DETAILED ACTION
Acknowledgements
This office action is in response to the claims filed March 30, 2026.
Claims 1-4, 6-8, 11-14, 16-22, and 23-26 are pending
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 .
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/30/2026 has been entered.
Eligible Subject Matter Under 35 USC § 101
Dependent claim 26 falls within the statutory categories of a machine respectively and is not directed to an abstract idea as the claims recite an integral output of the claim at the surgical site by tangible pump controller and surgical pump as supported by the specification and thus are subject matter eligible. The remaining claims are examined under 101 below.
Claim Rejection - 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 1-4, 6-8, 11-14, 16-22, and 23-25 are rejected to under 35 U.S.C 101 as not being directed to eligible subject matter the grounds set out in detail below:
Independent Claims 1, 16, and 22:
Eligibility Step 1 (does the subject matter fall within a statutory category?): Independent Claims 1 and 22 falls within the statutory category of machine. Independent claim 16 falls within the statutory category of method.
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?): Independent claims 1, 16, and 22 claimed invention is directed to a judicial exception.
The claim elements in the independent claims, 1, 16, and 22 (claim 1 being representative) which set forth the abstract idea are:
communicate device data comprising messages indicative of an active control state associated with the operation;
image data demonstrating a surgical site;
process the image data;
identify an intraoperative surgery status of the surgical site in response to the image data;
generate aggregate data comprising the intraoperative surgery status and the device data in a packet;
and communicate the aggregate data
identify a control configuration based on the aggregate data
initiate a control instruction configured to automatically activate the control configuration
and wherein each independently identifies the control configuration and controls the operation in response to a control instruction
which falls within “certain methods of organizing human activity” as managing personal behavior on how to operate during a surgical procedure based on data. See MPEP § 2106.04(a)(2).
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?): For Independent Claim 1, 16, and 22 this judicial exception is not integrated into a practical application.
In Claim 1, 16, and 22 the additional elements are:
A surgical control system for a plurality of surgical devices
A plurality of device controllers
a communication bus
a camera apparatus to capture image
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim elements as a whole.
The additional element, (a) and (b) is performing the abstract idea and stated as a tool or equivalent to apply the abstract idea as “apply-it”
The additional elements, (c) and (d) are merely applying the abstract idea as “apply-it” to gather and communicate data
Accordingly, claims 1, 16, and 22 does not integrate the abstract idea into a practical application.
Eligibility Step 2B (Does the claim amount to significantly more?): The independent claims 1, 16, and 22 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as analyzed above in step 2A prong 2 above, these additional elements, whether viewed individually or as an ordered combination, amount to no more than applying the abstract idea and thus insufficient to provide “significantly more”. Therefore, the claims do not amount to significantly more and the claims are ineligible.
Dependent Claims 2-4, 6-8, 11-14, 17-21, and 23-25:
Eligibility Step 1 (does the subject matter fall within a statutory category?):The dependent claims 2-4, 6-8, 11-14, and 23-25 fall within the statutory category of machine. The dependent claims 17-21 fall within the statutory category of method.
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?): Dependent claims 2-4, 6-8, 11-14, 17-21, and 23-25 claimed invention are directed to a judicial exception.
Dependent claims 2-4, 6-8, 11-14, 17-21, and 23-25 continue to limit the abstract idea in the independent claim by (1) limiting the intraoperative surgery status, (2) further limiting the device data, (3) further limiting the detected condition, and (4) further limiting the configuration of the operation and instructions thus, inheriting the same abstract idea which falls within “certain methods of organizing human activity” as managing personal behavior on how to operate during a surgical procedure based on data. See MPEP § 2106.04(a)(2).
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?): In Claims 2-4, 6-8, 11-14, 17-21, and 23-25 this judicial exception is not integrated into a practical application.
In Claims 2-4, 6-8, 11-14, 17-21, and 23-25 he additional elements not already recited in the independent claims are:
A user interface
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim elements as a whole.
The additional elements, (a), is stated as a computer tools or equivalent to apply the abstract idea as “apply-it” to output data
Eligibility Step 2B (Does the claim amount to significantly more?): Dependent claims 2-4, 6-8, 11-14, 17-21, and 23-25, do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as analyzed above in step 2A prong 2 above, these additional elements, whether viewed individually or as an ordered combination, amount to no more than apply it thus insufficient to provide “significantly more”. Therefore, the claims do not amount to significantly more and the claims are ineligible.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Independent Claims 1-4, 6-8, 11-14, 16-22, and 23-24 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shelton , IV et. al (hereinafter Shelton) (US20220104910Al)
As per claim 1, Shelton teaches:
A surgical control system for a plurality of surgical devices comprising: ([0032] discloses, “FIG . 3 is a surgical hub paired with a visualization system , a robotic system , and an intelligent instrument , in accordance with at least one aspect of the present disclosure” and see [0254] discloses, “FIG. 13 illustrates a block diagram of a computer implemented adaptive surgical system 9060 that is configured to adaptively generate control program updates for modular devices 9050, in accordance with at least one aspect of the present disclosure. In some exemplifications, the surgical system may include a surgical hub 9000, multiple modular devices 9050 communicably coupled to the surgical hub 9000, and an analytics system 9100 communicably coupled to the surgical hub 9000. Although a single surgical hub 9000 may be depicted, it should be noted that the surgical system 9060 can include any number of surgical hubs 9000, which can be connected to form a network of surgical hubs 9000 that are communicably coupled to the analytics system 9100. In some exemplifications, the surgical hub 9000 may include a processor 9010 coupled to a memory 9020 for executing instructions stored thereon and a data relay interface 9030 through which data is transmitted to the analytics system 9100.”)
A plurality of device controllers in communication with each of the plurality of surgical devices via a communication bus, ([0161] discloses, “Referring now to FIG. 3, a hub 106 is depicted in communication with a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112. The hub 106 includes a hub display 135, an imaging module 138, a generator module 140, a communication module 130, a processor module 132, a storage array 134, and an operating-room mapping module 133…[…]…In addition, the modular surgical enclosure also includes a communication bus between the first docking port and the second docking port, configured to facilitate communication between the first energy-generator module and the second energy-generator module. Referring to FIG. 3, aspects of the present disclosure are presented for a hub modular enclosure 136 that allows the modular integration of a generator module 140, a smoke evacuation module 126, and a suction/irrigation module 128. The hub modular enclosure 136 further facilitates interactive communication between the modules 140, 126, 128. The generator module 140 can be a generator module with integrated monopolar, bipolar, and ultrasonic components supported in a single housing unit slidably insertable into the hub modular enclosure 136. The generator module 140 can be configured to connect to a monopolar device 142, a bipolar device 144, and an ultrasonic device 146. Alternatively, the generator module 140 may comprise a series of monopolar, bipolar, and/or ultrasonic generator modules that interact through the hub modular enclosure 136. The hub modular enclosure 136 can be configured to facilitate the insertion of multiple generators and interactive communication between the generators docked into the hub modular enclosure 136 so that the generators would act as a single generator.”)
the device controllers configured to communicate device data comprising messages indicative of an active control state associated with the operation of each of the plurality of surgical devices; ([0375] discloses, “In some aspects, once a failure event associated with a surgical procedure has been identified, the surgical hub 206 and/or the cloud-based system 205 can subsequently flag or tag a surgical device/instrument 235 which was utilized during the surgical procedure for inoperability and/or removal. For example, in one aspect, information (e.g., serial number, ID) associated with the surgical device/ instrument 235 and stored at the surgical hub 206 and/or the cloud-based system 205 can be utilized to effectively block the surgical device/instrument 235 from being used again ( e.g., blacklisted). In another aspect, information ( e.g., serial number, ID) associated with the surgical device/instrument can initiate the printing of a shipping slip and shipping instructions to returning the surgical device/instrument 235 back to a manufacturer or other designated party so that a thorough analysis/inspection of the surgical device/instrument 235 can be performed ( e.g., to determine the cause of the failure). According to various aspects described herein, once the cause of a failure is determined (e.g., via the surgical hub 206 and/or the cloud-based system 205), the surgical hub 206 may download a program from the cloudbased system 205 for execution by the surgical device/ instrument 235 that corrects the determined cause of the failure (i.e., program that alters surgical device/instrument parameters to prevent the failure from occurring again).” And see [0376] discloses, “In some aspects, the primary display and/or the secondary display may be used to provide or display a notification that an operation error has occurred. For example, when a failure event associated with a surgical procedure has been identified, the surgical hub 206 and/or the cloud -based system 205 may send an error message to be displayed on one or more primary displays and/or secondary displays. The error message may indicate to a user that a failure event has occurred, may indicate instructions for correcting the error, may indicate recommendations for correcting the error, may indicate instructions that may alter the surgical procedure, and the like. For example, an error message on the primary display may provide instruction to a surgical error that may have occurred to a patient due to the failure event. As another example, an error message on a secondary display may provide instructions to a user on how to clear a misfired staple and reload a staple cartridge.” And also see [0377] and see [0511] discloses, “Further, the computer system can be programmed to provide notifications or prompts that indicate when the surgical staff is deviating from the baseline so that the surgical staff can alter their actions and optimize their performance or technique. In some aspects, the notifications can include warnings that the surgical staff is not utilizing proper technique (which can further include recommendations on corrective actions that the surgical staff can take to address their technique), suggestions for alternative surgical products, statistics regarding correlations between procedural variables ( e.g., time taken to complete the procedure) and the monitored physical characteristics of the surgical staff, comparisons between surgeons, and so on. In various aspects, the notifications or recommendations can be provided either in real time (e.g., in the OR during the surgical procedure) or in a post-procedure report.” And see [0537] Accordingly, the processor 244 controls 211606 a surgical device that is paired with the surgical hub 211801 in a manner that depends upon the particular determined characteristic or condition. For example, if the processor 244 determines 211604 that a surgical staff member 211803 is making a "change instrument mode" gesture, then the processor 244 can transmit a signal to or otherwise control 211606 a particular surgical instrument 211810 (or its associated generator) connected to the surgical hub 211801 to change the operational mode of the surgical instrument 211810 (e.g., change an electrosurgical surgical instrument)”)
a camera apparatus in communication with the plurality of medical devices via the communication bus, the camera apparatus comprising at least one controller of the device controllers configured to: ([0512] discloses, “FIG. 59 is a diagram of an illustrative OR setup, in accordance with at least one aspect of the present disclosure. In various implementations, the surgical hub 211801 can be connected to various one or more cameras 211802, surgical instruments 211810, displays 211806, and other surgical devices within the OR 211800 via a communications protocol ( e.g., Bluetooth), as described above under the heading SURGICAL HUBS.”)
capture image data demonstrating a surgical site; ([0650] discloses, “The surgical hub may instruct a first medical instrument to reconfigure its display to display data from a second medical instrument. The surgical hub may determine that the first medical instrument is being used in-situ along with the second medical instrument. The first medical instrument may be instructed to reconfigure its display to show a video and/or image from the second medical instrument. For example, the first medical instrument may be instructed to reconfigure its display to show a video of the surgical site taken from a camera of the second medical instrument. As another example, the first medical instrument may be instructed to reconfigure its display to show an image of the surgical site that may be overlaid with additional data. The image of the surgical site and/or the additional data may come from second medical instrument.” And see e.g.s [0515]-[0518])
process the image data; ([0512] discloses, “FIG. 59 is a diagram of an illustrative OR setup, in accordance with at least one aspect of the present disclosure. In various implementations, the surgical hub 211801 can be connected to various one or more cameras 211802, surgical instruments 211810, displays 211806, and other surgical devices within the OR 211800 via a communications protocol ( e.g., Bluetooth), as described above under the heading SURGICAL HUBS.” And see [0517] discloses, “Accordingly, the processor 244 evaluates 211010 the determined physical characteristic of the surgical staff member to a baseline. In one aspect, the baseline can correspond to the surgical context determined via situational awareness.” and see [0518] discloses, “In one aspect, the processor 244 can provide feedback to the surgical staff members in real time during the surgical procedure. The real-time feedback can include a graphical notification or recommendation displayed on a display 211806 within the OR 211800, audio feedback emitted by the surgical hub 211801 or a surgical instrument 211810, and so on. Further, the feedback can include suggestions that trocar port placements be shifted, that a surgical instrument be moved from one trocar port to another port, that the positioning of the patient being operated on be adjusted (e.g., situated at an increased table angle or rolled), and other such suggestions to improve access to the surgical site and minimize non-ideal surgical technique exhibited by the surgical staff.”)
identify an intraoperative surgery status of the surgical site in response to the image data; (see [0518] discloses, “Further, the feedback can include suggestions that trocar port placements be shifted, that a surgical instrument be moved from one trocar port to another port, that the positioning of the patient being operated on be adjusted (e.g., situated at an increased table angle or rolled), and other such suggestions to improve access to the surgical site and minimize non-ideal surgical technique exhibited by the surgical staff.”)
generate aggregate data comprising the intraoperative surgery status and the device data in a packet communicated over the communication bus; ([0243] discloses, “Based on connections to various surgical hubs 7006 via the network 7001, the cloud 7004 can aggregate data from specific data generated by various surgical instruments 7012 and their corresponding hubs 7006. Such aggregated data may be stored within the aggregated medical databases 7011 of the cloud 7004. In particular, the cloud 7004 may advantageously perform data analysis and operations on the aggregated data to yield insights and/or perform functions that individual hubs 7006 could not achieve on their own. To this end, as shown in FIG. 11, the cloud 7004 and the surgical hubs 7006 are communicatively coupled to transmit and receive information. The I/O interface 7005 is connected to the plurality of surgical hubs 7006 via the network 7001. In this way, the I/O interface 7005 can be configured to transfer information between the surgical hubs 7006 and the aggregated medical data databases 7011. Accordingly, the I/O interlace 7005 may facilitate read/write operations of the cloud-based analytics system. Such read/ write operations may be executed in response to requests from hubs 7006. These requests could be transmitted to the hubs 7006 through the hub applications. The I/O interface 7005 may include one or more high speed data ports, which may include universal serial bus (USB) ports, IEEE 1394 ports, as well as Wi-Fi and Bluetooth I/O interfaces for connecting the cloud 7004 to hubs 7006. The hub application servers 7002 of the cloud 7004 may be configured to host and supply shared capabilities to software applications (e.g., hub applications) executed by surgical hubs 7006. For example, the hub application servers 7002 may manage requests made by the hub applications through the hubs 7006, control access to the aggregated medical data databases 7011, and perform load balancing. The data analytics modules 7034” and see [0248] discloses, “The patient outcome analysis module 7028 can analyze surgical outcomes associated with currently used operational parameters of surgical instruments 7012. The patient outcome analysis module 7028 may also analyze and assess other potential operational parameters, in this connection, the recommendations module 7030 could recommend using these other potential operational parameters based on yielding better surgical outcomes, such as better sealing or less bleeding. For example, the recommendations module 7030 could transmit recommendations to a surgical 7006 regarding when to use a particular cartridge for a corresponding stapling surgical instrument 7012. Thus, the cloud-based analytics system, while controlling for common variables, may be configured to analyze the large collection of raw data and to provide centralized recommendations over multiple healthcare facilities (advantageously determined based on aggregated data). For example, the cloudbased analytics system could analyze, evaluate, and/or aggregate data based on type of medical practice, type of patient, number of patients, geographic similarity between medical providers, which medical providers/facilities use similar types of instruments, etc., in a way that no single healthcare facility alone would be able to analyze independently. The control program updating module 7026 could be configured to implement various surgical instrument 7012 recommendations when corresponding control programs are updated. For example, the patient outcome analysis module 7028 could identify correlations linking specific control parameters with successful (or unsuccessful) results. Such correlations may be addressed when updated control programs are transmitted to surgical instruments 7012 via the control program updating module 7026. Updates to surgical instruments 7012 that may be transmitted via a corresponding hub 7006 may incorporate aggregated performance data that was gathered and analyzed by the data collection and aggregation module 7022 of the cloud 7004. Additionally, the patient outcome analysis module 7028 and recommendations module 7030 could identify improved methods of using surgical instruments 7012 based on aggregated performance data.”)
and communicate the aggregate data over the communication bus; ([0243] discloses, “Based on connections to various surgical hubs 7006 via the network 7001, the cloud 7004 can aggregate data from specific data generated by various surgical instruments 7012 and their corresponding hubs 7006. Such aggregated data may be stored within the aggregated medical databases 7011 of the cloud 7004. In particular, the cloud 7004 may advantageously perform data analysis and operations on the aggregated data to yield insights and/or perform functions that individual hubs 7006 could not achieve on their own. To this end, as shown in FIG. 11, the cloud 7004 and the surgical hubs 7006 are communicatively coupled to transmit and receive information. The I/O interface 7005 is connected to the plurality of surgical hubs 7006 via the network 7001. In this way, the I/O interface 7005 can be configured to transfer information between the surgical hubs 7006 and the aggregated medical data databases 7011. Accordingly, the I/O interlace 7005 may facilitate read/write operations of the cloud-based analytics system. Such read/ write operations may be executed in response to requests from hubs 7006. These requests could be transmitted to the hubs 7006 through the hub applications. The I/O interface 7005 may include one or more high speed data ports, which may include universal serial bus (USB) ports, IEEE 1394 ports, as well as Wi-Fi and Bluetooth I/O interfaces for connecting the cloud 7004 to hubs 7006. The hub application servers 7002 of the cloud 7004 may be configured to host and supply shared capabilities to software applications (e.g., hub applications) executed by surgical hubs 7006. For example, the hub application servers 7002 may manage requests made by the hub applications through the hubs 7006, control access to the aggregated medical data databases 7011, and perform load balancing. The data analytics modules 7034” and see [0248] discloses, “The patient outcome analysis module 7028 can analyze surgical outcomes associated with currently used operational parameters of surgical instruments 7012. The patient outcome analysis module 7028 may also analyze and assess other potential operational parameters, in this connection, the recommendations module 7030 could recommend using these other potential operational parameters based on yielding better surgical outcomes, such as better sealing or less bleeding. For example, the recommendations module 7030 could transmit recommendations to a surgical 7006 regarding when to use a particular cartridge for a corresponding stapling surgical instrument 7012. Thus, the cloud-based analytics system, while controlling for common variables, may be configured to analyze the large collection of raw data and to provide centralized recommendations over multiple healthcare facilities (advantageously determined based on aggregated data). For example, the cloudbased analytics system could analyze, evaluate, and/or aggregate data based on type of medical practice, type of patient, number of patients, geographic similarity between medical providers, which medical providers/facilities use similar types of instruments, etc., in a way that no single healthcare facility alone would be able to analyze independently. The control program updating module 7026 could be configured to implement various surgical instrument 7012 recommendations when corresponding control programs are updated. For example, the patient outcome analysis module 7028 could identify correlations linking specific control parameters with successful (or unsuccessful) results. Such correlations may be addressed when updated control programs are transmitted to surgical instruments 7012 via the control program updating module 7026. Updates to surgical instruments 7012 that may be transmitted via a corresponding hub 7006 may incorporate aggregated performance data that was gathered and analyzed by the data collection and aggregation module 7022 of the cloud 7004. Additionally, the patient outcome analysis module 7028 and recommendations module 7030 could identify improved methods of using surgical instruments 7012 based on aggregated performance data.”)
identify a control configuration for atleast one of the surgical device based on the aggregate data (see [0256] The surgical hub 9000 can transmit the associated modular device 9050 data and outcome data to the analytics system 9100 for processing thereon. By transmitting both the perioperative data indicating how the modular devices 9050 are controlled and the procedural outcome data, the analytics system 9100 can correlate the different manners of controlling the modular devices 9050 with surgical outcomes for the particular procedure type. In some exemplifications, the analytics system 9100 may include a network of analytics servers 9070 that are configured to receive data from the surgical hubs 9000. Each of the analytics servers 9070 can include a memory and a processor coupled to the memory that is executing instructions stored thereon to analyze the received data. In some exemplifications, the analytics servers 9070 may be connected in a distributed computing architecture and/or utilize a cloud computing architecture. Based on this paired data, the analytics system 9100 can then learn optimal or preferred operating parameters for the various types of modular devices 9050, generate adjustments to the control programs of the modular devices 9050 in the field, and then transmit ( or "push") updates to the modular devices' 9050 control programs.” And see e.g. [0369] discloses, “When a failure event has been detected and/or identified ( e.g., which can be either during or after the surgical procedure), the surgical hub 206 may determine which of the surgical data is associated with the failure event ( e.g., failure event surgical data) and which of the surgical data may not be associated with the surgical event (e.g., non-failure event surgical data). According to an aspect of the present disclosure, a failure event may include, for example, a detection of one or more misfired staples during a stapling portion of a surgical procedure.….[….]…According to the various aspects described herein, in response to the detected and/or identified failure event, the surgical hub 206 may download a program from the cloud-based system 205 for execution by the surgical device/instrument 235 that corrects the detected issue (e.g., program that alters surgical device/ instrument parameters to prevent misfired staples, program that alters surgical device/instrument parameters to ensure correct sealing temperature).”)
initiate a control instruction configured to automatically activate the control configuration of one or more of the plurality of surgical devices. (see fig. 74 and see [0502] discloses, “The interactive secondary displays 13362, 13364 permit the clinician to step away from the remote command console 13370 and into the sterile field while maintaining control of the robot 13372. For example, the interactive secondary displays 13362, 13364 allow the clinician to maintain cooperative and/or coordinated control over the powered handheld surgical instruments) 13366 and the robotic surgical system at the same time. In various instances, information is communicated between the robotic surgical system, one or more powered handheld surgical instruments 13366, surgical hubs 13380, 13382, and the interactive secondary displays 13362, 13364. Such information may include, for example, the images on the display of the robotic surgical system and/or the powered handheld surgical instruments, a parameter of the robotic surgical system and/or the powered handheld surgical instruments, and/or a control command for the robotic surgical system and/or the powered handheld surgical instruments. [0503] In various instances, the control unit of the robotic surgical system (e.g. the control unit 13113 of the robotic surgical system 13110) is configured to communicate at least one display element from the surgeon's command console (e.g. the console 13116) to an interactive secondary display (e g. the display 13130). In other words, a portion of the display at the surgeon's console is replicated on the display of the interactive secondary display, integrating the robot display with the interactive secondary display. The replication of the robot display on to the display of the interactive secondary display allows the clinician to step away from the remote command console without losing the the visual image that is displayed there. For example, at least one of the interactive secondary displays 13362, 13364 can display information from the robot, such as information from the robot display and/or the surgeon s command console 13370. [0504] In various instances, the interactive secondary displays 13362, 13364 are configured to control and/or adjust at least one operating parameter of the robotic surgical system. Such control can occur automatically and/or in response to a clinician input.”)
and wherein each of the plurality of device controllers independently identifies the control configuration and controls the operation of the plurality of surgical devices in response to a control instruction. ([0256] discloses, “The surgical hub 9000 can transmit the associated modular device 9050 data and outcome data to the analytics system 9100 for processing thereon. By transmitting both the perioperative data indicating how the modular devices 9050 are controlled and the procedural outcome data, the analytics system 9100 can correlate the different manners of controlling the modular devices 9050 with surgical outcomes for the particular procedure type.” And see [0531] In one aspect, the computer system ( e.g., a surgical hub 211801) can be configured to allow surgical staff members to compare their technique to themselves, rather than to the baselines established by the sampled population or pre-programmed into the computer system. In other words, the baseline against which the computer system compares a surgical staff member can be the surgical staff member's prior performance in a particular surgical procedure type or a prior instance of utilizing a particular type of surgical instrument. Such aspects can be useful to allow surgeons to track improvements in their surgical techniques or document trial periods for new surgical products.” And see [0533] discloses, “In one aspect, the computer system ( e.g., a surgical hub 211801) can be configured to analyze trends in surgical device usage as surgeons become more experienced in performing particular surgical procedures ( or performing surgical procedures generally) or using new surgical instruments. For example, the computer system could identify motions, behaviors, and other physical characteristics that change dramatically as the surgeons become more experienced. Accordingly, the computer system can recognize when a surgeon is exhibiting suboptimal techniques early in the surgeon's learning curve and can provide recommendations about the optimal approach, prior to the suboptimal technique becoming ingrained in the surgeon.” And see [0537] discloses, e.g. “As yet another example, if the processor 244 determines 211604 that a surgical instrument 211810 is at a particular orientation when being (or as it is about to be) fired, the processor 244 can transmit a signal to or otherwise control 211606 the surgical instrument 211810 to modify the operational parameters of the surgical instrument 211810 (e.g., force to fire or maximum permitted articulation angle) accordingly. This would allow the surgical hub 211801 to control the functions of the surgical instruments 211810 to account for differences in placements and orientations of the surgical instruments 211810.” )
As per claim 2, Shelton teaches:
The surgical control system according to claim 1, wherein the intraoperative surgery status is identified in response to a combination of the device data with the image data and comprises an indication of at least one of a patient condition, a procedural step, a surgical device condition, and a surgical site condition. (see [0511] discloses, “Further, the computer system can be programmed to provide notifications or prompts that indicate when the surgical staff is deviating from the baseline so that the surgical staff can alter their actions and optimize their performance or technique. In some aspects, the notifications can include warnings that the surgical staff is not utilizing proper technique (which can further include recommendations on corrective actions that the surgical staff can take to address their technique), suggestions for alternative surgical products, statistics regarding correlations between procedural variables ( e.g., time taken to complete the procedure) and the monitored physical characteristics of the surgical staff, comparisons between surgeons, and so on. In various aspects, the notifications or recommendations can be provided either in real time (e.g., in the OR during the surgical procedure) or in a post-procedure report.” And see [0512] discloses, “FIG. 59 is a diagram of an illustrative OR setup, in accordance with at least one aspect of the present disclosure. In various implementations, the surgical hub 211801 can be connected to various one or more cameras 211802, surgical instruments 211810, displays 211806, and other surgical devices within the OR 211800 via a communications protocol ( e.g., Bluetooth), as described above under the heading SURGICAL HUBS.” And see [0517] discloses, “Accordingly, the processor 244 evaluates 211010 the determined physical characteristic of the surgical staff member to a baseline. In one aspect, the baseline can correspond to the surgical context determined via situational awareness.” and see [0518] discloses, “In one aspect, the processor 244 can provide feedback to the surgical staff members in real time during the surgical procedure. The real-time feedback can include a graphical notification or recommendation displayed on a display 211806 within the OR 211800, audio feedback emitted by the surgical hub 211801 or a surgical instrument 211810, and so on. Further, the feedback can include suggestions that trocar port placements be shifted, that a surgical instrument be moved from one trocar port to another port, that the positioning of the patient being operated on be adjusted (e.g., situated at an increased table angle or rolled), and other such suggestions to improve access to the surgical site and minimize non-ideal surgical technique exhibited by the surgical staff.”)
As per claim 3, Shelton teaches:
The surgical control system according to claim 1, wherein the device data is associated with the operation of each of the plurality of surgical devices and comprises messages communicating the active control state monitored by one or more of the plurality of surgical devices. ([0375] discloses, “In some aspects, once a failure event associated with a surgical procedure has been identified, the surgical hub 206 and/or the cloud-based system 205 can subsequently flag or tag a surgical device/instrument 235 which was utilized during the surgical procedure for inoperability and/or removal. For example, in one aspect, information (e.g., serial number, ID) associated with the surgical device/ instrument 235 and stored at the surgical hub 206 and/or the cloud-based system 205 can be utilized to effectively block the surgical device/instrument 235 from being used again ( e.g., blacklisted). In another aspect, information ( e.g., serial number, ID) associated with the surgical device/instrument can initiate the printing of a shipping slip and shipping instructions to returning the surgical device/instrument 235 back to a manufacturer or other designated party so that a thorough analysis/inspection of the surgical device/instrument 235 can be performed ( e.g., to determine the cause of the failure). According to various aspects described herein, once the cause of a failure is determined (e.g., via the surgical hub 206 and/or the cloud-based system 205), the surgical hub 206 may download a program from the cloudbased system 205 for execution by the surgical device/ instrument 235 that corrects the determined cause of the failure (i.e., program that alters surgical device/instrument parameters to prevent the failure from occurring again).” And see [0376] discloses, “In some aspects, the primary display and/or the secondary display may be used to provide or display a notification that an operation error has occurred. For example, when a failure event associated with a surgical procedure has been identified, the surgical hub 206 and/or the cloud -based system 205 may send an error message to be displayed on one or more primary displays and/or secondary displays. The error message may indicate to a user that a failure event has occurred, may indicate instructions for correcting the error, may indicate recommendations for correcting the error, may indicate instructions that may alter the surgical procedure, and the like. For example, an error message on the primary display may provide instruction to a surgical error that may have occurred to a patient due to the failure event. As another example, an error message on a secondary display may provide instructions to a user on how to clear a misfired staple and reload a staple cartridge.” And also see [0377] and see [0511] discloses, “Further, the computer system can be programmed to provide notifications or prompts that indicate when the surgical staff is deviating from the baseline so that the surgical staff can alter their actions and optimize their performance or technique. In some aspects, the notifications can include warnings that the surgical staff is not utilizing proper technique (which can further include recommendations on corrective actions that the surgical staff can take to address their technique), suggestions for alternative surgical products, statistics regarding correlations between procedural variables ( e.g., time taken to complete the procedure) and the monitored physical characteristics of the surgical staff, comparisons between surgeons, and so on. In various aspects, the notifications or recommendations can be provided either in real time (e.g., in the OR during the surgical procedure) or in a post-procedure report.” And see [0537] Accordingly, the processor 244 controls 211606 a surgical device that is paired with the surgical hub 211801 in a manner that depends upon the particular determined characteristic or condition. For example, if the processor 244 determines 211604 that a surgical staff member 211803 is making a "change instrument mode" gesture, then the processor 244 can transmit a signal to or otherwise control 211606 a particular surgical instrument 211810 (or its associated generator) connected to the surgical hub 211801 to change the operational mode of the surgical instrument 211810 (e.g., change an electrosurgical surgical instrument)”)
As per claim 4, Shelton teaches:
The surgical control system according to claim 3, wherein the detected condition comprises at least one of temperature data, pressure data, flow rate data, and current data detected by at least one of the surgical devices and identifies a state of the surgical site. (E.g.s are disclosed see [0511] discloses, “Further, the computer system can be programmed to provide notifications or prompts that indicate when the surgical staff is deviating from the baseline so that the surgical staff can alter their actions and optimize their performance or technique. In some aspects, the notifications can include warnings that the surgical staff is not utilizing proper technique (which can further include recommendations on corrective actions that the surgical staff can take to address their technique), suggestions for alternative surgical products, statistics regarding correlations between procedural variables ( e.g., time taken to complete the procedure) and the monitored physical characteristics of the surgical staff, comparisons between surgeons, and so on. [0517] discloses, “Accordingly, the processor 244 evaluates 211010 the determined physical characteristic of the surgical staff member to a baseline. In one aspect, the baseline can correspond to the surgical context determined via situational awareness.” and see [0518] discloses, “In one aspect, the processor 244 can provide feedback to the surgical staff members in real time during the surgical procedure. The real-time feedback can include a graphical notification or recommendation displayed on a display 211806 within the OR 211800, audio feedback emitted by the surgical hub 211801 or a surgical instrument 211810, and so on. Further, the feedback can include suggestions that trocar port placements be shifted, that a surgical instrument be moved from one trocar port to another port, that the positioning of the patient being operated on be adjusted (e.g., situated at an increased table angle or rolled), and other such suggestions to improve access to the surgical site and minimize non-ideal surgical technique exhibited by the surgical staff.” And see (e.g.s disclosed see [0367] discloses, “FIG. 30 illustrates various aspects of a system implemented method of identifying surgical data associated with a failure event (e.g., failure event surgical data) and communicating the identified surgical data to a cloud -based system 205 on a prioritized basis. The method comprises receiving 3838 surgical data at a surgical hub 206, wherein the surgical data is associated with a surgical procedure; time-stamping 3840 the surgical data; identifying 3842 a failure event associated with the surgical procedure; determining 3844 which of the surgical data is associated with the failure event (e.g., failure event surgical data); separating 3846 the surgical data associated with the failure event from all other surgical data (e.g., non-failure event surgical data) received at the surgical hub 206; chronologizing 3848 the surgical data associated with the failure event; encrypting 3850 the surgical data associated with the failure event; and communicating 3852 the encrypted surgical data to a cloudbased system 205 on a prioritized basis.” And see [0368] discloses, “More specifically, various surgical data may be captured during a surgical procedure and the captured surgical data, as well as other surgical data associated with the surgical procedure, may be communicated to the surgical hub 206. The surgical data may include, for example, data associated with a surgical device/instrument (e.g., FIG. 5, surgical device/instrument 235) utilized during the surgery, data associated with the patient, data associated with the facility where the surgical procedure was performed, and data associated with the surgeon.” And see [0369] When a failure event has been detected and/or identified ( e.g., which can be either during or after the surgical procedure), the surgical hub 206 may determine which of the surgical data is associated with the failure event ( e.g., failure event surgical data) and which of the surgical data may not be associated with the surgical event (e.g., non-failure event surgical data). According to an aspect of the present disclosure, a failure event may include, for example, a detection of one or more misfired staples during a stapling portion of a surgical procedure. For example, in one aspect, referring to FIG. 5, an endoscope 239 may take snapshots while a surgical device/instrument 235 comprising an end effector including a staple cartridge performs a stapling portion of a surgical procedure. In such an aspect, an imaging module 238 may compare the snapshots to stored images and/or images downloaded from the cloudbased system 205 that convey correctly fired staples to detect a misfired staple and/or evidence o fa misfired staple (e.g., a leak). In another aspect, the imaging module 238 may analyze the snapshots themselves to detect a misfired staple, and/or evidence of a misfired staple. In one alternative aspect, the surgical hub 206 may communicate the snapshots to the cloud-based system 205, and a component of the cloud-based system 205 may perform the various imaging module functions described above to detect a misfired staple and/or evidence of a misfired staple and to report the detection to the surgical hub 206. According to another aspect of the present disclosure, a failure event may include a detection of a tissue temperature which is below the expected temperature during a tissue-sealing portion of a surgical procedure and/or a visual indication of excessive bleeding or oozing following a surgical procedure ( e.g., FIG. 5, via endoscope 239). For example, in one aspect, referring to FIG. 5, the surgical device/instrument 235 may comprise an end effector, including a temperature sensor and the surgical hub 206, and/or the cloud-based system may compare at least one temperature detected by the temperature sensor ( e.g., during a tissue-sealing portion of a surgical procedure) to a stored temperature and/or a range of temperatures expected and/or associated with that surgical procedure to detect an inadequate/low sealing temperature. In another aspect, an endoscope 239 may take snapshots during a surgical procedure. In such an aspect, an imaging module 238 may compare the snapshots to stored images and/or images downloaded from the cloud-based system 205 that convey tissue correctly sealed at expected temperatures to detect evidence of an improper/insufficient sealing temperature ( e.g., charring, oozing/bleeding). Further, in such an aspect, the imaging module 238 may analyze the snapshots themselves to detect evidence of an improper/insufficient sealing temperature ( e.g., charring, oozing/bleeding). As another example, the surgical hub 206 may communicate the snapshots to the cloud-based system 205, and a component of the cloud-based system 205 may perform the various imaging module functions described above to detect evidence of an improper/insufficient sealing temperature and to report the detection to the surgical hub 206. According to the various aspects described herein, in response to the detected and/or identified failure event, the surgical hub 206 may download a program from the cloud-based system 205 for execution by the surgical device/instrument 235 that corrects the detected issue (e.g., program that alters surgical device/ instrument parameters to prevent misfired staples, program that alters surgical device/instrument parameters to ensure correct sealing temperature).”)/ current data is defined in the instant application specification paragraph [00105] as “(feedback)” therefore examiner interprets the types of feedback disclosed as reading on the claim language. The disclosure also teaches temperature data)
As per claim 6, Shelton teaches:
The surgical control system according to claim 3, wherein the detected condition is an operating condition of one or more of the plurality of surgical devices. ([0376] discloses, “In some aspects, the primary display and/or the secondary display may be used to provide or display a notification that an operation error has occurred. For example, when a failure event associated with a surgical procedure has been identified, the surgical hub 206 and/or the cloud -based system 205 may send an error message to be displayed on one or more primary displays and/or secondary displays. The error message may indicate to a user that a failure event has occurred, may indicate instructions for correcting the error, may indicate recommendations for correcting the error, may indicate instructions that may alter the surgical procedure, and the like. For example, an error message on the primary display may provide instruction to a surgical error that may have occurred to a patient due to the failure event. As another example, an error message on a secondary display may provide instructions to a user on how to clear a misfired staple and reload a staple cartridge.” And also see [0377])
As per claim 7, Shelton teaches:
The surgical control system according to claim 3, wherein the detected condition is a patient condition monitored by a patient monitor of the plurality of surgical devices. ([0494] discloses, “For example, the control circuit of a situationally aware surgical hub 5706 could determine that anesthesia is being induced in a patient through data received from one or more modular devices 5102 (FIG. 9) and/or patient monitoring devices 5124 (FIG. 9).”)
As per claim 8, Shelton teaches:
The surgical control system according to claim 1, wherein each of the device controllers independently reports and monitors the device data communicated as messages from each of the plurality of surgical devices. ( see Fig. 9-11 and see [0254] discloses, “The modular devices 9050 can include, for example, surgical stapling and cutting instruments, electrosurgical instruments, ultrasonic instruments, insufflators, respirators, and display screens. “ and see [0265] discloses, “The handle 6504 may include a transmitter 6506 that is configured to transmit instrument data from the controller 6528 to other components of the system 6500 (e.g., the LAN 6518, the cloud 6520, the console 6522, or the portable device 6526). The transmitter 6506 also may receive data (e.g., cartridge data, loading unit data, or adapter data) from the other components of the system 6500. For example, the controller 6528 may transmit instrument data including a serial number of an attached adapter (e.g., adapter 6508) attached to the handle 6504, a serial number of a loading unit (e.g., loading unit 6514) attached to the adapter, and a serial number of a multi-fire fastener cartridge (e.g., multi-fire fastener cartridge), loaded into the loading unit, to the console 6522. Thereafter, the console 6522 may transmit data (e.g., cartridge data, loading unit data, or adapter data) associated with the attached cartridge, loading unit, and adapter, respectively, back to the controller 6528. The controller 6528 can display messages on the local instrument display or transmit the message, via transmitter 6506, to the console 6522 or the portable device 6526 to display the message on the display 6524 or portable device screen, respectively. “ and see [0418] discloses, “Multiple surgical instrument controllers and multiple surgical instruments can be used concurrently in an operating room. Pressing or activating the wrong surgical instrument controller can lead to undesirable consequences. Aspects of the present disclosure present a solution in which the surgical hub 106 coordinates the pairing of surgical instrument controllers and surgical instruments to ensure patient and operator safety.” And see [0147] discloses, “In one example, as illustrated in FIG. 1, the surgical system 102 includes a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112, which are configured to communicate with one another and/or the hub 106. In some aspects, a surgical system 102 may include an M number of hubs 106, an N number of visualization systems 108, an O number of robotic systems 110, and a P number of handheld intelligent surgical instruments 112, where M, N, 0, and P may be integers greater than or equal to one.” And see [0507] discloses, “In various instances, the processor of a robotic surgical system and/or the surgical hub 13380, 13382, for example, may be progrannned with pre-approved functions of the robotic surgical system.” / examiner notes that the figures teach multiple surgical devices attached to controllers from surgical hubs which can send and receive message data)
As per claim 11, Shelton teaches:
The surgical control system according to claim 1, wherein the at least one controller processes the device data as a factor in the determination of the intraoperative surgery status. (see [0518] discloses, “In one aspect, the processor 244 can provide feedback to the surgical staff members in real time during the surgical procedure. The real-time feedback can include a graphical notification or recommendation displayed on a display 211806 within the OR 211800, audio feedback emitted by the surgical hub 211801 or a surgical instrument 211810, and so on. Further, the feedback can include suggestions that trocar port placements be shifted, that a surgical instrument be moved from one trocar port to another port, that the positioning of the patient being operated on be adjusted (e.g., situated at an increased table angle or rolled), and other such suggestions to improve access to the surgical site and minimize non-ideal surgical technique exhibited by the surgical staff.”)
As per claim 12, Shelton teaches:
The surgical control system according to claim 11, wherein the factor associated with the device data directs the at least one controller to identify the surgery status within a subset of a plurality of status categories. ([0514] discloses, “The surgical context determined by the surgical hub 211801 through situational awareness can be utilized to inform e valuations of the surgical staff performing the surgical procedure.” And see [0516] discloses, “Accordingly, the processor 244 determines 211008 a physical characteristic of one or more surgical staff members from the captured image(s). For example, the physical characteristic can include posture, as discussed in connection with FIGS. 61-62, or wrist angle, as discussed in connection with FIGS. 63-64. In other implementations, the physical characteristic can include the position, orientation, angle, or rotation of an individual's head, shoulders, torso, elbows, legs, hips, and so on.” and see [0518] discloses, “In one aspect, the processor 244 can provide feedback to the surgical staff members in real time during the surgical procedure. The real-time feedback can include a graphical notification or recommendation displayed on a display 211806 within the OR 211800, audio feedback emitted by the surgical hub 211801 or a surgical instrument 211810, and so on. Further, the feedback can include suggestions that trocar port placements be shifted, that a surgical instrument be moved from one trocar port to another port, that the positioning of the patient being operated on be adjusted (e.g., situated at an increased table angle or rolled), and other such suggestions to improve access to the surgical site and minimize non-ideal surgical technique exhibited by the surgical staff.” / examiner interprets the disclosed the different context of evaluation such as trocar information and positioning of surgeon as status categories under BRI)
As per claim 13, Shelton teaches:
The surgical control system according to claim 1, wherein the at least one controller infers a current intraoperative surgery status as a current surgery status in response to the device data. (see [0518] discloses, “In one aspect, the processor 244 can provide feedback to the surgical staff members in real time during the surgical procedure. The real-time feedback can include a graphical notification or recommendation displayed on a display 211806 within the OR 211800, audio feedback emitted by the surgical hub 211801 or a surgical instrument 211810, and so on. Further, the feedback can include suggestions that trocar port placements be shifted, that a surgical instrument be moved from one trocar port to another port, that the positioning of the patient being operated on be adjusted (e.g., situated at an increased table angle or rolled), and other such suggestions to improve access to the surgical site and minimize non-ideal surgical technique exhibited by the surgical staff.”)
As per claim 14, Shelton teaches:
The surgical control system according to claim 13, wherein the at least one controller infers the current surgery status further in response to a previously identified surgery status, such that the surgery status is identified in response to a combination of the device data and the previously identified surgery status. ([0517] discloses, “Accordingly, the processor 244 evaluates 211010 the determined physical characteristic of the surgical staff member to a baseline. In one aspect, the baseline can correspond to the surgical context determined via situational awareness. The processor 244 can retrieve the baselines for various physical characteristics from a memory (e.g., the memory 249 illustrated in FIG. 6) according to the given surgical context, for example. The baseline can include values or ranges of values for particular physical characteristics to be tracked during particular surgical contexts. The types of physical characteristics evaluated in different surgical contexts can be the same or unique to each particular surgical context.” And see [0518] discloses, “In one aspect, the processor 244 can provide feedback to the surgical staff members in real time during the surgical procedure. The real-time feedback can include a graphical notification or recommendation displayed on a display 211806 within the OR 211800, audio feedback emitted by the surgical hub 211801 or a surgical instrument 211810, and so on. Further, the feedback can include suggestions that trocar port placements be shifted, that a surgical instrument be moved from one trocar port to another port, that the positioning of the patient being operated on be adjusted (e.g., situated at an increased table angle or rolled), and other such suggestions to improve access to the surgical site and minimize non-ideal surgical technique exhibited by the surgical staff. In another aspect, the processor 244 can provide postoperative feedback to the surgical staff members. The postoperative feedback can include graphical overlays or notifications displayed on the captured video of the procedure that can be reviewed by the surgical staff for learning purposes, a post-surgery report indicating times or particular surgical steps where the surgical staff deviated from the baselines, and so on. Any visually identifiable physical characteristic ( or combination of physical characteristics; can be utilized as the basis for suggesting improvements in the technique exhibited by the surgical staff.” And see [0531] discloses, “In other words, the baseline against which the computer system compares a surgical staff member can be the surgical staff member's prior performance in a particular surgical procedure type or a prior instance of utilizing a particular type of surgical instrument.”)
As per claims 16-18, they are method claims which repeat limitations of claims 1, 3, and 4 the corresponding system claims, as a series of process steps as opposed to a collection of elements. Since the collective teachings of Shelton disclose the structural elements that constitute the system of claim 1, 3, and 4 it is respectfully submitted that they perform the underlying process steps, as well. As such, the limitations of claims 16-18 are rejected for the same reasons given above for claims 1, 3, and 4.
As per claim 19, Shelton teaches:
The method according to claim 16, wherein initiating the control instruction comprises displaying the control configuration as a prompt requesting a confirmation of the proposed control configuration. (see [0591] discloses, “A surgical hub and/or a secondary display may be used to configure a medical instrument. For example, a first medical instrument, such as an endo cutter, may fail and may be replaced with a second medical instrument which may be a new medical instrument. The surgical hub and/or medical instrument may receive an instruction from a user, such as a surgeon, to use the configuration and setup from the first medical instrument that failed and apply it to the second medical instrument. The surgical hub and/or secondary display may then send one or more instructions to the second medical instrument to provide medical instrument with the configuration and setup from the first medical instrument.” And see [0235] discloses, “The surgical hub 5104 can receive this data from the paired modular devices 5102 and other data sources 5126 and continually derive inferences ( i.e. , contextual information ) about the ongoing procedure as new data is received , such as which step of the procedure is being performed at any given time . The situ ational awareness system of the surgical hub 5104 can be able to , for example , record data pertaining to the procedure for generating reports , verify the steps being taken by the medical personnel , provide data or prompts ( e.g. , via a display screen ) that may be pertinent for the particular procedural step , adjust modular devices 5102 based on the context ( e.g. , activate monitors , adjust the FOV of the medical imaging device , or change the energy level of an ultrasonic surgical instrument or RF electrosurgical instru ment ) , and take any other such action described herein.” And see ([0647] discloses, “At 30500, it may be determined that a medical instrument may be sent to a back table to be used for a surgical task such as being reloaded, being cleaned, being reconfigured, and the like. The surgical hub and/or the medical instrument may instruct a display of the medical instrument according to the surgical task. The display of the medical instrument may be instructed to display data and/or instructions for or associated to the surgical task. For example, it may be determined that the medical instrument may need to be reloaded, it may be determined that the medical instrument is at a back table, and the display of the medical instrument may be instructed to display instructions for reloading the medical instrument. The medical instrument may be instructed to enter a reload mode. As another example, it may be determined that the medical instrument may need to be cleaned, it may be determined that the medical instrument is at a back table, and the display of the medical instrument may be instructed to display instructions for cleaning the medical instrument. The medical instrument may be instructed to enter a cleaning mode. As another example, it may be determined that the medical instrument may not be used for a further surgical task during a surgical procedure, it may be determined that the medical instrument may is at a back table, and the display of the medical instrument may be instructed to tum off. The medical instrument may be instructed to enter a power off mode.” And see [0648] discloses, “At the hack table, a user may view the instructions that are being displayed to perform a surgical task ( e.g. the current surgical task) for the medical instrument. For example, the medical instrument may need to be cleaned and/or reloaded, and the user may use the displayed instructions to clean and/or reload the medical instrument.”)
As per claim 20, Shelton teaches:
The method according to claim 19, further comprising: wherein initiating the control instruction further comprises mapping an input of a user interface of an active surgical device of the plurality of surgical devices or the camera apparatus, wherein the input of the user interface is mapped to receive a confirmation of the proposed control configuration in response to an activation of the input. ([0615] discloses, “As disclosed herein, cameras within the OR may be used such that the motions/actions of a user may be monitored and tracked. Sensors on the user or associated with the user may help with identification as well. The cameras may be used to identify the user. The cameras may be used to identify the instrument that is being controlled by the user. If present the camera within the patient (e.g., laparoscope, etc.) may be used to provide additional confirmation. Displays on the instrument or controlled through the instrument, which may be secondary displays, may prioritize the information to be shared with the surgeon based on the situational awareness of the procedure ( e.g., mode of operation of the device, status of the device, etc.).” and see [0623] discloses, “For example, the spatial awareness of the surgical hub may display data on a primary display, may display data on a secondary display, and/or may move data between the primary display and secondary display based on at least one of a detection of an instrument, a mapping of the operating room, a detection of a user, a change in a location of the surgical hub, a disconnection of an instrument, and the like.” And see [0647]-[0648])
As per claim 21, Shelton teaches:
The method according to claim 19, wherein in response to the input to the user interface associated with the confirmation, the user interface communicates the confirmation of the proposed control configuration to the communication bus. (see Fig. 21 and see e.g. [0702] discloses, “The display of the medical instrument may be reconfigured to indicate that a user feedback has been received. For example, the display of a medical device may highlight a parameter that may have been changed by user to indicate to the user that the parameter may have been changed. As another example, the display of the medical instrument may highlight a parameter that may have been changed by the user but may result in a surgical error to warn the user that the surgical error may occur. As another example, the display of the medical instrument may change the data that may be displayed as the feedback from the user may indicate that the user may prefer to view different data.” And see [0716] Communication between a primary screen, a secondary screen, and/or a surgical hub may occur. This communication may assist in determining where data, such as primary data, may be displayed. For example, a surgical hub may determine that a visual focus of a user indicates that the user is looking at a primary display. The surgical hub may then send a first instruction to the primary display to display data. The surgical hub may then then send a second instruction to a secondary display to cease displaying data, to remove data, or display another data. The surgical hub may send one or more messages to cause data that is being displayed on a primary display to be displayed on a secondary display. The surgical hub may send one or more messages to cause data that is being displayed on a secondary display to be displayed on a primary display.” And see [0615] and [0647]-[0648] / examiner notes that under BRI one of ordinary skill would understand that the hub and medical devices as well as display are communicating the information input by a user such as correction of an error or movement which may cause an error for example)
As per claim 22, Shelton teaches:
A surgical control system for a plurality of surgical devices comprising: ([0032] discloses, “FIG . 3 is a surgical hub paired with a visualization system , a robotic system , and an intelligent instrument , in accordance with at least one aspect of the present disclosure” and see [0254] discloses, “FIG. 13 illustrates a block diagram of a computer implemented adaptive surgical system 9060 that is configured to adaptively generate control program updates for modular devices 9050, in accordance with at least one aspect of the present disclosure. In some exemplifications, the surgical system may include a surgical hub 9000, multiple modular devices 9050 communicably coupled to the surgical hub 9000, and an analytics system 9100 communicably coupled to the surgical hub 9000. Although a single surgical hub 9000 may be depicted, it should be noted that the surgical system 9060 can include any number of surgical hubs 9000, which can be connected to form a network of surgical hubs 9000 that are communicably coupled to the analytics system 9100. In some exemplifications, the surgical hub 9000 may include a processor 9010 coupled to a memory 9020 for executing instructions stored thereon and a data relay interface 9030 through which data is transmitted to the analytics system 9100.”)
a plurality of device controllers in communication with each of the plurality of surgical devices via a communication bus, ([0418] discloses, “Multiple surgical instrument controllers and multiple surgical instruments can be used concurrently in an operating room. Pressing or activating the wrong surgical instrument controller can lead to undesirable consequences. Aspects of the present disclosure present a solution in which the surgical hub 106 coordinates the pairing of surgical instrument controllers and surgical instruments to ensure patient and operator safety.” And see [0147] discloses, “In one example, as illustrated in FIG. 1, the surgical system 102 includes a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112, which are configured to communicate with one another and/or the hub 106. In some aspects, a surgical system 102 may include an M number of hubs 106, an N number of visualization systems 108, an O number of robotic systems 110, and a P number of handheld intelligent surgical instruments 112, where M, N, 0, and P may be integers greater than or equal to one.” And see [0507] discloses, “In various instances, the processor of a robotic surgical system and/or the surgical hub 13380, 13382, for example, may be progrannned with pre-approved functions of the robotic surgical system.” ([0161] discloses, “Referring now to FIG. 3, a hub 106 is depicted in communication with a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112. The hub 106 includes a hub display 135, an imaging module 138, a generator module 140, a communication module 130, a processor module 132, a storage array 134, and an operating-room mapping module 133…[…]…In addition, the modular surgical enclosure also includes a communication bus between the first docking port and the second docking port, configured to facilitate communication between the first energy-generator module and the second energy-generator module. Referring to FIG. 3, aspects of the present disclosure are presented for a hub modular enclosure 136 that allows the modular integration of a generator module 140, a smoke evacuation module 126, and a suction/irrigation module 128. The hub modular enclosure 136 further facilitates interactive communication between the modules 140, 126, 128. The generator module 140 can be a generator module with integrated monopolar, bipolar, and ultrasonic components supported in a single housing unit slidably insertable into the hub modular enclosure 136. The generator module 140 can be configured to connect to a monopolar device 142, a bipolar device 144, and an ultrasonic device 146. Alternatively, the generator module 140 may comprise a series of monopolar, bipolar, and/or ultrasonic generator modules that interact through the hub modular enclosure 136. The hub modular enclosure 136 can be configured to facilitate the insertion of multiple generators and interactive communication between the generators docked into the hub modular enclosure 136 so that the generators would act as a single generator.”)
wherein each of the device controllers independently reports the device data from one of the plurality of surgical devices and monitors the device data communicated as messages from each of the plurality of surgical devices ([0242] discloses, “Moreover, the processors 7008 can execute the data analytics modules 7034 independently or in conjunction with hub applications independently executed by the hubs 7006. The central servers 7013 also may comprise aggregated medical data databases 2212, which can reside in the memory 2210.” And see [0276] During a surgical procedure, the surgical site may be displayed on a remote surgical hub display. The remote surgical hub display may be referred to as a primary display. During a surgical procedure, surgical devices may track and record surgical data and variables (e.g., surgical parameters) that may be stored in the instrument (see FIGS. 1-13 for instrument architectures comprising processors, memory, control circuits, storage, and the like).”)
wherein the device data is indicative of at least one of a control state and a detected condition associated with the operation of each of the plurality of surgical devices; ([0375] discloses, “In some aspects, once a failure event associated with a surgical procedure has been identified, the surgical hub 206 and/or the cloud-based system 205 can subsequently flag or tag a surgical device/instrument 235 which was utilized during the surgical procedure for inoperability and/or removal. For example, in one aspect, information (e.g., serial number, ID) associated with the surgical device/ instrument 235 and stored at the surgical hub 206 and/or the cloud-based system 205 can be utilized to effectively block the surgical device/instrument 235 from being used again ( e.g., blacklisted). In another aspect, information ( e.g., serial number, ID) associated with the surgical device/instrument can initiate the printing of a shipping slip and shipping instructions to returning the surgical device/instrument 235 back to a manufacturer or other designated party so that a thorough analysis/inspection of the surgical device/instrument 235 can be performed ( e.g., to determine the cause of the failure). According to various aspects described herein, once the cause of a failure is determined (e.g., via the surgical hub 206 and/or the cloud-based system 205), the surgical hub 206 may download a program from the cloudbased system 205 for execution by the surgical device/ instrument 235 that corrects the determined cause of the failure (i.e., program that alters surgical device/instrument parameters to prevent the failure from occurring again).” And see [0376] discloses, “In some aspects, the primary display and/or the secondary display may be used to provide or display a notification that an operation error has occurred. For example, when a failure event associated with a surgical procedure has been identified, the surgical hub 206 and/or the cloud -based system 205 may send an error message to be displayed on one or more primary displays and/or secondary displays. The error message may indicate to a user that a failure event has occurred, may indicate instructions for correcting the error, may indicate recommendations for correcting the error, may indicate instructions that may alter the surgical procedure, and the like. For example, an error message on the primary display may provide instruction to a surgical error that may have occurred to a patient due to the failure event. As another example, an error message on a secondary display may provide instructions to a user on how to clear a misfired staple and reload a staple cartridge.” And also see [0377] and see [0511] discloses, “Further, the computer system can be programmed to provide notifications or prompts that indicate when the surgical staff is deviating from the baseline so that the surgical staff can alter their actions and optimize their performance or technique. In some aspects, the notifications can include warnings that the surgical staff is not utilizing proper technique (which can further include recommendations on corrective actions that the surgical staff can take to address their technique), suggestions for alternative surgical products, statistics regarding correlations between procedural variables ( e.g., time taken to complete the procedure) and the monitored physical characteristics of the surgical staff, comparisons between surgeons, and so on. In various aspects, the notifications or recommendations can be provided either in real time (e.g., in the OR during the surgical procedure) or in a post-procedure report.” And see [0537] Accordingly, the processor 244 controls 211606 a surgical device that is paired with the surgical hub 211801 in a manner that depends upon the particular determined characteristic or condition. For example, if the processor 244 determines 211604 that a surgical staff member 211803 is making a "change instrument mode" gesture, then the processor 244 can transmit a signal to or otherwise control 211606 a particular surgical instrument 211810 (or its associated generator) connected to the surgical hub 211801 to change the operational mode of the surgical instrument 211810 (e.g., change an electrosurgical surgical instrument)”)
a camera apparatus in communication with the plurality of surgical devices via the communication bus, the camera apparatus comprising at least one controller configured to ([0512] discloses, “FIG. 59 is a diagram of an illustrative OR setup, in accordance with at least one aspect of the present disclosure. In various implementations, the surgical hub 211801 can be connected to various one or more cameras 211802, surgical instruments 211810, displays 211806, and other surgical devices within the OR 211800 via a communications protocol ( e.g., Bluetooth), as described above under the heading SURGICAL HUBS.”)
capture image data demonstrating a surgical site and identify a surgery status of the surgical site in response to the image data, wherein the surgery status is reported by the camera apparatus over the communication bus; ([0650] discloses, “The surgical hub may instruct a first medical instrument to reconfigure its display to display data from a second medical instrument. The surgical hub may determine that the first medical instrument is being used in-situ along with the second medical instrument. The first medical instrument may be instructed to reconfigure its display to show a video and/or image from the second medical instrument. For example, the first medical instrument may be instructed to reconfigure its display to show a video of the surgical site taken from a camera of the second medical instrument. As another example, the first medical instrument may be instructed to reconfigure its display to show an image of the surgical site that may be overlaid with additional data. The image of the surgical site and/or the additional data may come from second medical instrument.” And see e.g.s [0515]-[0518]) and see [0518] discloses, “Further, the feedback can include suggestions that trocar port placements be shifted, that a surgical instrument be moved from one trocar port to another port, that the positioning of the patient being operated on be adjusted (e.g., situated at an increased table angle or rolled), and other such suggestions to improve access to the surgical site and minimize non-ideal surgical technique exhibited by the surgical staff.”)
and wherein each of the device controllers independently identifies a control configuration for at least one of the surgical devices based on the at least one of the device data and the surgery status; and initiates a control instruction configured to automatically activate the control configuration of the at least one of the plurality of surgical devices. (see fig. 74 and see [0502] discloses, “The interactive secondary displays 13362, 13364 permit the clinician to step away from the remote command console 13370 and into the sterile field while maintaining control of the robot 13372. For example, the interactive secondary displays 13362, 13364 allow the clinician to maintain cooperative and/or coordinated control over the powered handheld surgical instruments) 13366 and the robotic surgical system at the same time. In various instances, information is communicated between the robotic surgical system, one or more powered handheld surgical instruments 13366, surgical hubs 13380, 13382, and the interactive secondary displays 13362, 13364. Such information may include, for example, the images on the display of the robotic surgical system and/or the powered handheld surgical instruments, a parameter of the robotic surgical system and/or the powered handheld surgical instruments, and/or a control command for the robotic surgical system and/or the powered handheld surgical instruments. [0503] In various instances, the control unit of the robotic surgical system (e.g. the control unit 13113 of the robotic surgical system 13110) is configured to communicate at least one display element from the surgeon's command console (e.g. the console 13116) to an interactive secondary display (e g. the display 13130). In other words, a portion of the display at the surgeon's console is replicated on the display of the interactive secondary display, integrating the robot display with the interactive secondary display. The replication of the robot display on to the display of the interactive secondary display allows the clinician to step away from the remote command console without losing the the visual image that is displayed there. For example, at least one of the interactive secondary displays 13362, 13364 can display information from the robot, such as information from the robot display and/or the surgeon s command console 13370. [0504] In various instances, the interactive secondary displays 13362, 13364 are configured to control and/or adjust at least one operating parameter of the robotic surgical system. Such control can occur automatically and/or in response to a clinician input.” And see [0256] discloses, “The surgical hub 9000 can transmit the associated modular device 9050 data and outcome data to the analytics system 9100 for processing thereon. By transmitting both the perioperative data indicating how the modular devices 9050 are controlled and the procedural outcome data, the analytics system 9100 can correlate the different manners of controlling the modular devices 9050 with surgical outcomes for the particular procedure type.” And see [0531] In one aspect, the computer system ( e.g., a surgical hub 211801) can be configured to allow surgical staff members to compare their technique to themselves, rather than to the baselines established by the sampled population or pre-programmed into the computer system. In other words, the baseline against which the computer system compares a surgical staff member can be the surgical staff member's prior performance in a particular surgical procedure type or a prior instance of utilizing a particular type of surgical instrument. Such aspects can be useful to allow surgeons to track improvements in their surgical techniques or document trial periods for new surgical products.” And see [0533] discloses, “In one aspect, the computer system ( e.g., a surgical hub 211801) can be configured to analyze trends in surgical device usage as surgeons become more experienced in performing particular surgical procedures ( or performing surgical procedures generally) or using new surgical instruments. For example, the computer system could identify motions, behaviors, and other physical characteristics that change dramatically as the surgeons become more experienced. Accordingly, the computer system can recognize when a surgeon is exhibiting suboptimal techniques early in the surgeon's learning curve and can provide recommendations about the optimal approach, prior to the suboptimal technique becoming ingrained in the surgeon.” And see [0537] discloses, e.g. “As yet another example, if the processor 244 determines 211604 that a surgical instrument 211810 is at a particular orientation when being (or as it is about to be) fired, the processor 244 can transmit a signal to or otherwise control 211606 the surgical instrument 211810 to modify the operational parameters of the surgical instrument 211810 (e.g., force to fire or maximum permitted articulation angle) accordingly. This would allow the surgical hub 211801 to control the functions of the surgical instruments 211810 to account for differences in placements and orientations of the surgical instruments 211810.” )
As per claim 23, Shelton teaches:
The surgical control system according to claim 1, wherein the automatic activation of the control configuration is preapproved within a predetermined operating range. ([0369] discloses, “For example, in one aspect, referring to FIG. 5, the surgical device/instrument 235 may comprise an end effector, including a temperature sensor and the surgical hub 206, and/or the cloud-based system may compare at least one temperature detected by the temperature sensor (e.g., during a tissue-sealing portion of a surgical procedure) to a stored temperature and/or a range of temperatures expected and/or associated with that surgical procedure to detect an inadequate/low sealing temperature….[…]…According to the various aspects described herein, in response to the detected and/or identified failure event, the surgical hub 206 may download a program from the cloud-based system 205 for execution by the surgical device/instrument 235 that corrects the detected issue (e.g., program that alters surgical device/ instrument parameters to prevent misfired staples, program that alters surgical device/instrument parameters to ensure correct sealing temperature).”)
As per claim 24, Shelton teaches:
The surgical control system according to claim 23, wherein the automatic activation of the control instruction is presented on a user interface and is activated in response to a confirmation received via the user interface confirming the initiation of the control instruction. (see [0503]-[0508] and see [0517] discloses, “Accordingly, the processor 244 evaluates 211010 the determined physical characteristic of the surgical staff member to a baseline. In one aspect, the baseline can correspond to the surgical context determined via situational awareness. The processor 244 can retrieve the baselines for various physical characteristics from a memory (e.g., the memory 249 illustrated in FIG. 6) according to the given surgical context, for example. The baseline can include values or ranges of values for particular physical characteristics to be tracked during particular surgical contexts. The types of physical characteristics evaluated in different surgical contexts can be the same or unique to each particular surgical context.” And see [0518] discloses, “In one aspect, the processor 244 can provide feedback to the surgical staff members in real time during the surgical procedure. The real-time feedback can include a graphical notification or recommendation displayed on a display 211806 within the OR 211800, audio feedback emitted by the surgical hub 211801 or a surgical instrument 211810, and so on. Further, the feedback can include suggestions that trocar port placements be shifted, that a sur-gical instrument be moved from one trocar port to another port, that the positioning of the patient being operated on be adjusted (e.g., situated at an increased table angle or rolled), and other such suggestions to improve access to the surgical site and minimize non-ideal surgical technique exhibited by the surgical staff. In another aspect, the processor 244 can provide postoperative feedback to the surgical staff members. The postoperative feedback can include graphical overlays or notifications displayed on the captured video of the procedure that can be reviewed by the surgical staff for learning purposes, a post-surgery report indicating times or particular surgical steps where the surgical staff deviated from the baselines, and so on. Any visually identifiable physical characteristic (or combination of physical characteristics; can be utilized as the basis for suggesting improvements in the technique exhibited by the surgical staff.” / examiner notes the disclosure teaches that a user interface is displayed that gives surgeon ability for confirmation of use of the robotic surgery arm with examples of scenarios where messages and notifications are given on a display)
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 25-26 are rejected to under 35 U.S.C. 103 as being unpatentable over Shelton , IV et. al (hereinafter Shelton) (US20220104910Al) in view of Hamel et. al (hereinafter Hamel) (US20110237880A1)
As per claim 25, Shelton does not teach:
The surgical control system according to claim 22, wherein the intraoperative surgery status is identified as a decreased visibility condition resulting from the introduction of blood in the image data, wherein the surgery status is identified based on a blood metric and a visibility metric that are independently tracked.
However, Hamel does teach:
The surgical control system according to claim 22, wherein the intraoperative surgery status is identified as a decreased visibility condition resulting from the introduction of blood in the image data, wherein the surgery status is identified based on a blood metric and a visibility metric that are independently tracked.([0074] discloses, “At step 212, depending on the video signatures matched, the system controller 34 selectively controls the outflow pressure and/or flow rate through the suction tubing 52, 57. The outflow pressure/flow rate control is dependent in part on the input pressure/flow rate values, and the type of identifiers. For example, in the case of a quantity of increasing blood areas detected by a video signature and provided with an identifier at step 154 as shown in FIG.4, the inflow/outflow and pressure values can be operated in a manner to flush blood from the surgical site 80 in a timely and effective manner. In Some embodiments, pulsing of irrigation fluid entering a Surgical site 80 removes the blood and provides a quality video image. The position of the stop cock 55 of the cannula 54 or the valve of wall suction unit 56 can automatically be adjusted by controller 34 to maximize the video image.” And see [0008] discloses, “If, during a period of 10 frames, the score sum is >30,000, blood is considered present, and if the score sum is >70,000, much blood is considered present.” And see [0052] discloses, “The image analysis subroutine 92 shown in FIG. 4 operates as follows. The subroutine 92 begins at start 148 and advances to process video image signals step 150 to obtain Video signature information from received video images. At step 150, the system controller 34 may conduct a plurality of Subcalculations or signature identification type operations on a video image, including comparisons with a sequence of previously stored video images. 0053 Image analysis subroutine 92 then advances to iden tify fast dispersion areas step 152. At step 152, processed Video signals are compared with previously received and stored processed video signals to identify the presence of Video signatures for fast dispersion red areas (bleeders) within Subsequent video images whereat blood is spreading at at least a predetermined minimum rate. If a bleeder is occur ring, the subroutine 92 advances to store identifier (ID) step 154. At step 154, the system controller 34 then stores an identifier or identification code identifying the presence of a bleeder in the video images for later control purposes.” And see [0056] and see [0065] and [0067])
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Shelton’s teachings of a surgical system as previously cited with Hamel’s teachings of utilizing a surgical pump to improve visibility of sites as previously cited, the motivation being Shelton teaches the concern of imaging systems having unrecognizable intraoperative space in relation to imaging and scopes which include pumps (e.g. see [0007]) thus it would be obvious to improve the imaging field with utilizing a surgical pump system for natural occurrences such as blood in the field of vision for a surgeon operating to improve the overall outcome for a patient.
As per claim 26, Shelton does not teach:
The surgical control system according to claim 25, wherein the plurality of surgical devices comprise a surgical pump and the plurality of device controllers comprise a pump controller, wherein in response to the blood in the image data, the pump controller identifies the control configuration adjusting at least one of an inflow setting or an outflow setting increasing a fluid pressure at the surgical site, wherein the control configuration differs based on the blood metric even when the visibility metric identifies similar visibility results.
However, Hamel teaches:
The surgical control system according to claim 25, wherein the plurality of surgical devices comprise a surgical pump and the plurality of device controllers comprise a pump controller, wherein in response to the blood in the image data, the pump controller identifies the control configuration adjusting at least one of an inflow setting or an outflow setting increasing a fluid pressure at the surgical site, wherein the control configuration differs based on the blood metric even when the visibility metric identifies similar visibility results. ([0041] discloses, “While pump system 50 is shown in FIG. 2 as having one Suction input and one irrigation output, it is contemplated that the pump system may have a plurality of Suction inputs. Wall suction unit 56 with valve control can connect to the Suction tubing 52 as well as other tubing, so that the pump system 50 only comprises an irrigation pump. A portable pump system for providing irrigation is also contemplated.” And see [0074] discloses, “At step 212, depending on the video signatures matched, the system controller 34 selectively controls the outflow pressure and/or flow rate through the suction tubing 52, 57. The outflow pressure/flow rate control is dependent in part on the input pressure/flow rate values, and the type of identifiers. For example, in the case of a quantity of increasing blood areas detected by a video signature and provided with an identifier at step 154 as shown in FIG.4, the inflow/outflow and pressure values can be operated in a manner to flush blood from the surgical site 80 in a timely and effective manner. In Some embodiments, pulsing of irrigation fluid entering a Surgical site 80 removes the blood and provides a quality video image. The position of the stop cock 55 of the cannula 54 or the valve of wall suction unit 56 can automatically be adjusted by controller 34 to maximize the video image.” And see [0100] discloses, “The order of steps 152,234,168 in subroutine 233 is provided for purposes of illustration only. The steps can be performed in any order, or essentially simultaneously.” And see [0101] discloses, “In the laparoscopic Surgical system, the signature match adjustment Subroutine therefore is similar to the sig nature match adjustment subroutine 106 shown in FIG. 6. A main difference is that the control of pressure steps 210, 212 are limited. In the laparoscopic Surgical system, in the event that Smoke is detected by the video images from the Surgical site, the Suction/irrigation tool 228 can automatically operate to remove smoke with the wall suction unit 56 via tubing 230. At the same time, the insufflator unit 224 provides additional gas via the handpiece 66 to the surgical site 80 for preventing the peritoneal cavity from collapsing. Further, power to the electrode 232 of an electrocautery device can be reduced or interrupted, if necessary, to limit the production of additional Smoke. 0102. With respect to both arthroscopic and laparoscopic Surgical systems, the cause of bleeding is less certain than other conditions resulting in degraded image quality. There fore, in some embodiments, when a bleeder is detected and none of the tool devices are operating, the system controller 34 determines the tool device or devices that were most recently operated. The system controller 34 can utilize this information to assist in determining what operations of fluid input/output, fluid pressure, or even which of plural fluid input/output devices to select for removing the bleeder from the video image.”)
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Shelton’s teachings with Hamel’s teachings for the same reasons given above for claim 25.
Response to Arguments Regarding 35 U.S.C 101 Rejection
Applicant's arguments on pages 1-3 of the remarks have been fully considered but they are not persuasive. Applicant argues Claims 1-4, 6-8, 11-14, 16-22, and 23-25 are rejected under 35 U.S.C. § 101 as allegedly not being directed to eligible subject matter. Applicant respectfully traverses this rejection. Claim 1 as amended recites specific technical elements, including a plurality of device controllers in communication with surgical devices via a communication bus and a camera apparatus configured to perform specific technical operations. The camera apparatus is configured to: capture image data demonstrating a surgical site; process the image data; identify an intraoperative surgery status of the surgical site in response to the image data; generate aggregate data comprising the intraoperative surgery status and device data indicative of an active control state in a packet; and communicate the aggregate data over the communication bus. Claim 1 further recites that each device controller independently identifies a control configuration and initiates a control instruction to automatically activate the control configuration of one or more of the plurality of surgical devices. This is not an abstract idea but rather a specific technical architecture for distributed surgical device control. For the sake of argument, if claim 1 is still considered abstract, the claim integrates any such exception into a practical application. First, the claim improves the functioning of surgical control technology by enabling real-time, distributed control of multiple surgical devices based on an intraoperative surgery status identified from image data combined with active control state data. The specification discloses that this architecture provides "improved operation of a variety of interconnected surgical or medical devices via a distributed control platform." As-Filed Specification, paragraph [0003]. Second, the claim implements the judicial exception with particular machines-a camera apparatus, device controllers, and surgical devices-that are integral to the claim, not merely generic computers. The camera apparatus is specifically configured to capture image data of a surgical site, identify an intraoperative surgery status, and generate aggregate data for broadcast over a communication bus. The device controllers independently identify control configurations and initiate control instructions to automatically activate those configurations. These are not generic computer functions but specific technical operations tied to surgical device control. Claim 16 as amended recites a method tied to specific technical operations including broadcasting device data indicative of an active control state, capturing image data with a camera apparatus, identifying a surgery status, generating aggregate data, and identifying a control configuration "wherein the control configuration is an intraoperative configuration of the at least one of the surgical devices." The recitation of an "intraoperative configuration" demonstrates that the control configuration is a real-time technical configuration of physical surgical equipment not abstract data management. This method improves surgical control technology by enabling coordinated, real-time device control based on image data and active control states. Claim 22 as amended recites device controllers that independently identify control configurations based on device data indicative of an active control state and an intraoperative surgery status identified from image data, and initiate control instructions to automatically activate control configurations of surgical devices. This distributed control architecture-where multiple device controllers independently respond to aggregate data comprising an intraoperative surgery status and active control state data-is a specific technical improvement to surgical control systems, not an abstract idea. MPEP § 2106.04(d) provides that a claim integrates a judicial exception into a practical application when it "improves the functioning of a computer or improves another technology or technical field." The amended claims recite specific technical improvements to surgical control systems by enabling distributed, real-time control of surgical devices based on intraoperative surgery status and active control state data. The claims are not directed to managing personal behavior but to a specific technical system for automated surgical device control with limited scope tied to the particular technical architecture recited. For at least the foregoing reasons, Applicant respectfully submits that claims 1-4, 6-8, 11- 14, 16-22, and 23-25 are patent eligible under 35 U.S.C. § 101, and withdrawal of the rejection is respectfully requested. Applicant notes that the Examiner has already found claim 26 to be subject matter eligible. See Office Action, page 4.
Examiner appreciates applicant’s arguments but does not find them persuasive. The claimed invention is directed to a certain method of organizing human activity enumerated subgrouping “following rules or instructions” (See MPEP § 2106.04(a)(2)) as the claimed invention recites managing personal behavior on how to operate during a surgical procedure based on data. Mere automation of an otherwise human activity even when executed by a generic surgical device as claimed where the specification defines these generic surgical devices where they are not limited but could be for e.g. a patient monitor or video console (see e.g. instant application specification [0026]) where controlling this device by means of configuration could simply be displaying information does not make the claims dispositive of being directed to an abstract idea. Rather, a computer based device can aid in the steps taken and the claims still be directed to an abstract idea if the computer environment is simply applied to more efficiently solve a problem which is not based on the computer environment itself but rather the abstract environment of prompting a human to behave in a certain manner when utilizing tools to follow certain instructions to perform a procedure at the broad level in which it is currently positively recited. On the contrary, it is not what WOULD be undertaken by a human but it is rather is it reasonable for someone of ordinary skill to follow rules and instructions to execute the steps as positively claimed to come to the end claimed result or output.
Furthermore, while additional elements such as e.g. a camera apparatus and the device controllers are positively claimed at their current broad level do not integrate the abstract idea into a practical application as they are applied therefore “apply-it” to gather and output data and as aforementioned mere controlling of a monitor to prompt or display information merely automated where a human would otherwise behave to perform a procedure with tools by mere exchange of this information when managing personal behavior is not enough to integrate in this case the abstract idea into a practical application and thus does not provide significantly more when claim construction of the claims as a whole is considered. The independent claims as positively recited are improvement to the abstract idea. If applicant’s line of reasoning were correct Alice Corp. would have been subject matter eligible. Furthermore, examiner notes claim 26 is eligible as the device itself is limited to a confined surgical device which is controlled to practically and affirmatively control and apply flow changes producing a tangible result and moves past merely a generic computer operation which could be executed by a human and merely prompting a user of adjustment.
Therefore, for the claims argued the 35 U.S.C 101 rejection is maintained for all claims aforementioned ineligible.
Response to Arguments Regarding 35 U.S.C § 102/103 Rejections
Applicant argues on pages 3-7 of the remarks applicant argues Rejection to Claims 1-4, 6-8, 11-14, 16-22, and 23-24 Claims 1-4, 6-8, 11-14, 16-22, and 23-24 are rejected under 35 U.S.C. §102(a)(2) as being anticipated by U.S. Patent Application Publication No. 2022/0104910 Al to Shelton, IV et al. (hereinafter "Shelton"). Office Action, page 8. Applicant respectfully traverses this rejection."A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference." Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987).Claim 1 as amended recites device data comprising messages indicative of "an active control state" associated with the operation of each of the plurality of surgical devices. The specification discloses that "[t]he control state may be an active control state associated with the current operation of the surgical device." As-Filed Specification, paragraph [0028]. Claim 1 as amended further recites that the camera apparatus is configured to "identify an intraoperative surgery status of the surgical site in response to the image data" and "generate aggregate data comprising the intraoperative surgery status and the device data in a packet communicated over the communication bus." The specification supports this feature, disclosing that the surgery status corresponds to the current state of the surgical site during the surgical procedure. See As- Filed Specification, paragraph [0030]. Claim 1 as amended also recites that "each of the plurality of device controllers independently identifies the control configuration and controls the operation of the plurality of surgical devices in response to a control instruction."
Shelton's cloud-based data aggregation relates to historical and outcome data for analytics purposes, not active control states during current operation or an intraoperative surgery status identified from image data for real-time device control. See Shelton, paragraph [0243] (describing aggregation of data "from specific data generated by various surgical instruments" for cloud-based analytics). In contrast, claim 1 as amended recites device data indicative of "an active control state" that reflects the current operation of the surgical devices, combined with an "intraoperative surgery status" identified from image data captured by a camera apparatus. The specification provides a non-limiting example of this claimed feature, disclosing that "the device data 42 may also be combined with the surgery status or image-based status information into aggregate data 44 by the system controller 24 of the video console 12a" and that "the device controllers 16 of the surgical devices 12 may monitor and respond by adjusting one or more settings accordingly to the vision-based condition associated with the surgery status reported in the aggregate data." As-Filed Specification, paragraphs [0033], [0029]. This claimed architecture-where a camera apparatus generates and broadcasts aggregate data comprising an intraoperative surgery status identified from image data combined with active control state data for independent device control-is fundamentally different from Shelton's cloud-based aggregation of historic data. Accordingly, Shelton does not disclose "aggregate data comprising the intraoperative surgery status and the device data" where the device data is indicative of "an active control state" and the intraoperative surgery status is identified from image data captured by a camera apparatus and broadcast over a communication bus to device controllers that independently identify control configurations, as recited by claim 1 as amended.
Claim 16 as amended recites "broadcasting device data comprising messages indicative of an active control state associated with the operation of each of the plurality of surgical devices" and "identifying a control configuration for at least one of the surgical devices based on the aggregate data, wherein the control configuration is an intraoperative configuration of the at least one of the surgical devices." The recitation of an "active control state" and an "intraoperative configuration" distinguishes the claimed method from Shelton's disclosure of cloud-based analytics that processes historical outcome data rather than active control states for real-time intraoperative device configuration. For reasons similar to those discussed above, Shelton does not disclose aggregate data comprising a surgery status identified from image data combined with device data indicative of an active control state, where the aggregate data is broadcast over a communication bus and used to identify an intraoperative configuration for independent device control, as recited by claim 16 as amended.
Claim 22 as amended that it recites that the device data is indicative of "an active control state" and that the camera apparatus is configured to "identify an intraoperative surgery status of the surgical site in response to the image data." Claim 22 further recites that "each of the device controllers independently: identifies a control configuration for at least one of the surgical devices based on the at least one of the device data and the intraoperative surgery status; and initiates a control instruction configured to automatically activate the control configuration." The specification discloses that "the system controller of the camera apparatus may access and generate aggregate data in a packet. Each packet of aggregate data may comprise the surgery status, the device data, and various control or status data associated with the plurality of surgical devices." As-Filed Specification, paragraph [0005]. Shelton does not disclose a camera apparatus that identifies an intraoperative surgery status from image data, where device controllers independently identify control configurations based on device data indicative of an active control state and the intraoperative surgery status, as recited by claim 22 as amended. Claims 2-4, 6-8, 11-14, 17-21, and 23-24 depend from claims 1, 16, or 22 and are allowable for at least the same reasons discussed above regarding the independent claims from which they depend. For at least the foregoing reasons, Applicant respectfully submits that claims 1-4, 6-8, 11-14, 16-22, and 23-24 are allowable over Shelton, and withdrawal of the rejection under 35 U.S.C. § 102(a)(2) is respectfully requested.
Examiner appreciates applicant’s argument but does not find it persuasive. Shelton teaches “the device controllers configured to communicate device data comprising messages indicative of an active control state associated with the operation of each of the plurality of surgical devices;” in atleast [0375] which discloses, “In some aspects, once a failure event associated with a surgical procedure has been identified, the surgical hub 206 and/or the cloud-based system 205 can subsequently flag or tag a surgical device/instrument 235 which was utilized during the surgical procedure for inoperability and/or removal. For example, in one aspect, information (e.g., serial number, ID) associated with the surgical device/ instrument 235 and stored at the surgical hub 206 and/or the cloud-based system 205 can be utilized to effectively block the surgical device/instrument 235 from being used again ( e.g., blacklisted). In another aspect, information ( e.g., serial number, ID) associated with the surgical device/instrument can initiate the printing of a shipping slip and shipping instructions to returning the surgical device/instrument 235 back to a manufacturer or other designated party so that a thorough analysis/inspection of the surgical device/instrument 235 can be performed ( e.g., to determine the cause of the failure). According to various aspects described herein, once the cause of a failure is determined (e.g., via the surgical hub 206 and/or the cloud-based system 205), the surgical hub 206 may download a program from the cloudbased system 205 for execution by the surgical device/ instrument 235 that corrects the determined cause of the failure (i.e., program that alters surgical device/instrument parameters to prevent the failure from occurring again).” And see [0376] discloses, “In some aspects, the primary display and/or the secondary display may be used to provide or display a notification that an operation error has occurred. For example, when a failure event associated with a surgical procedure has been identified, the surgical hub 206 and/or the cloud -based system 205 may send an error message to be displayed on one or more primary displays and/or secondary displays. The error message may indicate to a user that a failure event has occurred, may indicate instructions for correcting the error, may indicate recommendations for correcting the error, may indicate instructions that may alter the surgical procedure, and the like. For example, an error message on the primary display may provide instruction to a surgical error that may have occurred to a patient due to the failure event. As another example, an error message on a secondary display may provide instructions to a user on how to clear a misfired staple and reload a staple cartridge.” And also see [0377] and see [0511] discloses, “Further, the computer system can be programmed to provide notifications or prompts that indicate when the surgical staff is deviating from the baseline so that the surgical staff can alter their actions and optimize their performance or technique. In some aspects, the notifications can include warnings that the surgical staff is not utilizing proper technique (which can further include recommendations on corrective actions that the surgical staff can take to address their technique), suggestions for alternative surgical products, statistics regarding correlations between procedural variables ( e.g., time taken to complete the procedure) and the monitored physical characteristics of the surgical staff, comparisons between surgeons, and so on. In various aspects, the notifications or recommendations can be provided either in real time (e.g., in the OR during the surgical procedure) or in a post-procedure report.” And see [0537] Accordingly, the processor 244 controls 211606 a surgical device that is paired with the surgical hub 211801 in a manner that depends upon the particular determined characteristic or condition. For example, if the processor 244 determines 211604 that a surgical staff member 211803 is making a "change instrument mode" gesture, then the processor 244 can transmit a signal to or otherwise control 211606 a particular surgical instrument 211810 (or its associated generator) connected to the surgical hub 211801 to change the operational mode of the surgical instrument 211810 (e.g., change an electrosurgical surgical instrument)” thus examiner notes Shelton does disclose analyzing data and sending notifications comprising data such as recommendation in real time of surgical device operational mode for example or corrective actions for technique which is an active state of a surgical device by way of a surgeon using it as one of ordinary skill in the art would understand.
Further Shelton teaches “generate aggregate data comprising the intraoperative surgery status and the device data in a packet communicated over the communication bus;” in atleast [0243] which discloses, “Based on connections to various surgical hubs 7006 via the network 7001, the cloud 7004 can aggregate data from specific data generated by various surgical instruments 7012 and their corresponding hubs 7006. Such aggregated data may be stored within the aggregated medical databases 7011 of the cloud 7004. In particular, the cloud 7004 may advantageously perform data analysis and operations on the aggregated data to yield insights and/or perform functions that individual hubs 7006 could not achieve on their own. To this end, as shown in FIG. 11, the cloud 7004 and the surgical hubs 7006 are communicatively coupled to transmit and receive information. The I/O interface 7005 is connected to the plurality of surgical hubs 7006 via the network 7001. In this way, the I/O interface 7005 can be configured to transfer information between the surgical hubs 7006 and the aggregated medical data databases 7011. Accordingly, the I/O interlace 7005 may facilitate read/write operations of the cloud-based analytics system. Such read/ write operations may be executed in response to requests from hubs 7006. These requests could be transmitted to the hubs 7006 through the hub applications. The I/O interface 7005 may include one or more high speed data ports, which may include universal serial bus (USB) ports, IEEE 1394 ports, as well as Wi-Fi and Bluetooth I/O interfaces for connecting the cloud 7004 to hubs 7006. The hub application servers 7002 of the cloud 7004 may be configured to host and supply shared capabilities to software applications (e.g., hub applications) executed by surgical hubs 7006. For example, the hub application servers 7002 may manage requests made by the hub applications through the hubs 7006, control access to the aggregated medical data databases 7011, and perform load balancing. The data analytics modules 7034” and see [0248] discloses, “The patient outcome analysis module 7028 can analyze surgical outcomes associated with currently used operational parameters of surgical instruments 7012. The patient outcome analysis module 7028 may also analyze and assess other potential operational parameters, in this connection, the recommendations module 7030 could recommend using these other potential operational parameters based on yielding better surgical outcomes, such as better sealing or less bleeding. For example, the recommendations module 7030 could transmit recommendations to a surgical 7006 regarding when to use a particular cartridge for a corresponding stapling surgical instrument 7012. Thus, the cloud-based analytics system, while controlling for common variables, may be configured to analyze the large collection of raw data and to provide centralized recommendations over multiple healthcare facilities (advantageously determined based on aggregated data). For example, the cloudbased analytics system could analyze, evaluate, and/or aggregate data based on type of medical practice, type of patient, number of patients, geographic similarity between medical providers, which medical providers/facilities use similar types of instruments, etc., in a way that no single healthcare facility alone would be able to analyze independently. The control program updating module 7026 could be configured to implement various surgical instrument 7012 recommendations when corresponding control programs are updated. For example, the patient outcome analysis module 7028 could identify correlations linking specific control parameters with successful (or unsuccessful) results. Such correlations may be addressed when updated control programs are transmitted to surgical instruments 7012 via the control program updating module 7026. Updates to surgical instruments 7012 that may be transmitted via a corresponding hub 7006 may incorporate aggregated performance data that was gathered and analyzed by the data collection and aggregation module 7022 of the cloud 7004. Additionally, the patient outcome analysis module 7028 and recommendations module 7030 could identify improved methods of using surgical instruments 7012 based on aggregated performance data.” Thus the claim construction is interpreted as generating aggregate data which Shelton is doing which does comprise the interoperative surgery status such as performance data or operational parameters of the device data and communicates this over a communication bus. The claim does not limit at what time or when the data is transferred rather it limits to what type of data is transferred thus Shelton teaches the claim limitation further Shelton expands on the intraoperative data gathering and transferring of data in real time in [0511]. This same aforementioned argument applies to both claims 16 and 22 as they are similar in scope. Examiner maintains the 35 U.S.C . § 102 rejection.
Applicant further argues rejections to Claims 25-26. Claims 25-26 are rejected under 35 U.S.C. § 103 as being unpatentable over Shelton in view of U.S. Patent Application Publication No. 2011/0237880 Al to Hamel et al. (hereinafter "Hamel"). Office Action, page 49. Claims 25 and 26 depend from independent claim 22. As discussed above in response to the rejection under 35 U.S.C. § 102, claim 22 as amended recites that the camera apparatus is configured to "generate aggregate data comprising the surgery status and the device data in a packet communicated over the communication bus" and "communicate the aggregate data over the communication bus." Shelton does not disclose this feature, and Hamel does not remedy this deficiency. Accordingly, claims 25 and 26 are allowable for at least the same reasons as independent claim 22. Claim 25 as amended recites "wherein the surgery status is identified as a decreased visibility condition resulting from the introduction of blood in the image data, wherein the surgery status is identified based on a blood metric and a visibility metric that are independently tracked." The rejection alleges that Hamel discloses identifying "fast dispersion red areas (bleeders)." See Hamel, paragraph [0057]. However, Hamel does not disclose "a blood metric and a visibility metric that are independently tracked" as recited by claim 25 as amended. In contrast, the specification discloses that "the blood classifier 140 and the visibility metric 142 may be monitored by the vision module 60 independently, such that the surgical pump may vary the control settings associated with different events detected in the image data 26." As-Filed Specification, paragraph [0057]. Claim 26 as amended recites "wherein the control configuration differs based on the blood metric even when the visibility metric identifies similar visibility results." The specification discloses that "a low visibility associated with a visibility metric 142 may be communicated via the device network 14 to inform the pump controller 12c to increase a fluid exchange or rinse of the surgical site 28" and that "a blood-positive classification from the blood classifier 140 may indicate that the decreased visibility of the visibility metric 142 is associated with bleeding at the surgical site 28" such that "the increased fluid exchange should be accompanied by an increase in fluid pressure provided via the inflow to effectively tamponade the bleeding and clear the image data 26." As-Filed Specification, paragraph [0057]. Hamel does not disclose control configurations that differ based on a blood metric when visibility results are similar.
To reject a claim under 35 U.S.C. § 103, the Office must provide "a finding that the prior art included each element claimed, although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference." MPEP § 2143(A) (citing KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007)). Neither Shelton nor Hamel, alone or in combination, teaches or suggests "a blood metric and a visibility metric that are independently tracked" as recited by claim 25 as amended, or "the control configuration differs based on the blood metric even when the visibility metric identifies similar visibility results" as recited by claim 26 as amended. For at least the foregoing reasons, Applicant respectfully submits that claims 25 and 26 are allowable over Shelton in view of Hamel, and withdrawal of the rejection under 35 U.S.C. § 103 is respectfully requested.
Examiner appreciates applicant’s arguments but does not find them persuasive. Aforementioned arguments were given for claim 22. Further claims 25 and 26 Hamel teaches “The surgical control system according to claim 22, wherein the intraoperative surgery status is identified as a decreased visibility condition resulting from the introduction of blood in the image data, wherein the surgery status is identified based on a blood metric and a visibility metric that are independently tracked.” in atleast [0074] which discloses, “At step 212, depending on the video signatures matched, the system controller 34 selectively controls the outflow pressure and/or flow rate through the suction tubing 52, 57. The outflow pressure/flow rate control is dependent in part on the input pressure/flow rate values, and the type of identifiers. For example, in the case of a quantity of increasing blood areas detected by a video signature and provided with an identifier at step 154 as shown in FIG.4, the inflow/outflow and pressure values can be operated in a manner to flush blood from the surgical site 80 in a timely and effective manner. In Some embodiments, pulsing of irrigation fluid entering a Surgical site 80 removes the blood and provides a quality video image. The position of the stop cock 55 of the cannula 54 or the valve of wall suction unit 56 can automatically be adjusted by controller 34 to maximize the video image.” And see [0008] discloses, “If, during a period of 10 frames, the score sum is >30,000, blood is considered present, and if the score sum is >70,000, much blood is considered present.” And see [0052] discloses, “The image analysis subroutine 92 shown in FIG. 4 operates as follows. The subroutine 92 begins at start 148 and advances to process video image signals step 150 to obtain Video signature information from received video images. At step 150, the system controller 34 may conduct a plurality of Subcalculations or signature identification type operations on a video image, including comparisons with a sequence of previously stored video images. 0053 Image analysis subroutine 92 then advances to identify fast dispersion areas step 152. At step 152, processed Video signals are compared with previously received and stored processed video signals to identify the presence of Video signatures for fast dispersion red areas (bleeders) within Subsequent video images whereat blood is spreading at at least a predetermined minimum rate. If a bleeder is occur ring, the subroutine 92 advances to store identifier (ID) step 154. At step 154, the system controller 34 then stores an identifier or identification code identifying the presence of a bleeder in the video images for later control purposes.” And see [0056] and see [0065] and [0067]” Examiner notes the field is cleared due to decreased visibility by increasing or decreasing pressure of flow rate which results from blood in the surgical site. Further a scored sum metric of blood is tracked if considered present and then further a separate individual image analysis subroutine of sub calculations based on signature identifications is considered as independently tracked as the two calculations are separated.
Further Hamel teaches “The surgical control system according to claim 25, wherein the plurality of surgical devices comprise a surgical pump and the plurality of device controllers comprise a pump controller, wherein in response to the blood in the image data, the pump controller identifies the control configuration adjusting at least one of an inflow setting or an outflow setting increasing a fluid pressure at the surgical site, wherein the control configuration differs based on the blood metric even when the visibility metric identifies similar visibility results.” In atleast [0041] which discloses, “While pump system 50 is shown in FIG. 2 as having one Suction input and one irrigation output, it is contemplated that the pump system may have a plurality of Suction inputs. Wall suction unit 56 with valve control can connect to the Suction tubing 52 as well as other tubing, so that the pump system 50 only comprises an irrigation pump. A portable pump system for providing irrigation is also contemplated.” And see [0074] discloses, “At step 212, depending on the video signatures matched, the system controller 34 selectively controls the outflow pressure and/or flow rate through the suction tubing 52, 57. The outflow pressure/flow rate control is dependent in part on the input pressure/flow rate values, and the type of identifiers. For example, in the case of a quantity of increasing blood areas detected by a video signature and provided with an identifier at step 154 as shown in FIG.4, the inflow/outflow and pressure values can be operated in a manner to flush blood from the surgical site 80 in a timely and effective manner. In Some embodiments, pulsing of irrigation fluid entering a Surgical site 80 removes the blood and provides a quality video image. The position of the stop cock 55 of the cannula 54 or the valve of wall suction unit 56 can automatically be adjusted by controller 34 to maximize the video image.” And see [0100] discloses, “The order of steps 152,234,168 in subroutine 233 is provided for purposes of illustration only. The steps can be performed in any order, or essentially simultaneously.” And see [0101] discloses, “In the laparoscopic Surgical system, the signature match adjustment Subroutine therefore is similar to the sig nature match adjustment subroutine 106 shown in FIG. 6. A main difference is that the control of pressure steps 210, 212 are limited. In the laparoscopic Surgical system, in the event that Smoke is detected by the video images from the Surgical site, the Suction/irrigation tool 228 can automatically operate to remove smoke with the wall suction unit 56 via tubing 230. At the same time, the insufflator unit 224 provides additional gas via the handpiece 66 to the surgical site 80 for preventing the peritoneal cavity from collapsing. Further, power to the electrode 232 of an electrocautery device can be reduced or interrupted, if necessary, to limit the production of additional Smoke. 0102. With respect to both arthroscopic and laparoscopic Surgical systems, the cause of bleeding is less certain than other conditions resulting in degraded image quality. Therefore, in some embodiments, when a bleeder is detected and none of the tool devices are operating, the system controller 34 determines the tool device or devices that were most recently operated. The system controller 34 can utilize this information to assist in determining what operations of fluid input/output, fluid pressure, or even which of plural fluid input/output devices to select for removing the bleeder from the video image.” Examiner notes Hamel as previously argued teaches adjusting the inflow or outflow due to blood in the surgical site, further Hamel discloses, blood metric can be detected by video signature and also visibility metric can be determined by for example smoke in the area so while both see similar lack of visibility the cause can be from a blood metric or a visibility metric related to smoke where controller utilizes this information to determine what operations to take with fluid input/output.
Examiner maintains the 35 U.S.C. 103 rejection.
Prior Art Cited But Not Relied Upon
Roh et. al – (US20230277261)
Robotic system and method are described for performing latency managed telesurgery. The system comprises drone(s) to create a wireless network in one or more geographic areas between a surgical site and a remote surgeon. The system further comprises a computer that is configured to: receive a request that indicates that a telesurgery is to be performed between the first location and the second location at a scheduled time; determine that one or more equipment is available for use at the surgical site for the telesurgery at the scheduled time; send a first instruction that triggers measurement of a latency of the wireless network; determine, during the telesurgery, whether the latency of the wireless network is acceptable; and send a first message that indicates that the latency is not acceptable, where an operation of the drone(s) is adjusted or an additional drone is deployed in the one or more geographic areas.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashley Elizabeth Evans whose telephone number is (571) 270-0110. The examiner can normally be reached Monday – Friday 8:00 AM – 5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached on (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned 571-273-8300.
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/ASHLEY ELIZABETH EVANS/Examiner, Art Unit 3687
/MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687
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