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.
Claim 17 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites a method for dynamic adjustment of a surgical robotic system, that determines a surgical task and whether or not it is within metrics and a predefined surgical area and records data when the task is outside the defined metrics and ranges.
To start off, step 1 is covered as the claims recite a process.
Moving on to step 2A, this is a two-prong analysis. Under prong one, examiner is required to show the abstract idea, law of nature, or natural phenomenon. In this case, examiner points out that the steps of “determining a phase or a task of a surgical procedure”, “determining whether the phase or task is outside of an expected metrics range”, “determining whether the phase or task is to be performed in a predefined surgical area”, and “recording data with high fidelity information when it is determined that the phase or task is outside of the expected metrics range or when the task is to be performed in the predefined surgical area” are the abstract idea directed to a mental process. These limitations, under broadest reasonable interpretation, can be done in the mind other than the recitation of the generic computer component. That is, other than reciting “sensor data” nothing in the claim precludes the step from practically being performed in the mind. The steps of determining can simply mean detecting the task by visually viewing the surgery, and comparing it to predefined ranges and recording data can simply be done by an individual without computer components. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Under prong two, examiner is required to show that the judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements including: “sensor data”. In this case, all of the additional elements recited are being performed using a generic computer function such that it amounts no more than mere instructions to apply the exception using a generic computer component. The sensor data is merely data gathering that a generic computer can perform. Accordingly, these additional element do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea (MPEP 2106.05F). The claim is directed to an abstract idea.
Lastly for step 2B, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of sensor data amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claim is not patent eligible.
Examiner states that the claim recites a judicial exception, but is not integrated into a practical application (Step 2b of 2019 PEG). In particular the steps of the claim do not recite any additional element that is required for the claim to be performed, moreover the steps of the claim add insignificant extra-solution activity to the abstract idea. (See MPEP 2106.05 (g)). Therefore, the claim does not integrate the abstract idea into a practical application, because it does not impose any meaningful limits on practicing the abstract idea. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements recited. Dependent claims 18-20 do not integrate the abstract idea into a practical application.
Claim Rejections - 35 USC § 102
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.
Claim(s) 13 and 15-16 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by WO 2021/205178 THORNYCROFT et al., hereinafter “Thornycroft”.
Regarding claim 13, Thornycroft discloses a robotic system (Figure 5, element 500 and Para 1), comprising: a surgical console (Figure 5, element 512) including: a handle (Figure 5, elements 516 and 518) communicatively coupled to at least one of a robotic arm or a surgical instrument (Para 71; “An operator console may comprise input devices 516, 518 for controlling the state of the surgical robot 502, 504 arms and/or the instruments 506, 508 attached thereto”; coupled via wireless lines 514 and 522); and a computer (Figure 5, element 510) configured to: determine a phase or a task of a surgical procedure based on at least one of sensor data or a user command to perform the task (Para 77; “the control unit 510 is configured to detect from the inputs received from the surgical robots and, optionally, other inputs, events or conditions during the procedure” and “Examples of events or conditions that the control unit 510 may be able to detect include, but are not limited to, the stage of a procedure that is currently being performed”); determine whether the phase or task is to be performed in a predefined surgical area (Para 102; “Example events which may be detectable by the control unit 510 include, but are not limited to: a specific tissue type shown in the endoscope video; a specific body part or organ visible in the endoscope video; the distance between an instrument and an organ or body part is below a predetermined threshold”); reduce a range of motion of the robotic arm or the surgical instrument when the task is to be performed in the predefined surgical area (Para 73, 77, and 107 ““minimize scaling gain to 0.1 when gallbladder is visible” during a procedure); determine whether the phase or task is a safety critical task (Para 107; severing gall bladder is a safety critical task); and decrease a speed limit of the robotic arm when the task is determined to be a safety critical task (Para 107; reducing speed of scissors for severing gall bladder is a safety critical task).
Regarding claim 15, Thornycroft discloses the computer (Figure 5, element 510) is further configured to: determine whether the task is retraction; and record arm torque data when it is determined that the task is retraction (Para 17, 130, and 146).
Regarding claim 16, Thornycroft discloses the computer (Figure 5, element 510) is further configured to: determine whether the task is fine manipulation; and record grasping force when it is determined that the task is fine manipulation (Para 39-40, see also Para 115).
Claim Rejections - 35 USC § 103
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) 1-12, 14, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/205178 THORNYCROFT et al., hereinafter “Thornycroft”, in view of US 2019/0208641 Yates et al., hereinafter “Yates”.
Regarding claim 1, Thornycroft discloses a surgical robotic system (Figure 5, element 500 and Para 1), comprising: a robotic arm (Figure 5, elements 502 and 504) including a surgical instrument (Figure 5, element 506 and 508) coupled thereto; a surgical console (Figure 5, element 512) including: a handle (Figure 5, elements 516 and 518) communicatively coupled to at least one of the robotic arm or the surgical instrument (Para 71; “An operator console may comprise input devices 516, 518 for controlling the state of the surgical robot 502, 504 arms and/or the instruments 506, 508 attached thereto”; coupled via wireless lines 514 and 522); and a computer (Figure 5, element 510) configured to: determine a phase or a task of a surgical procedure based on at least one of sensor data or a user command to perform the task (Para 77; “the control unit 510 is configured to detect from the inputs received from the surgical robots and, optionally, other inputs, events or conditions during the procedure” and “Examples of events or conditions that the control unit 510 may be able to detect include, but are not limited to, the stage of a procedure that is currently being performed”); change a range of motion of one or more joints of the robotic arm or the surgical instrument based on the phase or the task of the surgical procedure (Para 73 and 77); change a speed limit of the robotic arm based on the phase or the task of the surgical procedure (Para 73 and 77; see also 107).
Thornycroft does not disclose change a rate of wireless transmission of data based on the phase or the task of the surgical procedure.
However, Yates discloses a method implemented by a surgical instrument (Abstract) and teaches change a rate of wireless transmission of data based on the phase or the task of the surgical procedure (Figure 46 shows different transmission rates based on a time in a surgical procedure; consider Para 530-532, more specifically Para 532 that discloses two different surgical activities (or tasks) FTC and FTF that are each at different transmission rates, one prioritized over the other).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed changing a rate of wireless transmission of data as taught in Yates, in the invention of Thornycroft, in order to transmit the relevant data based on maximum available transmission rates (Yates; Para 530-535).
Regarding claim 2, Thornycroft discloses the computer is further configured to change a speed limit of the robotic arm based on the phase or the task of the surgical procedure by increasing the speed limit of the robotic arm when the task is determined to be initial dissection (Para 107 discloses changing the speed of the scissors; the initial dissection is before the gallbladder is visible, the control unit can detect when the gallbladder is visible and ““reduce and lock scissor maximum speed for severing gall bladder” during a procedure”; therefore it is inherent that the scissors speed was increased before it was reduced for severing the gallbladder).
Regarding claim 3, Thornycroft discloses the computer is further configured to change a speed limit of the robotic arm based on the phase or the task of the surgical procedure by decreasing the speed limit when the task is determined to be a safety critical task (Para 107; reducing speed of scissors for severing gall bladder is a safety critical task).
Regarding claim 4, Thornycroft discloses the computer is further configured to change a range of motion of one or more joints of the robotic arm based on the phase or the task of the surgical procedure by changing the motion scaling between the handle and the robotic arm (Para 23; “instrument wrist motion gain parameters” and Para 73).
Regarding claim 5, Thornycroft discloses the computer is further configured to change a range of motion of the surgical instrument based on the phase or the task of the surgical procedure by reducing the range of motion of the surgical instrument when the task is to be performed in a predefined area (Para 73 and 107 ““minimize scaling gain to 0.1 when gallbladder is visible” during a procedure).
Regarding claim 6, Thornycroft discloses the computer is further configured to change an input mapping between the handle and the robotic arm and the surgical instrument based on the phase or the task of the surgical procedure (Para 73 and 77).
Regarding claim 7, Thornycroft discloses the computer is further configured to change the input mapping by amplifying rotation commands of the handle, remapping angles of the handle to change a start position of the handle, or changing control gains in the robotic arm (Para 73).
Regarding claim 8, Thornycroft discloses the computer is further configured to cause a display device (Figure 5, element 520) to overlay measurement scaling over surgical images, display contrast media, display visual enhancements, or display at least one pre-operative image matching a current surgical view based on the phase or the task of the surgical procedure (Para 71, 124, 126; see also Figure 9).
Regarding claim 9, Thornycroft discloses all the limitations of claim 1.
Thornycroft does not disclose the computer is further configured to change a rate of wireless transmission of data based on the phase or the task of the surgical procedure by increasing the rate of wireless transmission of data during dissection and suturing and reducing the rate of wireless transmission of data when a user is disengaged or when an instrument exchange is being performed.
However, Yates teaches the computer is further configured to change a rate of wireless transmission of data based on the phase or the task of the surgical procedure by increasing the rate of wireless transmission of data during dissection and suturing and reducing the rate of wireless transmission of data when a user is disengaged or when an instrument exchange is being performed (See Para 521-540 and Figure 46; the take away from those disclosures is that sample rates are increased during a powered cutting procedure up to 30-40 samples/sec; the rate is reduced between FTC and FTF).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed changing a rate of wireless transmission of data as taught in Yates, in the invention of Thornycroft, in order to transmit the relevant data based on maximum available transmission rates (Yates; Para 530-535).
Regarding claim 10, Thornycroft discloses the computer is further configured to: record arm torques in response to a determination by the computer that the task is retraction of the robotic arm or retraction of the surgical instrument (Para 17, 130, and 146); record grasping force of the surgical instrument in response to a determination by the computer that the task is fine manipulation (Para 39-40, see also Para 115); and stop record signals in response to a determination by the computer that a user is disengaged from the surgical console (Para 102 and claim 37).
Regarding claim 11, Thornycroft discloses all the limitations of claim 1.
Thornycroft does not disclose the computer is further configured to change a data recording rate based on the phase of the surgical procedure and a speed of the surgical instrument by increasing the data recording rate when the speed of the surgical instrument is increased.
However, Yates teaches the computer is further configured to change a data recording rate based on the phase of the surgical procedure (Figure 46 shows different transmission rates based on a time in a surgical procedure; consider Para 530-532, more specifically Para 532 that discloses two different surgical activities (or tasks) FTC and FTF that are each at different transmission rates, one prioritized over the other) and a speed of the surgical instrument by increasing the data recording rate when the speed of the surgical instrument is increased (Figure 46; rate increases with the increase in force of the instrument).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed changing a rate of wireless transmission of data as taught in Yates, in the invention of Thornycroft, in order to transmit the relevant data based on maximum available transmission rates (Yates; Para 530-535).
Regarding claim 12, Thornycroft discloses the computer is further configured to: determine if the phase or task is outside of an expected metrics range (Para 146).
Thornycroft does not disclose record data with high fidelity information when it is determined that the phase or task is outside of the expected metrics range.
However, Yates teaches record data with high fidelity information when it is determined that the phase or task is outside of the expected metrics range (Para 537 and Figure 46, b irregular FTF).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed changing a rate of wireless transmission of data as taught in Yates, in the invention of Thornycroft, in order to transmit the relevant data based on maximum available transmission rates (Yates; Para 530-535).
Regarding claim 14, Thornycroft discloses the computer is further configured to: determine if the phase or task is outside of an expected metrics range (Para 146).
Thornycroft does not disclose record data with high fidelity information when it is determined that the phase or task is outside of the expected metrics range.
However, Yates teaches record data with high fidelity information when it is determined that the phase or task is outside of the expected metrics range (Para 537 and Figure 46, b irregular FTF).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed changing a rate of wireless transmission of data as taught in Yates, in the invention of Thornycroft, in order to transmit the relevant data based on maximum available transmission rates (Yates; Para 530-535).
Regarding claim 17, Thornycroft discloses a method for dynamic adjustment of a surgical robotic system (Figure 5, element 500 and Para 1) including a robotic arm (Figure 5, elements 502 and 504) having a surgical instrument (Figure 5, element 506 and 508), the method comprising: determining a phase or a task of a surgical procedure based on at least one of sensor data or a user command to perform the task (Para 77; “the control unit 510 is configured to detect from the inputs received from the surgical robots and, optionally, other inputs, events or conditions during the procedure” and “Examples of events or conditions that the control unit 510 may be able to detect include, but are not limited to, the stage of a procedure that is currently being performed”); determining whether the phase or task is outside of an expected metrics range (Para 146); determining whether the phase or task is to be performed in a predefined surgical area (Para 102; “Example events which may be detectable by the control unit 510 include, but are not limited to: a specific tissue type shown in the endoscope video; a specific body part or organ visible in the endoscope video; the distance between an instrument and an organ or body part is below a predetermined threshold”).
Thornycroft does not disclose recording data with high fidelity information when it is determined that the phase or task is outside of the expected metrics range or when the task is to be performed in the predefined surgical area.
However, Yates teaches recording data with high fidelity information when it is determined that the phase or task is outside of the expected metrics range or when the task is to be performed in the predefined surgical area (Para 537 and Figure 46, b irregular FTF).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed recording data with high fidelity information as taught in Yates, in the invention of Thornycroft, in order to transmit the relevant data based on maximum available transmission rates (Yates; Para 530-535).
Regarding claim 18, Thornycroft discloses recording arm torques when it is determined that the task is retraction of the robotic arm or retraction of the surgical instrument (Para 17, 130, and 146); recording grasping force of the surgical instrument when it is determined that the task is fine manipulation (Para 39-40, see also Para 115); and stopping the recording of signals when it is determined that a user is not engaged with the system (Para 102 and claim 37).
Regarding claim 19, Thornycroft discloses all the limitations of claim 17.
Thornycroft does not disclose adjusting a data recording or wireless transmission rate when a speed of the surgical instrument is modified.
However, Yates teaches adjusting a data recording or wireless transmission rate when a speed of the surgical instrument is modified (Figure 46; rate increases with the increase in force of the instrument).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed changing a rate of wireless transmission of data as taught in Yates, in the invention of Thornycroft, in order to transmit the relevant data based on maximum available transmission rates (Yates; Para 530-535).
Regarding claim 20, Thornycroft discloses all the limitations of claim 17.
Thornycroft does not disclose changing a rate of wireless transmission of data based on the phase or the task of the surgical procedure by increasing the rate of wireless transmission of data during dissection and suturing and reducing the rate of wireless transmission of data when a user is disengaged or when an instrument exchange is being performed.
However, Yates teaches changing a rate of wireless transmission of data based on the phase or the task of the surgical procedure by increasing the rate of wireless transmission of data during dissection and suturing and reducing the rate of wireless transmission of data when a user is disengaged or when an instrument exchange is being performed (See Para 521-540 and Figure 46; the take away from those disclosures is that sample rates are increased during a powered cutting procedure up to 30-40 samples/sec; the rate is reduced between FTC and FTF).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed changing a rate of wireless transmission of data as taught in Yates, in the invention of Thornycroft, in order to transmit the relevant data based on maximum available transmission rates (Yates; Para 530-535).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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