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 .
Drawings
Applicant’s amendments to the drawings on January 2nd, 2026 have been accepted and overcome the previous objection.
Response to Arguments
Applicant’s arguments on pages 8 – 9, regarding the 101 rejection, have been fully considered and are persuasive. The examiner agrees that the present claims provide a technical improvement.
Applicant’s arguments on pages 9 – 15 have been fully considered but are moot due to the new grounds of rejection. While the examiner agrees that Malackowski does not teach remote operation of a robot, the new reference Fitzsimons cures this deficiency.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 5, 9 and 11 – 13, 16 and 18 rejected under 35 U.S.C. 103 as being unpatentable over Kowarschik (US Pub No: 2022/0415483 A1, hereinafter Kowarschik) in view of Czinger et al. (US Pub No: 2018/0339456 A1, hereinafter Czinger), Fitzsimons et al. (US Pub No: 2023/0165649 A1, hereinafter Fitzsimons) and Malackowski et al. (US Pub No: 2019/0142525 A1, hereinafter Malackowski).
Regarding Claim 1:
Kowarschik discloses:
A method for planning a remote-controlled navigation of medical objects in a hollow organ of a patient, the navigation being performable by robot or in a robot-supported manner using a robot system. Paragraph [0036] describes an automatic or semi-automatic navigation of a medical instrument through a hollow organ. This allows the treating person to maneuver the instrument via remote control.
and being visually monitored using an imaging system, wherein the robot system includes a drive system, a robot control unit, and at least one input unit remotely arranged at a distance from, the robot control unit, the method comprising. Paragraph [0054] describes a robot system 49 which has a robot control unit 50 which controls a drive system 48 for navigating an instrument. The robot control unit can receive input commands from the input unit 52. Paragraph [0068] describes a data transmission device.
supplying data for a planned navigation procedure of an object through the hollow organ with at least one navigation step. Paragraph [0054] describes a robot system 49 is designed for navigation of an instrument in a hollow organ of a patient.
Kowarschik does not disclose evaluating comparison data between a theoretical model and empirical data.
Czinger, in an analogous field of endeavor, teaches:
evaluating, by an evaluation system, the supplied data in terms of a performability level of the planned navigation procedure, wherein the evaluating is carried out based on a comparison with empirical data, based on a theoretical model, using a learning-based algorithm, or any combination thereof. Paragraph [0216] describes comparing theoretical and empirical measurements to estimate a variance of a physical component from a computer model.
and outputting an evaluation result to an output unit. Paragraph [0216] describes comparing theoretical and empirical measurements to estimate a variance of a physical component from a computer model.
Therefore, it would have been prima facie obvious to one of the ordinary skill in the art before the effective filing date, with a reasonable expectation for success, to have modified Kowarschik to incorporate the teachings of Czinger to show evaluating comparison data between a theoretical model and empirical data. One would have been motivated to do so to estimate a variance of a physical component from a computer model ([0216] of Czinger).
Kowarschik does not disclose a remotely connected transmission link and a property of the data transmission link.
Fitzsimons, in an analogous field of endeavor, teaches:
and remotely connected to, by at least one transmission link. Paragraph [0095] describes a surgical robot 122 that can be controlled by the surgeon 118 that is located in a different room, building, or other remote location. The console 116 includes one or more input control device 136 which cause the surgical robot 122 to manipulate one or more tools 126.
Therefore, it would have been prima facie obvious to one of the ordinary skill in the art before the effective filing date, with a reasonable expectation for success, to have modified Kowarschik to incorporate the teachings of Fitzsimons to show a remotely connected transmission link and a property of the data transmission link. One would have been motivated to do so to allow autonomous or semi-autonomous involving modification of hard tissue ([0002] of Fitzsimons).
Kowarschik does not disclose a property of the data transmission link.
Fitzsimons and Malackowski, in an analogous field of endeavor, teaches:
wherein the supplied includes at least one property of the data transmission link to be used, and wherein the evaluating takes account of at least the at least one property of the data transmission link. Paragraph [0095] describes a surgical robot 122 that can be controlled by the surgeon 118 that is located in a different room, building, or other remote location. The console 116 includes one or more input control device 136 which cause the surgical robot 122 to manipulate one or more tools 126. Paragraph [0384] describes a variety of telecommunication protocol, which defines transmission rates and bandwidths. Paragraph [0112] describes an operating parameter 310 that manages the RF transmission based on the data needful and sensor data.
Therefore, it would have been prima facie obvious to one of the ordinary skill in the art before the effective filing date, with a reasonable expectation for success, to have modified Kowarschik to incorporate the teachings of Malackowski to show a property of the data transmission link. One would have been motivated to do so to determine how long to transmit sensor data and what/how much sensor data to transmit from the tracker ([0112] of Malackowski).
Claim 12 is substantially similar to claim 1 and is rejected on the same grounds.
Regarding Claim 9:
Czinger teaches:
The method of claim 1, wherein the evaluation, the evaluation result, or the evaluation and the evaluation result are deposited in a database or table for use in a subsequent method. Paragraph [0099] describes databases 1510 that can store data from one or more memory devices.
Regarding Claim 11:
Kowarschik discloses:
The method of claim 1, wherein the at least one data transmission link includes a data transmission link between the robot control unit and the input unit. Paragraph [0054] describes a robot system 49 is designed for navigation of an instrument in a hollow organ of a patient.
Regarding Claim 13:
Kowarschik discloses:
The system of claim 12, wherein the imaging system includes an X-ray system. Paragraph [0041] describes a 3D X-ray system.
Regarding Claim 16:
Kowarschik, Czinger and Fitzsimons teach the above limitations in claim 1. Kowarschik, Czinger and Fitzsimons do not teach a property of the data transmission link.
Malackowski, in an analogous field of endeavor, teaches:
The method of claim 12, wherein the supplied data includes at least one property of the data transmission link to be used, and wherein the evaluating takes account of at least the at least one property of the data transmission link. Paragraph [0112] describes an operating parameter 310 that manages the RF transmission based on the data needful and sensor data.
Therefore, it would have been prima facie obvious to one of the ordinary skill in the art before the effective filing date, with a reasonable expectation for success, to have modified Kowarschik to incorporate the teachings of Malackowski to show a property of the data transmission link. One would have been motivated to do so to determine how long to transmit sensor data and what/how much sensor data to transmit from the tracker ([0112] of Malackowski).
Regarding Claim 5:
Kowarschik discloses:
The method of claim 3, wherein the supplied data also includes a type of the planned navigation procedure, a sequence of steps in the planned navigation procedure, patient data, data for the hollow organ, object data, a medicament to be applied, a contrast agent to be used, device data, X-ray parameters, user-specific data, or any combination thereof. Paragraph [0057] describes magnetic resonance angiography that can be selected and adjusted in order to map the respective body region and/or contrast medium distribution.
Claim 18 is substantially similar to claim 5 and is rejected on the same grounds.
Claim(s) 2, 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kowarschik in view of Czinger, Fitzsimons and Malackowski and further in view of Rafii-Tari et al. (US Pub No: 2018/0279852 A1, hereinafter Rafii).
Regarding Claim 2:
Kowarschik, Czinger, Fitzsimons and Malackowski teach the above limitations in claim 1. Kowarschik, Czinger, Fitzsimons and Malackowski do not teach an output evaluation result includes a probability of determining if a navigation procedure is performable.
Rafii, in an analogous field of endeavor, teaches:
The method of claim 1, wherein the output evaluation result includes a probability, with which the navigation procedure is performable. Paragraph [0119] describes a state estimator 440 that can perform Bayesian statistical analysis to determine a probability and confidence vale of each of a number of possible states.
Therefore, it would have been prima facie obvious to one of the ordinary skill in the art before the effective filing date, with a reasonable expectation for success, to have modified Kowarschik to incorporate the teachings of Rafil to show an output evaluation result includes a probability of determining if a navigation procedure is performable. One would have been motivated to do so to determine if the route is correct/safe enough.
Claim 15 is substantially similar to claim 2 and is rejected on the same grounds.
Regarding Claim 6:
Kowarschik discloses:
The method of claim 2, wherein the output evaluation result includes at least one suggestion for modifying the planned navigation procedure, and wherein a navigation procedure adapted by the modification has a higher or at least the same probability of performability compared to the planned navigation procedure. Paragraph [0057] describes magnetic resonance angiography that can be selected and adjusted in order to map the respective body region and/or contrast medium distribution.
Claim(s) 4, 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kowarschik in view of Czinger, Fitzsimons and Malackowski and further in view of Prior et al. (US Pub No: 2022/0047154 A1, hereinafter Prior).
Regarding Claim 4:
Kowarschik, Czinger, Fitzsimons and Malackowski teach the above limitations in claim 1. Kowarschik, Czinger, Fitzsimons and Malackowski do not teach a data transmission rate.
Prior, in an analogous field of endeavor, teaches:
The method of claim 3, wherein the at least one property of the data transmission link includes a data transmission rate. Paragraph [0089] describes a transmission rate of an image stream.
Therefore, it would have been prima facie obvious to one of the ordinary skill in the art before the effective filing date, with a reasonable expectation for success, to have modified Kowarschik to incorporate the teachings of Prior to show a data transmission rate. One would have been motivated to do so that the user knows how up to date the information displayed is.
Claim 17 is substantially similar to claim 4 and is rejected on the same grounds.
Regarding Claim 8:
Kowarschik discloses:
The method of claim 6, wherein the at least one modification suggestion has modifications with regard to at least one navigation step, with regard to the object used, with regard to the planned navigation path, with regard to a contrast agent, with regard to a medicament, with regard to X-ray parameters, or with regard to any combination thereof. Paragraph [0057] describes magnetic resonance angiography that can be selected and adjusted in order to map the respective body region and/or contrast medium distribution.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kowarschik in view of Czinger and Fitzsimons and Malackowski and further in view of Olson (US Pub No: 2015/0005785 A1, hereinafter Olson)
Regarding Claim 7:
Kowarschik, Czinger, Fitzsimons and Malackowski teach the above limitations in claim 1. Kowarschik, Czinger, Fitzsimons and Malackowski do not teach multiple suggestions for navigation routes.
Olson, in an analogous field of endeavor, teaches:
The method of claim 1, wherein the output evaluation result includes multiple suggestions including navigation procedures differing from the planned navigation procedure with a statement based on respective levels of performability. Paragraph [0122] describes planning an alternative path of the catheter.
Therefore, it would have been prima facie obvious to one of the ordinary skill in the art before the effective filing date, with a reasonable expectation for success, to have modified Kowarschik to incorporate the teachings of Olson to show multiple suggestions for navigation routes. One would have been motivated to do so to avoid predicted collisions (Abstract of Olson).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kowarschik in view of Czinger, Fitzsimons and Malackowski and further in view of Kaiser et al. (US Pub No: 2023/0016761 A1, hereinafter Kaiser).
Regarding Claim 10:
Kowarschik, Czinger, Fitzsimons and Malackowski teach the above limitations in claim 1. Kowarschik, Czinger, Fitzsimons and Malackowski do not teach a starting signal for a planned navigation procedure being triggered when the performability level reaches or exceeds a preset threshold value.
Kaiser, in an analogous field of endeavor, teaches:
The method of claim 1, wherein a starting signal for the planned navigation procedure is automatically triggered when the performability level reaches or exceeds a preset threshold value. Paragraph [0135] describes a navigation system that determines the respective fluctuations of the positions of any sensor that exceeds a first threshold. If it exceeds, the system is not started while if it is below, the system is started.
Therefore, it would have been prima facie obvious to one of the ordinary skill in the art before the effective filing date, with a reasonable expectation for success, to have modified Kowarschik to incorporate the teachings of Kaiser to show a starting signal for a planned navigation procedure being triggered when the performability level reaches or exceeds a preset threshold value. One would have been motivated to do so that the navigation system does not start if there is an issue with any of the sensors, etc….
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 JAY KHANDPUR whose telephone number is (571)272-5090. The examiner can normally be reached Monday - Friday 8:30 - 6:30.
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, Thomas Worden can be reached at (571) 272-4876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAY KHANDPUR/Primary Patent Examiner, Art Unit 3658