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 .
Response to Amendment
The amendment filed on 9/17/2026 has been entered. Claims 28-32, 34-37, 39-43, and 45-47 remain pending the application.
Response to Arguments
Applicant's arguments filed on 9/17/2026 have been fully considered but they are not persuasive.
Applicant argues on pages 10 that the previous rejection fails to disclose the limitations in the independent claims related to identifying operation of the implanted device because it does not identify an operating state of the device based on the interference. The Examiner respectfully disagrees. The claims need not be so narrowly construed. The Applicant seems to require that “operating state” mean an on or off state. The Examiner respectfully disagrees. Ramachandran discloses tracking the position of a device based on its interference and identifying an operating state of a device also reads on determining where the device is. For example, an implanted catheter is in an operating state when it is within a blood vessel of the patient rather than being outside of the patient. Accordingly, this argument is not persuasive. If the Applicant wishes to differentiate their invention in this manner, the Examiner recommends more specifically identifying what the Applicant considers to be an operating state or not.
Applicant argues on pages 11 that Ramachandran fails to disclose the newly added claims to the limitations related to reducing interference. The Examiner respectfully disagrees, newly cited portions of Ramachandran disclose these limitations in the claims as seen in the rejection below. Accordingly, this argument is not persuasive.
Applicant argues on page 11 that operation denotes active operation and that the Examiner has read the term operation out of the claims because the claims specifically require that operation cause the interference. The Examiner respectfully disagrees. Operation of a medical device does not only read actively turning a device on as the applicant seems to be implying. A person having skill in the art would understand that a catheter placed in a vessel to be operating. Ramachandran itself states that the presence of the devices alone causes electromagnetic interference. This is not an assertion by the Examiner but a direct citation from the prior art. If the Applicant wishes to only claim specific types of interference, the claims should be amended accordingly to read only on those types of operation. Accordingly, this argument is not persuasive.
Applicant argues on pages 11-12 that Ramachandran and Loring fail to disclose accounting for operation of a device. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See MPEP 2145. As cited in the previous rejection and the rejection below Ramachandran identifies devices based on their electromagnetic interference. Loring modifies Ramachandran to account for electromagnetic interference cause by operation implanted devices. Therefore, modified Ramachandran would be able identify devices based on electromagnetic interference cause by operation implanted devices. The applicant is reminded that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here, Ramachandran would be not be modified to literally incorporate the filters of Loring, but instead it is modified to consider electromagnetic interference caused by operation of the devices as well. Accordingly, this argument is not persuasive.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 28-32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Ramachandran et al. (US20140354300, hereafter Ramachandran) and Loring et al. (US20210282717, hereafter Loring).
Regarding claim 28, Ramachandran discloses a insertion tube positioning device configured to determine the position (Ramachandran, Para 35; “In this way, metallic distorters (like a surgical tool) or electronic devices which cause error in EM tracking can be identified within the EM field. If the type of distortion is known, the system can localize the position and orientation of the tool causing the distortion. This can account for the distorter and make EM tracking measurements more accurate or identify and eliminate the distorter from the environment altogether”) (Ramachandran, Para 33; “Referring to FIG. 2 with continued reference to FIG. 1, a block/flow diagram for characterizing distorters such as tools, instruments or devices to create a fingerprint or EM signature associated with the distorters is illustratively shown. The fingerprint is preferably employed for estimating the distorter's location and orientation. In block 202, a distortion morphology (or reach) of any known object is characterized (fingerprint). EM signatures are generated using the EM generator 124 to create a field that is distorted by the object”) (Ramachandran, Para 41; “In a clinical setting, if EM tracking is being used for guided navigation, the system 200 could be used to perform comparisons of the distortions at the limited EM sensor positions with the pre-operative morphologies or patterns saved to the database (142, FIG. 1) to identify the tool that is causing the distortion.”) (Ramachandran, Para 41-47 discussing this process) of an insertion tube within a patient (Ramachandran, Para 24; “sensing module 115 is configured to use EM signal feedback from EM sensing devices 104 to reconstruct EM space and track medical instruments or devices 102 […] A medical device or tool 102 may include an instrument […] Device 102 may include, e.g., a catheter, a guide wire, an endoscope, a probe, a robot, an electrode, a filter device, a balloon device, or other medical component, etc”; A PHOSITA would understand that the scope of the term endoscope fits within the broadest reasonable interpretation of the term insertion tube, additionally a PHOSITA would understand that many “other medical components” would include insertion tubes), the insertion tube comprising an electromagnetic sensor (Ramachandran, Para 16; "The embodiments can also add distortion morphologies of known tools to the overall error map by having sensors mounted on the tools and can compensate for errors that are induced by known distorters.") (Ramachandran, Para 24; "A medical device or tool 102 may include an instrument having an EM tracking sensor 104 mounted thereon or therein. Device 102 may include, e.g., a catheter, a guide wire, an endoscope, a probe, a robot, an electrode, a filter device, a balloon device, or other medical component, etc.") (Ramachandran, Para 45; " In an additional embodiment, a tracking sensor 322, e.g., an EM sensor or other sensor may be placed on a known tool and its location can be determined in real-time."), the insertion tube positioning device comprising:
a processing circuitry (Ramachandran, Para 24; “Memory 116 may store an EM sensing module 115 configured to interpret feedback signals from an EM sensing/tracking device 104. In one embodiment, sensing module 115 is configured to use EM signal feedback from EM sensing devices 104 to reconstruct EM space and track medical instruments or devices 102”) configured to:
receive information regarding an device implanted in a patient (Ramachandran, Para 18; “Each distorter has a unique distortion morphology, for example, the distortion patterns from a C-arm detector are known to be very different from those of an ablation catheter.”) (Ramachandran, Para 35; “In this way, metallic distorters (like a surgical tool) or electronic devices which cause error in EM tracking can be identified within the EM field.”), wherein operation of the implanted device causes interference with an electromagnetic field generated (Ramachandran, Para 18; “The ability of a tool to produce distortions in an EM field varies and depends on its size, shape and the material it is composed of. Each distorter has a unique distortion morphology, for example, the distortion patterns from a C-arm detector are known to be very different from those of an ablation catheter. A database is created and stores distortion fingerprints of various known objects”) (Ramachandran, Para 26; “As described above, metallic objects and electronic equipment can produce distortions in local magnetic fields and influence readings of the EM sensors 104. The present principles provide an EM sensing correction module 140 that may include one or more features for reducing distortions in the environment surrounding the tracking volume 150. The module 140 is configured to characterize distortions, e.g., as a measurement of a signature or fingerprint of the field distortion created by tools or objects in or near the target volume 150 [...] The module 140 is configured to provide one or more of the following task identify distorters (objects), optimize or filter the distortions present to more accurately track or sense EM radiation, sense a change to the EM field, warn of EM field changes, etc”) (Ramachandran, Para 24; "A medical device or tool 102 may include an instrument having an EM tracking sensor 104 mounted thereon or therein. Device 102 may include, e.g., a catheter, a guide wire, an endoscope, a probe, a robot, an electrode, a filter device, a balloon device, or other medical component, etc." A person having ordinary skill in the art would understand that operation of a catheter or a medical filter such as an IVC cause interference due the metallic materials in the device and operation of a catheter or a medical filter such as an IVC would include simply having it in place in the patient) over a torso of the patient (Ramachandran, Para 20; “In particular, the present principles are applicable to internal tracking procedures of biological systems, procedures in all areas of the body such as the lungs, gastro-intestinal tract, excretory organs, blood vessels, etc”) (Ramachandran, Para 25; “A field generator 124 is preferably installed in a vicinity of a patient or a target volume 150 so that the generator and the EM sensor or sensors 104 occupy a same environment. Sensing device 104 preferably includes one or more coils which are employed to detect of changes in EM field due to their movement. In this way, the coils of the sensors 104 permit tracking of instrument or device 102 relative to the patient and/or the tracking volume 150.”) (Ramachandran, Para 24; “In one embodiment, sensing module 115 is configured to use EM signal feedback from EM sensing devices 104 to reconstruct EM space and track medical instruments or devices 102. A medical device or tool 102 may include an instrument having an EM tracking sensor 104 mounted thereon or therein. Device 102 may include, e.g., a catheter, a guide wire, an endoscope, a probe, a robot, an electrode, a filter device, a balloon device, or other medical component, etc.”), and wherein the interference is caused by a pattern caused by the implanted device (Ramachandran, Para 41; “if EM tracking is being used for guided navigation, the system 200 could be used to perform comparisons of the distortions at the limited EM sensor positions with the pre-operative morphologies or patterns saved to the database”);
receive signals relating to changes in the electromagnetic field, the changes caused by insertion of the insertion tube into the patient’s body comprising an electromagnetic sensor (Ramachandran, Para 26; “As described above, metallic objects and electronic equipment can produce distortions in local magnetic fields and influence readings of the EM sensors 104. […] The module 140 is configured to characterize distortions, e.g., as a measurement of a signature or fingerprint of the field distortion created by tools or objects in or near the target volume 150 [...] The module 140 is configured to provide one or more of the following task identify distorters (objects), optimize or filter the distortions present to more accurately track or sense EM radiation, sense a change to the EM field, warn of EM field changes, etc”) (Ramachandran, Para 34; “Each distorter's contribution may be identified in the overall error in block 208. An approximate location and orientation of the distorter can also be estimated from this error contribution in block 210”) (Ramachandran, Para 35; “In this way, metallic distorters (like a surgical tool) or electronic devices which cause error in EM tracking can be identified within the EM field. If the type of distortion is known, the system can localize the position and orientation of the tool causing the distortion. This can account for the distorter and make EM tracking measurements more accurate or identify and eliminate the distorter from the environment altogether”);
normalize the received signals relating to changes in the electromagnetic field caused by the insertion of insertion tube into the patient’s body, based on the information regarding the implanted device and based on the pattern characterizing the interference with the electromagnetic field (Ramachandran, Para 33; “In block 206, the measured error in the clean environment is compared to overall error (error combined from all sources) with one or more distorters in block 206. Error measured during a procedure (live with all the distortions, e.g., arising from a detector, table, tool, etc.) is compared with what was measured in the “clean environment” (no distortions). The variation between these two error maps permits finding what portion of the overall error is caused due to a distorter”; the published specification of the instant application describes normalization to include identifying the strength and pattern of the interference in paragraphs 65 and 71.) (Ramachandran, Para 33; “Referring to FIG. 2 with continued reference to FIG. 1, a block/flow diagram for characterizing distorters such as tools, instruments or devices to create a fingerprint or EM signature associated with the distorters is illustratively shown. The fingerprint is preferably employed for estimating the distorter's location and orientation. In block 202, a distortion morphology (or reach) of any known object is characterized (fingerprint). EM signatures are generated using the EM generator 124 to create a field that is distorted by the object”) (Ramachandran, Para 45; "by knowing the errors that are induced in the tracking volume due to known distorters, the generation or error maps can be employed to compensate for these known errors, thus increasing the accuracy as well as the confidence of a clinician while performing a procedure”) (Paragraph 65 of the instant specification lists steps of normalization that are analogous to these steps), wherein the normalizing comprises:
identify operation of the implanted device based the pattern characterizing the interference with the electromagnetic field caused by the implanted device (Ramachandran, Para 19; “distortion fingerprinting is employed to characterize distortion morphology of known objects. After an initial calibration, the present system can, in conjunction with pre-calibrated sensors that dynamically measure errors, be employed to identify and localize the distorter. All distorters have a unique morphology and a varying reach to which the distorter distorts (due to varying morphology)”) (Ramachandran, Para 33-34; “Referring to FIG. 2 with continued reference to FIG. 1, a block/flow diagram for characterizing distorters such as tools, instruments or devices to create a fingerprint or EM signature associated with the distorters is illustratively shown. The fingerprint is preferably employed for estimating the distorter's location and orientation. In block 202, a distortion morphology (or reach) of any known object is characterized (fingerprint). EM signatures are generated using the EM generator 124 to create a field that is distorted by the object […] FIG. 4 illustratively shows an error map 248 for EM space in a “clean” environment. The clean environment represents a baseline reference EM field without distorters. In block 206, the measured error in the clean environment is compared to overall error (error combined from all sources) with one or more distorters in block 206. Error measured during a procedure (live with all the distortions, e.g., arising from a detector, table, tool, etc.) is compared with what was measured in the “clean environment” (no distortions). The variation between these two error maps permits finding what portion of the overall error is caused due to a distorter […] Each distorter's contribution may be identified in the overall error in block 208. An approximate location and orientation of the distorter can also be estimated from this error contribution in block 210. FIG. 5 shows scissors 240 in an EM environment in the vicinity of a C-arm detector 244. The scissors' signature and the detector's signature can be identified in an overall EM field signature 249 by subtracting out the reference baseline (248) from the measured error and comparing the remaining signature to the distortion morphologies stored in the database (142)”) (Ramachandran; Para 26; "The characterization of these fingerprints is performed in advance of any procedure and the fingerprints or distortion morphologies are stored in a database 142 where the fingerprints measured in real-time are correlated with identities of the objects that created the fingerprints.”) (Ramachandran, Para 18; "The amount of error can be differentiated between expected distorters and the overall distortion to identify if a known distorter is present in the field. A flag or warning is raised if distortions are detected due to unknown distorters.") (Ramachandran, Para 31; "In another embodiment, the database 142 stores the fingerprints that characterize the distortion morphology of any known object or device. The pre-calibrated sensors 144 compare expected distortions in a clean environment (reference) to dynamically measured errors during a procedure. The distorter or combination of distorters and their contribution are identified in the overall error. The presence of any unknown distorters is detected. In the event that a new distortion is detected, a warning may be indicated on the display 118 or at the interface 120."); and
reducing or eliminating, from the received signals, disturbances caused by the implanted device (Ramachandran, Para 26; "As described above, metallic objects and electronic equipment can produce distortions in local magnetic fields and influence readings of the EM sensors 104. The present principles provide an EM sensing correction module 140 that may include one or more features for reducing distortions in the environment surrounding the tracking volume 150.") (Ramachandran, Para 30; "The errors detected and mapped can be error compensated for known distorters.") (Ramachandran, Para 44; "This provides the overall error map 307, which combines sensor data from the error map of the clean environment and the distortion morphology of the distorters. The error visualization is updated in real-time [...] The system 100 compensates for errors induced due to known distorters, e.g., in EM tracking sensing data.") (Ramachandran, Para 45; "In addition, by knowing the errors that are induced in the tracking volume due to known distorters, the generation or error maps can be employed to compensate for these known errors, thus increasing the accuracy as well as the confidence of a clinician while performing a procedure."); and
determine the position of the insertion tube based on the normalized signals (Ramachandran, Para 35; “In this way, metallic distorters (like a surgical tool) or electronic devices which cause error in EM tracking can be identified within the EM field. If the type of distortion is known, the system can localize the position and orientation of the tool causing the distortion. This can account for the distorter and make EM tracking measurements more accurate or identify and eliminate the distorter from the environment altogether”) (Ramachandran, Para 33; “Referring to FIG. 2 with continued reference to FIG. 1, a block/flow diagram for characterizing distorters such as tools, instruments or devices to create a fingerprint or EM signature associated with the distorters is illustratively shown. The fingerprint is preferably employed for estimating the distorter's location and orientation. In block 202, a distortion morphology (or reach) of any known object is characterized (fingerprint). EM signatures are generated using the EM generator 124 to create a field that is distorted by the object”) (Ramachandran, Para 41; “In a clinical setting, if EM tracking is being used for guided navigation, the system 200 could be used to perform comparisons of the distortions at the limited EM sensor positions with the pre-operative morphologies or patterns saved to the database (142, FIG. 1) to identify the tool that is causing the distortion.”) (Ramachandran, Para 41-47 discussing this process).
Ramachandran does not clearly and explicitly disclose wherein the interference is characterized by a pattern caused by operation of the implanted device and characterizing the interference with the electromagnetic field caused by the operation of the implanted device.
In an analogous patient diagnostics field of endeavor Loring discloses wherein interference is characterized by a pattern caused by operation of an implanted device and normalizing signals based on based on the pattern characterizing the interference with the electromagnetic field caused by the operation of the implanted device (Loring, Para 18-25; “The systems and methods disclosed herein provide a solution to electromagnetic interference (EMI) that can occur […] when a patient is simultaneously using a circulatory support device […] The LVAD can generate high-frequency noise artifacts […] to reduce electromagnetic interference produced by a circulatory support device 116 of the patient 102, resulting in a filtered signal”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ramachandran to additionally account for situations wherein the interference is characterized by a pattern caused by operation of the implanted device and characterizing the interference with the electromagnetic field caused by the operation of the implanted device in order assist patients with serious heart conditions as taught by Loring (Loring, Para 3) while accounting for their implant, which improves reliability and accuracy.
Regarding claim 29, Ramachandran as modified by Loring above discloses all of the limitations of claim 28 as discussed above.
Ramachandran does not clearly and explicitly disclose wherein the implanted device is a ventricular assist device.
In an analogous patient diagnostics field of endeavor Loring discloses wherein an implanted device is a ventricular assist device (Loring, Para 18-25; “The systems and methods disclosed herein provide a solution to electromagnetic interference (EMI) that can occur […] when a patient is simultaneously using a circulatory support device […] The LVAD can generate high-frequency noise artifacts […] to reduce electromagnetic interference produced by a circulatory support device 116 of the patient 102, resulting in a filtered signal”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ramachandran wherein the implanted device is a ventricular assist device in order assist patients with serious heart conditions as taught by Loring (Loring, Para 3) while accounting for their implant, which improves reliability and accuracy.
Regarding claim 30, Ramachandran as modified by Loring above discloses all of the limitations of claim 28 as discussed above.
Ramachandran further discloses wherein the receiving of the information regarding the implanted device comprises measuring changes in the electromagnetic field caused by the operation of implanted device, in the absence of the insertion tube, relative to a baseline electromagnetic field measured in the absence of the implanted device (Ramachandran, Para 33-34; “Referring to FIG. 2 with continued reference to FIG. 1, a block/flow diagram for characterizing distorters such as tools, instruments or devices to create a fingerprint or EM signature associated with the distorters is illustratively shown. The fingerprint is preferably employed for estimating the distorter's location and orientation. In block 202, a distortion morphology (or reach) of any known object is characterized (fingerprint). EM signatures are generated using the EM generator 124 to create a field that is distorted by the object […] FIG. 4 illustratively shows an error map 248 for EM space in a “clean” environment. The clean environment represents a baseline reference EM field without distorters. In block 206, the measured error in the clean environment is compared to overall error (error combined from all sources) with one or more distorters in block 206. Error measured during a procedure (live with all the distortions, e.g., arising from a detector, table, tool, etc.) is compared with what was measured in the “clean environment” (no distortions). The variation between these two error maps permits finding what portion of the overall error is caused due to a distorter […] Each distorter's contribution may be identified in the overall error in block 208. An approximate location and orientation of the distorter can also be estimated from this error contribution in block 210. FIG. 5 shows scissors 240 in an EM environment in the vicinity of a C-arm detector 244. The scissors' signature and the detector's signature can be identified in an overall EM field signature 249 by subtracting out the reference baseline (248) from the measured error and comparing the remaining signature to the distortion morphologies stored in the database (142)”).
Regarding claim 31, Ramachandran as modified by Loring above discloses all of the limitations of claim 30 as discussed above.
Ramachandran further discloses wherein the measuring of the changes in the electromagnetic field caused by the operation of implanted device comprises identifying one or more characteristics of the interference (Ramachandran, Para 33-34; “Referring to FIG. 2 with continued reference to FIG. 1, a block/flow diagram for characterizing distorters such as tools, instruments or devices to create a fingerprint or EM signature associated with the distorters is illustratively shown. The fingerprint is preferably employed for estimating the distorter's location and orientation. In block 202, a distortion morphology (or reach) of any known object is characterized (fingerprint). EM signatures are generated using the EM generator 124 to create a field that is distorted by the object […] FIG. 4 illustratively shows an error map 248 for EM space in a “clean” environment. The clean environment represents a baseline reference EM field without distorters. In block 206, the measured error in the clean environment is compared to overall error (error combined from all sources) with one or more distorters in block 206. Error measured during a procedure (live with all the distortions, e.g., arising from a detector, table, tool, etc.) is compared with what was measured in the “clean environment” (no distortions). The variation between these two error maps permits finding what portion of the overall error is caused due to a distorter […] Each distorter's contribution may be identified in the overall error in block 208. An approximate location and orientation of the distorter can also be estimated from this error contribution in block 210. FIG. 5 shows scissors 240 in an EM environment in the vicinity of a C-arm detector 244. The scissors' signature and the detector's signature can be identified in an overall EM field signature 249 by subtracting out the reference baseline (248) from the measured error and comparing the remaining signature to the distortion morphologies stored in the database (142)”).
Regarding claim 32, Ramachandran as modified by Loring above discloses all of the limitations of claim 31 as discussed above.
Ramachandran does not clearly and explicitly disclose wherein the implanted device is a periodically operating device.
In an analogous patient diagnostics field of endeavor Loring discloses accounting for electromagnetic interference from a periodically operating device (Loring, Para 18-25; “The systems and methods disclosed herein provide a solution to electromagnetic interference (EMI) that can occur […] when a patient is simultaneously using a circulatory support device […] The LVAD can generate high-frequency noise artifacts […] to reduce electromagnetic interference produced by a circulatory support device 116 of the patient 102, resulting in a filtered signal”).
Loring is interpreted as disclosing this limitation in the claim because a person having ordinary skill in the art would understand that an LVAD falls within the scope of a periodically operating device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ramachandran wherein the implanted device is a ventricular assist device in order assist patients with serious heart conditions as taught by Loring (Loring, Para 3) while accounting for their implant, which improves reliability and accuracy.
Regarding claim 34, Ramachandran as modified by Loring above discloses all of the limitations of claim 28 as discussed above.
Ramachandran further discloses wherein the receiving of the information regarding the implanted device comprises receiving information regarding the type of the implanted device, wherein the interference of the implanted device with the electromagnetic field is assessed based on the type of the implanted device (Ramachandran, Para 18-19; “The amount of error can be differentiated between expected distorters and the overall distortion to identify if a known distorter is present in the field. A flag or warning is raised if distortions are detected due to unknown distorters […] distortion fingerprinting is employed to characterize distortion morphology of known objects. After an initial calibration, the present system can, in conjunction with pre-calibrated sensors that dynamically measure errors, be employed to identify and localize the distorter. All distorters have a unique morphology and a varying reach to which the distorter distorts (due to varying morphology). This variable reach and variable distorting morphology may be leveraged to intra-operatively detect the location of the distorting element. A sparse set of pre-calibrated EM sensors, the expected distortion in a ‘clean’ environment and dynamic distortion induced on the sensors during the procedure may be employed to compute error contribution. Pre-computed morphology of the distorter (e.g., a detector) has its error ‘contribution’ computed at the measurement points. If the contribution is beyond an acceptable threshold, a warning may be raised. The amount of error can be differentiated from ‘expected’ distorters from that of the overall distortion”).
Claims 35-37, 39-43, and 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Ramachandran et al. (US20140354300, hereafter Ramachandran), Loring et al. (US20210282717, hereafter Loring), and Besser et al. (US20180280093, hereafter Besser).
Regarding claim 35, Ramachandran discloses a insertion tube positioning system (Ramachandran, Para 24; “sensing module 115 is configured to use EM signal feedback from EM sensing devices 104 to reconstruct EM space and track medical instruments or devices 102 […] A medical device or tool 102 may include an instrument […] Device 102 may include, e.g., a catheter, a guide wire, an endoscope, a probe, a robot, an electrode, a filter device, a balloon device, or other medical component, etc”; A PHOSITA would understand that the scope of the term endoscope fits within the broadest reasonable interpretation of the term insertion tube, additionally a PHOSITA would understand that many “other medical components” would include insertion tubes) comprising:
an electromagnetic field generator configured to generate an electromagnetic field covering a treatment area of a patient (Ramachandran, Para 25; “A field generator 124 is preferably installed in a vicinity of a patient or a target volume 150 so that the generator and the EM sensor or sensors 104 occupy a same environment”) (Ramachandran, Para 25; “A field generator 124 is preferably installed in a vicinity of a patient or a target volume 150 so that the generator and the EM sensor or sensors 104 occupy a same environment. Sensing device 104 preferably includes one or more coils which are employed to detect of changes in EM field due to their movement. In this way, the coils of the sensors 104 permit tracking of instrument or device 102 relative to the patient and/or the tracking volume 150.”) (Ramachandran, Para 24; “In one embodiment, sensing module 115 is configured to use EM signal feedback from EM sensing devices 104 to reconstruct EM space and track medical instruments or devices 102. A medical device or tool 102 may include an instrument having an EM tracking sensor 104 mounted thereon or therein. Device 102 may include, e.g., a catheter, a guide wire, an endoscope, a probe, a robot, an electrode, a filter device, a balloon device, or other medical component, etc.”);
an insertion tube comprising an electromagnetic sensor (Ramachandran, Para 24; “sensing module 115 is configured to use EM signal feedback from EM sensing devices 104 to reconstruct EM space and track medical instruments or devices 102 […] A medical device or tool 102 may include an instrument […] Device 102 may include, e.g., a catheter, a guide wire, an endoscope, a probe, a robot, an electrode, a filter device, a balloon device, or other medical component, etc”; A PHOSITA would understand that the scope of the term catheter and endoscope fit within the broadest reasonable interpretation of the term insertion tube, additionally a PHOSITA would understand that many “other medical components” would include insertion tubes), the electromagnetic sensor configure to cause changes in the electromagnetic field (Ramachandran, Para 26-27; “As described above, metallic objects and electronic equipment can produce distortions in local magnetic fields and influence readings of the EM sensors 104 […] System 100 may undergo training where the module 140 is employed to characterize distortion morphology (or reach) of any known object. Each object is characterized to measure its signature or fingerprint so that it may be identified in more general EM fields”); and
a processing circuitry (Ramachandran, Para 24; “Memory 116 may store an EM sensing module 115 configured to interpret feedback signals from an EM sensing/tracking device 104. In one embodiment, sensing module 115 is configured to use EM signal feedback from EM sensing devices 104 to reconstruct EM space and track medical instruments or devices 102”) configured to:
receive signals relating to changes in the electromagnetic field, the changes caused by insertion into the patient’s body (Ramachandran, Para 26; “As described above, metallic objects and electronic equipment can produce distortions in local magnetic fields and influence readings of the EM sensors 104. […] The module 140 is configured to characterize distortions, e.g., as a measurement of a signature or fingerprint of the field distortion created by tools or objects in or near the target volume 150 [...] The module 140 is configured to provide one or more of the following task identify distorters (objects), optimize or filter the distortions present to more accurately track or sense EM radiation, sense a change to the EM field, warn of EM field changes, etc”) (Ramachandran, Para 34; “Each distorter's contribution may be identified in the overall error in block 208. An approximate location and orientation of the distorter can also be estimated from this error contribution in block 210”) (Ramachandran, Para 35; “In this way, metallic distorters (like a surgical tool) or electronic devices which cause error in EM tracking can be identified within the EM field. If the type of distortion is known, the system can localize the position and orientation of the tool causing the distortion. This can account for the distorter and make EM tracking measurements more accurate or identify and eliminate the distorter from the environment altogether”);
receive information regarding a device implanted into the patient, (Ramachandran, Para 18; “Each distorter has a unique distortion morphology, for example, the distortion patterns from a C-arm detector are known to be very different from those of an ablation catheter.”) (Ramachandran, Para 35; “In this way, metallic distorters (like a surgical tool) or electronic devices which cause error in EM tracking can be identified within the EM field.”), wherein operation of the implanted causes interference with the generated electromagnetic field (Ramachandran, Para 18; “The ability of a tool to produce distortions in an EM field varies and depends on its size, shape and the material it is composed of. Each distorter has a unique distortion morphology, for example, the distortion patterns from a C-arm detector are known to be very different from those of an ablation catheter. A database is created and stores distortion fingerprints of various known objects”) (Ramachandran, Para 26; “As described above, metallic objects and electronic equipment can produce distortions in local magnetic fields and influence readings of the EM sensors 104. The present principles provide an EM sensing correction module 140 that may include one or more features for reducing distortions in the environment surrounding the tracking volume 150. The module 140 is configured to characterize distortions, e.g., as a measurement of a signature or fingerprint of the field distortion created by tools or objects in or near the target volume 150 [...] The module 140 is configured to provide one or more of the following task identify distorters (objects), optimize or filter the distortions present to more accurately track or sense EM radiation, sense a change to the EM field, warn of EM field changes, etc”) (Ramachandran, Para 24; "Device 102 may include, e.g., a catheter, a guide wire, an endoscope, a probe, a robot, an electrode, a filter device, a balloon device, or other medical component, etc." A person having ordinary skill in the art would understand that operation of a catheter or a medical filter such as an IVC cause interference due the metallic materials in the device and operation of a catheter or a medical filter such as an IVC would include simply having it in place in the patient, additionally, the BRI of operation of a catheter would include inserting or removing the catheter, which would cause interference), and wherein the interference is caused by a pattern caused by the implanted device (Ramachandran, Para 41; “if EM tracking is being used for guided navigation, the system 200 could be used to perform comparisons of the distortions at the limited EM sensor positions with the pre-operative morphologies or patterns saved to the database”);
normalize the received signals relating to changes in the electromagnetic field caused by the insertion of insertion tube into the patient’s body, based on the information regarding the implanted device and based on the pattern characterizing the interference with the electromagnetic field (Ramachandran, Para 33; “In block 206, the measured error in the clean environment is compared to overall error (error combined from all sources) with one or more distorters in block 206. Error measured during a procedure (live with all the distortions, e.g., arising from a detector, table, tool, etc.) is compared with what was measured in the “clean environment” (no distortions). The variation between these two error maps permits finding what portion of the overall error is caused due to a distorter”; the published specification of the instant application describes normalization to include identifying the strength and pattern of the interference in paragraphs 65 and 71.) (Ramachandran, Para 33; “Referring to FIG. 2 with continued reference to FIG. 1, a block/flow diagram for characterizing distorters such as tools, instruments or devices to create a fingerprint or EM signature associated with the distorters is illustratively shown. The fingerprint is preferably employed for estimating the distorter's location and orientation. In block 202, a distortion morphology (or reach) of any known object is characterized (fingerprint). EM signatures are generated using the EM generator 124 to create a field that is distorted by the object”) (Ramachandran, Para 45; "by knowing the errors that are induced in the tracking volume due to known distorters, the generation or error maps can be employed to compensate for these known errors, thus increasing the accuracy as well as the confidence of a clinician while performing a procedure”) (Paragraph 65 of the instant specification lists steps of normalization that are analogous to these steps), wherein the normalizing comprises:
identifying operation of the implanted device based the pattern characterizing the interference with the electromagnetic field caused by the implanted device (Ramachandran, Para 19; “distortion fingerprinting is employed to characterize distortion morphology of known objects. After an initial calibration, the present system can, in conjunction with pre-calibrated sensors that dynamically measure errors, be employed to identify and localize the distorter. All distorters have a unique morphology and a varying reach to which the distorter distorts (due to varying morphology)”) (Ramachandran, Para 33-34; “Referring to FIG. 2 with continued reference to FIG. 1, a block/flow diagram for characterizing distorters such as tools, instruments or devices to create a fingerprint or EM signature associated with the distorters is illustratively shown. The fingerprint is preferably employed for estimating the distorter's location and orientation. In block 202, a distortion morphology (or reach) of any known object is characterized (fingerprint). EM signatures are generated using the EM generator 124 to create a field that is distorted by the object […] FIG. 4 illustratively shows an error map 248 for EM space in a “clean” environment. The clean environment represents a baseline reference EM field without distorters. In block 206, the measured error in the clean environment is compared to overall error (error combined from all sources) with one or more distorters in block 206. Error measured during a procedure (live with all the distortions, e.g., arising from a detector, table, tool, etc.) is compared with what was measured in the “clean environment” (no distortions). The variation between these two error maps permits finding what portion of the overall error is caused due to a distorter […] Each distorter's contribution may be identified in the overall error in block 208. An approximate location and orientation of the distorter can also be estimated from this error contribution in block 210. FIG. 5 shows scissors 240 in an EM environment in the vicinity of a C-arm detector 244. The scissors' signature and the detector's signature can be identified in an overall EM field signature 249 by subtracting out the reference baseline (248) from the measured error and comparing the remaining signature to the distortion morphologies stored in the database (142)”) (Ramachandran; Para 26; "The characterization of these fingerprints is performed in advance of any procedure and the fingerprints or distortion morphologies are stored in a database 142 where the fingerprints measured in real-time are correlated with identities of the objects that created the fingerprints.”) (Ramachandran, Para 18; "The amount of error can be differentiated between expected distorters and the overall distortion to identify if a known distorter is present in the field. A flag or warning is raised if distortions are detected due to unknown distorters.") (Ramachandran, Para 31; "In another embodiment, the database 142 stores the fingerprints that characterize the distortion morphology of any known object or device. The pre-calibrated sensors 144 compare expected distortions in a clean environment (reference) to dynamically measured errors during a procedure. The distorter or combination of distorters and their contribution are identified in the overall error. The presence of any unknown distorters is detected. In the event that a new distortion is detected, a warning may be indicated on the display 118 or at the interface 120."); and
reducing or eliminating, from the received signals, disturbances caused by the implanted device (Ramachandran, Para 26; "As described above, metallic objects and electronic equipment can produce distortions in local magnetic fields and influence readings of the EM sensors 104. The present principles provide an EM sensing correction module 140 that may include one or more features for reducing distortions in the environment surrounding the tracking volume 150.") (Ramachandran, Para 30; "The errors detected and mapped can be error compensated for known distorters.") (Ramachandran, Para 44; "This provides the overall error map 307, which combines sensor data from the error map of the clean environment and the distortion morphology of the distorters. The error visualization is updated in real-time [...] The system 100 compensates for errors induced due to known distorters, e.g., in EM tracking sensing data.") (Ramachandran, Para 45; "In addition, by knowing the errors that are induced in the tracking volume due to known distorters, the generation or error maps can be employed to compensate for these known errors, thus increasing the accuracy as well as the confidence of a clinician while performing a procedure."), and
determine the position of the insertion tube based on the normalized signal (Ramachandran, Para 35; “In this way, metallic distorters (like a surgical tool) or electronic devices which cause error in EM tracking can be identified within the EM field. If the type of distortion is known, the system can localize the position and orientation of the tool causing the distortion. This can account for the distorter and make EM tracking measurements more accurate or identify and eliminate the distorter from the environment altogether”) (Ramachandran, Para 33; “Referring to FIG. 2 with continued reference to FIG. 1, a block/flow diagram for characterizing distorters such as tools, instruments or devices to create a fingerprint or EM signature associated with the distorters is illustratively shown. The fingerprint is preferably employed for estimating the distorter's location and orientation. In block 202, a distortion morphology (or reach) of any known object is characterized (fingerprint). EM signatures are generated using the EM generator 124 to create a field that is distorted by the object”).
Ramachandran does not clearly and explicitly disclose wherein the interference is characterized by a pattern caused by operation of the implanted device and characterizing the interference with the electromagnetic field caused by the operation of the implanted device.
In an analogous patient diagnostics field of endeavor Loring discloses wherein interference is characterized by a pattern caused by operation of an implanted device and normalizing signals based on based on the pattern characterizing the interference with the electromagnetic field caused by the operation of the implanted device (Loring, Para 18-25; “The systems and methods disclosed herein provide a solution to electromagnetic interference (EMI) that can occur […] when a patient is simultaneously using a circulatory support device […] The LVAD can generate high-frequency noise artifacts […] to reduce electromagnetic interference produced by a circulatory support device 116 of the patient 102, resulting in a filtered signal”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ramachandran to additionally account for situations wherein the interference is characterized by a pattern caused by operation of the implanted device and characterizing the interference with the electromagnetic field caused by the operation of the implanted device in order assist patients with serious heart conditions as taught by Loring (Loring, Para 3) while accounting for their implant, which improves reliability and accuracy.
Ramachandran does not clearly and explicitly disclose a registration sensor configured to mark one or more anatomical locations on the patient’s torso; and generating an anatomical map of the patient's torso or match the patient's torso to a predefined anatomical map, based on the at least one anatomic location marked by the registration sensor; showing on the map a path of the insertion tube.
In an analogous insertion device positioning guidance system field of endeavor Besser discloses a registration sensor configured to mark one or more anatomical locations on a patient’s torso (Besser, Para 39; “a registration sensor configured to mark at least a first and a second anatomic locations relative to the reference coordinate system”); generating an anatomical map of the patient's torso or match the patient's torso to a predefined anatomical map, based on the at least one anatomic location marked by the registration sensor (Besser, Para 39; “processing circuitry configured to operate said field generator, read signals obtained from said the plate sensor, said reference sensor and said registration sensor, calculate a position and orientation thereof relative to said field generator, generate an anatomic map representing the torso of the subject and the first and second anatomic locations”); and showing on the map a path of an insertion tube (Besser, Para 38-39; “Disclosed herein is a system and method for guiding insertion of an insertable medical device (e.g., a tube, such as a feeding tube) […] processor/processing circuitry is further configured to facilitate visualization on the anatomic map of a position, orientation and path of a tip sensor, located in a distal tip section of the insertion device”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ramachandran to include a registration sensor configured to mark one or more anatomical locations on the patient’s torso; generating an anatomical map of the patient's torso or match the patient's torso to a predefined anatomical map, based on the at least one anatomic location marked by the registration sensor; and showing on the map a path of the insertion tube in order to make the insertion procedure considerably easier and safer, and ensuring that the insertion tube is inserted at a correct location as taught by Besser (Besser, Para 38-39).
Regarding claim 36, Ramachandran as modified by Loring and Besser above discloses all of the limitations of claim 35 as discussed above.
Ramachandran further discloses wherein the receiving of the information regarding the implanted device comprises measuring changes in the electromagnetic field caused by the operation of the implanted device in the absence of the insertion tube, relative to a baseline electromagnetic field measured in the absence of the implanted device (Ramachandran, Para 33-34; “Referring to FIG. 2 with continued reference to FIG. 1, a block/flow diagram for characterizing distorters such as tools, instruments or devices to create a fingerprint or EM signature associated with the distorters is illustratively shown. The fingerprint is preferably employed for estimating the distorter's location and orientation. In block 202, a distortion morphology (or reach) of any known object is characterized (fingerprint). EM signatures are generated using the EM generator 124 to create a field that is distorted by the object […] FIG. 4 illustratively shows an error map 248 for EM space in a “clean” environment. The clean environment represents a baseline reference EM field without distorters. In block 206, the measured error in the clean environment is compared to overall error (error combined from all sources) with one or more distorters in block 206. Error measured during a procedure (live with all the distortions, e.g., arising from a detector, table, tool, etc.) is compared with what was measured in the “clean environment” (no distortions). The variation between these two error maps permits finding what portion of the overall error is caused due to a distorter […] Each distorter's contribution may be identified in the overall error in block 208. An approximate location and orientation of the distorter can also be estimated from this error contribution in block 210. FIG. 5 shows scissors 240 in an EM environment in the vicinity of a C-arm detector 244. The scissors' signature and the detector's signature can be identified in an overall EM field signature 249 by subtracting out the reference baseline (248) from the measured error and comparing the remaining signature to the distortion morphologies stored in the database (142)”).
Regarding claim 37, Ramachandran as modified by Loring and Besser above discloses all of the limitations of claim 36 as discussed above.
Ramachandran further discloses wherein the measuring of the changes in the electromagnetic field caused by the operation of the implanted device comprises identifying one or more characteristics of the interference (Ramachandran, Para 33-34; “Referring to FIG. 2 with continued reference to FIG. 1, a block/flow diagram for characterizing distorters such as tools, instruments or devices to create a fingerprint or EM signature associated with the distorters is illustratively shown. The fingerprint is preferably employed for estimating the distorter's location and orientation. In block 202, a distortion morphology (or reach) of any known object is characterized (fingerprint). EM signatures are generated using the EM generator 124 to create a field that is distorted by the object […] FIG. 4 illustratively shows an error map 248 for EM space in a “clean” environment. The clean environment represents a baseline reference EM field without distorters. In block 206, the measured error in the clean environment is compared to overall error (error combined from all sources) with one or more distorters in block 206. Error measured during a procedure (live with all the distortions, e.g., arising from a detector, table, tool, etc.) is compared with what was measured in the “clean environment” (no distortions). The variation between these two error maps permits finding what portion of the overall error is caused due to a distorter […] Each distorter's contribution may be identified in the overall error in block 208. An approximate location and orientation of the distorter can also be estimated from this error contribution in block 210. FIG. 5 shows scissors 240 in an EM environment in the vicinity of a C-arm detector 244. The scissors' signature and the detector's signature can be identified in an overall EM field signature 249 by subtracting out the reference baseline (248) from the measured error and comparing the remaining signature to the distortion morphologies stored in the database (142)”).
Regarding claim 39, Ramachandran as modified by Loring and Besser above discloses all of the limitations of claim 36 as discussed above.
Ramachandran further discloses wherein the receiving of the information regarding the implanted device comprises receiving information regarding the type of the implanted device, wherein the interference of the implanted device with the electromagnetic field is assessed based on the type of the implanted device (Ramachandran, Para 18-19; “The amount of error can be differentiated between expected distorters and the overall distortion to identify if a known distorter is present in the field. A flag or warning is raised if distortions are detected due to unknown distorters […] distortion fingerprinting is employed to characterize distortion morphology of known objects. After an initial calibration, the present system can, in conjunction with pre-calibrated sensors that dynamically measure errors, be employed to identify and localize the distorter. All distorters have a unique morphology and a varying reach to which the distorter distorts (due to varying morphology). This variable reach and variable distorting morphology may be leveraged to intra-operatively detect the location of the distorting element. A sparse set of pre-calibrated EM sensors, the expected distortion in a ‘clean’ environment and dynamic distortion induced on the sensors during the procedure may be employed to compute error contribution. Pre-computed morphology of the distorter (e.g., a detector) has its error ‘contribution’ computed at the measurement points. If the contribution is beyond an acceptable threshold, a warning may be raised. The amount of error can be differentiated from ‘expected’ distorters from that of the overall distortion”).
Regarding claim 40, Ramachandran as modified by Loring and Besser above discloses all of the limitations of claim 35 as discussed above.
Ramachandran does not clearly and explicitly disclose wherein the implanted device is a ventricular assist device.
In an analogous patient diagnostics field of endeavor Loring discloses wherein an implanted device is a ventricular assist device (Loring, Para 18-25; “The systems and methods disclosed herein provide a solution to electromagnetic interference (EMI) that can occur […] when a patient is simultaneously using a circulatory support device […] The LVAD can generate high-frequency noise artifacts […] to reduce electromagnetic interference produced by a circulatory support device 116 of the patient 102, resulting in a filtered signal”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ramachandran wherein the implanted device is a ventricular assist device in order assist patients with serious heart conditions as taught by Loring (Loring, Para 3) while accounting for their implant, which improves reliability and accuracy.).
Regarding claim 41, Ramachandran discloses a method for guiding insertion of an insertion tube into a patient (Ramachandran, Para 24; “sensing module 115 is configured to use EM signal feedback from EM sensing devices 104 to reconstruct EM space and track medical instruments or devices 102 […] A medical device or tool 102 may include an instrument […] Device 102 may include, e.g., a catheter, a guide wire, an endoscope, a probe, a robot, an electrode, a filter device, a balloon device, or other medical component, etc”; A PHOSITA would understand that the scope of the term endoscope fits within the broadest reasonable interpretation of the term insertion tube, additionally a PHOSITA would understand that many “other medical components” would include insertion tubes) comprising:
applying an electromagnetic field covering a torso of the patient (Ramachandran, Para 20; “In particular, the present principles are applicable to internal tracking procedures of biological systems, procedures in all areas of the body such as the lungs, gastro-intestinal tract, excretory organs, blood vessels, etc”) (Ramachandran, Para 25; “A field generator 124 is preferably installed in a vicinity of a patient or a target volume 150 so that the generator and the EM sensor or sensors 104 occupy a same environment. Sensing device 104 preferably includes one or more coils which are employed to detect of changes in EM field due to their movement. In this way, the coils of the sensors 104 permit tracking of instrument or device 102 relative to the patient and/or the tracking volume 150.”) (Ramachandran, Para 24; “In one embodiment, sensing module 115 is configured to use EM signal feedback from EM sensing devices 104 to reconstruct EM space and track medical instruments or devices 102. A medical device or tool 102 may include an instrument having an EM tracking sensor 104 mounted thereon or therein. Device 102 may include, e.g., a catheter, a guide wire, an endoscope, a probe, a robot, an electrode, a filter device, a balloon device, or other medical component, etc.”); utilizing an external electromagnetic field generator (Ramachandran, Para 25; “A field generator 124 is preferably installed in a vicinity of a patient or a target volume 150 so that the generator and the EM sensor or sensors 104 occupy a same environment”);
inserting into the patient the insertion tube; wherein the insertion tube comprises an electromagnetic sensor (Ramachandran, Para 24; “sensing module 115 is configured to use EM signal feedback from EM sensing devices 104 to reconstruct EM space and track medical instruments or devices 102 […] A medical device or tool 102 may include an instrument […] Device 102 may include, e.g., a catheter, a guide wire, an endoscope, a probe, a robot, an electrode, a filter device, a balloon device, or other medical component, etc”; A PHOSITA would understand that the scope of the term endoscope fits within the broadest reasonable interpretation of the term insertion tube, additionally a PHOSITA would understand that many “other medical components” would include insertion tubes), the electromagnetic sensor configure to cause changes in the electromagnetic field (Ramachandran, Para 26-27; “As described above, metallic objects and electronic equipment can produce distortions in local magnetic fields and influence readings of the EM sensors 104 […] System 100 may undergo training where the module 140 is employed to characterize distortion morphology (or reach) of any known object. Each object is characterized to measure its signature or fingerprint so that it may be identified in more general EM fields”); and
utilizing processing circuitry (Ramachandran, Para 24; “Memory 116 may store an EM sensing module 115 configured to interpret feedback signals from an EM sensing/tracking device 104. In one embodiment, sensing module 115 is configured to use EM signal feedback from EM sensing devices 104 to reconstruct EM space and track medical instruments or devices 102”) to:
receive signals relating to changes in the electromagnetic field, the changes caused by insertion of the insertion tube into the patient’s body (Ramachandran, Para 26; “As described above, metallic objects and electronic equipment can produce distortions in local magnetic fields and influence readings of the EM sensors 104. […] The module 140 is configured to characterize distortions, e.g., as a measurement of a signature or fingerprint of the field distortion created by tools or objects in or near the target volume 150 [...] The module 140 is configured to provide one or more of the following task identify distorters (objects), optimize or filter the distortions present to more accurately track or sense EM radiation, sense a change to the EM field, warn of EM field changes, etc”) (Ramachandran, Para 34; “Each distorter's contribution may be identified in the overall error in block 208. An approximate location and orientation of the distorter can also be estimated from this error contribution in block 210”) (Ramachandran, Para 35; “In this way, metallic distorters (like a surgical tool) or electronic devices which cause error in EM tracking can be identified within the EM field. If the type of distortion is known, the system can localize the position and orientation of the tool causing the distortion. This can account for the distorter and make EM tracking measurements more accurate or identify and eliminate the distorter from the environment altogether”);
receive information regarding an implanted device implanted into the patient (Ramachandran, Para 18; “Each distorter has a unique distortion morphology, for example, the distortion patterns from a C-arm detector are known to be very different from those of an ablation catheter.”) (Ramachandran, Para 35; “In this way, metallic distorters (like a surgical tool) or electronic devices which cause error in EM tracking can be identified within the EM field.”), wherein operation of the implanted device causes interference with the applied electromagnetic field (Ramachandran, Para 18; “The ability of a tool to produce distortions in an EM field varies and depends on its size, shape and the material it is composed of. Each distorter has a unique distortion morphology, for example, the distortion patterns from a C-arm detector are known to be very different from those of an ablation catheter. A database is created and stores distortion fingerprints of various known objects”) (Ramachandran, Para 26; “As described above, metallic objects and electronic equipment can produce distortions in local magnetic fields and influence readings of the EM sensors 104. The present principles provide an EM sensing correction module 140 that may include one or more features for reducing distortions in the environment surrounding the tracking volume 150. The module 140 is configured to characterize distortions, e.g., as a measurement of a signature or fingerprint of the field distortion created by tools or objects in or near the target volume 150 [...] The module 140 is configured to provide one or more of the following task identify distorters (objects), optimize or filter the distortions present to more accurately track or sense EM radiation, sense a change to the EM field, warn of EM field changes, etc”) (Ramachandran, Para 24; "Device 102 may include, e.g., a catheter, a guide wire, an endoscope, a probe, a robot, an electrode, a filter device, a balloon device, or other medical component, etc." A person having ordinary skill in the art would understand that operation of a catheter or a medical filter such as an IVC cause interference due the metallic materials in the device and operation of a catheter or a medical filter such as an IVC would include simply having it in place in the patient, additionally, the BRI of operation of a catheter would include inserting or removing the catheter, which would cause interference), and wherein the interference is caused by a pattern caused by the implanted device (Ramachandran, Para 41; “if EM tracking is being used for guided navigation, the system 200 could be used to perform comparisons of the distortions at the limited EM sensor positions with the pre-operative morphologies or patterns saved to the database”);
normalize the received signals relating to changes in the electromagnetic field caused by the insertion of insertion tube into the patient’s body, based on the information regarding the implanted device and based on the pattern characterizing the interference with the electromagnetic field (Ramachandran, Para 33; “In block 206, the measured error in the clean environment is compared to overall error (error combined from all sources) with one or more distorters in block 206. Error measured during a procedure (live with all the distortions, e.g., arising from a detector, table, tool, etc.) is compared with what was measured in the “clean environment” (no distortions). The variation between these two error maps permits finding what portion of the overall error is caused due to a distorter”; the published specification of the instant application describes normalization to include identifying the strength and pattern of the interference in paragraphs 65 and 71.) (Ramachandran, Para 33; “Referring to FIG. 2 with continued reference to FIG. 1, a block/flow diagram for characterizing distorters such as tools, instruments or devices to create a fingerprint or EM signature associated with the distorters is illustratively shown. The fingerprint is preferably employed for estimating the distorter's location and orientation. In block 202, a distortion morphology (or reach) of any known object is characterized (fingerprint). EM signatures are generated using the EM generator 124 to create a field that is distorted by the object”) (Ramachandran, Para 45; "by knowing the errors that are induced in the tracking volume due to known distorters, the generation or error maps can be employed to compensate for these known errors, thus increasing the accuracy as well as the confidence of a clinician while performing a procedure”) (Paragraph 65 of the instant specification lists steps of normalization that are analogous to these steps) , wherein the normalizing comprises:
identifying operation of the implanted device based the pattern characterizing the interference with the electromagnetic field caused by the implanted device (Ramachandran, Para 19; “distortion fingerprinting is employed to characterize distortion morphology of known objects. After an initial calibration, the present system can, in conjunction with pre-calibrated sensors that dynamically measure errors, be employed to identify and localize the distorter. All distorters have a unique morphology and a varying reach to which the distorter distorts (due to varying morphology)”) (Ramachandran, Para 33-34; “Referring to FIG. 2 with continued reference to FIG. 1, a block/flow diagram for characterizing distorters such as tools, instruments or devices to create a fingerprint or EM signature associated with the distorters is illustratively shown. The fingerprint is preferably employed for estimating the distorter's location and orientation. In block 202, a distortion morphology (or reach) of any known object is characterized (fingerprint). EM signatures are generated using the EM generator 124 to create a field that is distorted by the object […] FIG. 4 illustratively shows an error map 248 for EM space in a “clean” environment. The clean environment represents a baseline reference EM field without distorters. In block 206, the measured error in the clean environment is compared to overall error (error combined from all sources) with one or more distorters in block 206. Error measured during a procedure (live with all the distortions, e.g., arising from a detector, table, tool, etc.) is compared with what was measured in the “clean environment” (no distortions). The variation between these two error maps permits finding what portion of the overall error is caused due to a distorter […] Each distorter's contribution may be identified in the overall error in block 208. An approximate location and orientation of the distorter can also be estimated from this error contribution in block 210. FIG. 5 shows scissors 240 in an EM environment in the vicinity of a C-arm detector 244. The scissors' signature and the detector's signature can be identified in an overall EM field signature 249 by subtracting out the reference baseline (248) from the measured error and comparing the remaining signature to the distortion morphologies stored in the database (142)”) (Ramachandran; Para 26; "The characterization of these fingerprints is performed in advance of any procedure and the fingerprints or distortion morphologies are stored in a database 142 where the fingerprints measured in real-time are correlated with identities of the objects that created the fingerprints.”) (Ramachandran, Para 18; "The amount of error can be differentiated between expected distorters and the overall distortion to identify if a known distorter is present in the field. A flag or warning is raised if distortions are detected due to unknown distorters.") (Ramachandran, Para 31; "In another embodiment, the database 142 stores the fingerprints that characterize the distortion morphology of any known object or device. The pre-calibrated sensors 144 compare expected distortions in a clean environment (reference) to dynamically measured errors during a procedure. The distorter or combination of distorters and their contribution are identified in the overall error. The presence of any unknown distorters is detected. In the event that a new distortion is detected, a warning may be indicated on the display 118 or at the interface 120."); and
reducing or eliminating, from the received signals, disturbances caused by the implanted device (Ramachandran, Para 26; "As described above, metallic objects and electronic equipment can produce distortions in local magnetic fields and influence readings of the EM sensors 104. The present principles provide an EM sensing correction module 140 that may include one or more features for reducing distortions in the environment surrounding the tracking volume 150.") (Ramachandran, Para 30; "The errors detected and mapped can be error compensated for known distorters.") (Ramachandran, Para 44; "This provides the overall error map 307, which combines sensor data from the error map of the clean environment and the distortion morphology of the distorters. The error visualization is updated in real-time [...] The system 100 compensates for errors induced due to known distorters, e.g., in EM tracking sensing data.") (Ramachandran, Para 45; "In addition, by knowing the errors that are induced in the tracking volume due to known distorters, the generation or error maps can be employed to compensate for these known errors, thus increasing the accuracy as well as the confidence of a clinician while performing a procedure."), and
determine the position of the insertion tube based on the normalized signal (Ramachandran, Para 35; “In this way, metallic distorters (like a surgical tool) or electronic devices which cause error in EM tracking can be identified within the EM field. If the type of distortion is known, the system can localize the position and orientation of the tool causing the distortion. This can account for the distorter and make EM tracking measurements more accurate or identify and eliminate the distorter from the environment altogether”) (Ramachandran, Para 33; “Referring to FIG. 2 with continued reference to FIG. 1, a block/flow diagram for characterizing distorters such as tools, instruments or devices to create a fingerprint or EM signature associated with the distorters is illustratively shown. The fingerprint is preferably employed for estimating the distorter's location and orientation. In block 202, a distortion morphology (or reach) of any known object is characterized (fingerprint). EM signatures are generated using the EM generator 124 to create a field that is distorted by the object”).
Ramachandran does not clearly and explicitly disclose wherein the interference is characterized by a pattern caused by operation of the implanted device and characterizing the interference with the electromagnetic field caused by the operation of the implanted device.
In an analogous patient diagnostics field of endeavor Loring discloses wherein interference is characterized by a pattern caused by operation of an implanted device and normalizing signals based on based on the pattern characterizing the interference with the electromagnetic field caused by the operation of the implanted device (Loring, Para 18-25; “The systems and methods disclosed herein provide a solution to electromagnetic interference (EMI) that can occur […] when a patient is simultaneously using a circulatory support device […] The LVAD can generate high-frequency noise artifacts […] to reduce electromagnetic interference produced by a circulatory support device 116 of the patient 102, resulting in a filtered signal”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ramachandran to additionally account for situations wherein the interference is characterized by a pattern caused by operation of the implanted device and characterizing the interference with the electromagnetic field caused by the operation of the implanted device in order assist patients with serious heart conditions as taught by Loring (Loring, Para 3) while accounting for their implant, which improves reliability and accuracy.
Ramachandran does not clearly and explicitly disclose marking one or more anatomical locations on the patient’s torso utilizing a registration sensor; and generating an anatomical map of the patient's torso or match the patient's torso to a predefined anatomical map, based on the at least one anatomic location marked by the registration sensor; showing on the map a path of the insertion tube; based on changes in the normalized signal.
In an analogous insertion device positioning guidance system field of endeavor Besser discloses marking one or more anatomical locations on a patient’s torso, utilizing a registration sensor (Besser, Para 39; “a registration sensor configured to mark at least a first and a second anatomic locations relative to the reference coordinate system”); generating an anatomical map of the patient's torso or match the patient's torso to a predefined anatomical map, based on the at least one anatomic location marked by the registration sensor (Besser, Para 39; “processing circuitry configured to operate said field generator, read signals obtained from said the plate sensor, said reference sensor and said registration sensor, calculate a position and orientation thereof relative to said field generator, generate an anatomic map representing the torso of the subject and the first and second anatomic locations”); and showing on the map a path of an insertion tube (Besser, Para 38-39; “Disclosed herein is a system and method for guiding insertion of an insertable medical device (e.g., a tube, such as a feeding tube) […] processor/processing circuitry is further configured to facilitate visualization on the anatomic map of a position, orientation and path of a tip sensor, located in a distal tip section of the insertion device”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ramachandran to include marking one or more anatomical locations on the patient’s torso utilizing a registration sensor; generating an anatomical map of the patient's torso or match the patient's torso to a predefined anatomical map, based on the at least one anatomic location marked by the registration sensor; and showing on the map a path of the insertion tube based on changes in the normalized signal in order to make the insertion procedure considerably easier and safer, and ensuring that the insertion tube is inserted at a correct location as taught by Besser (Besser, Para 38-39).
Regarding claim 42, Ramachandran as modified by Loring and Besser above discloses all of the limitations of claim 41 as discussed above.
Ramachandran further discloses wherein the receiving of the information regarding the implanted device comprises measuring changes in the electromagnetic field caused by the operation of the implanted device in the absence of the insertion tube, relative to a baseline electromagnetic field measured in the absence of the implanted device (Ramachandran, Para 33-34; “Referring to FIG. 2 with continued reference to FIG. 1, a block/flow diagram for characterizing distorters such as tools, instruments or devices to create a fingerprint or EM signature associated with the distorters is illustratively shown. The fingerprint is preferably employed for estimating the distorter's location and orientation. In block 202, a distortion morphology (or reach) of any known object is characterized (fingerprint). EM signatures are generated using the EM generator 124 to create a field that is distorted by the object […] FIG. 4 illustratively shows an error map 248 for EM space in a “clean” environment. The clean environment represents a baseline reference EM field without distorters. In block 206, the measured error in the clean environment is compared to overall error (error combined from all sources) with one or more distorters in block 206. Error measured during a procedure (live with all the distortions, e.g., arising from a detector, table, tool, etc.) is compared with what was measured in the “clean environment” (no distortions). The variation between these two error maps permits finding what portion of the overall error is caused due to a distorter […] Each distorter's contribution may be identified in the overall error in block 208. An approximate location and orientation of the distorter can also be estimated from this error contribution in block 210. FIG. 5 shows scissors 240 in an EM environment in the vicinity of a C-arm detector 244. The scissors' signature and the detector's signature can be identified in an overall EM field signature 249 by subtracting out the reference baseline (248) from the measured error and comparing the remaining signature to the distortion morphologies stored in the database (142)”).
Regarding claim 43, Ramachandran as modified by Loring and Besser above discloses all of the limitations of claim 42 as discussed above.
Ramachandran further discloses wherein the measuring of the changes in the electromagnetic field caused by the operation of the implanted device comprises identifying one or more characteristics of the interference (Ramachandran, Para 33-34; “Referring to FIG. 2 with continued reference to FIG. 1, a block/flow diagram for characterizing distorters such as tools, instruments or devices to create a fingerprint or EM signature associated with the distorters is illustratively shown. The fingerprint is preferably employed for estimating the distorter's location and orientation. In block 202, a distortion morphology (or reach) of any known object is characterized (fingerprint). EM signatures are generated using the EM generator 124 to create a field that is distorted by the object […] FIG. 4 illustratively shows an error map 248 for EM space in a “clean” environment. The clean environment represents a baseline reference EM field without distorters. In block 206, the measured error in the clean environment is compared to overall error (error combined from all sources) with one or more distorters in block 206. Error measured during a procedure (live with all the distortions, e.g., arising from a detector, table, tool, etc.) is compared with what was measured in the “clean environment” (no distortions). The variation between these two error maps permits finding what portion of the overall error is caused due to a distorter […] Each distorter's contribution may be identified in the overall error in block 208. An approximate location and orientation of the distorter can also be estimated from this error contribution in block 210. FIG. 5 shows scissors 240 in an EM environment in the vicinity of a C-arm detector 244. The scissors' signature and the detector's signature can be identified in an overall EM field signature 249 by subtracting out the reference baseline (248) from the measured error and comparing the remaining signature to the distortion morphologies stored in the database (142)”).
Regarding claim 45, Ramachandran as modified by Loring and Besser above discloses all of the limitations of claim 42 as discussed above.
Ramachandran further discloses wherein the receiving of the information regarding the implanted device comprises receiving information regarding the type of the implanted device, wherein the interference of the implanted device with the electromagnetic field is assessed based on the type of the implanted device (Ramachandran, Para 18-19; “The amount of error can be differentiated between expected distorters and the overall distortion to identify if a known distorter is present in the field. A flag or warning is raised if distortions are detected due to unknown distorters […] distortion fingerprinting is employed to characterize distortion morphology of known objects. After an initial calibration, the present system can, in conjunction with pre-calibrated sensors that dynamically measure errors, be employed to identify and localize the distorter. All distorters have a unique morphology and a varying reach to which the distorter distorts (due to varying morphology). This variable reach and variable distorting morphology may be leveraged to intra-operatively detect the location of the distorting element. A sparse set of pre-calibrated EM sensors, the expected distortion in a ‘clean’ environment and dynamic distortion induced on the sensors during the procedure may be employed to compute error contribution. Pre-computed morphology of the distorter (e.g., a detector) has its error ‘contribution’ computed at the measurement points. If the contribution is beyond an acceptable threshold, a warning may be raised. The amount of error can be differentiated from ‘expected’ distorters from that of the overall distortion”).
Regarding claim 46, Ramachandran as modified by Loring and Besser above discloses all of the limitations of claim 41 as discussed above.
Ramachandran does not clearly and explicitly disclose wherein the implanted device is a ventricular assist device.
In an analogous patient diagnostics field of endeavor Loring discloses wherein an implanted device is a ventricular assist device (Loring, Para 18-25; “The systems and methods disclosed herein provide a solution to electromagnetic interference (EMI) that can occur […] when a patient is simultaneously using a circulatory support device […] The LVAD can generate high-frequency noise artifacts […] to reduce electromagnetic interference produced by a circulatory support device 116 of the patient 102, resulting in a filtered signal”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ramachandran wherein the implanted device is a ventricular assist device in order assist patients with serious heart conditions as taught by Loring (Loring, Para 3) while accounting for their implant, which improves reliability and accuracy.
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Ramachandran, Loring, and Besser as applied to claim 28 above, and further in view of Levine et al. (US20060030771, hereafter Levine).
Regarding claim 47, Ramachandran as modified by Loring and Besser above discloses all of the limitations of claim 28 as discussed above.
Ramachandran does not clearly and explicitly disclose wherein the processing circuitry is configured to receive the information regarding the implanted device directly from the implanted device.
In an analogous electromagnetic tracking system for an implanted medical device field of endeavor Levine (Levine, Para 1; “The present invention generally relates to an electromagnetic tracking system”) discloses receiving information regarding an implanted device directly from the implanted device (Levine, Para 33; “Transmitter 12 can be attached or embedded in the medical device at the point of interest”) (Levine, Para 40; “Transmitter 12 may also transmit information other than P&O and/or telemetry. For example, transmitter 12 may transmit a signal including a unique identifier to receiver 14. The identification signal may include information or data related to the instrument or implant to which transmitter 12 may be attached. For example, transmitter 12 may broadcast a signal that identifies a type of guidewire to which transmitter 12 is attached. The identification information may include any information useful to discern a type of instrument or implant or an identity of a manufacturer, patient or host, for example. The identification signal may be created by circuitry external to transmitter 12, as described above, or the identification signal may be unique to the data. For example, an identification signal used to identify an implant created by a first manufacturer may differ in any one of frequency or amplitude from an implant created by a second manufacturer”) (Levine, Para 36; “Transmitter 12 may broadcast P&O information (or any other information, as described below) continuously”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ramachandran wherein the processing circuitry is configured to receive the information regarding the implanted device directly from the implanted device in order to allow for an accurate, reliable, and easy to use system for tracking and identification of devices as taught by Levine (Levine, Para 17) which can be used to verify the identifications of the devices from the EM distortions.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JOHN D LI/Primary Examiner, Art Unit 3798
