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 Office Action is responsive to the claims filed on 08/19/2024. Claims 1-20 are presently pending in this application.
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 1-4, 6, 7, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Alambeigi (WO 2023205621 A2) in view of Cox (US 20110295108) and Sowards (US 20220160209).
Regarding claim 1, Alambeigi teaches a tracking and steering system (Pg. 1, Abstract; apparatus and methods for enhancing the steerability of catheters… further comprise systems and methods for detecting the location of a magnetic element via magnetic sensors) comprising:
a medical device (Pg. 12, ln. 14-26; an apparatus 100 comprises a segmented tubular member 110, Fig. 1) including a magnetic element coupled with a distal portion of the medical device (Pg. 12, ln. 14-26; comprises a permanent magnet 120 coupled to second end 112 of segmented tubular member 110);
a sensor placed external to a patient and configured to detect a magnetic field strength of the magnetic element of the medical device (Pg. 32, Ln. 26-33; Specific embodiments can also be integrated with a magnetic localization system; Pg. 34, ln. 15-25; In this embodiment, magnetic sensors 300 are coupled to an electromagnet 130 (e.g. Helmholtz coils) and are configured to detect a location of permanent magnet 120 coupled to segmented tubular 110 as part of a magnetically steerable catheter 160, as previously described herein; Fig. 16-17 shows the sensors are external to the patient);
a steering magnet disposed external to the patient and including an electromagnet configured to attract the magnetic element of the medical device (Pg. 12, ln. 27-32; electrical current to electromagnet 130 and control a magnetic force exerted by electromagnet 130 on permanent magnet 120; Pg. 14, ln. 3-13; When currents are excited in the coils, steering torque is generated to the permanent magnet 120, which controls the direction of the catheter's distal segment);
a console (Pg. 12, ln. 26-32; Apparatus 100 also comprises a controller 170 configured to control an electrical current to electromagnet) configured to:
receive magnetic field strength information from the sensor and determine positional information for a distal tip of the medical device (Pg. 34, ln. 5-24; put the magnet at a series of known positions and collects the data, and then solves for the magnet strength and sensor location parameters by a least square problem. This least square problem solves for the M and ps that minimizes the discrepancy between magnet location estimated using the M and p values and the known location; magnetic sensors 300 are coupled to an electromagnet 130 (e.g. Helmholtz coils) and are configured to detect a location of permanent magnet 120 coupled to segmented tubular 110 as part of a magnetically steerable catheter 160); and
simultaneously activate the sensor and deactivate the steering magnet or simultaneously activate the steering magnet and deactivate the sensor (Pg. 40, ln. 11-29; magnetic localization is used to provide real-time feedback on the catheter tip location to the surgeon, and no steering field is needed. When the catheter tip comes to the proximity of the bifurcated portion of the vascular structure, the localization method for the catheter switches to a radiographic (e. g. x-ray imaging), and a magnetic field is turned on to steer the robotic catheter towards the target branch, as shown in steps (b) - (c); Fig. 20) and
a display configured (Pg. 18, ln. 19-28; display devices (e.g. monitors) 230, Fig. 10) to receive positional information from the console and display an image of the patient and display an icon representing a location of the medical device relative to the patient (Pg. 6, ln. 5-9; comprise a visual display configured to display a position of the permanent magnet; Fig. 17 shows a display 230 displaying an image displaying an icon representing a location of the medical device relative to the patient).
Alambeigi does not explicitly teach the sensor is placed on an external surface of a patient;
the steering magnet is disposed on the external surface of the patient;
the console includes memory and one or more processors.
Cox, however, teaches a sensor (Paragraph [0076]; sensor 50 is employed by the system 10 during TLS operation to detect a magnetic field produced by the magnetic elements 106 of the stylet 100) placed on an external surface of a patient (Paragraph [0076]; TLS sensor 50 is placed on the chest of the patient, Fig. 2); and
the console (Paragraph [0077]; the TLS sensor 50 is operably connected to the console 20 of the system 10, Fig. 1 and 2) includes memory and one or more processors (Paragraph [0062]; processor 22, including non-volatile memory such as EEPROM for instance, is included in the console 20 for controlling system function during operation of the system 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Alambeigi such that the sensor is placed on an external surface of the patient as taught by Cox because it would have been a well understood method of placing the sensors for electromagnetic tracking of the magnetic medical object, that further would have allowed placing the sensors in predetermined locations to thereby more accurately provide placement position of the medical object with respect the patient’s anatomy (Cox, Paragraph [0076]-[0077]). It further would have been obvious to have modified the console of Alambeigi to have included memory and one or more processors as taught by Cox because it would have been well understood components for controlling system function during operation of the system.
Together Alambeigi and Cox do not explicitly teach the steering magnet is disposed on the external surface of the patient.
Sowards, however, teaches a steering magnet (Paragraph [0201]; steerable by an external magnetic device 902) is disposed on the external surface of the patient (Paragraph [0036]; an external magnetic device placed on the patient body).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Alambeigi and Cox such that the steering magnet is disposed on the external surface of the patient as taught by Sowards because it would have been a well understood method of placing the steering magnet to steer the magnetic medical instrument using an external magnet that further would have allowed placement of the magnet to directly steer the instrument toward a target location (Sowards, Paragraph [0036] and [0203]).
Regarding claim 2, together Alambeigi, Cox, and Sowards teach all of the limitations of claim 1 as noted above.
Alambeigi further teaches the medical device includes one or more of a catheter (Pg. 14, ln. 3-13; permanent magnet 120 is arranged at the catheter distal segment).
Regarding claim 3, together Alambeigi, Cox, and Sowards teach all of the limitations of claim 1 as noted above.
Alambeigi further teaches the magnetic element of the medical device is a permanent magnet or a magnetically responsive material (Pg. 12, ln. 14-26; apparatus 100 further comprises a permanent magnet 120 coupled to second end 112 of segmented tubular member 110).
Regarding claim 4, together Alambeigi, Cox, and Sowards teach all of the limitations of claim 1 as noted above.
Alambeigi further teaches the console is configured to receive an input from a clinician to switch between simultaneously activating the sensor and deactivating the steering magnet, and simultaneously activating the steering magnet and deactivating the steering magnet (Pg. 18, ln. 24-25; the steering is controlled with the magnetic actuation of one or more electromagnets 130 via controller 170 operated by surgeon 210; Pg. 40, ln. 11-29; the localization method for the catheter switches to a radiographic (e. g. x-ray imaging), and a magnetic field is turned).
Regarding claim 6, together Alambeigi, Cox, and Sowards teach all of the limitations of claim 1 as noted above.
Alambeigi further teaches the positional information includes location, orientation, or shape of the medical device (Pg. 33, ln. 11-30; where the magnetic field from a PM or a coil is measured and used to estimate its location and orientation).
Regarding claim 7, together Alambeigi, Cox, and Sowards teach all of the limitations of claim 1 as noted above.
Alambeigi further teaches the steering magnet is formed integrally with the sensor to align the steering magnet (Pg. 34, ln. 15-24; magnetic sensors 300 are coupled to an electromagnet 130 (e.g. Helmholtz coils) and are configured to detect a 20 location of permanent magnet 120 coupled to segmented tubular 110 as part of a magnetically steerable catheter 160, as previously described herein) with a predefined location when the sensor is disposed over the patient (Pg. 15, ln. 27-33; segmented tubular member 110 that enables the catheter to remotely steer in the shown leg's bifurcations in FIGS. 1 and 2).
Alambeigi does not explicitly teach the sensor is disposed over a sternum of the patient.
Cox, however, further teaches the sensor is disposed over a sternum of the patient (Paragraph [0076]; The TLS sensor 50 is placed on the chest of the patient in a predetermined location).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Alambeigi in view of Cox and Sowards such that the sensor is disposed over a sternum of the patient as further taught by Cox because it would have allowed providing information to the clinician as to the position and orientation of the catheter distal end during its transit to a desired position with respect to a node of the patient's heart (Cox, Paragraph [0058]).
Regarding claim 12, together Alambeigi, Cox, and Sowards teach all of the limitations of claim 1 as noted above.
Alambeigi does not explicitly teach a polarity of the electromagnet is reversed to change the steering magnet between attracting and repelling the medical device magnetic element.
Sowards, however, further teaches a polarity of the electromagnet is reversed to change the steering magnet between attracting and repelling the medical device magnetic element (Paragraph [0202]; Depending on the configuration of the electromagnet 902 and the distal tip 900… the electromagnet 902 attracts or repels the distal tip 900, may be utilized to steer the distal tip 900 of the catheter 195).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Alambeigi in view of Cox and Sowards such that the polarity of the electromagnet is reversed to change the steering magnet between attracting and repelling the medical device magnetic element as taught by Sowards because it would further allow more options for steering of the medical device by the electromagnet (Sowards, Paragraph [0202]) and thus allow for steering in more directions by the device placed on the body.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Alambeigi in view of Cox and Sowards as applied to claim 1 above, and further in view of Anderson (US 20210386315) and Kim (US 20210220068).
Regarding claim 5, together Alambeigi, Cox, and Sowards teach all of the limitations of claim 1 as noted above.
Alambeigi further teaches simultaneously activating the sensor and deactivating the steering magnet (Pg. 40, ln. 11-29; magnetic localization is used to provide real-time feedback on the catheter tip location to the surgeon, and no steering field is needed. When the catheter tip comes to the proximity of the bifurcated portion of the vascular structure, the localization method for the catheter switches to a radiographic (e. g. x-ray imaging), and a magnetic field is turned on to steer the robotic catheter towards the target branch, as shown in steps (b) - (c); Fig. 20).
Together Alambeigi, Cox, and Sowards do not explicitly teach the console is further configured to switch between activating the sensor and deactivating the steering magnet, and activating the steering magnet and deactivating the sensor at between 5Hz and 50Hz.
Anderson, however, teaches activating the sensor and deactivating the sensor (Paragraph [0076]; using a single catheter guidewire-mounted permanent magnet and a planar array of 3D magnetometer sensors results in an accuracy in locating the catheter) at between 5Hz and 50Hz (reference locations are updated at a 50 Hz rate).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor of Alambeigi in view of Cox and Sowards such that the activating the sensor and deactivating the sensor occurred at between 5Hz and 50Hz as taught by Anderson because it would have allowed the locations of the detected permanent magnets to be updated without a noticeable delay (Paragraph [0076]) which would have made tracking the catheter smoother.
Together Alambeigi, Cox, Sowards, and Anderson do not explicitly teach activating and deactivating the steering magnet at between 5Hz and 50Hz.
Kim, however, teaches activating and deactivating the steering magnet (Paragraph [0036]; “electromagnetic actuation (EMA) system” may refer to a system that controls the three-dimensional locomotion and direction of a microrobot; a wide range of resonant frequency with a maximum magnetic field and little phase delay) at between 5Hz and 50Hz (Paragraph [0038]; the resonant frequency range of the circular Helmholtz coils may be 15-100 Hz).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have obvious to have modified the sensor of Alambeigi in view of Cox, Sowards, and Anderson such that the activating the steering magnet and deactivating the steering magnet occurred at between 5Hz and 50Hz as taught by Kim because it would have magnetic field generation frequency can be maximized by a resonance control circuit, thereby enhancing the propulsion force of the microrobot (Paragraph [0060]) and thereby improve the propulsion and steering of the medical object.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Alambeigi in view of Cox and Sowards as applied to claim 1 above, and further in view of Marvi (US 20220395332).
Regarding claim 8, together Alambeigi, Cox, and Sowards teach all of the limitations of claim 1 as noted above.
Together Alambeigi, Cox, and Sowards do not explicitly teach the steering magnet is formed as a separate standalone device from the sensor and is communicatively coupled with one or both of the sensor and the console by wired or wireless communication.
Marvi, however, teaches the steering magnet (Paragraph [0068]; a magnetic end effector 112 having one or more magnets) is formed as a separate standalone device from the sensor (Paragraph [0069]; Output signals of the magnetic field sensors 115 and respiration sensors 117 may be provided to the one or more processors 120.; Fig. 1 shows magnetic field sensors and respiration sensors are separate devices from the magnetic end effector 112) and is communicatively coupled with one or both of the sensor and the console by wired or wireless communication (Paragraph [0023]; generating an output signal responsive to the sensing, and comparing the output signal to a desired range of output signal values. In certain embodiments, responsive to the comparison, the method further comprises adjusting position of an end effector configured to apply the magnetic field to the premagnetized material; Paragraph [0069]; such information may be sent to the motor signal converter(s) 118 using a wired or wireless connection).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Alambeigi in view of Cox and Sowards such that the steering magnet is formed as a separate standalone device from the sensor and is communicatively coupled with one or both of the sensor and the console by wired or wireless communication as taught by Marvi because it would have further allowed sensing the directionality of the magnetic field produced by the magnetic end effector and thereby determine whether the steering magnetic field is sufficient to move the medical device to the target or if the magnetic fields need to be adjusted (Paragraph [0069] and [0081]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Alambeigi in view of Cox and Sowards as applied to claim 1 above, and further in view of Pollak (US 20200397525).
Regarding claim 9, together Alambeigi, Cox, and Sowards teach all of the limitations of claim 1 as noted above.
Alambeigi further teaches the steering magnet is worn by the patient and aligns the steering magnet with a predetermined location on an exterior of the patient (Fig. 16 and 17 shows the steering magnet is worn around the leg of the patient and aligns steering around the leg vasculature).
Together Alambeigi, Cox, and Sowards do not explicitly teach the steering magnet is coupled to a garment.
Pollak, however, teaches steering magnet (Paragraph [0040]; magnetic devices 240, Fig. 2) is worn by the patient and aligns the steering magnet with a predetermined location on an exterior of the patient (Paragraph [0030]; a drape device 200 temporarily covering the chest of patient 10 can be used to facilitate the navigation and installation of transvenous devices; Paragraph [0012]; In some cases, the one or more electromagnets can be used to influence the positioning of the distal tip).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the steering magnet of Alambeigi in view of Cox and Sowards to be coupled to a garment that is worn by the patient and aligns the steering magnet with a predetermined location on an exterior of the patient as taught by Pollack because it would have been a well understood method of positioning the steering magnets that further would have facilitated the navigation and installation of transvenous devices by allowing proper align with the patient (Paragraph [0030]-[0031]).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Alambeigi in view of Cox and Sowards as applied to claim 1 above, and further in view of Katims (US 5121750).
Regarding claim 10, together Alambeigi, Cox, and Sowards teach all of the limitations of claim 1 as noted above.
Together Alambeigi, Cox, and Sowards do not explicitly teach one or both of the sensor and the medical device includes an electrode configured to detect an electrical impulse, and wherein the console is configured to determine a presence of a pacemaker, and in response to the console determining the presence of the pacemaker, the console prevents the steering magnet from being activated.
Katims, however, teaches one or both of the sensor and the medical device includes an electrode configured to detect an electrical impulse (Col. 3, ln. 21-32; These tip located electrodes allow the monitoring of the electrical potentials in the region of the tissue), and wherein the console is configured to determine a presence of a pacemaker (Col. 6, ln. 10-31; A sudden monitored pacemaker potential increase could indicate that the transmission contact area located at 9, for example, has come in close proximity of the monitored pacemaker node PN. Another sudden return to the previous monitored potential amplitude thereafter associated with a movement of the electrical catheter 1 would indicate that distal tip 10 of the is no longer close to the pacemaker node PN as it has moved away from this location while traveling along the blood vessel 12.), and in response to the console determining the presence of the pacemaker, the console prevents the steering magnet from being activated (Col. 8, ln. 24-Col. 9, ln. 3; Col. 9, ln. 19-24; When the monitored potential then decreases during backward catheter movement by a certain percentage as determined by the electronic catheter monitoring system 50 the system display will indicate "STOP", thereby indicating that the catheter tip 10 is in the correct location).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Alambeigi in view of Cox and Sowards such that the one or both of the sensor and the medical device includes an electrode configured to detect an electrical impulse, and wherein the console is configured to determine a presence of a pacemaker, and in response to the console determining the presence of the pacemaker, the console prevents the steering magnet from being activated because it would allow positioning of the catheter in the correct or safe location is the place before the maximum potential is reached (Katims, Col. 9).
Regarding claim 11, together Alambeigi, Cox, Sowards, and Katims teach all of the limitations of claim 1 as noted above.
Alambeigi does not explicitly teach the console provides one or more of a visual, audible, and tactile alert to a clinician to indicate the steering magnet is deactivated due to the presence of the pacemaker being detected.
Katims, however, teaches the console provides one or more of a visual, audible, and tactile alert to a clinician to indicate the steering magnet is deactivated due to the presence of the pacemaker being detected (Col. 8, ln. 55-65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the the console provides one or more of a visual, audible, and tactile alert to a clinician to indicate the steering magnet is deactivated due to the presence of the pacemaker being detected because it would have allowed the physician to know the catheter is in the correct position and thereby perform further surgical procedures such as placement of CVC (Katims, Col. 1-2).
Claims 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Marvi (US 20220395332) in view of Sowards (US 20220160209), Moll (US 20080218770) and Burnside (US 20170215762).
Regarding claim 13, Marvi teaches a tracking and steering system (Abstract; system and method for determining position of a steerable assembly within tissue of an animal body… directionality of magnetic field applied to the premagnetized material, to determine a three-dimensional (3D) trajectory of the steerable assembly) comprising:
a medical device (Paragraph [0068]; a system 100 with a steerable assembly 105, Fig. 1) comprising:
a first magnetic element coupled with a distal portion thereof (Paragraph [0069]; the steerable assembly 105, e.g., including a magnetic needle 122; Fig. 1); and
a first integrated optical-fiber having a plurality of fiber Bragg grating (“FBG”) sensors along a portion thereof (Paragraph [0084]; a portion of a fiber bragg grating (FBG) sensor 352 that may be utilized with a system for determining position of a steerable assembly within tissue of an animal body, Fig. 6);
a steering magnet (Paragraph [0068]; implement steering subsystem 102 utilizes a magnetic end effector 112 having one or more magnets, Fig. 1) disposed external to a patient (Paragraph [0065]; one magnetic field source (e.g., generated by one or more end effectors such as one or more robotic arm(s)) external to an animal body, Fig. 1) comprising:
a second magnetic element (Paragraph [0068]; utilizes a magnetic end effector 112); and
a tether extending from the steering magnet (Paragraph [0068]; The magnetic end effector 112 may be moved in three dimensions using a robotic arm 114 (e.g., six-degree of freedom (6DOF) robotic arm) that is controlled by one or more motor drivers 116; Fig. 1);
a console (Paragraph [0099]; computer system 500) including memory (Paragraph [0099]; a main memory 504 (e.g., read-only memory (ROM), flash memory, dynamic random access memory (DRAM), such as synchronous DRAM (SDRAM), etc.), and a static memory 506) and one or more processors (Paragraph [0099] and [0101]; includes a processing device or processor 502… configured to execute processing logic in instructions for performing the operations and steps) configured to:
convert FBG sensor-reflected optical signals from the first integrated optical-fiber in the medical device (Paragraph [0084]; reflected signal 356C may be detected by a light detector associated with a FBG driver/detector unit (not shown), and analyzed to determine one or more of force, strain, or shape experienced by the FBG sensor 352; system for determining position of a steerable assembly) and the tether into plottable data (Paragraph [0089]; One or more additional sensors 313 (e.g., to sense physical position of the robotic arm) may be provided) by way of a plurality of optical signal-converter algorithms (Paragraph [0084]; reflected signal 356C may be detected by a light detector associated with a FBG driver/detector unit (not shown), and analyzed to determine one or more of force, strain, or shape experienced by the FBG sensor 352; system for determining position of a steerable assembly) to determine position information for a distal tip of the medical device and the steering magnet (Paragraph [0084]; determining position of a steerable assembly; Paragraph [0089]; sense physical position of the robotic arm); and
a display (Paragraph [0092]; A display 348) configured to provide an image of the patient, a first icon indicating a position of the medical device (Paragraph [0092]; A display 348 may be used to show position of one or more portions of the steerable assembly 305 relative to the 3D model of tissue of the animal body).
Marvi does not explicitly teach the steering magnet is disposed on an external surface of a patient;
the tether including a second integrated optical-fiber having a plurality of FBG sensors along a portion thereof;
using the plurality of optical signal-converter algorithms to determine position information for the steering magnet;
and a second icon indicating a position of the steering magnet relative to each other.
Sowards, however, teaches a steering magnet (Paragraph [0201]; steerable by an external magnetic device 902) is disposed on the external surface of the patient (Paragraph [0036]; an external magnetic device placed on the patient body).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Marvi such that the steering magnet is disposed on the external surface of the patient as taught by Sowards because it would have been a well understood method of placing the steering magnet to steer the magnetic medical instrument using an external magnet that further would have allowed placement of the magnet to directly steer the instrument toward a target location (Sowards, Paragraph [0036] and [0203]).
Together Marvi and Sowards do not explicitly teach the tether including a second integrated optical-fiber having a plurality of FBG sensors along a portion thereof;
using the plurality of optical signal-converter algorithms to determine position information for the steering magnet;
and a second icon indicating a position of the steering magnet relative to each other.
Moll, however, teaches the tether having an integrated optical-fiber having a plurality of fiber Bragg grating (“FBG”) sensors along a portion (Paragraph [0048]; one or more Bragg sensing fibers may be included with each of the arms of a robotic arm; a separate Bragg fiber sensor (16) may be disposed on each link of the robotic arm (28), Fig. 6; paragraph [0058]; extending from a sensor module (106), along the entire length of the robotic arm (98) all the way to the tip of the end effector (100).) thereof;
convert FBG sensor-reflected optical signals from the integrated optical-fiber in the tether by way of a plurality of optical signal-converter algorithms to determine position information for the steering magnet (Paragraph [0058]; The sensor module (106) of this illustration collects all the sensed data and communicates the data to the computer system (92) via a cable or wirelessly. In another implementation, the sensor module (106) may be configured to analyze the data from the fiber sensors (16) and then simply communicate the position data directly to the computer system (92); Paragraph [0057]; computer system (92) may accurately know the location and orientation of the end effector (100)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Marvi in view of Sowards such that the tether has an integrated optical-fiber having a plurality of fiber Bragg grating (“FBG”) sensors along a portion thereof and converts FBG sensor-reflected optical signals from the integrated optical-fiber in the tether by way of a plurality of optical signal-converter algorithms to determine position information for the steering magnet because it would have been a well understood method of determining the position of a too such as the steering magnet at the end of a robot arm, that further would have provided additional redundancy to the positioning system (Paragraph [0068]) and allow measuring the position of the steering magnet when the electromagnets are not active.
Together Marvi, Sowards, and Moll do not explicitly teach a second icon representing a location of the steering magnet.
Burnside, however, teaches a second icon representing a location of the steering magnet (Paragraph [0082]; FIG. 11 further shows an icon 394 that represents the EM coil 276… as depicted on the screenshot 380 of the display 30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Marvi in view of Sowards and Moll to include a second icon representing a location of the steering magnet because it would have served as a reference marker to further assist in determining the location of the catheter (or other medical device) with respect to a landmark, such as the chest of the patient (Burnside, Paragraph [0082]).
Regarding claim 14, together Marvi, Sowards, Moll, and Burnside teach all of the limitations of claim 13 as noted above.
Marvi further teaches medical device includes one of a catheter, guidewire, or stylet (Paragraph [0003]; with such tubular bodies being embodied in catheters, cannulas, guide wires, or the like.).
Regarding claim 15, together Marvi, Sowards, Moll, and Burnside teach all of the limitations of claim 13 as noted above.
Marvi further teaches the first magnetic element of the medical device is one of a permanent magnet or a magnetically responsive material (Paragraph [0066]-[0067]; an implement comprising a premagnetized material, such as a magnetized metal needle), and wherein the second magnetic element of the steering magnet is one of a permanent magnet or an electromagnet (Paragraph [0067]; magnetically actuated using multiple permanent magnets… In certain embodiments, electromagnets may be used instead of permanent magnets).
Regarding claim 16, together Marvi, Sowards, Moll, and Burnside teach all of the limitations of claim 13 as noted above.
Marvi further teaches a positional information of the distal tip of the medical device and the steering magnet includes location or shape (Paragraph [0084]; for determining position of a steerable assembly within tissue of an animal body; determine one or more of force, strain, or shape experienced by the FBG sensor 352).
Regarding claim 17, together Marvi, Sowards, Moll, and Burnside teach all of the limitations of claim 13 as noted above.
Marvi further teaches the tether is coupled to the console (Paragraph [0069]; software operating on a personal computer to calculate a desired pose of the robotic arm 114… using a wired or wireless connection, and motor input information may be communicated to the motor driver(s) 116 for operating the robotic arm 114).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Marvi in view of Sowards, Moll, and Burnside as applied to claim 13 above, and further in view of Viswanathan (US 20160192995).
Regarding claim 18, together Marvi, Sowards, Moll, and Burnside teach all of the limitations of claim 13 as noted above.
Marvi further teaches the console further includes one or more logic engines configured to determine a position of the distal portion of the medical device relative to a position of the steering magnet (Paragraph [0086]; the three-dimensional trajectory of the steerable assembly and a desired path of the steerable assembly within the tissue of the animal body may be determined, and responsive to the error determination, directionality and/or position of a magnetic field source arranged to apply a magnetic field to the premagnetized material may be adjusted (e.g., by moving the 3D robotic arm and/or adjusting a magnetic field if an electromagnet is associated with the 3D robotic arm)) and activate the steering magnet when the distal portion of the medical device approaches a target location (Paragraph [0093]; The central processor(s) may be used to translate a desired position and orientation of the magnetic needle 422 to a magnetic field configuration to be provided by the robotic arm 414 and the magnetic end effector 412 and such magnetic field configuration may be translated to position and field strength of the magnetic end effector 412. The foregoing translations may be provided to an inverse kinematic determination unit 418, which may provide signals to position joints of the robotic arm 414 at specific joint angles, while applying desired magnetic field strength to the magnetic needle 422.).
Marvi does not explicitly teach deactivating the steering magnet when the distal portion of the medical device is advanced past the target location.
Viswanathan, however, teaches deactivating the steering magnet when the distal portion of the medical device is advanced past the target location (Paragraph [0047]; the remote navigation system so as to apply a suitable magnetic field vector to make adjustments to the ablation catheter tip position along with suitable insertion/retraction of the catheter (also generally applied by the remote navigation system) until it arrives at the target.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Marvi in view of Sowards, Moll, and Burnside to include deactivating the steering magnet when the distal portion of the medical device is advanced past the target location as taught by Viswanathan because it would have allowed optimally accessing target locations in a subject anatomy.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Marvi (US 20220395332) in view of Alambeigi (WO 2023205621 A2), Cox (US 20110295108), Sowards (US 20220160209), Moll (US 20080218770) and Burnside (US 20170215762).
Regarding claim 19, Marvi teaches a tracking and steering system (Abstract; system and method for determining position of a steerable assembly within tissue of an animal body… directionality of magnetic field applied to the premagnetized material, to determine a three-dimensional (3D) trajectory of the steerable assembly) comprising:
a medical device (Paragraph [0068]; a system 100 with a steerable assembly 105, Fig. 1) including a magnetic element coupled with a distal portion of the medical device (Paragraph [0069]; the steerable assembly 105, e.g., including a magnetic needle 122; Fig. 1);
a steering magnet (Paragraph [0068]; implement steering subsystem 102 utilizes a magnetic end effector 112 having one or more magnets, Fig. 1) and including an electromagnet configured to attract the magnetic element of the medical device (Paragraph [0067]; magnetically actuated using multiple permanent magnets… In certain embodiments, electromagnets may be used instead of permanent magnets), the steering magnet including a tether (Paragraph [0068]; The magnetic end effector 112 may be moved in three dimensions using a robotic arm 114 (e.g., six-degree of freedom (6DOF) robotic arm) that is controlled by one or more motor drivers 116; Fig. 1);
a console (Paragraph [0099]; computer system 500) including memory (Paragraph [0099]; a main memory 504 (e.g., read-only memory (ROM), flash memory, dynamic random access memory (DRAM), such as synchronous DRAM (SDRAM), etc.), and a static memory 506) and one or more processors (Paragraph [0099] and [0101]; includes a processing device or processor 502… configured to execute processing logic in instructions for performing the operations and steps) configured to:
convert sensor from the tether into plottable data (Paragraph [0089]; One or more additional sensors 313 (e.g., to sense physical position of the robotic arm) may be provided) to determine position information for the steering magnet (Paragraph [0084]; determining position of a steerable assembly; Paragraph [0089]; sense physical position of the robotic arm); and
a display (Paragraph [0092]; A display 348) configured to receive positional information from the console and display an image of the patient (Paragraph [0021]; method further comprises superimposing the three-dimensional trajectory of the steerable assembly on the three-dimensional model of the tissue of the animal body), display a first icon representing a location of the medical device relative to the patient (Paragraph [0092]; A display 348 may be used to show position of one or more portions of the steerable assembly 305 relative to the 3D model of tissue of the animal body).
Marvi does not explicitly teach a sensor placed on an external surface of a patient and configured to detect a magnetic field strength of the magnetic element of the medical device;
the steering magnet is disposed on the external surface of the patient;
the tether having an integrated optical-fiber having a plurality of fiber Bragg grating (“FBG”) sensors along a portion thereof;
receive magnetic field strength information from the sensor and determine positional information for a distal tip of the medical device;
simultaneously activate the sensor and deactivate the steering magnet or simultaneously activate the steering magnet and deactivate the steering magnet;
convert FBG sensor-reflected optical signals from the integrated optical-fiber in the tether by way of a plurality of optical signal-converter algorithms to determine position information for the steering magnet
and a second icon representing a location of the steering magnet.
Alambeigi, however, teaches a medical device (Pg. 12, ln. 14-26; an apparatus 100 comprises a segmented tubular member 110, Fig. 1) including a magnetic element coupled with a distal portion of the medical device (Pg. 12, ln. 14-26; comprises a permanent magnet 120 coupled to second end 112 of segmented tubular member 110);
a sensor placed external to a patient and configured to detect a magnetic field strength of the magnetic element of the medical device (Pg. 32, Ln. 26-33; Specific embodiments can also be integrated with a magnetic localization system; Pg. 34, ln. 15-25; In this embodiment, magnetic sensors 300 are coupled to an electromagnet 130 (e.g. Helmholtz coils) and are configured to detect a location of permanent magnet 120 coupled to segmented tubular 110 as part of a magnetically steerable catheter 160, as previously described herein; Fig. 16-17 shows the sensors are external to the patient);
a steering magnet disposed external to the patient and including an electromagnet configured to attract the magnetic element of the medical device (Pg. 12, ln. 27-32; electrical current to electromagnet 130 and control a magnetic force exerted by electromagnet 130 on permanent magnet 120; Pg. 14, ln. 3-13; When currents are excited in the coils, steering torque is generated to the permanent magnet 120, which controls the direction of the catheter's distal segment);
receive magnetic field strength information from the sensor and determine positional information for a distal tip of the medical device (Pg. 34, ln. 5-24; put the magnet at a series of known positions and collects the data, and then solves for the magnet strength and sensor location parameters by a least square problem. This least square problem solves for the M and ps that minimizes the discrepancy between magnet location estimated using the M and p values and the known location; magnetic sensors 300 are coupled to an electromagnet 130 (e.g. Helmholtz coils) and are configured to detect a location of permanent magnet 120 coupled to segmented tubular 110 as part of a magnetically steerable catheter 160); and
simultaneously activate the sensor and deactivate the steering magnet or simultaneously activate the steering magnet and deactivate the sensor (Pg. 40, ln. 11-29; magnetic localization is used to provide real-time feedback on the catheter tip location to the surgeon, and no steering field is needed. When the catheter tip comes to the proximity of the bifurcated portion of the vascular structure, the localization method for the catheter switches to a radiographic (e. g. x-ray imaging), and a magnetic field is turned on to steer the robotic catheter towards the target branch, as shown in steps (b) - (c); Fig. 20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Marvi such that a sensor is placed external a patient and configured to detect a magnetic field strength of the magnetic element of the medical device; receive magnetic field strength information from the sensor and determine positional information for a distal tip of the medical device; and simultaneously activate the sensor and deactivate the steering magnet or simultaneously activate the steering magnet and deactivate the steering magnet as taught by Alambeigi because it would have allowed magnetic catheter tip tracking while minimizing x-ray radiation required to ensure safety during catheter navigation (Pg. 40, ln. 1-10) and further provide real-time feedback on the catheter tip location to the surgeon when no steering field is needed, while switching the tracking system while the magnetic steering is activated (Pg. 40, ln. 11-29).
Together Marvi and Alambeigi do not explicitly teach the sensor is placed on an external surface of a patient;
the steering magnet is disposed on the external surface of the patient;
the tether having an integrated optical-fiber having a plurality of fiber Bragg grating (“FBG”) sensors along a portion thereof;
convert FBG sensor-reflected optical signals from the integrated optical-fiber in the tether by way of a plurality of optical signal-converter algorithms to determine position information for the steering magnet
and a second icon representing a location of the steering magnet.
Cox, however, teaches a sensor (Paragraph [0076]; sensor 50 is employed by the system 10 during TLS operation to detect a magnetic field produced by the magnetic elements 106 of the stylet 100) placed on an external surface of a patient (Paragraph [0076]; TLS sensor 50 is placed on the chest of the patient, Fig. 2); and
the console (Paragraph [0077]; the TLS sensor 50 is operably connected to the console 20 of the system 10, Fig. 1 and 2) includes memory and one or more processors (Paragraph [0062]; processor 22, including non-volatile memory such as EEPROM for instance, is included in the console 20 for controlling system function during operation of the system 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Marvi in view of Alambeigi such that the sensor is placed on an external surface of the patient as taught by Cox because it would have been a well understood method of placing the sensors for electromagnetic tracking of the magnetic medical object, that further would have allowed placing the sensors in predetermined locations to thereby more accurately provide placement position of the medical object with respect the patient’s anatomy (Cox, Paragraph [0076]-[0077]).
Together Marvi, Alambeigi, and Cox do not explicitly teach the steering magnet is disposed on the external surface of the patient;
the tether having an integrated optical-fiber having a plurality of fiber Bragg grating (“FBG”) sensors along a portion thereof;
convert FBG sensor-reflected optical signals from the integrated optical-fiber in the tether by way of a plurality of optical signal-converter algorithms to determine position information for the steering magnet
and a second icon representing a location of the steering magnet.
Sowards, however, teaches a steering magnet (Paragraph [0201]; steerable by an external magnetic device 902) is disposed on the external surface of the patient (Paragraph [0036]; an external magnetic device placed on the patient body).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Marvi in view of Alambeigi and Cox such that the steering magnet is disposed on the external surface of the patient as taught by Sowards because it would have been a well understood method of placing the steering magnet to steer the magnetic medical instrument using an external magnet that further would have allowed placement of the magnet to directly steer the instrument toward a target location (Sowards, Paragraph [0036] and [0203]).
Together Marvi, Alambeigi, Cox, and Sowards do not explicitly teach the tether having an integrated optical-fiber having a plurality of fiber Bragg grating (“FBG”) sensors along a portion thereof;
convert FBG sensor-reflected optical signals from the integrated optical-fiber in the tether by way of a plurality of optical signal-converter algorithms to determine position information for the steering magnet
and a second icon representing a location of the steering magnet.
Moll, however, teaches the tether having an integrated optical-fiber having a plurality of fiber Bragg grating (“FBG”) sensors along a portion (Paragraph [0048]; one or more Bragg sensing fibers may be included with each of the arms of a robotic arm; a separate Bragg fiber sensor (16) may be disposed on each link of the robotic arm (28), Fig. 6; paragraph [0058]; extending from a sensor module (106), along the entire length of the robotic arm (98) all the way to the tip of the end effector (100).) thereof;
convert FBG sensor-reflected optical signals from the integrated optical-fiber in the tether by way of a plurality of optical signal-converter algorithms to determine position information for the steering magnet (Paragraph [0058]; The sensor module (106) of this illustration collects all the sensed data and communicates the data to the computer system (92) via a cable or wirelessly. In another implementation, the sensor module (106) may be configured to analyze the data from the fiber sensors (16) and then simply communicate the position data directly to the computer system (92); Paragraph [0057]; computer system (92) may accurately know the location and orientation of the end effector (100)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Marvi in view of Alambeigi, Cox, and Sowards such that the tether has an integrated optical-fiber having a plurality of fiber Bragg grating (“FBG”) sensors along a portion thereof and converts FBG sensor-reflected optical signals from the integrated optical-fiber in the tether by way of a plurality of optical signal-converter algorithms to determine position information for the steering magnet because it would have been a well understood method of determining the position of a too such as the steering magnet at the end of a robot arm, that further would have provided additional redundancy to the positioning system (Paragraph [0068]) and allow measuring the position of the steering magnet when the electromagnets are not active.
Together Marvi, Alambeigi, Cox, Sowards, and Moll do not explicitly teach a second icon representing a location of the steering magnet.
Burnside, however, teaches a second icon representing a location of the steering magnet (Paragraph [0082]; FIG. 11 further shows an icon 394 that represents the EM coil 276… as depicted on the screenshot 380 of the display 30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Marvi in view of Alambeigi, Cox, Sowards, and Moll to include a second icon representing a location of the steering magnet because it would have served as a reference marker to further assist in determining the location of the catheter (or other medical device) with respect to a landmark, such as the chest of the patient (Burnside, Paragraph [0082]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Alambeigi (WO 2023205621 A2) in view of Cox (US 20110295108), Sowards (US 20220160209), Anderson (US 20210386315), and Kim (US 20210220068).
Regarding claim 20, Alambeigi teaches a method (Pg. 1, Abstract; apparatus and methods for enhancing the steerability of catheters… further comprise systems and methods for detecting the location of a magnetic element via magnetic sensors) of placing a medical device (Pg. 12, ln. 14-26; an apparatus 100 comprises a segmented tubular member 110, Fig. 1), comprising:
advancing a distal tip of the medical device intravascularly (Pg. 12, ln. 27-32; Accordingly, controller 170 can be used to guide permanent magnet 120 as it is advanced through artery 140 and into smaller diameter lumens in the vascular network), the distal tip including a medical device magnetic element (Pg. 12, ln. 14-26; comprises a permanent magnet 120 coupled to second end 112 of segmented tubular member 110);
placing a steering magnet external to a patient to modify a position of the distal tip disposed intravascularly, the steering magnet including an electromagnetic element (Pg. 12, ln. 27-32; electrical current to electromagnet 130 and control a magnetic force exerted by electromagnet 130 on permanent magnet 120; Pg. 14, ln. 3-13; When currents are excited in the coils, steering torque is generated to the permanent magnet 120, which controls the direction of the catheter's distal segment);
detecting a magnetic field strength of the medical device magnetic element by way of a sensor placed external to the patient (Pg. 34, ln. 5-24; put the magnet at a series of known positions and collects the data, and then solves for the magnet strength and sensor location parameters by a least square problem. This least square problem solves for the M and ps that minimizes the discrepancy between magnet location estimated using the M and p values and the known location; magnetic sensors 300 are coupled to an electromagnet 130 (e.g. Helmholtz coils) and are configured to detect a location of permanent magnet 120 coupled to segmented tubular 110 as part of a magnetically steerable catheter 160); and
modifying an activation state of the steering magnet and the sensor, by way of a console, to alternate between simultaneously activating the steering magnet and deactivating the sensor (Pg. 40, ln. 11-29; magnetic localization is used to provide real-time feedback on the catheter tip location to the surgeon, and no steering field is needed. When the catheter tip comes to the proximity of the bifurcated portion of the vascular structure, the localization method for the catheter switches to a radiographic (e. g. x-ray imaging), and a magnetic field is turned on to steer the robotic catheter towards the target branch, as shown in steps (b) - (c); Fig. 20), and simultaneously deactivating the steering magnet and activating the sensor at a rate of between 5Hz and 50Hz.
Alambeigi does not explicitly teach the sensor is placed on an external surface of a patient;
the steering magnet is disposed on the external surface of the patient;
switching between activating the sensor and deactivating the steering magnet, and activating the steering magnet and deactivating the steering magnet at between 5Hz and 50Hz.
Cox, however, teaches a sensor (Paragraph [0076]; sensor 50 is employed by the system 10 during TLS operation to detect a magnetic field produced by the magnetic elements 106 of the stylet 100) placed on an external surface of a patient (Paragraph [0076]; TLS sensor 50 is placed on the chest of the patient, Fig. 2); and
the console (Paragraph [0077]; the TLS sensor 50 is operably connected to the console 20 of the system 10, Fig. 1 and 2) includes memory and one or more processors (Paragraph [0062]; processor 22, including non-volatile memory such as EEPROM for instance, is included in the console 20 for controlling system function during operation of the system 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Alambeigi such that the sensor is placed on an external surface of the patient as taught by Cox because it would have been a well understood method of placing the sensors for electromagnetic tracking of the magnetic medical object, that further would have allowed placing the sensors in predetermined locations to thereby more accurately provide placement position of the medical object with respect the patient’s anatomy (Cox, Paragraph [0076]-[0077]). It further would have been obvious to have modified the console of Alambeigi to have included memory and one or more processors as taught by Cox because it would have been well understood components for controlling system function during operation of the system.
Together Alambeigi and Cox do not explicitly teach the steering magnet is disposed on the external surface of the patient; and
switching between activating the sensor and deactivating the steering magnet, and activating the steering magnet and deactivating the steering magnet at between 5Hz and 50Hz.
Sowards, however, teaches a steering magnet (Paragraph [0201]; steerable by an external magnetic device 902) is disposed on the external surface of the patient (Paragraph [0036]; an external magnetic device placed on the patient body).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Alambeigi and Cox such that the steering magnet is disposed on the external surface of the patient as taught by Sowards because it would have been a well understood method of placing the steering magnet to steer the magnetic medical instrument using an external magnet that further would have allowed placement of the magnet to directly steer the instrument toward a target location (Sowards, Paragraph [0036] and [0203]).
Together Alambeigi, Cox, and Sowards do not explicitly teach switching between activating the sensor and deactivating the steering magnet, and activating the steering magnet and deactivating the steering magnet at between 5Hz and 50Hz.
Anderson, however, teaches activating the sensor and deactivating the sensor (Paragraph [0076]; using a single catheter guidewire-mounted permanent magnet and a planar array of 3D magnetometer sensors results in an accuracy in locating the catheter) at between 5Hz and 50Hz (reference locations are updated at a 50 Hz rate).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor of Alambeigi in view of Cox and Sowards such that the activating the sensor and deactivating the sensor occurred at between 5Hz and 50Hz as taught by Anderson because it would have allowed the locations of the detected permanent magnets to be updated without a noticeable delay (Paragraph [0076]) which would have made tracking the catheter smoother.
Together Alambeigi, Cox, Sowards, and Anderson do not explicitly teach activating and deactivating the steering magnet at between 5Hz and 50Hz.
Kim, however, teaches activating and deactivating the steering magnet (Paragraph [0036]; “electromagnetic actuation (EMA) system” may refer to a system that controls the three-dimensional locomotion and direction of a microrobot; a wide range of resonant frequency with a maximum magnetic field and little phase delay) at between 5Hz and 50Hz (Paragraph [0038]; the resonant frequency range of the circular Helmholtz coils may be 15-100 Hz).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have obvious to have modified the sensor of Alambeigi in view of Cox, Sowards, and Anderson such that the activating the steering magnet and deactivating the steering magnet occurred at between 5Hz and 50Hz as taught by Kim because it would have magnetic field generation frequency can be maximized by a resonance control circuit, thereby enhancing the propulsion force of the microrobot (Paragraph [0060]) and thereby improve the propulsion and steering of the medical object.
Response to Arguments
Claim Rejections under – 35 U.S.C. § 112(b)
Examiner acknowledges the amendments to claim 5 and withdraws all previous rejections under 35 USC 112(b).
Claim Rejections under – 35 U.S.C. § 103
Applicant's arguments filed 11/08/2025 have been fully considered but they are not persuasive.
Regarding arguments to claim 1, Applicant argues the rejection of Alambeigi and Cox in view of Sowards to be improper as modifying the magnetic coils of Alambeigi to be disposed on the external surface of the patient would disrupt the configuration of the coils and thus the function of the system of the device of Alambeigi. Examiner respectfully disagrees. Examiner would like to point out the reference of Alambeigi teaches the electromagnetic coils are used to steer and control the direction of the medical device but fails to teach the explicit limitation of “disposed on the surface of the patient”. Alambeigi depicts the coils around the leg and does not appear to be contacting the leg, but the magnetic fields around passing through the leg appear to be independent of the legs themselves. Sowards is relied upon to teach that magnets can be placed on the surface of the body for steering, as described in at least paragraph [0036]. Furthermore, Sowards explicitly teaches the external magnet being an electromagnetic device, as described in paragraph [0035]. One of ordinary skill in the art would have realized that an electromagnetic device, for example the pair of Helmholtz coils in the system of Alambeigi, can be placed in contact with the patient and provide electromagnetic steering. Furthermore, by providing electromagnetic steering, and the fact that the magnetic fields around passing through the leg appear to be independent of the legs themselves, the modification is considered to not change the function of Alambeigi . The act of placing the magnets in contact with the patient is considered to read on the claimed limitation as understood in its broadest reasonable interpretation. Furthermore, one would be motivated to modify the system of Alambeigi such that the magnets contact the patient because it would ensure positioning of the magnetic fields of the system with respect to the target area of the leg and thus allow a more direct steering the instrument to a target area.
Applicant further argues the modification from the cylindrical configuration of sensors to that of the sensors being the skin surface would disrupt the uniform configuration of the Helmholtz coils. Examiner respectfully disagrees. Examiner would like to point out the modification of Alambeigi in view of Cox is adjusting the sensors of Alambeigi to be in contact with the patient and thus placed on the external surface of the patient as claimed. Cox is relied upon to teach EM sensors can be placed in contact with a patient. Such a modification would thus not change the function of the sensors ability to detect the magnetic fields and further calibrate the magnetic fields with the sensors, but merely change the position of the sensors with respect to the leg and the patient.
Regarding arguments to claim 13, Applicant argues the modification of Marvi in view of Sowards would require substantial redesign of the system of Marvi and would change the functions of the system of Marvi. Examiner respectively disagrees. Examiner would like to point out the system of Marvi teaches a steering magnet comprising a magnetic element in the form of an end effector and a tether extending from the magnet in the form of robotic arm. Marvi fails to explicitly teach the magnet element contacts the patient such that the steering magnet is disposed on the external surface of the patient as claimed. Sowards is relied upon to teach that magnets can be placed on the surface of the body for steering, as described in at least paragraph [0036]. One of ordinary skill in the art would have realized that an magnetic device, for example the magnet of robot arm in the system of Marvi, can be placed in contact with the patient and provide electromagnetic steering, and read on the limitations as claimed. Applicant further argues Marvi fails to teach any sensors, algorithms, feedback loops, or means by which the end effector might be moved relative to the body while also maintaining contact with the skin surface of the body and accommodating for different skin surface shapes and any movement of the skin surface. Examiner would like to point out such limitations are not recited in the claims and are not considered within the scope of the claims. The act of merely contacting the robot arm with the patient, even manually by a user for example, is considered to read on the claimed limitations as understood in its broadest reasonable interpretation. Such an modification of Marvi in view of Sowards would not change the function of Marvi. One would have been motivated to modify Marvi such that the steering magnet is disposed on the external surface of the patient because it would have allowed directly steering the medical instrument to a target area.
Arguments regarding claims 19 and 20 are not persuasive for similar reasons as described above with respect to claims 1 and 13.
Regarding further arguments with respect to claim 20, Applicant argues Anderson and Kim do not teach activating and deactivating the sensor and the steering magnet as claimed. With respect to the Anderson reference, Applicant argues the reference of Anderson is directed toward the measurement and calculation rate and does not teach turning the sensors on and off at a rate between 5 and 50 Hz. 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). Examiner would like to point out the reference of Alambeigi teaches switching the magnetic steering field and magnetic localization as described in pg. 40, ln. 11-29 and depicted in Fig. 20. Such act of switching steering field and the localization is considered to read on the claimed limitations of simultaneously activating/deactivating the sensor and the steering magnet as understood in its broadest reasonable interpretation. Alambeigi fails to explicitly teach the rate at which the switching occurs. The Anderson reference is relied upon to teach the rate of 50 Hz, and further that one would be motivated to choose a rate as it would allow locations of the magnet to be tracked and updated without noticeable delay. Applicant further argues the reference of Kim teaches rotating a magnetic field but does not teach the activating and deactivating the magnet. Examiner respectfully disagrees. Alambeigi is already teaches activating/deactivating the sensor and the steering magnet, but not the rate as claimed, as noted above. Kim is relied upon to teach a rate of 5-50 Hz as claimed. Furthermore, Kim teaches the rotating magnetic field is performed by a 3-axis Helmholtz coil as depicted in Fig. 4B. One of ordinary skill in the art would understand that rotating a constant magnetic field in a 3-axis coil would require, at least in one axis, reducing the current through one pair of coils to zero and applying a current in the opposite direction. Such adjustment of current is considered to be activating and deactivating the magnets as understood in its broadest reasonable interpretation. Thus Kim is relied upon to teach activating and deactivating the magnet at the claimed rate. One would have been motivated to choose such a rate because it is known for enhancing propulsion of a steerable magnetic object.
For these reasons, rejections of claims 1, 13, 19, and 20 are maintained.
Rejections of claims 1-20 under 35 USC 103 are maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 Dean N Edun whose telephone number is (571)270-3745. The examiner can normally be reached M-F 8am-5:30pm.
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/DEAN N EDUN/Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
02/22/26