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 .
This is in response to Applicant’s communication filed on 12/19/23, wherein:
Claims 1,4, 6, 10-12, 15-16, 22, 32, 38-42, 44, 46, 52, 55-56 are currently pending;
Claims 2-3, 5, 7-9, 13-14, 17-21, 23-31, 33-37, 43, 45, 47-51, 53-54, 57-66 have been cancelled.
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.
Claim(s) 1, 4, 10-12, 16, 22, 32, 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over PARMAR (US 2020/0368494) in view of SUEHARA ET AL (US 2014/0088411). Herein after PARMAR and SUEHARA
As for claim 1, PARMAR discloses A robotic control system {see at least figure 3, par. 0005}, comprising:
a hub configured to adjust an axial position of an interventional device; a driven magnet coupled with the hub {see at least figure 1, figure 5, item 34, figure 6, item 34 and; and pars. 0012, 0015, 0053, 0066 which discloses hub coupled with ferromagnetic components/actuators 34 (driven magnet) couple to the guidewire, catheter};
a hub adapter configured to move in at least one direction based on an input provided by a user of the robotic control system; a drive magnet coupled with the hub adapter and configured to magnetically couple with the driven magnet in an operable state of the robotic control system such that the driven magnet moves in response to a movement of the drive magnet {see at least figures 3 item 23, 27, figure 5 item 23; pars. 0011, 0013-0015, 0052. 0064-65, 0070 discloses hub adapter coupled with drive magnetic element 23 and 27. For example, pars. 0013-0015 that at least one other external magnet (drive magnet 23, 27) is coupled to one or more ferromagnetic component (driven magnet 34) within the tube that is, in turn, coupled to the catheter that is also within the tube; and the at least one other external magnet is moved to provide a motive force to move at least a portion of the catheter from inside the tube to inside the body}.
PARMAR discloses claimed invention as indicated above. For example, PARMAR at least pars. 0012-0013 discloses the external magnets (drive magnet) provide a magnetic field that translates down the length of the sterile tube in the proximal direction toward the body, and is are rotatable around the circumference of the tube to provide rotation about the central axis of the guidewire and/or catheter within the tube. PARMAR further discloses electronic sensor that measures resistive force and/or deformation of the guidewire as shown in par. 0058. However, PARMAR is silent with respect to a sensor coupled with the hub or the hub adapter and configured to measure a magnitude of a magnetic field on the sensor.
SUEHARA discloses this limitation as least in figure 2, pars. 0062, 0065, 0107-0108 which discloses the catheter 200 include magnetic sensor to detect the magnetic field and the sensor is coupled to the hub 15. Therefore, it would have been obvious to one of ordinary skill in the art before the effective of filing date of the claimed invention to incorporate the magnetic sensor of SUEHARA into the system of PARMAR in order to detect the strength of magnetic field in PARMAR for safety, and efficiency during complex procedures.
As for claim 4, PARMAR / SUEHARA discloses wherein the sensor is a magnetometer {see SUEHARA at least pars. 0062, 0065, 0107-0108}.
As for claim 10, PARMAR / SUEHARA discloses wherein the robotic control system is configured to determine a magnitude of a net external force acting on the hub in the at least one direction based on the measured magnitude of the magnetic field on the sensor {see SUEHARA pars. 0062, 0065, 0107-0108; and PARMAR at least par. 0058}.
As for claim 11, PARMAR / SUEHARA discloses wherein the robotic control system is configured to provide an alert when the net external force in the at least one direction reaches or exceeds a threshold value {see PARMAR at least par. 0058}.
As for claim 12, PARMAR / SUEHARA discloses the robotic control system is configured to automatically implement a correction action when the net external force in the at least one direction reaches or exceeds a threshold value {see PARMAR at least figures 1-2, pars. 0049-0051, 0058, 0065}. It would have been obvious to implement a correction when the forced reaches a threshold in order to prevent or avoid accident in medical procedure.
As for claim 16, PARMAR / SUEHARA discloses wherein the hub is coupled to the hub adapter across a sterile barrier, wherein the hub is positioned on a sterile side of the sterile barrier and the hub adapter is positioned on a nonsterile side of the sterile barrier {see PARMAR at least figures 3, 5, pars. 0011, 0053}.
As for claim 22, PARMAR / SUEHARA discloses a second hub configured to adjust an axial position of a second interventional device; a second driven magnet coupled to the second hub; a second hub adapter configured to move in the at least one direction based on an input provided by the user of the robotic control system; a second drive magnet coupled with the second hub adapter and configured to couple with the second driven magnet such that the second driven magnet moves in response to movement of the second drive magnet; and a second sensor coupled with the second hub or the second hub adapter and configured to measure a magnitude of a second magnetic field {see PARMAR at least figures 3, 5 and pars. 0011-0015}.
As for claim 32, PARMAR / SUEHARA at least four hub adapters each having a magnet and four corresponding hubs, wherein each of the four hub adapters has a sensor configured to measure a magnitude of a magnetic field on the sensor from the magnet of each of the corresponding hubs. Since PARMAR discloses one or more hub and hub adapter with magnetic (external magnets and ferromagnetic components) in pars. 0011-0013, it would have obvious to one of ordinary skill in the art before the effective of the claimed invention to have four hub and hub adapter into the system of PARMAR / SUEHARA as desired.
As for claim 38, PARMAR / SUEHARA discloses a ring magnet coupled with the hub and/or the hub adapter, the ring magnet positioned and configured to provide the magnetic field on the sensor {see at least figures 3, 5 item 23 and figure 6 ,item 34, pars. 0011-0012}.
As for claim 39, PARMAR / SUEHARA discloses wherein the sensor is configured to also measure a direction of the magnetic field on the sensor so that the robotic control system can determine a magnitude and a direction of a displacement of the hub relative to the hub adapter {see SUEHRA figure 2, pars. 0062, 0065, 0107-0108; and PARMAR pars. 0012, 0015, 0061}.
As for claim 40, PARMAR / SUEHARA discloses comprising a controller configured to determine a magnitude of a net external force acting on the hub in the at least one direction based on the measured magnitude of the magnetic field on the sensor; wherein the robotic control system is configured to output a warning to the user of the robotic control system when the magnitude of the net external force acting on the hub in the at least one direction reaches a threshold value comprising a predetermined percentage of a breakaway force {see PARMAR at least figures 1-2, pars. 0049-0051, 0065}.
Allowable Subject Matter
Claims 41-42, 44, 46, 52, 55-56 allowed.
Claims 6 and 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Canale et al (US 2022/0233263): A robotic drive system for driving one or more elongated medical devices, the robotic drive can include a linear member and at least four device modules coupled to the linear member.
Clark et al (US 2022/0233820): System, apparatus and methods for supporting and driving elongated medical devices in a robotic catheter based procedure system.
Burkholz et al (US 2017/0348511): Medical device, system and methods utilizing permanent magnet and magnetizable feature.
Murphy (US 2014/0276233): catheter force measurement apparatus and method.
Zupkofska et al (US 2016/0178519): Fig, 8, par. 0094 discloses catheter 206 include sensor to generate and detect the strength of a magnetic field.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kira Nguyen whose telephone number is (571)270-1614. The examiner can normally be reached on Monday to Friday 9:00-5:00 ET.
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/KIRA NGUYEN/Primary Examiner, Art Unit 3656