotate, so as to adjust the viewing angle of the display 212.”),
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the display configured to display prompts/options (such as fig. 14A, 622 and 646) for an operator of the device to guide the surgical tool portion to the first target location (point of entry) in the patient (such as the anatomical structure inside the patient) (see col. 18, lines 33-43);
and a computing device coupled to the display assembly or the bracket (See fig. 2a, 204 and 212 and col. 7: “In an example configuration, the computing device 204 includes a processing portion or unit 206, a power supply 208, an input portion 210, a display 212, a memory portion 214, a user interface portion 216, and an accelerometer 215.”),
the computing device comprising one or more processors coupled to memory (see annotated fig. 2A below, col. 7, lines 29-41 &61-67, col. 8, lines 1-3, col. 24, lines 49-67, and col. 25, lines 1-8),
but does not disclose wherein the computing device configured to:
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receive, from the controller computing device/robotic control component, instructions to present a change in a position of the device to bring the tool portion closer to the first target location in the patient;
and present, based on the instructions, a guidance prompt for the operator that indicates the change in the position of the surgical tool, receive, from the surgical tool, a signal from a button mounted on the surgical tool to switch from the first target location to a second target location;
receive, from the controller computing device, updated instructions to present a change in a position of the surgical tool to bring the surgical tool closer to the second target location in the patient;
and
present, based on the updated instructions, the guidance prompt for the operator that indicates the change in position of the surgical tool to approximate the surgical tool to the second target location.
However, Greer teaches systems, methods, and devices for moving the tool of a medical robot along a single axis (see abstract, lines 1-7 (first sentence)). The system (figs. 1A, 2C, and 3C) teaches wherein the computing device is configured to:
receive, from the controller computing device/computer system, instructions/commands to present a change in a position of the device to bring the tool portion closer to the first target location in the patient by actuating a button located on the user input device (see para 0010, first sentence , para 0012, see para 0013: In some embodiments, the computer system may also be configured to receive a command (e.g., after the command identifying the starting location) indicating a new (e.g., a second) target location. In some embodiments, the computer system may also be configured to receive a command (e.g., after the command identifying the starting location) indicating a new (e.g., a second) starting location……… “In some embodiments, the computer system may also be configured to receive a command (e.g., after the command identifying the starting location) indicating a new (e.g., a second) target location. In some embodiments, the computer system may also be configured to receive a command (e.g., after the command identifying the starting location) indicating a new (e.g., a second) starting location.” ), and present, based on the instructions, a guidance prompt for the operator that indicates the change in the position of the surgical tool responsive to a button push on the input device (see para 0012),
receive, from the surgical tool, a signal from a button mounted on the input device (indirectly coupled to the surgical tool) to switch from the first target location to a second target location (see para 0012—the computer system is configured to move the biopsy tool from one starting location to the target location along a single axis for an automated biopsy and is prompted through the executing function to begin when a button is pressed on the user’s input device in order to move the tool portion);
receive, from the controller computing device, updated instructions to present a change in a position of the surgical tool to bring the surgical tool closer to the second target location in the patient (target location for entering the patient during the biopsy – see para 0012, para 0013: “ Thus, in some embodiments, the computer system may be configured to perform at least the following functions: receive a command (e.g., through a user's touch of the screen displaying the relevant GUI) identifying a target location for a tool used in an automated movement by a robotic arm; receive a command identifying a starting location for the tool; receive a command to execute an automated move along a path (e.g., a line) defined at least in part by the starting location and the target location; and execute the automated move such that the tool, which may have a longitudinal axis, travels along the path (e.g., along a single axis). That path also may be aligned with the tools longitudinal axis.”, and para 0059-0060);
and
present, based on the updated instructions, the guidance prompt for the operator that indicates the change in position of the surgical tool to approximate the surgical tool to the second target location (see para 0047, last two sentences, para 0059-0061, and para 0064 – because the change in position of the surgical tool is occurring in a 2D or 3D virtual environment on the MRID (magnetic resonance display screen), the position of the surgical tool is approximated at the second target location prior to executing the automated biopsy surgical procedure).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Mata with the teachings of Greer to arrive at the claimed invention. Such modification would improve the system by providing a compact hand-held device used to ensure the tool position and alignment is optimal for each stage of the surgical procedure, ultimately ensuring control for the instruments when performing the surgical procedure is conducted in a smooth and effective manner for both the surgeon and patient.
Regarding claim 13, Mata as modified teaches the system of claim 11, wherein the connector comprises a clamp that couples to the body of the surgical tool (see annotated fig. 2B below).
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Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Mata in view of Greer, and further in view of US 2019/0365391 A1 to Nikou et al. (hereinafter “Nikou”).
Regarding claim 5, Mata as modified teaches the device of claim 1, but does not explicitly disclose wherein the device further comprising a button that, when actuated, causes the tool portion to perform a function of the tool portion.
However, Nikou teaches wherein a button, when actuated, caused the tool portion to perform a function of the tool portion (actuation of a rotating surgical tool) (para 0011).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Mata with the button actuator of Nikou to arrive at the claimed invention, since such modification would improve the system by allowing the surgical tool to be hand-controlled by the surgeon, ultimately making the surgical procedure easier for the surgeon to perform.
Claims 6, 10, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mata in view of Greer, and further in view of US 2008/0009697 A1 to Haider et al. (hereinafter “Haider”).
Regarding claim 6, Mata as modified teaches the device of claim 1, but does not disclose wherein the device comprises one or more position sensors, and wherein the computing device is further configured to receive the tool information from the one or more position sensors.
However, Haider teaches a device comprising one or more position sensors (see para 0011, para 0038, and para 0087), and wherein the computing device is further configured to receive the tool information from the one or more position sensors (para 0006-0007 and para 0011).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teaching of Mata with the teachings of Haider to arrive at the claimed invention. Such modification would improve the system by ensuring the computer system can compensate for tool deflection during the course of the surgical procedure while maintaining proper tracking on the surgical tool during the procedure, ultimately ensuring the surgical procedure is performed in a safe and effective manner while avoiding injuries from taking place during the surgical procedure for the patient.
Regarding claim 10, Mata as modified teaches the device of claim 1, further comprising a wireless interface/wireless point-to-point communication for transmitting images to the instrument assembly (fig. 2A, 202, col. 8, lines 4-12, and col. 9, lines 21-32), but does not explicitly disclose wherein the computing device is configured to provide the tool information and receive the instructions via the wireless interface.
However, Haider teaches wherein the computing device is configured to provide the tool/surgical instrument information and receive the instructions via the wireless interface/unit (para 0139-0140).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Mata with the teachings of Haider to arrive at the claimed invention, since such modification would improve the system by allowing the surgeon to operate the device more freely while receiving the necessary information to perform the surgical procedure, allowing the surgical procedure to be performed more efficiently.
Regarding claim 16, Mata as modified teaches the system of claim 11, but does not disclose wherein the device comprises one or more position sensors, and wherein the computing device is further configured to receive the tool information from the one or more position sensors.
However, Haider teaches a device comprising one or more position sensors (see para 0011, para 0038, and para 0087), and wherein the computing device is further configured to receive the tool information from the one or more position sensors (para 0006-0007 and para 0011).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teaching of Mata with the teachings of Haider to arrive at the claimed invention. Such modification would improve the system by ensuring the computer system can compensate for tool deflection during the course of the surgical procedure while maintaining proper tracking on the surgical tool during the procedure, ultimately ensuring the surgical procedure is performed in a safe and effective manner while avoiding injuries from taking place during the surgical procedure for the patient.
Regarding claim 20, Mata as modified teaches the system of claim 11, further comprising a wireless interface/wireless point-to-point communication for transmitting images to the instrument assembly (fig. 2A, 202, col. 8, lines 4-12, and col. 9, lines 21-32), but does not explicitly disclose wherein the computing device is configured to provide the tool information and receive the instructions via the wireless interface.
However, Haider teaches wherein the computing device is configured to provide the tool/surgical instrument information and receive the instructions via the wireless interface/unit (para 0139-0140).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Mata with the teachings of Haider to arrive at the claimed invention, since such modification would improve the system by allowing the surgeon to operate the device more freely while receiving the necessary information to perform the surgical procedure, allowing the surgical procedure to be performed more efficiently.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Mata in view of Greer, and further in view of US 2010/0100081 A1 to Tuma et al. (hereinafter “Tuma”).
Regarding claim 3, Mata as modified teaches the device of claim 1, further comprising a housing/body, a display assembly (see fig. 2A-2B, 205 and 212, and col. 9, lines 33-41), and a computing device connected to the display and the housing/body (see fig. 1 and fig. 2A-2B, 204), but does not explicitly disclose wherein the device houses both the display assembly and the computing device.
However, Tuma teaches a surgical instrument containing a hand-held region and a function region/tip containing a display used for image-guided and navigation-assisted surgical procedures (abstract, lines 1-5). The device (fig. 1) contains a housing for both the display assembly/navigation system (see fig. 7-75 and para 0043-0045, ) and the computing device/computing hardware components/elements (see fig. 1 and para 0046-0047).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Mata with housing system of Tuma to arrive at the claimed invention. Such modification would improve the system by providing a more compact and comfortable surgical device for the surgeon, ultimately making the hand-held surgical device more comfortable for the surgeon during the surgical procedure.
Regarding claim 4, Mata as modified teaches the device of claim 3, wherein the tool portion is coupled to the housing (see annotated fig. 2A below).
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Claim 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Mata in view of Greer, and further in view of US 7,302,288 B1 to Schellenberg.
Regarding claim 7, Mata as modified teaches the device of claim 1, further comprising one or more indicators (see fig. 5A-5C, and col. 21, lines 1-8), but does not disclose wherein each of the one or more indicators are mounted at a respective predetermined position on the device.
However, Schellenberg teaches a tool used for a surgical navigation system (see abstract, line 1). The tool (fig. 2) contains one or more indicators mounted at respective predermined positions on the device (see abstract, fig. 2, 200-208, col. 2, lines 25-32, and col. 5, lines 55-61 and lines 62-67, and col. 6, lines 1-7).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Mata with the teachings of Schellenberg to arrive at the claimed invention. Such modification would improve the system by allowing the surgeon to identify the current position of the device and allow for the device to be properly relocated to a desired position for the surgical procedure, ultimately ensuring the surgical procedure is performed in a safe and effective manner while avoiding injuries from taking place during the surgical procedure for the patient.
Regarding claim 17, Mata as modified teaches the system of claim 11, further comprising one or more indicators (see fig. 5A-5C, and col. 21, lines 1-8), but does not disclose wherein each of the one or more indicators are mounted at a respective predetermined position on the system.
However, Schellenberg teaches a tool used for a surgical navigation system (see abstract, line 1). The tool (fig. 2) contains one or more indicators mounted at respective predermined positions on the device (see abstract, fig. 2, 200-208, col. 2, lines 25-32, and col. 5, lines 55-61 and lines 62-67, and col. 6, lines 1-7).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Mata with the teachings of Schellenberg to arrive at the claimed invention. Such modification would improve the system by allowing the surgeon to identify the current position of the device and allow for the device to be properly relocated to a desired position for the surgical procedure, ultimately ensuring the surgical procedure is performed in a safe and effective manner while avoiding injuries from taking place during the surgical procedure for the patient.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Mata in view of Greer, and further in view of US 7, 327,221 B1 to Callaghan et al. (hereinafter “Callaghan”).
Regarding claim 9, Mata teaches the device of claim 1 containing one power supply for computing device connected to a tool portion (see fig. 2A, 204 and 226, fig. 3, and col. 7, lines 4-19), but does not disclose wherein the device comprises a respective power interface for each of the computing device and the tool portion.
However, Callaghan teaches a system and method for configuring and monitoring devices utilizing a power line network, wherein each network device (such as a logic controller, machine, or sensor), contains a power line interface to facilitate communication over a power line network (see abstract, lines 1-5). The system (fig. 1) contains a respective power line interface (see fig. 1, 150) for each a computing device (fig. 1, 120) and a plurality of controllers (see fig. 1, col. 4, lines 51-67 and col. 5, lines 1-3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Mata with the teachings of Callaghan to arrive at the claimed invention. Such modification would lead to a reasonable expectation for success, since the prior art shows the use of multiple power interfaces to achieve a higher power output in the system.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable Mata in view of Greer, and further in view of US 6, 450, 978 B1 to Brosseau et al. (hereinafter “Brosseau”).
Regarding claim 12, Mata as modified teaches the system of claim 11, further comprising the surgical tool (see fig. 2B, 226 and col. 11: “ In an example, the surgical instrument 203 includes a cutting instrument 226 that includes a proximal end 226b adjacent to the body 205 of the surgical instrument 203, and a cutting tip 226a opposite the proximal end 226b of the cutting instrument 226.”),
wherein the device further comprises a grip portion that allows the operator to hold and position (operate) the device/medical instrument (abstract, col. 4, lines 54-67, col. 5, lines 1-11, see annotated fig. 2A-2B below),
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But does not disclose wherein the device further comprises a grip portion that allows the operator to hold and position the device while the bracket is coupled to the body of the surgical tool.
However, Brosseau teaches a computer aided surgical system and method that uses 3D models of anatomical structures and a user interface (with a positioning system) in order to register in real-time the relative position of the anatomical structure /target area and surgical tool (abstract, lines 1-7). The system (fig. 2) contains a surgical tool comprising a grip portion (due to functioning as an awl) that allows the operator to hold and position the device, while the bracket is coupled to the body of the surgical tool (see annotated fig. 2 below, col. 5, lines 19-23, and col. 7, lines 3-6).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Mata with the teachings of Brosseau to arrive at the claimed invention, since such modification would improve the system by providing an alternative connection component for another surgical tool or another component needed for the medical device, ultimately enhancing the usability of the hand-held device.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Mata in view of Greer, and further in view of US 2004/0047044 A1 to Dalton.
Regarding claim 14, Mata as modified teaches the system of claim 11, wherein the connector is a bracket/adaptor (see fig. 7B, 252, col. 9, lines 56-67, and col. 10, lines 1-22), and wherein the display assembly is coupled to the bracket (see annotated fig. 7B below), but does not disclose wherein the display assembly or the computing device are coupled to the bracket using threaded screws or bolts.
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However, Dalton teaches an apparatus and method for visually enhancing the ability to perform a surgical procedure (see abstract, lines 1-2). The system (fig. 1) contains a display/display assembly (see fig. 1, 120) are coupled to a carrier (fig. 1, 130) and a reflective member (fig. 1, 110), via either bolts, screws, or clamps (see para 0030).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Mata with the teachings of Dalton to arrive at the claimed invention, since such modification would improve the system by ensuring that the connection of the display assembly or computing device to the bracket is secure, ensuring the surgical procedure is conducted smoothly, while reducing the likelihood of injury occurring to both the patient and surgeon.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Mata in view of Greer, and further in view of US 2020/0405403 A1 to Shelton, IV et al. (hereinafter “Shelton”).
Regarding claim 18, Mata as modified teaches the system of claim 11 containing a computing device (col. 6, lines 53-67) and a communications interface/input portion (fig. 3, 208 and col. 7, lines 20-28), but does not explicitly disclose wherein the system further comprises a communications interface via which the computing device communicates data with the controller computing device.
However, Shelton teaches wherein the system further comprises a communications interface via which the communication controller/computing device communicates data with the controller computing device / system controller (stored in the primary surgical tower) (para 0827).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Mata with the teachings of Shelton to arrive at the claimed invention. Such modification would lead to a reasonable expectation for success, since the system would need a communications interface to communicate with the computing device/system controller and the controller computing device/ communications controller in order to transmit data needed to control the surgical instrument, allowing the system to function as needed for proper functionality of the surgical system.
Regarding claim 19, Mata as modified teaches the system of claim 18 containing a power interface/power supply (see fig. 3, 208), wherein the communications interface/ input portion (contained with the processing portion) attaches to a power interface/power supply of the surgical tool/instrument to receive power for the computing device (fig. 2A, 204) and the display assembly/display (see figs. 2A, 212, fig. 2B, fig. 3, and col. 6, lines 64-67 and col. 7, lines 1-28).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Mata in view of Haider, Nikou, and Greer.
Regarding claim 21, Mata teaches a method (col. 24, lines 56-62), comprising:
determining, by the one or more processors, a position of the tool in a three-dimensional (3D) reference frame that includes a plurality of target locations in a patient (see figs. 4A-4C – 124, 126, and 226, col. 12, lines 1-6 and lines 56-67, col. 13, lines 1-22, figs. 14A-15, col. 4, lines 1-16, and col. 16, lines 4-22), determining, by one or more processors, a change in position of the tool that causes a portion of the tool to move closer to a first target location of the plurality of target locations in the 3D reference frame (figs. 4B-4C, 126, 226, and 226a, col. 3, lines 5-11, col. 7, lines 61-67, col. 8, lines 1-3, col. 13, 13-37, fig. 5B-5C – 130 and 132, col. 24, lines 23-48 (emphasis on the last sentence: “By way of an IM nailing example, a medical professional can maintain the orientation image 129 illustrated in FIG. 5C while drilling, so as to drill holes having the appropriate orientation at the target locations 126.”), figs. 17-19, 124, 130, 132, and 620, and col. 20, lines 51-60 and col. 21, lines 1-21), but does not disclose
identifying, by one or more processors coupled to memory, tool information from a tool having a mounted display assembly coupled to a computing device, and
tracking, by one or more processors, using signals received from an image capture device, a position of the tool based on determined positions of indicators mounted on the tool,
generating, by the one or more processors, based on the change in the position of the tool determined by the one or more processors, display instructions that cause the tool to display a prompt to a user of the tool to adjust the position of the tool,
However, Haider teaches the system (fig. 1) contains one or more processors coupled to memory (para 0050) and a hand-held surgical tool with a display (see fig. 16), and a computer that provides tool information in response to information being detected from the surgical tool (see para 0006-0007), and wherein the controller/microcontroller (connected to the OR computer) is used for monitoring and controlling the tool (fig. 17, para 0140, lines 1-4), and
tracking, by the one or more processors, using signals received from an image capture device/position detection device (see para 0090), a position of the tool based on determined positions of indicators/position markers mounted on the tool (see fig. 4 and 2, 105, fig. 16, para 0006, para 0029, para 0040, para 0088, para 0090, and para 0144), and discloses determining,
by the one or more processors, a change in the position of the tool in a 3D reference frame (see fig. 16, 226 and fig. 17, 226).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Mata with the tool system and tracking system of Haider to arrive at the claimed invention, since such combination would improve the system by ensuring the surgeon’s tool is in the proper position to execute a safe and accurate surgical procedure for the patient.
Although Haider teaches the information disclosed above, Mata nor Haider explicitly disclose generating, by the one or more processors, based on the change in the position of the tool determined by the one or more processors, display instructions that cause the tool to display a prompt to a user of the tool to adjust the position of the tool.
However, Nikou teaches identifying, by one or more processors coupled to memory (para 0050), from the controller computing device/robotic control component, instructions to present a change in a position of the device to bring the tool portion closer to the target location in the patient (see abstract, fig. 3 below, para 0052, and para 0057-0060), and present, based on the instructions, a guidance prompt/movement information for the operator that indicates the change in the position of the device/rotating tool (connected to the tool assembly)(see fig. 3 below and para 0057), and generating, by the one or more processors, based on the change in the position of the tool determined by the one or more processors, display instructions that cause the tool to display a prompt to a user of the tool to adjust the position of the tool (para 0050 and para 0057), and providing, by the one or more processors, the display instructions to the computing device/surgical navigation system mounted on the tool (para 0057), and a pushbutton that can be used to facilitate actuation of the rotating tool (see para 0011).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the modified teachings of Mata with the instruction system of Nikou to arrive at the claimed invention, since such combination would improve the system by ensuring the surgeon’s tool is in the proper position to execute a safe and accurate surgical procedure for the patient.
Although Mata as modified teaches the limitation disclosed above, Mata, Haider, nor Nikou explicitly disclose receiving a signal from a button mounted on the tool to switch from the first target location of the plurality of target locations to a second target location of the plurality of target locations;
and
updating, by the one or more processors, display instructions that cause the tool to update the displayed prompt to adjust the position of the tool to approximate the tool to the second target location.
However, Greer teaches systems, methods, and devices for moving the tool of a medical robot along a single axis (see abstract, lines 1-7 (first sentence)). The system (figs. 1A, 2C, and 3C) teaches wherein the computing device is configured to:
receive, from the controller computing device/computer system (para 0069, first two sentences), instructions to present a change in a position of the device to bring the tool portion closer to the first target location in the patient by actuating a button located on the user input device (see para 0010, first sentence, para 0012, see para 0013: In some embodiments, the computer system may also be configured to receive a command (e.g., after the command identifying the starting location) indicating a new (e.g., a second) target location. In some embodiments, the computer system may also be configured to receive a command (e.g., after the command identifying the starting location) indicating a new (e.g., a second) starting location……… “In some embodiments, the computer system may also be configured to receive a command (e.g., after the command identifying the starting location) indicating a new (e.g., a second) target location. In some embodiments, the computer system may also be configured to receive a command (e.g., after the command identifying the starting location) indicating a new (e.g., a second) starting location.”);
and present, based on the instructions, a guidance prompt (located on the GUI) for the operator that indicates the change in the position of the device responsive to a button push on the tool portion/input device (see para 0012),
transmit a signal to the controller computing device to switch from the first target location to a second target location (see para 0012—the computer system is configured to move the biopsy tool from one starting location to the target location along a single axis for an automated biopsy and is prompted through the executing function to begin when a button is pressed on the user’s input device in order to move the tool portion);
receive, from the controller computing device, updated instructions to present a change in a position of the surgical tool to bring the surgical tool closer to the second target location in the patient (target location for entering the patient during the biopsy – see para 0012, para 0013: “ Thus, in some embodiments, the computer system may be configured to perform at least the following functions: receive a command (e.g., through a user's touch of the screen displaying the relevant GUI) identifying a target location for a tool used in an automated movement by a robotic arm; receive a command identifying a starting location for the tool; receive a command to execute an automated move along a path (e.g., a line) defined at least in part by the starting location and the target location; and execute the automated move such that the tool, which may have a longitudinal axis, travels along the path (e.g., along a single axis). That path also may be aligned with the tools longitudinal axis.”, and para 0059-0060);
and
present, based on the updated instructions, the guidance prompt for the operator that indicates the change in position of the surgical tool to approximate the surgical tool to the second target location (see para 0047, last two sentences, para 0059-0061, and para 0064 – because the change in position of the surgical tool is occurring in a 2D or 3D virtual environment on the MRID (magnetic resonance display screen), the position of the surgical tool is approximated at the second target location prior to executing the automated biopsy surgical procedure).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Mata with the teachings of Greer to arrive at the claimed invention. Such modification would improve the system by providing a compact hand-held device used to ensure the tool position and alignment is optimal for each stage of the surgical procedure, ultimately ensuring control for the instruments when performing the surgical procedure is conducted in a smooth and effective manner to preserve the safety of the patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Moctezuma De La Barrera et al. (US 2004/0054489 A1) teaches a method for calibrating the position and tip of a surgical tool.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792