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
Claims 1-26 are pending in this application. Claims 15-26 are withdrawn, and Claims 1-14 have been examined on the merits.
Election/Restrictions
Applicant’s election without traverse of claims 1-14 drawn to Invention I in the reply filed on 05/12/26 is acknowledged.
Claims 15-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being
drawn to a nonelected Invention II drawn to a system, there being no allowable generic or linking claim.
Drawings
The drawings are objected to because the values and labels in Figure 10 are illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification does not describe how the localization data is being combined or how it is further being used to determine spatial location.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Leeuw (“Center-Out Radial Sampling with Off-Resonant Reconstruction for Efficient and Accurate Localization of Punctate and Elongated Paramagnetic Structures”, 2013, Magnetic Resonance in Medicine, 69:1611–1622) in view of Weiss (US20120203100A1).
Regarding Claim 1,
Leeuw teaches a system, comprising: one or more non-transitory media storing data and executable instructions; and a processor configured to access the non-transitory media and execute the instructions (corresponding disclosure in at least [pg. 1614, “Methods: Reconstruction and Postprocessing], where there is a storage, or the database, and a processor for the instructions, or Matlab, which performs postprocessing “Postprocessing was performed using Matlab (The Math Works, Natick, MA). The radially acquired k-space data, interpolated to a rectangular grid, was exported from the scanner database”), the instructions comprising:
image reconstruction code programmed to reconstruct images based on acquired magnetic resonance (MR) data and provide reconstructed image data, in which at least some of the MR data includes a representation of a device within a field of view (corresponding disclosure in at least [pg. 1614, “Methods: Phantom Setup], where the imaged target is a phantom with a device (the brachytherapy needle) “Phantom B consisted of a 7-cm-thick highly inhomogeneous piece of porcine tissue containing fat, connective tissue and bone, submersed in agarose gel doped with 32mg MnCl2.4H2O per liter distilled water. The phantom contained four brachytherapy seeds” and further in [pg. 1614, “Methods: Imaging Parameters”], where MR imaging was completed on the phantom, which was then reconstructed “MR imaging was performed on a 1.5T whole body MRI… Reconstruction was performed using a filtered back projection reconstruction method, with a filter type B”)
localization code programmed to provide localization data representative of at least one of a location, orientation and/or shape of the device based on the reconstructed image data (corresponding disclosure in at least [pg. 1620, “Discussion”] and Figure 8, where there is a localization code providing localization data of the device based on the reconstruction image, or the co-RASOR images, which show the object dimensions, with Figure 8 further showing the orientation, shape, location of the device “The location of the center of the field perturbers on the co-RASOR images agreed to within one voxel with the locations of the centers on CT. Also the object dimensions determined from co-RASOR images corresponded to the known object dimensions to within one voxel. Dedicated postprocessing of reconstructed co-RASOR images was further shown to allow optimal localization of the center of a perturber semi-automatically and with good reproducibility”); and
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Figure 8 of Leeuw
off-resonance control code programmed to control an MR imaging system to provide radio frequency (RF) pulses at one or more off-resonant frequencies to excite off- resonance spins near a current-carrying coil carried by the device within the field of view, such that the acquired MR data is representative of the off-resonance excitation during MR image acquisition (corresponding disclosure in at least [1611, “Introduction”], where off-resonance (co-RASOR) is used, and the images acquired are representative of such off-resonance excitation “we have presented a method, center out Radial Sampling with Off-Resonance reception(co RASOR) which, in principle, solves the localization problem by forcing signal to pile-up in the geometrical center of punctuate and elongated paramagnetic structures… In the Co-RASOR technique, a frequency offset is applied during signal reception in a center-out radial acquisition” and further in Figure 8g, h, and I, where the images are representative of the off-resonance excitation).
Leeuw does not teach a current-carrying coil carried by the device.
Weiss, in a similar field of endeavor, teaches a similar concept (device localization) of a current-carrying coil carried by the device (corresponding disclosure in at least Figure 1 and [0080] and [0083], where the catheter carries a coil, which is within the cooling line in the catheter “ the radio frequency transmission line 106 is connected to a coil 406 which is located inside of the cooling line” and further “ FIG. 1 the radio frequency transmission line 106 and the radio frequency trap 118 are both shown as being within the cooling line 104”).
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Figure 1 of Weiss
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the coil carried by the device as taught by Weiss. One of the ordinary skill in the art would have been motivated to incorporate this because the coil is used as a radiofrquency trap and absorbs RF energy.
Regarding Claim 2, Leeuw and Weiss teach the limitations of Claim 1, and Leeuw further teaches the MR imaging system, in which the MR imaging system is configured to generate the acquired MR data based on RF pulses and magnetic field gradients provided within the field of view during the MR image acquisition (corresponding disclosure in at least [pg. 1614, “Methods: Imaging Parameters”], where the imaging system generates MR data based on the RF pulses and magnetic field gradients, the pulses being within the field of view to obtain the object “phantom A and B were scanned using a birdcage head coil. Phantom C was scanned utilizing a surface coil with two elliptical elements with short axis 14 cm and long axis 17cm. A 3D free induction decay was acquired using a center-out radial read-out. Two acquisitions were per formed on phantom A to validate reconstruction co-RASOR and to study the effect of the imaging resolution.”).
Regarding Claim 3, Leeuw and Weiss teach the limitations of Claim 2, and Weiss further teaches wherein the off-resonance control code is programmed to control at least some of the RF pulses provided by the MR imaging system concurrently with current pulses provided to the current carrying coil during the MR image acquisition (corresponding disclosure in at least [0099], where the control code controls both MR imaging system pulses and the pulses for the coil “Similarly if the radio frequency generator 1118 contains a reflected power meter for measuring the reflected power of a test frequency that is injected into the radio frequency ablation catheter 1120 there may be specialized code within the catheter control module 1142 which allows microprocessor 1132 to determine if there is a failure of the radio frequency ablation catheter 1120. The computer program product also comprises a magnetic resonance imaging control module 1144 for controlling the functionality of the magnetic resonance imaging system”).
Regarding Claim 4, Leeuw and Weiss teach the limitations of Claim 3, and Weiss further teaches wherein the off-resonance control code is programmed to control the at least some of the RF pulses to be provided at a frequency that is offset from the Larmor frequency to selectively excite off-resonant spins adjacent to the current-carrying coil (corresponding disclosure in at [0098]-[0100], where the frequency is set at the Larmor frequency for imaging and some of the frequency is off-set for ablation “during the use of the radio frequency ablation catheter to ablate tissue, the acquisition of magnetic resonance imaging data may induce currents in the radio frequency transmission line that lead to additional tip electrode 1124 heating. If this additional heating of the tip electrode 1124 in either of these two cases exceeds a predetermined safety threshold, magnetic resonance imaging may be stopped… The large difference in frequency between the Larmour frequency and the frequency used for ablation allows the radio frequency traps to effective filter at the Larmour frequency without a large attenuation at the frequency used to produce ablation”).
Regarding Claim 12, Leeuw and Weiss teach the limitations of Claim 1, and Leeuw further teaches wherein the localization code is programmed to control the image reconstruction code to produce a plurality of reconstructed image sets based on different sets of the acquired MR data, conjugates of reconstructed images, different weight matrices, and/or different coil sensitivity maps (corresponding disclosure in at least Figure 3, where a plurality of reconstructed images are based on different sets of acquired MR Data, or the different frequency offsets “The top row shows the acquired co-RASOR images, while the bottom row shows the reconstructed co-RASOR images. Image d shows the image acquired with a frequency offset of 2kHz, reconstructed on-resonance”).
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Figure 3 of Leeuw
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Leeuw (“Center-Out Radial Sampling with Off-Resonant Reconstruction for Efficient and Accurate Localization of Punctate and Elongated Paramagnetic Structures”, 2013, Magnetic Resonance in Medicine, 69:1611–1622) and Weiss (US20120203100A1) as applied in Claim 1, and in further view of Bock (“Active Catheter Tracking Using Parallel MRI and Real Time Image Reconstruction”, 2006, Magnetic Resonance in Medicine, 55:1454–1459).
Regarding Claim 5, Leeuw and Weiss teach the limitations of Claim 1, but does not teach rephaser control code programmed to control the MR imaging system to omit RF refocusing pulses during the MR image acquisition, such that the acquired MR data is representative of MR signals in the field of view in the absence of RF refocusing pulses during the MR image acquisition.
Bock, in a similar field of endeavor, teaches a similar concept (MRI image acquisition) of rephaser control code programmed to control the MR imaging system to omit RF refocusing pulses during the MR image acquisition, such that the acquired MR data is representative of MR signals in the field of view in the absence of RF refocusing pulses during the MR image acquisition (corresponding disclosure in at least [pg. 1455, “Materials and Methods: Real-time MRI Pulse Sequences], where RF refocusing pulses were not used/omitted (gradient echo was used) to project the images “Between each acquisition of subsequent trueFISP images a projection measurement for device tracking was inserted, which acquired three orthogonal gradient echo projections of the tracking coil signals using nonselective excitation pulses. Since nonselective device tracking disturbs the magnetization steady state established by the slice-selective trueFISP sequence, magnetization storage (–/2) and recovery ( /2) pulses were inserted before and after the tracking block to reduce artifacts from transient magnetization. T”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated omitting refocusing pulses as taught by Bock. One of the ordinary skill in the art would have been motivated to incorporate this because omitting refocusing pulses entails a gradient echo sequence, which is used for faster acquisition, beneficial for acquiring real-time data.
Regarding Claim 6, the combined references noted above teach the limitations of Claim 5, and an acquisition user interface programmed (corresponding disclosure in at least [0097] of Weiss, where there is a user interface “The microprocessor 1132 is also connected to and able to send instructions to a user interface 1134. The user interface 1134 comprises components for receiving input data from an operator and also for displaying information or graphics for an operator”) to select at least one of the off-resonance control code and the rephaser control code to be implemented by the imaging system during the MR image acquisition, the acquired MR data being provided based on the selected off-resonance control code and/or rephaser control code (corresponding disclosure in at least [pg. 1455, “Materials and Methods: Real-time MRI Pulse Sequences”] of Bock, where gradient and RF settings (the control codes) can be changed, thus acquiring the MRI images using rephaser control code “Coil coordinate information was then sent through a local Ethernet connection using dedicated TCP/IP software routines to the hardware computer con trolling the gradient and RF settings, and the slice position was shifted to the current catheter coil position”).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Leeuw (“Center-Out Radial Sampling with Off-Resonant Reconstruction for Efficient and Accurate Localization of Punctate and Elongated Paramagnetic Structures”, 2013, Magnetic Resonance in Medicine, 69:1611–1622) and Weiss (US20120203100A1) as applied in Claim 1, and in further view of Overall (“Ensuring Safety of Implanted Devices Under MRI Using Reversed RF Polarization”, 2010, Magnetic Resonance in Medicine, 64:823–833).
Regarding Claim 7, Leeuw and Weiss teach the limitations of Claim 1, but do not teach wherein the instructions further comprise: reverse polarization code programmed to control the image reconstruction code to apply reverse polarization reconstruction with respect to the acquired MR data and provide the reconstructed image data.
Overall, in a similar field of endeavor, teaches a similar concept (MRI imaging and reconstruction) of wherein the instructions further comprise: reverse polarization code programmed to control the image reconstruction code to apply reverse polarization reconstruction with respect to the acquired MR data and provide the reconstructed image data (corresponding disclosure in at least [pg. 831-832, “Differences between transmit and receive reversal”], where reverse polarization is used to acquire MR data for reconstruction “In our direct-drive bird cage, receiver polarization is synthesized in software from the two channels of received data, and both forward and reversed polarization images can be reconstructed from the same dataset”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated reverse polarization for reconstruction as taught by Overall. One of the ordinary skill in the art would have been motivated to incorporate this because reverse polarization is a safer design, especially as there are heating risks with devices in patients.
Regarding Claim 8, Leeuw and Weiss teach the limitations of Claim 1, but do not teach wherein the instructions further comprise: pattern matching code programmed to provide the localization data based on the acquired MR data and an expected MR signal.
Overall, in a similar field of endeavor, teaches a similar concept of pattern matching code programmed to provide the localization data based on the acquired MR data and an expected MR signal (corresponding disclosure in at least Figure 6, where there is pattern matching by comparing the data acquired and expected or simulated MR signal “Simulated images of an axial current (top) of 60 mA qualitatively agree with acquired images from a coupled guidewire(bottom)”).
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Figure 6 of Overall
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated pattern matching as taught by Overall. One of the ordinary skill in the art would have been motivated to incorporate this because it is common practice to have simulation data to compare the acquired results to for determining accuracy of the location and acquired experimental signals.
Regarding Claim 9, the combined references noted above teach the limitations of Claim 8, and Overall further teaches reverse polarization code programmed to control the image reconstruction code to apply reverse polarization reconstruction with respect to the acquired MR data and provide the reconstructed image data; and a reconstruction user interface programmed to invoke at least one of the reverse polarization code and the pattern matching code (corresponding disclosure in at least [pg. 831-832, “Differences between transmit and receive reversal”], where reverse polarization is used to acquire MR data for reconstruction “In our direct-drive bird cage, receiver polarization is synthesized in software from the two channels of received data, and both forward and reversed polarization images can be reconstructed from the same dataset” and further in Figure 6 where the software also invokes a pattern matching code).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Leeuw (“Center-Out Radial Sampling with Off-Resonant Reconstruction for Efficient and Accurate Localization of Punctate and Elongated Paramagnetic Structures”, 2013, Magnetic Resonance in Medicine, 69:1611–1622) , Weiss (US20120203100A1) and Overall (“Ensuring Safety of Implanted Devices Under MRI Using Reversed RF Polarization”, 2010, Magnetic Resonance in Medicine, 64:823–833) as applied in Claim 8, and in further view of Ahmad (US20150212177A1).
Regarding Claim 10, the combined references noted above teach the limitations of Claim 8, and Overall further teaches pattern matching (Figure 6), but does not teach wherein the pattern matching code is programmed to compare the acquired MR data to expected MR signal generated based on Biot-Savart simulations for the device.
Ahmad, in a similar field of endeavor, teaches a similar concept (MRI image reconstruction) of wherein the pattern matching code is programmed to compare the acquired MR data to expected MR signal generated based on Biot-Savart simulations for the device (corresponding disclosure in at least [0064], where Biot-Savart simulations are used for generating an expected MR signal “To compare imaging results from UIS, VRS, and VISTA, a 120×120 dynamic digital phantom with 48 temporal frames was created in Matlab (Mathworks, Natick, Mass. USA). The phantom consisted of both dynamic and static features. The dynamic ellipses had periodic motion, with the frequency of the motion inversely proportional to the acceleration rate, R. To emulate experimental conditions, twelve uniformly spaced circular receive coils were simulated around the phantom using the Biot-Savart law”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of Biot-Savart law as taught by Ahmad One of the ordinary skill in the art would have been motivated to incorporate this because it’s a commonly used model for visualization of magnetic fields and electrical currents.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Leeuw (“Center-Out Radial Sampling with Off-Resonant Reconstruction for Efficient and Accurate Localization of Punctate and Elongated Paramagnetic Structures”, 2013, Magnetic Resonance in Medicine, 69:1611–1622) and Weiss (US20120203100A1) as applied in Claim 1, and in further view of Walsh (“Adaptive Reconstruction of Phased Array MR Imagery”, 2000, Magnetic Resonance in Medicine, 43:682-690, Applicant admitted prior art).
Regarding Claim 11, Leeuw and Weiss teach the limitations of Claim 1, and Leeuw further teaches wherein the localization code is further programmed to: control the MR imaging system to generate multiple sets of the acquired MR data based on different parameters for the off-resonance control code and/or the rephaser control code (corresponding disclosure in at least [pg. 1614, “Methods: Imaging Parameters”], where different parameters were used for multiple sets of MR data, with two scans for different sets being acquired “Two acquisitions were per formed on phantom A to validate reconstruction co-RASOR and to study the effect of the imaging resolution. The imaging parameters for phantom A included: First scan: nonselective excitation by a radiofrequency block pulse with a bandwidth of 26kHz, field of view (FOV) 1283mm3, scan matrix 1283, TE 0.15ms, repetition time 4.7ms, flip angle (θ)15◦, read-out bandwidth 868Hz/pixel, and one signal average, resulting in a scan duration of 2min and 34s. Second scan: nonselective excitation by a radiofrequency block pulse with a bandwidth of 26kHz, FOV 1283mm3, scan matrix 643, reconstructed to 1283, TE 0.18ms, repetition time 6.1ms, θ15◦, read-out bandwidth 1750Hz/pixel and one signal average, resulting in a scan duration of 50.7s”);
control the image reconstruction code to provide a respective set of the reconstructed image data based on each of the sets of the acquired MR data (corresponding disclosure in at least [pg. 1614, “Methods: Reconstruction and Postprocessing”], where reconstruction is completed for each of the sets with different parameters “For each frequency offset applied during reconstruction co-RASOR, a phase ramp was applied in k space. The phase ramp consisted of a multiplication of the complex data by e−i2πδf0t′ , which corresponds to the first exponential in Eq. 4. In total, 160 image reconstructions were performed, with frequency offsets between −8kHz and 8kHz with a step size of 100Hz”);
compute respective localization data for the device based on each set of the reconstructed image data (corresponding disclosure in at least Figure 3, where localization data based on the reconstructed data is computed “The top row shows the acquired co-RASOR images, while the bottom row shows the reconstructed co-RASOR images. Image d shows the image acquired with a frequency offset of 2kHz, reconstructed on-resonance”);
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Figure 3 of Leeuw
And determining the spatial location of the device (corresponding disclosure in at least [pg. 1620, “Discussion”], where the location of the device is determined “The location of the center of the field perturbers on the co-RASOR images agreed to within one voxel with the locations of the centers on CT”), but does not teach combining the respective localization data.
Walsh, in a similar field of endeavor, teaches a similar concept (MRI reconstruction) of combining the respective localization data (corresponding disclosure in at least [pg. 689, “Results: Multicoil Reconstruction Prior to Image Formation”], where localized data, or the individual coil datasets, which have a known location, are combined “, adaptive matched filtering was employed to coherently combine four individual-coil datasets prior to FFT-based image formation”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated combining the localization data as taught by Walsh. One of the ordinary skill in the art would have been motivated to incorporate this because combining the images maximizes the SNR in the resulting image (corresponding disclosure in at least [pg 682, “Introduction”] of Walsh).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Leeuw (“Center-Out Radial Sampling with Off-Resonant Reconstruction for Efficient and Accurate Localization of Punctate and Elongated Paramagnetic Structures”, 2013, Magnetic Resonance in Medicine, 69:1611–1622) and Weiss (US20120203100A1) as applied in Claim 1, and in further view of Sitti (US20240041532A1).
Regarding Claim 13, Leeuw and Weiss teach the limitations of Claim 1 and the device being a catheter, but do not teach wherein the catheter includes a plurality of multi-axial coils disposed about a body of the catheter, and each of the coils has a respective axis positioned to provide for selective movement of the catheter relative to the respective axis.
Sitti, in a similar field of endeavor, teaches a similar concept (catheter navigation) of wherein the system comprises the device and the device is a catheter, the catheter includes a plurality of multi-axial coils disposed about a body of the catheter, and each of the coils has a respective axis positioned to provide for selective movement of the catheter relative to the respective axis (corresponding disclosure in at least [0098], where there is a catheter with multi-axial coils, each coil corresponding disclosure in at least to respective axes “a catheter 1 is shown in a perspektiv view in five different states/positions. Furthermore a cartesian coordinate system is shown comprising a X-axis, a Y-axis a and a Z-Axis, wherein an angle betwenn these axes is 90°, respectively. A magnetic field comprising a magnetic field vector B0 aligned in parallel to the X-axis is present” and further in [0105], where there is an electric current being provided for movement “The Lorentz force that is generated by the side coils 7-10 leads to a movement of the tip 2 of the cathter 1 substantially in the YZ-plane, as shown in FIG. 1 . Depending on the direction/polarity of the current (indicated by +I and −I in FIG. 1 ) supplied to the side coils 7-10, the tip 2 moves to the left or the right when current is supplied to the first and the second side coil”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated multi-axial coils on a catheter for selective movement as taught by Sitti. One of the ordinary skill in the art would have been motivated to incorporate this because it incorporates a method of device steering which is compatible with MR.
Regarding Claim 14, Leeuw and Weiss teach the limitations of Claim 1 and Leeuw further teaches localization data ([pg. 1620, “Discussion]), but does not teach actuation control configured to provide electrical current to at least one actuation coil at a distal end portion of the catheter to deflect the distal end portion of the catheter based on the localization data, and/or wherein the system further comprises an insertion actuator being configured to move at least the distal end portion of the catheter axially in response to an actuation control signal, in which the instructions include insertion control code programmed to provide the actuation control signal based on the localization data.
Sitti, in a similar field of endeavor, teaches a similar concept (catheter navigation) of wherein the instructions include actuation control configured to provide electrical current to at least one actuation coil at a distal end portion of the catheter to deflect the distal end portion of the catheter, and/or wherein the system further comprises an insertion actuator being configured to move at least the distal end portion of the catheter axially in response to an actuation control signal, in which the instructions include insertion control code programmed to provide the actuation control signal based on the localization data (corresponding disclosure in at least [0110], where there is an electrical current, or the Lorentz force based steering, for deflection of the distal end portion of the catheter “It has been demonstrated integrating such actuators to catheters through the use of copper coils for Lorentz force-based steering in blood vessels and the heart. In this approach, controlling microcoil current polarity directly translates to a tip deflection of the tip 2 in the respective direction (se FIG. 1 )”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated providing electrical current to the actuation coil at the distal end portion of a catheter to deflect the distal end portion as taught by Sitti. One of the ordinary skill in the art would have been motivated to incorporate this because using the electrical current for deflection of the distal end provides a method of device steering which is compatible with MR. Further, incorporating deflection in the distal end improves navigation in narrow vessels or locating tight angles.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Such prior arts include Wang (“MR Guided Active Catheter Tracking”, 2015, Magn Reson Imaging) regarding the tracking and localization of a catheter using coils, Zhang et al. (“Real-time MR navigation and localization of an intravascular catheter with ferromagnetic components”, 2010, Magn Reson Mater Phy), regarding navigation and localization of a catheter, Gu (US20170184692A1) in regards to MR coil tracking, and Paul (US20170303997A1), in regards to tracking a catheter with a coil in MRI imaging.
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/K.E.K./Examiner, Art Unit 3797
/ANNE M KOZAK/Supervisory Patent Examiner, Art Unit 3797
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