DETAILED ACTION
Acknowledgements
This office action is in response to the claims filed October 07, 2025.
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 .
Response to Amendment(s)
Claims 1-4, 6-8, 11-14, 16-22, and 23-26 remain pending. The amended claims have overcome the claim objections(s) and the 112(b) rejection(s).
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 at least one of a control state and a detected condition associated with the operation;
image data demonstrating a surgical site;
process the image data;
identify a surgery status of the surgical site in response to the image data;
generate aggregate data comprising the 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
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 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.”)
at least one device controller 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 at least one device controller configured to communicate device data comprising messages 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 medical 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; ([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 a 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 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 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 at least one of a control state and a detected condition 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 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 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 surgery status is identified as a decreased visibility condition resulting from the introduction of blood in the image data.
However, Hamel does teach:
The surgical control system according to claim 22, wherein the surgery status is identified as a decreased visibility condition resulting from the introduction of blood in the image data. ([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.”)
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.
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. ([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.”)
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 6-9 of the remarks have been fully considered but they are not persuasive. Applicant argues Claims 1-22 were rejected under 35 U.S.C. § 101 as not being directed to eligible subject matter for a variety of reasons. As previously noted in the Interview Summary section, each of the independent claims is amended in this response to affirmatively recite the initiation of a control instruction that automatically activates a control configuration for one or more of a plurality of surgical devices. As supported by the detailed description and the corresponding figures, the control systems and the corresponding surgical devices are neither generic devices nor computerized processes capable of execution with a generic computer. Instead, each of the pending independent claims recites affirmative detection, identification, and data gathering steps that are also applied to initiate automated control configurations to improve the operation of a surgical control system. Accordingly, the amended claims are not directed to abstract ideas or laws of nature and eligible for patent protection. When applied to the streamlined analysis for subject matter eligibility, the subject matter of the independent claims, as amended, are eligible for patenting under both Prong l and Prong 2 of revised step 2A. That is, when considered under Prong 1, the affirmatively claimed structure including the plurality of surgical devices, camera apparatus, as well as the corresponding detection and affirmatively recited control instructions, which clearly do not correspond to abstract ideas but rather affirmatively claim machines that are eligible for patent protection. Further, even if for the sake of argument the structure of the independent claims is deemed abstract in nature, the subject matter is clearly integrated into a practical application in the form of a surgical control system that not only detects conditions from a variety of nongeneric devices but further affirmatively initiates control instructions to control the surgical devices. For at least these reasons, withdrawal of the pending rejection under Section 101 for lack of subject matter eligibility is respectfully requested for each of the independent claims and the corresponding dependent claims. Upon review of the pending claims as amended, the Examiner's patient consideration as to the specific concern driving the Section 101 analysis is respectfully requested following the guidance of MPEP 2106.04. That is, "[t]he Supreme Court's concern that drives this 'exclusionary principle' is pre-emption. Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980. The Court has held that a claim may not preempt abstract ideas, laws of nature, or natural phenomena, even if the judicial exception is narrow (e.g., a particular mathematical formula such as the Arrhenius equation)." While it is understood that preemption is not a standalone test for determining eligibility, when considered in light of the two-part framework, the nongeneric nature devices recited in the claims and the affirmatively recited steps are tailored to only include specific operations for surgical devices. While the pending claims may cover several different surgical devices as supported by the detailed description, the operations and corresponding structure clearly recite patent-eligible machines and corresponding processes. For at least these reasons, favorable consideration and withdrawal of the rejection under Section 101 is respectfully requested.
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 coule 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 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.
Therefore, for the claims argued the 35 U.S.C 101 rejection is maintained.
Response to Arguments Regarding 35 U.S.C § 102 Rejection
Applicant argues on pages 4-8 of the remarks 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"). It is submitted that the cited references do not teach or suggest each and every element in the claimed invention as amended.
Claim 1 is amended in this response. As amended, claim 1 recites: A surgical control system for a plurality of surgical devices comprising: at least one device controller in communication with each of the plurality of surgical devices via a communication bus, the at least one device controller configured to communicate device data comprising messages 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; 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: capture image data demonstrating a surgical site; process the image data; identify a surgery status of the surgical site in response to the image data; 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; identify a control configuration for at least one of the surgical devices based on the aggregate data; and initiate a control instruction configured to automatically activate the control configuration of one or more of the plurality of surgical devices, 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.
In particular, claim 1 is amended to recite that the at least one controller is configured to identify a control configuration for at least one surgical device based on the aggregate data and initiate a control instruction configured to automatically activate the control instruction of one or more of the plurality of surgical devices. Further, each of the plurality of device controllers independently identifies the control configuration and controls the operation of the plurality of devices in response to the control instruction. At least these operations of the surgical control system of amended claim 1 are not disclosed, expressly or inherently, by the references as cited. For at least these reasons, withdrawal of the rejection to claim 1 is respectfully requested. As amended, claim 1 recites features previously cited in claim 15. For example, claim 15 previously recited controller configured to identify a proposed control configuration for at least one of the surgical devices based on the aggregate data. In reference to these features, the cited passages of Shelton are not relevant and do not support a rejection for either anticipation or obviousness. As cited, paragraph [0591] of Shelton provides instruction as to how a medical instrument can be replaced based on the receipt of an instruction from the user applying a configuration and set up from the first medical instrument to a second medical instrument. Additionally, paragraph [0592] is cited as providing for accessing and applying a set of parameters based on user preferences. However, it is unclear how these passages are relevant to the identification of a control configuration for surgical devices based on aggregate data, including the surgery status identified in response to image data and device data indicative of one or more control states of the plurality of surgical devices. In contrast, the configuration and set up cited to support the rejection of claim 15 as previously recited, relates to the receipt of an instruction from a user indicating a configuration or the access of a user preference in the form of an "established set of parameters," presumably accessed in memory. Accordingly, the cited passages of Shelton correspond to the manual configuration or automated configuration based on data accessed in memory and does not relate to or otherwise render obvious the identification of a control configuration for surgical devices based on the aggregate data as claimed. Therefore, the cited passages of Shelton failed to anticipate every element of claim 1 in combination with claim 15 and further failed to render obvious every element of claim 1 as amended in this response. For at least these reasons, favorable consideration of claim 1 and withdrawal of the rejection under Section 102 is respectfully requested. Claims 2-4, 6-8, and 11-14 ultimately depend from claim 1, and, therefore, these claims are allowable for at least the reasons provided in support of claim 1. Claims 5, 9-10, and 15 have been cancelled. Accordingly, withdrawal of the rejections under 35 U.S.C. § 102(a)(2) to claims 2- 4, 6-8, and 11-14 is respectfully requested. As amended, claim 16 recites: A method for controlling a surgical control system in communication with a plurality of surgical devices, the method comprising: broadcasting device data comprising messages 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 via a communication bus in communication with a plurality of device controllers of the plurality of surgical devices; capturing image data demonstrating a surgical site with a camera apparatus; identifying a surgery status of the surgical site in response to the image data; generating aggregate data comprising the surgery status and the device data in a packet; and communicating the aggregate data over the communication bus; identifying a control configuration for at least one of the surgical devices based on the aggregate data; and initiating a control instruction configured to automatically activate the control configuration of one or more of the plurality of surgical devices, wherein each of the plurality of device controllers independently controls an operation of the plurality of surgical devices in response to at least one of the device data and the aggregate data.
Similar to claim 1, amended claim 16 recites a method for controlling a plurality of surgical devices including identifying a control configuration for at least one of the surgical devices based on the aggregate data and initiating a control instruction configured to automatically activate the control configuration of one or more of the plurality of surgical devices. Accordingly, the deficiencies of the pending rejection as discussed in the foregoing remarks in support of claim 1 are similarly applicable to amended claim 16. Therefore, the cited passages of Shelton neither expressly nor inherently anticipate every element of amended claim 16. For at least these reasons, withdrawal of the rejection to claim 16 is respectfully requested. Claims 17-21 ultimately depend from claim 16, and, therefore, these claims are allowable for at least the reasons provided in support of claim 16. Accordingly, withdrawal of the rejections under 35 U.S.C. § 102(a)(2) to claims 17-21 is respectfully requested. Claim 22 is amended in this response. As amended, claim 22 recites: A surgical control system for a plurality of surgical devices comprising: a plurality of device controllers in communication with each of the plurality of surgical devices via a communication bus, 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 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; 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 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; 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. Claim 22 recites each of a plurality of device controllers independently identify a control configuration for at least one surgical device based on the at least one of the device data and the surgery status. Claim 22 further recites that the device controllers independently initiate a control instruction configured to automatically activate the control configuration for the at least one of the plurality of surgical devices. Accordingly, the cited passages of Shelton failed to anticipate every element of amended claim 22 for reasons similar to those previously discussed in reference to claim 1. Withdrawal of the rejection to claim 22 is respectfully requested for at least these reasons. Claims 23-26 are added in this response and depend, directly or indirectly, from claims 1 or 22. Accordingly, it is submitted that claims 23-26 are allowable for at least the reasons set forth in support of either claim 1 or 22. Support for these claims may be found at least in the paragraphs 48-52 and corresponding FIGS. 5 and 6 of the application as filed and published in US Publication No. 2024/0304320A1. Favorable consideration of newly added claims 23-26 is respectfully requested.
Examiner appreciates applicants arguments but does not find them persuasive. Examiner notes the claims are interpreted under what is broadest and reasonable one of ordinary skill in the art would understand in light of the specification but not reading the specification into the claims. Examiner first interprets the claim limitations (claim 1 being representative) which is argued by applicant “identify a control configuration for atleast one of the surgical device based on the aggregate data 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.” Identification of a control configuration for at least the one surgical device based on aggregate data is interpreted as the system relying on more than simply a button pressed by a surgeon for example but rather aggregate data which can be historical, current, or other data gathered by system to define what setting or other automatically needs to be configured thus Shelton teaches this with the cited passages given by examiner, see Shelton [0256] which 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. 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).” Thus Shelton does teach analyzing aggregated data to configure and program settings (control configurations) automatically.
Furthermore, examiner interprets “ initiate a control instruction configured to automatically activate the control configuration of one or more of the plurality of surgical devices.” As a further step to initiate (broad term) this setting (control construction) to automatically activate the setting of atleast one surgical device in use, therefore Shelton is cited as teaching in fig. 74 and see [0502] which 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 Shelton does teach the automatic control / adjustment of atleast a setting/ parameter of the robotic surgical system based on data and affirmatively disclosed procedure happening in a sterile field. There is no specific limitation to what setting or any further limitation on how or what the control or automation is explicitly thus under BRI Shelton teaches the claim construction as recited.
Finally, examiner interprets the recited “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.” As meaning that the surgical devices are separate devices which have separate controllers which can take settings (control configuration) to control some operation in response to a command or instruction thus Shelton is cited as teaching in [0256] which 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.” )
Therefore, Shelton gives another example of the separate nature of each surgical device and more than one controller operating from a surgical hub which identifies the surgical device as being a unique and specific surgical device to take a control configuration or setting and a command to control the operation of the surgical device as one of ordinary skill would understand under BRI that the operational parameters or settings are modified automatically to fire a certain surgical device controlled by a controller at this certain setting based on a transmitted signaled command. Claim 1 is argued as representative by examiner but the aforementioned argument of interpretation and reasoning for why the art of record reads on the claims is applied to the remaining independent claims and therefore the depend claims as a whole in response to applicants explicit arguments presented. The Examiner maintains the 35 U.S.C 102 rejection for the aforementioned claims argued.
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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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