DETAILED CORRESPONDENCE
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This non-final first office action on merits is in response to the Patent Application filed on 26 November 2024. Claims 1-20 are pending and considered below.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Applicants claim of priority to Provisional Application filed 27 November 2023 is acknowledged and therefore the instant application is afforded a priority date of 27 November 2023.
Claim Rejections - 35 USC § 101
After evaluation under the requirements of the 2019 PEG Revised Steps 2A and 2B as well as MPEP 2106 Examiner has determined the instant invention is not directed to a judicial exception but is instead directed to a practical application as detailed by the claims which specifically detail the management of data with respect to bandwidth considerations such that specific bandwidth adjustments are made with respect to available bandwidth determinations.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Shelton et al. (20220331047) (hereinafter Shelton1) in view of Shelton et al. (20220273299) (hereinafter Shelton2).
Claim 1: Shelton1 discloses a computer-implemented method, comprising:
during performance of a surgical procedure on a patient , receiving, at a first surgical system ([288 ,”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, situational awareness system of the surgical hub 5104 is 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 instrument), and take any other such action described above” 351 “detecting 6011 the surgical data can include receiving a first surgical data and a second surgical data, wherein the first surgical data and the second surgical data are both relevant to the current surgical task and/or are associated with one, or more, active surgical devices,” 716 “surgical system 14000 can include a surgical hub 14002 in communication with patient monitoring devices 14004, surgical devices/instruments 14006, tracking system 14008, and visualization system 14010. The surgical system 14000, surgical hub 14002, surgical devices/instruments 14006, and visualization system 14010 can be similar in many aspects, respectively, to any of the surgical systems,”]), a first dataflow from a second surgical system ([719, 720 “surgical hub 14002 can be configured to receive a plurality of data streams related to a surgical procedure. The plurality of data streams related to a surgical procedure can include any combination of data received from patient monitoring devices 14004, surgical devices/instruments 14006, tracking system 14008, visualization system 14010, and/or server,” 731 “practiced by any combination of the surgical systems, surgical hubs, tracking systems, visualization systems, patient monitoring devices, surgical devices/instruments, AR devices, any of the components thereof, and any other devices and systems disclosed herein, such as surgical systems 1, 2, 50, 52, 14000, surgical hubs 6, 56, 5104, 14002, tracking system,”]), the first dataflow including first data regarding a measured patient parameter that the first surgical system is configured to use in performing a function during the performance of the surgical procedure ([315 “surgical data can be associated with tissue flow, clamping force, firing force, among other tissue and/or instrument parameters, which can be monitored and displayed to the clinician in multiple ways in real time to allow for adjustments to the firing process or to alert the surgeon of a potentially malformed staple region,” 332 “the parameter is a sensor parameter, which can be an internal sensor of the surgical instrument 21, or any other sensor, configured to measure a parameter needed for proper operation of the surgical procedure. The detection of a triggering event, such as activation of the surgical instrument 21 prior to receiving the parameter, may cause the system 6000 to assign a high priority value to visual content, for example in the form of an overlay, requesting a permission to ignore, or proceed without, the missing parameter, or requesting entry of the missing parameter,” 443 “surgical data comprise control data, biomarker measurements, and/or other operational indicators of operations and/or outcomes associated with a surgical instrument 21. In certain exemplifications, the surgical data can be any data indicative of a higher propensity of malformed staples and/or poorly sealed tissue. In certain instances, the surgical data can be associated with tissue flow, clamping force, firing force, among other tissue and/or instrument parameters, which can be monitored and displayed to the clinician in multiple ways in real time to allow for adjustments to the firing sequence or to alert the surgeon of a potentially malformed staple region,” 542 “system can adjust overlaid information based on monitored parameters associated with a patient reaching or exceeding a parameter threshold. In one aspect, any number of sensors or systems can monitor parameters associated with a patient, such as heart rate, and adjust the overlaid information accordingly. In one aspect, the system can monitor a value of various parameters and compare the values to parameters thresholds that are stored in a memory. In the event the value of the parameter reaches or exceeds a parameter threshold, the system can adjust the overlaid information to information the user of the occurrence of the threshold being reached or exceeded such that subsequent action can be taken. In some embodiments, the system can overlay corrective actions on the display that can aid in dropping the value of the parameter below the parameter threshold,”]); Examiner Note: Examiner under a broadest reasonable interpretation interprets the disclosures of Shelton with respect to the reception and processing of surgical system relevant data flows from first and second surgical systems and as well including surgical system specific data flows as well as the measurement of patient related parameters and the analysis of the collected data and the provision of data to the surgeon in order to perform specifically selected and relevant procedures as related to performance measures. Thus the system as disclosed by Shelton specifically details the selection and performance of specifically relevant surgical procedures for optimal patient treatment.
Shelton1 does not explicitly disclose however Shelton2 discloses:
determining that a trigger event occurred ([542 “any suitable combination of wake-up events, or triggers, can be used to switch the control system of a staple cartridge from its sleep mode to its wake mode,” 543 “wake-up triggers can include, for example, installing a battery into the surgical instrument, removing the surgical instrument from a charging station, and/or attaching the surgical instrument to a robotic surgical system,” 545-550]) during the performance of the surgical procedure such that a sum of a first bandwidth of the first dataflow and a second bandwidth of a second dataflow exceeds an available bandwidth ([582 “algorithm 1000 includes detecting 1002 a bandwidth or capacity (B) of data transmission between the sensor array and a remote processing unit,” 584 “modulation (e.g. 1014, 1016) of the sensor parameter of the subset of sensors is further based on real-time constraints of data bandwidth (B), power discharge rate (D), and/or power remaining capacity (C),” 623 “algorithm 1000 includes detecting 1002 a data-transmission bandwidth (B), or maximum data-transmission rate through the transmission system 1045. The data-transmission bandwidth (B) can be detected 1002 in multiple ways. For example, data can be transferred through the transmission system 1045 at rates that are increased gradually, or incrementally, until an error is detected, or the signal strength is no longer able to permit higher rates of transfer,” 624, 625 “transmission rates associated with successful transmissions during one or more prior uses of a surgical instrument 1022 are stored, and are then used in detecting 1002 a bandwidth (B) in subsequent uses of the surgical instrument 1022, or other similar surgical instruments,” 627-630, 677 “in-use calibration can be performed automatically as a part of an activation, initialization, and/or wake-up sequence. In one example, the measurements can be compared to stored values of the known resistive, capacitive, and/or inductive properties, and a final adjustment to the sensor array 1162 measurements can be determined 1162 based on the measurements and the stored values,”]); Examiner Note: As disclosed by Shelton above Examiner interprets the provision of timely detection of trigger events as related to the performance of surgical procedures as related to the implementation of bandwidth determined dataflow elements and the associated adjustments of the provided data transfer processes to disclose the detailed elements of the claimed invention. Therefore the cited to prior art reference Shelton discloses the provision of trigger related data flow management.
in response to determining that the trigger event occurred ([542 “any suitable combination of wake-up events, or triggers, can be used to switch the control system of a staple cartridge from its sleep mode to its wake mode,” 543 “wake-up triggers can include, for example, installing a battery into the surgical instrument, removing the surgical instrument from a charging station, and/or attaching the surgical instrument to a robotic surgical system,” 545-550]), and during the performance of the surgical procedure, adjusting at least one of the first and second dataflows such that the sum of the first and second bandwidths does not exceed the available bandwidth ([582 “algorithm 1000 includes detecting 1002 a bandwidth or capacity (B) of data transmission between the sensor array and a remote processing unit,” 584 “modulation (e.g. 1014, 1016) of the sensor parameter of the subset of sensors is further based on real-time constraints of data bandwidth (B), power discharge rate (D), and/or power remaining capacity (C),” 623 “algorithm 1000 includes detecting 1002 a data-transmission bandwidth (B), or maximum data-transmission rate through the transmission system 1045. The data-transmission bandwidth (B) can be detected 1002 in multiple ways. For example, data can be transferred through the transmission system 1045 at rates that are increased gradually, or incrementally, until an error is detected, or the signal strength is no longer able to permit higher rates of transfer,” 624, 625 “transmission rates associated with successful transmissions during one or more prior uses of a surgical instrument 1022 are stored, and are then used in detecting 1002 a bandwidth (B) in subsequent uses of the surgical instrument 1022, or other similar surgical instruments,” 627-630, 677 “in-use calibration can be performed automatically as a part of an activation, initialization, and/or wake-up sequence. In one example, the measurements can be compared to stored values of the known resistive, capacitive, and/or inductive properties, and a final adjustment to the sensor array 1162 measurements can be determined 1162 based on the measurements and the stored values,”]). Examiner Note: As disclosed by Shelton above Examiner interprets the provision of timely detection of trigger events as related to the performance of surgical procedures as related to the implementation of bandwidth determined dataflow elements and the associated adjustments of the provided data transfer processes to disclose the detailed elements of the claimed invention. Therefore the cited to prior art reference Shelton discloses the provision of trigger related data flow management.
Therefore it would be obvious for Shelton1 to determining that a trigger event occurred during the performance of the surgical procedure such that a sum of a first bandwidth of the first dataflow and a second bandwidth of a second dataflow exceeds an available bandwidth and in response to determining that the trigger event occurred, and during the performance of the surgical procedure, adjusting at least one of the first and second dataflows such that the sum of the first and second bandwidths does not exceed the available bandwidth as per the steps of Shelton2 and as a result of determining trigger events with respect to the collection and interpretation of device related data flows and the determination of bandwidth related information, optimizing the processing of the collected data and the delivery of surgically related processes to patients.
Claims 2 and 15: Shelton1 in view of Shelton2 discloses the method of claims 1 and 14 above and Shelton1 further discloses wherein the second dataflow is one of: flow from the first surgical system to the second surgical system; and flow within the first surgical system ([253 “visualization system 8, guided by the hub 6, is configured to utilize the displays 7, 9, 19 to coordinate information flow to operators inside and outside the sterile field,” 409-411, 428-430, 609 “Functional data are all data related to the individual steps, processes, and sub-processes involved in the surgical procedure. Flow data encompass the actual sequence of procedures and processes including models. Operational data relate to the application of various pieces of surgical equipment, along with devices and tools. Informational matters include all data acquired during the procedure, documents, and data models of the procedure,” 613 “interactive surgical system could run multiple scenarios virtually to determine an “optimal” workflow. Future similar procedures could use the updated flow to gain efficiency and lower fatigue,” 961]). Examiner Note: Examiner notes that Shelton1 discloses a wide range of flow related processes implemented by the surgical systems and therefore Examiner concludes the reference discloses all relevant aspects of the measure and determination of flow parameters.
Claim 3: Shelton1 in view of Shelton2 discloses the method of claim 1 above and Shelton2 further discloses wherein the first bandwidth is one of: a bandwidth between the first and second surgical systems; and a bandwidth of the first surgical system ([578 “aspects of the present disclosure are directed to circuits and/or algorithms for optimizing sensor data collection, transmission, and/or processing based on real-time constraints of data bandwidth or capacity, power transfer or discharge rate, and/or remaining power capacity,” 579-581, 582 “algorithm 1000 includes detecting 1002 a bandwidth or capacity (B) of data transmission between the sensor array and a remote processing unit, detecting 1004 a discharge rate (D) of a power source configured to supply power to the end effector, and modulating 1008 a sensor parameter of a sensor, or a subset of sensors, of the sensor array based on a detected value of the bandwidth (B) and a detected value of the discharge rate (D),” 584, 609, 623-628]).
Therefore it would be obvious for Shelton1 wherein the first bandwidth is one of: a bandwidth between the first and second surgical systems; and a bandwidth of the first surgical system as per the steps of Shelton2 and as a result of determining trigger events with respect to the collection and interpretation of device related data flows and the determination of bandwidth related information, optimizing the processing of the collected data and the delivery of surgically related processes to patients.
Claim 4: Shelton1 in view of Shelton2 discloses the method of claim 1 above and Shelton2 further discloses wherein the adjusting comprises changing a prioritization of the first and second dataflows ([622 “Determining 1081 a priority level of one or more sensor subsets, in accordance with one or more algorithms (e.g. algorithms 1010, 1080), can be achieved in multiple ways. In one example, the priority level can be a binary priority level, where the control circuit 1026 is configured to select between, for example, a high-priority level or a low-priority level. In certain instances, the high-priority level is associated with the active mode 1083, while the low-priority level is associated with the idler mode,”]).
Therefore it would be obvious for Shelton1 wherein the adjusting comprises changing a prioritization of the first and second dataflows as per the steps of Shelton2 and as a result of determining trigger events with respect to the collection and interpretation of device related data flows and the determination of bandwidth related information, optimizing the processing of the collected data and the delivery of surgically related processes to patients.
Claim 5: Shelton1 in view of Shelton2 discloses the method of claim 1 above and Shelton2 further discloses wherein the adjusting comprises changing time-related access to the at least one of the first and second dataflows ([579 “various aspects of the present disclosure are directed to circuits and/or algorithms that optimize sensor data collection, transmission, and/or processing based on one or more detected aspects of the surgical instrument, the surgical task being performed by the surgical instrument, and/or signal(s) from a situationally-aware surgical hub,” 580, 581 “Optimizing sensor data collection, transmission, and/or processing can be achieved by modulating, adapting, or adjusting one or more sensor parameters associated with data collection, transmission, and/or processing such as, for example, sensor sampling rate, sampling drive current and/or voltage, collection rate, sensor data resolution, sensor-data transmission rate, duration of activation, and/or frequency of activation,” 583 “algorithm 1010 depicting a control program or a logic configuration for optimizing sensor data collection, transmission, and/or processing in connection with a sensor array configured to detect one or more conditions of an end effector of a surgical instrument. The algorithm 1010 includes receiving 1012 one or more signals indicative of a priority level of sensor data of a subset of sensors of the sensor array, and modulating 1014 a sensor parameter of the subset of sensors based on the detected priority level of the sensor data,” 584 “sensor parameter of the subset of sensors is further based on real-time constraints of data bandwidth (B), power discharge rate (D), and/or power remaining capacity (C),” 585 “sensor-parameter modulation comprises adjusting sampling time of the signal analyzer, reducing the number of active sensors, multiplexing/combining individual sensors into a single sensor, and/or analyzing different combinations of sensors,” 587-590]). Examiner Note: Shelton2 discloses a wide range of data collection and management as related to a wide variety of sensing devices and dataflow adjustments such as time related access and therefore Examiner interprets the disclosures of Shelton2 to be applicable to the instant claim.
Therefore it would be obvious for Shelton1 wherein the adjusting comprises changing time-related access to the at least one of the first and second dataflows as per the steps of Shelton2 and as a result of determining trigger events with respect to the collection and interpretation of device related data flows and the determination of bandwidth related information, optimizing the processing of the collected data and the delivery of surgically related processes to patients.
Claim 6: Shelton1 in view of Shelton2 discloses the method of claim 1 above and Shelton2 further discloses wherein the adjusting comprises temporarily storing one of the first data of the first dataflow or the second data of the second dataflow ([579 “various aspects of the present disclosure are directed to circuits and/or algorithms that optimize sensor data collection, transmission, and/or processing based on one or more detected aspects of the surgical instrument, the surgical task being performed by the surgical instrument, and/or signal(s) from a situationally-aware surgical hub,” 580, 581 “Optimizing sensor data collection, transmission, and/or processing can be achieved by modulating, adapting, or adjusting one or more sensor parameters associated with data collection, transmission, and/or processing such as, for example, sensor sampling rate, sampling drive current and/or voltage, collection rate, sensor data resolution, sensor-data transmission rate, duration of activation, and/or frequency of activation,” 583 “algorithm 1010 depicting a control program or a logic configuration for optimizing sensor data collection, transmission, and/or processing in connection with a sensor array configured to detect one or more conditions of an end effector of a surgical instrument. The algorithm 1010 includes receiving 1012 one or more signals indicative of a priority level of sensor data of a subset of sensors of the sensor array, and modulating 1014 a sensor parameter of the subset of sensors based on the detected priority level of the sensor data,” 584 “sensor parameter of the subset of sensors is further based on real-time constraints of data bandwidth (B), power discharge rate (D), and/or power remaining capacity (C),” 585 “sensor-parameter modulation comprises adjusting sampling time of the signal analyzer, reducing the number of active sensors, multiplexing/combining individual sensors into a single sensor, and/or analyzing different combinations of sensors,” 587-590]). Examiner Note: Shelton2 discloses a wide range of data collection and management as related to a wide variety of sensing devices and dataflow adjustments such as time related access and therefore Examiner interprets the disclosures of Shelton2 to be applicable to the instant claim.
Therefore it would be obvious for Shelton1 wherein the adjusting comprises temporarily storing one of the first data of the first dataflow or the second data of the second dataflow as per the steps of Shelton2 and as a result of determining trigger events with respect to the collection and interpretation of device related data flows and the determination of bandwidth related information, optimizing the processing of the collected data and the delivery of surgically related processes to patients.
Claim 7: Shelton1 in view of Shelton2 discloses the method of claim 1 above and Shelton1 further discloses wherein the first surgical system is configured to use data in the second data flow in performing a second function during the performance of the surgical procedure ([351 “surgical data can include receiving a first surgical data and a second surgical data, wherein the first surgical data and the second surgical data are both relevant to the current surgical task and/or are associated with one, or more, active surgical devices,” 360 “presenting the first livestream of the first surgical field onto the display to presenting a second livestream of the second surgical field onto the display. In some exemplifications, the second surgical field is associated with a second surgical task that follows the first surgical task in the surgical procedure,” 361, 362 “displaying resource-allocation controls of the system resource, in response to detecting the failure, for example by overlaying 6052 the resource-allocation controls on a livestream of a surgical field of the surgical procedure,” 366 “first task can be a visualization task, e.g., providing a spectral view, of the surgical field, and the second task can be energizing a surgical energy device to seal tissue grasped by the surgical energy device in the surgical field, for example. The generator module 27 can be configured to power the surgical energy device to seal the tissue by application of therapeutic energy to the tissue,’]). Examiner Note: Examiner under a broadest reasonable interpretation interprets the disclosures of Shelton1 with respect to managing a wide range of livestream data flows to assist in the performance of equipment management to disclose the above claimed limitation.
Claims 8 and 17: Shelton1 in view of Shelton2 discloses the method of claims 1 and 14 above and Shelton1 further discloses wherein the trigger event is one of:
performance of a predetermined step of the surgical procedure by a surgeon performing the surgical procedure ([248 “interactive surgical system 1 that includes one or more surgical systems 2 and a cloud-based system 4. The cloud-based system 4 may include a remote server 13 coupled to a storage device 5. Each surgical system 2 includes at least one surgical hub 6 in communication with the cloud 4. For example, the surgical system 2 may include a visualization system 8, a robotic system 10, and handheld intelligent surgical instruments 12, each configured to communicate with one another and/or the hub,” 249, 272, 288 “timeline 5200 depicts the typical steps that would be taken by the nurses, surgeons, and other medical personnel during the course of a lung segmentectomy procedure, beginning with setting up the operating theater and ending with transferring the patient to a post-operative recovery room,” 481, 576 “Cloud-based data specific to the surgeon operating in a specific surgical case (and/or all completed surgical cases of this type) along with device position data, may permit the AI system to recognizes the current procedure step, and use this information to predict the next step of the procedure. Using this prediction, the augmented reality display may be updated to present the predicted next action to be taken and/or predicted outcomes based on previous cases,” 579 “data may be mined and analyzed to predict the most likely next step to be taken by the surgeon. Non-limiting examples of predictive modeling may use one or more of classification models, regression models, and Markov chain models. The prior procedural data may include imaging data and data obtained from the specific devices while they are used in the procedure,”]);
a predetermined patient biomarker variation ([315 “surgical data comprise control data, biomarker measurements, and/or other operational indicators of operations and/or outcomes associated with a surgical instrument,” 384 “visual representation of surgical data, e.g., a biomarker, is presented in a static display mode, e.g., solid color not highlighted, while values associated with the biomarker remain within a predetermined range, or below a predetermined threshold,” 443]).
Shelton1 does not explicitly disclose however Shelton2 discloses:
congestion of traffic using the available bandwidth ([578 “circuits and/or algorithms for optimizing sensor data collection, transmission, and/or processing based on real-time constraints of data bandwidth or capacity, power transfer or discharge rate, and/or remaining power capacity,” 579 “optimize sensor data collection, transmission, and/or processing based on one or more detected aspects of the surgical instrument, the surgical task being performed by the surgical instrument, and/or signal(s) from a situationally-aware surgical hub, which can represent a priority level of the sensor data,” 581 “Optimizing sensor data collection, transmission, and/or processing can be achieved by modulating, adapting, or adjusting one or more sensor parameters associated with data collection, transmission, and/or processing such as, for example, sensor sampling rate, sampling drive current and/or voltage, collection rate, sensor data resolution, sensor-data transmission rate, duration of activation, and/or frequency of activation,”]);
loss of data in the first dataflow ([584 “sensor parameter modulation (e.g. 1014, 1016) can be performed on one or more sensor parameters associated with data collection, transmission, and/or processing such as, for example, sensor sampling rate, sampling drive current and/or voltage, collection rate, sensor data resolution, sensor-data transmission rate, duration of activation, and/or frequency of activation. In certain instances, the modulation (e.g. 1014, 1016) of the sensor parameter of the subset of sensors is further based on real-time constraints of data bandwidth (B), power discharge rate (D), and/or power remaining capacity (C),” 585, 587, 588 “algorithm 1010 may include adjusting a sensor parameter of a first subset of sensors of the sensor array based on the priority level of the sensor data received from a second subset of the sensor array. For example, during articulation of the end effector, the algorithm 1010 may decrease a sampling parameter of a first subset of sensors relevant to closure and/or firing of the end effector, and may increase a sampling parameter of a second subset sensors relevant to articulation. The adjustments improve the resolution of the articulation sensor data without data and/or power overtaxing,” 589, 590]); Examiner Note: Examiner under a broadest reasonable interpretation interprets the disclosures of Shelton with respect to the adjustment of data collection and sampling parameters to compensate for data loss or data management within the system.
Therefore it would be obvious for Shelton1 wherein congestion of traffic using the available bandwidth and loss of data in the first dataflow as per the steps of Shelton2 and as a result of determining trigger events with respect to the collection and interpretation of device related data flows and the determination of bandwidth related information, optimizing the processing of the collected data and the delivery of surgically related processes to patients.
Claims 9 and 18: Shelton1 in view of Shelton2 discloses the method of claims 1 and 14 above and Shelton2 further discloses further comprising, after the adjusting, transmitting data on the adjusted at least one of the first and second dataflows ([579 “various aspects of the present disclosure are directed to circuits and/or algorithms that optimize sensor data collection, transmission, and/or processing based on one or more detected aspects of the surgical instrument, the surgical task being performed by the surgical instrument, and/or signal(s) from a situationally-aware surgical hub,” 580, 581 “Optimizing sensor data collection, transmission, and/or processing can be achieved by modulating, adapting, or adjusting one or more sensor parameters associated with data collection, transmission, and/or processing such as, for example, sensor sampling rate, sampling drive current and/or voltage, collection rate, sensor data resolution, sensor-data transmission rate, duration of activation, and/or frequency of activation,” 583 “algorithm 1010 depicting a control program or a logic configuration for optimizing sensor data collection, transmission, and/or processing in connection with a sensor array configured to detect one or more conditions of an end effector of a surgical instrument. The algorithm 1010 includes receiving 1012 one or more signals indicative of a priority level of sensor data of a subset of sensors of the sensor array, and modulating 1014 a sensor parameter of the subset of sensors based on the detected priority level of the sensor data,” 584 “sensor parameter of the subset of sensors is further based on real-time constraints of data bandwidth (B), power discharge rate (D), and/or power remaining capacity (C),” 585 “sensor-parameter modulation comprises adjusting sampling time of the signal analyzer, reducing the number of active sensors, multiplexing/combining individual sensors into a single sensor, and/or analyzing different combinations of sensors,” 587-590]). Examiner Note: Shelton2 discloses a wide range of data collection and management as related to a wide variety of sensing devices and dataflow adjustments such as time related access and therefore Examiner interprets the disclosures of Shelton2 to be applicable to the instant claim.
Therefore it would be obvious for Shelton1 wherein after the adjusting, transmitting data on the adjusted at least one of the first and second dataflows as per the steps of Shelton2 and as a result of determining trigger events with respect to the collection and interpretation of device related data flows and the determination of bandwidth related information, optimizing the processing of the collected data and the delivery of surgically related processes to patients.
Claim 10: Shelton1 in view of Shelton2 discloses the method of claim 1 above and Shelton1 further discloses wherein the determining and the adjusting is performed using a processor of the first surgical system, the determining and the adjusting is performed using a processor of a surgical hub communicatively coupled with the first and second surgical systems, or the determining and the adjusting is performed using a processor of a cloud-based remote server communicatively coupled with the first and second surgical systems ([248 “cloud-based system 4 may include a remote server 13 coupled to a storage device 5. Each surgical system 2 includes at least one surgical hub 6 in communication with the cloud 4. For example, the surgical system 2 may include a visualization system 8, a robotic system 10, and handheld intelligent surgical instruments 12, each configured to communicate with one another and/or the hub 6. In some aspects, a surgical system 2 may include an M number of hubs 6, an N number of visualization systems 8, an O number of robotic systems,” 249, 253-258, 288-294]).
Claim 11: Shelton1 in view of Shelton2 discloses the method of claim 1 above and Shelton1 further discloses wherein the first surgical system is a first type of surgical system; and the second surgical system is a second, different type of surgical system ([248 “computer-implemented interactive surgical system 1 that includes one or more surgical systems 2 and a cloud-based system 4. The cloud-based system 4 may include a remote server 13 coupled to a storage device 5. Each surgical system 2 includes at least one surgical hub 6 in communication with the cloud 4. For example, the surgical system 2 may include a visualization system 8, a robotic system 10, and handheld intelligent surgical instruments 12, each configured to communicate with one another and/or the hub 6. In some aspects, a surgical system 2 may include an M number of hubs 6, an N number of visualization systems 8, an O number of robotic systems,” 249-266]).
Claims 12 and 19: Shelton1 in view of Shelton2 discloses the method of claims 11 and 14 above and Shelton1 further discloses wherein the first type of surgical system and the second type of surgical system are each one of a hospital network ([235, 248, 249, 254]) a database ([274, 312, 317, 584]) a surgical instrument ([235, 241, 248]), or a surgical cart ([249, 790, 791]).
Claims 13 and 20: Shelton1 in view of Shelton2 discloses the method of claim 1 above and Shelton1 further discloses a surgical system, comprising: the first surgical system of claim 1; and the second surgical system of claim 1 ([288 ,”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, situational awareness system of the surgical hub 5104 is 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 instrument), and take any other such action described above” 351 “detecting 6011 the surgical data can include receiving a first surgical data and a second surgical data, wherein the first surgical data and the second surgical data are both relevant to the current surgical task and/or are associated with one, or more, active surgical devices,” 716 “surgical system 14000 can include a surgical hub 14002 in communication with patient monitoring devices 14004, surgical devices/instruments 14006, tracking system 14008, and visualization system 14010. The surgical system 14000, surgical hub 14002, surgical devices/instruments 14006, and visualization system 14010 can be similar in many aspects, respectively, to any of the surgical systems,”]). Examiner Note: Examiner notes that Shelton1 discloses a wide range of functional systems for the provision of related surgery processes.
Claim 14: Shelton1 discloses a computer-implemented method, comprising:
receiving, at a first surgical system and in real time with performance of a surgical procedure on a patient ([288 ,”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, situational awareness system of the surgical hub 5104 is 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 instrument), and take any other such action described above” 351 “detecting 6011 the surgical data can include receiving a first surgical data and a second surgical data, wherein the first surgical data and the second surgical data are both relevant to the current surgical task and/or are associated with one, or more, active surgical devices,” 716 “surgical system 14000 can include a surgical hub 14002 in communication with patient monitoring devices 14004, surgical devices/instruments 14006, tracking system 14008, and visualization system 14010. The surgical system 14000, surgical hub 14002, surgical devices/instruments 14006, and visualization system 14010 can be similar in many aspects, respectively, to any of the surgical systems,”]), a first dataflow of patient data from a second surgical system ([719, 720 “surgical hub 14002 can be configured to receive a plurality of data streams related to a surgical procedure. The plurality of data streams related to a surgical procedure can include any combination of data received from patient monitoring devices 14004, surgical devices/instruments 14006, tracking system 14008, visualization system 14010, and/or server,” 731 “practiced by any combination of the surgical systems, surgical hubs, tracking systems, visualization systems, patient monitoring devices, surgical devices/instruments, AR devices, any of the components thereof, and any other devices and systems disclosed herein, such as surgical systems 1, 2, 50, 52, 14000, surgical hubs 6, 56, 5104, 14002, tracking system,”]);
the first surgical system using the received the first dataflow of patient data to perform a first function in real time with the performance of the surgical procedure ([315 “surgical data can be associated with tissue flow, clamping force, firing force, among other tissue and/or instrument parameters, which can be monitored and displayed to the clinician in multiple ways in real time to allow for adjustments to the firing process or to alert the surgeon of a potentially malformed staple region,” 332 “the parameter is a sensor parameter, which can be an internal sensor of the surgical instrument 21, or any other sensor, configured to measure a parameter needed for proper operation of the surgical procedure. The detection of a triggering event, such as activation of the surgical instrument 21 prior to receiving the parameter, may cause the system 6000 to assign a high priority value to visual content, for example in the form of an overlay, requesting a permission to ignore, or proceed without, the missing parameter, or requesting entry of the missing parameter,” 443 “surgical data comprise control data, biomarker measurements, and/or other operational indicators of operations and/or outcomes associated with a surgical instrument 21. In certain exemplifications, the surgical data can be any data indicative of a higher propensity of malformed staples and/or poorly sealed tissue. In certain instances, the surgical data can be associated with tissue flow, clamping force, firing force, among other tissue and/or instrument parameters, which can be monitored and displayed to the clinician in multiple ways in real time to allow for adjustments to the firing sequence or to alert the surgeon of a potentially malformed staple region,” 542 “system can adjust overlaid information based on monitored parameters associated with a patient reaching or exceeding a parameter threshold. In one aspect, any number of sensors or systems can monitor parameters associated with a patient, such as heart rate, and adjust the overlaid information accordingly. In one aspect, the system can monitor a value of various parameters and compare the values to parameters thresholds that are stored in a memory. In the event the value of the parameter reaches or exceeds a parameter threshold, the system can adjust the overlaid information to information the user of the occurrence of the threshold being reached or exceeded such that subsequent action can be taken. In some embodiments, the system can overlay corrective actions on the display that can aid in dropping the value of the parameter below the parameter threshold,”]); Examiner Note: Examiner under a broadest reasonable interpretation interprets the disclosures of Shelton with respect to the reception and processing of surgical system relevant data flows from first and second surgical systems and as well including surgical system specific data flows as well as the measurement of patient related parameters and the analysis of the collected data and the provision of data to the surgeon in order to perform specifically selected and relevant procedures as related to performance measures. Thus the system as disclosed by Shelton specifically details the selection and performance of specifically relevant surgical procedures for optimal patient treatment.
the first surgical system using second data received by the first surgical system in a second dataflow in real time with the performance of the surgical procedure to perform a second function in real time with the performance of the surgical procedure ([305 “Surgical displays (e.g., displays 7, 9, 19, 35, 62, 65, 66, 67, and 89) play an important function within the operating room, by provide useful information to a clinician (e.g.,surgeon, surgical staff) that can used to, among other things, assess the progress of a surgical procedure, determine subsequent steps to take in the surgical procedure,” 306 “imaging device, such as one of the many imaging devices described elsewhere herein, is used to capture a livestream of a surgical field during a surgical procedure. A display shows this livestream captured by the imaging device such that the clinician can view the surgical field during the surgical procedure,” 310 “FIG. 12 illustrates a surgical visualization system 6000, according to one aspect of this disclosure,” 460 “one or more functions of the aforementioned methods are executed by one or more components of the computer-implemented interactive surgical system 1 such as, for example, one or more components of the surgical visualization system 6000, for example. In certain instances, the components executing the one or more functions of the aforementioned methods communicate through wireless and/or wired communication interfaces. In various instances, a memory of the computer-implemented interactive surgical system 1, e.g., memory 6003, stores program instructions that, when executed by a processor (e.g., processor 85), cause the processor to effect one or more functions of the aforementioned methods,” 533 “system can adjust information overlaid on the display based on a detection that a triggering event was induced by a surgical instrument utilized by a particular user. In some aspects, the system can determine what surgical devices are actively being used by what surgical personnel based on data received from sensors, modules, and/or visualization systems within the OR. In one example embodiment, the system can determine an energy device is actively being used based on data received from the generator module 40. In one example embodiment, the system can determine a surgical device is actively being used based on data received from the sensor module 29. In one example embodiment, the system can determine a surgical device is actively being used based on data received from an imaging module,” 534 “Based on the detected event and instrument origination, the system can adjust the overlaid information on the display, such as a wearable AR device worn by the surgeon,” 601 “communications arising from functions or activities deemed critical to the procedure at any specified time may have priority over communications that may, for example, be associated with routine patient monitoring. These communications may be prioritized among the members of the surgical team. Thus, relevant data generated by critical devices being used during a specific portion of a procedure may be communicated directly to all relevant members of the surgical team to convey device useful information,” 605 “interactive surgical system may determine a task of a member of the surgical team based on one or more of the situational awareness of the intelligent surgical instrument status, the team member's functional role, and the step in the procedure. The situational awareness may be used to adapt the augmented reality virtual object display information based on the task at hand,” 609 “Functional data are all data related to the individual steps, processes, and sub-processes involved in the surgical procedure. Flow data encompass the actual sequence of procedures and processes including models. Operational data relate to the application of various pieces of surgical equipment, along with devices and tools. Informational matters include all data acquired during the procedure, documents, and data models of the procedure,” 680, 681, 721 “user (e.g., an OR staff member) using the AR device 66 is able receive information related to a surgical procedure, in real time, based on at least some of the plurality of different data streams. The user can use this information to assist with decision making during the surgical procedure. Moreover, because of the real-time display of this information, the user may be able to more effectively make decisions that affect critical aspects of the surgical procure compared to other methods of communicating information in the OR,”]) Examiner Note: Examiner under a broadest reasonable interpretation interprets the extensive disclosures of Shelton1 with respect to the collection of first and second surgical system dataflows in real time and the timely adjustment of system procedures with respect to the procedural information as related to collected second data and the performance of iterative functions to optimize the performance of the surgical procedures.
Shelton1 does not explicitly disclose however Shelton2 discloses:
adjusting, based on occurrence of a trigger event in real time ([542 “any suitable combination of wake-up events, or triggers, can be used to switch the control system of a staple cartridge from its sleep mode to its wake mode,” 543 “wake-up triggers can include, for example, installing a battery into the surgical instrument, removing the surgical instrument from a charging station, and/or attaching the surgical instrument to a robotic surgical system,” 545-550]) with the performance of the surgical procedure that results in the first and second dataflows exceeding a total bandwidth limit, at least one of the first or second dataflows so that the first and second dataflows do not exceed the total bandwidth limit ([582 “algorithm 1000 includes detecting 1002 a bandwidth or capacity (B) of data transmission between the sensor array and a remote processing unit,” 584 “modulation (e.g. 1014, 1016) of the sensor parameter of the subset of sensors is further based on real-time constraints of data bandwidth (B), power discharge rate (D), and/or power remaining capacity (C),” 623 “algorithm 1000 includes detecting 1002 a data-transmission bandwidth (B), or maximum data-transmission rate through the transmission system 1045. The data-transmission bandwidth (B) can be detected 1002 in multiple ways. For example, data can be transferred through the transmission system 1045 at rates that are increased gradually, or incrementally, until an error is detected, or the signal strength is no longer able to permit higher rates of transfer,” 624, 625 “transmission rates associated with successful transmissions during one or more prior uses of a surgical instrument 1022 are stored, and are then used in detecting 1002 a bandwidth (B) in subsequent uses of the surgical instrument 1022, or other similar surgical instruments,” 627-630, 677 “in-use calibration can be performed automatically as a part of an activation, initialization, and/or wake-up sequence. In one example, the measurements can be compared to stored values of the known resistive, capacitive, and/or inductive properties, and a final adjustment to the sensor array 1162 measurements can be determined 1162 based on the measurements and the stored values,”]). Examiner Note: As disclosed by Shelton above Examiner interprets the provision of timely detection of trigger events as related to the performance of surgical procedures as related to the implementation of bandwidth determined dataflow elements and the associated adjustments of the provided data transfer processes to disclose the detailed elements of the claimed invention. Therefore the cited to prior art reference Shelton discloses the provision of trigger related data flow management..
Therefore it would be obvious for Shelton1 to adjust, based on occurrence of a trigger event in real time with the performance of the surgical procedure that results in the first and second dataflows exceeding a total bandwidth limit, at least one of the first or second dataflows so that the first and second dataflows do not exceed the total bandwidth limit as per the steps of Shelton2 and as a result of determining trigger events with respect to the collection and interpretation of device related data flows and the determination of bandwidth related information, optimizing the processing of the collected data and the delivery of surgically related processes to patients.
Claim 16: Shelton1 in view of Shelton2 discloses the method of claim 14 above and Shelton1 further discloses wherein the adjusting comprises at least one of:
the adjusting is performed using a processor of the first surgical system, the adjusting is performed using a processor of a surgical hub communicatively coupled with the first and second surgical systems, or the adjusting is performed using a processor of a cloud-based remote server communicatively coupled with the first and second surgical systems ([248 “cloud-based system 4 may include a remote server 13 coupled to a storage device 5. Each surgical system 2 includes at least one surgical hub 6 in communication with the cloud 4. For example, the surgical system 2 may include a visualization system 8, a robotic system 10, and handheld intelligent surgical instruments 12, each configured to communicate with one another and/or the hub 6. In some aspects, a surgical system 2 may include an M number of hubs 6, an N number of visualization systems 8, an O number of robotic systems,” 249, 253-258, 288-294]).
Shelton1 does not explicitly disclose however Shelton2 discloses:
changing a prioritization of the first and second dataflows, ([622 “Determining 1081 a priority level of one or more sensor subsets, in accordance with one or more algorithms (e.g. algorithms 1010, 1080), can be achieved in multiple ways. In one example, the priority level can be a binary priority level, where the control circuit 1026 is configured to select between, for example, a high-priority level or a low-priority level. In certain instances, the high-priority level is associated with the active mode 1083, while the low-priority level is associated with the idler mode,”])
changing time-related access to the at least one of the first and second dataflows, and temporarily storing data of one of the first dataflow and the second dataflow ([579 “various aspects of the present disclosure are directed to circuits and/or algorithms that optimize sensor data collection, transmission, and/or processing based on one or more detected aspects of the surgical instrument, the surgical task being performed by the surgical instrument, and/or signal(s) from a situationally-aware surgical hub,” 580, 581 “Optimizing sensor data collection, transmission, and/or processing can be achieved by modulating, adapting, or adjusting one or more sensor parameters associated with data collection, transmission, and/or processing such as, for example, sensor sampling rate, sampling drive current and/or voltage, collection rate, sensor data resolution, sensor-data transmission rate, duration of activation, and/or frequency of activation,” 583 “algorithm 1010 depicting a control program or a logic configuration for optimizing sensor data collection, transmission, and/or processing in connection with a sensor array configured to detect one or more conditions of an end effector of a surgical instrument. The algorithm 1010 includes receiving 1012 one or more signals indicative of a priority level of sensor data of a subset of sensors of the sensor array, and modulating 1014 a sensor parameter of the subset of sensors based on the detected priority level of the sensor data,” 584 “sensor parameter of the subset of sensors is further based on real-time constraints of data bandwidth (B), power discharge rate (D), and/or power remaining capacity (C),” 585 “sensor-parameter modulation comprises adjusting sampling time of the signal analyzer, reducing the number of active sensors, multiplexing/combining individual sensors into a single sensor, and/or analyzing different combinations of sensors,” 587-590]);
Therefore it would be obvious for Shelton1 to changing a prioritization of the first and second dataflows, change time-related access to the at least one of the first and second dataflows, and temporarily storing data of one of the first dataflow and the second dataflow as per the steps of Shelton2 and as a result of determining trigger events with respect to the collection and interpretation of device related data flows and the determination of bandwidth related information, optimizing the processing of the collected data and the delivery of surgically related processes to patients.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Please see attached References Cited form 892.
See Roh et al. (11,464,589) for disclosures related to the implementation of a robotic system for the performance of latency managed telesurgery including the implementation of drones facilitating communication between surgical site and remote surgeon. See at least pages 1-3.
See Shelton et al. (20220273300) for disclosures related to the facilitation of the operations including end effectors to grasp and manage tissue as related to medical procedures and the implementation of a wide range of operations. See at least paras. [471]-[507].
See Shelton et al. (20220238235) for disclosures related to the generation of event triggers for patients as related to patient related biomarkers and the tracking of patient related recoveries post-surgery. See at least paras. [37]-[100].
See Shelton et al. (20210196266) for disclosures related to the operation of a surgical instrument assembly comprised of sensing systems and the coordination of surgical instrument operations. See at least paras. [535]-[569].
See Tran et al. (20210196266) for disclosures related to the implementation of heart monitoring including the implementation of a wide range of sensors and operations designed to operate within a bandwidth coordination system for the transference of data. See at least paras. [68]-[97].
See Sorrells et al (WO 2022/132138 A1) for disclosures related to generating device, application, and user bandwidth demand profiles, the hub device may also determine a current user state of mind for a user. When a current bandwidth demand exceeds the available total bandwidth, the hub device may dynamically allocate portions of the available total bandwidth to demanding devices. See at least pages 1-5.
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/DAVID J STOLTENBERG/Primary Examiner, Art Unit 3685