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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claim recites a controller, thus is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim 1 recites the limitations:
1. A controller comprising: at least one processor; memory coupled to the at least one processor, the memory storing computer-executable instructions; and wherein the at least one processor is configured to execute the computer-executable instructions to cause the controller to
determine a clinical driving scenario associated with a percutaneous device, and
set driving characteristics associated with the percutaneous device based on the clinical driving scenario and information included in a driving profile,
wherein the information included in the driving profile includes information associating particular clinical driving scenarios with particular driving characteristics.
These limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it recites steps determining a clinical driving scenario associated with the instrument, set driving characteristics associated with the device based on the scenario and information in a profile which includes associated information with characteristics. These actions fall under the Mental Processes category defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion)”. A human, such as surgeon and/or physician, could mentally perform tasks of determining a scenario of instrument either following trajectory, inserting into a tissue, or stop the movement of the instrument, using his/her judgement, and one can set the associated movement (Either to advance further or stop, retract, change direction) of the instrument based on the judgement of physician. The profile includes information associated with scenarios with characteristics which can be performed by physician to formulate a table or chart of relationship between scenario with associated characteristics in a paper. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
at least one processor; memory coupled to the at least one processor, the memory storing computer-executable instructions; and wherein the at least one processor is configured to execute the computer-executable instructions to cause the controller to
This claim element is processing and storage steps, which is insignificant pre-post solution activity. The use of processor and memory do not integrate the judicial exception as it is merely used to perform the judicial exception set forth above. This pre/post solution activity does not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 1 is ineligible.
Claim 2-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a controller and therefore, an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claims recites the limitations:
“determine the clinical driving scenario based on positional information indicating a distance the percutaneous device is inserted in a patient (Claim 2).”
“determine the clinical driving scenario based on a comparison of the distance the percutaneous device is inserted into the patient and an estimated patient vascular length (Claim 3).”
“ the positional information includes at least one of information indicating a position of an arm of an imaging system relative to a patient (Claim 4),”
“wherein the user control signals indicate requested movement of a percutaneous device being controlled by the controller; and set the driving characteristics of the percutaneous device by modifying the user control signals based on the clinical driving scenario and the information included in the driving profile (claim 5),”
“determine the clinical driving scenario based on a field of view of imaging system or position of an imaging system relative to a patient, wherein the field of view of the imaging system represents a zone between an access site and the head of the patient (Claim 6).”
“information adjusting the particular driving characteristics under the particular clinical driving scenarios (Claim 7).”
These limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to performing observation of the image showing positional information, such as distance inserted and comparison of the distance and an estimated vascular length, and mentally determining the scenario (plan) by observing where the imaging device is located relative to a patient or FOV, and determining information of changing characteristics under scenarios, as well as modifying movement request based on the determined scenarios and information in the profile. A human, such as physician, could mentally perform tasks of observing the image to determine how far the instrument inserted into the patient, comparing the distance to the estimated target to determine scenario of manipulating instrument into the target and drawing a conclusion that certain driving characteristics to be changed for particular scenarios. Moreover, a human can mentally determine the possible scenario and information based on observation of imaging device position relative to a patient or observing the image FOV. One can also determine desired movement of the device and send request to set the characteristics by changing the instruction/request based on the scenarios and information which can be all performed ion mental framework using judgement and logical reasoning. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
at least one processor; memory coupled to the at least one processor, the memory storing computer-executable instructions; and wherein the at least one processor is configured to execute the computer-executable instructions to cause the controller to
This claim element is processing and storage steps, which is insignificant pre-post solution activity. The use of processor and memory do not integrate the judicial exception as it is merely used to perform the judicial exception set forth above. This pre/post solution activity does not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claims 2-7 are ineligible.
Claims 8-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 7 rejection.
Claim 8 recites the following elements: “at least one of a type of percutaneous device, a configuration of the percutaneous device, a distance the percutaneous device is inserted in a patient or whether a distal portion of the percutaneous device is still fully within an existing percutaneous device.”
Claim 9 recites the examples of particular driving characteristics.
This claim element refers to collection of information which fell into metal type abstract idea as set forth above for claims 1 and 7, and types of scenarios and driving characteristics are mere data collection and selecting a particular type of data to be collected for analysis and driving characteristics such as velocity, acceleration, and other parameters, which amounts to a pre and post-solution insignificant activity.
This pre-solution and post-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 8-9 are ineligible.
Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claim recites a controller, thus is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim 1 recites the limitations:
determine a distance a percutaneous device is inserted in a patient and
generate adjusted user control signals based on the distance the percutaneous device is inserted in the patient, and
These limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it recites steps determining a distance of instrument inserted in a patient, receive control signals to control the instrument based on the distance. These actions fall under the Mental Processes category defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion)”. A human, such as surgeon and/or physician, could mentally perform tasks of determining a distance of instrument inserted in a patient by observing the distance and depth of the instrument inserted into a patient, and judge whether to continue with inserting into a tissue, or stop the movement of the instrument, using mental framework, and one can set the associated movement (Either to advance further or stop, retract, change direction) of the instrument based on the judgement of physician, and generate instruction (user control signal) to execute the judgement.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
at least one processor; memory coupled to the at least one processor, the memory storing computer-executable instructions; and wherein the at least one processor is configured to execute the computer-executable instructions to cause the controller to
receive user control signals from a driver interface, wherein the driver interface is configured to respond to user interaction with the driver interface to control movement of the percutaneous device,
transmit the adjusted user control signals to a motive device configured to move the percutaneous device in accordance with the adjusted user control signals.
This claim element is processing and storage steps, which is insignificant pre-post solution activity. The use of processor and memory as well as a driver interface do not integrate the judicial exception as it is merely used to perform the judicial exception set forth above.
Moreover, receiving the control signal and transmitting signals are an insignificant post-extra solution activity of just transmitting a signal from point A to point B. The limitation does not provide any positive recitation of the actual movement of the motive device to result in positive movement of the percutaneous device with the adjusted control signals.
This pre/post solution activity does not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 10 is ineligible.
Claims 11-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a controller and therefore, an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claims recites the limitations:
“determine the distance the percutaneous device is inserted in the patient on kinematic information (Claim 11).”
“determine the distance the percutaneous device is inserted in the patient based , at least in part, on a position of an imaging system relative to the patient (claim 12)”
“determine the distance the percutaneous device is inserted in the patient based , at least in part, on a location of a percutaneous device manipulation system relative to the patient (claim 13)”
“determine the distance the percutaneous device is inserted in the patient based , at least in part, on a displacement of a cartridge along a drive-axis of a percutaneous device manipulation system (claim 14)”
“generate the adjusted user control signals by altering the user control signals based on at least one of a field of view of imaging system or position of an imaging system relative to a patient, wherein the field of view of the imaging system represents a zone between an access site and the head of the patient (Claim 15).”
“generate the adjusted user control signals based on profile information included in a driving profile, wherein the profile information included in the driving profile includes first information associating the distance the percutaneous device is inserted in the patient with movement characteristics of the percutaneous device (Claim 16),”
These limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to performing observation of the image showing positional information, such as determining the distance inserted based on kinematic information, displacement of a cartridge, imaging system and manipulation device, and mentally determining the adjustment by observing where the imaging device is located relative to a patient or FOV, and determining information of changing characteristics under scenarios, as well as modifying movement request based on the determined scenarios and information in the profile. A human, such as physician, could mentally perform tasks of observing the image to determine how far the instrument inserted into the patient, comparing the distance to the estimated target to determine direction/instructions of manipulating instrument into the target and drawing a conclusion that certain driving characteristics to be changed for particular scenarios. Moreover, a human can mentally determine the possible scenario and information based on observation of imaging device position relative to a patient or observing the image FOV. One can also determine desired movement of the device and send request to set the characteristics by changing the instruction/request based on the scenarios and information which can be all performed ion mental framework using judgement and logical reasoning. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
at least one processor; memory coupled to the at least one processor, the memory storing computer-executable instructions; and wherein the at least one processor is configured to execute the computer-executable instructions to cause the controller to
This claim element is processing data and storage steps, which is insignificant pre-post solution activity. The use of processor and memory do not integrate the judicial exception as it is merely used to perform the judicial exception set forth above. This pre/post solution activity does not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claims 11-16 are ineligible.
Claims 17-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 16 rejection.
Claim 17 recites the examples of information associating the movement characteristics including device safe-loading position, device type or a configuration of the percutaneous device.
Claim 18 recites the examples of movement characteristics including a peak velocity limit or peak acceleration limit.
This claim element refers to collection of information which fell into mental type abstract idea as set forth above for claims 10 and 16, and types of scenarios and driving characteristics are mere data collection and selecting a particular type of data to be collected for analysis and driving characteristics such as velocity, acceleration, and other parameters, which amounts to a pre and post-solution insignificant activity.
This pre-solution and post-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claims 17-18 are ineligible.
Claim 19 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claim recites a robotic device, thus is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim 19 recites the limitations:
determine a clinical driving scenario associated with the robotic device, wherein the clinical driving scenarios includes a distance of the percutaneous device is inserted in a patient, and
set driving characteristics of the robotic device based on the clinical driving scenario and information included in a driving profile, wherein the information included in the driving profile includes information associating particular clinical driving scenarios with particular driving characteristics, and
generate the motor control signals based on the driving characteristics.
These limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it recites steps of determining a scenario, a distance of instrument inserted in a patient, setting driving characteristics of the robotic device based on the profile and information including particular driving scenarios with particular driving characteristics. These actions fall under the Mental Processes category defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion)”. A human, such as surgeon and/or physician, could mentally perform tasks of determining a distance of instrument inserted in a patient oy observing the distance and determine a scenario, such as different scenarios of whether to continue with inserting into a tissue, or stop the movement of the instrument, using mental framework, and one can set the associated movement of the robotic arm associated with the instrument (Either to advance further or stop, retract, change direction) based on the judgement of physician. One can further generate signal, that can be an instruction to retract, move or stop the instrument to the robotic arm.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
“A motor configured to impart motion to a percutaneous device in response to motor control signals,”
“a driver interface configured to transmit user control signals to a controller in response to user manipulation of the driver interface,”
“a controller coupled to the motor and the driver interface,”
This claim element is a motor, a driver interface and a controller, all are claimed with high generality of computer element (processing, transmitting signals and controlling) of performing the judicial exception set forth above, thus falls into insignificant pre-post and post-solution solution activity. The use of a motor, driver interface and a controller do not integrate the judicial exception as it is merely used to perform the judicial exception set forth above.
This pre/post solution activity does not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 19 is ineligible.
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 19 rejection.
Claim 20 recites further limitations:
The motor configured to impart the motion to the percutaneous device by moving a cartridge coupled to the motor along a drive axis in response to the motor control signals, wherein movement of the cartridge moves the percutaneous device.
This claim element refers a cartridge, coupled to the motor which is configured to manipulate the percutaneous device, which falls into pre and post-solution activity of the judicial exception set forth above for claim 19, as cartridge and motor carries out the instruction set forth above, but is recited with “configured to” thus falls into insignificant post solution activity.
The limitation does not provide any positive recitation of the actual movement of the cartridge and motor to result in positive movement of the percutaneous device with the adjusted control signals.
This pre-solution and post-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 20 is ineligible.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-6 and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites “a percutaneous device” and it is not definite whether it is same or different from previously recited percutaneous device in claim 1.
Claim 6 recites the limitation "the head of the patient" in line 14 page 2. There is insufficient antecedent basis for this limitation in the claim, since “a head of the patient “was not previously recited in claims 1 and 6.
Claim 15 recites the limitation "the head of the patient" in line 19 page 4. There is insufficient antecedent basis for this limitation in the claim, since “a head of the patient “was not previously recited in claims 10 and 15.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-13, and 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Wu et al.,” US 2024/0173088 (hereinafter Wu).
Regarding to claim 1, Wu teaches a controller (a controller [0007]) comprising:
at least one processor (processors [0211]); memory coupled to the at least one processor (a memory [0211]), the memory storing computer-executable instructions (programmable instructions stored on memory [0212]); and
wherein the at least one processor is configured to execute the computer-executable instructions (programmable instructions stored on memory to execute algorithms [0212]) to cause the controller to:
determine a clinical driving scenario associated with a percutaneous device (different modes, passive mode, instrument centering mode [0014]; various operational modes upon determination of predefined condition [0133], surgical instrument for laparoscopic surgery [0008]; instrument can be a needle coupled to the robotic arms [0259]), and
set driving characteristics associated with the percutaneous device based on the clinical driving scenario and information included in a driving profile (user-specific profile store the predetermined configuration associated with the modes [0191]), wherein the information included in the driving profile includes information associating particular clinical driving scenarios with particular driving characteristics ( preset configurations based on the selected surgical procedure [0355], [0360]).
Regarding to claims 2 and 4-9, Wu teaches all limitations of claim 1 as discussed above.
Wu further teaches following limitations:
Of claim 2, wherein the at least one processor is further configured to execute the computer-executable instructions to cause the controller to: determine the clinical driving scenario based on positional information indicating a distance the percutaneous device is inserted in a patient ([0011]; trocar position detection module determining position of the trocar port inserted within the patient, measuring true position can ensure actual motion of the robot arms or instruments matches a commanded motion of the robot arms or instrument in robotic assist mode [0230]; determining a distance from the instruments to the trocar ports [0241];Figure 16 illustrates viscosity levels of the instrument, which is a function of the speed of the instrument and distance of the tip of the instrument from the trocar point, in case, determine to switch the operational mode to co-manipulation mode [0251]; Based on position data of surgical instrument coupled to the robotic arm, transition robot arm to the haptic mode [0257])
Of claim 4, wherein: the positional information includes at least one of, information indicating a position of an arm of an imaging system relative to a patient, a location of a percutaneous device manipulation system relative to the patient, a position of a cartridge along a drive-axis of the percutaneous device manipulation system, image recognition of a marker on the patient, or image recognition of a marker on the percutaneous device (position of surgical instruments, patient position [0131] position of surgical instrument relative to the system, e.g. camera head, coupler, fiducial markers [0202]).
Of claim 5, wherein the at least one processor is further configured to execute the computer-executable instructions to cause the controller to: receive user control signals from a driver interface, wherein the user control signals indicate requested movement of a percutaneous device being controlled by the controller (controller configured to cause the robot arm to switch to the instrument centering mode responsive to user input, user interface [0012]; a user interface operatively coupled to the processor, user input received by the user interface [0032]; User interface receive user input including adjustments to the predetermined amount of movement at the handle of the surgical instrument, robot arms to automatically switch to the passive mode or co-manipulation mode [0216]) and set the driving characteristics of the percutaneous device by modifying the user control signals based on the clinical driving scenario and the information included in the driving profile (adjust the information/parameters accordingly on the mode determined by user input via user interface [0216]).
Of claim 6, wherein the at least one processor is further configured to execute the computer-executable instructions to cause the controller to: determine the clinical driving scenario based on at least one of a field of view of an imaging system or a position of an imaging system relative to a patient (identifying a target surgical instrument within a field of view of the laparoscope based on the image data and switching the robot arm to an instrument centering mode to move the laparoscope to maintain the target surgical instrument within the field of view [0014]), wherein the field of view of the imaging system represents a zone between an access site at which the percutaneous device is inserted into the patient and the head of the patient (Surgical space within the patient, [0128]; user can zoom in and out for optimal view [0290], [0294], Figures 15, 22, and 30A-B show zone between an access site and the head of the patient).
Of claim 7, wherein the information included in the driving profile includes: information adjusting the particular driving characteristics under the particular clinical driving scenarios (analyze the operating characteristics of robot arm to determine whether to switch the operational mode to different mode [0251]; adjusting the amount of force applied to the distal region of the robot arm and slow down as the stage assembly reaches its maximum extension range [0161]).
Of claim 8, wherein the particular clinical driving scenarios include: at least one of a type of percutaneous device, a configuration of the percutaneous device, a distance the percutaneous device is inserted in a patient, or whether a distal portion of the percutaneous device is still fully within an existing percutaneous device (Figure 16 shows table of predefined values for a range of sample instrument types [0252], trocars in optimal position [0261])
Of claim 9, wherein the particular driving characteristics include: at least one of a peak velocity, a peak acceleration, jerkiness, a peak rotational velocity, a peak rotational acceleration, a displacement per input ratio, a maximum absolute displacement, a maximum force, a maximum linear displacement, or a rotational lockout (a velocity exceeding a predetermined velocity threshold (which reads on claimed maximum velocity) [0275]; adjusting the amount of force applied to the distal region of the robot arm and slow down as the stage assembly reaches its maximum extension range [0161])
Regarding to claim 10, Wu teaches a controller (a controller [0007]) comprising:
at least one processor (processor [0211]); memory (a memory [0211]) coupled to the at least one processor, the memory storing computer-executable instructions (programmable instructions stored on memory [0212]); and
wherein the at least one processor is configured to execute the computer-executable instructions to cause the controller to determine a distance a percutaneous device is inserted in a patient (determining a distance from the instruments to the trocar ports [0241]),
receive user control signals from a driver interface (User interface used to receive inputs from a user [0216]), wherein the driver interface is configured to respond to user interaction with the driver interface to control movement of the percutaneous device (User interface may receive user input including adjustments to the predetermined amount of movement at the handle of surgical instrument to switch to different mode [0216]), generate adjusted user control signals based on the distance the percutaneous device is inserted in the patient ([0251]), and transmit the adjusted user control signals to a motive device configured to move the percutaneous device in accordance with the adjusted user control signals (System cause to move robot arm responsive to the movement of the distal region of the robot arm by the user, causing motorized joint to rotate [0164]; platform may adjust information/parameters accordingly [0216]; user input at the graphical user interface cause movement of the robot arm via the motorized joints to maintain a position of the surgical instrument [0352]).
Regarding to claims 11-13 and 15-18, Wu teaches all limitations of claim 10 as discussed above.
Wu further teaches following limitations:
Of claim 11, wherein the at least one processor is further configured to execute the computer-executable instructions to cause the controller to: determine the distance the percutaneous device is inserted in the patient based on kinematic information (tracked movement of the distal end of a laparoscope obtained by system, position/movement of robot arm based on the current kinematics of robot arm [0225]; determining the position of robot arm and the surgical instrument attached thereto, in real time based on encoder of the joints [0229])
Of claim 12, wherein the at least one processor is further configured to execute the computer-executable instructions to cause the controller to: determine the distance the percutaneous device is inserted in the patient based, at least in part, on a position of an imaging system relative to a patient ( movement of camera head of the laparoscope about the trocar (which is located on the patient’s skin) [0246]; position of surgical instruments, patient position [0131] position of surgical instrument relative to the system, e.g. camera head, coupler, fiducial markers [0202]).
Of claim 13, wherein the at least one processor is further configured to execute the computer-executable instructions to cause the controller to: determine the distance the percutaneous device is inserted in the patient based, at least in part, on a location of a percutaneous device manipulation system relative to the patient (tracked movement of the distal end of a laparoscope obtained by system, position/movement of robot arm based on the current kinematics of robot arm [0225]; determining the position of robot arm and the surgical instrument attached thereto, in real time based on encoder of the joints [0229])
Of claim 15, wherein the at least one processor is further configured to execute the computer-executable instructions to cause the controller to: generate the adjusted user control signals by altering the user control signals based on at least one of a field of view of an imaging system, or a position of an imaging system relative to a patient (identifying a target surgical instrument within a field of view of the laparoscope based on the image data and switching the robot arm to an instrument centering mode to move the laparoscope to maintain the target surgical instrument within the field of view [0014]), wherein the field of view of the imaging system represents a zone between an access site at which the percutaneous device is inserted into the patient and the head of the patient (Surgical space within the patient, [0128]; user can zoom in and out for optimal view [0290], [0294], Figures 15, 22, and 30A-B show zone between an access site and the head of the patient).
Of claim 16, wherein the at least one processor is further configured to execute the computer-executable instructions to cause the controller to: generate the adjusted user control signals based on profile information included in a driving profile, wherein the profile information included in the driving profile includes first information associating the distance the percutaneous device is inserted in the patient with movement characteristics of the percutaneous device (Figure 16 illustrates viscosity levels of the instrument, which is a function of the speed of the instrument and distance of the tip of the instrument from the trocar point, in case, determine to switch the operational mode to co-manipulation mode [0251]; Based on position data of surgical instrument coupled to the robotic arm, transition robot arm to the haptic mode [0257])
Of claim 17. wherein the profile information included in the driving profile further includes: second information associating the movement characteristics of the percutaneous device with at least one of a percutaneous device safe-loading position, a percutaneous device type, or a configuration of the percutaneous device (Figure 16 shows table of predefined values for a range of sample instrument types [0252], trocars in optimal position [0261])
Of claim 18, wherein: the movement characteristics of the percutaneous device include at least one of a peak velocity limit, a peak acceleration limit, a jerkiness limit, a rotational velocity limit, a displacement per input ratio, an absolute displacement limit, a rotational lockout, a maximum force limit, or a linear displacement limit (a velocity exceeding a predetermined velocity threshold (which reads on claimed maximum velocity) [0275]; adjusting the amount of force applied to the distal region of the robot arm and slow down as the stage assembly reaches its maximum extension range [0161]).
Regarding to claim 19, Wu teaches a robotic device comprising:
a motor configured to impart motion to a percutaneous device in response to motor control signals (motors controlled by a processor [0156]);
a driver interface configured to transmit user control signals to a controller in response to user manipulation of the driver interface (User interface may receive user input including adjustments to the predetermined amount of movement at the handle of surgical instrument to switch to different mode [0216]); and
a controller coupled to the motor and the driver interface (user input received by a user interface operatively coupled to a controller, and via the controller, apply torque to motorized joints, [0224]; user input at the graphical user interface cause movement of robot arm via one or more motorized joints [0352])
wherein the controller is configured to determine a clinical driving scenario associated with the robotic device, wherein the clinical driving scenario includes a distance the percutaneous device is inserted in a patient ([0011]; trocar position detection module determining position of the trocar port inserted within the patient, measuring true position can ensure actual motion of the robot arms or instruments matches a commanded motion of the robot arms or instrument in robotic assist mode [0230]; determining a distance from the instruments to the trocar ports [0241];Figure 16 illustrates viscosity levels of the instrument, which is a function of the speed of the instrument and distance of the tip of the instrument from the trocar point, in case, determine to switch the operational mode to co-manipulation mode [0251]; Based on position data of surgical instrument coupled to the robotic arm, transition robot arm to the haptic mode [0257]); set driving characteristics of the robotic device based on the clinical driving scenario and information included in a driving profile (user-specific profile store the predetermined configuration associated with the modes [0191]), wherein the information included in the driving profile includes information associating particular clinical driving scenarios with particular driving characteristics (preset configurations based on the selected surgical procedure [0355], [0360]), and generate the motor control signals based on the driving characteristics (System cause to move robot arm responsive to the movement of the distal region of the robot arm by the user, causing motorized joint to rotate [0164]; platform may adjust information/parameters accordingly [0216]; user input at the graphical user interface cause movement of the robot arm via the motorized joints to maintain a position of the surgical instrument [0352]).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Wu as applied to claim 2 above, and further in view of “Kottenstette et al.,” US 2020/0129740 (hereinafter Kottenstette).
Regarding to claim 3, Wu teaches all limitations of claim 2 as discussed above.
Wu does not further disclose that determine the clinical driving scenario based on a comparison of the distance the percutaneous device is inserted into the patient and an estimated patient vascular length.
However, in the analogous field of endeavor in navigating a surgical instrument in a patient, Kottenstette teaches determining a remaining path length being a distance between the distal portion of the elongated medical device and the target location (thus reads on claimed comparing the distance of the device and an estimated patient vascular length; if the distal portion of the device is off path, advance the device to the target location at a velocity determined based on the remaining path length using the drive assembly [0008], [0041], [0051]-[0052]).
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 robotic surgical system as taught by Wu to incorporate teaching of Kottenstette, since comparing the distance to an estimated patient vascular length was well known in the art as taught by Kottenstette. One of ordinary skill in the art could have combined the elements as claimed by Wu with no change in their respective functions, configuring the adjustment of velocity of advancement based on the remaining path, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide alert and adjustment based on the remaining path length ([0054]), and there was reasonable expectation of success.
Claims 14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wu as applied to claims 11 and 19 above, and further in view of “Fischvogt et al.,” US 2023/0346378 (hereinafter Fischvogt).
Regarding to claims 14 and 20, Wu teaches all limitations of claims 11 and 19 as discussed above.
Wu does not further disclose wherein the at least one processor is further configured to execute the computer-executable instructions to cause the controller to: determine the distance the percutaneous device is inserted in the patient based, at least in part, on a displacement of a cartridge along a drive-axis of a percutaneous device manipulation system.
However, in the analogous field of endeavor in navigating a surgical instrument in a patient, Fischvogt teaches a surgical robotic system includes a cartridge in the housing for holding instruments, wherein the cartridge works as a reloading module, include a sensor/encoder which can be displacement transducers for detecting movement or position of the surgical instrument ([0072]-[0073]).
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 robotic manipulation device as taught by Wu to incorporate teaching of Fischvogt, since a cartridge and detecting position of the instrument using displacement transducer at the cartridge was well known in the art as taught by Fischvogt. One of ordinary skill in the art could have combined the elements as claimed by Wu with no change in their respective functions, configuring a cartridge to hold to move and reload the end effector with the surgical tool, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to store a plurality of surgical tool and to move the surgical tool ([0011]) and to sense movement or a position of the surgical instrument using displacement transducer ([0072]), and there was reasonable expectation of success.
Conclusion
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/PATRICIA J PARK/Primary Examiner, Art Unit 3798