DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/23/2025 has been entered.
Status of Claims
This action is in reply to the present action filed on 12/23/2025.
Claims 1, 8-11, 13-17 have been amended.
Claim 2 has been canceled.
Claims 18 and 19 have been added.
Claims 1 and 3-19 are currently pending and have been examined.
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 and 3-19 are rejected under 35 USC § 101 as being directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1 Analysis:
Independent Claims 1, 13, and 17 are within the four statutory categories. Claims 1, 13, and 17 are directed to a method, system, and non-transitory computer-readable storage medium (i.e. machine) respectively. Dependent Claims 3-12 and 18-19 are drawn toward the method and Claims 14-16 are drawn toward the system and therefore the dependent claims also fall into one of the four statutory categories.
Step 2A Analysis – Prong One:
Claim 1, which is indicative of the inventive concept, recites the following:
A method for monitoring remote control suitability, the method comprising: capturing, by a first sensor of a sensor unit, a first instantaneous suitability parameter of a medical member of remote operating staff,
the first instantaneous suitability parameter of the medical member of remote operating staff having a value and characterizing a procedure-specific instantaneous suitability of the medical member of remote operating staff for monitoring, remotely controlling, or monitoring and remotely controlling a medical device using a remote control unit,
wherein the medical member of remote operating staff is equipped to remotely control the medical device using the remote control unit,
wherein the remote control unit is configured to provide the medical device with a control signal, and wherein the first instantaneous suitability parameter is provided by the remote control unit, the sensor unit for capturing the medical member of remote operating staff, or the remote control unit and the sensor unit;
identifying, based on the first instantaneous suitability parameter, whether a reduction in the suitability of the medical member of remote operating staff exists;
in the case of affirmation in the identifying, providing the medical device with an alternative [instructions] control signal;
and in the case of negation in the identifying, providing the medical device with the [instructions] control signal; and
capturing, by a second sensor of the sensor unit, a second instantaneous suitability parameter, the second instantaneous suitability parameter being of an alternative medical member of remote operating staff, the second instantaneous suitability parameter of the alternative medical member of remote operating staff having a value of characterizing a procedure-specific instantaneous suitability of the alternative medical member of remote operating staff for monitoring, remotely controlling, or monitoring and remotely controlling the medical device using an alternative remote control unit,
wherein the alternative medical member of remote operating staff is equipped to remotely control the medical device using the alternative remote control unit,
wherein in the case of affirmation in the identifying, the method further comprises comparing the first instantaneous suitability parameter of the medical member of remote operating staff and the second instantaneous suitability parameter of the alternative medical member of remote operating staff, and
wherein the instantaneous alternative [instructions] control signal is provided as a function of the comparison of the first instantaneous suitability parameter and the second instantaneous suitability parameter.
The limitations as shown in underline above, given the broadest reasonable interpretation, cover the abstract idea of certain methods of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions, and/or mental process that a neurologist should follow when testing a patient for nervous system malfunctions - in this case, monitoring a member of a remote operating staff using a medical device for a procedure and identifying if a reduction in the suitability of the member exists, determining the suitability of an alternative medical member, and comparing the instantaneous suitability of the two members), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements” and will be discussed in further detail below.
Dependent Claims 3-11, 14-16, and 19 include other limitations directed to the abstract idea. For example, Claim 3 recites a changeover to remote control of the medical device by an alternative member using an alternative remote control unit, Claim 4 recites providing a member of on-site operating staff with a workflow indication, Claim 5 recites repeatedly capturing and identifying, Claim 6 recites identifying a procedural step using procedural planning, Claim 7 recites receiving the maximum value or desired execution, Claim 8 recites adapting the maximum value or desired execution to a historic operating behavior of the member of the remote operating staff, Claim 9 recites identifying a change in communication, Claim 10 recites repeatedly querying the status of the member of the staff, Claim 11 recites identifying atypical position or movement as a reduction in suitability, Claim 14 recites capturing the first and second instantaneous suitability parameter, Claim 15 recites capturing an alternative user and if there is a reduction in the suitability of the member, Claim 16 recites providing a member of the on-site operating staff with a workflow indication for carrying out a further procedural step, Claim 19 recites what the suitability parameter can include. These limitations only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04. Additionally, any limitations in the dependent clams not addressed above are part of the abstract idea and will be further addressed below. Hence, dependent Claims 2-11 and 14-16 are nonetheless directed towards fundamentally the same abstract idea as independent Claims 1, 13, and 17.
Step 2A Analysis- Prong Two:
Claims 1, 13, and 17 are not integrated into practical application because the additional elements (i.e. the non-underlined limitations above- in this case, the remote control unit, first and second sensor, sensor unit, alternative remote control unit, and medical device of Claim 1, the provisioning unit, medical device, remote control unit, first and second sensor, alternative remote control unit, and sensor unit of Claim 13, and a non-transitory computer-readable storage medium, processor, medical device, remote control unit, first and second sensor, alternative remote control unit, and sensor unit of Claim 17) are recited at a high level of generality (i.e. as a generic processor performing generic computer functions) such that they amount to no more than mere instructions to apply an exception using generic computer parts. For example, applicant’s specification explains that providing the alternative control signal and/or the control signal may include, for example, storage on a computer-readable storage medium and/or transfer to a provisioning unit and/or the medical device [0018]. Further, the additional elements of the sensor, sensor unit, medical device, and remote control unit generally link the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(1) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. For example, Applicant’s specification explains that the remote control unit is configured to provide a control signal to the medical device (Applicant’s specification, ¶ 0009). The sensor unit may include, for example, an optical sensor (e.g., a camera) and/or an acoustic sensor (e.g., a microphone) and/or a mechanical sensor (e.g., a push button) that is configured to capture the member of remote operating staff … the sensor unit may be at least partially (e.g., fully) integrated in the remote control unit [0015]. The medical device may be configured to receive the control signal from the remote control unit. Further, the medical device may be remotely controlled by the remote control unit (e.g., by the control signal) [0011]. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into practical application because they do not impose any meaningful limits on the abstract idea. Therefore, independent Claims 1, 13, and 17 are directed to an abstract idea without practical application.
Dependent Claims 2-3, 7, 9-12, and 14-19 recite additional elements. Claim 3 recites a new additional element of an alternative remote control unit and specifies the alternative control signal comprises a changeover of the control of the medical device to an alternative remote control unit. Claim 7 recites a new additional element of a data storage unit and specifies receiving of a maximum value and/or desired execution from the data storage unit. Claim 9 repeats the previously recited additional elements of the remote control unit and sensor unit and specifies verbal communication of the member of the of the staff is captured by the remote control unit and/or the sensor unit. Claim 10 repeats the previously recited remote control unit and specifies the remote control unit repeatedly queries the status of the member of the remote operating staff and identifies a reduction in suitability. Claim 11 repeats the previously recited sensor unit and specifies the sensor unit repeatedly captures positioning and/or movement to identify a reduction in suitability. Claim 12 recites the medical device and recites a new additional element of a medical imaging device, medical treatment device, and remote manipulation unit and specifies the medical device comprises a medical imaging device, medical treatment device, and/or a remote manipulation unit for robotic movement of a medical object. Claim 14 repeats the previously recited sensor unit and specifies the sensor unit captures the first and second instantaneous suitability parameter. Claim 15 recites a new additional element of an alternative remote control unit and specifies the alternative remote control unit captures an alternative user input and on presentation of a reduction in the suitability of a member of the remote operating staff, provides the medical device with the alternative control signal. Claim 16 recites a new additional element of a output unit and specifies the output unit provides a member of on-site operating staff with a workflow indication for onsite operation of the medical device. Claim 18 recites new additional elements and specifies the sensor unit includes an acoustic or mechanical sensor (new elements). Claim 19 repeats the previously recited medical device and specifies what the value of the first suitability parameter comprises of the medical member for monitoring and/or remotely controlling the medical device. However, these additional elements are used in their expected fashion, so they do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on the abstract idea. These limitations amount to no more than mere instructions to apply an exception, and hence, do not integrate the aforementioned abstract idea into practical application.
Step 2B Analysis:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements of the remote control unit, first and second sensor, sensor unit, control signal, alternative control signal, and medical device of Claim 1, the provisioning unit, medical device, control signal, alternative control signal, remote control unit, first and second sensor, and sensor unit of Claim 13, and a non-transitory computer-readable storage medium, processor, medical device, remote control unit, control signal, alternative control signal, first and second sensor, and sensor unit of Claim 17 amount to no more than mere instructions to apply an exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). MPEP 2106.05(I)(A) indicates that merely stating “apply it” or equivalent to the abstract idea cannot provide an inventive concept (“significantly more”). Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of the sensor, sensor unit, medical device, and remote control unit were considered to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the ‘significantly more’ analysis and has been found insufficient to provide significantly more. MPEP2106.05 (A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide an inventive concept (‘significantly more"). Accordingly, even in combination, these additional elements do not provide significantly more. As such, Claims 1, 13, and 17 are not patent eligible.
Dependent Claims 5 and 8 do not recite any additional elements and only narrow the abstract idea. Claim 5 narrows the abstract idea by specifying the capturing and identifying are repeatedly executed until a termination condition occurs. Claim 8 narrows the abstract idea by specifying adapting the maximum value and/or the desired execution to a historic operating behavior of the member.
Dependent Claims 3-4, 6, 9-11, and 14 recite previously recited additional elements, which are not eligible for the reasons stated above, and further narrow the abstract idea. Claim 3 narrows the previously recited additional element of the alternative remote control unit by specifying an alternative member of the remote operating staff controls the alternative remote control unit. Claim 4 narrows previously recited additional element of the alternative control signal by specifying it provides workflow indications for carrying out a further procedural step. Claim 6 narrows previously recited additional element of the control signal by specifying the control signal identifying a procedural step using procedural planning or the control signal. Claim 9 narrows the previously recited additional elements of the remote control unit and the sensor unit by specifying they identify verbal communication and any changes in the communication. Claim 10 narrows the previously recited additional element of the remote control unit by specifying the remote control unit repeatedly queries the staff and determines if there is a reduction in suitability. Claims 11 and 14 narrows the previously recited additional element of the sensor unit by specifying the sensor unit captures the staff positioning or movement and determines a reduction in suitability. Claim 19 repeats the previously recited medical device and specifies what the value of the first suitability parameter comprises of the medical member for monitoring and/or remotely controlling the medical device.
Dependent Claims 7, 12, 16, and 18 recite new additional elements. Claim 7 recites a new additional element of a data storage unit and specifies receiving of a maximum value and/or desired execution from the data storage unit. Claim 12 recites the medical device and recites a new additional element of a medical imaging device, medical treatment device, and remote manipulation unit and specifies the medical device comprises a medical imaging device, medical treatment device, and/or a remote manipulation unit for robotic movement of a medical object. Claim 16 recites a new additional element of a output unit and specifies the output unit provides a member of on-site operating staff with a workflow indication for onsite operation of the medical device. Claim 18 recites new additional elements of an acoustic and mechanical sensor and specifies the sensor unit includes an acoustic and/or mechanical sensor. Hence, Claims 3-12 and 14-19 do not include any additional elements that amount to “significantly more” than the judicial exception.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination does not add anything that is already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1 and 3-19 are nonetheless rejected under 35 U.S.C 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
Claims 1, 3-5, 11-19 are rejected under 35 USC § 103 as being unpatentable over Hannaford et al. (US 20110238079 A1) in view of Shelton et al. (US 20190201126 A1) and Makrinich et al. (US 20210313050 A1).
Regarding Claim 1, Hannaford discloses the following:
A method for monitoring remote control suitability, the method comprising: (Hannaford discloses resent systems and methods, etc., extend the spectrum of surgical expertise to a level appropriate for the type and nature of battlefield wounds [0005].)
…member of remote operating staff for monitoring, remotely controlling, or monitoring and remotely controlling a medical device using a remote control unit, (Hannaford discloses a local surgical cockpit comprising a local surgical console configured for transmitting surgical movements of local surgeon operating the local surgical console to a remote surgery site, and a head-mounted display disposed in front of the local surgeon's eyes in surgical position in the cockpit to operate the console for surgery, wherein the head-mounted display can be configured to depict at least images of a remote surgical site under remote operation by the operator [0011].)
wherein the medical member of remote operating staff is equipped to remotely control a medical device using a remote control unit, (Hannaford discloses the present methods, devices, systems, etc., are related to a local surgical cockpit comprising …and a remote surgical console configured such that the operator can operate the console for remote surgery while in the seat [0008].)
wherein the remote control unit is configured to provide the medical device with a control signal, (Hannaford discloses the systems…are directed to a local surgical cockpit comprising a local surgical console configured for transmitting surgical movements of an operator operating the local surgical console to a remote surgery site, and comprising at least one virtual console control knob presented virtually to the operator and configured to be manipulated by the operator to generate control signals for a corresponding remote device at a remote operation site [0030].)
the sensor unit for capturing the medical member of remote operating staff, or the remote control unit and the sensor unit; (Hannaford discloses the local surgical cockpit can be part of a system and the system further can comprise remote image sensors operably connected to the head-mounted display to transmit the image of the remote surgical site [0011]. The local surgical cockpit can be part of a system and the system further can comprise remote 3-dimensional audio sensors operably connected to the local 3-dimensional audio such that the local 3-dimensional audio precisely transmit 3-dimensional audio signals from the remote 3-dimensional audio sensors [0037].)
using the alternative remote control unit, (Hannaford discloses a local surgical cockpit comprising a local surgical console configured for transmitting surgical movements of local surgeon operating the local surgical console to a remote surgery site, and a head-mounted display disposed in front of the local surgeon's eyes in surgical position in the cockpit to operate the console for surgery, wherein the head-mounted display can be configured to depict at least images of a remote surgical site under remote operation by the operator [0011].)
…for monitoring, remotely controlling, or monitoring and remotely controlling the medical device using an alternative remote control unit, (Hannaford discloses a local surgical cockpit comprising a local surgical console configured for transmitting surgical movements of local surgeon operating the local surgical console to a remote surgery site, and a head-mounted display disposed in front of the local surgeon's eyes in surgical position in the cockpit to operate the console for surgery, wherein the head-mounted display can be configured to depict at least images of a remote surgical site under remote operation by the operator [0011].)
Hannaford teaches a remote control unit utilized by a medical member of remote operating staff, but does not teach that the remote control unit provides the instantaneous suitability parameter of the medical member. However, Shelton teaches:
capturing, by a first sensor of a sensor unit, a first instantaneous suitability parameter of a medical member of …operating staff, (Shelton teaches the surgical hub 211801 executing the process 211000 can analyze the posture of a surgical staff member and provide recommendations if the staff member's posture deviates from the baseline [0319]. In various aspects, the imaging device 124 includes at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, Charge-Coupled Device (CCD) sensors and Complementary Metal-Oxide Semiconductor (CMOS) sensors [0196].)
the first instantaneous suitability parameter of the medical member of…operating staff having a value and characterizing a procedure-specific instantaneous suitability of the medical member… (Shelton teaches the computer system…indicate when the surgical staff is deviating from the baseline so that the surgical staff can alter their actions and optimize their performance or technique…the notifications can include warnings that the surgical staff is not utilizing proper technique …, suggestions for alternative surgical products, statistics regarding correlations between procedural variables…and the monitored physical characteristics of the surgical staff, comparisons between surgeons,…[0310]. The baseline physical characteristic can be determined or calculated from data aggregated from all of the surgical hubs 211801 that are communicably connected to the cloud computing system, which allows for the cloud computing system to compare surgical staff members' 211803 techniques across a number of medical facilities [0318].)
and wherein the first instantaneous suitability parameter is provided by the [remote control unit], (Shelton teaches determining, by the computer system, a physical characteristic of the individual…; retrieving, by the computer system, a baseline physical characteristic corresponding to the surgical context; and determining, by the computer system, whether the physical characteristic of the individual deviates from the baseline (Claim 9). Shelton teaches the suitability is determined via a computer system, not a remote control unit.)
identifying, based on the first instantaneous suitability parameter, whether a reduction in the suitability of the medical member of remote operating staff exists; (Shelton teaches the surgical hub 211801 executing the process 211000 can analyze the posture of a surgical staff member and provide recommendations if the staff member's posture deviates from the baseline. Poor, unexpected, or otherwise improper posture can indicate, for example, that the surgeon is fatigued, is having difficulty with a particular surgical step, is utilizing the surgical instrument incorrectly, has positioned the surgical instrument incorrectly, or is otherwise acting in a potentially risky manner that could create danger [0319].)
in the case of affirmation in the identifying, providing the medical device with an alternative …; (Shelton teaches providing notifications when a staff member is deviating from a baseline posture can be beneficial to alert unaware users as to their risky conduct so that they can take corrective actions or allow other individuals to take corrective actions (e.g., swap a fatigued staff member for a fresher individual) [0319].)
and in the case of negation in the identifying, providing the medical device with the control signal. (Shelton teaches the surgical hub 211801 can be programmed to be especially sensitive to deviations between the surgical staff members performance and the corresponding baselines so that the surgical hub 211801 can reinforce the proper techniques for using the surgical device when the trial period is ongoing [0330]. This is interpreted as if the user continues the procedure properly, the system allows them to continue.)
and capturing, by a second sensor of the sensor unit, a second instantaneous suitability parameter, the second instantaneous suitability parameter being of an alternative medical member of…operating staff, (Shelton teaches the surgical hub 211801 executing the process 211000 can analyze the posture of a surgical staff member and provide recommendations if the staff member's posture deviates from the baseline [0319]. In various aspects, the imaging device 124 includes at least one image sensor and one or more optical components [0196]. The notifications can include… comparisons between surgeons, and so on…the computer system can be programmed to automatically analyze and compare staff members' techniques and instrument usage skills [0310]. The Examiner interprets the analyzing of different staff member’s techniques as the analysis of an alternative member.)
the second instantaneous suitability parameter of the alternative medical member …having a value and characterizing a procedure-specific instantaneous suitability of the alternative medical member of …operating staff … (Shelton teaches the computer system…indicate when the surgical staff is deviating from the baseline so that the surgical staff can alter their actions and optimize their performance or technique. In some aspects, the notifications can include warnings that the surgical staff is not utilizing proper technique …, suggestions for alternative surgical products, statistics regarding correlations between procedural variables…and the monitored physical characteristics of the surgical staff, comparisons between surgeons,…[0310]. The baseline physical characteristic can be determined or calculated from data aggregated from all of the surgical hubs 211801 that are communicably connected to the cloud computing system, which allows for the cloud computing system to compare surgical staff members' 211803 techniques across a number of medical facilities [0318].)
wherein the alternative medical member of …operating staff is equipped to …control the medical device (Shelton teaches providing notifications when a staff member is deviating from a baseline posture can be beneficial to alert unaware users as to their risky conduct so that they can take corrective actions or allow other individuals to take corrective actions (e.g., swap a fatigued staff member for a fresher individual) [0319].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the remote control unit for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate the monitoring of the operating staff and a determination when the staff member lowers in suitability as taught by Shelton. This modification would create a system and method which is capable of identifying when the performance of the staff member below the standard and ensures the procedure runs properly and safely (see Shelton, ¶ 0007).
Hannaford and Shelton do not teach comparing the suitability of the two members to one another which is met by Makrinich:
wherein in the case of affirmation in the identifying, the method further comprises comparing the first instantaneous suitability parameter of the medical member of …operating staff and the second instantaneous suitability parameter of the alternative medical member of…operating staff, (Makrinich teaches displaying information from two medical professionals in a side-by-side fashion, in a table, in a graph, or in another visual arrangement that compares data between the professionals. This display allows a medical professional to compare his or her statistics against statistics of other medical professionals. For example, the display may depict a quantity of fluid leaks associated with a particular surgeon alongside a quantity of fluid leaks associated with a different surgeon. Comparisons can be made for any surgical-event related category… [0101].)
and wherein the… alternative control…is provided as a function of the comparison of the first instantaneous suitability parameter and the second instantaneous suitability parameter (Makrinich teaches when a surgeon is needed for a particular surgery, the surgeon may be selected based on a comparison of the multiple surgeons scores related to the particular surgery. For example, the surgery may be a spinal disk replacement. Accordingly, the surgeon with the highest competency-related score for spinal disk replacement procedures may be selected [0283]. The Examiner interprets this as selecting the member that is best suited based on comparison for control of the procedure.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the remote control unit for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate the comparison of medical members and the selection of the most suitable member for control as taught by Makrinich. This modification would create a system and method which improves analysis of a medical professionals performance to enhance surgeries (see Makrinich, ¶ 0099).
Regarding Claim 17, this Claim recites limitations that are substantially similar to those recited in Claim 1 above; thus, the same rejection applies. Hannaford does not disclose the following limitations met by Shelton:
non-transitory computer-readable storage medium that stores instructions executable by one or more processor (Shelton teaches the non-transitory computer-readable medium includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer) [0357].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate the use of a non-transitory computer-readable storage medium as taught by Shelton. This modification would create a system and method which is capable of performing various steps that can be stored within a memory in the system (see Shelton, ¶ 0357).
Regarding Claim 3, Hannaford, Shelton, and Makrinich teach the limitations as seen in the rejection of Claim 1 above. Hannaford discloses the following:
wherein providing the …control signal comprises … remote control of the medical device by the … medical member of remote operating staff using the …remote control unit. (Hannaford discloses the present methods, devices, systems, etc., are related to a local surgical cockpit comprising …and a remote surgical console configured such that the operator can operate the console for remote surgery while in the seat [0008].)
Hannaford does not disclose the following limitations met by Shelton:
…changeover…to…control of the medical device by an alternative member of…operating staff using an alternative…control (Shelton teaches providing notifications when a staff member is deviating from a baseline posture can be beneficial to alert unaware users as to their risky conduct so that they can take corrective actions or allow other individuals to take corrective actions (e.g., swap a fatigued staff member for a fresher individual) [0319].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate switching to an alternative staff member when the current member becomes less suitable as taught by Shelton. This modification would create a system and method which is capable of identifying when the performance of the staff member below the standard and ensures the procedure runs properly and safely (see Shelton, ¶ 0007).
Regarding Claim 4, Hannaford, Shelton, and Makrinich teach the limitations as seen in the rejection of Claim 1 above. Hannaford further discloses:
providing the …control signal (Hannaford discloses the systems … configured to be manipulated by the operator to generate control signals for a corresponding remote device at a remote operation site [0030].)
Hannaford does not disclose the following limitations met by Shelton:
providing the alternative… (Shelton teaches providing notifications when a staff member is deviating from a baseline posture can be beneficial to alert unaware users as to their risky conduct so that they can take corrective actions or allow other individuals to take corrective actions (e.g., swap a fatigued staff member for a fresher individual) [0319].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate switching to an alternative staff member when the current member becomes less suitable as taught by Shelton. This modification would create a system and method which is capable of identifying when the performance of the staff member below the standard and ensures the procedure runs properly and safely (see Shelton, ¶ 0007).
Hannaford and Shelton do not teach the following limitations met by Makrinich:
… providing a member of on-site operating staff with a workflow indication for on-site operation of the medical device, for carrying out a further procedural step, or for a combination thereof. (Makrinich teaches the information may be provided during the medical procedure. For example, this may include generating an alert or notification for a physician performing the medical procedure, which may inform the physician of a correct procedure to follow…the information may be provided to nurses, technicians, support staff, medical facility administrators, or the like [0329].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate providing on-site staff with instructions as taught by Makrinich. This modification would create a system and method which is capable of executing optimal procedures (see Makrinich, ¶ 0007).
Regarding Claim 5, Hannaford, Shelton, and Makrinich teach the limitations as seen in the rejection of Claim 1 above. Hannaford and Shelton do not teach the following limitations met by Makrinich:
wherein the capturing and the identifying are repeatedly executed until a termination condition occurs. (Makrinich teaches when a video feed is a real time broadcast of the surgical procedure, the operations may be repeated after a certain quantity of video frames from a video feed is received. The operations are continuously repeated to ascertain during the surgical procedure when the surgical instrument is projected to deviate from the surgical plane [0165-166].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate repeatedly carrying out the steps until an optimal condition occurs as taught by Makrinich. This modification would create a system and method which is capable of executing optimal procedures (see Makrinich, ¶ 0007).
Regarding Claim 11, Hannaford and Shelton teach the limitations as seen in the rejection of Claim 1 above. Hannaford further discloses:
Sensor unit repeatedly captures… movement the medical member of remote operating staff (Hannaford discloses the present methods, devices, systems, etc., are related to a local surgical cockpit comprising …and a remote surgical console configured such that the operator can operate the console for remote surgery while in the seat [0008]. The local surgical cockpit can be part of a system and the system further can comprise remote image sensors operably connected to the head-mounted display to transmit the image of the remote surgical site [0011].)
Hannaford does not disclose the following limitations met by Shelton:
wherein the sensor unit repeatedly captures a positioning, movement, or positioning and movement of the member of remote operating staff, wherein the identifying comprises identifying an atypical positioning, movement, or positioning and movement of the medical member of …operating staff, (Shelton teaches accordingly, the processor 244 determines 211008 a physical characteristic of one or more surgical staff members from the captured image(s). For example, the physical characteristic can include posture, as discussed in connection with FIGS. 18-19, or wrist angle, [0315].)
and wherein the existence of an atypical positioning, a movement, or atypical positioning and movement of the medical member of …operating staff is identified as a reduction in suitability. (Shelton teaches providing notifications when a staff member is deviating from a baseline posture can be beneficial to alert unaware users as to their risky conduct so that they can take corrective actions or allow other individuals to take corrective actions (e.g., swap a fatigued staff member for a fresher individual) [0319].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate the monitoring of the operating staff positioning to use as a determination of suitability as taught by Shelton. This modification would create a system and method which is capable of identifying when the performance of the staff member below the standard and ensures the procedure runs properly and safely (see Shelton, ¶ 0007).
Regarding Claim 12, Hannaford, Shelton, and Makrinich teach the limitations as seen in the rejection of Claim 1 above. Hannaford further discloses:
wherein the medical device comprises a medical imaging device, a medical treatment device, a remote manipulation unit for robotic movement of a medical object, or any combination thereof. (Hannaford discloses the systems…are directed to a local surgical cockpit comprising a local surgical console configured for transmitting surgical movements of an operator operating the local surgical console to a remote surgery site, and comprising at least seven degrees of freedom for a local surgical instrument manipulated by a robotic arm manipulated by the operator [0018].)
Regarding Claim 13, Hannaford discloses the following:
A system..., (Hannaford discloses the present systems…comprise local surgical cockpits comprising local surgical consoles [0006].)
wherein the medical member of remote operating staff is equipped to remotely control the medical device using the remote control unit, (Hannaford discloses the present methods, devices, systems, etc., are related to a local surgical cockpit comprising …and a remote surgical console configured such that the operator can operate the console for remote surgery while in the seat [0008].)
wherein the remote control unit is configured to provide the medical device with a control signal, (Hannaford discloses the systems…are directed to a local surgical cockpit comprising a local surgical console configured for transmitting surgical movements of an operator operating the local surgical console to a remote surgery site, and comprising at least one virtual console control knob presented virtually to the operator and configured to be manipulated by the operator to generate control signals for a corresponding remote device at a remote operation site [0030].)
a sensor unit for capturing the medical member of remote operating staff, or the remote control unit and the sensor unit, (Hannaford discloses the local surgical cockpit can be part of a system and the system further can comprise remote image sensors operably connected to the head-mounted display to transmit the image of the remote surgical site [0011]. The local surgical cockpit can be part of a system and the system further can comprise remote 3-dimensional audio sensors operably connected to the local 3-dimensional audio such that the local 3-dimensional audio precisely transmit 3-dimensional audio signals from the remote 3-dimensional audio sensors [0037].)
wherein the remote control unit is configured to capture a user input of the medical member of remote operating staff, (Hannaford discloses an input device disposed at a hand of the operator and operably linked to provide input to a corresponding device located at the remote surgical site [0010].)
and wherein the medical device is configured to be remotely controlled by the control signal. (Hannaford discloses the systems…are directed to a local surgical cockpit comprising a local surgical console configured for transmitting surgical movements of an operator operating the local surgical console to a remote surgery site, and comprising at least one virtual console control knob presented virtually to the operator and configured to be manipulated by the operator to generate control signals for a corresponding remote device at a remote operation site [0030].)
Hannaford does not disclose the following limitations met by Shelton:
and a medical device configured to monitor … control suitability, the…control suitability comprising capture, by a sensor of a sensor unit, of an instantaneous suitability parameter of a medical member of …operating staff, (Shelton teaches the surgical hub 211801 executing the process 211000 can analyze the posture of a surgical staff member and provide recommendations if the staff member's posture deviates from the baseline. Poor, unexpected, or otherwise improper posture can indicate, for example, that the surgeon is fatigued, is having difficulty with a particular surgical step, is utilizing the surgical instrument incorrectly, has positioned the surgical instrument incorrectly, or is otherwise acting in a potentially risky manner that could create danger [0319]. In various aspects, the imaging device 124 includes at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, Charge-Coupled Device (CCD) sensors and Complementary Metal-Oxide Semiconductor (CMOS) sensors [0196].)
and wherein the instantaneous suitability parameter is provided by the [remote control unit], (Shelton teaches determining, by the computer system, a physical characteristic of the individual…; retrieving, by the computer system, a baseline physical characteristic corresponding to the surgical context; and determining, by the computer system, whether the physical characteristic of the individual deviates from the baseline (Claim 9). Shelton teaches the suitability is determined via a computer system, not a remote control unit. It would have been obvious to combine the teachings of Shelton and Hannaford to have the remote control unit disclosed by Hannaford determine the suitability parameter.)
wherein the provisioning unit is configured to identify, based on the instantaneous suitability parameter, whether reduction in the suitability of the member of remote operating staff exists, (Shelton teaches determining, by the computer system, whether the physical characteristic of the individual deviates from the baseline physical characteristics [0009, Fig. 15]. A posture that deviates from the baseline characteristic is considered a reduction in suitability.)
wherein in the case of affirmation in the identification, the provisioning unit is configured to provide the medical device with the alternative control signal, (Shelton teaches providing notifications when a staff member is deviating from a baseline posture can be beneficial to alert unaware users as to their risky conduct so that they can take corrective actions or allow other individuals to take corrective actions (e.g., swap a fatigued staff member for a fresher individual) [0319].)
wherein in the case of negation in the identification, the remote control unit is configured to provide the medical device with the control signal as a function of the user input, (Shelton teaches the surgical hub 211801 can be programmed to be especially sensitive to deviations between the surgical staff members performance and the corresponding baselines so that the surgical hub 211801 can reinforce the proper techniques for using the surgical device when the trial period is ongoing [0330]. This is interpreted as if the user continues the procedure properly, the system allows them to continue.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate the monitoring of the operating staff and a determination when the staff member lowers in suitability as taught by Shelton. This modification would create a system and method which is capable of identifying when the performance of the staff member below the standard and ensures the procedure runs properly and safely (see Shelton, ¶ 0007).
Regarding Claim 14, Hannaford, Shelton, and Makrinich teach the limitations as seen in the rejection of Claim 13 above. Hannaford does not disclose the sensor unit determining the suitability parameter which is met by Shelton:
further comprising the sensor unit configured to capture the first instantaneous suitability parameter and the second instantaneous suitability parameter. (Shelton teaches the visualization system 108 includes one or more imaging sensors, one or more image-processing units, one or more storage arrays, and one or more displays that are strategically arranged with respect to the sterile field, as illustrated in FIG. 2 [0203]. The notifications can include… comparisons between surgeons, and so on …the computer system can be programmed to automatically analyze and compare staff members' techniques and instrument usage skills [0310]. The Examiner interprets the analyzing of different staff member’s techniques as the analysis of an alternative member.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate the sensor capturing a suitability parameter of the staff member as taught by Shelton. This modification would create a system and method which is capable of identifying when the performance of the staff member below the standard and ensures the procedure runs properly and safely (see Shelton, ¶ 0007).
Regarding Claim 15, Hannaford, Shelton, and Makrinich teach the limitations as seen in the rejection of Claim 13 above. Hannaford further discloses:
the …remote control unit, (Hannaford discloses the present methods, devices, systems, etc., are related to a local surgical cockpit comprising …and a remote surgical console configured such that the operator can operate the console for remote surgery while in the seat [0008]. Configured to be manipulated by the operator to generate control signals for a corresponding remote device at a remote operation site [0030].))
wherein the medical device is further configured to be remotely controlled by the alternative control signal. (Hannaford discloses the systems and methods, etc., herein can also comprise a modular approach wherein multiple surgical consoles can network supporting collaborative surgery regardless of the physical location of the surgeons or other operators relative to each other and/or relative to the surgical site [0006].)
capture an …user input… (Hannaford discloses an input device…linked to provide input to a corresponding device located at the remote surgical site [0010].)
Hannaford does not disclose the following limitations met by Shelton:
the alternative medical member… (Shelton teaches providing notifications when a staff member is deviating from a baseline posture can be beneficial to alert unaware users as to their risky conduct so that they can take corrective actions or allow other individuals to take corrective actions (e.g., swap a fatigued staff member for a fresher individual) [0319].)
and on presentation of a reduction in the first instantaneous suitability of the medical member of … operating staff, provide the medical device with the alternative … as a function of the alternative user input, (Shelton teaches the computer system can be programmed to provide notifications or prompts that indicates when the surgical staff is deviating from the baseline so that the surgical staff can alter their actions and optimize their performance [0310]. Therefore, monitoring the surgical staff members' postures during the course of a surgical procedure and providing notifications when a staff member is deviating from a baseline posture can be beneficial to alert unaware users as to their risky conduct so that they can take corrective actions or allow other individuals to take corrective actions (e.g., swap a fatigued staff member for a fresher individual) [0319].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate the use of an alternative member to conduct the procedure as taught by Shelton. This modification would create a system and method which is capable of identifying when the performance of the staff member below the standard and ensures the procedure runs properly and safely (see Shelton, ¶ 0007).
Hannaford and Shelton do not teach the following limitations met by Makrinich:
wherein the alternative remote control unit is configured to: capture an alternative user input of the alternative medical member… (Makrinich teaches displaying information from two medical professionals in a side-by-side fashion…that compares data between the professionals. This display allows a medical professional to compare his or her statistics against statistics of other medical professionals…the display may depict a quantity of fluid leaks associated with a particular surgeon alongside a quantity of fluid leaks associated with a different surgeon. Comparisons can be made for any surgical-event related category… [0101]. The surgeon may be selected based on a comparison of the multiple surgeons scores related to the particular surgery. For example, the surgery may be a spinal disk replacement. Accordingly, the surgeon with the highest competency-related score for spinal disk replacement procedures may be selected [0283].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the remote control unit for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate comparing the suitability of the alternative member as compared to the current member as taught by Makrinich. This modification would create a system and method which improves analysis of a medical professionals performance to enhance surgeries (see Makrinich, ¶ 0099).
Regarding Claim 16, Hannaford, Shelton, and Makrinich teach the limitations as seen in the rejection of Claim 13 above. Hannaford further discloses:
a remote control unit…remote operating staff (Hannaford discloses the present methods, devices, systems, etc., are related to a local surgical cockpit comprising …and a remote surgical console configured such that the operator can operate the console for remote surgery while in the seat [0008].)
Hannaford does not disclose the limitations met by Shelton:
on presentation of a reduction in instantaneous suitability of …operating staff, (Shelton teaches providing notifications when a staff member is deviating from a baseline posture can be beneficial to alert unaware users as to their risky conduct so that they can take corrective actions or allow other individuals to take corrective actions (e.g., swap a fatigued staff member for a fresher individual) [0319].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate the use of an alternative member to conduct the procedure as taught by Shelton. This modification would create a system and method which is capable of identifying when the performance of the staff member below the standard and ensures the procedure runs properly and safely (see Shelton, ¶ 0007).
Hannaford and Shelton do not teach the limitations met by Makrinich:
further comprising an output unit that,… is configured to provide a member of on-site operating staff with a workflow indication for on-site operation of the medical device, for carrying out a further procedural step, or for a combination thereof. (Makrinich teaches the information may be provided during the medical procedure. For example, this may include generating an alert or notification for a physician performing the medical procedure, which may inform the physician of a correct procedure to follow…the information may be provided to nurses, technicians, support staff, medical facility administrators, or the like [0329]. The alert/notification being provided it interpreted as the output.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate providing on-site staff with instructions via an output as taught by Makrinich. This modification would create a system and method which is capable of executing optimal procedures (see Makrinich, ¶ 0007).
Regarding Claim 18, Hannaford, Shelton, and Makrinich teach the limitations as seen in the rejection of Claim 1 above. Hannaford and Shelton do not teach the following limitations met by Makrinich:
the sensor unit includes an optical sensor, an acoustic sensor, a mechanical sensor, or any combination thereof configured to capture the medical member of remote operating staff. (Makrinich teaches room 101 may include one or more microphones (e.g., audio sensor 111, as shown in FIG. 1), several cameras (e.g., overhead cameras 115, 121, and 123, and a tableside camera 125) for capturing video/image data during surgery [0060].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the remote control unit for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate the use of an acoustic sensor to capture the medical member as taught by Makrinich. This modification would create a system and method which improves analysis of a medical professionals performance to enhance surgeries (see Makrinich, ¶ 0099).
Regarding Claim 19, Hannaford, Shelton, and Makrinich teach the limitations as seen in the rejection of Claim 1 above. Hannaford does not disclose the following limitations met by Shelton:
the value of the first instantaneous suitability parameter rates a bodily suitability, a cognitive suitability, a technical suitability, or any combination thereof of the medical member of remote operating staff for monitoring, remotely controlling, or monitoring and remotely controlling the medical device. (Shelton teaches the notifications can include warnings that the surgical staff is not utilizing proper technique (which can further include recommendations on corrective actions that the surgical staff can take to address their technique),… [0310]. The processor 244 determines 211008 a physical characteristic of one or more surgical staff members from the captured image(s) [0315].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the remote control unit for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate the suitability parameters including a bodily and/or technical suitability as taught by Shelton. This modification would create a system and method which is capable of identifying when the performance of the staff member below the standard and ensures the procedure runs properly and safely (see Shelton, ¶ 0007).
Claims 6-8 are rejected under 35 USC § 103 as being unpatentable over Hannaford, Shelton, and Makrinich in view of Shirado et al. (US 20140032281 A1).
Regarding Claim 6, Hannaford, Shelton, and Makrinich teach the limitations as seen in the rejection of Claim 1 above. Hannaford further discloses:
further comprising identifying a procedural step using procedural planning, the control signal, or the procedural planning and the control signal, (Hannaford discloses the at least one virtual console control knob can be a binary switch configured to provide on/off signals to the corresponding remote device. The at least one virtual console control knob can be a gradual control knob configured to provide gradual control signals to the corresponding remote device [0031]. The display device can further display further augmented information …can comprise …a preplanned trajectory for a surgical tool [0014].)
Hannaford and Shelton do not teach the following limitations met by Shirado:
wherein the identifying comprises comparing a number of attempts to execute the procedural step with a specified maximum value, execution of the procedural step with a specified desired execution, or a combination thereof. (Shirado teaches the operational skill parameter acquiring unit of the evaluation …is configured to acquire the number of errors in remote control performed by an operator as an operational skill parameter [0021]. The number of errors is interpreted as number of attempts, as the step would need to be redone if an error occurred.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate determining the number of attempts it takes to execute the procedure as taught by Shirado. This modification would create a system and method which is capable of evaluating the skill of the worker and ensure the procedure is carried out precisely (see Shirado, ¶ 0006).
Regarding Claim 7, Hannaford, Shelton, Makrinich, and Shirado teach the limitations as seen in the rejection of Claim 6 above. Shelton further teaches:
further comprising receiving the maximum value, the desired execution, or the combination thereof from a data storage unit, (Shelton teaches the surgical hub 5104 can be configured to determine the type of surgical procedure being performed, retrieve the corresponding checklists, product location, or setup needs (e.g., from a memory), and then compare the current operating theater layout to the standard layout for the type of surgical procedure that the surgical hub 5104 determines is being performed [0290]. The Examiner interprets the surgical setup needs as the desired execution which is saved in a memory.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate the desired execution being retrieved from a data storage as taught by Shelton. This modification would create a system and method which is capable of ensuring the procedure is carried out according to the standards (see Shelton, ¶ 0007).
Hannaford, Shelton, and Makrinich do not teach the following limitation met by Shirado:
wherein the maximum value, the desired execution, or the combination thereof is specified according to a standardized or statistical execution of the procedural step. (Shirado teaches data analysis may further employ outcome analytics processing, and using standardized approaches may provide beneficial feedback to either confirm surgical treatments and the behavior of the surgeon or suggest modifications to surgical treatments and the behavior of the surgeon [0237].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate determining the desired execution as specified by the standardized execution of the procedural step as taught by Shirado. This modification would create a system and method which is capable of evaluating the skill of the worker and ensure the procedure is carried out precisely (see Shirado, ¶ 0006).
Regarding Claim 8, Hannaford, Shelton, Makrinich and Shirado teach the limitations as seen in the rejection of Claim 6 above. Hannaford and Shelton do not teach the limitations met by Makrinich:
further comprising adapting the maximum value, the desired execution, or the combination thereof to a historic operating behavior of the medical member of remote operating staff for execution of the procedural step. (Makrinich teaches the at least one associated surgical event may be selected automatically, for example based on the selection of the particular surgical event-related category, based on past behavior of a user… [0107]. System 401 may include a database 411 for storing various types of data related to previously conducted surgeries (i.e., historical surgical data that may include historical image, video or audio data, text data, doctors' notes, data obtained by analyzing historical surgical data, and other data relating to historical surgeries) [0129].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate determining the desired execution based upon the historical operating behavior of the staff as taught by Makrinich. This modification would create a system and method which is capable of determining the staff member’s typical behavior (see Makrinich, ¶ 0007).
Claims 9 and 10 are rejected under 35 USC § 103 as being unpatentable over Hannaford, Shelton, and Makrinich in view of Onishi et al. (US 20210176175 A1).
Regarding Claim 9, Hannaford, Shelton, and Makrinich teach the limitations as seen in the rejection of Claim 1 above. Hannaford further discloses:
wherein a verbal communication of the medical member of remote operating staff is captured by the remote control unit, the sensor unit, or the remote control unit and the sensor unit, (Hannaford discloses the local surgical cockpit can be part of a system and the system further can comprise remote 3-dimensional audio sensors operably connected to the local 3-dimensional audio such that the local 3-dimensional audio precisely transmit 3-dimensional audio signals from the remote 3-dimensional audio sensors [0037]. The head-mounted display…which retention structure can be actuated by at least one hand control located on the cockpit, or by voice control or otherwise as desired [0011].)
Hannaford, Shelton, and Makrinich do not teach the following limitations met by Onishi:
wherein the identifying comprises identifying a change in communication, and wherein the existence of a change in communication is identified as a reduction in a suitability of the medical member of remote operating staff. (Onishi teaches the derivation unit 104 makes a determination about existence of a change in a communication state by determining whether a terminal is in a communication state [0063].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate identifying a change in communication as taught by Onishi. This modification would create a system and method which is capable identifying potential issues in communication (see Onishi, ¶ 0007).
Regarding Claim 10, Hannaford, Shelton, and Makrinich teach the limitations as seen in the rejection of Claim 1 above. Hannaford, Shelton, and Makrinich do not teach the following limitations met by Shelton:
… is identified as a reduction in suitability (Shelton teaches the surgical hub 211801 executing the process 211000 can analyze the posture of a surgical staff member and provide recommendations if the staff member's posture deviates from the baseline. Poor, unexpected, or otherwise improper posture can indicate, for example, that the surgeon is fatigued, is having difficulty with a particular surgical step, is utilizing the surgical instrument incorrectly, has positioned the surgical instrument incorrectly, or is otherwise acting in a potentially risky manner that could create danger [0319].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the remote control unit for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate the monitoring of the operating staff and a determination when the staff member lowers in suitability as taught by Shelton. This modification would create a system and method which is capable of identifying when the performance of the staff member below the standard and ensures the procedure runs properly and safely (see Shelton, ¶ 0007).
Hannaford, Shelton, and Makrinich do not teach querying a medical member and detecting a delayed response which is met by Onishi:
the remote control unit repeatedly queries a status of the medical member of remote operating staff, and wherein a delayed, an incorrect, or a missing input by the medical member of remote operating staff in response to the query…(Onishi teaches the derivation unit 104 also specifies a …increase or decrease in a communication delay, or a communication rate, or any combination thereof related to the terminal [0062].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate identifying a delayed response in communication as taught by Onishi. This modification would create a system and method which is capable identifying potential issues in communication (see Onishi, ¶ 0007).
Response to Arguments
Regarding rejections under 35 USC 101 to Claims 1 and 3-19, Applicant’s arguments have been considered but are not persuasive. The rejection has been updated in light of the amendments above.
Regarding rejections under 35 USC 103 to Claims 1 and 3-19, Applicant’s arguments have been considered but are not persuasive. The rejection has been updated in light of the amendments above.
Applicant argues, with regard to Claim 1, that Shelton et al. and Bhatt et al. do not fill the gaps not met by Hannaford. Shelton et al. do not teach or disclose “the instantaneous alternative control signal is provided as a function of the comparison of the first instantaneous suitability parameter and the second instantaneous suitability parameter,” (see Applicant’s remarks, p. 14-15).
Applicant’s arguments are rendered moot, as the rejection of Claim 1 has been updated in light of the amendments, rejecting the claim over Hannaford in view of Shelton and Makrinich.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA R GEDRA whose telephone number is (571)270-0944. The examiner can normally be reached Monday - Friday 8:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter H Choi can be reached at (469)295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA R. GEDRA/Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681