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 .
Claim Objections
Claim 1 is objected to because of the following informalities: minor error in antecedent basis. The claim should be amended to “[…] an imaging system configured, for the image support during the navigation of the medical device […]” in order to establish proper antecedent basis. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: imaging system and monitoring system in Claim 1, medical imaging system in Claim 2, gaze detection system in Claims 4 and 14, display unit in Claims 6-7, and control device in Claim 9.
The disclosure cites:
The imaging system is embodied as a medical imaging system for mapping the medical device in an organ and/or tissue ([0032]);
The monitoring system is configured to monitor whether the medical device is moving, to initiate a first risk-reducing measure if the image support by the imaging system is deactivated ([0011]), may monitor an image support state ([0012]), to check an image content of the image data and/or the graphical representation of the image data for a predetermined criterion ([0037]), to initiate a second risk-reducing measure if the image content does not meet the predetermined criterion ([0037]), to initiate a third risk-reducing measure and/or a fourth risk-reducing measure depending on a result of the detection of the gaze direction ([0043]), determine the movement of the medical device based on the presence of the at least one control signal ([0064]), to deactivate the at least one control signal with the aid of the control device within the first measure ([0068]), to monitor whether the medical device is moving depending on the senor signal ([0071]), determine the movement of the medical device based on the presence of the at least one sensor signal ([0074]), to receive a combination of the at least one sensor signal and the at least one control signal and to monitor both signals independently of one another ([0075]), and may include a data processing system ([0028]);
The medical imaging system is configured for mapping the medical device in an organ and/or tissue ([0032]) and may be an X-ray system, a fluoroscopy system, an angiography system, a magnetic-resonance tomography system, or an ultrasound system, or may include one or more such imaging modalities ([0035]);
The gaze detection system is configured to detect the gaze direction of a user ([0043]), for further image processing ([0044]), to detect whether the display unit is in the gaze direction of the user ([0046), may include a camera that is directed at a position where the user is located ([0044]), and may be part of the data processing system or coupled thereto ([0045]);
The display unit is disclosed as a monitor ([0020]) on which the graphical representation of the image data is displayed for image support and may be located at the predetermined position ([0046]); and
The control device is configured to generate at least one control signal for actuating the at least one actuator, in particular to automatically move the medical device ([0061]), to generate at least one control signal for each individual actuator of the at least one actuator ([0062]), and may include a user input device and may then generate the at least one control signal from the input signal of the user input device and thereby actuate the at least one actuator ([0063]).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claims 1, 4, 6-7, and 14, the claims recite the limitations “imaging system,” “monitoring system” in Claim 1, “gaze detection system” in Claims 4 and 14, and “display unit” in Claims 6-7 which are interpreted under 35 U.S.C. 112(f) according to analysis made of record. The “imaging system,” “monitoring system,” “gaze detection system,” and “display unit” are described exclusively in terms of the functions they perform, without naming a structure intended to be used, and therefore applicant has not demonstrated possession of that structure.
Claims not explicitly addressed above are rejected as depending from a rejected claim and failing to cure deficiencies of the parent claim.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim limitations “imaging system,” “monitoring system” in Claim 1, “gaze detection system” in Claims 4 and 14, and “display unit” in Claims 6-7 invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any specific, sufficient structure that performs the function of the claim. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims not explicitly addressed above are rejected as depending from a rejected claim and failing to cure deficiencies of the parent claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 8-13 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wenderow et al. (US 20140039305).
Regarding Claim 1, Wenderow teaches a user assistance system for image support during navigation of a medical device, (Abstract “A robotic catheter procedure system includes a bedside system and a workstation. The bedside system includes an actuating mechanism configured to engage and to impart movement to a percutaneous device. The workstation includes a user interface and a control system configured to be operatively coupled to the user interface, the bedside system, and a medical imaging system.”), the user assistance system comprising:
a) an imaging system configured, for image support during the navigation of the medical device, ([0024] “imaging system 32” and [0030] “Imaging system 32 may also be configured to take one or more x-ray images during a catheter based medical procedure (e.g., real-time images) to assist the user of workstation 14 to properly position a guide wire, guide catheter, working catheter, stent, etc. during the procedure.”), to:
(1) generate image data that at least partially maps the medical device ([0030] “Imaging system 32 may also be configured to take one or more x-ray images during a catheter based medical procedure (e.g., real-time images) to assist the user of workstation 14 to properly position a guide wire, guide catheter, working catheter, stent, etc. during the procedure.”); and
(2) display a graphical representation of the image data ([0030] “The image or images may be displayed on first monitor 26 and/or second monitor 28.”); and
b) a monitoring system, ([0024] “Bedside system 12 and/or imaging system 32 also may provide feedback signals (e.g., operating conditions, warning signals, error codes, etc.) to workstation 14. Bedside system 12 may be connected to workstation 14 via a communication link 38 that may be a wireless connection, cable connectors, or any other means capable of allowing communication to occur between workstation 14 and beside system 12.”), configured to:
(1) monitor whether the medical device is moving ([0026] “controls 16 include a touch screen 18, a dedicated guide catheter control 29, a dedicated guide wire control 23, and a dedicated working catheter control 25. In this embodiment, guide wire control 23 is a joystick configured to advance, retract, or rotate a guide wire, working catheter control 25 is a joystick configured to advance, retract, or rotate a working catheter, and guide catheter control 29 is a joystick configured to advance, retract, or rotate a guide catheter. In addition, touch screen 18 may display one or more icons (such as icons 162, 164, and 166) that control movement of one or more percutaneous devices via bedside system 12. Controls 16 may also include a balloon or stent control that is configured to inflate or deflate a balloon and/or a stent. Each of the controls may include one or more buttons, joysticks, touch screens, etc., that may be desirable to control the particular component to which the control is dedicated.”); and
(2) initiate a first risk-reducing measure when the image support by the imaging system is deactivated, ([0024] “Bedside system 12 and/or imaging system 32 also may provide feedback signals (e.g., operating conditions, warning signals, error codes, etc.) to workstation 14,” where “operating conditions” and “error codes” are interpreted as when the imaging system is deactivated, and [0040] “controls 16 may be configured to allow the user positioned at workstation 14 to directly control operation of imaging system 32 via interaction with controls 16 that specifically operate imaging system 32 (e.g., via interaction with an imaging start button, an image system "on-off" button […])"), and, according to the monitoring by the monitoring system, the medical device is moving at a same time ([0038] “controls 16 and controller 40 located at workstation 14 are communicably coupled to various portions of bedside system 12 to allow the user to control movement of guide wire 58, working catheter 60 and guide catheter 64 and any other percutaneous devices that bedside system 12 is equipped with” and [0061] “procedure control module 98 is configured to continue to generate the control signals that cause capture of images at the same time as it is generating the control signals that cause movement of the percutaneous device.”).
Regarding Claim 2, Wenderow teaches all limitations of Claim 1, as discussed above. Furthermore, Wenderow teaches wherein the imaging system is a medical imaging system for mapping the medical device in an organ and/or tissue ([0029] “Imaging system 32 may be any medical imaging system that may be used in conjunction with a catheter based medical procedure (e.g., angiogram system, non-digital x-ray, digital x-ray, CT, MRI, ultrasound, etc.). In an exemplary embodiment, imaging system 32 is a digital x-ray imaging device that is in communication with workstation 14.”).
Regarding Claim 8, Wenderow teaches all limitations of Claim 1, as discussed above. Furthermore, Wenderow teaches at least one actuator configured to move the medical device ([0033] “catheter procedure system 10 includes a guide wire actuating mechanism 50, a working catheter actuating mechanism 52, and a guide catheter actuating mechanism 54.”).
Regarding Claim 9, Wenderow teaches all limitations of Claim 8, as discussed above. Furthermore, Wenderow teaches a control device configured to: generate at least one control signal for actuating the at least one actuator ([0033] “Catheter procedure system 10 may include various actuating mechanisms that engage and impart motion to an associated percutaneous device in response to a user's manipulation of controls 16 and/or under control of controller 40.”); and provide the at least one control signal to the at least one actuator and to the monitoring system, ([0049] “control signals 116 generated by procedure control module 98 are communicated from controller 40 to the various actuators of bedside system 12, to imaging system 32, to contrast injection system 13, and to any other device or system controlled by controller 40.”), wherein the monitoring system is configured to monitor, depending on the control signal, whether the medical device (4) is moving ([0058] “Controller 40 (e.g., via instructions of procedure control module 98) is configured such that image capture via imaging system 32 is triggered when the user first begins to interact with one of the input devices or controls of controls 16 but prior to triggering movement of the percutaneous device in response to the user's interaction with the input device” and [0059] “working catheter joystick 25, is shown in the resting position (e.g., the non-actuated position, prior to movement of the control by the user). Working catheter control 25 may include an activation zone 184 surrounding control 25 such that control 25 is located within activation zone 184 when the control is in the resting position. With the control in the resting position, controller 40 does not generate control signals to either imaging system 32 or bedside system 12.”).
Regarding Claim 10, Wenderow teaches all limitations of Claim 9, as discussed above. Furthermore, Wenderow teaches wherein the first risk-reducing measure comprises deactivating the at least one actuator ([0027] “Controls 16 may include an emergency stop button 31 and a multiplier button 33. When emergency stop button 31 is pushed a relay is triggered to cut the power supply to bedside system 12” and [0073] “If the user has stopped operating controls 16, then at step 204, contrast injection, image capture and percutaneous device movement are stopped when the user stops manipulating controls 16.”).
Regarding Claim 11, Wenderow teaches all limitations of Claim 1, as discussed above. Furthermore, Wenderow teaches at least one sensor configured to issue a sensor signal depending on a movement of the medical device, wherein the monitoring system is configured to monitor whether the medical device is moving depending on the sensor signal ([0077] “The bedside system may have one or more sensors which detect the distance that it has advanced or retracted the percutaneous device into or out of the patient. For instance, if the device is a guide or working catheter or a guide wire the bedside system may have a sensor which detects the distance forward into the patient or the distance backward out of the patient it has moved the catheter or guide wire.”).
Regarding Claim 12, Wenderow teaches all limitations of Claim 1, as discussed above. Furthermore, Wenderow teaches wherein the first risk-reducing measure comprises issuing at least one warning signal ([0024] “Bedside system 12 and/or imaging system 32 also may provide feedback signals (e.g., […] warning signals […]) to workstation 14.”).
Regarding Claim 13, Wenderow teaches all limitations of Claim 12, as discussed above. Furthermore, Wenderow teaches wherein the at least one warning signal comprises a visual signal, and wherein the user assistance system is configured to display the visual signal ([0025] “Workstation 14 includes a user interface 30” and [0028] “User interface 30 may include a first monitor 26 and a second monitor 28.”).
Regarding Claim 16, Wenderow teaches a method for image support during navigation of a medical device, (Abstract “A robotic catheter procedure system includes a bedside system and a workstation. The bedside system includes an actuating mechanism configured to engage and to impart movement to a percutaneous device. The workstation includes a user interface and a control system configured to be operatively coupled to the user interface, the bedside system, and a medical imaging system” and [0002] “The present invention relates specifically to catheter systems and methods incorporating control of a medical imaging system.”), the method comprising:
a) generating, by an imaging system, a graphical representation of image data that at least partially maps the medical device ([0030] “Imaging system 32 may also be configured to take one or more x-ray images during a catheter based medical procedure (e.g., real-time images) to assist the user of workstation 14 to properly position a guide wire, guide catheter, working catheter, stent, etc. during the procedure.”);
b) displaying, by the imaging system, the graphical representation of the image data ([0030] “The image or images may be displayed on first monitor 26 and/or second monitor 28.”);
c) monitoring, by a monitoring system whether the medical device is moving ([0026] “controls 16 include a touch screen 18, a dedicated guide catheter control 29, a dedicated guide wire control 23, and a dedicated working catheter control 25. In this embodiment, guide wire control 23 is a joystick configured to advance, retract, or rotate a guide wire, working catheter control 25 is a joystick configured to advance, retract, or rotate a working catheter, and guide catheter control 29 is a joystick configured to advance, retract, or rotate a guide catheter. In addition, touch screen 18 may display one or more icons (such as icons 162, 164, and 166) that control movement of one or more percutaneous devices via bedside system 12. Controls 16 may also include a balloon or stent control that is configured to inflate or deflate a balloon and/or a stent. Each of the controls may include one or more buttons, joysticks, touch screens, etc., that may be desirable to control the particular component to which the control is dedicated.”); and
d) initiating, by the monitoring system, a first risk-reducing measure when the image support by the imaging system is deactivated, ([0024] “Bedside system 12 and/or imaging system 32 also may provide feedback signals (e.g., operating conditions, warning signals, error codes, etc.) to workstation 14,” where “operating conditions” and “error codes” are interpreted as when the imaging system is deactivated, and [0040] “controls 16 may be configured to allow the user positioned at workstation 14 to directly control operation of imaging system 32 via interaction with controls 16 that specifically operate imaging system 32 (e.g., via interaction with an imaging start button, an image system "on-off" button […])"), and, according to the monitoring by the monitoring system, the medical device is moving at a same time ([0038] “controls 16 and controller 40 located at workstation 14 are communicably coupled to various portions of bedside system 12 to allow the user to control movement of guide wire 58, working catheter 60 and guide catheter 64 and any other percutaneous devices that bedside system 12 is equipped with” and [0061] “procedure control module 98 is configured to continue to generate the control signals that cause capture of images at the same time as it is generating the control signals that cause movement of the percutaneous device.”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Wenderow et al. (US 20140039305) in view of Kaethner et al. (US 20210338346).
Regarding Claim 3, Wenderow teaches all limitations of Claim 1, as discussed above. However, Wenderow does not explicitly teach wherein the monitoring system is configured to: check an image content of the image data and/or the graphical representation of the image data for a predetermined criterion; and initiate a second risk-reducing measure when the image content does not meet the predetermined criterion and, according to the monitoring by the monitoring system, the medical device is moving at the same time.
In an analogous medical monitoring field of endeavor, Kaethner teaches a user assistance system for image support during navigation of a medical device, ([0024] “The medical system 1 has a robotic system and an imaging device (e.g., an X-ray device 10)”), wherein the monitoring system, ([0025] “system control 16”), is configured to:
a) check an image content of the image data and/or the graphical representation of the image data for a predetermined criterion ([0027] “For this evaluation AW, the image is analyzed (e.g., with the aid of an image recognition system) to determine whether a branch, a bifurcation, a peculiarity, or an anomaly of the hollow organ is present. It is also possible for an analysis to be performed to determine whether a deviation of the path of the object from an existing path planning exceeds a certain (e.g., preset) threshold value and/or whether any other error tolerance is exceeded.”); and
b) initiate a second risk-reducing measure when the image content does not meet the predetermined criterion and, according to the monitoring by the monitoring system, the medical device is moving at the same time ([0030] “further signals to be output together with the interruption, such as, for example, optical, acoustic, or haptic warning signals. It is also possible for prompts or suggestions for certain actions to be output and displayed to the operator (e.g., a suggestion for contrast medium administration (when the situation relevant to decision-making and/or safety consisted in that the hollow organ was no longer recognizable on the image), a suggestion for path correction (when a threshold value for a path deviation from a planned path is exceeded), a suggestion for a branch (in the case of a bifurcation), or a suggestion that the movement be slowed down).”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Wenderow with the monitoring system of Kaethner because it allows the operator to initiate measures to resolve the situation if necessary, or stop the procedure all together, as taught by Kaethner in [0029], minimizing or avoiding harm to the patient.
Regarding Claim 15, Wenderow teaches all limitations of Claim 12, as discussed above. Furthermore, Kaethner teaches wherein the at least one warning signal comprises an acoustic signal ([0030] “it is possible for further signals to be output together with the interruption, such as, for example, […] acoustic, […] warning signals.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Wenderow with the monitoring system of Kaethner because the modification improves patient safety, as taught by Kaethner in [0033], and immediately and distinctly alerts the operator of error, as opposed to only a visual alert, which an operator may miss.
Claims 4-7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Wenderow et al. (US 20140039305) in view of Ruiz Morales et al. (US 20130030571).
Regarding Claim 4, Wenderow teaches all limitations of Claim 1, as discussed above. However, Wenderow does not explicitly teach a gaze detection system configured to detect a gaze direction of a user, wherein the monitoring system is configured to initiate a third risk-reducing measure and/or a fourth risk-reducing measure depending on a result of the detecting of the gaze direction.
In an analogous robotized surgery field of endeavor, Ruiz Morales teaches a user assistance system for image support during navigation of a medical device, (Abstract “A robotized surgery system (10) comprises at least one robot arm (11) which acts under the control of a control console (12) intended for the surgeon” and [0019] “telecamera 14”), comprising a gaze detection system, configured to detect a gaze direction of a user, ([0024] “eye movement tracking system or so-called “eye tracker” for detecting the direction of the surgeon’s gaze towards the console”), wherein the monitoring system is configured to initiate a third risk-reducing measure and/or a fourth risk-reducing measure depending on a result of the detecting of the gaze direction ([0024] “The console 12 also comprises an eye movement tracking system 21 or so-called "eye tracker" […] for controlling the surgical system also depending on the gaze directions detected” and [0034] “It has been found to be particularly advantageous for the tracking system to send a command which disables the movement of the robot arms when a direction of the gaze which falls outside of the screen, or at least outside of the screen zone which reproduces the operating field, is detected” and [0064] “the HMI application is intuitive and easy to use since it may be controlled by the surgeon's gaze (together with or without an activation confirmation device). The main advantages are that the surgeon is able to use his/her eyes in order to select and assign the robot arms to the manipulators without removing his/her hands from the manipulators.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Wenderow with the gaze detection system of Ruiz Morales because the modification prevents movements of the device (e.g., surgical tools) without direct supervision of the surgeon, as taught by Ruiz Morales in [0034], which may harm the patient.
Regarding Claim 5, the modified system of Wenderow teaches all limitations of Claim 4, as discussed above. Furthermore, Ruiz Morales teaches wherein the monitoring system is configured to initiate the third risk-reducing measure when the gaze detection system does not detect the gaze direction of the user and, according to the monitoring by the monitoring system, the medical device is moving at the same time ([0034] “It has been found to be particularly advantageous for the tracking system to send a command which disables the movement of the robot arms when a direction of the gaze which falls outside of the screen, or at least outside of the screen zone which reproduces the operating field, is detected” and [0053] “A so-called "dead man's" function is thus obtained for activating the robot and keeping it activated while the user is looking at the screen.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Wenderow with the gaze detection system of Ruiz Morales for the same reasons as Claim 4 above.
Regarding Claims 6-7, the modified system of Wenderow teaches all limitations of Claim 4-5, as discussed above. Furthermore, Wenderow teaches a display unit configured to display the graphical representation of the image data ([0030] “The image or images may be displayed on first monitor 26 and/or second monitor 28.”).
Moreover, Ruiz Morales teaches wherein the monitoring system is configured to initiate the fourth risk-reducing measure when the gaze detection system determines that the gaze direction of the user is not directed at the display unit and, according to the monitoring by the monitoring system, the medical device is moving at the same time (Abstract “The console (22) comprises advantageously a screen (23) with at least one zone (23) for viewing the operating field and, among the commands which can be performed depending on the gaze directions, there is advantageously an automatic command for enabling or disabling the movement of the robot arm (11) when a gaze direction which falls within or outside of said zone (23) of the screen is detected” and [0034] “It has been found to be particularly advantageous for the tracking system to send a command which disables the movement of the robot arms when a direction of the gaze which falls outside of the screen, or at least outside of the screen zone which reproduces the operating field, is detected”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Wenderow with the gaze detection system of Ruiz Morales for the same reasons as Claim 4 above.
Regarding Claim 14, Wenderow teaches all the limitations of Claim 13, as discussed above.
Furthermore, Ruiz Morales teaches
a) a gaze detection system configured to detect a gaze direction of a user ([0024] “eye movement tracking system or so-called “eye tracker” for detecting the direction of the surgeon’s gaze towards the console”); and a display unit configured to display: (1) the graphical representation of the image data (Claim 16 “the console (12) comprises a screen (22) with at least one zone for viewing the operating field”); and (2) the visual signal (taught by Wenderow, as discussed above, where a display is capable of displaying any such indicator or signal) at a display position that lies in the detected gaze direction of the user, ([0033] “by means of the tracking system 21 it is possible to detect the direction of the surgeon's gaze towards the screen 22 and define which zone of the screen he/she is looking at or not looking at.” Where the visual signal may displayed in a specific zone of the surgeon’s gaze.),
b) wherein the monitoring system is configured to initiate a third risk-reducing measure when the gaze detection system does not detect the gaze direction of the user and, according to the monitoring by the monitoring system, the medical device is moving at the same time, ([0034] “It has been found to be particularly advantageous for the tracking system to send a command which disables the movement of the robot arms when a direction of the gaze which falls outside of the screen, or at least outside of the screen zone which reproduces the operating field, is detected” and [0053] “A so-called "dead man's" function is thus obtained for activating the robot and keeping it activated while the user is looking at the screen.”), or
c) wherein the monitoring system is configured to initiate a fourth risk-reducing measure when the gaze detection system determines that the gaze direction of the user is not directed at the display unit and, according to the monitoring by the monitoring system, the medical device is moving at the same time (Abstract “The console (22) comprises advantageously a screen (23) with at least one zone (23) for viewing the operating field and, among the commands which can be performed depending on the gaze directions, there is advantageously an automatic command for enabling or disabling the movement of the robot arm (11) when a gaze direction which falls within or outside of said zone (23) of the screen is detected” and [0034] “It has been found to be particularly advantageous for the tracking system to send a command which disables the movement of the robot arms when a direction of the gaze which falls outside of the screen, or at least outside of the screen zone which reproduces the operating field, is detected”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Wenderow with the gaze detection system and display unit of Ruiz Morales because the modification prevents movements of the device (e.g., surgical tools) without direct supervision of the surgeon, as taught by Ruiz Morales in [0034], which may harm the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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