DETAILED ACTION
This is responsive to amendments filed on 03/11/2026 in which claims 1-17 are presented for examination; Claims 1,13 and 17 have been amended.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claim 1:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?” Yes, it’s a method(process)
Step 2a Prong 1 (judicial exception)
Step 2A (1): “Does the claim recite an abstract idea, law of nature, or natural phenomenon? Yes , the claim comes under mental processes and organizing human activity.
Claim 1 recites:
“A method for automatic allocation and display of responsibility in a telemedicine procedure with at least one medical device, the telemedicine procedure involving at least two persons of medical staff of which at least one first person is positioned locally to the at least one medical device and at least one second person is positioned remotely from the at least one medical device, the method comprising: planning an operational sequence of procedural steps for a performance of the telemedicine procedure; retrieving an information profile for the at least one first person and the at least one second person, wherein a respective information profile contains information on a history of procedures performed jointly by the at least one first and second persons; ascertaining a competency classification of the at least one first person and the at least one second person for each procedural step in the telemedicine procedure based on at least the information profiles; determining an allocation of responsibility from the competency classifications ascertained for the at least one first person and at least one second person in relation to one another for at least one procedural step that is being carried out or is pending, wherein the allocation comprises a primary responsibility and a secondary responsibility for operating the at least one medical device; wherein the determination further takes into account a reciprocal influence between information for at least the first person and information for at least the second person, a correlation between information for at least the first person and information for at least the second person, or the reciprocal influence and the correlation; displaying the allocation of responsibility to the at least one first person and the at least one second person, wherein each of the at least one first person and the at least one second person is shown their assigned responsibility; wherein the block is automatically removed during the telemedicine procedure if the retrieved information profiles indicate that the at least one first person and the at least one second person have jointly performed a plurality of similar procedures in the past.
All the limitations above are abstract idea related to the mental process (concepts performed in the human mind (including an observation, evaluation, judgment, opinion)) with the exception of bold and underlined limitations. Claim language pertains to assigning tasks to different persons in a surgical environment in hospital. The person could be present inside the surgery room with the patient or outside . The responsibilities/tasks can be written and assigned using pen and paper. Also assignment of tasks is based on the physician’s skill and competency , and also the capability described by the person himself(if he is able to perform the specific task or not). The allocation of responsibility can be done mentally and via a paper and pen; for example, one can assign the primary responsibility to main surgeon, and secondary responsibility to assistants. This is normal in any surgical procedure, that there are certain tasks that can only be performed by the surgeon, and can’t be performed by the assistance or nurse. Even, within two surgeons one can on paper and pen assign the responsibilities, as to which procedure should be performed by which surgeon, and who will take the lead role. A task can be assigned based on skill and competency level and also the historical procedures performed . All of this can be easily done on paper.
Step 2A(2): Prong Two: evaluate whether the claim recites additional elements that integrate the exception into a practical application of the exception. NO
The claim does recite additional elements; however they don’t integrate the exception into a practical application of the exception.
automatic allocation (Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
display(Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
telemedicine(Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
medical device(Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
automatically removed(Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
Step 2B: evaluate whether the claim recites additional elements that amount to an inventive concept (aka “significantly more”) than the recited judicial exception? NO
As discussed previously with respect to Step 2A Prong Two, the additional element in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Dependent claims 2-12 further narrows the abstract idea and add the additional elements of “control unit”, “display unit”, “medical device” , “robot-aided navigation”.
Under step 2A, prong two, the additional elements don’t integrate the exception into a practical application of the exception as merely adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f).
As discussed previously with respect to Step 2A Prong Two, the additional elements in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Regarding claim 13, it is rejected under the same rationale as claim 1, and adds the additional elements of “system,” “display”, “device”, “operating units”
Under step 2A, prong two, the additional elements don’t integrate the exception into a practical application of the exception as merely adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f).
As discussed previously with respect to Step 2A Prong Two, the additional elements in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Dependent claims 14-16 further narrows the abstract idea described in claim 13 , and adds the additional elements of “control unit”, “medical device”, “retrieval unit”, “data transmission path”
Under step 2A, prong two, the additional elements don’t integrate the exception into a practical application of the exception as merely adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f).
As discussed previously with respect to Step 2A Prong Two, the additional elements in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Regarding claim 17, it is rejected under the same rationale as claim 1. In addition, it adds the additional elements of “system”, “telemedicine procedure”:”, “medical device”, “radiographic system”, “robotic system”, “display unit”.
Under step 2A, prong two, the additional elements don’t integrate the exception into a practical application of the exception as merely adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f).
As discussed previously with respect to Step 2A Prong Two, the additional elements in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-10, 12-16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Roh et al(US 20230215554 A1) in view of Shelton et al. (US 20220384019 A1)
Regarding claim 1, Roh teaches a method for automatic allocation and display of responsibility in a telemedicine procedure with at least one medical device,
the telemedicine procedure involving at least two persons of medical staff of which at least one first person is positioned locally to the at least one medical device and at least one second person is positioned remotely from the at least one medical device, the method comprising (para, “[0135] ….. In some procedures, a physician at the operating room can control a portion of a surgical procedure and a remote physician can control another portion of the surgical procedure. This allows coordination between local and remote physicians. In some procedures, the surgery module 622 can receive input from both physicians and determine which input controls the instruments of the robotic surgery system. To increase accuracy, the modules in the cloud 618 can use a user-specific speech processing module for each physician. The user-specific speech processing module can be trained pre-operatively using speech input from each physician.”):
planning an operational sequence of procedural steps for a performance of the telemedicine procedure ( para, “[0126] The surgical plan can also include healthcare information, surgical team information, assignments for surgical team members, or the like. The healthcare information can include surgical room resources, hospital resources (e.g., blood banks, standby services, available specialists, etc.), local or remote consultant availability, insurance information, cost information (e.g., surgical room costs, surgical team costs, etc.).”
Also, para, “[0100] The robotic surgical system 400 can include multiple consoles 420 to allow multiple users to simultaneously or sequentially perform portions of a surgical procedure. The term “simultaneous” herein refers to actions performed at the same time or in the same surgical step. The number and configuration of consoles 420 can be selected based on the surgical procedure to be performed, number and configurations of surgical robots, surgical team capabilities, or the like.”);
wherein the block is automatically removed during the telemedicine procedure if the retrieved information profiles indicate that the at least one first person and the at least one second person have jointly performed a plurality of similar procedures in the past : (Note: This is contingent language, and removing of the block is not required, thus patentable weight is not given to this limitation.)
Roh does not explicitly teach:
retrieving an information profile for the at least one first person and the at least one second person, wherein a respective information profile contains information on a history of procedures performed jointly by the at least one first and second persons;
ascertaining a competency classification of the at least one first person and the at least one second person for each procedural step in the telemedicine procedure based on at least the information profiles;
determining an allocation of responsibility from the competency
classifications ascertained for the at least one first person and at least one second person in relation to one another for at least one procedural
step that is being carried out or is pending,
wherein the allocation comprises a primary responsibility and a secondary responsibility for operating the at least one medical device;
wherein the determination further takes into account a reciprocal influence between information for at least the first person and information for at least the second person, a correlation between information for at least the first person and information for at least the second person, or the reciprocal influence and the correlation;
displaying the allocation of responsibility to the at least one first person and the at least one second person , wherein each of the at least one first person and the at least one second person is shown their assigned responsibility;
And automatically applying a block to a corresponding step of the telemedicine procedure comprising one or more operating functions for at least one medical device for at least one person that is allocated secondary responsibility;
Shelton teaches:
retrieving an information profile for the at least one first person and the at least one second person, wherein a respective information profile contains information on a history of procedures performed jointly by the at least one first and second persons (para, “[0237] HCP profile information 35524 may include the skill set(s) of the HCPs, certifications, and/or the experience level of HCPs. For example, HCP profile information may indicate the number of years an HCP has worked on a type of task, a type of surgery, and/or in the field. HCP profile information may indicate an expected duration an HCP takes to complete a task. HCP profile information 35524 may include surgical outcomes associated with the HCPs. HCP profile information 35524 may include HCP collaboration data, such as the number of procedures certain HCPs have worked together on. HCP profile information 35524 may include hours worked (e.g., during a period of time), and/or work hours (e.g., when an upcoming shift may start, when the current shift may end).”)
ascertaining a competency classification of the at least one first person and the at least one second person for each procedural step in the telemedicine procedure based on at least the information profiles(para, “[0239] The aggregated data 35572 may be used to determine upcoming activity levels and may identify the time and location where additional HCP(s) may be needed. The skill level and/or experiences associated with the additional HCP(s) may be determined and indicated by the computing system. The computing system may identify HCP(s) to accommodate the needs, for example, based on the HCP profile information 35524, planned HCP assignment 35520, HCP monitoring data 35522 (e.g., HCP biomarker measurements), and/or updated HCP assignment 35536. HCP skill level, experience level, availability, fatigue level and/or stress level may be determined based on the HCP profile information 35524, planned HCP assignment 35520, HCP biomarkers 35522, and/or updated HCP assignment 35536, and used by the computing system to identify HCP(s) suitable for meeting the identified needs.”)
determining an allocation of responsibility from the competency
classifications ascertained for the at least one first person and at least one second person in relation to one another for at least one procedural
step that is being carried out or is pending (para ,”[0269] The computing system may monitor the HCPs' movement, as described herein. Upon detecting that an HCP leaves the OR, the computing system may determine adjustments to the ownership and responsibilities to remaining HCPs in OR and display updated indications on the dashboard. The adjustments may be indicated to the HCPs via audible indications. Other indications on the dashboard may be provided to the individual HCPs via personal audio devices. For example, indications of risks associated with a step may be provided via audio devices. The computing system may receive an indication from a lead HCP, such as a surgeon to adjust the content of the dashboard in real-time and may indicate the adjustments to other HCPs.”
Also, “[0272] For example, surgical outcomes (e.g., complications, success rating(s), surgery duration, or the like) may be correlated with HCP team combinations, HCP experience level, HCP skill set and/or the like. The computing system may generate HCP assignment recommendations, such as recommending specific HCP for a specific procedure, recommending a specific HCP for a specific task, and/or recommending a team combination for a procedure, based on the surgical outcome-HCP correlation data.”)
wherein the allocation comprises a primary responsibility and a secondary responsibility for operating the at least one medical device (para, “[0647] As shown in FIG. 34, HCP(s) ID and/or role may be determined, for example, using RF signals or facial recognition algorithms. The camera 38250 may monitor HCPs 38252, 38254, 38256, and 38258 within an OR. For example, the camera may use facial recognition algorithms to identify the HCPs within the OR. The camera 38250 may monitor (e.g., capture) the faces of the HCP(s) 38260, 38262, 38264, and 38266 within the OR. Based on the faces of the HCP(s), the camera may use facial algorithms to identify the HCPs. For example, the camera may receive RFID signals from an ID card 38268, 38270, 38272, and 38274 on the HCP(s). Based on the RFID signals, the camera may determine the HCP(s) ID and/or role. Based on the HCP(s) ID, the camera may determine the HCP(s) roles. For example, the camera may determine that HCP 38252 is the primary surgeon, HCP 38254 is the anesthesiologist, HCP 28256 is the physician assistant, and/or HCP 38258 is the nurse. The determinations described herein may be performed by the surgical computing system.”
Also, para “[0030] The computing system may adjust a control access level of an HCP based on a request from other HCP(s) in the OR. For example, if the computing system blocks a control input by the HCP, such as a scrub nurse, the computing system may send a message to other HCP in the OR, such as a surgeon. The message may be or may include an access control level adjustment message. If the other HCP, such as the surgeon, determines that the scrub nurse should be able to control the surgical instrument, e.g., turning on the surgical instrument before handing the instrument to the surgeon, the surgeon may send an access control level adjustment request to the computing system. The computing system may, based on receiving the access control level adjustment request from the surgeon, adjust the access control of the scrub nurse. The computing system may send a notification, such as an access control level adjustment notification, to the HCP. The notification may notify the HCP that the access control level associated with the HCP has been adjusted by other HCP, such as the surgeon.” Note: here surgeon has primary responsibility to operate the machine, but can adjust the access level to provide control to secondary reasonability (nurse).);
wherein the determination further takes into account a reciprocal influence between information for at least the first person and information for at least the second person, a correlation between information for at least the first person and information for at least the second person, or the reciprocal influence and the correlation (para, “[0252] The HCP energy level may be compared to one or more thresholds such as good-energy threshold, moderate-risk threshold, and/or high-risk threshold. The computing system may determine HCP assignment adjustments based on the measured energy levels associated with the HCPs, the projected energy levels associated with the HCPs, the one or more HCP energy thresholds and/or the surgical procedure information (including planned and/or updated surgical procedure information). For example, upon determining that an HCP's energy level (e.g., measured and/or projected energy level) falls below a threshold, the computing system may prompt the HCP to take a break, assign the HCP a less demanding task and/or identify another HCP to assume the HCP's assigned task.” Also, see para 0240.);
displaying an allocation of responsibility to the at least one first person and the at least one second person , wherein each of the at least one first person and the at least one second person is shown their assigned responsibility (para, “[0228] As shown in FIG. 12, planned data may be updated based on surgical monitoring data. Using OR1 35550 as an example, planned surgical data may include, but not limited to, planned surgical procedure 35512 (e.g., procedure steps, scheduled timing and expected duration associated with the procedure steps, and/or the like), planned resource allocation 35516 (e.g., surgical instrument or other supplies associated with the procedure steps), and/or planned HCP assignment 35520 (e.g., which HCP is assigned to which surgical task(s)). Surgical monitoring data may include, but not limited to, procedure progression data 35514, actual resource utilization information 35518 (e.g., information indicating if and when a surgical instrument is used during a surgical procedure), and/or HCP monitoring data 35522 (e.g., biomarker measurements and/or biomarker indications obtained via the wearable sensing system(s) 20011 described herein, HCP movement data, HCP step monitoring data, and/or other HCP monitoring data obtained via camera(s) in the OR). Procedure progression data 35514 may indicate the type of the surgery, current step of the surgery, the HCP(s) working on the surgery and/or other information indicative of procedure progression…..”
Also, para “[0248] For example, the procedure summary information 35720 may indicate that a lung lobectomy is being carried out in OR1 35750. As shown, the procedure summary information 35720 may indicate that HCP PA-a is assigned to work on the lung lobectomy procedure in OR1 35750……” Note: Also, see Fig. 14.
Para “[0255] Resource allocation adjustments (e.g., surgical resource change recommendations) associated with multiple ORs may be generated based on the aggregated resource allocation and utilization data. As shown in FIG. 14, the procedure carried out in OR2 35755 may be a gastrectomy procedure, and PA-b may be assigned to work on the procedure. ….” Note: Also, see para 0245, 0246);
and automatically applying a block to a corresponding step of the telemedicine procedure comprising one or more operating functions for at least one medical device for at least one person that is allocated secondary responsibility (para, “[0031] The computing system may adjust a control access level of an HCP based on a surgical step in a surgical procedure. The computing system may identify a current surgical step in the surgical procedure. Based on the current surgical step, the computing system may adjust the control access level of the HCP. For example, to prevent an inadvertent control of a surgical instrument, the computing system may adjust the control access level of the HCP when the computing system determines the current surgical step matches with operating the surgical instrument. The computing system may block the control input by the HCP in other surgical steps.”
Also, para “[0370] The computing system may determine whether to effectuate the detected control input by the HCP. The computing system may determine whether to effectuate the control input by the HCP based on the access control level associated with the HCP. If the computing system determines that the HCP is authorized to control the surgical instrument (e.g., HCP is authorized to effectuate the control input to control the surgical instrument) based on the access control level, the computing system may effectuate the control input by the HCP to control the surgical instrument. If the computing system determines that the HCP is unauthorized to control the surgical instrument (e.g., the HCP is unauthorized to effectuate the control input to control the surgical instrument) based on the access control level associated with the HCP, the computing system may block the control input by the HCP to control the surgical instrument.”);
It would have been obvious for a person of ordinary skill in the art to apply allocation of responsibilities according to competency teachings of Shelton into the teachings of Roh at the time the application was filed in order to assign HCP based on the measured energy levels. (Para “[0252] The HCP energy level may be compared to one or more thresholds such as good-energy threshold, moderate-risk threshold, and/or high-risk threshold. The computing system may determine HCP assignment adjustments based on the measured energy levels associated with the HCPs, the projected energy levels associated with the HCPs, the one or more HCP energy thresholds and/or the surgical procedure information (including planned and/or updated surgical procedure information). For example, upon determining that an HCP's energy level (e.g., measured and/or projected energy level) falls below a threshold, the computing system may prompt the HCP to take a break, assign the HCP a less demanding task and/or identify another HCP to assume the HCP's assigned task..” Note: Also, see para, 0271)
Regarding claim 2 , Roh as modified by Shelton teaches the method of claim 1.
Roh as modified by Shelton does not explicitly teach wherein ascertaining includes a weighting of the information.
Shelton further teaches wherein ascertaining includes a weighting of the information(para, “[0239] The aggregated data 35572 may be used to determine upcoming activity levels and may identify the time and location where additional HCP(s) may be needed. The skill level and/or experiences associated with the additional HCP(s) may be determined and indicated by the computing system. The computing system may identify HCP(s) to accommodate the needs, for example, based on the HCP profile information 35524, planned HCP assignment 35520, HCP monitoring data 35522 (e.g., HCP biomarker measurements), and/or updated HCP assignment 35536. HCP skill level, experience level, availability, fatigue level and/or stress level may be determined based on the HCP profile information 35524, planned HCP assignment 35520, HCP biomarkers 35522, and/or updated HCP assignment 35536, and used by the computing system to identify HCP(s) suitable for meeting the identified needs.” Note: here the competency (suitable for meeting needs) is ascertained by weighting information such as availability, skill level, experience level, etc.…. )
It would have been obvious for a person of ordinary skill in the art to apply team building teachings of Shelton into the teachings of Roh as modified by Shelton at the time the application was filed in order to identify the best overall team to complete the procedure for the patient outcomes. (Para 0240, “….The computing system may identify the best overall team to complete the procedure for the patient outcomes, efficiency and/or cost.”)
Regarding claim 3 , Roh as modified by Shelton teaches the method of claim 1.
Roh further teach :
wherein the at least one first person is assigned a first display unit and the at least one second person is assigned to a second display unit(para, “[0099] The user 421 can use the console 420 to view and control the surgical robot 440. The console 420 can be communicatively coupled to one or more components disclosed herein and can include input devices operated by one, two, or more users. The input devices can be hand-operated controls, but can alternatively, or in addition, include controls that can be operated by other parts of the user's body, such as, but not limited to, foot pedals. The console 420 can include a clutch pedal to allow the user 421 to disengage one or more sensor-actuator components from control by the surgical robot 440. The console 420 can also include display or output so that the one of more users can observe the patient being operated on, or the product being assembled, for example. In some embodiments, the display can show images, such as, but not limited to medical images, video, etc.”
Also, para “[0100] The robotic surgical system 400 can include multiple consoles 420 to allow multiple users to simultaneously or sequentially perform portions of a surgical procedure….”)
Roh does not explicitly teach:
and a display of the determined allocation of responsibility is provided both on the first display unit and on the second display unit.
Shelton teaches:
and a display of the determined allocation of responsibility is provided both on the first display unit and on the second display unit (para, “[0228] As shown in FIG. 12, planned data may be updated based on surgical monitoring data. Using OR1 35550 as an example, planned surgical data may include, but not limited to, planned surgical procedure 35512 (e.g., procedure steps, scheduled timing and expected duration associated with the procedure steps, and/or the like), planned resource allocation 35516 (e.g., surgical instrument or other supplies associated with the procedure steps), and/or planned HCP assignment 35520 (e.g., which HCP is assigned to which surgical task(s)). Surgical monitoring data may include, but not limited to, procedure progression data 35514, actual resource utilization information 35518 (e.g., information indicating if and when a surgical instrument is used during a surgical procedure), and/or HCP monitoring data 35522 (e.g., biomarker measurements and/or biomarker indications obtained via the wearable sensing system(s) 20011 described herein, HCP movement data, HCP step monitoring data, and/or other HCP monitoring data obtained via camera(s) in the OR). Procedure progression data 35514 may indicate the type of the surgery, current step of the surgery, the HCP(s) working on the surgery and/or other information indicative of procedure progression. Procedure progression data 35514 may include the surgical procedure and the contextual information that a surgical hub may derive as described herein with respect to FIGS. 8 and 11, and/or information that may be derived via camera-based surgical monitoring data.”
Also para, “[0243] As FIG. 14 show example display summarizing surgical procedures, HCP, surgical device stock status, highlighting deficiencies and recommending remediations across multiple operating rooms. The procedure summary information may indicate the type of surgery, the planned duration for each surgical step, and projected/update duration for the surgical step based on the surgical monitoring information. Procedure summary information may include planned, actual and projected HCP assignment information, planned, actual and projected surgical step information, and/or planned, actual and projected surgical resource information.”),
It would have been obvious for a person of ordinary skill in the art to display teachings of Shelton into the teachings of Roh as modified by Shelton at the time the application was filed in order to identify the best overall team to complete the procedure for the patient outcomes. (Para 0240, “….The computing system may identify the best overall team to complete the procedure for the patient outcomes, efficiency and/or cost.”)
Regarding claim 4 , Roh as modified by Shelton teaches the method of claim 3. Shelton further teaches wherein a first display of the determined allocation of responsibility on the first display unit and a second display on the second display unit differ as a function of the assigned persons (Para, “[0252] The HCP energy level may be compared to one or more thresholds such as good-energy threshold, moderate-risk threshold, and/or high-risk threshold. The computing system may determine HCP assignment adjustments based on the measured energy levels associated with the HCPs, the projected energy levels associated with the HCPs, the one or more HCP energy thresholds and/or the surgical procedure information (including planned and/or updated surgical procedure information). For example, upon determining that an HCP's energy level (e.g., measured and/or projected energy level) falls below a threshold, the computing system may prompt the HCP to take a break, assign the HCP a less demanding task and/or identify another HCP to assume the HCP's assigned task.”)
It would have been obvious for a person of ordinary skill in the art to apply display teachings of Shelton into the teachings of Roh as modified by Shelton at the time the application was filed in order to identify the best overall team to complete the procedure for the patient outcomes. (Para 0240, “….The computing system may identify the best overall team to complete the procedure for the patient outcomes, efficiency and/or cost.”)
Regarding claim 5 , Roh as modified by Shelton teaches the method of claim 1.
Shelton further teaches wherein a release of operating functions of the at least one medical device or of other devices is activated automatically for at least one person allocated primary responsibility. (Para, “[0025] A computing system may receive an access authorization adjustment request of an HCP from one or more other HCPs in the OR. In examples, a lead surgeon may increase or decrease the access authorization of an HCP. In examples, during an emergency, a computing system may adjust the access authorization of an HCP. Based on the emergency situation and/or a request from another HCP, a previously unauthorized HCP may have access to enter, exit, or be within the virtual boundary of a restricted access area.” Note: here, we can see that lead surgeon has more access which are activated automatically by access authorization; whereas for other HCP, they might not have authorization (thus block on those functions), and lead can increase or decrease (bloc or unblock).);
It would have been obvious for a person of ordinary skill in the art to apply allocation of responsibilities according to competency teachings of Shelton into the teachings of Roh as modified by Shelton at the time the application was filed in order to assign HCP based on the measured energy levels. (Para “[0252] The HCP energy level may be compared to one or more thresholds such as good-energy threshold, moderate-risk threshold, and/or high-risk threshold. The computing system may determine HCP assignment adjustments based on the measured energy levels associated with the HCPs, the projected energy levels associated with the HCPs, the one or more HCP energy thresholds and/or the surgical procedure information (including planned and/or updated surgical procedure information). For example, upon determining that an HCP's energy level (e.g., measured and/or projected energy level) falls below a threshold, the computing system may prompt the HCP to take a break, assign the HCP a less demanding task and/or identify another HCP to assume the HCP's assigned task..” Note: Also, see para, 0271)
Regarding claim 6 , Roh as modified by Shelton teaches the method of claim 5.
Shelton further teaches wherein the block, the release, or the block and the release is displayed on respective display units for the at least two persons ([0253] For example, as shown in FIG. 14, the computing system, based on the measured and projected HCP energy level, may determine that PA-c is trending lower energy, with energy level dropping below the moderate-risk threshold around t3 and moving towards the high-risk threshold. The computing system may determine, for example, based on the planned procedure information and procedure progression data associated with OR3 35760, that the procedure PA-c is assigned to is a potentially long procedure. The computing system may identify another assignment for PA-c based on the surgical progression information associated with the other operating rooms. For example, a shorter and/or less risky procedure, such as procedure in OR1 35750 may be identified for HCP PA-c. The computing system may identify PA-a, whose energy level is projected to remain above the good-energy threshold, as a replacement HCP for PA-a. The timing for re-assignment may be determined based on the projected time of an HCP's energy level crossing a threshold, and/or a projected or estimated downtime for the HCP as determined based on the procedure progression information.”
It would have been obvious for a person of ordinary skill in the art to apply responsibility block teachings of into the teachings of Roh as modified by Shelton at the time the application was filed in order to provide fail-safe mechanism. (Para, “[0005] Finally, with respect to robotic surgery, the end-user must have the ability to pause or stop the robotic arm at any point during the procedure. Even though robotic devices are designed with several fail-safe mechanisms, the end-user must always supervise and have complete control of the robotic device…..”)
Regarding claim 7, Roh as modified by Shelton teaches the method of claim 1.
Roh further teaches wherein the at least one first person is assigned a first control unit and the at least one second person is assigned a second control unit (para, “[0134] In some embodiments, the system can identify a user associated with the speech input and can determine whether the user is authorized to control the robotic system. In response to determining that the user is authorized, the system can generate one or more actions to be performed by the robot as discussed below. The modules in the cloud 618 can analyze user profiles for each of the surgical team members to perform user identification, authorization, etc. The modules in the cloud 618 can be trained using pre-operative and intraoperative speech training based on the surgical plan, obtained anatomical data, or the like.”
Also, para “[0096] The network adapter 312 can include a firewall that governs and/or manages permission to access proxy data in a computer network and tracks varying levels of trust between different machines and/or applications. The firewall can be any number of modules having any combination of hardware and/or software components able to enforce a predetermined set of access rights between a particular set of machines and applications, machines and machines, and/or applications and applications (e.g., to regulate the flow of traffic and resource sharing between these entities). The firewall can additionally manage and/or have access to an access control list that details permissions including the access and operation rights of an object by an individual, a machine, and/or an application, and the circumstances under which the permission rights stand.”)
Regarding claim 8 , Roh as modified by Shelton teaches the method of claim 1.
Shelton further teaches wherein the information profile of the at least two persons comprises at least one of information on: their place of residence, their training, their specialization, their language, their level of experience, or a number of similar procedures previously performed (para, “[0240]……The computing system may identify an HCP or a team of HCPs to complete the procedure based on HCP availability, the determined skillset(s) associated with the procedure, the HCPs' experience level, the HCPs' skill level, surgical outcomes associated with the HCPs and/or HCP collaboration data. The computing system may identify the best overall team to complete the procedure for the patient outcomes, efficiency and/or cost.”
Also, para “[0271] Aggregated historic surgical procedure data may be used to recommend HCP assignment and team combinations. Historic surgical procedure data may include staffing information (e.g., HCP team combinations, HCP experience level, HCP skill set and/or the like), time, OR turnover, complication rate, patient outcomes and/or surgical resource utilization associated with surgical procedures carried out in the past.”)
It would have been obvious for a person of ordinary skill in the art to apply team building teachings of Shelton into the teachings of Roh as modified by Shelton at the time the application was filed in order to identify the best overall team to complete the procedure for the patient outcomes. (Para 0240, “….The computing system may identify the best overall team to complete the procedure for the patient outcomes, efficiency and/or cost.”)
Regarding claim 9, Roh as modified by Shelton teaches the method of claim 1.
Shelton further teaches wherein updates to the respective information profile of the persons or of the procedural steps are used in order to determine, display, or determine and display competency classifications or a distribution of responsibility updated in real time (para, “0228] As shown in FIG. 12, planned data may be updated based on surgical monitoring data. Using OR1 35550 as an example, planned surgical data may include, but not limited to, planned surgical procedure 35512 (e.g., procedure steps, scheduled timing and expected duration associated with the procedure steps, and/or the like), planned resource allocation 35516 (e.g., surgical instrument or other supplies associated with the procedure steps), and/or planned HCP assignment 35520 (e.g., which HCP is assigned to which surgical task(s)). Surgical monitoring data may include, but not limited to, procedure progression data 35514, actual resource utilization information 35518 (e.g., information indicating if and when a surgical instrument is used during a surgical procedure), and/or HCP monitoring data 35522 (e.g., biomarker measurements and/or biomarker indications obtained via the wearable sensing system(s) 20011 described herein, HCP movement data, HCP step monitoring data, and/or other HCP monitoring data obtained via camera(s) in the OR). Procedure progression data 35514 may indicate the type of the surgery, current step of the surgery, the HCP(s) working on the surgery and/or other information indicative of procedure progression. Procedure progression data 35514 may include the surgical procedure and the contextual information that a surgical hub may derive as described herein with respect to FIGS. 8 and 11, and/or information that may be derived via camera-based surgical monitoring data.”
Also, para “[0245] Procedure summary information 35720, 35725 and 35730 may include HCP assignment information, surgical step information, and/or surgical resource information, which may be updated in real time as the surgeries progress. HCP monitoring data 35765 may be indicated along the same timeline. As shown, the energy levels of the HCPs, for example, physician assistant a (PA-a), physician assistant b (PA-b), physician assistant c (PA-c), who are assigned to OR1 35750, OR2 35755, OR3 35760 may be indicated.”)
It would have been obvious for a person of ordinary skill in the art to apply team building teachings of Shelton into the teachings of Roh as modified by Shelton at the time the application was filed in order to identify the best overall team to complete the procedure for the patient outcomes. (Para 0240, “….The computing system may identify the best overall team to complete the procedure for the patient outcomes, efficiency and/or cost.”)
Regarding claim 10, Roh as modified by Shelton teaches the method of claim 1.
Roh further teaches wherein the telemedicine procedure comprises at least one robot-aided navigation of an object in a hollow organ of a patient (para, “[0113] The data system 450 can improve surgical planning, monitoring (e.g., via the display 422), data collection, surgical robotics/navigation systems, intelligence for selecting instruments, implants, etc. The data system 450 can execute, for example, surgical control instructions or programs for a guidance system (e.g., ML guidance system, AI guidance system, etc.), surgical planning programs, event detection programs, surgical tool programs, etc. For example, the data system 450 can increase procedure efficiency and reduce surgery duration by providing information insertion paths, surgical steps, or the like…….”
Also, para “[0116] Embodiments can provide a means for mapping the surgical path for neurosurgery procedures that minimize damage through artificial intelligence mapping. The software for artificial intelligence is trained to track the least destructive pathway. The physician can make an initial incision based on a laser marking on the skin that illuminates the optimal site. Next, a robot can make a small hole and insert surgical equipment (e.g., guide wires, cannulas, etc.) that highlights the best pathway. This pathway minimizes the amount of tissue damage that occurs during surgery. Mapping can also be used to identify one or more insertion points associated with a surgical path.”)
Regarding claim 12, Roh as modified by Shelton teaches the method of claim 1.
Shelton further teaches wherein communications and interactions between the at least two persons are monitored or regulated on the basis of the competency classifications, the information profiles, or the competency classifications and the information profiles (para, “[0025] A computing system may receive an access authorization adjustment request of an HCP from one or more other HCPs in the OR. In examples, a lead surgeon may increase or decrease the access authorization of an HCP. In examples, during an emergency, a computing system may adjust the access authorization of an HCP. Based on the emergency situation and/or a request from another HCP, a previously unauthorized HCP may have access to enter, exit, or be within the virtual boundary of a restricted access area.”
Also, para, “[0269] The computing system may monitor the HCPs' movement, as described herein. Upon detecting that an HCP leaves the OR, the computing system may determine adjustments to the ownership and responsibilities to remaining HCPs in OR and display updated indications on the dashboard. The adjustments may be indicated to the HCPs via audible indications. Other indications on the dashboard may be provided to the individual HCPs via personal audio devices. For example, indications of risks associated with a step may be provided via audio devices. The computing system may receive an indication from a lead HCP, such as a surgeon to adjust the content of the dashboard in real-time and may indicate the adjustments to other HCPs.”
Also, “[0277] FIG. 18 shows an example adjustments of HCP assignments based on aggregated surgical monitoring data across multiple ORs. As shown, at 35832, surgical monitoring data associated with multiple surgical procedures in operation rooms may be obtained. At 35834, surgical monitoring data across multiple ORs may be aggregated. At 35836, HCP assignments may be updated based on the aggregated surgical monitoring data.” Note: also for explicit teaching of regulating interaction, see rejection with regard to claim 5, where the communication and actions between two users can be regulated based on competency (mentor can observe and take control, see abstract))
It would have been obvious for a person of ordinary skill in the art to apply team building teachings of Shelton into the teachings of Roh as modified by Shelton at the time the application was filed in order to identify the best overall team to complete the procedure for the patient outcomes. (Para 0240, “….The computing system may identify the best overall team to complete the procedure for the patient outcomes, efficiency and/or cost.”)
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Roh as modified by Shelton and in view of Roberts et al. (US 20190035502 A1)
Regarding claim 11, Roh as modified by Shelton teaches the method of claim 1.
Roh as modified by Shelton does not explicitly teach wherein at least one pretrained machine learning algorithm is used for the determination of the competency classification, the allocation of responsibility, or the determination of the competency classification and the allocation of responsibility.
Roberts teaches wherein at least one pretrained machine learning algorithm is used for the determination of the competency classification, the allocation of responsibility, or the determination of the competency classification and the allocation of responsibility (para, “[0089] Further, embodiments of the disclosure may be used as a learning tool to optimize care team assignments. For instance, embodiments may associate a patient's outcome with the care team assignment and utilize that information to determine optimal care team compositions based on which care team assignments are associated with in better patient outcomes. Optimal care team compositions may include an optimal number of care team members, an optimal combination of roles/specialties on a care team, or individual clinicians who are associated with better outcomes. For instance, if two patients who present with chest pain both see a cardiologist but only one patient sees an oncologist, embodiments may determine whether the patients have different outcomes and, if so, utilize that information with information learned from other interactions to determine whether a combination of both a cardiologist and oncologist for patients with chest pain is better than only a cardiologist. Further, the optimal number or frequency of interactions with a patient or the optimal types of actions, including, in some aspects, the sequence of actions, may be learned based on patient outcomes. Such learning techniques may involve using one or more machine-learning models. Understanding optimal care teams and interactions with the patient may lead to improved results for patients in the future.”)
It would have been obvious for a person of ordinary skill in the art to apply team building teachings of Roberts into the teachings of Roh as modified by Shelton at the time the application was filed in order to build a team that leads improved results for patients. (Para 0089, “Such learning techniques may involve using one or more machine-learning models. Understanding optimal care teams and interactions with the patient may lead to improved results for patients in the future.”)
Allowable Subject Matter
Claims 13-16 and 17 are allowed over the prior art. The amended limitation “wherein the block is automatically removed during the telemedicine procedure if the retrieved information profiles indicate that the at least one first person and the at least one second person have jointly performed a plurality of similar procedures in the past” overcomes the prior art of record and rejection regarding claims 13-16 and 17 have been removed.
Response to Arguments
Applicant's arguments filed on 03/11/2026 have been fully considered but they are not persuasive.
Remarks - 35 USC § 112
Applicant’s arguments with regard to 112(a) rejection are persuasive, and the rejection has been removed.
Remarks - 35 USC § 101
In remarks, Pg. 9-10, applicant contends:
“The Examiner argues that the invention covers concepts that are directed to "organizing human activity" or a "mental process" that could be done with pen and paper. The Applicants respectfully disagree as this analysis fails to consider the claim as a whole, which recites a concrete technological process that cannot be performed by a human and is not related to organizing human activity. Specifically, the amended claim recites a method where a computer-controlled system automatically removes a block on a physical medical device. This is a specific control action that changes the functionality of the machine. This action is triggered by a specific, data-driven rule: querying retrieved information profiles to determine "if the at least one first person and the at least one second person have jointly performed a plurality of similar procedures in the past." This process is not an abstract mental step. A human cannot, with pen and paper, dynamically modify the control permissions of a remote medical device during a procedure based on a real-time query of historical collaboration data. The claim recites an improvement to the technology of telemedicine control systems by implementing a dynamic, trust-based safety protocol. This protocol enhances operational flexibility for experienced teams while maintaining strict safety interlocks for new teams, solving a technical problem inherent to remote collaboration in surgery.”
The concept of not allowing Somone to operate the tool based on a condition is an abstract idea; for example, if we know that person is not qualified to operate/perform a surgery, we have rules that will not allow the person to perform the surgery without qualification. What mentally can’t be achieve is the fact that based on the condition, the medical device is automatically blocked or unblocked. This aspect is merely applying the access restriction on the device. Basically, the access restriction can be performed mentally or paper and pen based on policy; however, in the instant case this abstract idea is being implemented using the computer. The claims or specification, don’t provide any technical details as to how the technology of blocking/unblocking is being improved; as far as the claims are concerned, simple condition is being used to block/unblock the tool. Neither the claims present, any solution to technical problem. The locking/unlocking of devices or functions of device without any technical details is merely applying computer as a tool.
In remarks, Pg. 11, applicant contends:
“The claims are integrated into a practical application of failsafe performance by automatically activating a block on operating functions for a person who holds secondary responsibility for a given procedural step. The claim integrates the concept of responsibility allocation into a practical application that improves the safety and efficiency of the medical device's operation. It is not merely "applying" an abstract idea; it is a specific implementation that results in an improved technological process. Therefore, the claim is patent-eligible under 35 U.S.C. § 101. The Applicants respectfully request the rejection be withdrawn.”
Automatically activating a block does not integrate the claim limitation in to practical application. The assigned tasks can be taken over by the specified /responsible person when certain conditions are met, and can be easily done in daily life. As for example, the nurse will not have access to medical device to perform surgery, if she is not qualified to do so. The failsafe is being provided, which is more that mental step; however, it doesn’t integrate into practical application because the claims or the specification don’t provide any technical details, as to how the failsafe or lock/unlock technology is being improved. The examiner have conveyed this aspect multiple times, and applicant is not providing any details as to what technology is being improved or what technical problem is being solved. The applicant is rather providing a conclusory statement that “responsibility allocation into a practical application that improves the safety and efficiency of the medical device's operation.” As stated in applicant’s remarks, improving the safety is not a technical improvement; by not letting a nurse do a surgeon’s job, we are improving the safety; however that is not a technical improvement. The same goes toward the efficiency, how locking/unlocking provides efficiency? It rather provides failsafe mechanism, which is a safety mechanism.
Remarks - 35 USC § 103
Applicant’s arguments regarding 103 rejection are persuasive and , prior art rejection for claims 13-16 and 17 has been removed. As per claim 1, claim 1 is a method claim, and contingent language is not being given patentable weight. MPEP, 2111.04 (II) recites:
“The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim. If the claimed invention requires the first condition to occur, then the broadest reasonable interpretation of the claim requires step A. If the claimed invention requires both the first and second conditions to occur, then the broadest reasonable interpretation of the claim requires both steps A and B.”
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HUMA WASEEM whose telephone number is (571)272-1316. The examiner can normally be reached Monday-Friday(9:00am - 5:00 pm) EST.
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/HUMA WASEEM/Examiner, Art Unit 3686
/JASON B DUNHAM/Supervisory Patent Examiner, Art Unit 3686
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