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 .
Status of Claims
This action is in reply to the present action filed on 06/05/2026.
Claims 1, 13, 17, and 19 have been amended.
Claims 20 and 21 have been added.
Claims 1 and 3-21 are currently pending and have been examined.
This action is made FINAL.
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 3-21 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 18-21 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 in real-time, 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, automatically providing the medical device with an alternative [instructions] control signal;
and in the case of negation in the identifying, automatically providing the medical device with the [instructions] control signal; and
capturing, by a second sensor of the sensor unit in real-time, 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 automatically 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 alternative [instructions] control signal is automatically provided as a function of the comparison of the first instantaneous suitability parameter and the second instantaneous suitability parameter, and
wherein the value of the first instantaneous suitability parameter and the value of the second instantaneous suitability parameter include a real-time suitability rating of the medical member and the alternative medical member of remote operating staff, respectively, for monitoring, remotely controlling, or monitoring and remotely controlling the medical device.
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, wherein the suitability parameter includes a suitability rating of the medical member and alternative member of remote operating staff), 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 19-21 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 first and second instantaneous suitability parameters rate, in real-time. Claim 20 recites in the case of affirmation in the identifying, providing an alternate [instruction] as a function of an alternative user input. Claim 21 recites automatically routing control. 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 3-11, 14-16, and 19-21 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 14-21 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. Claim 20 recites the medical device, control signal, and alternative control signal and specifies automatically providing the medical device with the alternative control signal as a function of an alternative user input of the alternative medical member or providing the medical device with the control signal as a function of a user input of the medical member. Claim 21 recites the medical device and alternative remote control signal and specifies automatically routing, by a provisioning unit (a new additional element), control of the medical device from the remote control unit to the alternative remote control unit or an output unit of 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, whether considered individually or as an ordered combination, 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, 14, and 20 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. Claim 20 recites the medical device, control signal, and alternative control signal and specifies automatically providing the medical device with the alternative control signal as a function of an alternative user input of the alternative medical member or providing the medical device with the control signal as a function of a user input of the medical member.
Dependent Claims 7, 12, 16, 18, and 21 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. Claim 21 recites the medical device and alternative remote control signal and specifies automatically routing, by a provisioning unit (new element), control of the medical device from the remote control unit to the alternative remote control unit or an output unit of the medical device. Hence, Claims 3-12 and 14-21 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 3-21 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, and 21 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 present 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,… for monitoring, remotely controlling, or monitoring and remotely controlling the medical device. (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 in real-time, 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]. Any one of or all of the devices 1a-1n/2a-2m coupled to the network hub or network switch may collect data in real time and transfer the data to cloud computers for data processing and manipulation [0236].)
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.)
…automatically providing the medical device with…control signal… automatically providing the medical device with the control signal… (Shelton teaches proactively and automatically controlling the paired modular devices 5102 according to the particular step of the surgical procedure that is being performed to reduce the number of times that medical personnel are required to interact with or control the surgical system 5100 during the course of a surgical procedure [0287].)
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. Any one of or all of the devices 1a-1n/2a-2m coupled to the network hub or network switch may collect data in real time and transfer the data to cloud computers for data processing and manipulation [0236].)
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].)
…a real-time suitability rating of the medical member… (Shelton teaches computer systems described herein are programmed to evaluate the surgical staff during the course of a surgical procedure (e.g., how they are using surgical instruments) and propose suggestions to improve the surgical staff members' techniques… the computer system can be programmed to provide notifications or prompts that indicate when the surgical staff is deviating from the baseline so that the surgical staff can alter their actions and optimize their performance or technique…the notifications or recommendations can be provided either in real time (e.g., in the OR during the surgical procedure) or in a post-procedure report. Accordingly, the computer system can be programmed to automatically analyze and compare staff members' techniques and instrument usage skills [0310].)
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 in real time 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…suitability parameter of the medical member of …operating staff and the second…suitability parameter of the alternative medical member of… the 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 automatically provided as a function of the comparison of the first…suitability parameter and the second… suitability parameter… and wherein the value of the first …suitability parameter and the value of the second…suitability parameter include a…suitability rating of the medical member and the alternative medical member of remote operating staff, respectively,… (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. [T]he disclosed embodiments provide solutions for automated assessment of surgical competency and presenting surgical video clips associated with the assessment thereby enabling object, accurate, and efficient review of persons performing or otherwise involved with surgical procedures. [0240].)
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).
Regarding Claim 21, Hannaford, Shelton, and Makrinich teach the limitations as seen in the rejection of Claim 1 above. Hannaford discloses the following:
wherein…providing the medical device with the…control signal comprises… control of the medical device (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:
automatically routing, by a provisioning unit,… (Shelton teaches proactively and automatically controlling the paired modular devices 5102 according to the particular step of the surgical procedure that is being performed…[0287].)
control of the medical device from the …control unit to the alternative …or an output unit of 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]. The notifications or recommendations can be provided either in real time (e.g., in the OR during the surgical procedure) or in a post-procedure report. Accordingly, the computer system can be programmed to automatically analyze and compare staff members' techniques and instrument usage skills [0310].)
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).
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).
Claim 20 is rejected under 35 USC § 103 as being unpatentable over Hannaford, Shelton, and Makrinich in view of Seifert et al. (US 20120107784 A1).
Regarding Claim 20, Hannaford, Shelton, and Makrinich teach the limitations as seen in the rejection of Claim 1 above. Hannaford further discloses:
…providing the medical device with 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:
wherein in the case of affirmation in the identifying, automatically 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].)
and wherein in the case of negation in the identifying, automatically providing the medical device with the control…comprises automatically 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.)
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 providing an alternative medical member as a function of a user input which is met by Seifert:
the alternative …signal as a function of an alternative user input of the alternative medical member, …as a function of a user input of the medical member. (Seifert teaches when the button 26 is pressed or touched, the surgeon 16 or medical personal can obtain several types of help. Activating or pressing the button 26 sends a signal that requests assistance during a surgical procedure. In one example, the button 26 can be pressed to provide immediate technical support [0013]. The Examiner interprets the button being pressed as user input of the medical 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 remote control unit for remote operation of a medical device using a remote control and sensor as disclosed by Hannaford to incorporate user input resulting in an alternative user as taught by Seifert. This modification would create a method which can mitigate frustration, stress and operating room time (see Seifert, ¶ 0002).
Response to Arguments
Regarding rejections under 35 USC 101 to Claims 1 and 3-21, Applicant’s arguments have been considered but are not persuasive. The rejection has been updated in light of the amendments above.
Applicant argues claims 1, 13, and 17 include the real-time capture of suitability ratings using sensors and the automatic conditional provisioning of control signals. Claims 1, 13, and 17 now recite a specific framework that transforms live sensor data (e.g., real-time sensor data) into an automated routing (or provisioning) of control signals for a medical device (e.g., automatically providing the medical device with the alternative control signal based on a real-time suitability rating). See, specification, [0013]-[0015] and [0027]. The limitations, specifically automatically provisioning an alternative control signal to a medical device during a real-time medical procedure, are not merely directed to an abstract idea (see Applicant’s Remarks, p. 13).
Regarding (a), Examiner respectfully disagrees. There is nothing in the independent claims that provides an indication for what “the medical device being provided with the alternative control signal” entails. Therefore, using broadest reasonable interpretation, although the control signal is an additional element, the information provided on the signal can be interpreted as merely a workflow which is entirely abstract and therefore cannot provide a practical application. Furthermore, efficiency (i.e., “automatically” and “real-time”) is not enough to amount to a practical application via an improvement to computer or technology (see MPEP § 2106.05(a)(I) examples that the courts have indicated may not be sufficient to show an improvement in computer-functionality: ii. accelerating a process of analyzing audit log data when the increased speed comes solely from the capabilities of a general-purpose computer, FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089, 1095, 120 USPQ2d 1293, 1296 (Fed. Cir. 2016)) (also see MPEP § 2106.05(f)(2) stating “"claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not provide an inventive concept (Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367 (Fed. Cir. 2015)”), and, thus, the combination of the generic computer components do not provide a non-conventional and non-generic arrangement of known, conventional pieces; note this is applied to Step 2B as well as Step 2A Prong 2).
Applicant argues that the claimed limitations go beyond "Mental Processes" and instead integrate into a practical application by providing a specific tool for routing control signals from different units to a medical device based on a real-time sensor-captured suitability rating, and do not merely recite calculating a parameter or organizing human activity. Specifically, the claimed limitations present a specific, concrete technical improvement in provisioning remote control signals to a medical device, such as automating a conditional switchover of control signals during an active procedure, thus enabling precise control of the medical device rather than generic observation of human activity. See, id., paras. [0024]-[0027]. The claimed limitations provide a framework that identifies how the system behaves by physically provisioning control signals (e.g., automatically provisioning an alternative control signal conditioned upon an event), rather than merely identifying that a parameter has changed (see Applicant’s Remarks, p. 13-14).
Regarding (b), Examiner respectfully disagrees. Examiner firstly notes that the claims are not identified in the rejection as being mental processes, but rather they are identified as reciting certain methods of organizing human activity. Further, there is nothing in the independent claims that provide any indication regarding what the providing of the alternative control signal entails or when such control signal is provided. Examiner notes that Claim 4 indicates “providing the alternative control signal comprises 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”. Such embodiment of an alternative control signal provides no practical application as a workflow is an entirely abstract idea and is not aligned with the argued control of a medical device argued above.
Applicant argues the claimed limitations enable the system to evaluate the suitability of a medical member of a remote operating staff and handle control signals accordingly, not through general monitoring, but through the specific computational arrangement of comparing sensor-captured ratings in real-time to trigger an automatic conditional handoff to an alternative control signal. See, id., paras. [0020], [0021], and [0027]. This specific technical configuration solves a problem in complex medical environments where manual "mental" evaluation of remote operating staff "suitability" or crossover/switchover coordination (e.g., based on the evaluation) is difficult or impossible for a human operator to perform with high precision. The claimed limitations require sensor capture, where the identified state (e.g., a real-time suitability rating satisfying a condition) is used to govern safe, automated provisioning of control to the medical device (p. 14).
Regarding (c), Examiner respectfully disagrees. There is nothing in the independent claims that indicate what the trigger for the switchover of the control signal entails. Examiner notes that there is nothing specific about the computational arrangement in the independent claims and the additional elements of the medical device, sensor unit, remote control, and control signal are recited at such a high level of generality, and employing generic devices to execute an abstract idea does not add a practical application, similar to how limiting the abstract idea in Flook to petrochemical and oil-refining industries was insufficient. Applicant argues the “specific technical configuration” is difficult or impossible for a human operator to perform with high precision. Examiner disagrees because there is nothing in the identified abstract idea that cannot be carried out by a human following rules or steps to carry out the limitations. The claims are recited at such a high level of generality such that there are no specifications in the independent claims regarding what level of suitability is required for a change over of the control signal. There is no indication in the independent claims regarding what providing the alternative control signal entails.
Applicant argues the rejection under 35 U.S.C. § 101 improperly characterizes the "identifying," "capturing," and "providing" steps as a "Mental Processes." See, Office Action, pp. 3-5. The claim limitations recite a specialized multi-sensor configuration that is intrinsically tied to a physical state (e.g., the real-time suitability rating of a medical member) of a remotely controlled medical device setup. Specifically, the use of a real-time (or instantaneous) provisioning mechanism improves the network communication system itself (e.g., accuracy and safety of the signal provisioning/routing itself). A human cannot mentally map real-time sensor-captured ratings to an instantaneous and automatic switchover of an active control signal without the specific aid of the automatic conditional provisioning framework (p. 14-15).
Regarding (d), Examiner respectfully disagrees. Examiner firstly notes that the claims are not grouped as mental processes, but rather certain methods of organizing human activity. Further, the sensor units are not a part of the abstract idea and are additional elements which could provide a practical application. However, such sensor units are recited at a high level of generality such that they amount to no more than generally linking the use of the judicial exception to a technological environment. There is nothing about the “specialized multi-sensor configuration” that makes such limitation an unconventional use for such generic additional element, and there is nothing in the claim that identifies the sensors as being specialized.
Furthermore, efficiency is not enough to amount to a practical application via an improvement to computer or technology under Step 2A Prong 2 (see MPEP § 2106.05(a)(I) examples that the courts have indicated may not be sufficient to show an improvement in computer-functionality: ii. accelerating a process of analyzing audit log data when the increased speed comes solely from the capabilities of a general-purpose computer, FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089, 1095, 120 USPQ2d 1293, 1296 (Fed. Cir. 2016)) (also see MPEP § 2106.05(f)(2) stating “"claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not provide an inventive concept (Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367 (Fed. Cir. 2015)”), and, thus, the combination of the generic computer components do not provide a non-conventional and non-generic arrangement of known, conventional pieces; note this is applied to Step 2B as well as Step 2A Prong 2).
Applicant argues that the limitations are not well-understood, routine, or conventional in the art, because the claimed limitations require a specific conditional sensor-comparison logic to capture a real-time suitability rating and automatically execute a real-time signal switchover. This is a level of structure and functionality that exceeds conventional, generic computer function with respect to remote control of a medical device (p. 15).
Regarding (e), Examiner respectfully disagrees. Examiner notes that if it was asserted in the office action that the additional elements of the claims were well-understood, routine, conventional, then the Examiner would have to provide Berkheimer evidence to support this statement. However, the Office Action groups the additional elements of the claims as generic computer components and generally linking to a technological field of use which do not require any evidence as support. MPEP 2106.07(a)(III) states at Step 2A Prong Two or Step 2B, there is no requirement for evidence to support a finding that the exception is not integrated into a practical application or that the additional elements do not amount to significantly more than the exception unless the examiner asserts that additional limitations are well-understood, routine, conventional activities in Step 2B. The Examiner has not asserted the limitations as well-understood, routine, conventional activities and because of this, does not need to provide Berkheimer evidence.
Applicant argues new dependent claim 21 recites that providing the alternative control signal includes "automatically routing, by a provisioning unit, control of the medical device from the remote control unit to the alternative remote control unit or an output unit of the medical device." In other words, the provisioning unit configured to route control pathways to an alternative remote control unit or an output unit of a medical device (e.g., local medical device) during a medical procedure provides an integration into a practical application that improves the operation of the medical device itself (p. 15).
Regarding (f), Examiner respectfully disagrees. If it is asserted that the invention improves upon a conventional technology, a technical explanation as to how to implement the invention should be present in the specification. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Conversely, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology. An indication that the claimed invention provides an improvement can include a discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art (MPEP § 2106.05(a)). Here, the claims are recited such that they merely claim the idea of a solution or outcome without any details how such solution is accomplished. There is no indication how such a result of routing the control signal is accomplished and no description of the mechanism for accomplishing the result, and therefore the limitation of Claim 21 does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words “apply it”.
Regarding rejections under 35 USC 103 to Claims 1 and 3-21, Applicant’s arguments have been considered but are not persuasive. The rejection has been updated in light of the amendments above.
Applicant argues Hannaford, Shelton, Makrinich, Shirado, and Onishi do not teach "automatically 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," where "the alternative control signal is automatically provided as a function of the comparison of the first instantaneous suitability parameter and the second instantaneous suitability parameter," as recited by independent claim 1. As stated in the Office Action (p. 18), Hannaford and Shelton do not disclose "wherein in the case of affirmation in the identifying, the method further comprises comparing the first instantaneous suitability parameter of the member of remote operating staff and the second instantaneous suitability parameter of the alternative member of remote operating staff," 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." (see Applicant’s Remarks, p. 16-18).
Regarding (a), Examiner respectfully disagrees. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The combination of Hannaford, Shelton, and Makrinich teach all of the limitations of claim 1 and should not be argued individually. Shelton does not teach comparing the suitability parameters of the first and the alternative members, and such limitation is taught by Makrinich. Makrinich does not teach the suitability being in real time. However, Shelton does teach automatically providing control of a device (see Shelton, ¶ 0287). Examiner further notes that using broadest reasonable interpretation, Makrinich selecting the surgeon that is deemed the most suitable by statistics (¶ 0283) is a function of a comparison of suitability parameters.
Applicant argues that the user-interfaced comparison and selection in Makrinich et al. is not an "automatic" comparison. Further, historical statistics or scores are not instantaneous or real-time parameters. At most, Makrinich et al. disclose "automatically" verifying video clips, "automatically" assessing deviations in techniques, and/or "automatically" assigning a particular surgeon to a particular prospective surgical procedure. See, paras. [0225], [0345], and [0362]. This automation is not a comparison of instantaneous suitability parameters. In other words, Makrinich et al. do not teach or disclose automatically comparing instantaneous suitability parameters determined by sensors for different remote operating staff for a medical device, respectively, and determining which of the different remote operating staff controls the medical device based on the comparison. Accordingly, Makrinich do not teach "automatically 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," where "the alternative control signal is automatically provided as a function of the comparison of the first instantaneous suitability parameter and the second instantaneous suitability parameter," as recited by independent claim 1. Shirado and Onishi do not fill the gaps and have not been cited as doing so (p. 18-19).
Regarding (b), Examiner respectfully disagrees. Shelton teaches automatically analyzing and comparing staff members' techniques and instrument usage skills [0310]. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The combination of Hannaford, Shelton, and Makrinich teach all of the limitations of claim 1 and should not be argued individually.
Applicant argues Makrinich et al. do not teach capturing first and second instantaneous suitability parameters in real-time, where the first and second instantaneous suitability parameters include real-time suitability ratings. Accordingly, Makrinich et al. do not teach or disclose that "the value of the first instantaneous suitability parameter and the value of the second instantaneous suitability parameter include a real-time suitability rating of the medical member and the alternative medical member, respectively, of remote operating staff for monitoring, remotely controlling, or monitoring and remotely controlling the medical device," as recited by independent claim 1 (p. 20-21).
Regarding (c), Examiner respectfully disagrees. Shelton does not teach comparing the suitability parameters of the first and the alternative members, and such limitation is taught by Makrinich. However, Shelton does teach determining that the suitability of the member has decreased in real-time with real time feedback to the staff members (see Shelton, ¶ 0310, 0317).
Applicant argue that a person having ordinary skill in the art would have no motivation to combine the teleoperated surgical cockpit of Hannaford with the local alert system of Shelton et al. or the pre-operative planning of Makrinich, as doing so would require a complete redesign of the functional architecture of the teleoperated network and render it inoperable for its intended purpose. Shirado and Onishi do not fill the gaps and have not been cited as doing so (p. 26).
Regarding (d), Examiner respectfully disagrees. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivation for Shelton being incorporated into Hannaford would create a system capable of identifying when the performance of the staff member is below the standard and ensures the procedure runs properly and safely (see Shelton, ¶ 0007). The motivation for Makrinich being incorporated into Hannaford improves analysis of a medical professional’s performance to enhance surgeries (see Makrinich, ¶ 0099). Examiner notes that just because Applicant does not agree with the motivation given does not mean one was not provided.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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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/OLIVIA R. GEDRA/Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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